Shoukhrat Mitalipov and his research team at Oregon Health and Science University (OHSU) are back in the news with a big announcement: They have become the first scientists to create human embryonic stem cells using a cloning technique called somatic cell nuclear transfer or SCNT. Scientists have been unsuccessfully attempting this feat for over a decade; indeed, many had given up in favor of work with induced pluripotent stem (iPS) cells. The success raises questions about which kind of stem cells will drive research on regenerative medicine, as well as significant concern about human reproductive cloning and the use of women’s eggs that cloning requires.
Mitalipov and his team were recently in the news for their research on mitochondria replacement techniques, which raises serious concerns because it involves a form of inheritable human genetic modification. The media however paid more attention to yesterday's announcement. The cloning paper, published in Cell on Wednesday, prompted a range of assessments. It was called a “landmark” discovery here and here, but scientists quoted here and here were far more restrained.
A stem-cell showdown
Much of the news coverage reflects surprise that scientists are still investigating cloning techniques at all, since iPS cells appear to provide disease-specific and patient-specific lines while avoiding many of the technical difficulties and ethical quandaries of SCNT. Unlike cloning-derived ESCs, iPS cells don’t necessitate the retrieval of eggs from women, or the production of cloned embryos that could be misused in efforts at reproductive cloning. Understandably, many comparisons are now being made between the two methods (Nature called it a “showdown”).
New Scientistreported that tissues made with iPS cells have tended “to accumulate mutations and suffer abnormal patterns of gene activation.” But not everyone is convinced that making stem cells through cloning will soon – if ever – become medically useful. Carolyn Johnson at the Boston Globecommented that “the discovery would no doubt be a bigger deal if in 2007, scientists had not discovered that there was a different, simpler way to create stem cells that bear a patient’s own genome and are pluripotent, possessing the capacity to develop into any of the myriad cells and tissues in the body.” David Brown of the Washington Post also noted that “few experts think that production of stem cells through cloning is likely to be medically useful soon, or possibly ever,” and quoted MIT biologist Rudolf Jaenisch’s opinion that the study “has no clinical relevance.”
George Daley, a stem cell expert at Children’s Hospital Boston, notes that, “it’s essential to compare the cells from the two methods.” According to Nature, Mitalipov and his team are already doing exactly that – conducting a study of comparisons between iPS and SCNT cells derived from the same donor cell. There will certainly be ongoing updates on this front.
Reproductive human cloning?
The Center for Genetics and Society raised the issue of human reproductive cloning in a press statement, and pointed out that the United States – unlike some 60 other countries – still has no federal prohibition against it. “If we're going to be having cloned embryos in laboratories around the country, said CGS’s Marcy Darnovsky, “we really need to get our act together and have a law that prohibits human reproductive cloning.” GenomeWeb picked up this argument here, and NPR looks at the prospects on the policy landscape here.
Many other news outlets also voiced concern that the SCNT work could be used to attempt reproductive human cloning. Paul Knoepfler provides a useful diagram that illustrates the “elephant in the room” of the close relationship between research and reproductive cloning. He acknowledges that cloned babies will not “be bouncing out all over the place anytime now,” but says that “yesterday’s story does of course relate to human reproductive cloning and it is a real, deeply serious concern longer term. Some crazy person will try to clone humans.” Dr David King of Human Genetics Alert raises similar points and says that the OHSU research is an "irresponsible" project that has created "the baby that would-be human cloners have been waiting for: a method for reliably creating cloned human embryos".
Mitalipov’s team is understandably eager to dissociate their work from the possibility of reproductive cloning. Nature reports, “Mitalipov has tried without success for more than a decade to produce a monkey by cloning. [Co-author] Tachibana says that an upcoming publication will explain why reproductive cloning of humans is not possible using their SCNT technique.” Professor Robin Lovell-Badge, head of developmental genetics at the National Institute for Medical Research, similarly reiterates that years of cloning work with animals has affirmed that it would be unsafe to try in humans, so: “For this reason alone it should not be attempted."
More demand for women’s eggs?
Relatively few news stories explored how the SCNT success might affect the demand for women’s eggs and the health of the women who undergo invasive procedures to provide them, though a number mentioned that Mitalipov’s work used fewer eggs than previous cloning experiments. As Chris Mason of University College London told New Scientist, "Mitalipov clearly has very high efficiency ... However, it still boils down to needing to get human eggs."
Payments to women who provide eggs for research are controversial because of concerns that they encourage women to overlook the significant health risks of egg retrieval. Many women’s health advocates point out that because follow-up studies on egg retrieval have been so inadequate, getting “informed consent” to take the risks is challenging if not impossible.
Another troubling aspect of the OHSU study is that at least five of the authors of the Cell article work as practicing reproductive endocrinologists, raising concern that some may have themselves overseen the egg retrieval procedures. It is therefore unclear whether the study followed the recommendations of the International Society for Stem Cell Research that in order to avoid conflicts of interest, “wherever possible, the treating physician or infertility clinician should not also be the investigator who is proposing to perform research on the donated materials” [pdf].
The OHSU study reports some troubling findings about egg retrieval protocols, including the fact that one of the hormonal drugs typically used for ovarian stimulation results in “sub-optimal quality oocytes,” and that “premium quality” eggs are produced when fewer are retrieved in a stimulated cycle. This suggests that the hyper-stimulation protocols frequently used in fertility procedures are not only dangerous for the women who undergo them, but may also be hazardous to the health of their prospective children.
As the CGS press statement points out, these adjustments to standard IVF protocols “were made in order to obtain ‘optimized’ eggs for research, not to protect women from adverse effects” of egg retrieval. The focus, ironically, is “on the quality of the eggs, not on the well-being of the women.”
Jason Richwine was forced to resign from the Heritage Foundation by a media storm about his offensive comments on race and IQ. That's remarkable, and perhaps significant, but there are likely more and bigger headlines to come.
The background in brief: Richwine co-authored a Heritage position paper titled "The Fiscal Cost of Unlawful Immigrants and Amnesty to the U.S. Taxpayer," clearly published to oppose immigration reform.The paper was unwelcome to all but right-wing extremists, for various reasons, and it soon came out that Richwine's 2009 doctoral thesis included such statements as (on p. 66):
No one knows whether Hispanics will ever reach IQ parity with whites, but the prediction that new Hispanic immigrants will have low-IQ children and grandchildren is difficult to argue against.
His dissertation proceeded to explore "the proposition that immigration policy should select for IQ" (p. 123). That wasn't explicitly in the Heritage study, but it certainly provided a handy cudgel. The report was released on Monday May 6, his thesis was reported on Wednesday, and he "resigned" on Friday. One of Richwine's mentors was Charles Murray, of The Bell Curve infamy, who promptly tweeted:
Thank God I was working for Chris DeMuth and AEI, not Jim DeMint and Heritage, when The Bell Curve was published. Integrity. Loyalty. Balls.
From Murray's perspective, he has a point. For the rest of us, it's actually heartening that such opinions have become toxic. And the dust-up has provoked some insightful commentary (e.g., Ta-Nehisi Coates at The Atlantic, Ari Rabin-Havt at Media Matters, Diego von Vacano at The Monkey Cage).
However, it's also important to note that "respectable" politicians have always been willing to jettison those that go too far. William Shockley, for instance, was effectively shunned in the 1970s, but Murray and Richard Herrnstein had no trouble putting their work into the public sphere in the 1990s. And indeed the backlash to the backlash may already be starting, as Andrew Sullivan (who, as editor of The New Republic, published excerpts from The Bell Curve) detects "red flags about intellectual freedom."
Race and IQ may now be a dangerous combination, but the combination of genetics and IQ is definitely on the rise. China's BGI has for a while been running a research project on "genius genes," headed by Zhao Bowen, who claimed in February that it would produce results in three months. That would be now. Well, we don't have the data or the analysis, but we are seeing a burst of publicity.
An article in the London Times on May 14 (unrelated to the news about Richwine) includes more caveats than previously:
"The reality is that the genomics of IQ will be much more complex than saying: 'Look, here are the genes for genius.' We will be talking about hundreds, possibly thousands of genes and mutations, each with a tiny effect on IQ. Will someone somewhere want to try to engineer intelligence in embryos? Will someone claim they can make your unborn child more intelligent? Of course they will. But it's not technically possible now and won't be for decades," Zhao says.
Sure. But the caption to one of the accompanying photos reads:
If Zhao Bowen discovers the intelligence gene, he may be able to determine a baby's IQ from a blood sample
A simultaneous article in Nature News says that the project "is slated to begin data analysis in the next few months." It reports that BGI is "halfway through its sequencing" but the rest of the work might take as long as a year. It also includes a noteworthy comment from Harvard geneticist Daniel MacArthur:
If they think they're likely to get much useful data out of this study, they're almost certainly wrong.
That's likely true—but no real reason for comfort. The researchers will find something. And someone will abuse the findings. History tells us that's a given. The fallacy may not be that Hispanics (who, ahem, are a cultural community not a race) are dumb, or Jews (essentially a religious group) are smart, or Asians (a broad geographical set) are good at math, or any such nonsense. But suggesting that this embryo has brilliance while this one does not … that could become a very significant problem.
Talking Biopolitics began in 2011 with webinars on synthetic biology and assisted reproductive technologies. It continued in 2012 with interviews of Bill McKibben, Dorothy Roberts, and Harriet Washington. We are excited to announce that Talking Biopolitics is back for 2013, featuring conversations with Miriam Zoll, George Estreich, Ruha Benjamin, and Donna Dickenson that are open and free for everyone.
Each of these cutting-edge thinkers has recently published a book that engages with different facets of the challenges raised by human biotechnologies. They address provocative questions about assisted reproduction, personalized medicine, prenatal gene sequencing, stem cell research, and much more. Their work provides invaluable insights into the new biopolitics we need.
The 2013 series kicks off on May 21 with a live web interview by the Center for Genetics and Society’s Associate Executive Director Diane Tober of Miriam Zoll, award-winning writer and international public health and reproductive rights advocate. Miriam’s new book, Cracked Open: Liberty, Fertility and the Pursuit of High Tech Babies, gives a moving and unblinking account of the emotional anguish, health complications, ethical quandaries and financial costs of her own fertility journey. She also delivers vital insights into the consequences of our failure to adequately understand and regulate the business of assisted reproduction. Find more information and RSVP here.
The second event on June 3 features George Estreich, who will be interviewed by the Longmore Institute on Disability’s Emily Beitiks. George’s book, The Shape of the Eye: A Memoir, is an award-winning account of his family and life with daughter Laura, who has Down syndrome. He asks how the new non-invasive fetal gene tests are affecting women’s experiences of pregnancy and childbearing, and how they might change our personal and social feelings about disabilities such as Down syndrome. The Shape of the Eye is a powerful and moving contemplation of what it means to be human and what it means to be different. Find more information and RSVP here.
In the third event on June 25, CGS Executive Director Marcy Darnovsky interviews Ruha Benjamin, assistant professor of Sociology and African American studies at Boston University. Ruha’s new book, People’s Science: Bodies and Rights on the Stem Cell Frontier, delves into stem cell research, arguing that public engagement must be considered in controversial scientific advances. She particularly advocates for the voices of people with disabilities, African Americans, and women, showing that citizens have the power to influence science, and not merely the other way around. Find more information and RSVP here.
On July 16, we hear from author, activist and scholar Donna Dickenson, interviewed by Osagie Obasogie, Senior Fellow at CGS and Associate Professor of Law at the University of California, Hastings. Donna’s new book, Me Medicine vs. We Medicine: Reclaiming Biotechnology for the Common Good, is an essential read for anyone trying to make sense of personalized medicine. She makes a powerful case for taming "me-centeredness" and market domination of medicine, and for renewing our commitments to public health and the common good. Find more information and RSVP here.
Posted by Gina Maranto, Biopolitical Times guest contributor on May 9th, 2013
The print edition of the May 4/5 issue of the Wall Street Journal devoted almost two full pages to a piece by Sarah Elizabeth Richards, author of the new book from Simon & Schuster, Motherhood Rescheduled, published May 7. They also ran an accompanying piece by Christine Rosen, senior editor of the New Atlantis, on "The Ethics of Egg Freezing," but gave it so little space it seemed like an afterthought. (The online versions are here and here.)
Richards' piece, accompanied by a huge photograph, spanned the whole front page of the Review section, and most of page 2. The visual rhetoric suggested nothing so much as triumphalism: Richards is posed in ¾ frontal position standing against a black background wearing a scarlet sweater and camisole set matched by her fingernail polish. On her face is a look of either bemusement or smugness, or maybe both. She's looking offstage with steely eyes and the fingers of her left hand clutch a white stuffed lamb by the belly—rather too tightly for the lamb's comfort, it seems to me. In white type, the caption reads, "It was the best investment I ever made.” That investment was having her eggs retrieved and cryopreserved.
The headline is pure sales: “Why I Froze My Eggs (And You Should, Too),” while the pull quote under it invokes both present and past discourses regarding working women: “Amid the talk of ‘leaning in,’ and ‘having it all,” we’ve ignored the most powerful gender equalizer.” The first allusion suggests that Richards thinks she can go Cheryl Sandberg one better. The second allusion seems dated, but introduces the essential element of childbearing, which is, after all, Richards’ paramount goal.
Now, Richards says, women can achieve biological parity with men by using technology to provide themselves with the reproductive equivalent of a time machine: their bodies might be old, but their frozen eggs will be forever younger. The implication is that in the business arena, the only thing that matters is being able to compete in one's youth—to fight it out on the lower corporate rungs, where the battle is most intense, in order to rise in the ranks. Only then can one take a breath and think about one's personal life. Richards buys into this world view, and in the process, renders motherhood just one more CV item.
The lack of sentimentality in Richards’ whole description of the enterprise of freezing eggs is pronounced: that cuddly little lamb, clutched so tightly, seems to advertise that a desire for motherhood should not be confused with having warm and fuzzy feelings (those might render one vulnerable in the workplace, after all). Richards discloses some emotional responses regarding her quest to freeze her eggs, but they have mostly to do with control: when she awakes from an egg retrieval procedure she feels heartened, but she also feels empowered, freed of the "punishing pressure to seek a new mate." (At least in this piece, Richards never mentions the possibility of single parenthood and frequently invokes online dating.) The tales she recounts of other women who have also frozen their eggs read like descriptions of partners in some supply chain relationship ensuring that a product moves to market.
At the same time, Richards is singularly naïve in her acceptance of the rationales and arguments offered by the industry. She cites the American Society of Reproductive Medicine’s recent recategorization of egg freezing as non-experimental without mentioning that ASRM is referring to medical applications (such as chemotherapy) and explicitly disagrees with her:
“Marketing this technology for the purpose of deferring childbearing may give women false hope and encourage women to delay childbearing. Patients who wish to pursue this technology should be carefully counseled.”
Richards deploys straw men, such as an argument supposedly advanced by "critics of 'social freezing' ... that biological deadlines serve a purpose in life: Without them, a woman would have little incentive to sit through dozens of Match.com dates to find a partner and father for her children.” Surely, no reputable critic of egg freezing has suggested that oocytes evolved the way they have in order to ensure that women would get with the program and take mating seriously.
In fact, critics have challenged the procedure on numerous grounds, including risks involved in egg retrieval, side effects from the drugs used to stimulate the ovaries to produce multiple eggs, potential complications from the surgical removal of the ripened eggs, and possible development of ovarian hyperstimulation syndrome. Christine Rosen mentions other legitimate criticisms in her piece on ethics, including the ways in which “egg freezing could undermine arguments for greater workplace accommodation and flexibility for women and children,” and the ways in which egg freezing furthers the march toward ever more manipulation of human eggs, sperm, and embryos under the neo-eugenic banner.
Posted by George Estreich, Biopolitical Times guest contributor on May 9th, 2013
If our entertainments reveal what’s on our collective minds, then we seem to be thinking quite a bit about human modification. Spider-Man, X-Men, the Aaron Cross of the most recent Bourne thriller: all have powers, and all are genetically different, whether bitten, mutated, or engineered.
The Twilight books, and their subsequent movie adaptations, aren’t usually thought of in this vein. But despite the air of romance, Stephenie Meyer’s four-book series, in which a human girl (Bella) falls in love with a pale yet hot vampire boy (Edward) is really about superheroes. And like the hyphenated superheroes of recent movies, Meyer’s vampires are genetically different: they have a superabundance of chromosomes. (The vampires have twenty-five pairs, unlike our twenty-three.)
In our fang-free human life, having extra chromosomes is not usually seen as a plus. Aneuploidies, including Down syndrome, have been targets of prenatal testing as long as such testing has existed. As such, those conditions attract a host of polarizing questions, not least about abortion. In Breaking Dawn—the last book in the Twilight series—these questions come to the fore. Bella, still a mortal, becomes pregnant with a half vampire child thought to be a risk to her life, and a danger to the society around her. Edward wants her to abort, and she wants to keep the child.
The quarrel, and indeed the book, is framed by genetics. The high chromosome count signifies both ultimate superpower (in the case of the vampires) and the undesirable child (in the case of Bella’s fetus). The Twilight series, in other words, evokes both our fears about human modification and our anxieties about reproduction.
Today marks the nine-year anniversary of 26-year-old Dan Markingson's premature death. His story, covered previously here at Biopolitical Times, illustrates the medical-industrial complex at its worst: greedy university professors who put pharma profits before their patients' well-being, combined with ongoing institutional support from the University of Minnesota.
Many alumnae, myself included, have declared our disappointment at our alma mater. And recently, a number of important people of international reach have been motivated by Markingson's story and are demanding justice on his behalf. A change.org petition, initiated by Markingson's friend Mike Howard, implores Minnesota Governor Mike Dayton to investigate the case. Despite ongoing efforts by the U of M to bury the issue, advocates for Markingson continue to demand answers and are gaining increasing support.
High-profile signatures have already come from:
three former editors of the New England Journal of Medicine
Vera Sharav, the founder of the Alliance for Human Research Protection
and many other prominent bioethicists, health practitioners, academics, and community members (see the list here).
I encourage Biopolitical Times readers to learn more about Markingson's story. If you do, you will almost certainly want to sign the petition.
It’s important to bring attention to this issue to help prevent further cases like it. But equally important, the petition helps honor the memory of Dan Markingson, a real person, not just a symbol, whose family is hurting deeply today.
With political dividing lines carved deep into the collective consciousness, wading through the ethical minefield of embryo creation and destruction is a challenge. A recent New England Journal of Medicine (NEJM) article, “Made-to-Order Embryos for Sale — A Brave New World?” by I. Glenn Cohen and Eli Y. Adashi tackles the controversial issue of for-profit embryo creation. Possibly in an attempt to come out on a particular side of the political line, it sweeps what is truly novel about the practice under the rug.
The issue gained prominence last November, when the Los Angeles Timescovered a Davis fertility clinic, California Conceptions, and their falsely named Donated Embryo Program. “Donated embryos” typically refer to the gift of embryos left over from a couple’s IVF procedure to another, infertile couple. The embryos belong to the people whose gametes created them, and they make the decision about whether, when and to whom they should be given.
What California Conceptions does is completely different: It creates batches of embryos from donated sperm and eggs, keeps them in an embryo bank on site, and divvies them up to sell to multiple parties for a profit. As the LA Times reporter put it, “The clinic, not the customer, controls the embryos, typically making babies for three or four patients while paying just once for the donors and the laboratory work.”
The news about California Conceptions’ program caused a surge of public outrage (well chronicled here by Dr. Craig Sweet, medical and practice director of Embryo Donation International.) Andrew Vorzimer, a Los Angeles fertility lawyer said,
Make no mistake, this is commodification. These are not donated embryos. Rather, they are embryos created from donors hand-selected by California Conceptions. It is one step removed from a mail order catalog. The only difference is that the product being sold is nascent human life.
Cohen and Adashi do not share this concern. They compare the practice of creating and selling embryos to the sale of gametes and to the use of gametes and embryos for stem cell research. They conclude that, “viewed through a legal and ethical lens, the concerns raised by this potentiality appear to be similar to those associated with widely accepted and more common reproductive technologies.”
But made-to-order embryos present a different set of questions. Reverting to the reasoning behind other technologies or practices does not address what is troubling about this.
For example, they make the argument that embryo destruction for the purpose of stem cell research raises concerns about “respect for personhood” comparable to those raised about “made-to-order” embryos. But this is only the case if you believe that embryos inherently have a claim to personhood. If you do not share this view, then the authors are leaving out the crucial difference: the embryos used for stem cell research will never become people. However, the creation of an embryo that is implanted into a woman (with a pregnancy-or-your-money-back guarantee) is about “respect for personhood” because it turns actual nascent life into a commodity, sold for a profit just like any other.
That is what is unique about this practice. But the NEJM article dismisses this and concludes that there is really only one important difference: “the lack of clear legal guidance as to the parentage of the embryos in question.”
“Parentage” is plainly not the real issue. As is the norm with gamete donation, the sperm and egg donors that were used to create the embryo would not be likely to have any claim to parenthood. The embryos will actually not have any kind of “parentage” at all. They will rather be owned by the fertility clinic, until a woman implants one into her womb.
California Conceptions markets their service as cheaper than using third-party eggs and IVF, and less time consuming than adoption. But it’s important to note that along with the heightened element of commodification, an additional imperative for “design” has seeped into their approach. To offset their costs, they have to produce embryos that multiple couples will find desirable as products. Cohen and Adashi may not find these “eugenic overtones” worrying, but acknowledging their existence is telling enough.
There is no federal law governing the sale of embryos and Cohen and Adashi note that it “appears to be legal in all but two states.” Indeed, this was the justification offered by Jennalee Ryan, who gained notoriety several years ago after advertising “the world’s First Human Embryo Bank” online. That turned out to be a failed business plan, run from her living room, but she explained, “You know how it works? If there is no law against it, it’s legal.”
It’s one thing for eccentric business entrepreneurs to try to exploit a poorly regulated system. The fact that established scholars have made the case that we should accept selling embryos as ethical is much more troubling.
A bill being considered in the California legislature would allow researchers to pay women cash for their eggs. If passed, it would overturn established policies including guidelines from the National Academy of Sciences, the rules of the California stem cell agency, and a 2005 California law authored by then-state Senator Deborah Ortiz, known as a champion of women’s health and medical research. All these policies state that women who undergo egg retrieval for research can be compensated for their expenses, but not paid beyond that.
The new bill, AB 926, is sponsored by the American Society for Reproductive Medicine, which instigated the proposed legislation and is lobbying hard for it. Misleadingly worded to suggest that the bill promotes equity for women by offering “fair compensation,” the bill is really about trying to increase the number of eggs for research—where there is a perceived “shortage” of eggs and competition with the infertility industry—and has nothing to do with a concern for women. AB 926 in fact would have serious short-term and long-term health implications for women, especially college-age and low-income women, who may be enticed to put themselves at risk by selling their eggs out of financial need.
A fact sheet by the bill’s author, Assembly member Susan Bonilla, argues that women who provide eggs for research should be “treated equally to all other research subjects.” But these women are not at all like traditional research subjects in clinical trials. Their reactions to experimental drugs or procedures are not under study. Nor are the researchers in this situation investigating the health implications of egg retrieval. Instead, they are seeking raw material—women’s eggs—for their work.
Further, if researchers are paying thousands of dollars for each cycle of egg retrieval, they will likely be tempted to try to obtain as many as possible from each woman, and may consciously or sub-consciously make decisions from an economic position. Unfortunately, the more eggs retrieved in a procedure, the greater the risks to women’s health.
Although many women undergo egg retrieval for their own or other people’s fertility treatment, the procedure involves high doses of powerful hormones, some of them being used off label, and carries risks that are both significant and under-studied. Despite efforts by women’s health advocates, follow-up studies to determine the procedure’s effects on women are inadequate. Attempts to encourage assisted reproduction clinics to take part voluntarily in a registry of women who have undergone egg retrieval have mostly been ignored by the fertility industry. Without that information, women cannot possibly make an informed decision about the safety of providing eggs even for fertility treatment, let alone for research purposes.
AB 926 claims to be motivated by concerns for women’s equity and for advancing responsible medical research. Those are worthy goals. But, unfortunately, this bill undermines both.
Current status of the bill: AB 926 was passed by the Assembly Health Committee on April 16. It will go next either to the Appropriations Committee or straight to the Assembly floor. If approved by the Assembly, it will go to the Senate, where it will be voted on again.
Last week, some 15 French activists in chimpanzee masks disrupted a Forum on Synthetic Biology at the National Center for Arts and Crafts in Paris. This was the first public event held by the "Observatoire de la biologie de synthèse," a body set up by the government to monitor and debate the technology and its social implications. The meeting was effectively shut down. The only reports available are in French (by protesters here, by organizers here) but this placard speaks for itself:
To participate is to accept
I have to admit, my first reaction to seeing pictures of this protest was to laugh out loud and cheer. It's easy to agree with slogans such as "Non à la Vie Synthetique." (Translation is inexact but that's roughly "No to Living Synthetically.")
But are they right to claim that to engage in debate over how to implement synthetic biology is to concede the thin end of the wedge — to trade in your principles for a seat at the table — or is this counter-productive flamboyance?
In this particular case, critics of synthetic biology have in fact been part of the private discussions that preceded this public event. I have no idea if they managed to change the dynamic or to raise significant questions in the minds of civil servants, let alone representatives of industry. But the reaction to this disruption might be to drive all discussion away from public view, and it's hard to see how that could be helpful.
Conversely, it is vital that policymakers understand the depth of feeling on the issue. Opinion polls tell a nuanced story, according to research conducted by the Wilson Center (abstract here). The public is skeptical, and capable of making fine distinctions. But that doesn't mean that industry can rely on passive acquiescence by any means. The kind of drama enacted in Paris does show that opposition is not only mild and general but also intense. That's worth something.
The relationship between campaigners and negotiators is often fraught with suspicion, as a couple of other current controversies illustrate. Some of those who worked hard on California's GM labeling proposition last year are skeptical about the value of the new federal labeling bill (which the Center for Food Safety is supporting). Will it "pre-empt anything any of the states will be doing?", one asked me in a private communication. Will the big food companies make sure that "any federal bill passed will be way gutted"? Such cynicism is easy to understand, and important to factor into activist strategizing.
By coincidence, I just received an announcement from the Global Justice Ecology Project (GJEP), which works at multiple levels, nationally and internationally, to stand up for native forests and promote climate justice, among other issues. The latest email was about the Stop GE Trees Campaign, which includes planned public protest at the the Tree Biotechnology 2013 Conference in Asheville at the end of May.
We are kicking off the week with a teach-in on May 27 followed by a mass march to the conference center on May 28th. We are organizing and encouraging affinity group actions throughout the week to ensure the GE tree industry does not get a moment's rest during their stay in Asheville.
Sleep deprivation is presumably not on the actual program of activities. But a combination of education, media-friendly actions, and specifically directed demonstrations seems like a plausible plan. And I hope someone is holding the USDA and others accountable.
Conflicts between principled activists (or radical nutcases) and sensible legislators (or sell-out collaborators) are long-standing and not about to disappear. Nor should they, in my view. We certainly need debate and discussion. We also need to recognize how important these issues are. So perhaps the appropriate response is not to choose: Perhaps we need both direct action and seats at the table.
An undated Daily Mail article that is actually over a decade old continues to spread misinformation about the current state of human genetic modification. In fact, the operations it describes were shut down by the FDA in 2001, and the specific techniques it refers to have been abandoned.
The article begins with the provocative statement, “The world's first genetically modified humans have been created, it was revealed last night.” There is no date anywhere within it, which has led to a great deal of confusion. Many understandably believe it happened last night given that today’s date shows up at the top of the page.
These reports, and the Daily Mail article, discuss up to 30 births that followed a process called ooplasmic transfer. Fifteen of these babies were reportedly born at the Institute for Reproductive Medicine and Science of St Barnabas in New Jersey under the guidance of Professor Jacques Cohen in an attempt to help infertile women have a child. Altering the human germline – something he was aware he was doing and in fact made a point of publicizing – was not of great concern to him.
However, many others were quite concerned. BBC News Online reported,
Altering the germline is something that the vast majority of scientists deem unethical given the limitations of our knowledge.
It is illegal to do so in many countries and…
The [US Government Recombinant DNA Advisory] Committee said that in no circumstances would it consider any request for government funds that would result in modification of the human germline.
In June 2001 the FDA communicated with the fertility clinics that were attempting ooplasmic transfer and told them to stop, indicating that such protocols would have to be undertaken under Investigational New Drug exemptions. The FDA letters cited concerns regarding the genetic abnormalities found in resulting children (including Turner’s syndrome and Pervasive Developmental Disorder), the lack of oversight, the paucity of safety data, and the resulting permanent changes to the human genome.
Understanding this history is particularly important right now as the UK contemplates granting the world’s first regulatory approval for a variation of these techniques, mitochondria replacement, which would also modify the human germline. Biopolitical Times (1, 2, 3) and many others (1, 2, 3) have pointed out that mitochondria replacement is unneeded to prevent future children affected by mitochondria disease , would be extraordinarily risky for any resulting children, and would violate widespread legal prohibitions and a globally observed understanding against human germline engineering.
Back in 2001 no one would have guessed that the UK would be the country to go against the worldwide consensus against such human experimentation. Lord Robert Winston, Professor of Science and Society and Emeritus Professor of Fertility Studies at Imperial College, told the BBC: “There is no evidence that this technique is worth doing... I am very surprised that it was even carried out at this stage. It would certainly not be allowed in Britain.” Additionally, the Human Fertilisation and Embryology Authority (HFEA), the UK’s regulatory agency for reproductive medical activities, said that it would not license the technique because it involved altering the germline.
Despite or perhaps because of the publicity around the current controversy, the old Daily Mail article continues to circulate and lead to commentaries based on the false assumption that this just happened. Just how much confusion has this created? Here are some of the recent re-postings and commentaries based on the 2001 article:
The hosts of the recent Al Jazeera debate ‘The Baby Blueprint’ were understandably confused about the issue when they noted that they had just learned from an article that 30 genetically modified babies were born last year.
Misinformation has been a hallmark of the debate around mitochondria replacement. Adding the accurate date to the Daily Mail article could help alleviate some of the confusion. Hopefully this will be remedied soon.
Happy Earth Day everyone! The question of how to protect our planet is one of the most pressing of our time, and everywhere you look, there are different ideas about the best way to manage the crises of climate change, environmental disasters, and loss of biodiversity. One solution that has been gaining some popularity lately is synthetic biology. A recent conference at the University of Cambridge in the UK brought together leading conservationists and synthetic biologists to consider how new technologies may be used to benefit the planet.
However, the heart of synthetic biology is not conservation, but creation. Synthetic biologists make headlines because they seem to see themselves as God-like figures who can make the natural world better. It is exactly this kind of hubris that has led to many of the largest environmental disasters. As Biopolitical Times contributor Pete Shanks argues,
The entire approach of designing and controlling nature is at odds with the deepest goals of the environmental movement. We cannot live in harmony with a world we are actively trying to redesign in accordance with our whims.
Shanks called this trend for exactly what it is: greenwashing. Collaboration with environmentalists is great PR for a field that poses extreme environmental risks and is entirely unregulated. From the “transparently phony concept” of “de-extinction,” to the news that pharmaceutical giant Sanofi is producing a synthetic malaria drug, which will really amount to “the start of a new hi-tech assault on farmers,” synthetic biology ventures certainly engage the environment; whether they will be good for it is quite another matter.
As appealing as they might sound, these grandiose and messianic promises are not only false but dangerous. Synthetic biofuels have been widely criticized (see: 1, 2, 3, 4) as a non-starter solution to the climate crisis, which threaten to harm the environment and prompt massive land grabs in the global South. In addition, the field threatens to re-entrench corporate dominance and global inequality by opening the door to patents on synthetic life-forms and genomes. And none of this is to mention serious risks to public health and worker safety that much synthetic biology research poses.
In honor of Earth Day, here’s to the public policies, and societal and personal changes, that address the root of the problems facing our Earth. One synthetic biologist at Cambridge made the glib statement that this technology will win simply because those in favor of it are younger than those who are against it. (He did walk it back.) Well, here’s one young person who is not convinced that synthetic biology will save us all.
On Monday, April 15, the U.S. Supreme Court held its hearing on the Myriad gene patent case. Their ruling is not expected until June, and it's hard to tell what that will be. It's not inconceivable that, as with the healthcare decision last year, the court will come up with a creative and unexpected approach, which might lead to a narrow rather than sweeping ruling. These sample headlines give a sense of the initial reactions:
Justices Seem Wary of Bold Action in Gene Patent Case (New York Times)
High Court Justices Seek Compromise in Gene-Patent Case (Bloomberg)
Supreme Court skeptical of patent on breast cancer gene (USA Today)
Jacab Sherkow at the Stanford Law and Biosciences blog had perhaps the most detailed review of the oral arguments, which he called "wide-ranging — and often-times confusing." He noted that some of the justices seemed to have difficulty with basic genetics, and tended to cling to analogies of dubious applicability. Bravely, he concluded:
I count at least five votes decidedly on board to invalidate Myriad's claims: Chief Justice Roberts, and Justices Kennedy, Ginsburg, Sotomayor, and Kagan.
As to the rest, he placed Alito and Breyer stalwartly in Myriad's camp, pegged Thomas as even-handed on patents, and "all bets are off when it comes to Justice Scalia and anything scientific."
Outside the Court, Breast Cancer Action (BCA) — one of the plaintiffs in the case — held a rally in support, which CGS had endorsed. The next day, BCA's Karuna Jaggar appeared on HuffPost Live in an entertaining debate: The host was amazed (and professionally delighted) that a discussion of patents could come to a close with four panelists simultaneously trying to shout over each other.
Jaggar had cowritten a Los Angeles Timesop-ed with CGS's Marcy Darnovsky that appeared the Friday before. The subtitle (adapted from a famous quote by Jonas Salk) sums up the plaintiff's point of view:
You can't patent the sun; why should you be able to patent human genes?
In a few months, we'll know how many justices agree.
Synthetic biology scored a public-relations coup last week, when pharmaceutical giant Sanofi announced the start of commercial production of a "semisynthetic" version of artemisinin, the key ingredient of the principal anti-malarial compound. Up to now, arteminisin has been derived from the sweet wormwood plant.
The synthetic process was developed by Amyris, the company founded by University of California, Berkeley professor Jay Keasling, largely funded by the Gates Foundation, and licensed at no cost to Sanofi. The announcement was accompanied by a technical paper in Nature, emphasizing in the abstract that:
Because all intellectual property rights have been provided free of charge, this technology has the potential to increase provision of first-line antimalarial treatments to the developing world at a reduced average annual price.
Similarly, the Sanofi press release [pdf] stressed that:
Sanofi is committed to producing semisynthetic artemisinin using a no-profit, no-loss production model, helping to maintain a low price for developing countries.
Now, is that any way for a company with $43 billion in sales to act? Admittedly, the artemisinin market is a mere $90 million or so a year [pdf], so it's not like they're giving away all that much.
The publicity is priceless, but so is the loss-leader aspect. Keasling seems to have given the game away in Cambridge last week, saying that they expect to take over the entire global market, forcing the many small producers (mostly in China, also Vietnam and East Africa) to, ah, diversify their portfolios into wheat or potatoes. He told Nature:
I don't make the decision about what gets produced, the marketplace decides. What I do is provide more options.
Keasling made $17 million when Amyris went public; the company was built on this project. His dismissal of responsibility for the livelihoods of thousands of small farmers is reminiscent of Tom Lehrer's classic take on German rocket scientist Wernher von Braun [video]:
"Once the rockets are up, who cares where they come down?
That's not my department," says Wernher von Braun.
But this profitable piece of charity comes at major cost — for others:
Synthetic anti-malarial compound is bad news for artemisia farmers
That's the headline of a piece in The Guardian by Jim Thomas of the ETC Group, whose backgrounder on the whole subject is here. This was followed up by a press release from SynBioWatch, a coalition that includes CGS:
New "Semisynthetic" Anti-Malarial Drug is Unneeded and Sets Dangerous Precedent While Threatening Farmer Livelihoods.
These civil society responses need much more attention. Attempts to buy respectability for novel technologies — via greenwashing and related tactics — need to be exposed.
Which is not to say that there may not be useful results from synthetic techniques. Another synthetic biology advance was also touted last week: the ability to synthesize a vaccine against bird flu. This could save two weeks in a five-month production cycle, which sounds promising. The Centers for Disease Control and other U.S. agencies are working with Novartis and Craig Venter's Synthetic Genomics Vaccines Inc. to develop this process. Human safety trials may start later this year.
There is certainly room for discussion of this project and others envisioned by promoters of synthetic biology. That was the avowed intent of last week's Cambridge conference on "How will synthetic biology and conservation shape the future of nature?" The background paper [pdf] is a good resource, especially the extensive Endnotes. The conference itself has provoked some interesting, skeptical responses from Jim Thomas and Ed Gillespie. De-extinction was downplayed, it seems, though definitely mentioned. (See my article at Alternet on the use of "de-extinction" for PR purposes, as well as this post on semi-hidden human applications.)
And we have not heard the last of artemisinin. Keasling and other Amyris founders have started a nonprofit, Zagaya, which has won yet another Gates grant to investigate a lower-cost method of manufacturing artemisinin.
Wildly divergent headlines about a study of Alzheimer’s disease vividly illustrate the depth and breadth of the confusion that plagues our thinking about racial categories in genetic research. The New York Times billed the study (published in The Journal of the American Medical Association) this way:
The article by Gina Kolata appears to be an accurate account of the researchers’ key finding, which is that “there is no major genetic difference that could account for the slight excess risk” of Alzheimer’s among people who identify themselves as African American.
But should this be a headline-worthy surprise? Do the study and the article about it – no doubt motivated by a sincere desire to be racially inclusive – in fact wind up suggesting that race is a biological reality rather than a social and political category? Do they foster the notion that health disparities are best explained by genetic rather than social differences?
The "Blacks Have Same Gene Changes as Whites" headline in The New York Times may raise eyebrows for its suggestion that discovering genetic similarity between African Americans and white Americans is something new. But that problematic subtext pales in comparison to the treatment of the very same study by dozens of other media outlets.
If you want a sense of the challenge that faces us, take a minute to look at the headlines below, the results of a Google search on the terms “gene” and “Alzheimer's” conducted on April 9 about an hour after The New York Times article appeared.
Yes, the stars are doing it! 40-year-old Sofia Vergara revealed in the April issue of Voguethat she has to watch what she eats because she’s seeing a fertility specialist and taking pills and hormone injections to prepare for egg retrieval, in order to freeze them for use at a later date.
The Modern Family star explains:
They want to get as many eggs as they can because usually you produce them but they're not good. They have to be perfect, perfect perfect ones. My boyfriend [Nick Loeb] is 37, younger than me, never had kids.
Vergara isn’t the only celebrity embarking on “social egg freezing,” which is now being promoted as a way for women to pursue a career and delay childbearing until a more convenient time. Kim Kardashian (32) and Coco Austin (33), wife of rapper Ice-T, have also gone through the procedure, and talked about it publicly.
What’s next? I can imagine an egg-freezing reality TV show, with 24-hour-a-day cameras chronicling women injecting themselves with hormones, detailing every emotional reaction and trip to the clinic. The climax: an announcement of who produced the most “perfect” eggs.
But egg extraction isn’t really a laughing matter. The hormones that “shut down” the ovaries can cause long-term debilitating symptoms. The hormones used to stimulate the ovaries to produce multiple eggs can also have serious side effects, though they are fortunately rare; several women have died from complications of ovarian hyper-stimulation. The egg extraction procedure itself, in which a needle is inserted into a woman’s reproductive organs to suck out eggs, can also be risky and can lead to scarring and ovarian damage.
When women are facing medical procedures that can cause infertility, such as chemotherapy for cancer treatment, they may find these risks worthwhile. Extracting and freezing eggs for social reasons – so that a woman could pursue her career or wait for Mr. Right to come along before defrosting – raises a different set of ethical considerations. In short, social egg freezing is nothing to be taken lightly.
In other “egg-related news,” scientists say they are developing the capability to turn human eggs into powdered form, skipping the inconvenience and cost of storing them in expensive cryo-preservation facilities. A woman could conveniently store her egg sachet in her lingerie drawer, or in her kitchen cabinet next to her cinnamon and other spices. Simply add water, sperm, find the turkey baster in the kitchen drawer, and voila. Ahhh…the modern conveniences of reproduction without all the mess and fuss! Just be careful which spice you reach for when cooking up that romantic breakfast for two.
The American College of Medical Genetics and Genomics (ACMG) released a report on "incidental findings" in genetic tests on March 21, and kicked up a storm of controversy within the field of medical ethics. Their recommendations are more nuanced than some initial reports suggested, but they deserve wider discussion than they have had so far.
At issue is the question of what to do if genetic testing for one reason shows up data that could be relevant to another condition. The report is titled "ACMG Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing Report" [pdf]. That led to some headlines suggesting that patients should be told all such results, but MIT Technology Review had perhaps the most accurate:
Doctors Should Tell Patients About Some, But Not All, Unexpected Genetic Findings
The ACMG report only discusses mutations in 57 specific genes that are associated with about 5 kinds of disease (see this summary by Ricki Lewis in Scientific American). Nevertheless, it ventures into very controversial territory (as discussed in Nature News), attempting to bridge the gap between what it calls "genetic libertarians" and "genetic empiricists."
The genetic libertarians "feel that patients have the right to full and complete accounting of all possible risks." The empiricists are more skeptical about most disease-gene associations and believe that "it is irresponsible to create the psychological burdens of being a 'patient in waiting.'" The report tries to balance these viewpoints, but no one seems satisfied.
Certainly, neither group is likely to be reassured by headlines such as this (the text is more subtle) at the Genomes Unzipped blog:
No choice for you
Another pithy reaction to the recommendations, quoted in the March 29 issue of Science (abstract; full text behind paywall), comes from bioethicist Susan Wolf, on providing genetic data to patients:
The fact that I support offering them does not mean I support inflicting them.
A separate, major source of concern is that the recommendations explicitly apply to children. This on its face seems to contradict the guidelines issued by the same body (along with the American Academy of Pediatrics) only a month earlier. The Science article explores these inconsistencies; the latest report's authors find a distinction that at least some of the authors of the previous one do not recognize.
If nothing else, ACMG has demonstrated how hard these issues are, and thereby how important it is that this conversation continues. Theirs is a "pioneering effort" as Muin Khory, founding director of CDC′s National Office of Public Health Genomics, told Nature. But really, as the ACMG working group acknowledges, it's only the start of the discussion.
India has been considered the “surrogacy capital of the world” for some time, with thousands of couples yearly now having children by hiring Indian women as surrogates. But new regulations are poised to upend these arrangements. Seizing on the change as a business opportunity, the self-described “medical tourism portal” PlanetHospitaldeclared in a press release last month, “So long Surrogacy in India, Hello Surrogacy in Mexico and Thailand.”
India’s new regulations prohibit surrogacy for gay couples, unmarried couples, and singles, who have made up a sizeable portion of the clientele and who will now have to reconsider their options. Among them are Paul Taylor-Burn and his partner Josh, who are keenly aware of the regulatory about-face. Living in Perth, Australia, where commercial surrogacy is illegal, they turned to a surrogacy agency in India, seeing it as an affordable and reliable way around Australia's rules. They are now anxiously awaiting their baby’s birth, fearing that the new requirements will leave their child stateless and prevent them from bringing him or her home.
Quick to see an opening in the international “medical tourism” marketplace, PlanetHospital announced that it is now offering surrogacy in Mexico and Thailand for straight and gay clients. Founder and CEO Rudy Rupak is neither shy nor modest about what he is doing. He recently boasted,
First I pioneered medical tourism, then Indian surrogacy for western patients, then gay surrogacy in India, surrogacy in Panama, the first HIV surrogacy, kidney transplants with a global donor exchange, micro insurance, and who knows what else.
Now I get to pioneer surrogacy in Mexico and Thailand all while watching surrogacy in India unravel spectacularly.
Many observers of international surrogacy have voiced ethical qualms about exploiting poor women’s bodies to help the wealthier. Europeans, Australians, Canadians and others have chosen to rent Indian women’s wombs despite legal barriers in their own country; many from the US go to India to save money. What made India so enticing was the minimum of “onerous regulations” that intended parents faced. But surrogacy in India has been characterized by a host of problems, with numerous Indian surrogates being subjected to various kinds of mistreatment and at least one tragic death.
This is not what Rupak means by the “unraveling” of surrogacy in India. He is referring instead to the new regulations, which though they unfairly discriminate against gays, single women and unmarried people, are also aimed at minimizing adverse outcomes for surrogates.
What will it mean if Mexico and Thailand become the new surrogacy frontier? Will there be adequate protection for surrogates, as well as for the children they bear and for the parents who will raise these children? Or will these countries be a new Wild West where anything (cheaply) goes?
PlanetHospital’s announcement shows no evidence of concern about these questions. Instead, it focuses on the company’s plans to attract clients from all over the world. Rupak notes,
We think most of our Australian and Asian would-be parents will go to Thailand and our US and Canadian would-be parents will be going to Mexico (“Cancun baby! Woohoo” takes on a whole new meaning now doesn’t it?).
Another advantage to Mexico over India, he assures potential clients, is that “we can tell you the gender of your baby (so you no longer have to paint the baby’s room yellow).” And, Rupak gushes, “Mexican egg donors tend to be a lot more Caucasian and have features that Westerners appreciate.”
Referring to itself as a “non-judgmental” “concierge service,” PlanetHospital is happy to cater to any desire, though extra fees are often involved. Want a boy? That will be “$6,000 for PGD which almost guarantees a male.” How about a very special woman to provide an egg? “Egg donors are usually $5000 but unusual requests are higher.”
PlanetHospital’s marketing literature appears oblivious to controversies about sex and trait selection, and Rupak seems genuinely confused by the negative feedback his crass comments have prompted. Perhaps this is not surprising, though, from the founder of a company whose business model relies on skirting regulations meant to protect people who are, after all, involved with highly sensitive procedures.
Commercial surrogacy is not an innocent and harmless business transaction, though PlanetHospital has described it as comparable to shoe shopping. Providing a concierge-like experience to those seeking a baby via international surrogacy can simply outsource the worries and problems to others, and risks treating women’s bodies as replaceable goods in the global marketplace.
The reason that many countries prohibit commercial surrogacy is its potential to exploit women and commodify their bodies. It often entices women who are in difficult or vulnerable positions to serve as surrogates, while prioritizing the desires and convenience of the parents. Where it is legal, it is crucial that its ethical, social, and political complications not be overlooked.
Antonio Regalado of MIT Technology Review got a nice scoop at the TEDx DeExtinction conference: George Church and Robert Lanza are starting a company together. It's going to be involved in reviving extinct species and so their tentative name for it is "Ark Corporation."
Church is bringing to the table his synthetic biology expertise, long-standing interest in tweaking genomes, and entrepreneurial savvy. Lanza has been cloning cattle and other species for ages, and like Church boasts years of experience in public relations.
Regalado reports that Lanza has filed numerous patent applications for using iPS cells to make "animals of a desired genetic make-up," as well as to re-create extinct ones, and also for purposes of human reproduction. Indeed, he claims that he and Church will have backing from "top human IVF clinics" for their new venture. Why?
Here's one possible scenario: Theoretically, iPS techniques could one day be used to make sperm from a woman's cells or eggs from a man's; it's already been done in mice. This immediately raises the prospect of gay and lesbian couples having children together that are related to both of them. Any effort to do this would be an extraordinarily dangerous experiment, but that doesn't mean it hasn't been proposed. (See this Op-ed by Marcy Darnovsky: "Female Sperm and Gay Guinea Pigs.") Perhaps some fertility clinics think they might get in on the ground floor of a profitable new product line?
And then there is the possibility of adjusting the genetic make-up of gametes to create actual "designer babies." Church, however, insists he and Lanza are not going into human reproduction. This is his denial:
"It's not part of the company. And if it were, we wouldn't be saying it."
It seems clear that the "de-extinction" talk is a sideshow for them, "a goodwill thing," in Church's words. Commercial cloning of cows and pigs, which has been mooted for over a decade now, is a more plausible goal for making serious money in the medium term. But it's not a stretch to think that human applications may be in prospect.
As Biopolitical Times readers know all too well, profits can often come before the health and safety of patients in clinical drug trials. A troubling case at the University of Minnesota (my alma mater, though I am no longer proud to say so) provides a powerful illustration.
Despite his inability to give informed consent, 26-year-old Dan Markingson was enrolled by his doctor in the U of M CAFÉ study (an acronym for Comparison of Atypicals in First-Episode Schizophrenia), sponsored by pharmaceutical giant Astra Zeneca. His mother, Mary Weiss, came to believe that the trial was in fact harming him, and that he was not receiving the proper help and treatment he sorely needed. She desperately fought to get her son out of the trial, but to no avail. On May 7, 2004, her worst fears were confirmed, and Markingson committed suicide in a most brutal manner.
After several lawsuits and investigations, justice still has not come for Mary Weiss. And she has been subjected to numerous personal attacks along the way. You can read the full and complex story here, here, and here. After minimal gains combined with recently discovered evidence that suggests the University’s investigation is incomplete, Weiss and Markingon’s close friend Mike Howard initiated an online petition, asking Minnesota governor Mark Dayton to investigate. Howard explains his motivation for the petition:
I cannot tell anyone else what way of speaking out is most aligned with his or her own personal principles. However, I believe those of us who are personally affected by these issues must break the silence about the human rights violations inherent in coerced participation in psychiatric research. While University of Minnesota researchers used many unethical methods to force Dan to participate in this research study, the most egregious of them was fear. Dan was afraid that there was no alternative to taking part in the study, and that he would face a complete loss of liberty if he did not participate.
The Change.org petition already has over 1,000 signatures, including former editors-in-chief of the New England Journal of Medicine Jerome Kassirer and Marcia Angell and many other noted bioethicists. University of Minnesota professor and bioethicist Carl Elliott has been particularly instrumental over the past three years in bringing this case into the public eye, expressing shame at his home university. Elliott writes:
Of course, I am not asking anyone to sign the petition without looking at the evidence. What I am saying is that if you look at the evidence, you will conclude that an injustice was inflicted on a vulnerable family at the worst possible moment. This is not a hard case. It is an easy case where ordinary people have looked the other way for too long. We can never make things right for Mary Weiss, but by signing this petition, at least we can try to ensure that what happened to Dan does not happen to anyone else.
A recent study at Henry Ford Hospital in Detroit found that African-American children are three times as likely as Caucasian children to be sensitive to at least one food allergen, and concluded that this is due to “race and possibly genetics.” In a ScienceDaily press release, lead investigator Dr. Haejim Kim said,
Our findings suggest that African Americans may have a gene making them more susceptible to food allergen sensitization or the sensitization is just more prevalent in African American children than white children at age 2 [emphasis added].
The study was conducted by giving kids skin tests for sensitivity to food and environmental allergens. As described in the press release, it involved no genetic testing at all, and did not control for variables such as environment or socio-economic differences. Yet Dr. Kim was willing to speculate that the racial disparities between allergy rates observed by her team are related to racial genetic differences.
Kim went on to note that more research is needed to determine if African Americans “have a [susceptibility] gene” or not. But predictably, her ambiguous comment unleashed misleading media coverage that turned a speculative remark into the definitive conclusion that racial disparities in children’s allergy rates are due to genes that vary by race. Some examples:
What explains the appeal of this kind “gene fetishism” and of linking it to race? It’s certainly not any overwhelming scientific evidence.
One body of research has focused on environmental factors in allergy. A study published in Clinical Pediatrics, for example, found that peanut allergies are twice as prevalent in urban centers as in rural communities, and hypothesized that the high level of pollutants found in urban areas may contribute to the development of the allergies. Other studies support the so-called “hygiene hypothesis” – the idea that living in a cleaner environment may make people's immune systems more sensitive, and increase the prevalence of allergies.
In short, the jury is still out on the causes of food and environmental allergies. What we can say with some degree of confidence is that popular news outlets too often depict inconclusive research as fact, and that this tendency seems particularly strong when the topic is related to race and genetics.
Posted by Jessica Cussins & Pete Shanks on March 21st, 2013
The UK agency that regulates assisted reproduction announced in a March 20 press statement that it has found “broad public support” for procedures that would modify the genes of future generations. But a closer look at its report shows something quite different.
The Human Fertilisation and Embryology Authority (HFEA)'s report described a public consultation that it undertook to "take the public temperature" on an "important and emotive issue." The issue in question is whether human trials should be conducted on mitochondria replacement techniques that would constitute a form of inheritable genetic modification.
Mitochondria are tiny organelles that power all animal and plant cells, and have their own DNA, known as mtDNA. Women affected by mitochondrial disease are at risk of passing it on to their children (mtDNA is inherited only from mothers). One way around that would theoretically be to replace the mtDNA in a woman's egg with healthy mtDNA from another woman, creating what are popularly known as "three-parent babies." The techniques involved, described in more detail here, are being developed in Newcastle, UK (hence the HFEA interest), and in Oregon and New York.
But a very large ethical and social issue looms over these procedures. As Marcy Darnovsky explains in the Center for Genetics and Society's press release,
Changing the genes we pass on to our children is a bright ethical line that should not be crossed. It has been observed by scientists around the world, adopted as law by more than 40 countries, and incorporated in several international treaties.
It would be wrong for the UK to disregard this global bioethical consensus, especially when there are safe alternatives available for the very few people who would be candidates for the procedures.
The implications of crossing that line were spelled out vividly in a response to the HFEA announcement by David King of Human Genetics Alert:
Historians of the future will point to this as the moment when technocrats crossed the crucial line, the decision that led inexorably to the disaster of genetically engineered babies and consumer eugenics. This was the moment at which they casually tossed the bioethical consensus of the last 30 years into the trash.
The HFEA consultation process involved several different approaches. By far the largest number of people involved took part in the on-line open consultation questionnaire, which gathered 1836 responses. Of those, 1260 came from individuals or organizations who filled in the questionnaire on-line. (Details are in Annex IV of the report.) There were also 569 letters and e-mails, 503 of which had responses not tied into the particular questions asked.
Question 1 asked for views on "offering (one or both of) these techniques to people at risk of passing on mitochondrial disease to their child" and received 1235 responses. Of those, "349 state that they consider both acceptable, while 106 agree but with some caveats, but 502 say they are not acceptable." In addition, "some 300" of the "503 non-questionnaire responses" state that they do not think either of the techniques are acceptable.
To state this more clearly: The majority disagree with the introduction of both mitochondria replacement techniques.
Question 5 reiterates this public disapproval. It asks, "If the law changed to allow mitochondria replacement to take place in a specialist clinic regulated by the HFEA, how should decisions be made on who can access this treatment?" and offers several alternatives. By far the most popular choice (551 out of 1,143) was "4) I do not think mitochondria replacement should be permitted in treatment at all." In addition, "many" of the 55 who chose the tightest regulation opposed the procedure but selected a second-best option "as it offered the most intensive regulation of the treatment." And "others [who did not select an option] simply reiterated their opposition to mitochondria replacement."
Why, then, is the HFEA misrepresenting its own data to claim the public's "broad support"? Perhaps it is placing more import on the other four "strands" of the public engagement project. These included deliberative public workshops where thirty people were recruited to meet twice in Newcastle, Cardiff and London; a public opinion survey; two open consultation meetings that in total included 92 participants and had a pre-selected panel of speakers; and a patient focus group with six participants. The sentiment in these strands tended to be more in favor of the techniques, but was still mixed and varied considerably.
Some of the work in these aspects is problematic, too. The public opinion survey involved 979 interviews with random members of the UK public who were likely to have low knowledge of the issues involved, and was designed to start with generalities about science and research and only then proceed to "the more ethically challenging subjects." (That's a classic way to design polls to obtain the result you want.) The later discussion groups actually dropped a reference to one study that had caused uncertainty and concern among earlier participants, on the grounds that its relevance was tangential; the report noted that "for some participants their trust in the safety of these techniques is relatively fragile, and easily disrupted by new information."
But reporting such uncertainty would, of course, dilute the message that HFEA is sending to the UK Department of Health, which must now decide whether to draft regulations to allow the procedure. If they do, the proposals would then need the approval of both houses of Parliament. And it is quite clear what the HFEA's recommendation is. Prof Lisa Jardine, who chairs the HFEA, told the BBC that the UK was in one of the most advanced positions in the world:
"Other countries are astounded that we're this far on in the discussions," she said.
Clearly this report is meant to "advance" rather than simply document public reaction. The picture of "public support" that the HFEA is now painting is misleading at best.
Unfortunately, every major news outlet took the bait. The majority of articles about the HFEA announcement reference "widespread public support" either right in the title or near the lead. Titles included "UK: Public OK with creating babies from 3 people" from the Associated Press (widely reprinted) and "'Three parent babies' one step closer: survey reveals support for radical IVF therapy" from the London Independent.
Let us hope that the Department of Health reads the report more carefully.
On the morning of April 15, while the Supreme Court hears oral arguments in the landmark lawsuit challenging the patents on the so-called “breast cancer genes,” Breast Cancer Action (BCA) will hold a rally on the courthouse steps to take a stand against all human gene patenting. Like the lawsuit itself, the rally is a first.
BCA is a plaintiff in Association for Molecular Pathology v. Myriad Genetics, Inc. along with Our Bodies Ourselves; four scientific organizations representing more than 150,000 researchers and laboratory professionals; and individual researchers, genetic counselors and breast cancer patients. The Supreme Court hearing is the culmination of a legal process that began in 2009, when the American Civil Liberties Union and the Public Patent Foundation filed the lawsuit against Myriad Genetics, the University of Utah Research Foundation and the US Patent Office.
BCA’s announcement of the rally opens with the question, “Can anyone own the sun or the air?” and the answer, “The very idea is absurd…Breast Cancer Action believes that human genes belong to human beings, not corporations.” It continues:
Allowing corporations to patent human genes is wrong and is actively harming women’s health. When a corporation controls human genes, corporate profits will always come before our health.
An important and timely article, “The British Embryo Authority and the Chamber of Eugenics,” appears this week in The Huffington Post. Stuart Newman, Professor of Cell Biology and Anatomy at New York Medical College, discusses the Human Fertilisation and Embryology Authority’s (HFEA) public consultation on the social and ethical considerations of “mitochondria replacement,” and takes the agency to task for entertaining the legality of a procedure that he sees as inherently unsafe and problematic.
Unlike in vitro fertilization (IVF), which “generates embryos from the biological components that evolved to serve this function,” mitochondria replacement radically alters an embryo through the introduction of genetic material from a third person, piecing together various parts of cells in novel ways. Newman notes that humans are the product of evolution, not design, and that it is a fundamental misconception to believe that billions of years of complexity could be tweaked with any predictable outcome.
Furthermore, Newman separates the question of the desirability of avoiding mitochondrial diseases, which affect 1 in 5,000-10,000 people, from a supposed right to have one's own children by any means necessary, and points out that a technique to modify people who do not yet exist should not be conflated with medical treatment for actual sick people.
The attempt to improve future people is not medicine, however, but a new form of eugenics. In its willingness to risk producing damaged offspring by modifying embryos' genomes, this "correctionist" eugenics goes even beyond the "selectionist" version of the forced sterilization programs for criminals and others considered biologically inferior conducted in the United States and Europe throughout most of the 20th century (and brought to an extreme in Nazi Germany).
Activities that are clearly covered by the Nuremberg Code prohibiting nonconsensual human experimentation are recast by proponents of gene-altering technologies as within the alleged rights of parents to exert proprietary control over the characteristics of their prospective offspring.
Why would the HFEA toy with a technology imbued with such problematic implications for individuals and society? Newman concludes with some words of caution:
The ironic lesson of the new drive toward DNA-based eugenics (of which the mitochondrial replacement techniques would be the thin end of the wedge), is that despite its being the special initiative of an avowedly progressive sector of biomedicine, it actually brings together some of the most regressive strains of traditional and modern society: valuation of people according to their biological characteristics, parental proprietorship, the marauding entrepreneur and evolution denialism.
The HFEA's members may imagine that they are taking cautious steps toward a genetically brighter future, but in actuality they are drawing on darker forces promoting the misuse of technology with clear potential for individual and social harms.
Many of the scientists currently working on mitochondria replacement are eager to promote their techniques as safe and ready to move to human clinical trial; a cautionary look, such as this, from notable scientists is thus extremely valuable and timely.
Whole Foods Market announced on March 8th that all genetically modified foods they sell will need to be labeled within five years. That makes them the first national grocery chain in the U.S. to do so, and they played this as common sense. A. C. Gallo, the company's president, told the New York Times:
We've seen how our customers have responded to the products we do have labeled. Some of our manufacturers say they've seen a 15 percent increase in sales of products they have labeled.
Perhaps even more important is that the Whole Foods brand has come under attack from natural-foods activists more than once recently, for deceptive advertising, cozying up to Monsanto, and even initially refusing to support California's labeling proposition last year, though they later came around. The company is also notorious for a long-standing opposition to unions. This announcement can be seen, therefore, as a relatively benevolent form of greenwashing.
And five years? That makes the effort sound more like a publicity stunt than ever: By 2018, it is entirely possible that the industry will have no choice but to label GMOs. In Washington State, the deadline, if I-522 passes, is July 2015.
Still, as Ronnie Cummins of the Organic Consumers Association (an important force in this and related efforts) noted, the Whole Foods announcement is a major victory for consumers and a major defeat for Monsanto and the rest of the biotech industry.
A high-profile, all-day, all-star event in Washington, DC on March 15 will focus on "de-extinction." It's an independently organized TED event — TEDxDeExtinction — hosted by National Geographic, and organized by Stewart Brand and Ryan Phelan as part of the "Revive and Restore" project within The Long Now Foundation. It claims to be "the first-ever public exploration of the subject of reviving extinct species."
The 25 announced speakers are a distinguished bunch, including a lot of scientists. Big names include George Church (of recent Neanderthal notoriety) and Robert Lanza (long-time cloning maven for ACT), but also there will be researchers reporting on their work to clone, revive or re-create:
and the woolly mammoth
Also invited are conservation biologists, some of whom are likely to have qualms about the concept; at least one journalist (Carl Zimmer); and law professor Hank Greely, who dislikes the neologism "de-extinct" but generally supports the idea, as long as it isn't tried with hominids.
Mammoths are clearly on the program, featured in Scientific American's blog post on the conference (and in the subhead of the reprint at Salon). Neanderthals are not listed, but National Geographic just put up another long article about re-creating them, complete with medical justifications. For instance, it quotes anthropologist John Hawks:
We're looking at an ancient population that had thick, dense bones and strong muscles. If you could find some way to tweak the human biology in a way to make it more Neanderthal-like, that might treat osteoporosis and muscle wasting.
(The Editor's note at the end of that piece says that the TEDxDeExtinction conference will be streamed live on NationalGeographic.com, and provide the cover story for their April issue)
Meanwhile, some contrary opinions about efforts to clone Neanderthals are being expressed, including Greely's essay and this prediction from Yale geneticist James Noonan:
What's more likely to happen is you're going to get really sick or lethal mutations. You're going to get a lot of dead proto-Neanderthals.
Simultaneously, the London Natural History Museum has launched an exhibit called "Extinction: Not the End of the World?" which seems to be trying to generate press, partly by looking at the extinction of humans. And there will be a conference in Cambridge, UK, in April on the topic, "How will Synthetic Biology and Conservation Shape the Future of Nature?"
Stewart Brand, long-time environmentalist turned techno-enthusiast, shares a knack for publicity with George Church, the personal genomics and synthetic biology champion, and Robert Lanza, the cloning expert. In this effort, they are combining to both build and ride a wave of attention. It bears watching. And those of us who disagree with the vision of an entirely artificial environment filled with simulacra of species should not let it go unchallenged.
Posted by Abby Lippman, Biopolitical Times guest contributor on March 6th, 2013
According to a recent article in the Malaysian New Straits Times, the country’s participation as a "node" in the global Human Variome Project "is expected to revolutionise the healthcare industry in Malaysia, save lives and reduce the cost of the healthcare budget."
Not only that, but HVP founder Robert Cotton has an idea for a new gizmo that the New Straits Times seems to be taking seriously – and that thus surely warrants some thought.
Basically, the idea seems to be to give gene tests to as many Malaysians as possible; convince them to make their DNA data public; and then provide a cell phone app to accessibly store all of an individual's DNA sequences. Then, "when [two people] want to get married and have children, they place their telephones together, and a voice will come out saying you both have a very serious defect and we suggest you see a genetic counsellor."
But does this approach really take full advantage of future technological possibilities? Why stop here?
For example, why wait until folks are engaged to activate cell phone connections? Why not put up a link to an online matchmaking service and let the computers pre-select people first? This would work for straights as well as lesbians and gays seeking partners.
And the app could connect to a GPS system so you can find people nearby with compatible DNA patterns. Then, once you’ve met and married and had children, the system could let schools link in to determine how to place your kids and identify preemptively those they want to medicate to ensure they are "good" students.
Of course, all this DNA information will likely also be encrypted into electronic medical records, driver's licenses, and passports. The underlying rationale would be the same for all the applications – to provide sure ways to identify individuals. Combine those databases with facial-recognition software and CCTV cameras (or just Google glasses), and anonymity becomes a completely outmoded concept.
The medical applications are just the start. What else could someone do with the certain knowledge that a particular individual, identified by his or her DNA, was in a specific place at a certain time? Break into their house (the burglar of course being disguised with pre-hacked, customized data)? Cheat with their spouse? Or even target them for selective assassination?
The combinations are endless. And I do wish they were only dystopian imaginings. But the grandiose plans for Malaysia do suggest that at least some of this may be what tomorrow brings. "We are hoping to extend our help to countries around the region like Thailand, Vietnam and Brunei. Malaysia may not be as advanced as Australia, for instance, but we are moving."
Let's hope these apps don't move beyond the factory doors.
Abby Lippman has spent decades following developments in applied genetic and reproductive technologies. Her main interests as a feminist researcher, writer and activist center on women's health and the politics of health. She is also Professor Emerita in the Department of Epidemiology, Biostatistics and Occupational Health at McGill University.
A debate on the question “Should We Prohibit Genetically Engineered Babies?,” sponsored by Intelligence Squared, took place in New York City on February 13 and is now being broadcast on NPR stations across the country. Unfortunately for those seeking a thoughtful approach to one of the most consequential societal challenges we face, the speakers taking the “no” side seemed more interested in scoring debating points than in honestly grappling with the question at hand.
Arguing for the motion – that is, in favor of public policies that would prevent genetically engineered babies – were Sheldon Krimsky, Professor of Urban & Environmental Policy at Tufts University and Chair of the Council for Responsible Genetics; and Robert Winston, Professor of Science and Society and Emeritus Professor of Fertility Studies at Imperial College. Arguing against were Nita Farahany, Professor of Law and Genome Sciences and Policy at Duke University and a member of the Presidential Commission for the Study of Bioethical Issues; and Lee Silver, professor of molecular biology and public policy at Princeton University.
“The GenRich—who account for 10 percent of the American population—all carry synthetic genes. Genes that were created in the laboratory….The GenRich are a modern-day hereditary class of genetic aristocrats….All aspects of the economy, the media, the entertainment industry, and the knowledge industry are controlled by members of the GenRich class… Naturals work as low-paid service providers or as laborers.”
Unfortunately, such scenarios – which have been promulgated not just by Silver, but also by several other high-profile scientists and pundits – were not examined during the debate. In fact, the social and ethical meanings of genetically engineered babies were only lightly engaged. Instead, the discussion focused on Farahany’s central argument: She emphasized, over and over, that prohibiting inheritable genetic modification would preclude a little-known technique called “mitochondria replacement.” Farahany staked the debate on the point that if any potential benefit at all to inheritable genetic modification can be identified, then opposing prohibitions is imperative.
This debating tactic hijacked the rest of the discussion, ambushing Krimsky’s and Winston’s efforts to raise the broad social and ethical ramifications of altering the genes that we pass down to children and future generations. The relentless focus on the “beautiful babies” that could be born after mitochondria replacement served to eclipse the longstanding and widespread understanding that efforts to create “genetically engineered babies” would be profoundly dangerous. None of the debaters, for example, pointed out that the overwhelming majority of scientists and policy makers consider inheritable genetic modification to be a bright line that should not be crossed. Nor did it come up that this view has been codified by law in more than forty countries.
Several variations on this procedure are currently being investigated by researchers in the US and the UK. The idea is to construct an egg or embryo using DNA from two women, in order to allow a woman with a certain subset of mitochondrial disease to have a child who has almost all of her genes, but another woman’s unaffected mitochondrial DNA.
Mitochondria replacement would not create “designer babies” in the common meaning of the term. The transferred DNA would be limited to the small amount that exists outside the nucleus of the cell, which has no effect on most traits. But the genetic change would be passed on to all future generations. And permitting this one kind of inheritable genetic modification could be used as a wedge that opens the door to more and different kinds.
Though Farahany made shrewd use of mitochondria replacement as a debate strategy, she misrepresented many aspects of its development and utility. She referred to the procedure as “safe” although there are very serious concerns about its safety, not the least because a majority of the embryos researchers have created with the technique show abnormalities. She described it as a way to “altogether eliminate” passing on mitochondrial disease, when in fact most women with mitochondrial disease wouldn’t even be candidates for the procedure, since the majority of cases are caused not by unhealthy inherited mitochondria but by mutations in nuclear DNA or by spontaneous or environmentally caused mutations in mitochondrial DNA.
In addition, Farahany incorrectly claimed that mitochondria replacement in humans is being done in the UK. It is true that researchers at Newcastle University are eager to begin clinical trials, but they have not done so because the UK is one of the many countries in which inheritable genetic modification is not permitted. The Human Fertilisation and Embryology Authority is currently considering the safety, ethical, and social implications of allowing mitochondria replacement as an exception to this prohibition.
Farahany also said that mitochondria replacement is being used in the United States; she referred to a woman she knows with a four-year-old child born after such a procedure. If this is true, whoever performed the procedure did so in dubious legal and ethical circumstances: In 2002, the FDA shut down an experiment in which several dozen babies were born after an older kind of mitochondria replacement technique, citing serious health risks and social concerns. The US researchers currently working on mitochondria replacement acknowledge that they would need to do further testing before asking for approval to begin clinical trials.
Farahany attempted to bolster her position by tapping into well-rehearsed political narratives. She argued that genetically modifying one’s child should be understood as an extension of “choice,” and characterized policies prohibiting inheritable genetic modification as unwarranted government intrusion into reproduction. But as many have noted, inheritable genetic modification doesn’t fit into the “choice” framework: Deciding whether to terminate a pregnancy is very different from deciding what kinds of traits a child should or shouldn’t have. She also appealed to opponents of abortion rights with the (dubious) claim that mitochondria replacement wouldn’t require that embryos be destroyed, as does an alternative approach, pre-implantation genetic diagnosis.
In the event that mitochondria replacement is approved, its immediate impact would be small: It simply isn’t a procedure for which there is much demand. It can’t treat or cure anyone who has mitochondrial disease, and a minority of women who are affected by the condition have a form caused solely by problematic mitochondrial DNA. Among those who do, who are concerned with passing on very serious conditions, many would likely choose less risky options – adoption, using third-party eggs, or using preimplantation genetic diagnosis to screen out severely affected embryos.
But regulatory approval for mitochondria replacement would be the first instance of official recognition for inheritable genetic modification. And if debate tactics like those used by Farahany and Silver are a portent, it would make honest discussion of what’s at stake in decisions about inheritable genetic modification far more difficult.
This debate will reach large numbers of people, many of whom have never before heard of mitochondria replacement, or thought at any length about what genetically engineered babies would mean. That their introduction to this critical challenge is marked by slick rhetoric rather than honest consideration is a shame, and a perilous one.
Posted by Gina Maranto, Biopolitical Times guest contributor on March 4th, 2013
The unfortunate truth is that discredited ideas never do die, they just rise again in slightly altered forms—witness eugenics. Despite the horrors perpetuated in its name, including forced sterilization and the Holocaust, the eugenic impulse is with us still. One of the forms it takes is schemes for “improving” offspring through the selection and manipulation of embryos.
In the last year or so, one neo-eugenic advocate in particular has been garnering media attention. He’s Julian Savulescu, holder of an array of titles, including an endowed chair and directorship of a center at the University of Oxford funded by the Uehiro Foundation on Ethics and Education.
Savulescu also edits the Journal of Medical Ethics, which affords him significant influence in guiding academic discourse and research in the field. The theme of the journal’s February 2013 issue is “the biomedical enhancement of moral status,” a project that would surely count as eugenic in nature.
Writing about himself in third person in his online CV, Savulescu lays claim to the vanguard of neo-eugenics, proclaiming that
For the last 10 years, through a series of publications (4 monographs, 1 special journal issue, 29 book chapters, 45 articles), Savulescu has led the debate on the ethics of genetic selection and human enhancement.
Not one to hide his light under a bushel, he goes on to tout his statistics: He grants top spot in his list of publications to a 2001 Bioethics article, “Procreative Beneficence: Why We Should Select the Best Children,” adding the gloss
27 articles responding to it, 14 exclusively. Landmark article arguing selection of children is not only permissible, but morally desirable. Introduced novel concept of Procreative Beneficence (cited by 137 – high citations are uncommon in the Humanities). 5th Highest Accessed Bioethics article 2010.
A new policy statement from the American Academy of Pediatrics (AAP) and the American College of Medical Genetics (ACMG) discusses how to decide whether to perform a genetic test on a child. These guidelines are not binding, and are mostly aimed at physicians. They are generally sensible, but how much influence they will have – either on medical practice and public understanding – is questionable.
In most cases, what the guidelines imply is: Slow down.
Always put the best interests of the child first
Make testing decisions with the benefit of expert counseling
Avoid testing minors for adult-onset diseases
Do not use commercial direct-to-consumer (DTC) tests for children
The guidelines also discuss newborn screening (generally supported), carrier testing (not routinely advised), histocompatibility for stem cell donation (be very careful), adoption (focus on the child's needs), and when to disclose results and to whom (counseling is strongly recommended). They advise against school-based programs "because the school environment is unlikely to be conducive to voluntary participation, thoughtful consent, privacy, confidentiality, or appropriate counseling about test results."
In addition to the policy statement (abstract here, links to pdf) published in Pediatrics, a "Technical report: ethical and policy issues in genetic testing and screening of children" appears in Genetics in Medicine (full text, links to pdf). It places the recommendations in several contexts, including historical, medical, psychological, legal, commercial and ethical. It's good on spelling out the various possible benefits and harms of, for instance, testing for adult-onset conditions; and it appropriately discusses such concerns as misdiagnosis and the discovery of misattributed parentage. It's a valuable background document.
Of course, there are not enough counselors, and too many physicians have inadequate training in genetics; the guidelines rather wave this away by encouraging education and saying that counseling can be given by any "health care provider with appropriate training and expertise." (The PHG Foundation calls this a "refreshingly pragmatic approach.") And it's certainly a problem that "only a few DTC companies specify that their websites are not directed to children" (Technical Report, p. 8, citing a 2010 paper [pdf]).
What can we expect from the DTC industry? Based on past experience, there is a disturbing possibility that some companies will use these guidelines – which have rightly been described as aiming to "put the brakes on testing children" – in a perverse way, as part of a push to increase testing. The pitch would go something like this: Sometimes testing is appropriate, say the AAP and ACMG, and you of course are a well-informed parent; your case must be one of the exceptions, even if the fine print suggests it's not. We've already seen some of that dynamic in prenatal tests, where the company websites display guidelines that, read carefully, suggest their customers should not use the product.
Headlines such as "Experts issue guidelines for gene tests in kids" (Reuters, Chicago Tribune, and others) and the like (Time) reinforce the wrong message. Prefixing it with "The DNA Dilemma" (Parade) helps a little, as does "Questions raised about genetic testing in children," which the Boston Globe used on Monday. Better yet is the Globe'sfirst take, the previous Thursday:
Physician organizations recommend against genetic testing for children
Posted by George Estreich, Biopolitical Times guest contributor on February 28th, 2013
A recent episode of The Today Show, on which I first commented here, profiles an expectant couple, Jason and Robin Vosler, who tell the audience about the results of their prenatal test on air. They explain that their fetus does not have Down syndrome: “We’re safe,” Ms. Vosler said. Host Matt Lauer then reveals to them something they hadn’t known – that their fetus is male.
Though nominally a human interest story, the segment was functionally an infomercial for Sequenom’s MaterniT21Plus, one of the new noninvasive prenatal tests (NIPT) for Down syndrome and other chromosomal conditions. The couple testified to the test’s value, as did NBC’s Chief Medical Editor, the woman’s OB-GYN, and the Chief Medical Officer of Sequenom. No competing test was mentioned, and MaterniT21Plus was compared favorably to invasive diagnostic tests (amniocentesis and chorionic villi sampling).
In my previous blog post, I discussed the conflicted view our society holds of Down syndrome and disability. In this one, I want to consider several key issues: the way NIPT is presented in the diagnostic situation; the way medical authority is used, or misused, to sell the technology to both patients and the public; the question of sex selection; and the challenge of how to respond publicly to these problems.
For years now, parents have advocated for a genuinely balanced approach to the presentation of Down syndrome, whether in prenatal or postnatal contexts. That approach would neither shy away from potential complications, nor frame a child with Down syndrome as an avoidable mistake.
Writing in The New York Times, science journalist Nicholas Wade reports on the recent discovery that a 35,000-year-old genetic mutation accounts for some of the phenotypic variations found in East Asian populations. From Wade’s article:
Gaining a deep insight into human evolution, researchers have identified
a mutation in a critical human gene as the source of several
distinctive traits that make East Asians different from other races….Each race
has a different set of selected regions, reflecting the fact that the
human population had dispersed from its African homeland and faced
different challenges that led to genetic adaptation on each continent
Wade’s choice of words here is deeply troubling. He is apparently rejecting the widely accepted understanding that “race” is a social and political category, not a biological one.
As an anthropologist who has taught cultural and medical anthropology, biological anthropology, and integrative and molecular biology, I find this both surprising and disturbing. To be clear, the concern is not about the fact that variation exists between (as well as within) human groups, however we define those groups. Nor is there any disagreement that human beings – all of us stemming from a common origin in Africa – have adapted to different environmental contexts. The concern is about the way in which the term “race” is still being constructed as a biological reality by those who should know better – especially when they write for a publication with the influence and reach of The New York Times.
But don’t just take my word for it. Let’s look at the scientific evidence. Two of the primary lessons of the Human Genome Project are first, that human beings, regardless of ancestry or geographic origins, are greater than 99.9% the same at the molecular level; and second, that there is more variation within groups – however defined – than between them. According to a Human Genome Project report:
DNA studies do not indicate that separate classifiable subspecies
(races) exist within modern humans. While different genes for physical
traits such as skin and hair color can be identified between
individuals, no consistent patterns of genes across the human genome
exist to distinguish one race from another. There also is no genetic
basis for divisions of human ethnicity. People who have lived in the
same geographic region for many generations may have some alleles in
common, but no allele will be found in all members of one population and
in no members of any other.
Al Gore – former vice president, Nobel Peace Prize recipient, best-selling author, high-tech and green-tech entrepreneur, and Paul Revere of climate change – has recently released The Future: Six Drivers of Global Change. The book’s ambitious goal – and one that should be high priority for us all – is figuring out how to safeguard a truly human future when, as Gore puts it, “[d]emocracy and capitalism have both been hacked.”
One of the six drivers Gore identifies is “The Reinvention of Life and Death,” which he suggests is parallel to climate change in its importance for the human future. In a chapter of that title, he covers human biotech and related issues at length. The discussion is wide-ranging, with anecdotes and comments about topics including personalized medicine, inheritable genetic modification, gene patenting, epigenetics, synthetic biology, bioweapons, human cloning, stem cell research, eugenics past and present, the Singularity, human enhancement, athletic gene doping, fetal gene tests, and genetic discrimination.
Gore draws on the observations of a range of players in biotech-related research and policy. He quotes the Center for Genetics and Society’s Richard Hayes and myself (though he misidentifies my affiliation in what seems to be an editing error).
Gore is clearly unsettled by the social and ethical challenges that many of these practices and technologies pose. His language is often striking, as in his comment about the “new capability to change the being in human being” and his reference to the prospect of “Earth Inc” (i.e., global capitalism) moving into the domain of life. He asks,
Will the emergent potential for altering the fabric of life and the genetic design of human beings be accompanied by the emergence of wisdom sufficient for the far-reaching decisions that will soon confront us, or will these technologies be widely dispersed without adequate consideration of the full spectrum of consequences they could entail?
And in his concluding pages, he calls for protocols to guide decisions about human genetic modification.
[W]e should place priority on the development of safeguards against unwise permanent alterations in the human gene pool. Now that we have become the principal agents of evolution, it is crucially important to recognize that the pursuit of short-term goals through human modification can be dangerously inconsistent with the long-term best interests of the human species. As yet, however, we have not developed adequate criteria – much less decision-making protocols – for use in guiding such decisions. We must do so quickly.
Gore has promoted the book on the David Letterman and Jon Stewart shows, and at numerous appearances. The reviews have been mixed, but telling. The Wall Street Journal warns, “Readers of the former vice president's book might be excused for thinking that all of the evils in the world come from corporations.” The New York Times ends on an equivocal note: “Whether the forces of enlightened public opinion will prevail over clashing values and conflicting interests remains to be seen.” But the book-buying public is clearly taking note: As of February 21, The Future has reached number 4 on The New York Timeshardcover nonfiction list.
Let’s hope The Future sparks wider and deeper appreciation of human biotechnologies as one of the key forces we need to harness for the common good, and that it nourishes the sense of urgency and big-picture thinking it exemplifies.
The United Nations Special Rapporteur on Torture (SRT) issued a report this month about practices that are justified as health care, but that actually constitute cruel, inhuman or degrading treatment. The report breaks new ground with its acknowledgment that torture and human rights violations can take place within medical settings, that it is not merely a historical problem, and that the LGBTQI community is often targeted for such abuses.
Section 88 of the 23-page report reads,
The Special Rapporteur calls upon all States to repeal any law allowing intrusive and irreversible treatments, including forced genital-normalizing surgery, involuntary sterilization, unethical experimentation, medical display, “reparative therapies” or “conversion therapies”, when enforced or administered without the free and informed consent of the person concerned. He also calls upon them to outlaw forced or coerced sterilization in all circumstances and provide special protection to individuals belonging to marginalized groups.
Forced sterilization has previously been recognized as a human rights violation that most severely affects women from marginalized populations. The Open Society Institute’s (OSI) 2011 report, Against Her Will: Forced and Coerced Sterilization of Women Worldwide, has been an invaluable resource in that effort. It specifically brought attention to the coerced sterilizations of Roma women, women living with HIV, and women with disabilities, and noted that medical personnel are rarely held accountable for these human rights abuses. OSI’s publication helped inform the SRT’s report on all of these groups and is referenced throughout.
The recognition that transgender and intersex people are also disproportionately targeted for coerced sterilizations has previously received less attention and is an important addition to the SRT’s new report. The inclusion of a transgender perspective may well be thanks to Micah Grzywnowicz, an activist who has been fighting against the human rights abuses of transgender people for years. Sex reassignment surgery and sterilization remain requirements for legal gender recognition in most countries around the world today (including 20 American states and 29 European countries).
The inclusion of people with intersex conditions in the SRT’s report is due in large part to Advocates for Informed Choice (AIC), an organization that fights for the civil rights of children born with variations of sex anatomy. Intersex children are often subjected to involuntary genital-normalizing surgery and sterilization without their informed consent in an attempt to "fix" their sex. AIC was thrilled to see this practice recognized as a human rights abuse in the final report, and has high hopes for what may come next.
This is a very significant development. The SRT is an influential voice in setting international human rights norms, and governments around the world will look to this report in creating their own laws and policies.
Both AIC Executive Director Anne Tamar-Mattis and Micah Grzywnowicz will attend the UN Human Rights Council in Geneva in early March to continue to educate human rights officials on the abuses that the LGBTQI community faces around the world.
A lack of conformity to traditional gender norms should not be grounds for dehumanizing treatment. Though the mere existence of this report does not ensure that forced genital normalizing surgeries and sterilizations will end globally, the setting of a new international standard is important. It provides a valuable tool for activists, and will increasingly pressure states to honor the human rights of all of their citizens.
BGI, the Chinese genome-sequencing behemoth, has been attracting attention from feature writers over the last couple of weeks (MIT Technology Review, Business Week, Financial Times). That's only going to get more intense, it seems, as BGI delves deeper into the long-standing controversy about inherited intelligence. A Wall Street Journal article on February 15th, by Gautam Naik, was headlined:
A Genetic Code for Genius?
with the subhead:
In China, a research project aims to find the roots of intelligence in our DNA; searching for the supersmart
The project is being run by Zhao Bowen, described in the first sentence of the WSJ story as "a 20-year-old wunderkind." But it's misleading to think of it as a purely Chinese effort. MIT Technology Reviewdescribes BGI as "the enabler of other people's ideas," with this as a major example. BGI is doing the sequencing and genetic comparison, and picking up half the tab, with a hefty contribution from the Shenzhen government, but the project was conceived by Stephen Hsu, now of Michigan State, and substantially relies on samples gathered by Robert Plomin, of King's College, London.
Hsu has been discussing genes and intelligence for several years, since he was a physics professor at the University of Oregon; we gave him some "mild ridicule" in 2011, noted his connection with BGI and warned that we should keep an eye on this. He made no bones about his desire to identify the alleles for intelligence, select for them, and work on "possible near term genetic engineering for intelligence."
Plomin has been working on IQ for decades. As long ago as 1976, he published an letter on "Heritability of IQ" in Science, responding (as did many others) to M.W. Feldman and R.C. Lewontin. In 1994, he and others claimed to have found "DNA markers associated with high versus low IQ" and "the genetic basis of complex human behaviors." (A 2010 survey, however, found there had been no "reliably reproducible contributions from individual genes"). In the same year, he was also one of the signatories of the Wall Street Journalop-ed "Mainstream Science on Intelligence," which weighed in on the Bell Curve controversy, essentially supporting the book and its inflammatory suggestions about the "intelligence gap" between racial groups in U.S. society.
In 1998, Plomin claimed to have found an intelligence gene, though admitting it only accounted for "about 2 percent of the variance, or 4 I.Q. points." In 2000, he was leading a research team that claimed to be "homing in on the genes for genius." Since then he seems to have been frustrated by the "missing heritability" problem — the failure to find genes that explain inheritance of specific attributes. (GeneWatch published a useful survey of his career in November 2011.) He continues to work on twin studies and supplied blood samples of high-IQ people to BGI.
The concept of general intelligence (g) itself has been for years, and remains, intensely controversial, as indeed are twin studies. Moreover, the search for the supposed genetic basis of complex human behaviors keeps coming up dry. People do, however, keep looking, as the new book Genetic Explanations: Sense and Nonsense (Harvard University Press, 2013) examines in detail. Jeremy Gruber, who edited the book with Sheldon Krimsky, told the Wall Street Journal that there are real dangers in this kind of approach to investigating intelligence, which has been used in the past
to target particular racial groups or individuals and delegitimize them. I'd be very concerned that the reductionist and deterministic trends that still are very much present in the world of genetics would come to the fore in a project like this.
Zhao Bowen, however, is undaunted. He's been working on this since 2010, when he was 17; his plan then was to sequence the genes of 1000 of his highest-achieving classmates. That didn't come off, but connecting with Hsu and Plomin must have been a dream come true. His team is now comparing the genomes of 2200 high-IQ people with several thousand random people, and he seems to be very confident:
"The genetic basis of intelligence has been ignored for a very long time," says Mr. Zhao. "Our data will be ready in three months' time."
Whatever they find is all too likely to trigger a flurry of ill-informed headlines about the genes of geniuses and the limitations of the rest of us. This could even lead to a new round of advocacy for eugenics, whether in a state-sponsored or strictly commercial implementation. We'd better be ready.
An ancient corpse was found buried in a parking lot in Leicester, England, and DNA identified his remains as Bad King Richard III — that's roughly the story that ran around the globe recently, and it's almost entirely incorrect. Richard Plantagenet (pictured at left) was indeed King, for a couple of turbulent years, but after he was killed in the Battle of Bosworth Field, he was demonized by the victors. (Over a century later, a playwright of genius piled on.) His remains were found last September, but the official identification was announced this month, and the genetic evidence was the least of it.
For a start, the body was found where he was buried; they were looking for it. Richard was interred without much ceremony at a small local chapel, which was destroyed about 50 years later when Henry VIII broke with the Catholic Church. Archaeological work about five years ago suggested the location, now the site of a local government car park, to which the team got access. The skeleton was consistent with that of a 32-year-old man with scoliosis, whose skull had been badly cut by a sword and a halberd; contemporary accounts said his head had been "shaved," presumably metaphorically. Radiocarbon dating also put the remains in the right ballpark, though it's not very exact. Short of an ID bracelet, we can only conclude that, as Thoreau wrote, the "circumstantial evidence is very strong, as when you find a trout in the milk."
The DNA evidence, in contrast, was actually rather weak. It came from a comparison of mitochondrial DNA with two living descendants of Richard's sister, and the match was described by an expert as "rare enough to be interesting, but not rare enough to be conclusive." (Scientists are now trying to amplify and match the Y chromosome as well, which requires, inter alia, heroic assumptions of marital fidelity over many generations.) But — as with the identification of Osama bin Laden — the view of the authorities seems to be that the public is so besotted with the "CSI effect" that only DNA will do.
It doesn't have to be that way. Just last week, there was another finding in England, which provoked this classic, and only slightly inaccurate, headline in the Guardian:
Missing Cornish lord found in his own grave
Sir James Tillie, who passed away in 1713, left instructions that his servants should leave him sitting by the window and supplied with food and wine "until the day of resurrection, which he expected to be imminent." After a couple of years, when neither apocalypse nor rapture had manifested, they gave up and dumped him, and probably his chair, in a vault. This tomb was recently discovered, examined, and closed again once the current owner of the property had toasted his predecessor with a glass of the estate's own sloe gin. He told the press:
"There are no plans to exhume the body or to undergo any further DNA tests. There is not really any doubt about who the remains belong to."
Ah, the reality-based community. If only the fourth estate, and those who feed them headlines, would join it.
Many women are understandably drawn to these ideas, but have struggled to find credible information about the true risks of egg retrieval and others’ experiences of it. The US fertility industry is minimally regulated, and there are too few studies of the long-term impacts of donation. Though some personal accounts have surfaced over the years, such isolated stories fail to provide the in-depth insights that are needed. A forum that welcomes open conversation about all aspects of the egg donor experience could help make the experience more transparent and create community with multi-dimensional discussion and the power to change the terrain.
This is the impetus behind Raquel Cool and Claire Burns’ new project, We Are Egg Donors. As egg donors themselves, both women understand what the process entails, and how alienating it can be. Cool is an artist and writer living in Santa Cruz, California who began donating her eggs in 2011. The contradictions and discrepancies she experienced inspired her recent solo exhibition, Live Nude Eggs. Burns is a playwright and performer from Toronto, Canada. After donating her eggs in 2004 she wrote the play Hatched, an investigative piece that delves into the complicated ethical and social dilemmas of egg donation.
The goal of We Are Egg Donors is to promote advocacy and support for egg donors, and to change the conversation. Women who have donated in the past, are considering it in the future (or are just curious), and experts across relevant fields are all invited to join in on the conversation. In a recent email Cool and Burns explain:
Egg donation doesn't need to be an isolating experience when there are thousands of women around the world going through the same process. We are building a community. There are no ongoing resources for egg donors... and we want to change that.
We also believe that women should have access to support and evidence-based information presented by an entity that does not profit from her participation.
We are shifting the narrative that egg donors are voiceless biological resources or strictly doe-eyed altruists. It's a complex experience and we're ready to have an honest conversation about it.
Complex, indeed. Many women who have donated their eggs have nuanced views on the experience. Even if everything goes well, the implications of perpetrating certain standards of beauty and success and being paid for parts of your body can sit uneasily. Additionally, many women do experience negative physical and psychological impacts.
One danger of raising the visibility of egg donors through this self-advocacy model is that it could encourage young women to join this group of attractive and successful people. And a superficial reading of the website could lead one to imagine that if so many others have done this, it must be fine.
Hopefully, We Are Egg Donors can manage those risks and help inform women considering donation of all the potential problems that can arise. The power of access to information that doesn’t stem from a commercial entity can’t be overstated. Hopefully too, this forum will provide solace to those who have donated their eggs and have since experienced alienation, or physical or psychological harm. Lastly, the existence of this community may help raise awareness that long-term follow-up on the impacts of egg donation is sorely needed.
This is the very beginning of the project and We Are Egg Donors is still in the research phase. They are looking for insight, involvement, and resources in order to make this a thoughtful and empowering space. Reach out to them here if you would like to get involved or learn more.
After five years of denials, Israeli government officials have admitted to targeting Ethiopian Jewish immigrant women with long-acting contraceptive injections without their consent. Most of the women were either coerced into accepting the Depo Provera injections while living in Israeli-run transit camps in Ethiopia, or were unaware that the injections produced temporary sterilization.
This controversy first surfaced in 2008, when Sebba Reuven interviewed 35 Ethiopian women awaiting immigration to Israel. Some of their stories were included in a report by Israeli investigative journalist Gal Gabbay that aired several weeks ago on Israeli Educational Television. One Ethiopian woman explained:
We said we won’t have the shot. They told us, “if you don’t you won’t go to Israel…you won’t get aid or medical care.” We were afraid…We didn’t have a choice. Without them and their aid we couldn’t leave there. So we accepted the injection. It was only with their permission that we were allowed to leave.
After arriving in Israel, the Ethiopian immigrants still received Depo Provera in disproportionate numbers in the HMOs providing health care services. According to a report by Hedva Eyal at Isha L’Isha, a feminist organization in Haifa, among the 4833 Israeli women injected with Depo Provera between 2005 and 2008, 57% were of Ethiopian origin—yet Ethiopians comprise less than 2% of the population. Over the past 10 years, Ethiopians in Israel have experienced a 50% decline in birthrate.
Women’s groups in Israel were alerted to the situation in 2008, when Rachel Mangoli, who runs a day care center for 120 Ethiopian children in a suburb of Tel Aviv with a large Ethiopian community, observed that she had received only one new child in the previous three years. According to Mangoli:
I started to think about how strange the situation was after I had to send back donated baby clothes because there was no one in the community to give them to.
In 2008, when queried about the discrepancy between Depo Provera use among Ethiopians and other groups, Israeli Health Minister Yaacov Ben Yezri reportedly explained that Ethiopian women had a “cultural preference” for contraceptive injection. However, World Health Organization reports on contraceptive use in Ethiopia reveal that this is not the case; in fact, three-quarters of women in Ethiopia using birth control choose the contraceptive pill. Ethiopian-born social worker Mekonen-Dego told the Los Angeles Times that “the suggestion Ethiopian women can’t be trusted with responsibility for their own health is outrageous.”
Haaretz reported this week that Health Ministry Director General Prof. Ron Gamzu has now ordered four health maintenance organizations to discontinue prescriptions of Depo Provera for women of Ethiopian origin if “for any reason there is concern that they might not understand the ramifications of the treatment.” Sharona Eliahu Chai, a lawyer for the Association of Civil Rights in Israel (ACRI), whose complaint prompted Gamzu’s response, said:
Findings from investigations into the use of Depo Provera are extremely worrisome, raising concerns of harmful health policies with racist implications in violation of medical ethics.
The use of Depo Provera among Ethiopian immigrants is particularly disturbing because its side effects—including depression, dizziness, abdominal pain, loss of bone density, and possibly increased breast and cervical cancer rates—are well-known. To impose it without proper consent amounts to a potentially harmful policy of compulsory contraception.
The Depo Provera scandal takes place against the background of the Israeli government pro-natalist policies that provide incentives for other (fairer) Jewish women to produce more children, in part as a demographic race with Palestinians. Unfortunately, this contradictory approach to reproductive policy is in keeping with the social and ethnic stratification of Israeli society. In The Chosen Body (2002), Meira Weiss describes Israeli “body politics” that put white Ashkenazi (European Jewish) male bodies at the top of the social hierarchy. In descending order, they are followed by Mizrahi (Middle Eastern Jews), and then by Ethiopian Jews. Only Israeli Arabs, non-Jewish immigrants, and Palestinians in the Occupied Palestinian Territories rank lower.
The coerced prescription of Depo Provera to Ethiopian Jews also stems from broader dynamics in Israeli society. These include lingering questions voiced by a number of Ultra Orthodox Israeli rabbis and others about whether Ethiopian immigrants are actually Jewish; concern that African immigrants in general are a drain on the system and will, as Prime Minister Benjamin Netanyahu put it, “threaten our existence as a Jewish and democratic state”; and widespread discrimination against Ethiopian Jews, who often live in marginalized and impoverished communities and who face social barriers to equal access to jobs, education and housing.
World-wide, the struggle for reproductive and social justice demands attention. The Israeli Health Ministry’s revised directive about the use Depo Provera is a small step in the right direction. However, the discriminatory policies of the Israeli government, toward various ethnic and religious groups, require continued scrutiny.
Should states be allowed to collect and analyze DNA without a search warrant for those arrested but not convicted of a crime? The U.S. Supreme Court will tackle this question on February 26 when it hears King v. Maryland, a case that will have a profound impact on the future of the country’s criminal justice system.
In 2009, Maryland police arrested Alonzo King for waving a shotgun in public, a felony in the state, and required him to submit his DNA. Though he later pled guilty to a reduced charge, which would not have required the DNA sample, it had already been used to link him to an unsolved rape case six years prior, for which he was then sentenced to life in prison. The Maryland Court of Appeals reversed this ruling on the basis that the DNA collection was a breach of the Fourth Amendment protection against unreasonable search and seizure. If the Supreme Court comes to the same conclusion, it will draw an important line in the sand about what constitutes misuse of genetic information.
Electronic Frontier Foundation’s amicus brief of February 4 points to the critical flaw in thinking of DNA as merely a means to identify individuals.
Maryland officials claim that DNA is necessary for definitive identification, but they do not use the sample to "identify" the arrestee. Instead, they use the sample for other investigatory purposes – retaining and repeatedly accessing the wealth of personal information disclosed by an individual's genetic material despite lacking individualized suspicion connecting the arrestee to another crime. This violates the Fourth Amendment.
The ACLU’s February 1 brief offers important information about how DNA collection from arrestees does not actually increase the number of crimes solved. The brief cites numerous reports that have found it to be more effective to spend resources on searching crime-scene samples, rather than on increasing the number of offender profiles in the database. They share an elucidating example of how over the top the practice of pre-conviction DNA collection can be:
The federal government can require you to give a DNA sample if you are arrested for walking your pet off-leash (or with a leash more than 6 feet long), or even parking violations on federal land. The government should not be able to seize, analyze, and permanently databank your DNA just because you took your dog to the park with a 7-foot leash.
Unreasonable search and seizure is not the only concern surrounding the requirement of collecting DNA samples from arrestees. The Council for Responsible Genetics filed a brief with the Supreme Court on February 4, making the case that this practice specifically puts minorities under increased surveillance, since they are already disproportionately targeted for arrests. As CGS Senior Fellow Osagie Obasogie argued in Playing the Gene Card, the increasingly used practices of partial and familial searches will only intensify this problem, leading to further injustices and discrimination against under-represented people and communities.
Despite all of these concerns, there is currently a lot of momentum in the other direction. All states require DNA from people convicted for a felony, but over the past decade twenty-eight states and the federal government have additionally moved to mandate the collection of DNA from at least some arrestees. Last month, President Obama signed the Katie Sepich Enhanced DNA Collection Act, which will help pay for the remaining states to follow suit.
The appropriate use of DNA samples for criminal justice purposes is being hotly contested all over the country. In just the past week proposals to expand DNA collection have been introduced in Colorado and Michigan, while less than stellar results have emerged from New York surrounding their implementation of partial-match technology and mishandling of DNA evidence in crime labs. The Opinion staff at the Los Angeles Daily News wrote a scathing account of one California District Attorney’s suggestion that all undocumented immigrants should be required to submit their DNA in order to stay in the country, renouncing the notion as Orwellian and adding,
"Innocent until proven guilty" is a foundation of American democracy and freedom. When we chip away at that, we're sliding toward Big Brother's totalitarianism.
California currently takes DNA samples from people arrested for non-violent crimes, including drug or property crimes, where DNA evidence has nothing to do with the case at hand, and is not required to destroy the samples if the arrestee is released without charges. Both the California Supreme Court and the Ninth Circuit Court of Appeals are currently holding their decisions on the legality of this practice to first see what happens with King v. Maryland. The Supreme Court decision will either reverse the trend of this erosion of privacy, or formally entrench it as the national norm.
Only a couple of years ago, people were amazed at the idea of genetically testing a fetus using no more than a pin-prick of the mother's blood. Suddenly, the tests have become big business: Illumina recently paid almost half a billion dollars to acquire Verinata, one of at least four companies selling fetal tests, with Sequenom, Ariosa and Natera. Perhaps as a sign of the money to be made, lawsuits have beenflying among them. The talk is now of the tests' scope being determined not by the technology but by the market for it.
Non-invasive prenatal genetic testing was theorized at least 15 years ago, and demonstrated in principle by 2008. Sequenom announced [pdf] that it expected to launch a product in 2009, but that turned out to be so over-optimistic that it triggered an SEC investigation; the launch came in late 2011. Meanwhile, the concept was discussed in an AAAS article by Hank Greely and Jaime King in 2010. Greely's 2011 article in Nature, "Get ready for the flood of fetal gene screening" caused a ripple of concern, as did one shortly thereafter in Science Progress by CGS's Marcy Darnovsky with the prescient title:
One Step Closer to Designer Babies:
New Noninvasive Prenatal Genetic Testing Could Change Human Pregnancy Forever
Not enough people paid enough attention, it seems, until much more recently. In September 2012, New Scientist published an explanatory piece by Harriet Washington titled, "Do You Really Want To Know Your Baby's Genetics?" (an excellent introduction). In December, Wired ran a feature on the subject and just last month, two notable articles appeared, both with warnings in their titles. Scientific American said that "Fetal Genome Screening Could Prove Tragic" while MIT Technology Review introduced their survey as "A Brave New World of Prenatal DNA Sequencing."
What seems to have jarred at least some science journalists out of a kind of complacency is the clear demonstration that the technology is not just for autosomal disorders any more. (See George Estreich's posts for much more on the whole issue of testing for Down syndrome, the most publicized of them.) And choosing traits is getting much closer.
Initially, the tests on the market were specifically aimed at conditions in which the fetus has a duplicated chromosome other than the X or Y chromosome. Then some of them expanded to include several X- and Y-chromosome conditions. And now scientists from Tufts and Verinata have demonstrated that they can identify "fetal sub chromosome abnormalities" down to as little as 100 kilobases of DNA. That is not a product yet, but Verinata's chief science officer was quoted by Bloomberg as saying that they would give "serious consideration" to developing one:
"It won't be tomorrow," he said. "The study shows that this is no longer a technical issue for us. Now it's more of a question of how does the market want to drive forward with this."
Rival company Sequenom, which was the first on the market with an autosome test, seems even more committed to the process. Chief medical officer Alan Bombard told MIT Technology Review:
"We are just getting started with [abnormal numbers of five specific chromosomes], but we will be expanding this to single gene disorders."
It was only in December last year that The American College of Obstetricians and Gynecologists Committee on Genetics and The Society for Maternal-Fetal Medicine Publications Committee issued their guidelines on noninvasive prenatal testing, which acknowledged its potential but cautioned:
Cell free fetal DNA testing should be an informed patient choice after pretest counseling and should not be part of routine prenatal laboratory assessment. Cell free fetal DNA testing should not be offered to low-risk women or women with multiple gestations because it has not been sufficiently evaluated in these groups. A negative cell free fetal DNA test result does not ensure an unaffected pregnancy. A patient with a positive test result should be referred for genetic counseling and should be offered invasive prenatal diagnosis for confirmation of test results.
Solid, conservative, sensible. And much too late. That recommendation came after Sequenom had already sold some 60,000 tests and was on pace to double that number this year alone. The companies like to cite the statement as approval; Sequenom even includes the phrase "should not be part of routine prenatal laboratory assessment," though careless readers might overlook it, because they recast the sentence to imply that informed patients should choose to have the test.
This train seems to be careening down the tracks, and the medical establishment is just not keeping up with it. The NIH has launched a five-year, $25-million program to study the partly related issue of genomic screening in newborns, which is welcome, but already may be too late. In five years will screening be common (if not actually routine) not for newborns but for first-trimester fetuses? And how are we, as a society, going to react to that?
California has a long and deeply troubling history of eugenics that includes the forced sterilization of tens of thousands of men and women. In 2003, the state Senate passed a resolution urging “every citizen of the state to become familiar with the history of the eugenics movement, in the hope that a more educated and tolerant populace will reject any similar abhorrent pseudoscientific movement should it arise in the future.”
Unfortunately, the resolution did not include concrete mechanisms for achieving this important goal, and most Californians still know little or nothing about their state’s eugenic legacies.
A group of California high school students has now started an online petition at Change.org to help turn the resolution’s aspiration into reality. The petition outlines specific and powerful recommendations for teaching the long-ignored history of eugenics in meaningful ways.
The students want the California Board of Education to change the standards for U.S. history textbooks and the language of the California educational code so that curricula on sterilization and eugenics are introduced in public high schools. They offer specific recommendations for the curricula, which include thinking about why eugenics was considered a viable solution to societal problems, looking at different eras of sterilization in the state (including very recent occurrences), thinking about how the history is both intertwined with and separate from the eugenic practices of Nazi Germany, and thinking about the ongoing relevance of eugenics for genetic technology today.
In California as elsewhere in the United States, eugenic views and practices were maintained by respected medical practitioners in the name of morality and science. The students recognize that this framework is particularly dangerous because of its power to affect opinion and justify institutionalized discrimination; they also recognize that this thinking is not limited to the past. They quote State Attorney General Bill Lockyer, who was forthright about the matter in an official 2003 letter acknowledging California’s eugenic history.
“At the Dawn of an era when cloning and genetic engineering offer both great promise and great peril, we must learn from our history, teach our children about our past and be mindful of our future.”
The students’ effort to change the state’s official history curricula and textbooks may seem daunting, but the passage in 2011 of California’s FAIR (Fair, Accurate, Inclusive, Respectful) Education Act – which mandates the inclusion of contributions of people with disabilities and lesbian, gay, bisexual, and transgender people in social studies curricula and textbooks – has set an important precedent. The FAIR Education Act demonstrates that what kids are taught can be changed to more closely reflect the truth, and the effort to spread awareness about eugenics can follow a similar model. California public high schools should be required to use U.S. history textbooks that don’t ignore these issues.
Eugenics is unfortunately not merely a concern for the history books. Shockingly, forced sterilizations have occurred in very recent years in some California prisons. And potential misuses of new genetic and reproductive technologies raise concerns about a “new eugenics.” Learning from the mistakes of the past, and acknowledging the harm they are causing in the present, is the best way to avoid repeating injustices down the road.
Now seems to be a ripe moment for addressing the legacies of eugenics in the U.S. There are several ongoing efforts to offer compensation to victims of forced sterilizations around the country, including the recent bills in Virginia and North Carolina. In California however, where none of the estimated 20,000 victims of state-sponsored sterilization are still alive, educational reform could be the most effective way to address these past wrongs.
Californians deserve to know the truth about their state’s – and their country’s – role in the history of eugenics. The victims of forced sterilization deserve to have their story told. This is a critical moment to learn about the complexities and possibilities of justice, equality, and human rights.
The student petition is one of the most uplifting and creative ways to grapple with this painful history that I have seen. Please consider helping these students’ effort and sign the petition today.
One of many protests against forced sterilization in Sweden, Stockholm Pride Parade, 2010
The law in Sweden that for more than 30 years had required transgender people to undergo sterilization before they could be legally recognized as another gender has been deemed unconstitutional and in violation of the European Convention on Human Rights.
A year ago, the government was unable to repeal the law because a small conservative group managed to block the effort. International human rights activists fought back, gaining media attention and putting significant pressure on the country. The European Council’s Human Rights Commissioner declared that the law did in fact violate human rights, and an amendment was proposed by the Swedish National Board of Health and Welfare.
Finnish center-right MEP Sirpa Pietikäinen told the European Parliament LGBT Intergroup, “This isn’t about LGBT rights; it’s about human rights and torture, cruel, inhuman and degrading treatment.”
Green MEP from Spain, Raül Romeva i Rueda, added: “The government’s decision is rather surprising: forcibly sterilising transgender people is recognised as inhumane across the political spectrum. It’s barbaric, outdated and highly unnecessary—not to mention against Sweden’s human rights commitments.”
Amanda Brihed, who underwent forced sterilization when she had male-to-female realignment, has become a public advocate for transgender rights. In a recent interview with Vice, she described the social environment transgender people face in Sweden.
“We still aren't considered to be human beings. Our protection against discrimination, threats, violence and hate-crimes is still very limited. We're not even protected in labor laws. Forced sterilization is just the tip of an iceberg.”
Brihed is one of more than 500 people who were sterilized under Sweden’s law; she is part of the class action and is hoping to receive some compensation from the state. Ulrika Westerlund, head of the Swedish Federation for Lesbian, Gay, Bisexual and Transgender Rights, has suggested that 200,000 kronor ($31,000) per person would be an acceptable amount. In 1999, Sweden offered 175,000 kroner to those who had been forcibly sterilized under a eugenics program that wasn’t abolished until 1996.
In the United States, though sterilization is not required before gender reassignment surgery, efforts to monetarily compensate victims of state-sponsored eugenic sterilization have thus far hit dead ends. Are there lessons to be learned from the successes in Sweden?
The fight for humane treatment of a minority group must walk the fine line of simultaneously voicing the concern of one specific group (thus outlining the boundaries of what constitutes that group) while making the case that there is no fundamental difference between that group and the human community at large; that they are just as deserving of human rights as others. The protests in Sweden and around the world against the dehumanization of transgender people have walked this line with deft skill.
The new ruling in Sweden is a reminder of the power of the human rights framework. The United States has historically not given much weight to international human rights conventions and has lagged on establishing guidelines for new technologies, medicines, and practices.
George Church hit a nerve when he recently discussed re-creating Neanderthals with an "adventurous human female" surrogate, in Der Spiegel. The media attention rapidly became fierce, with dozens of outlets carrying the remarks. Yesterday, Church told the Boston Herald that the whole kerfuffle was based on "poor translation."
As for cloning a Neanderthal, he said, "I'm certainly not advocating it
… I'm saying, if it is technically possible someday, we need to start
talking about it today."
It's good to hear Church disavowing the idea of using genetic
engineering, synthetic biology and human surrogates to create a
Neanderthal clone baby, at least for the time being. But it's
disingenuous of him to shift all the blame onto the translation process.
The phrase that clearly got the most attention was "adventurous female
human" — and that comes straight from the prologue of his own recent book, Regenesis: How Synthetic Biology Will Reinvent Nature and Ourselves (co-authored with Ed Regis, published in October 2012):
If society becomes comfortable with cloning and sees value in
true human diversity, then the whole Neanderthal creature itself could
be cloned by a surrogate mother chimp — or by an extremely adventurous
Is Church personally looking for a human surrogate to gestate a
Neanderthal clone, right this minute? No. Is he willing to openly
advocate for the scenario that he describes in some technical detail?
Not forthrightly, and both in his book and in the interview that sparked
the recent furor, he includes "ifs" and caveats. Does he think that the
process will be technically feasible in the foreseeable future?
Emphatically yes. He's been talking about this and similar projects for
several years. For example:
Dr. Church said there might be an alternative approach that would
"alarm a minimal number of people." The workaround would be to modify
not a human genome but that of the chimpanzee, which is some 98 percent
similar to that of people. The chimp's genome would be progressively
modified until close enough to that of Neanderthals, and the embryo
brought to term in a chimpanzee.
"The big issue would be whether enough people felt that a
chimp-Neanderthal hybrid would be acceptable, and that would be broadly
discussed before anyone started to work on it," Dr. Church said.
Is there a gene for mass murder? Of course not. But within a week of the December 14 elementary school massacre in Newtown, state authorities were planning to do genetic tests on the tissues of the man who committed the horrific crime and then killed himself. There are real risks involved in this, and few — if any — scientific merits.
Lanza's DNA will be analysed not because it will be useful but because it can be analysed. The ease of DNA sequencing will lead to a dangerous temptation to focus on minor, even spurious, genetic correlations at the expense of non-genetic factors that are more influential.
But aside from being a distraction, can sequencing Lanza's genes do any harm? Why not give them a look?
As a society, we have a record of attributing criminal tendencies to biological traits, and basing social policy on the results. Remember phrenology? Remember eugenics? Another false scientific theory that is particularly relevant is the "criminal chromosome." The 1961 discovery that some men have two Y chromosomes led to the suggestion that they must be doubly male — "super male" — and therefore prone to aggression. In 1968 the New York Times and other major publications jumped on this bandwagon. Social consequences soon followed:
Newborn screening programs were set up in several states to identify baby boys who were XYY.
In 1970, President Richard Nixon's personal medical advisor proposed testing the genes of every American child between ages six and eight, in order to identify those with "criminal potential." He suggested that "hard-core 6-year-old" children be sent to "camps" where they could learn to be "good social animals."
In the same year, the eminent geneticist H. Bentley Glass told the annual meeting of the American Association for the Advancement of Science that he looked forward to the time when pregnant women would be required by the government to abort XYY "sex deviants."
A psychologist at Johns Hopkins Hospital tried to treat 13 XYY boys and men with behavior problems by chemical castration. It didn't work, but its side effects included weight gain — and suicide.
Most of this happened after there was expert testimony and published research showing — correctly — that XYY men were not more likely to be criminal than XY men.
In the wake of a tragedy like the Newtown massacre, it may be understandable to grasp at simple explanations, and to fall prey to spurious correlations. But to think that genes will tell us who to fear is a serious misunderstanding of genetic science. And history tells us that such erroneous ideas are extremely likely to lead to demonizing some group of people, whether identified by the shape of their head or the color of their skin or the religion of their ancestors — or the particular configuration of their DNA.
Church is currently developing technology in his lab that can be used to make human cells similar to those of Neanderthals. Eventually, an "adventurous female human" needs to be found as a surrogate mother for the first Neanderthal baby ...
(It sounds no better in the original German, here.**)
Church had previously voiced his enthusiasm about using a chimpanzee as a surrogate for a Neanderthal-like baby. Originally, this seems to have been an outgrowth of proposals in 2008 to revive the extinct mammoth, in part by reprogramming and then re-engineering an elephant's cells.
At that time, Church proposed the chimp workaround for creating Neanderthals as an alternative to using humans that would "alarm a minimal number of people." He seems to have lost whatever inhibitions he then had.
He also seems to be callously indifferent to the fate of the women who would supply eggs for his experiment, and then, he hopes, offer their bodies as surrogates. (One woman? He's going to get this right the first time? That seems unlikely.)*** Other people's bodies — even, perhaps, his own — are mere phenomena, to be investigated and played with, to satisfy his own abundant curiosity.
His ambitions are not limited to reviving our long-lost cousins. He also hopes to tweak human genetic design, to extend lifespan ("What if we were all 120?"), to program in resistance to viruses, and then ... well, he has previously written that:
Our methods treat the chromosome as both an editable and an evolvable template, permitting the exploration of vast genetic landscapes.
Church is aware that some people are strongly opposed to this kind of technology, but he clearly does not understand why. The Der Spiegel interview closes ominously with his assertion that while mingling human DNA with that of other species has always been off-limits, "this barrier will fall."****
He's not just misogynist, though the effect on women would be the first bad consequence of his deluded fantasies. He's downright misanthropic. A benevolent, even gregarious, misanthrope perhaps; but a deeply misguided one.
Update 1/22/13: Church has strongly objected to the way many outlets reported this story, and insists that he is "certainly not advocating" impregnating a woman with a Neanderthal embryo. He blames, in part, translation problems. More context will be provided in a later post. In the meantime, some minor edits and comments are called for:
*It is incorrect to say he "told" Der Spiegel that he would "soon" be looking; rather, he delineated a theoretical process. In the now-posted English Q&A, from which the German interview is clearly derived, he was asked, "Will you witness the birth of a Neanderthal baby in your lifetime?" He replied, "That depends on a hell of a lot of things, but I think so."
**The Q&A does include significant caveats, such as: "However, the prerequisite would, of course, be that human cloning is acceptable to society." But the phrase "an extremely adventurous female human" is in the Prologue (p. 11) of his book Regenesis, used in this exact context, and Der Spiegel asked him about it. Church's principal focus in the discussion is on the benefits to be obtained from these experiments.
***Church specifically discusses creating "a cohort, so they [the neo-Neanderthals] would have some sense of identity." That considerably increases the number of women who would be at risk.
**** From the Q&A: "So far, the definition of different species has been that they can't exchange DNA. But more and more, this species barrier is falling. Humans will probably share genes with all sorts of organisms."
Posted by Abby Lippman, Biopolitical Times guest contributor on January 17th, 2013
Forget about glass ceilings, sexism in employment, gender inequities, and all those other structural and societal policies and practices that put obstacles in the way of women (as well as racialized groups) who want to get ahead. Maybe it's just that they are more likely to lack the unimaginatively-named rs4950 genotype, a DNA pattern that seems to be "passed down from parents" – just like the privileges and power that groom the offspring of some for "leadership."
Perhaps these new findings will be of interest to those who like to start orienting toddlers for their future careers even before they've found them places in upscale daycare programs. The news may also please those already excited by the same authors' findings that "happiness is significantly influenced by genetic variation"
In this case, the source was said to be a serotonin transporter gene (SLC6A4) -- even though the authors hedged their enthusiasm noting that a "combination of economics and genetics "was of "rising salience."
In any event, I'm interested here in the newer hyped data about rs4950, apparently a "marker residing on a neuronal acetylcholine receptor gene (CHRNB3)" of which two copies, one from each parent, seem to be the lucky dose for getting ahead. And hey: acetylcholine seems to have something to do with being impulsive or patient – though the authors at least don't yet try to draw causal links for any of this.
Most people will read of the "leadership gene" through press releases and media reports and not see all the caveats, cautionary details, and various uncertainties the authors acknowledge in the published paper, and this is a pity. Because what they will read or hear is a clear "Yes" in response to the straightforward question: "Is there a gene for leadership?" And so easily erased will be the equally strong, if not stronger, "yes" that is established as the answer to questions about whether gender plays a role in leadership. (And unfortunately, too, the authors seem to recognize this but nevertheless fail to correctly control for sex in their major analyses.)
All this leads to one of my major concerns with this (and similar) work. Given the very well-documented and persisting gendered "leadership" gaps in business as in academia, why should we care about genetic polymorphisms that explain little if anything of why some succeed and others are prevented from doing so? Conversely, why do we not care appropriately about all the structural and societal determinants that make it impossible for so many who want to climb up the corporate ladder?
Many social conditions can be conveniently ignored if corporations can screen job applicants and pick out the genetically predisposed who can be given a "go straight to the boardroom" card when handed their MBA degree. With this latest "quick fix," who will invest in social change?
Of course, it'll be important to figure out how to avoid potential genetic discrimination, and perhaps give a token nod to understanding any environmental factors that may play a role in the standard refrain about "nature/nurture" interactions. But last time I checked, there are few funds for studying the "nurture" component and grossly insufficient policies to control discrimination based on the former – and so once again, genetic determinism may trump attention to social policy changes that break ingrained practices of gender and racial judgments in hiring practices.
Abby Lippman has spent decades following developments in applied
genetic and reproductive technologies. Her main interests as a feminist
researcher, writer and activist center on women's health and the
politics of health. She is also Professor Emerita in the Department of
Epidemiology, Biostatistics and Occupational Health at McGill
The outpouring of anguish and protest at the brutal gang rape and murder of a young woman in Delhi has sparked reflection about the various manifestations of misogyny that are deeply entrenched in India – and from which other cultures, including our own, are far from immune. Among the dots being connected to violence against women is the widespread practice of sex selection.
Shalini Nataraj, director of advocacy and partnerships for the Global Fund for Women, mentions sex-selective abortion both in her comments on KQED Forum and in an op-ed in the San Francisco Chronicle. Nataraj names sex selection as an aspect of the “rising tide of crimes committed against women” and puts it in the context of both “the social and cultural paradigms that enable and trivialize rape globally” and the women’s organizations that are battling these conditions.
Mira Kamdar, author of Planet India: The Turbulent Rise of the Largest Democracy and the Future of Our World (2008), also raises sex-selective abortion, son preference and India’s “growing gender gap” as part of “deep-seated culture of misogyny” in her article in The Atlantic. Like Nataraj, she makes a point of acknowledging that violence against women is not confined to India. In Planet India, she provides additional context and nuance about the sex selection crisis, explaining that instead of fading away with modernization and economic improvement as many expect, it is in fact getting worse:
One of the most perverse effects of India’s rising prosperity is the increase in sex-selective abortion, which is practiced far more commonly by the rich or aspiring middle class than by the poor. Indians want to improve their economic prospects. They see one sure way of doing so: avoid having a girl child and the expense of a big dowry...
A society with skewed sex ratios, millions on the move as they migrate from place to place in search of livelihoods, and a gross devaluation of women is naturally a society prone to violence against women in all its forms.
Kamdar also notes the new reproductive technologies, most of them developed in the US, that exacerbate the problem of sex selection. “Truly insidious,” she writes, “is the practice of sex-selective sperm sorting followed by artificial insemination. This technique is virtually untraceable.”
Another commentary, this one by early-childhood educator, Harvard College administrator and Time columnist Erika Christakis, is headlined bluntly, “Rape in India: A Result of Sex Selection?” In her widely noted piece, Christakis focuses less on the broad social, political and cultural dynamics underlying sex selection, emphasizing instead “fundamental demographic forces” and “the problem of `missing girls’ as an issue of international security.” And though she acknowledges sex selection in countries including Albania, Georgia and Armenia as well as in India and China, she doesn’t mention either sex selection – or for that matter violence against women – as problems in North America or Western Europe.
Neither sex selection nor violence against women look exactly alike or erupt from precisely the same underlying dynamics in different parts of the world. But as important as it is to understand the differences, it is also crucial to consider – and to confront – the similarities and interlocking influences.
A somewhat breathless headline in The Atlantic recently declared 2013 to be the Year of the Stem Cell. Which may not be good news for the field: There's been lots going on in the last couple of weeks, some of it hopeful, but some of it downright scandalous.
First the unequivocally good news: The U.S. Supreme Court refused to intervene to stop federal funding of embryonic stem cell (ESC) research. This ends a suit brought by a pair of researchers who work on adult stem cells; they technically won a brief stay on funding but that was suspended and then overturned on appeal, and the appeal will not be reconsidered. The policy President Obama put in place in 2009 will therefore continue.
Also promising is that ACT's clinical trials of ESC-based therapies are in process, thus far successfully, and the clinical trial Geron suspended will soon resume. Research continues on iPS cells, some of it ethically problematic, but some potentially very useful.
In the glass-half-full category is the growing media attention to the dangers posed by stem-cell scam artists. Perhaps the most extraordinary story is that of a woman who had a face lift that used her own adult stem cells, which led to small chunks of bone forming in her eyelid. Fortunately the FDA seems to be moving to regulate stem-cell clinics, of which the most discussed in the U.S. is Celltex. Paul Knoepfler, the prominent stem-cell researcher and blogger, commenting on a recent story about the company's troubles with the FDA, points out:
The worst-case scenario is not that the therapy won't work, but rather that it will kill or seriously injure the patient.
Meanwhile, Celltex is engaged in lawsuits with its former partner, RNL Bio. (Incidentally, the former bioethicist Glenn McGee, whose brief tenure with Celltex raised eyebrows last year, is now with RNL Europe GmbH, as its "key executive.") Meanwhile, RNL Bio is in legal trouble in Korea again, this time for smuggling stem cells out of the country and into China and Japan.
But if that's bad, this (via Haaretz) could be ugly:
Stem cell tourism prepares for take-off
Though prohibited in the West, innovative treatment in Eastern Europe and Asia is attracting a growing number of desperately ill people.
There is more, and in the western hemisphere. For instance, the Bahamas is proposing to include stem cells as "an important part of the country's medical tourism thrust." The government task force rejects the use of ESCs, but embraces iPS and adult stem cell technology, in the hopes that it will "jump start a more than $100 million medical tourism industry."
The stem cell business is developing rapidly, and increasingly international in scope. Clearly there are some delicate issues about intrusion into personal decisions. Indeed, Arnold Caplan, of Case Western, has suggested that if you want to pay $25,000 for a placebo, "go do it." That seems, at best, to ignore the real-world consequences: Desperate people may have a right to choose high-risk, low-probability courses of action if they affect no one but themselves, but does anyone really think there won't be shysters ready to defraud them?
In spite of an end-of-year flurry of deals, last year was relatively slow for mergers and acquisitions in the genomics and related sectors, according to GenomeWeb, and this year may not be much more active. This seems to be because technology is in something of a holding pattern. There are hopes of the "$1 million medicine" but for the moment that only applies to very small niche markets; widespread gene therapies remain distant prospects, and even genomic sequencing is in a phase of "incremental" advances. Still, some recent moves are worth noting.
Illumina, the genomic sequencing and analysis company, was at the center of several stories. Roche, the Swiss pharmaceutical giant, tried to buy Illumina for $6.7 billion, but eventually backed out, saying the company was "not willing to abandon the totally unrealistic price they were asking for." Besides, there are "several alternatives to get hold of gene-sequencing technology," so Roche could yet make waves in the field.
Meanwhile, Illumina bought Verinata Health for $350 million, which could rise to $450 million. That gives them rights to the verifi® non-invasive prenatal test, which detects Down syndrome and two other trisomies, and is being expanded to cover Turner and Klinefelter syndromes, among others. Presumably more R&D funds will be available for the product, though some analysts are skeptical about the synergies available in the short term.
In other news related to testing, Amgen bought DeCODE Genetics for $415 million, but discontinued its direct-to-consumer (DTC) division, DeCODEme. This is good news for 23andMe, which almost simultaneously raised $50 million in new financing, with the goal of increasing the number of customers in its database from 180,000 to a million. The money came from current investors, including Google, and Russian Internet billionaire Yuri Milner.
On a much smaller scale, Geron finally managed to find a buyer for its embryonic stem cell (ESC) technology. That is BioTime Acquisition Corporation (BAC), a subsidiary of BioTime, which was founded by Michael West, who founded both Geron and Advanced Cell Technology, and seems to be developing a network of businesses. BAC is run by Thomas Okarma, the former CEO of Geron, and a long-time advocate for the ESC trials, which were cancelled after he was fired. This deal is basically funded by a $10 million investment from an unnamed private investor (someone seems to know who), half of it rolled through BioTime and half put straight into BAC, in which Geron also keeps an interest.
West's talents may be wasted on these little deals; what could the man do with a few billion to play with?
An AquAdvantage® Salmon (back) & a non-transgenic Atlantic salmon (front) of the same age. (From AquaBounty)
The Food and Drug Administration (FDA) seems to be close to allowing the sale of genetically modified (GM) salmon. This would be the first GM animal ever allowed into the U.S. food supply, and as such could be an important precedent.
No final decision has officially been made, pending public comment (see below for contact details) but the FDA has tentatively concluded that the fish is safe, on what seems to be shaky evidence.
The FDA seems to be trying to minimize publicity: Friday is the best day to publish documents you'd rather not talk about, and the Friday before Christmas (in the midst of a noisy Washington stand-off over taxes) is about as good as it gets. That's when the agency released its "Preliminary Finding of No Significant Impact" (pdfs linked here) on the subject of AquAdvantage® Salmon, a modified Atlantic salmon made by AquaBounty that includes genes from two other species.
This transparently political piece of timing followed, and may have been provoked by, a transparently political complaint that the failure until then to release a report that is still dated May 4th was transparently political. Well, of course it was. So is the fact that the FDA's Environmental Assessment (EA) report is severely limited in scope, as it explicitly acknowledges (pdf, p. 10):
Social, economic, and cultural effects have not been analyzed and evaluated in this draft EA.
And why is that? On one level, it's because the salmon, though aimed at the U.S. market by a company incorporated in Delaware, will be grown in Panama from Canadian eggs (pp. 1–6, 49–64). So the environmental impact in the U.S., narrowly considered, is zero. Unless, of course, some of the humans or other inhabitants (animal, vegetable or mineral) become ill. But that likely won't happen because, best they can tell, these GM salmon are just like ordinary Atlantic salmon (pp. 2, 26–34). Except that they grow unusually fast. Oh, and the ones they are thinking about putting on the market are triploid: they have three sets of chromosomes, instead of the usual two.
Triploidy does admittedly produce "abnormalities" (Briefing Packet, 2010 [BP, pdf], pp. 25–33). But there's a good reason for inducing it, via pressure shock treatment applied to the fertilized eggs (BP, p. 52):
Female triploid salmon are effectively reproductively incompetent, providing additional environmental and intellectual property safeguards.
Aha! It's a kind of Terminator technology. However, skip ahead to p. 57:
We have confidence that the method will provide triploid rates greater than 98% for most inductions.
Wonderful. So one or two of every 100 fish will not be "reproductively incompetent." But, hey, what are the odds they'll escape, breed and terrify New York by climbing up the Empire State Building? Well, every year millions of farmed salmon do escape, and cause environmental damage and genetic contamination. Have these been genetically modified for docility? They don't say so.
The FDA is ready to conclude that "there is a reasonable certainty of no harm from consumption of food from triploid ABT salmon" but not for the diploid version, "due to uncertainties regarding the allergenicity of the tested tissue in a study of low quality" (BP, p. 109). Really? Oh, yes, and the other studies are not much better, notes Michael Hansen of the Consumers Union,
"FDA has allowed this fish to move forward based on tests of allergenicity of only six engineered fish, tests that actually did show an increase in allergy-causing potential."
See also BP, p. 103, and this article by Martha Rosenberg in Food Consumer, which cites several academics raising more questions about the studies on which the FDA relied.
Let's face it, salmon raised in containment in Panama from eggs made in Prince Edward Island are not going to feed the world. At best, this is a niche product. So why is Intrexon, a synthetic biology company, investing in and trying to buy AquaBounty, which was recently said to be close to bankruptcy? For that matter, why is the Genetic Literacy Project taking to both Slate and Forbes to hype up this product and accuse the White House of ethics violations? Well, as AquaBounty CEO Ron Stotish told the AP,
"This is about more than Aquabounty and more than salmon."
Indeed it is. This is politics, and it's a high-stakes game for the whole biotechnology industry. That's a significant reason why the environmental assessment process is so limited; it's also why the FDA is still hedging its bets:
"The release of these materials is not a decision on whether food from AquAdvantage Salmon requires additional labeling; nor is it a decision on the new animal drug application currently under review. It also does not provide a final food safety determination."
Every move to label GM food is, of course, fought tooth and nail by the industry, but they may actually be losing that struggle. In California, they had to spend at least $46 million to beat Proposition 37, whose proponents raised $9 million and barely lost, 49–51 [pdf]. The closeness of that race seems to have encouraged activists in Washington, Vermont, Iowa, New Mexico, and elsewhere. The FDA could really stir the pot by requiring labeling of GM salmon.
Meanwhile, the FDA is accepting comments on the AquAdvantage® Salmon, either electronic or written, until February 25, 2013. Comments, which should reference Docket No. FDA-2011-N-0899, can be posted via www.regulations.gov, or mailed to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
The image DNA Lab Center uses for its Native
American DNA Testing Services of New York
The question of who belongs to what Native American tribe has long been politically, socially, and legally fraught. In the 1930s, for example, the US government passed “blood quantum laws” that defined tribal membership – a particularly sensitive episode that demonstrates the many flaws with outside declarations of who has the required amount of “Indianness.” The delineations of identity in those laws were often based on imperfect records and ignorance of the fact that tribal membership has always been a complex combination of factors, not all of them biological.
Native American tribes now have their own varying membership criteria. But controversies continue. The growth of casino gaming and the resulting profits have led some tribes to tighten their requirements, and thousands have had their tribal citizenship revoked. James Mills of Creating Stronger Nations, a Native-owned company that consults with tribal communities and nations, has said, “The moment you draw a line in the sand on enrollment, the moment you have rules, there is going to be some unfairness. There is no perfect system. There just isn’t one.”
DNA ancestry tests are nonetheless currently being marketed to Native Americans as though they could be this “perfect system.” Advertisements make bold claims such as,
Discover your personal history: Cherokee? Apache? Choctaw?” - DNA Spectrum. What’s your tribe? Mayan? Navajo? Salish?” - DNA Tribes. “Discover your Native American History” - Family Tree DNA.
As UC Berkeley assistant professor of science, technology, and environmental policy Kim Tallbear and University of Texas assistant professor of molecular anthropology Deborah Bolnick have noted, the central message of such advertisements is “that DNA testing proves Native American identity in a scientifically objective manner.”
How does this affect tribes’ hard-fought sovereignty? How does it impact tribal and personal identity?
A few tribes have adopted DNA testing. Some see it as a way to end disagreements over disenrollment, reasoning that if some kind of identity test has to be utilized, perhaps this is one of the better options. Sure, such tests could never identify social or political access to membership, but they can at least give an accurate portrayal of genetic ancestry, right?
Well, in a word, no.
The freedmen are descendents of black slaves who were owned by the Cherokee. They have been involved in legal battlesfor years with the Cherokee Nation over their membership status. Many have difficulty tracing their lineage to the Dawes Rolls, used in the years around the turn of the 19th century to determine tribal membership, because blacks were often excluded simply due to their racial appearance, despite having been part of the Cherokee tribe for a century at that point. Many freedmen hoped that DNA ancestry tests would help prove that they are in fact Cherokee.
In 2004 a number of freedmen took DNA ancestry tests from the company African Ancestry. The test results were a disappointment to them because they showed low percentages of Native American markers. Instead they revealed something unexpected: an unusually high number of European ancestry markers, which coincidently match the high degree found among the Cherokee. Though this ancestry almost certainly did come from the Cherokee, the tests themselves had no way to prove that, and so did little to clarify the situation.
The markers that are used to “determine” Native American ancestry are typically five different haplotypes on the mitochondrial DNA that are thought to have descended from the founding ancestors, which are passed down only through the maternal line. On the paternal side, there are two primary haplogroups seen in modern Native Americans. These markers test only one line of ancestry each and so are necessarily imperfect; furthermore, while these markers appear more frequently in Native Americans, they are also found in people all over the world. The premise that genetic tests can reveal your specific tribe is especially misleading because neighboring tribes have never been completely isolated from each other. Inter-marriage, raids, adoption, displacement, invasion, and changes in delineation mean that there is no clear-cut genetic way to distinguish one tribe from another.
Though DNA testing is not actually able to provide definitive biological answers, it is nonetheless expensive ($150 - $600 per individual). It’s no wonder that DNA ancestry companies market to Native Americans; even if just a fraction of the thousands in a tribe take the test, the profits add up.
Native American poet and novelist Sherman Alexie doesn’t think tribes should succumb to the aggressive marketing of DNA testing. He argues that “DNA is an utterly white thing to do. It’s capitalism, it’s racism, it’s apartheid, it’s colonial.”
Deborah Bolnick asks, “Why should tribes give up authority to a test that can’t reliably affiliate a test-taker with a specific tribe or ensure that tribal members are culturally connected and committed to the tribe’s future?”
As concluded by the Indigenous Peoples Council on Biocolonialism, the notion that a DNA ancestry test could dictate who is and who is not a member of a Native American tribe undercuts tribal sovereignty. Biology is clearly only one factor in Native American membership or identity; cultural experiences often have much greater weight. Even if DNA ancestry tests are only considered for the additional scientific “facts” they bring to bear, the frequency of false positives and false negatives means they are not a reliable way to determine complex ancestral histories. With so much on the line legally, politically, and socially, it seems irresponsible for DNA ancestry testing companies to promise definitive answers about tribal membership.
Mitinori Saitou and colleagues in Kyoto created mice by using sperm and eggs grown from iPS cells,
though supplied ovaries were also needed, at least for the time being.
This sparked immediate speculation about human applications, as did an
earlier Chinese technique of generating sperm. In Korea, there was a push to remove restrictions on human research cloning, and eventually reproductive cloning. Korean animal cloning also garnered free publicity via reality TV.
Inheritable genetic modification
Scientists at the Oregon Health and Science University combined
sperm with the nuclear DNA from one egg and the mitochondrial DNA from
another to generate blastocysts (and embryonic stem cells). If carried
to term, these would be “3-parent babies”
and, the scientists acknowledge, constitute human germline
modification, also known as inheritable genetic modification (IGM). The
team produced live monkeys
using this method in 2009, and are pushing the US Food and Drug
Administration to approve human clinical trials, although all human
germline interventions have previously been considered off limits by
scientists around the world and more than 40 countries have passed laws
against it. In the UK, the HFEA has started a public consultation about allowing similar mitochondrial replacement techniques.
General advocacy of IGM
was on the rise this year: various proponents advocated it as an
alternative to geoengineering, a military technique, a routine
application for making better children, or even a moral duty to create “designer babies.” Critical discussion of the “eugenic impulse” also broadened, while some (particularly several proponents of synthetic biology) tried perversely to reclaim it as a positive, even ethical, desire.
Prenatal, newborn and other genetic testing
The direct-to-consumer (DTC) gene testing industry attracted some new investment, and controversially began considering whole-genome sequencing, particularly for babies.
The development of private databases that can be sold for research use
began to draw more attention, especially since promises of anonymity
seemed increasingly implausible.
Non-invasive prenatal diagnostic (NIPD) testing, which analyzes fetal DNA circulating in the mother's blood, was shown to be feasible, raising eugenic concerns and complex ethical issues. The marketing of such tests, and the ideology behind them, was questioned in detail on this blog (1, 2, 3).
Following a Biopolitical Times tradition, we present some of our favorite blog posts of the year, out of almost 150 by 15 different contributors. Thanks to all the guests! In alphabetical order:
California Genetic Privacy Arguments Go National
Arguments in California court cases and legislative initiatives about genetic privacy arguments have gone national, and the Presidential Commission for the Study of Bioethical Issues has weighed in.
Genetic April Foolery on NPR and in The Economist The mainstream media is increasingly getting into the April Fools game. This year featured at least two established news organizations suddenly finding a sense of humor and using genetic technologies to, at least for one day, betray their loyal readers’ trust.
2012 has seen more venture capital investment in genomics firms than any previous year. Two big deals went down in the genetic testing world just last week. Biotech mogul Amgen bought Iceland-based deCODE for $415 million, and 23andMe raised $50 million from a Russian internet billionaire, Google and other investors. These seemingly totally separate deals may actually be related; the former may give us insight into 23andMe’s true mission.
While deCODE made a brief foray into the direct to consumer (DTC) testing market with its 2007 deCODEme product, the company has been primarily focused on creating a “universal health database” of Icelanders, to be used by researchers, ever since its founding in 1996. The database and not the testing kit was what made the company appealing to Amgen, which has announced that it has no plans to continue the deCODEme service, which cost $1100 — far more than its direct competitor, the 23andMe DTC genetic testing kit.
In 23andMe’s news release and much of the accompanying mainstream press coverage, CEO Anne Wojcicki emphasized that her company’s new capital would be used primarily to lower the test’s price to $99 (from $299) and thereby achieve the company’s goal of reaching one million users. Why is it so important to have a million users? In Wojcicki’s words, “By having 1 million individual users you can get to a scale where researchers are running data queries through 23andMe, where drug studies leverage our data, and where individuals can more easily be connected to studies that could benefit them.”
Whatever happened to the company’s original mission? That was to be a “leading personal genetics company dedicated to helping individuals understand their own genetic information through DNA analysis technologies and web-based interactive tools.” Now it seems the company’s real goal is to “create a [very valuable] data platform that can be easily searched and used by researchers all over the world.”
23andMe’s primary message is “own your own data,” but there’s a caveat: If a researcher does discover a miracle drug thanks to your genetic information, you do not own any portion of the resulting profit. Indeed, 23andMe already has a patent for genes associated with Parkinson’s. The Supreme Court may make that worthless when it rules in the Myriad case in a few months, but the principle of profit remains.
There is regrettable precedent here. Remember John Moore? Henrietta Lacks? Tissues from these patients generated enormous amounts of wealth but the patients themselves had no ownership, or say, in how their own bodies were used.
But John Moore and Henrietta Lacks were unsuspecting victims of doctors who shirked their duty to obtain informed patient consent. Technically, 23andMe users cannot be; a whopping 90% of the 180,000 people who have thus far sent their DNA in to be analyzed have affirmatively opted to share their information with researchers. Similarly, the deCODE subjects were all entirely voluntary participants in the massive genetic project in Iceland. But even deCODE came under fire for — you guessed it — privacy concerns.
One reporter aptly noted, “As genetics testing becomes more common and the data passes through more hands, there’s an increased chance the data could accidentally leak out.” Although there is a federal law on genetic privacy and nondiscrimination, it does not protect against discrimination in the contexts of life insurance, disability insurance, or long-term care insurance. That is worrisome. As long as the federal government fails to extend the law, state legislatures are left to protect citizens who make themselves vulnerable in the name of medical advances, and so far the states have taken markedly different, and sometimes superficial, approaches.
It’s becoming increasingly apparent that the value of the DTC gene testing business is really in amassing and selling gigantic genetic information databases. Now that a private company is poised to take the game to a new level, it’s past time for our representatives to flesh out the rules. If 23andMe is going to play hardball, all of us who wish to see medicine capitalize on genetic understanding deserve at least a helmet.
Posted by Gina Maranto, Biopolitical Times guest contributor on December 13th, 2012
Donna Dickenson has written a highly accessible guide to the ethical implications of biotechnology for the well-designed and edited “All that Matters” series from the British publisher Hodder Education. Pitched to a general audience, Bioethics features lively chapter titles – "Girls! Sell your eggs and enjoy the nightlife of Chennai," "Snowflakes, techno-coolies and the Tooth Fairy: some wonders of stem cell science." But it also delves into pithy questions about the limits of science, the problems raised by the patenting of genes, the corrosive role of the profit motive in medicine, and the injustices spawned by reproductive technologies, among others.
Dickenson, Emeritus Professor of Medical Ethics and Humanities at the University of London and winner of the prestigious International Spinoza Lens Award in 2006, situates her discussion of biotechnology primarily against a backdrop of justice, asking how the field promotes or undermines social equality. She also considers the more troubling prospect that biotechnology will usher in "the demise of nature" by making fundamental and irreversible changes in organisms (and ecosystems).
Repeatedly, Dickenson combats biotechnologists’ facile claims that they only serve the public good by pointing to the ways in which money and personal ambition change the equation. She also effectively confronts arguments – often put forward by scientists and pro-science journalists – that criticisms of biotechnology invariably constitute fear-mongering. As Dickenson rightly points out, public participation in decision making is a necessary counterweight to corporate and other problematic institutional forces. Moreover, she gives multiple examples of how poor women especially are exploited in the global market for eggs and wombs.
Within chapters of Bioethics, case studies, definitions of terms, and descriptions of medical techniques provide helpful detail and clarification. A helpful addendum, "100 Ideas," provides suggestions for further readings; summaries of landmark court rulings; brief descriptions of films and literary works dealing with bioethics; and lists of websites, think tanks and activist organizations, and leading thinkers in the field.
Dickensen defuses jargon and makes history compelling. We are, after all, just people trying to understand the complex circumstances of our own lives, and if some physician asks us if he can use our blood or suck eggs from our ovaries (what would that process involve, exactly?) or sample our DNA, we’d like to know how to make such decisions in terms we understand. Dickenson supplies those terms, and more. She helps us understand how individual medical choices become, in an age of Big Data and automated DNA sequencing and transnational markets for our biological essence – what Dickenson terms "body shopping" – a matter of public concern. What happens in the "privacy" of a clinic can lead to disquieting trends that have major implications for all of us, such as transnational surrogacy or the exploitation for corporate profit of the genetic material of ethnic groups.
Dickenson also asks us to move beyond our conventional understandings of what, after all, prove to be non-conventional acts. Biotechnology has ushered in choices that no human has previously been afforded – or, as some might say, given the opportunity to make. How do we weigh our own self regard against larger social and species concerns? Whose baby is this? What could scientists’ goals today mean for generations to come? Dickenson endorses the view, as expressed by Richard Hayes of the Center for Genetics and Society, that biotechnology in all its forms should "support rather than undermine social justice, equality, human rights, ecological integrity, and the common good." Full disclosure: I was unaware when I volunteered to review this book that it included a quote of one of my blog posts. That fact in no way influenced the character of my review.
Gina Maranto is Co-Director of Ecosystem Science and Policy and coordinator of the Environmental Science and Policy program at the University of Miami's Leonard and Jayne Abess Center. She is the author of Quest for Perfection: The Drive to Breed Better Human Beings (1996).
Posted by George Estreich, Biopolitical Times guest contributor on December 11th, 2012
In my last blog post, I wrote about The Amazing Spider-Man, in which an overreaching scientist (spoiler alert) turns into a human-lizard hybrid. Having begun with a wish to cure disease, the scientist literally loses his humanity, and by movie’s end, he’s trying to get the entire city of New York to join him on his personal journey of reptilian self-discovery. Why cure, when you can improve?
Watching the scaly scientist stomping around the sewers and streets of Manhattan, I was reminded of Lee Silver’s Remaking Eden: How Genetic Engineering and Cloning Will Transform the American Family. Silver, a molecular biologist and futurist, also speculates that healing will lead to something more extreme. His projected future begins with parents choosing healthier children, but this inevitably leads to a divide between the “Genrich,” who can afford to engineer their children, and the “Naturals,” who cannot. In a few hundred years the green-skinned, formerly human creatures have arrived. (They live on “the ice-covered northern polar cap of Mars,” and they “barely resembled the primitive Naturals still roaming the third planet Earth.”) Remaking Eden first came out in 1997. Fourteen years later, as recently reported in Science, Silver is writing the story’s beginning into reality. His new company, GenePeeks, uses a “proprietary algorithm” to “predict disease risk in hypothetical children based on the DNA of prospective parents”:
Silver and Morriss [his partner in the company] are still sorting out which diseases to include in testing.“The initial approach is to focus on serious, life-changing, life-threatening childhood diseases,” [CEO Anne] Morriss says. This might include hundreds of rare recessive diseases, “because there’s no controversy” there, Silver says.
The company’s website features the prominent headline “Protecting our children,” a curious formulation: unless the algorithm in question can not only predict unhealthy children with certainty, but also heal them, the business plan actually hinges on preventing the children deemed to be unhealthy. It’s also curious that the specific diseases to be prevented have not even been decided on; what has been decided, clearly, is an expansion beyond disease. Healing is only “the initial approach,” severe disease provides an uncontroversial starting point, and the “proprietary algorithm” offers the means. (For a closer look at GenePeeks' approach to business, see Pete Shanks' recent post.)
The webpage has only two images: one is a beautiful, healthy baby, and the other is a laptop. Two double helixes, one red and one blue, are streaming onto the screen from above. It is (forgive the pun) a pregnant image. An uncluttered white background suggests labs, medical spaces, purity. The child is alone; the parents are reduced to double helixes, streaming into the computer. Context and story are absent: we have only the promise of technology, and the perfect child.
Why do the aesthetics matter? For several reasons. First, they are being used to appeal to consumers, and so they elide, or replace, the serious discussion that should attend a technological practice of this scope. Second, the child’s beauty is ethically charged: the beautiful child is the one you want, implicitly opposed to the potential children being tested for. Third, those aesthetics are not simply expressed in a book; they are potentially amplified by the technology on offer. It is one thing to advance an idea about health or disability, another thing entirely to write it into the genome. But we live in a time when our stories and our codes are increasingly interwoven.
This is particularly true in the case of GenePeeks – not only because the company occupies a part of the trajectory mapped out in Silver’s book, but also because Anne Morriss, the CEO, has a son with one of the rare diseases in question. According to the Science article, Morriss links that fact to the company’s mission. She “believes that expanded testing could help others avoid her family’s fate: Her son was born with MCAD deﬁciency, a rare recessive disorder in which both parents carry a disease mutation. MCAD deﬁciency is treatable with dietary modiﬁcation, and Morriss says her son is thriving.”
Morriss’ story, her experience, and the meaning she finds all deserve to be honored and respected. However, there are always other meanings: a child’s arrival interacts in unpredictable ways with previously held values, so we should not assume, for any condition, that one person’s experience is representative. In the case of MCAD, where one parent might head up a biotech company, another might start a nonprofit foundation to disseminate information to parents, or fund research that directly helps people living with MCAD, or found a company that manufactures delicious, MCAD-friendly TV dinners, or look around for an unused ribbon color with which to promote an awareness parade. Not every parent sees a child’s condition as a fate to avoid.
In any case, the founders are casting a very wide net for fateful conditions. “[S]erious, life-changing, life-threatening”: what, exactly, counts as “serious”? It’s more than a rhetorical question, because there are many conditions – for example, being deaf – which seem like tragedies to the outside world, but are often experienced as a positive identity from the inside. But then, Morriss and Silver are also hoping to forecast the chances of autism and Type 1 diabetes.
Can that forecast be accurately made? The Science article provides skepticism from scientists and bioethicists both. I’m a writer, not a geneticist, so I can’t comment on the specifics. However, a recent story airing on NPR, even from my layman’s perspective, seems relevant: it turns out that we are all carrying around a lot more disease mutations than anyone thought, and lots of people can be perfectly healthy despite being carriers. The word that keeps coming up in the article is surprised, as in “the prestigious, top-of-their-field geneticists were surprised at the number of disease mutations.” (I’m paraphrasing.)
I don’t want to be rude, but if we’ve been only recently surprised by the number of genes we have, and more recently surprised that most diseases are multigenic, and only just found out that we can have buckets of mutations and be A-OK – well, either Silver and Morriss must have one hell of an algorithm, or they’re selling a certainty they don’t have. To quote the Harvard geneticist Ronald Green, "The critical take-home medicine here – one that needs to be reinforced over and over – is that as we enter the age of genomic medicine, simply having a mutation in a disease gene does not mean you have the disease or will get the disease."
Of course, it’s possible that Silver’s algorithm may lead to an unintended result: the recognition that none of us is without risk. It may be that this recognition may even lead to broader acceptance of the humans who already exist – and the further recognition that, even if our technologies of prenatal detection improve, we will still need to build a world that is inclusive and fair.
Will this actually happen? As a primitive Natural, I find it hard to say. Perhaps, one day, a more evolved being will be able to give the answer.
received his M.F.A. in poetry from Cornell University. His first book, a
collection of poems entitled Textbook Illustrations of the Human Body,
won the Gorsline Prize from Cloudbank Books. His memoir about raising a
daughter with Down syndrome, The Shape of the Eye, was published in SMU
Press’ Medical Humanities Series. Praised by Abraham Verghese as “a
poignant, beautifully written, and intensely moving memoir,” The Shape
of the Eye was awarded the 2012 Oregon Book Award in Creative
Nonfiction. Estreich lives in Oregon with his family.
The company that generated the initial wave of publicity, and remains by far the best known, is 23andMe. Many people thought at first that their business plan was purely consumer focused: individuals would pay to get their spit kits and have their genes analyzed and the company would make a buck on the procedure. But as early as 2007 there were suggestions that Google had an interest in gathering genetic data. And it soon became clear that the fine print reserved the company the right to sell (theoretically anonymized) customer data to researchers.
Selling access to massive databanks seemed to make more business sense than what was becoming called recreational genomics. And now 23andMe has made a potentially very significant move in that direction by getting on the NIH payroll. The company has received $573,000 in grant funding to perform genome-wide studies on allergy risks; to investigate error rates in sequencing technologies; and to "develop tools to build out 23andMe's database," reports GenomeWeb. With this and last month's announcement that the company has filed for FDA clearance of some of its tests, it seems that another reinvention may be underway.
The idea of FDA regulation of the DTC industry has been controversial all along. Many observers, including CGS, have called for it; many libertarian-leaning scientists have opposed it; 23andMe seems to be accepting it; and other companies appear to be trying to evade it. A new enterprise called GenePeeks plans to test donated sperm and purchasers' eggs to see if they have matching recessive genes that could result in a child with a disorder. The fledgling company will take the genomes of both gamete providers and combine them on the computer, to make thousands of possible "virtual children."
Why do it this way rather than with a lab test? Well, partly, explains Ron Bailey of Reason, because it is "a way to get around Food and Drug Administration medical device and diagnostics regulations." You see, they are not analyzing the male; that might be the unauthorized practice of medicine. Nor are they analyzing the female; that too might be illegal. They are analyzing a mash-up! Cunning, eh? (The lawyers will surely intervene. Won't they?)
Something similar may perhaps be going on with Gene by Gene Ltd. That's the parent company of Family Tree DNA (ancestry tests), DNA Findings (paternity tests) and DNA Traits, which offers "CLIA regulated health diagnostic tests to … certified medical professionals and researchers." Now Gene by Gene has launched a fourth subsidiary, DNA DTC, which "offers a wide range of Research Use Only (RUO) tests." These include complete genome sequencing for an introductory price of $5,495. It looks as though they are aimed at professional researchers, the tag line being "Your Research," but the generally reliable Dan Vorhaus is convinced that individual consumers can order directly. He may be right: Why else call it DNA DTC?
But — and this could be the most significant part of the gambit — what is on sale is what Vorhaus calls "the first data-only DTC product." In other words, the company will send you raw data, not including any interpretive results about what it all means. So, no analysis, no medical involvement, no FDA oversight? This could be another wrinkle in the tangled path of genetic testing on the way to the marketplace.
Analysis of the data has always seemed to be of the essence. Some have estimated very high costs for whole-genome analysis, others think that's hugely exaggerated. Many people are discussing how to integrate whole-genome analysis into healthcare, and some are warning of the perils of hype and of swamping an already stretched medical system. (Do check out the current issue of GeneWatch.) And of course there are a few investors and entrepreneurs figuring out how best to profit from this technology.
Naturally, there are political implications: Should we let the Chinese take over a U.S. firm? That's "a red herring," says George Church, who boasts that "I could sequence your DNA for $4,000 from a handshake." He's probably right about the Chinese, and he's definitely far too sanguine about the privacy issues.
How the DTC industry will eventually manage remains unclear. It seems likely that, as with the 19th-century California Gold Rush, the merchants will be the ones who profit. But in this case, it may not be the miners — that is, scientists — who lose out, but all the rest of us.
Jonathan Kahn, a law professor at Hamline University and a Biopolitical Times guest blogger, has just published an extraordinary book titled Race In A Bottle that details the birth, life, and death (?) of BiDil.
BiDil is the first drug to receive FDA approval to treat a specific racial group – African-Americans suffering from heart failure. But, the story of how BiDil became “race-specific” is quite a doozy, and Kahn provides a masterful narrative that is rich, thoughtful, and entertaining. A description of the book appears below; it can be purchased from Amazon by clicking here or from Columbia University Press by clicking here. I highly recommend it.
"At a ceremony announcing the completion of the first draft of the human genome in 2000, President Bill Clinton declared, “I believe one of the great truths to emerge from this triumphant expedition inside the human genome is that in genetic terms, all human beings, regardless of race, are more than 99.9 percent the same.” Yet despite this declaration of unity, biomedical research has focused increasingly on mapping that .1 percent of difference, particularly as it relates to race.
"This trend is exemplified by the drug BiDil. Approved by the FDA in 2005 as the first drug with a race-specific indication on its label, BiDil was originally touted as a pathbreaking therapy to treat heart failure in black patients and help underserved populations. Upon closer examination, however, Jonathan Kahn reveals a far more complex story. At the most basic level, BiDil became racial through legal maneuvering and commercial pressure as much as through medical understandings of how the drug worked. Using BiDil as a central case study, Kahn broadly examines the legal and commercial imperatives driving the expanding role of race in biomedicine, even as scientific advances in genomics could render the issue irrelevant. He surveys the distinct politics informing the use of race in medicine and the very real health disparities caused by racism and social injustice that are now being cast as a mere function of genetic difference. Calling for a more reasoned approach to using race in biomedical research and practice, Kahn asks readers to recognize that, just as genetics is a complex field requiring sensitivity and expertise, so too is race, particularly in the field of biomedicine."
Posted by George Estreich, Biopolitical Times guest contributor on November 29th, 2012
To be interested in questions of human enhancement, while also being a sucker for Hollywood blockbusters about superheroes, makes for an odd movie experience. Immersed in a fictional world both saved and threatened by the enhanced, you’re aware of the world you’ve just paid to escape. You feel doubled, like the superheroes themselves—though since you’re sitting on the couch and not saving the world, the division is less profound. You don’t have secret powers, just cognitive dissonance; your perception, not your identity, is split.
A few nights ago, I watched The Amazing Spider-Man on Blu-Ray. (Warning: many spoilers ensue.) The movie reboots the franchise that began in 2002, and this time around, the genetic enhancement of human beings is far more central to the plot. Just as in the first series, the high school student Peter Parker, bitten by a genetically modified spider, develops superpowers; but this time around, the spider comes from a corporation whose business model depends on “cross-species genetics,” and Peter’s nemesis—the scientist Curtis Connors, once the research partner of Peter’s deceased father—is a man with one arm, who not only longs to generate a working limb, but dreams of a world where disability and disease are erased.
For Dr. Connors, pressure from his corporate employer pushes these dreams across a moral border. Oscorp’s namesake CEO—Norman Osborn, whom we never see—needs the technology to extend his life. Facing the loss of his job and funding, Connors injects himself to prove his research can work in humans. He collapses, and in a gorgeously creepy scene, awakens to his new self: Peeling back a dry, plantlike husk, he discovers a new arm both fetal and disproportionately large, the veins visible through translucent skin. In the logic of the fantastic, from Dr. Jekyll and Mr. Hyde to The Fly to The Amazing Spider-Man, Faustian choices lead to swift transformations. The hand soon becomes a giant claw, and Connors acquires a tail, reptilian eyes, and green pebbled skin to go with his resonant English accent. Before long, he has torn his way out the back of a taxi and is throwing cars off a bridge.
The special effects are good, but as the plot shows, the movie’s focus on genetic modification is more than incidental.
For those who have struggled with the emotional, physical, and monetary stresses of trying unsuccessfully to start a family by using other people’s eggs or sperm, there is another option: embryo donation. Though a resulting child isn’t genetically related to either intended parent, the mother will be able to carry and give birth to the child, and the parents can be there from day one of the child’s life.
Typically, the available embryos are the result of in vitro fertilization treatments. People who don’t wish to give any of their “leftover” embryos to research or discard them have the option of donating them to another couple. In theory this kind of arrangement is a win-win for all involved: a happy alternative for the donors, and a new chance for a child for the recipients.
Several organizations have been established to facilitate these embryo donations. The reality, however, is that though there are hundreds of thousands of frozen embryos in this country, few people opt to donate theirs to other intended parents, and there is a long wait for couples hoping to receive one.
“The California Conceptions Donated Embryo Program was started in hopes of changing this imbalance,” reads the informational page on embryo donation at the website of California IVF: Davis Fertility Clinic. But California Conceptions differs from other embryo donation organizations in a crucial way: They create the embryos themselves.
The fertility doctor who introduced this concept, Dr. Ernest Zeringue, reportedly saw it as a way to remain competitive in a largely unregulated fertility industry. He offers IVF with pre-made embryos for about half the cost of traditional IVF, and with an unheard of deal: Pregnancy for $9,800 or your money back. The Davis clinic says that nearly 200 couples have used this service already, with a 95% success rate.
Zeringue’s prospective patients are sent extensive profiles of sperm and egg donors before they commit; if there is sufficient interest, the clinic purchases the selected sperm and eggs and makes the embryos. Zeringue is able to cut costs because he creates batches of embryos, which he distributes among multiple patients, keeping any extras frozen for future use. When embryos are left over from IVF, they belong to the genetic parents; in this scenario, they belong to the clinic.
Zeringue doesn’t see a problem with this. He states that the embryos "are still treated ethically. They are no different than embryos that have a person's name assigned to them." But many believe that selling pre-made embryos crosses an ethical boundary.
Dr. Craig Sweet, medical and practice director of Embryo Donation International, sees Zeringue’s creation of “McEmbryos” as an unethical variation of the work to which he has given his life. He disputes Zeringue’s claim that this method can even be considered “embryo donation” explaining,
“Embryo donation occurs when patients with excess cryopreserved embryos make the amazing decision to donate their frozen embryos to patients in need. The L.A. Times report indicates that California Conceptions is creating embryos through the combination of donor eggs and donor sperm and marketing them as donated embryos. If they are claiming they are donated embryos, nothing could be further from the truth.”
Andrew Vorzimer, a Los Angeles fertility lawyer and “an unapologetic advocate for access to assisted reproduction,” raises a similar point and is alarmed that a company has control over the embryos.
Make no mistake, this is commodification. These are not donated embryos. Rather, they are embryos created from donors hand-selected by California Conceptions. It is one step removed from a mail order catalog. The only difference is that the product being sold is nascent human life.
A similar kind of embryo bank has been attempted before. In 2007, CGS Senior Fellow and UC Hastings Law Professor Osagie Obasogie wrote an op-ed for the Boston Globe titled “‘Wal-martization’ of Embryos” about the Abraham Center for Life, “the world’s first human embryo bank.” The Texas center drastically cut costs by purchasing sperm and eggs wholesale and running out of founder Jennalee Ryan’s home. Many commentators voiced concern that Ryan was designing and selling genetically desirable babies. She accepted only attractive and college-educated donors, and offered patients their choice of “designer” traits. In effect, hers was a sort of Walmart with couture aspirations.
Slate writer William Saletan pointed out at the time that “Ryan represents the next wave of industrial rationality. She's bringing the innovations of Costco and Burger King to the business of human flesh.” But what works for groceries and burgers didn’t work so well in this case. After just a few months, Ryan closed the center because she was losing too much money. She was also the subject of an FDA investigation.
Interestingly, her old website is now a blog with adoption tips; and Ryan now works as a “baby-broker” at A Silver Spoon Adoptions Inc, one of the first adoption facilitation agencies, where she earns a fee matching birth mothers with adoptive parents. It turns out that Ryan is completely surrounded in controversy, having changed her name and the face of her company many times, possibly in part to take advantage of lax regulations in the fertility industry.
Zeringue, however, is not a rogue entrepreneur working out of his living room. He is a trained infertility specialist and the founder of California IVF: Davis Fertility Center, Inc. Have the past five years served to legitimize the selling of retail embryos? Zeringue’s business model and the issues it raises will be discussed at a meeting in January of the ethics committee of the American Society for Reproductive Medicine.
The Council for Responsible Genetics has just released a new issue of GeneWatch devoted to the developing field of whole genome sequencing. Articles include interviews with an Aetna medical director, an appointee to the Presidential Commission for the Study of Bioethical Issues, and a professor at the Institute of Genetic Medicine at Johns Hopkins University.
The interviewees all agreed that sequencing technology is still a long way from being able to offer the “personalized medicine” we’ve heard so much about, and that in the meantime, there are a few potential pitfalls about which we should be talking. Anita Allen of the Presidential Commission warns of privacy concerns surrounding whole genome sequencing data collection, storage, and sharing.
The issue also includes several thoughtful commentaries. Dr. Helen Wallace, head of Genewatch UK, also voices privacy concerns. She notes that surreptitious surveillance could easily become a reality because “[i]f everyone has their genetic sequence stored in a database, this allows them to be tracked using the sequence as a unique identifier which is left on coffee cups and wine glasses wherever they go.”
In addition to serious concerns, the issue raises questions about the science itself. Donna Dickenson points out that whole genome sequencing really hasn’t caused the “paradigm shift” in medical care that’s been touted by scientists and politicians alike. Genetic testing for cancer susceptibility is now a routine part of clinical care, but because there are so many parts of the genome “that are associated with cancer in a yet undetermined way,” these tests can only be used for a few types of cancers. Indeed Dickenson notes that most major diseases are caused by complex interactions among genes, and between genes and environmental factors. Thus for most people, genome sequencing would do little to guide medical care.
If the scientific evidence alone does not substantiate the claim of a medical revolution, then the enormous interest in genome sequencing must be attributable at least in part to social and economic factors. And surely there’s reason to believe that they loom large. As Dickenson notes, expiring patents drive pharmaceutical companies to look for new markets, and it would be advantageous for the medical care system if patients could be persuaded to pay for genetic typing out of their own pockets.
For these views and more, don’t miss GeneWatch: Whole Genome Sequencing in Medicine.
The U.S. Supreme Court has decided to considerMaryland vs. King, a potentially very significant case about the collection by police of DNA from suspects rather than convicts. (For background, see this post.) The Court's decision, expected next year, will likely affect at least 27 states, and Federal law. The summary at Lexology, an online commercial law publication, isolates the main issue:
High tech squares off with the Fourth Amendment
No one can really predict how the Supreme Court will view the issues involved. Maryland's Attorney General Doug Gansler is predicting a 9–0 ruling upholding the law. But Stephen Mercer of the Office of the Public Defender clearly disagrees:
The fourth amendment and article 26 [Maryland] were intended to place an obstacle between the exercise of police power and citizens.
Criminal lawyer Marcus Berghahn performs a nice tap-dance:
Where the purpose of the DNA collection is the detection of crime and prosecution of an individual, the statute will not likely be constitutional. To the extent that the DNA collection is framed as using the data obtained from the DNA to identify the individual, the statute may be constitutional.
Meanwhile, Wisconsin, like many other states, is about to consider a "DNA at arrest" law. Illinois is collecting DNA from current residents who were convicted of serious sex crimes in other states. California's related case is still awaiting a decision from the U.S. 9th Circuit Court of Appeals.
Internationally, use of forensic DNA continues to increase. Thailand has brought in the FBI to consult on developing a national DNA database. Uzbekistan has announced plans to create one too, which "will be required of those convicted of or currently serving a sentence for grave crimes" but is also described as "voluntary," which might be ominous; under consideration is a law "on genetic registration."
Posted by Gina Maranto, Biopolitical Times guest contributor on November 21st, 2012
I finally got around to reading Hanna Rosin’s article, “The End of Men,” which ran in the Atlantic Monthly in July/August this year. I’d heard some of the noise about the piece back then and figured that like other members of the genre (e.g., Francis Fukuyama’s The End of History and the Last Man, or John Horgan’s The End of Science) the title served more as a provocation than a believable prognostication – Fukuyama published in 1992 and Horgan in 1996, and last I checked, history and science are still ginning along.
I was actually kind of sorry to find that I was right. I’m not going to take on Rosin’s overarching argument about the ascendancy of women on a post-industrial planet, mainly because where to start? Despite a few nods to trends in Korea, India, and China, her optic is white, 1-per-centish, and American. But I am going to take apart her claim that there is a global shift afoot that is “eroding the historical preference for male children,” which is based mostly on, it seems, wishful thinking, suspect data, and faulty logic.
Rosin fills most of her seven-paragraph lede with a lot of fluff and color about the cowboy predilections of reproductive physiologist Ronald Ericsson. Given all the details about his ranch and Marlboro commercials and his Old West “swagger,” it comes as a surprise that the real reason for his being there is so that he can deliver a pronouncement about an epochal shift. Rosin quotes him as saying, “Did male dominance exist? Of course it existed. But it seems to be gone now. And the era of the firstborn son is totally gone.”
Why choose Ericsson to deliver this news? Well, because in 1973, Ericsson and two colleagues had published a letter in Nature describing a technique for sorting Y-chromosome-bearing sperm – that is, those that would produce male offspring – from those carrying X chromosomes. The method could reliably produce samples that contained 85% Y-bearing sperm.
When I interviewed Ericsson in 1984 for a Discover piece I wrote on sex selection, the cowboy schtick was thankfully not in evidence. The concern of ethicists, feminists, and others I spoke with then was that such techniques would be used overwhelmingly to have sons. Ericsson was unconcerned, categorically dismissing any objections to sperm sorting.
The body as marketplace is a loaded zone. The collision of uncomfortable realities, significant amounts of money, and appeals to altruism produces multiple simultaneous stories about who benefits and who does not. New ways to form families become feasible through third-party eggs, and happy success stories from recipients are plenty. But there is limited information on how those who provide their eggs feel about the exchange.
Ruth Ragan, who donated her eggs sixteen years ago, wrote last year about her reaction on the New York Times’ parenting blog. She initially wanted to donate her eggs for altruistic reasons. She had received two blood transfusions from friends for a spinal fusion surgery in her youth and was looking for a way to repay this kindness. She found the procedure fairly difficult though; the hyperstimulation of her ovaries left her “bloated and in extreme abdominal pain” days after the retrieval. Her gynecologist scolded her for undergoing such a risky procedure, and she did not consider donating again.
As Ragan grew older and had her own child, she became aware of “lasting psychological effects as a result of the anonymous egg donation process.” She wondered if any children had resulted, if they were psychologically affected by the means of their conception, if they knew all the medical information they needed, and if their parents treated them well. She found some limited studies on the children of gamete donations that somewhat eased her concerns, but almost nothing on how donors fare.
The body of research that is available suggests that anonymous donors are forgotten once their bounty is recovered. Most of the research lies in clinical outcomes for recipients and the impact of donor characteristics on recipient pregnancy outcomes. The search for perfect donors continues, but no one is following up to make sure the once-perfect donors remain perfect.
There is, however, a growing body of first-person accounts from egg donors. Most, like Ragan’s, are full of ambivalence. A personal account in Jezebel tells the story of a woman who needed the money and had a fairly good egg retrieval experience, but still struggled with the implications. As a “white, blonde, thin, straight, smart, relatively mentally stable and able-bodied” woman, she worried she was perpetuating the notion that particular attributes are more desirable than others. In Confessions of a Serial Egg Donor, Julia Derek recounts her experience as a 12-time egg donor. She was shunned by the fertility industry when she began to experience severe medical problems due to her donations.
A recent article in the independent Santa Cruz newspaper Good Times tells the story of Raquel Cool, an egg donor and artist. Cool grew up in a tri-cultural military household that moved every few years; a fascinating part of the fertility industry for her is its ability to deconstruct normative understandings of family and parenthood. From her point of view, it not only leads to the possibility of family formation for recipients, but also allows donors access to certain kinds of motherhood.
For example, if you want to carry a child, you can become a surrogate carrier and rent out your womb; or, if you wanted to raise a child full time, but temporarily, you can become a foster parent; and if you want to pass on your genes, you can become an egg donor.
Cool says she has a “biological urge” to pass on her genes, but at least at the moment is not concerned with raising a child genetically related to her; she plans to adopt. She comments that though egg retrieval was initially “very much about being maternal,” her attitude has changed to a “desire to impregnate as many people as possible,” adding that she is “fascinated by technology and the ability to let a woman do that.” This fascination with the body as economy and vehicle was the inspiration for her new art installation, “Live Nude Eggs,” which opened this month in Santa Cruz’s Vapr Labs.
Cool’s narrative differs from many other accounts of the egg donor experience. Unlike the women in the award-winning documentary Eggsploitation, she does not see herself as a victim of an unregulated fertility industry. Though egg donation is her primary source of income, she doesn’t relate to it as something she needs in order to get by. She also doesn’t feel foiled by marketing techniques that sell the concept as the ultimate altruistic gift, practices that are well documented in Rene Almeling’s book “Sex Cells.” Instead, being an egg donor has fed Cool’s desire to constantly experience new things and push herself outside her comfort zone. (She has also donated blood, hair, and been a research subject.) Even the medical complications she has faced, including ovarian hyperstimulation syndrome (“My ovaries went from the size of walnuts to grapefruits”) have not deterred her from her desire to use her body in imaginative and experimental ways.
In short, Cool, who is a “27-year-old, college-educated, trilingual triathlete of Chinese-American descent,” is a “perfect donor.” But even she has experienced the alienation that comes from the process. She has been advised against meeting with the intending parents, has limited interaction with the clinic, and has never met another egg donor. When she specifically asked to speak with one, the agency insisted that it be a three-way call that included them. Her “Live Nude Eggs” exhibit calls into question the complete exposure that is required of an egg donor – the exhibit includes a series of intimate photographs of her as she undertakes the many elements of the retrieval process.
Cool has found egg donation to be an incredibly lop-sided experience, noting “you truly feel like you’re on the observed side of a one-way mirror.” While she is asked to give intending parents incredibly detailed and thorough information about herself, all she is given is their first names. After the procedure is over, all she learns is ‘yes’ or ‘no’; either her eggs resulted in a pregnancy or they did not.
Despite this imbalanced transparency, Cool feels that egg donors are not exploited or “completely commodified”; she sees the exchange that takes place as an economic transaction that is a two-way street.
I think the language that’s being used in the industry right now is kind of like feel-good market speak, where you’re giving the gift of life, you’re such an altruist. But that, to me, is ultimately marketing, and it really downplays the true transaction at hand, which is that it’s a business. Egg donors are a part of that business. And whether someone is ethically opposed to that, I leave it to them to decide. The installation raises those questions, you know, what are the implications of using your biology as a source of economy.
Those implications can be seen in the tension around the simultaneous framing of egg donation as altruistic gift, economic transaction, and biological legacy. How women come to terms with these frames seems to drastically impact their view of the health risks of egg retrieval, their role in the process, the fertility industry in general, and the families that are formed as a result of their biological material. As more women speak up about their experiences, those considering egg donation will be better prepared for all of the ways it could affect them, not only while they are a “perfect donor” but throughout all the stages of their life.
The Center for Genetics and Society has sent a letter strongly recommending against changing the United Kingdom law that – like those in dozens of other countries – prohibits procedures that would alter the genes we pass on to our children. Please consider adding your voice to this effort here.
A research team at the United Kingdom’s Newcastle University is working on techniques that produce human eggs containing genetic material from two women, and using them to create human embryos – and potentially children – with DNA from three parents. Children born after such “mitochondrial replacement” procedures would pass these genetic changes to their children and all subsequent generations.
Testing the procedure in humans is currently illegal in the UK because it would constitute inheritable genetic modification – that is, it would irreversibly alter the human germline. Over 40 countries prohibit human germline engineering because of its profound social and ethical consequences, but the Newcastle researchers are eager to change the UK law so that they can bring their technique to clinical trial.
Mitochondrial replacement would not alter genes in the nucleus. But the prohibition against human germline engineering represents a critical line in the sand. If the Newcastle proposal to alter mitochondrial genes is approved, we will have crossed that line; it will be harder to argue against other inheritable genetic modifications in the future.
Like the research team from Oregon Health and Science University whose research was recently in the headlines, the Newcastle scientists stress that their procedures are worthwhile because they would enable women with unhealthy mitochondria to have a (mostly) genetically related child without mitochondrial disease. Inherited disease caused by mitochondrial DNA is relatively rare, affecting about 1 in 5,000-10,000 births. Women at risk of having an affected child have several other (far less experimental) options available to them, so these extreme procedures would be considered only in a very small number of cases. Because mitochondrial DNA and nuclear DNA interact with each other consistently and in complex ways that are imperfectly understood, the health risks to any future children created using these procedures would be very large. And these future children would obviously be unable to give their consent.
The Human Fertilization and Embryology Authority (HFEA) ruled last year that a minimum number of further tests would be required before the safety of mitochondrial replacement in humans could be assessed (section 5.4). Even though these tests have not yetbeen completed, the HFEA is moving forward in an effort to gauge the public’s point of view on the controversial technology. They have launched a public consultation to debate the ethical and social implications of the two novel technologies under discussion: pronuclear transfer (PNT) and maternal spindle transfer (MST).
HFEA’s consultation website has information on the science behind the new techniques being proposed and on various ethical concerns. The results of the consultation will be passed on to the Secretary of State for Health in the UK who will make the next decision as to whether these technologies can move to clinical trial in humans.
Please voice your thoughts or concerns on these issues by submitting them to the HFEA’s public consultation by December 7. For more information on the many social and ethical implications of mitochondrial transfer, please see the letter the Center for Genetics and Society has submitted to the Chair of the HFEA and to the Secretary of State for Health in the UK here. Please also check back for updated information on our website.
Posted by George Estreich, Biopolitical Times guest contributor on November 13th, 2012
One of the many mini-scandals in the recent Presidential election erupted when Ann Coulter tweeted a reference to President Obama as a “retard.” As the father of a sixth grader with Down syndrome, I found the tweet simultaneously sickening and reassuring. Sickening, because of the ubiquity of the word; reassuring, because of the pushback. Coulter clearly assumed that her use of the word would be shocking enough to generate attention, but not shocking enough to incur any cost. She was clearly wrong.
On disability as on many other issues, our mores are changing with unbelievable speed. What was acceptable last year is less so this year, and taboo next year. Most heartening of all after Coulter’s blunder was the public reply made by John Franklin Stephens:
I’m a 30 year old man with Down syndrome who has struggled with the public’s perception that an intellectual disability means that I am dumb and shallow. I am not either of those things, but I do process information more slowly than the rest of you. In fact it has taken me all day to figure out how to respond to your use of the R-word last night…
Well, Ms. Coulter, you, and society, need to learn that being compared to people like me should be considered a badge of honor.
No one overcomes more than we do and still loves life so much.
Come join us someday at Special Olympics. See if you can walk away with your heart unchanged.
A friend you haven’t made yet, John Franklin Stephens Global Messenger
In a world where people with disabilities have made such strides, what are we to make of the spate of new prenatal tests that claim to identify fetuses with chromosomal conditions early in pregnancy? There is no easy answer, but it is hard to deny the tension between their implicit message and the one delivered by Mr. Stephens.
Selling at Sequenom
One of these tests is made and marketed by a company called Sequenom.
Emma Warin and her baby are healthy, but they are participating in a study that is analyzing the family's entire genetic code
If you could get a printout of your entire genome for $1000, would you? What about one for your child?
Human genetics expert Ricki Lewis, PhD and author of several genetics textbooks and thousands of scientific articles, says she’ll pass. In her view of whole genome sequencing (WGS), “the state of the science provides both too much and too little information.” It reveals too much information, she explains, in that many segments of the sequence are useless or uninterpretable, or code for late-onset disease for which there is no known cure or treatment. At the same time, Lewis says, that the sequence reveals too little information – and always will – because “we need to know more than a string of DNA letters or a list of gene variants. We need to know how our genes interact.”
In a recent series in Time magazine on whole genome sequencing for children, reporter Bonnie Rochman explores these concerns by profiling families, doctors, and genetic testing companies. She seems particularly struck by how Americans’ need-to-know ethos can skew their understanding of the risks and benefits of whole genome sequencing.
In some cases, of course, the benefits of having a child’s genome sequenced are clear. As Rochman notes, “WGS can provide early warning about some of the deadliest and most debilitating diseases. Those warnings, in turn, can enable timely treatment or at least allow people to make plans about long-term care” when treatment isn’t possible.
So for a child like Juliet Belcher, who has significant physical and cognitive impairments with no explanation as to why, WGS might provide critical information about a diagnosis and a treatment plan. Juliet’s parents, who decided that for them the benefits outweighed the risks, have yet to hear back about her genome.
Another mother whose child suffers from impaired physical and cognitive development that doctors have been unable to diagnose made the same decision. Laurie Hunter has received the results of her daughter Amanda’s genome test – and they were damaging enough that she has questioned why she participated. “Sometimes,” she says, “what you don’t know is easier.” What made the results so upsetting was that they uncovered nothing about Amanda’s problems. The only abnormality doctors could identify was a genetic deletion that could code for rare, fast-growing tumors, but that unfortunately is located in a part of the human genome about which medical professionals still know very little. The discovery about the heightened risk of future cancer was something with which the Hunter family felt unable to cope. “I feel completely overwhelmed with information. Now it just feels like a waiting game,” Laurie explained.
The Hunters’ experience seems to affirm what skeptics like Lewis believe: that for healthy people – children or adults – the risks of uncertain or non-actionable results make WGS unpalatable. But it appears that many young families don’t agree. Rochman reports that one study has enrolled 2500 families, many with healthy newborns, who have agreed to have their babies’ genomes sequenced. These children, who didn’t themselves choose to know about all their genetic information, may have to continue worrying about it long after their parents are gone.
Rochman also touches on the companies that offer direct-to-consumer gene tests, and the plans by some to move into whole genome sequencing. Anne Wojcicki, founder and CEO of 23andMe, told Rochman that as a parent, “the most responsible thing I can do is get as much information about my children as possible,” with or without the guidance of a doctor. But other leaders in the industry disagree. Maryland-based GeneDx will only provide genetic testing at the request of a doctor; San Diego-based Illumina, which is already offering WGS directly to consumers, refuses to sequence kids who aren’t sick. “We do it on children when we’re trying to save their lives,” CEO Jay Flatley told Rochman. “We don’t believe parents have a legal or ethical right to do this [just for fun].”
And then there are the social and economic drawbacks to widespread genome sequencing. Rochman raises some of these concerns in the final article in her series, under the title “Why Cheaper Genetic Testing Could Cost Us a Fortune.” As the whole-genome tests become cheaper and more widely available, what happens when parents try to interpret the inherently uncertain results? Will their anxiety wind up dramatically increasing the number of unnecessary extra medical procedures performed, and make insurance costs skyrocket? The need-to-know frenzy that individual parents feel could wind up having a seriously negative effect on the entire health care system.
Cloud Atlas is a remarkable movie adaptation of an extraordinary novel. David Mitchell's book is a complex nesting of half a dozen novellas covering several centuries, past, present and future. The film, by the Wachowskis of Matrix fame and Tom Twyker (Run Lola Run), intercuts all six stories to tell them simultaneously.
The cinematic tricks (involving extensive changes of which Mitchell thoroughly approves — he even has a cameo) do not hide the serious issues behind the sometimes flashy stories. At root, both book and movie are concerned with the ultimate mystery of what it is to be human, and with the dreadful depths and transcendent heights that individuals and societies can reach. One of the many disconcerting ironies is that the character who most specifically articulates this is a fabricant — a created, genetically engineered clone named Sonmi-451.
Sonmi-451and her identical colleagues were produced to be servers in a fast-food restaurant in Neo-Seoul. (Old Seoul has been drowned by the effects of climate change.) The genetic engineering is not intended to confer superhuman powers but rather to create subhuman simulacra of people who can be reliably enslaved by the “pure-bloods” and the corporations.
The book explains that fabricants are physically dependent on a drug whose intentional side effect is functional stupidity. But Sonmi-451 transcends her engineered limitations, joins (or is exploited by) a rebellion against the corpocracy, and composes a moving manifesto about human possibility. She becomes a martyr, and the ramifications ripple down the ages to the era of post-apocalyptic barbarism that comprises the sixth Cloud Atlas story, when some worship her as a deity. For a logical explanation of all this, read the book; for a visceral experience, see the movie.
You may want to know before you go to the movie that the same actors play different roles in each of the stories, and that sometimes they are so disguised they're hard to recognize. Halle Berry, who is wonderful as everything from a Pacific Islander to a German Jew, claims she actually failed to recognize fellow actors on set: "Oh my god, Hugh Grant, I had no idea that was you." Grant, in turn, claims that the chance to play (as one of his six parts) a 23rd-century cannibal chief was something he could not turn down: "There was very little throat-slitting in Sense and Sensibility, I remember."
Critical reaction to the film has been mixed. Roger Ebert calls it "one of the most ambitious films ever made" and insists it needs to be seen two or three times. Others are less enthusiastic, or even downright hostile; at Rotten Tomatoes, the audience rates it higher than the average critic. Despite the star-studded cast (Tom Hanks, Susan Sarandon, and others in addition to Berry and Grant), it's already slipping at the U.S. box office. So go see it soon.
Last week, the European Society of Human Genetics policy committee chastised Myriad Genetics for refusing to share its genetic research on the grounds that the information is commercially sensitive. According to the committee’s chair, Professor Martina Cornel, Myriad has stated that its goal is to enter the European genetic testing market more vigorously. To that end, it would be in the company’s interest to keep as much information as secret as it possibly can.
The new controversy surrounds a database Myriad began compiling nearly 10 years ago. While Myriad primarily uses its patented BRCA genetic test to look for cancer-causing mutations, it has also used the test to compile a database of “variants of unknown significance” gathered from patients and their families. If made available for review, scientists and lawyers argue, these variants could help facilitate the work of researchers around the world. However, Myriad refuses to share its database on the grounds that it contains trade secrets. Meanwhile, Myriad continues to enjoy free access to public databases compiled by other scientists.
The response from scientists and lawyers in the US and Europe reflects the divided opinion in the biotech field about the ongoing legal challenge to the patents on the BRCA genes that Myriad currently claims. With Association for Molecular Pathology v. Myriad Genetics sitting in the Supreme Court’s inbox, we at CGS have a signed a new amicus brief authored by Debra Greenfield, attorney and Adjunct Assistant Professor at the UCLA Institute for Society and Genetics.
As we previously reported, the issue in the Myriad case is whether gene patents are patent-eligible compositions of matter under the Patent Act, or whether they are patent-ineligible products of nature under long-standing case law. In Mayo v. Promethus, a recent Supreme Court decision to which the justices directed the Federal Circuit to look for guidance in the Myriad case, the legal issue was where the line is drawn between a patent-eligible method and a patent-ineligible law of nature (not a product of nature as in Myriad). Greenfield characterizes Mayo’s “essential concern” as being related to patents that preempt too much future use of natural phenomena and inhibit or impede innovation. Thus the product of nature at issue in Myriad can be compared to the law of nature delineated in Mayo, and Myriad’s patents should similarly be invalidated. Furthermore, Greenfield argues that “isolating and synthesizing these molecules do not change their identity,” and that “despite minute structural changes they are not markedly different from what is found in nature.”
We will just have to wait and see whether the Supreme Court decides to rule on the Myriad case. There is good reason to think it will given all the compelling arguments about the deleterious effects of the patents. As Greenfield argues, these negative consequences stem from the fact that the patent claims are so general that they preempt “all uses of fundamental principles of molecular biology and genetics,” and so sweeping that they cover “both ‘known and unknown’ uses of the embodied information of the BRCA 1/2 genes.”
When the American Society for Reproductive Medicine (ASRM) announced last week that it was removing its “experimental” label from egg freezing, the resulting media coverage highlighted certain issues while others were left notably missing. Many articles focused on women who want to delay childbearing for social reasons – until they find the right man or get that promotion for example (1,2,3) – with some lauding egg freezing as an unproblematic path to freedom and autonomy. A number of articles neglected entirely the fact that ASRM is recommending that the procedure only be used by women at risk of losing their fertility due to medical treatments such as chemotherapy. And while some accounts mentioned the scant evidence about safety for children born from frozen eggs, few discussed the risks for women who undergo ovarian stimulation and multiple egg extraction.
Also under-reported was the prospect that egg freezing will trigger what one observer called a “paradigm shift” in the fertility industry: a proliferation of frozen egg banks, larger online databases of egg providers, and an intensification of “catalog shopping” for their eye color, height, ethnicity, and other traits.
While a few companies have been offering frozen eggs for non-medical purposes for years, advertising has recently kicked into high gear. My Egg Bank, which offers only frozen eggs, started shipping this past June. Its website raves that “patients can now achieve the same clinical success rates as traditional egg donation programs… AT HALF THE COST.” It boasts that it “only use[s] the highest quality donors” who have been pre-tested for 21 genetic conditions, and that it provides “care conveniently planned around your busy schedule.” Anyone can search through its database of donors and traits, though only current patients can view the women’s pictures (in order to protect their anonymity).
At the website of The World Egg Bank, by contrast, simply providing an email address and the name of a hospital is enough to grant you full access to donor profiles, which are oddly reminiscent of Myspace profiles. Each woman has a page with multiple photos of herself, and descriptions of her looks, ethnicity, educational level, talents, and activities.
The World Egg Bank provides both fresh and frozen eggs, but makes its preference crystal clear. The page titled “Are You Better with Fresh or with Frozen?” outlines many problems with fresh eggs, mentioning the hormone supplements the donor has to take for egg retrieval, increased costs, the trouble of coordinating the donor’s and recipient’s menstrual cycles, the travel that is necessary, and the fact that you’ll just have to “trust her commitment to following medical protocol.” The frozen egg section mentions not a single potential downfall except that the company’s selection of frozen eggs is not yet as big as it would like (there seem to be only 13 frozen egg donors currently, in contrast with hundreds of fresh egg donors). It doesn’t mention anything about the risks of egg extraction, which seems to suggest that it’s somehow safer if the eggs are frozen – even though the procedure is exactly the same.
From the point of view of recipients, brokers and clinics, the use of frozen eggs certainly does remove certain obstacles. Medical director of the South Florida Institute for Reproductive Medicine Juergen Eisermann told a reporter that acquiring fresh eggs is “never fun,” and that with frozen eggs, “you have no idea how much administrative time it saves us. It’s incredible. We want to convince more of our patients to do frozen.” He went on to complain about being at the mercy of an egg donor’s whims, and shared a story of one who wanted to jaunt off for a boat race when her estrogen levels were ideal for egg extraction.
But there are serious reasons for concern about the prospect of frozen egg banks. In a blog post at Egg Donation Inc., David Randall points out that
it is impossible to overstate how easy it is for a “fly by night” online frozen egg agency to send genetic material that bears no relation to the donor claimed by the agency as there is simply no guarantee that an agency who traffics in frozen eggs over the internet can guarantee that eggs are in fact from the individual who the agency claims they are from.
He also notes that “buying eggs, embryos, or other genetic material over the internet could be considered illegal in some jurisdictions in the United States, Canada, and Europe.” In the assisted reproduction industry, he says, “You very much get what you pay for.”
The spread of large frozen egg banks could change the experience, and potentially the quality, of egg donation. It could lead to another change as well: the outsourcing of egg donation to other countries. Egg banks like to advertise the diversity of their donors. With the need for local eggs gone, it is easy to imagine clinics trying to increase their profits by looking to Eastern Europe or South East Asia for example, where they could find women with desirable traits who would be willing to give their eggs for less. If commercial dynamics encourage egg retrieval, like surrogacy, to become a cross-border arrangement, the risks of exploitation could dramatically increase.
California's Proposition 37, which would require labeling of genetically modified food, is being battered by a million dollars a day of deceptive commercials. The race is close to a tie, with one poll putting Prop. 37 behind and the Los Angeles Times having it ahead by a tight 44–42, down from huge leads a month earlier in both surveys.
What's behind this change is a lethal combination of money and lies, and up to a point the lies are working. Before the campaign started, labeling had about 91% support. Negative campaigning has driven that down below 50%.
The No on 37 campaign goes out of its way to avoid mentioning genetically modified organisms, or GMOs. Instead, it presents a farrago of misleading, incomplete, irrelevant and confusing claims about "increased costs to consumers, arbitrary exemptions [and] shakedown lawsuits." The opponents have actually been forced to retract a couple of commercials for claiming or implying endorsements they don't have, and they may even be criminally liable for misrepresenting the FDA's position. The Organic Consumers Association (OCA) has compiled a startling summary of "37 lies and dirty tricks brought to you by Monsanto and the No on 37 campaign."
If California were a swing state in presidential politics, the TV time to spread this misinformation might not be available. As it is, however, opponents of Prop. 37 have raised at least $44 million, and it's still coming in. DuPont kicked in another half-million yesterday. Monsanto now has over $8 million invested, according to OCA's useful list of major funders.
That's not the most spent on a measure this year: According to Reuters, Prop. 32, an anti-union measure, has attracted $128 million ($59m for, $69m against) and Governor Brown's tax plan, Prop. 30, almost as much ($62 for, $53m against). But it's by far the biggest discrepancy: Yes on 37 has raised a relatively modest $7 million.
The race, however, is still very much on. Endorsements of Proposition 37 keep growing, including by the California Democratic Party, the Los Angeles City Council (and many others) and politicians at every level from U.S. Senator on down. The Yes campaign recently released its own TV ad, and is hoping for a final, grassroots effort to leaflet, demonstrate, and vote.
Posted by Abby Lippman, Biopolitical Times guest contributor on October 31st, 2012
Why do harmful genes persist in a population? In a recently published paper, University of Michigan researchers demonstrated that depending on their environmental and biological context, "hundreds of genes" are either harmful or beneficial to an organism – in this case, yeast.
There's a term for this insight, which has been around since the 1950s: antagonistic pleiotropy. It may not slide smoothly off the tongue. In fact, it may seem just some more scientific jargon. But it actually captures an important biological phenomenon that we ignore at great risk. The fact that the same gene harms or helps, depending on the situation, sounds a serious warning to those who want to tinker around.
Yes, many genes – no one knows how many – are what Harold Arlen and Johnny Mercer called “a two-face, a worrisome thing [that]'ll leave ya to sing the blues in the night" if we don't attend to their duplicity.
And before anyone comments that humans are not single-celled organisms like yeast, and returns to tinker-toying with humans, note the researchers’ prediction that "humans should have even more antagonistic pleiotropy." This would mean, they say, that "treatment that removes a disease-causing genetic effect may lead to adverse effects in other aspects of life."
Back in 1995, Dorothy Nelkin and M. Susan Lindee published the first edition of "The DNA Mystique: The Gene as a Cultural Icon." It's taken a while for both scientists and non-scientists to get their heads around the notion – and implications – of epigenetics, and to acknowledge that "DNA is not our destiny." The ramifications of antagonistic pleiotropy may be no less relevant to sickness and health, and, importantly, to our understanding of genetics and society.
Abby Lippman has spent decades following developments in applied genetic and reproductive technologies. Her main interests as a feminist researcher, writer and activist center on women's health and the politics of health. She is also Professor Emerita in the Department of Epidemiology, Biostatistics and Occupational Health at McGill University.
In a recent CBS News video segment,
Eric E. Schadt, chair of the Department of Genetics and Genomic
Sciences at Mount Sinai School of Medicine, enthusiastically discussed
the benefits of whole-genome sequencing. When asked about the
technology’s potential down sides, he answered:
The social implications, what sorts of policy we should be
thinking about, those are the discussions we should be having right now,
about how to leverage this information in ways that are benefitting
humankind, not biasing the type of population through unnatural
selection of traits.
Given this view, one would imagine that Schadt’s department is
deeply engaged with these discussions. In at least one way, it is. He
explained that the school is addressing the social and ethical
complexities of whole-genome sequencing by offering a first-of-its-kind
course in which students analyze entire genomes (either their own or an
anonymous sample) and then take part in a research study on the effects
of getting this information.
Put another way, the school is
hoping to determine the ethics of a new technology they’ve adopted by
performing it on their students and taking stock of the damage.
course is called “Practical Analysis of Your Personal Genome” and
currently has 20 people enrolled, including MD and PhD students, genetic
counseling students, and junior faculty. The students will be able to
use Mount Sinai’s own equipment to sequence and analyze more than four
million genetic variants, at no cost to them. Though most of these
variants are not fully understood, they will be the basis of predictions
about the students’ risks of developing thousands of diseases, their
responses to medicine, and clues to their ancestry. The information will
be relevant not just to them, but also to their family members,
including any children they may have. The department is covering the
expenses, which will be a few thousand dollars per genome.
the students’ sequencing and analysis work is just one aspect of the
course. Through a questionnaire-based study, the students will also be
taking part in a research project that aims to assess the utility of
whole-genome sequencing, the degree to which the exercise improves their
knowledge of genomics, and the impact of so much sensitive information
on their psychological well-being. The school hopes the results of this
research will shed light on how to deal with the complexities and
sensitivities of genomic data. The results will be available after the
class concludes in December and, as Assistant Professor of Genetics and
Genomic Sciences Randi E. Zinberg noted in Mount Sinai’s press release,
the school has big plans for how it will utilize the study. “We look
forward to sharing our learning from this course with other medical
schools and graduate schools worldwide to help advance the breadth and
depth of medical genetics education.”
Scientists in Oregon have published a paper [abstract]
that explicitly challenges the legal and procedural system that forbids
genetic experiments on future generations. And much of the media didn't
seem to notice how radical the proposal is. Just look at these
DNA-swap technology almost ready for fertility clinic (Nature News)
Exchange of DNA Between Egg Cells May Help Prevent Mitochondrial Diseases (Science Now)
These articles are by respected journalists (who, to be fair, may
not have written the headlines) in serious journals and newspapers. And
they appear to ignore the implications of the title of the peer-reviewed paper they are discussing:
Towards germline gene therapy of inherited mitochondrial diseases
Shoukrat Mitalipov (pictured above) and colleagues deserve some
credit for being forthright. They created "three-parent" blastocysts
(essentially as discussed here) and tested them by generating embryonic stem cells. Three years ago, they used the same process in monkeys, and produced four live offspring.
If the same procedure were to be used to generate human babies, as they
propose, it would constitute germline intervention — changing the genes
of future people — which has been off limits for years.
Craig Venter seems to take great pleasure in making outlandish claims about how he will save us all. At the inaugural Wired Health Conference held in New York City on October 16, he did not disappoint. He announced his plans to revolutionize healthcare with “a 3-D printer for DNA, a 3-D printer for life” that would allow one to print a functioning vaccine that had been digitized and emailed anywhere in the world.
Though he was willing to concede that “regulation will be an interesting part of this,” a look into the potential dangers of this technology shows that regulation needs to be more than just an “interesting” side note. Errors in printing could lead to unknown changes in the behavior of a vaccine and have harmful consequences. The opportunity for misuse is particularly terrifying. If a vaccine can so easily be shared around the world, so too can a harmful virus. Biological warfare that could claim your inbox as its battleground would have devastating consequences. As Wired reporter Daniela Hernandez notes,
Mistaking an American Express bill for a scam and deleting it might decrease your credit rating, but downloading, printing and injecting a dangerous retrovirus masquerading as a vaccine is potentially life-threatening.
For some, the idea of bio-printing vaccines seems plausible. Printing 3D objects already takes place: The US military, for example, can remotely print replacement parts or fix technical problems. Emailing and printing short segments of the sequence of a viral vaccine (though not the actual vaccine) already occurs as well. A recent article in New Scientist speculates that perhaps macromolecules could also be emailed “[a]s long as you have a printer that can deposit a repertoire of nucleotides, sugars and/or amino acids where they belong, and link them up chemically.”
Others are skeptical. Policy researcher Edward Hammond, for example, commented in an email that Venter’s project will not be successful “in our lifetimes, if ever.” He noted,
The sequence of a viral vaccine is many steps removed from a functional actual vaccine, the manufacture of which requires other physical inputs, for example media and equipment for conditions to grow copies (often unique to a specific vaccine); means by which to ensure proper dosing; needles; etc, etc, etc.…
But if such a "printer" existed, a few more steps away would be printing a functional pathogen… The security-minded folks out there simply would not permit such a thing to happen – they would not allow the essentially complete means to produce a pandemic pathogen to be placed inside an ubiquitous package whose owner merely needed to know how to press a button in order to operate the machine.
Ain't gonna happen.
Venter's proposal may not become a reality anytime soon, but it could well be heard as a wake up call. As new biotechnologies alter the dimensions of safety and health, thoughtful regulation will be increasingly important. Understanding the risks now is the best way to assure that the technology develops in a responsible way.
Would you believe there’s a company called Fame Daddy whose website offers sperm donated by “a top class portfolio of donors from across the celebrity world” so that women who want to be mothers and need sperm can enjoy “the ultimate intimate VIP access?”
If you think this is a real deal, you’re in good company – so did the nationally distributed Canadian newspaper Globe and Mail, the UK's major commercial TV network ITV, and others.
See what you think after you watch the promotional video below.
In a recent appearance on HBO’s Real Time With Bill Maher, McKibben talked about the radical implications of climate change and mentioned the troubling proposal made by some scientists and politicians to "alter [human] behavior and physiology" to deal with these changes.
The Food and Drug Administration (FDA) is stepping up its oversight of companies peddling unproven and unlicensed stem-cell therapies. They have just released the stern warning letter they sent in September to Celltex, the controversial Texas company that became notorious after it treated Gov. Rick Perry and was entangled in a separate bioethics scandal. Summaries can be found at Pharmalot and at the Knoepfler Stem Cell Lab Blog (which had several earlier useful posts), while the letter itself is here.
The FDA's letter detailed its complaint that Celltex is illegally marketing an unlicensed drug, as well as reiterating a number of complaints about the company's manufacturing processes. In parallel, the FDA sent what is essentially a cease-and-desist letter (full text) to Texas Applied Biomedical Services, the review board that approved CellTex's activities.
Celltex has responded, disagreeing with the FDA's views on legality but promising to meet FDA requirements "no matter how high the hurdles may be, to ensure access to this technology." The 10-page letter is here, and a press release can be found here.
It certainly seems that the FDA is moving to take control of this nascent and regrettably scandal-ridden industry. By coincidence, they are also being forced to deal with a meningitis outbreak, traced to a pharmacy to which they sent a warning letter in 2006. However, a lack of regulatory clarity is said to have hampered the agency with, in that case, disastrous results. Let us hope that processes and procedures have improved. Stem cell treatments clearly need thorough oversight.
The world of stem cell research is full of colorful characters. Here's a quick update on a couple we have been following for years, and one shooting star who seems to heading back to obscurity.
Since the abrupt abandonment in November 2011 of its once highly touted clinical trial using a treatment based on embryonic stem cells (ESCs), Geron has been casting around for someone to take over its stem-cell business. Now, a really surprising candidate has emerged: BioTime, which was founded by Michael West, who founded Geron. West, who became notorious for the clone-your-own-spare-parts theory of stem-cell research, was ousted from Geron and moved on to Advanced Cell Technology, which finally let him go not long before starting clinical trials of embryonic stem-cell therapies. At his latest venture, he recently hired Thomas Okarma, who ran Geron until he in turn was pushed out, shortly before the company abandoned clinical trials on ESCs. There has been no response yet from Geron.
Meanwhile, Glenn McGee, the peripatetic bioethicist last seen resigning from CellTex in controversial circumstances, after resigning as editor of the American Journal of Bioethics (AJOB) in controversial circumstances, appears to be in Berlin. There are reports (based on a plausible-looking letter in German) that he took a job with RNL Europe, based in Germany, at a salary of 400,000 Euros. This letter was briefly posted at Lee Buckler's Cell Therapy Blog, but was taken down, apparently because Buckley couldn't find confirmation and McGee didn't reply to tweets. So maybe it's not true, or premature, or contingent on work permits, or something. However, speculation is not dampened by the news that McGee's wife, Summer Johnson, has resigned her position as co-editor of AJOB, and severed all connection with Bioethics.net and its ancillary enterprises.
Finally, it seems that the career of Japanese stem-cell researcher Hisashi Moriguchi has hit the headlines and then the skids in record time. Last week, his claims to have used induced pluripotent stem cells to successfully treat heart-failure patients ran on the front page of Yomiri Shimbun, Japan's biggest daily newspaper, with a circulation of about 10 million. But he had not done anything of the sort, as was discovered within days. Moreover, Moriguchi also claimed, as he has before, that he acted with approval from a Harvard IRB. No, he had not. Paul Knoepfler's Stem Cell Blog deserves a lot of credit for exposing this fraud, as does Nature's David Cyranoski. But Moriguchi is undoubtedly right when he admits that his "career as a researcher is probably over."
No kidding. Genetic privacy issues have been the focus of California court cases and legislative initiatives in recent years. In fact, about a year and a half ago, California officials seemed to have resolved two hot topics in favor of more stringent protections for individuals who had DNA samples taken without giving informed consent. First, a California Court of Appeal struck down as unconstitutional the state’s 2004 amendment requiring felony arrestees to provide their DNA to police.
Second, Governor Brown signed into law Senator Alex Padilla’s (D-Pacoima) bill which prohibits “surreptitious sequencing,” i.e. sending someone else’s cigarette butt or used tissue to a lab for genetic analysis without his or her knowledge. The law also proscribes genetic discrimination in housing, employment, education, public accommodations, health insurance, life insurance, mortgage lending, and elections – a major expansion over the current federal law (the Genetic Information Nondiscrimination Act, or GINA) which prohibits discrimination only in the areas of health insurance and employment.
And now it seems the President’s bioethics commission is pushing the feds to catch up with California.
On the legislative side of the DNA privacy issue, the Presidential Commission has recommended that, just as the California legislature has done, Congress (and other states’ legislatures) should “protect individual privacy by prohibiting unauthorized whole genome sequencing without the consent of the individual from whom the sample came.”
In the courts, the constitutionality of the California felony arrestee DNA collection law is currently being reargued. The Ninth Circuit just held an en banc hearing and will soon decide for itself whether the California law is unconstitutional. Why re-scrutinize the same issues in a different court? Because federal courts are not required to follow state courts’ interpretations of federal law, and also because the California Supreme Court granted review of the case last year, thereby calling the issues into question again.
Will the bioethics commission’s opinion about the potential misuses of genetic information push federal judges and legislators to follow in the footsteps of their California counterparts? We won’t know for some time. But what we know now is that the “nation’s leaders in medicine, science, ethics, religion, law, and engineering” agree that the information embedded in individuals’ DNA is sensitive and vulnerable enough under current laws that it should be handed over only after informed consent has been obtained.
Posted by George Estreich, Biopolitical Times guest contributor on October 17th, 2012
Since I started researching and writing about the new fetal gene tests that can detect Down syndrome and other disorders from a maternal blood sample early in pregnancy, the ads for Sequenom's MaterniT21 have been appearing regularly on my computer screen. Whatever you think about Sequenom, they have their online marketing together.
I'm writing about the new fetal gene tests not because I oppose them in some blanket way, but because I think that a robust conversation is necessary if our medical advances are to help us. In that conversation, we need to talk not only in narrow terms about the relative efficacy of these tests, but about the assumptions and wishes to which they appeal, the vision of health they present, and the broader social consequences of that vision.
And because the tests in question are products, it’s worth looking at the way these products are sold. The companies know this: their websites are slick, expensive-looking, carefully worded. These are acts of persuasion, subordinate to the goal of making a profit; and whether we like it or not, they are a part of our society's conversation about biomedicine, not outside it.
So in the spirit of continuing that conversation, I'll begin with a response to my last post, where I took issue with the idea that "90% of all fetuses with Down syndrome are aborted." I wrote that in fact 90% of all fetuses positively diagnosed are aborted. However, as I was quickly informed, even in the case of a positive diagnosis, the number of terminations ranges widely, from 50 to 90%, depending on the sample. These points were offered as part of a spirited Facebook discussion among bloggers, and though I (weakly) protested that the 50-to-90-percent thing was actually a figure I linked to, I accept the correction.
The numbers matter not only for the obvious reason that our deliberations should be based on the best data available, but also because they suggest the complexity of the situation. The 90% figure – whether claimed for all fetuses, or all fetuses diagnosed – implies a solid consensus, a slam dunk, almost like a recommendation. 67% is something else: it suggests a process of deliberation (as does the widespread refusal of amniocentesis, which only 2% of women currently use). By extension, it also suggests that a test may not automatically result in “peace of mind.”
It’s also important to realize that not all prenatally identifiable conditions are the same, and that prospective parents do not react the same way. These are not merely decisions about biology, but about values. So with Tay-Sachs disease, for example, there is far greater agreement among prospective parents about the need for prenatal testing and selective abortion.
This is unsurprising: Tay-Sachs is not only invariably fatal and incompatible with long life, but it is inheritable within a relatively small community. That means that there is likely to be shared experience of the disease, and an awareness of its possibility. Down syndrome, however, except in the very rare case of translocation trisomy 21, is not inheritable: it occurs at random. Therefore, it is far less likely that a prospective parent will have direct knowledge of Down syndrome.
What, then, will fill the gap? To ask the larger question: How will the conditions we seek to prevent be portrayed? And, as a corollary: How will the need to sell a product shape the portrait?
The Nobel Prize in Physiology or Medicine upstaged an arguably even more significant announcement that built on the same research. Mitinori Saitou and colleagues in Kyoto created mice by using sperm and eggs grown from “induced pluripotent” stem cells (iPSCs).
Think about it: This is extraordinary. They took fully developed adult cells, transmuted them into iPSCs, induced those to develop into gametes — both male and female — which they combined to form embryos that were implanted and brought to term as mouse pups. This is as close as we have come yet to creating life: cloning without a donor egg.
Well, nearly. Most reports slightly exaggerated how far this effort had succeeded. At present, supplied ovaries are needed for the procedure to work, as a sort of scaffold on which the oocytes grew, so they have not yet eliminated the need for eggs, but they expect to in the foreseeable future. According to Science Now:
Saitou says that with a bit more progress in understanding the complex interactions at work, they may be able to coax the cells through the entire oocyte development process in a lab dish. If successful, "we may be able to skip the grafting," he says.
That prospect has already provoked a worldwide round of headlines, many of them jumping immediately to possible human applications. Which is hardly surprising, since the formal academic paper in Scienceconcludes [sub req'd]:
Combined with a previous study, our system serves as a robust
foundation to investigate and further reconstitute female germline
development in vitro, not only in mice, but also in other mammals,
It really is not hard to imagine a scenario in which an infertile person becomes artificially (though perhaps unreliably and expensively) fertile. Theoretically, people with no functional gametes, or gay men or women, could have babies genetically related to both members of the couple and to no one else. Indeed, as Ronald Green pointed out, DNA theft becomes a somewhat plausible threat:
When you think about the commercial possibilities of people selling to infertile people babies produced from George Clooney or Jennifer Aniston, or whatever, you have to worry about it.
None of that is going to happen soon, and it might not happen at all — research is never entirely predictable — but these concepts are rapidly moving from speculative fantasy to the point where they deserve serious discussion.
Saitou, like Nobelist Shinya Yamanaka, is well aware of ethical issues: “Right now,” he says, “using oocytes has this moral and legal burden.” On the prospect of “parentless” children, he says that “the biological, ethical, and legal issues they will raise defies the imagination.”
Which is true, but at least as disturbing is the idea of using these technologies not only to create related offspring for the previous infertile but to specify what that child will look like, and maybe more. That’s the prospect that led Hank Greely to respond, on NPR (audio):
Wow. That's my general reaction. Repairing hearts, repairing brains, repairing kidneys, that's all good and important, and we'd all love to be able to do that. But this involves making the next generation. ... It will change the world if it happens, by giving parents — I hope parents, potentially governments or insurers or doctors or somebody else — but in the US, I suspect it will give parents a greater ability to choose the genetic traits of their children.”
That could mean, Rob Stein suggests, "babies with blue eyes or blond hair, or a talent for sports or music." This point was largely lost in coverage that stressed a potential new fertility treatment. The availability of huge numbers of gametes, which could allow the refinement of genetic modification techniques, might wind up bringing germline engineering into the realms of technical possibility.
That is a prospect that goes to the heart of the concerns of the Center for Genetics and Society. As a society, indeed a global civilization, we need a long, deep and well-informed debate. There will be disagreements; we must not flinch from confronting them. It is no exaggeration to say that the future of our species may be at stake.
No, scientists have not created hypoallergenic milk, no matter what the headlines say (1, 2, 3, 4 and many more, even including Genetic Engineering and Biotechnology News). They have created a calf that seems to produce milk missing one protein that may be a cause of allergic reactions; but its milk contains greater levels of another protein, casein, that is definitely allergenic.
The research was published in PNAS this week, and apparently most journalists could not resist distorting the facts in favor of a cute story about a techno-fix for the milk allergies that affect between two and three percent of infants, who usually outgrow them. (Lactose intolerance is different, and much more common.)
New Zealand scientists performed a noteworthy technical trick in engineering a cow to produce milk that does not contain the protein BLG. They tweaked a skin cell, then used it to create a clone. As usual, the process was very inefficient: 57 embryos were transferred, five pregnancies resulted and one live calf was born, for some unknown reason without a tail. The Guardian has a reasonable summary, and quotes one of the authors:
We first of all consider our genetically modified cow a great tool to study allergenicity and do not envision any practical application any time soon.
The Los Angeles Times, in an article prompted by this report, did mention the casein problem. Dr. Robert Wood of Johns Hopkins told the paper that it presents "probably the worst-case scenario for most of our patients," since those allergic to BLG are usually allergic to a variety of proteins. But, especially in light of this, the framing of the LA Times piece was shocking:
Scientists fret over FDA slowness on genetically altered animals
The piece is worth reading, however, for a summary of the various attempts to sell us GM and/or cloned creatures as food — cows, salmon, pigs, goats and chickens, not to mention corn and soy and other crops. As though presenting a justification, it notes that "the public routinely consumes processed foods made with genetically modified corn and soybeans." There is, however, no mention of the undoubted fact that many people do not realize that, nor of this article in the same paper a couple of days earlier, about the California initiative to label foods containing GMOs:
Poll finds Prop. 37 is likely to pass
Just because something is an impressive piece of technological wizardry is no guarantee that anyone wants it, or even that it's useful. And journalists have a responsibility not to promote stories about hypoallergenic breakthroughs that are flatly false.
The ACLU has just petitioned the US Supreme Court to review a Federal Circuit Court’s decision in the landmark Myriad Genetics gene patent case. The lawsuit, which seeks to invalidate patents for two genes associated with hereditary forms of breast and ovarian cancer, was filed in 2009 on behalf of plaintiffs who include women’s health groups, medical research organizations and breast cancer patients. The outcome is likely to have significant implications for scientific research and access to medical care.
The ACLU’s request was expected after Judge Alan Lourie ruled again that an isolated DNA sequence is a “composition of matter” that is eligible to be patented under federal law. The ACLU contends that the Federal Circuit Court decision did not adequately incorporate the Supreme Court’s recent ruling in Mayo v. Prometheus into its analysis. But Judge Lourie simply stated that the Mayo case isn’t controlling in the gene patent context. He found that the issue at hand is “solely whether the claims to isolated BRCA DNA [the genes in contention], to methods for comparing DNA sequences, and to a process for screening potential cancer therapeutics meet the threshold test for patent-eligible subject matter” and that “Mayo does not control the question of patent-eligibility of such claims.” Plain and simple, according to Judge Lourie, the claims pertaining to isolated DNA molecules are composition-of matter-claims that are expressly authorized under federal law.
If it’s so plain and simple, then why have the ACLU and dozens of professional and public interest organizations (including the Center for Genetics and Society, which has signed several amicus briefs in the case[1, 2]) invested time and money in this fight?
Because the United States Constitution gives to Congress the power to “promote the Progress of Science and useful Arts, by securing for limited Times to...Inventors the exclusive Right to their...Discoveries.” Patents incentivize investment in research and development by guaranteeing an exclusive right (for a finite period of time) to profit from hard work, innovation and investment. And patents make possible future improvements in technology. Patents holders have to fully disclose their inventions to the Patent and Trademark Office in order to get that profit monopoly, so once the patent expires, new folks can come in and build a bigger and better version of the invention.
Sounds good, right? But there’s a catch. People can’t patent something (a “composition of matter”) that occurs naturally. To do so would be to undermine the whole point of patents by rewarding someone who didn’t put in any work and by making new innovation nearly impossible since the basic building blocks provided by nature would be off limits to those looking to make improvements later on. In Mayo, the Supreme Court drew a line in the sand to separate the natural from the human-made, but Judge Lourie said that line is on a different beach. See what you think:
Prometheus Lab’s first patent, which the Supreme Court invalidated on March 20, 2012, simply describes the result of an entirely natural process—the body’s metabolization of ingested drugs. Its claim set forth a relationship between the concentration of a certain metabolite in the blood and the effectiveness of a dosage of a drug; if the concentration of the metabolite was below a certain specified range, the drug would be ineffective, and if the concentration was higher, the drug would likely cause harm to the patient. The Court found that the relation between the concentration of the drug in the bloodstream and the drug’s efficacy was an entirely natural phenomenon, and therefore unpatentable.
As the Court summarized it, Prometheus’s first claim
simply tells doctors to . . . measure (somehow) the current level of the relevant metabolite” and the other claims go on to tell doctors to “use particular (unpatentable) laws of nature . . . to calculate the current toxicity/inefficacy limits, and [then] reconsider the drug dosage in light of the law.
Judge Lourie found the claims in Mayo to be entirely distinct from those in Myriad. The supposed “natural phenomenon” in the Mayo case was the concentration of metabolites in the blood, but in the Myriad case it is isolated DNA. And like it or not, “isolated DNA molecules . . . are not found in nature.” They are “prepared from products of nature, [but] so is every other composition of matter.”
Comparing isolated DNA molecules to manufactured plastic products and modern medicines, Judge Lourie landed on one side of a fine line the federal courts have been trying to draw for decades. Natural phenomena have long been deemed unpatentable, but too broad of an interpretation of what counts as a natural phenomenon could eviscerate patent law because all innovations at some level use laws of nature. As Judge Lourie put it, “patents on life-saving material and processes, involving large amounts of risky investment, would seem to be precisely the types of subject matter that should be subject to the incentives of exclusive rights.”
In what appeared to be a nod to the multitude of amicus briefs and expert opinions that have addressed the undesirable practical implications of permitting such patents, Judge Lourie specifically noted several examples of what the legal issues in the Myriad case do not include. First, he wrote, the legal issue “is not about whether individuals suspected of having an increased risk of developing breast cancer are entitled to a second opinion.” Next, it is not about “whether it is desirable for one company to hold a patent or license covering a test that may save people’s lives.” Additionally, it does not address “whether the claims at issue are novel or nonobvious or too broad.” More to the point, Judge Lourie opined that “disapproving of patents on medical methods and novel biological molecules are policy questions best left to Congress.”
But the ACLU disagrees, for good reason. Policy is embedded in the very fabric of the Constitution’s Patent Clause and lies behind all the best judicial decisions—patent-related or not.
This most recent ruling by Judge Lourie was a narrow one. The issue was patent eligibility only. Despite the fact isolated DNA sequences are, for now, considered patentable compositions of matter, each proposed patent will have to meet all the criteria of patentability including novelty, non-obviousness, and utility. But there’s still a possibility that Congress could, as Judge Lourie noted, decide to revise current statutory law and specifically exclude isolated DNA as patentable subject matter for policy reasons. There’s also the possibility that the Supreme Court will do it…rumor is they’ve made a policy decision once or twice before.
Can inheritable genetic modification ever be appropriate? For many years, it’s been widely accepted that altering the human “germ line” – that is, making any genetic changes that would be passed on to future generations – is a not-to-be-crossed bright line. This line has been codified in law in some three dozen countries, including most of Europe and Canada.
Now some UK scientists are mounting a policy effort to push over the germ line – in the name of medicine, and without intentionally changing any phenotypic traits, but discarding the bright line nonetheless. In mid-September, the UK agency that regulates assisted reproduction – the Human Fertility and Embryology Authority (HFEA) – launched a public consultation about proposed IVF techniques that would constitute germline genetic modification, and has published an extensive website to explain the issue and solicit public comment. In the words of HFEA chair Lisa Jardine, the agency will “take the public temperature on this important and emotive issue.”
The techniques, known as “mitochondrial replacement,” involve creating embryos with portions of eggs from two different women. The goal is to allow a woman to pass on to her future children all her own genetic material with the exception of a small number of genes in her defective mitochondria, which are organelles outside the nucleus of an egg that are involved with cellular metabolism. The mother’s mitochondrial DNA would be replaced by material from another woman’s egg, so any child born after such procedures would inherit a small amount of DNA from that other woman.
This is portrayed as an innovative medical approach that might help people have healthy children. But it also raises thorny questions about whether attempting the techniques would be risky enough that it would constitute unethical human experimentation, and about whether allowing the techniques could open the door to additional forms of inheritable genetic modification.
The move was widely covered in the British media, where the story ran under headlines about “3-parent babies” (The TelegraphandHuffington Post UK) “3-parent families” (The Independent) or “3-parent IVF” (Reuters). It was little noticed by the US media, though the new web-TV platform HuffPost Live carried a panel discussion in which I participated.
The HFEA consultation, which runs until December 7, is supposed to address ethical concerns, not questions about safety. But the kinds of safety considerations presented by mitochondrial replacement are in fact an ethical matter. Using risky and unproven techniques is one thing when a person’s life or well-being is at stake and there are no alternatives. But that’s not the situation here. Mitochondrial replacement is aimed not at existing people, but at future children. And there is an alternative: Parents at risk of passing on mitochondrial disease could elect to use IVF with eggs provided by an unaffected woman. Though the resulting child would not be genetically related to the mother, neither would it be put at risk by a biologically radical experiment.
Many observers say that there is not nearly enough research evidence to know whether the new techniques would be safe. And similar biologically extreme technologies provide reason for concern. One example came to public attention in 2001, when U.S. scientists using a similar but less invasive technique to initiate a small number of pregnancies were told by the FDA to stop because of chromosomal and developmental problems in resulting fetuses and one child (1, 2).
Questions have also been raised about how many people might be candidates for mitochondrial replacement techniques. The HFEA press release and website state that 1 in 200 children are born with “a form of mitochondrial disease.” But that number appears to be significantly inflated: Other sources put the rate at 1 in 4000, 6500, or 8500 (1, 2, 3). The HFEA’s incidence rate might refer to conditions that are affected by mitochondrial DNA, but these involve little-understood interactions between mitochondrial and nuclear DNA, and wouldn’t necessarily be avoided by mitochondrial replacement.
The HFEA acknowledges that mitochondrial replacement is a form of germline modification, which is banned in dozens of countries, and that “this may raise important social and ethical questions.” It includes on its website a short video with people expressing a range of views. At a London news briefing, HFEA Chair Jardine said that
once we have genetic modification we have to be damn sure that we are happy. Because this is not about us. This is not about our children. It's not even about our grandchildren. It's about many generations down the line what the consequences might be.
A key concern is whether allowing mitochondrial replacement could set a policy precedent. If it were to be approved, would advocates of inheritable genetic modification use it as a wedge for more extensive “designer-baby” manipulations?
Dr. David King of Human Genetics Alert, a UK public-interest organization, has tracked the development of genetic modification techniques and the policies related to them for years. He believes that mitochondrial replacement techniques could in fact “set a precedent for allowing the creation of genetically modified designer babies,” and that this risk is not outweighed by any pressing need, since third-party eggs for those concerned about passing on mitochondrial disease provides an alternative. That the technique “is even being considered is a reflection of medical consumerism and scientists' fetish for employing the most hi-tech methods," he said.
A bizarre tragedy is playing out in Houston. Some commentators are calling it "a landmark case in motherhood" but it seems more like either a horrible misunderstanding or an appalling case of exploitation. Certainly, the dearth of public policy about surrogacy bears some of the responsibility.
Briefly, Cindy Close wanted to be a mother, and her platonic friend Marvin McMurrey wanted to be a father. By her account, McMurrey agreed to supply his sperm and to help raise the child. Because she was in her 40s, she was advised to use IVF and a third-party egg provider. She became pregnant with twins.
On the day of the (premature) birth in July, McMurrey informed the hospital that Close was a surrogate and the children were his. The babies now are living with his boyfriend, Phong Nguyen. Close sees them for two hours a day, Monday through Friday, but is not allowed to breastfeed them because of the terms of a restraining order McMurrey and Nguyen obtained. Both McMurrey and Close are suing: he claims she was merely a surrogate, and she is asking for custody and child support.
McMurrey is refusing to comment on the advice of his attorney, but Close is giving interviews. She insists that she did not even know that he was gay until the day the twins were born. (The two of them briefly dated about six years ago, but were never in a sexual relationship.) They had been discussing the possibility of having children together for five years, and she expected to be the primary parent. "If anything," she told the Houston Chronicle, "I thought he would lose interest because I didn't expect him to be a very involved father."
McMurrey did pay for the procedure. His family is rich, and he owns a car dealership; according to her [in this CNN video], he not only offered her the chance to be a stay-at-home mom, he suggested that she would be "financially securing" her own home. At his insistence, she did sign an affidavit declaring him the biological father, admitting that she is "not genetically related to the children" and "did not receive compensation" for her voluntary services.
This is not a typical surrogacy contract, if for no other reason than the timing: it was signed on July 3, and the children were born that some month. She didn't consider it to be a contract, and did not consider herself a surrogate. He, on the other hand, could not have made one because under Texas law the intended parents must be married, and gay marriage is not recognized.
Surrogacy and related procedures continue to raise complex emotional,
ethical and legal issues around the world, especially when gay parents
are involved. In the UK, a lesbian couple recently won a court battle
with the surrogate mother and sperm donor, whose wife seems particularly
upset. In Oakland, a lesbian is suing the FDA because she does not want
her chosen sperm donor to follow the FDA's procedures. A gay sperm
donor in Britain has won visitation rights for the child a lesbian
couple are raising. Since McMurrey and Nguyen live in Texas, if they want to raise a child to whom at least one of them is genetically related, they have significant roadblocks to overcome.
The courtroom battle between Close and McMurrey seems to be heated. Her attorney, Grady Reiff, has called for
his attorney, Ellen Yarrell, to be removed from the case, because of what he called an "evil" line of questioning about abortion. Yarrell suggested that it was relevant because Close had told Fox 26 News that McMurrey had destroyed her only chance at children, but this seems to be the interview mentioned and that's not what she said — she said that "after giving me my dream, he's taking it away."
If there is no signed contract, then as Andrew Vorzimer has pointed out, this is not technically a surrogate case. And yet the penumbra of surrogacy surrounds it. How else to explain the actions of the first judge who awarded temporary custody to the presumed biological father over the gestational mother?
The explanation can be found in one word: class. He is rich, and she is not. He is well-groomed, she is kind of frumpy. He is a businessman, she earns "a modest income in printing." Oh, and he was in court while she was not; possibly while she was in the hospital.
She certainly seems to have been naive; apparently he floated the idea of "moving to Oregon, along with his friend, Phong Nguyen" and she never suspected they were gay. But should her naivete be a justification for exploitation, if that is indeed what occurred?
The court that awarded McMurrey temporary custody of the babies may have pictured him as a responsible parent, and Close as a surrogate who changed her mind. That court only heard his side of the story. She now has an attorney who seems like a strong advocate, and the judge expects to rule
Update, Oct. 4: Professor James W. Paulsen, a Texas family law expert, suggests that the legal process now unfolding is unusual, and may need to be restarted. He speculates that McMurrey may deliberately be dragging the proceedings out:
If Mr. McMurrey’s partner can hold on to the children for six months while things are tied up in court, under Texas law he can ask for custody on his own, even though he has no biological ties to the children. By then, the children may have bonded with him more than with their birth mother.
Posted by Center for Genetics and Society on September 28th, 2012
A video recording is now available of this public event, held at the University of California at Berkeley School of Law on August 28, 2012.
much of the 20th century, California was at the forefront of eugenic
ideology and practices in the United States, and holds the dubious
distinction of being the state with the highest number of eugenic
sterilizations performed under the authority of law – some 20,000
procedures between 1909 and the mid-1950s. Coerced sterilizations
continued in public hospitals into the 1970s, and it has recently come
to light that in very recent years, women prisoners in California have
been sterilized without their consent or knowledge. Today, California is
a leader in research and services related to human genomics and
assisted reproductive technologies. Speakers at this public event considered the long history of eugenics in California and explored
continuities and discontinuities in the uses and misuses of genetic
ideas and practices.
Welcome: Dean Christopher Edley, Berkeley School of Law
Moderator: Troy Duster, Chancellor’s Professor and Senior Fellow at the Warren Institute for Law and Social Policy, UC Berkeley
Eugenic Sterilization in California: Stories and Statistics
Miroslava Chávez-García, University of California at Davis and Alexandra Minna Stern, University of Michigan
provide an overview of the patterns of the 20,000 eugenic
sterilizations performed in California state institutions from 1909 to
1979, with close attention to race, gender, class, and diagnosis. We
will also highlight stories of sterilization victims and the ways in
which they attempted to challenge the state's authority to control and
contain their reproductive rights. As we will demonstrate, the process
had a devastating impact on the victims.
¿Más Bebés? (documentary film)
Renee Tajima-Peña, University of California at Santa Cruz; Virginia
Espino, University of California at Santa Cruz, and Kate Trumbull,
The feature-length documentary ¿Más Bebés?
(working title) investigates the history of Mexican American women who
allege they were coercively sterilized at Los Angeles County-USC Medical
Center during the 1960s and 70s. Many spoke no English, and testified
that they were prodded into tubal ligations during active labor. The
sterilizations triggered the 1978 class action lawsuit, Madrigal v.
Quilligan, and a protest campaign that galvanized the Chicana feminist
Eugenics in California Women’s Prisons Today
Kimberly Jeffrey and Courtney Hooks, Justice Now
Justice Now has been working collaboratively with people in
California’s women’s prisons to document how prisons violate the
international right to family and function as a tool of reproductive
oppression. Presenters will place a spotlight on personal experience
with as well as the systemic pattern of destruction of reproductive
capacity of women of color and gender variant people in California
women’s prisons through several state-sanctioned policies, including
forced and coerced sterilizations (e.g. the illegal and routine
sterilization of hundreds of people in prison during labor and
delivery), and other violations of safe motherhood and reproductive
Should We Worry About a New Eugenics?
Marcy Darnovsky, Center for Genetics and Society
fast-developing genetic and reproductive technologies offer significant
benefits, but can also be misused in ways that exacerbate existing
inequalities and create entirely new forms of injustice. California, a
hotbed of eugenic advocacy in the last century, is today a center of
biotechnology research and commercial development and the assisted
reproduction sector, as well as home to some troubling
techno-enthusiastic ideologies. Our efforts to confront California's
eugenic history can help prevent these dynamics from veering toward a
This event was co-sponsored by the Center for Genetics and Society and the UC Berkeley Haas Diversity Research Center, the UC Berkeley School of Law, as well as the Institute for the Study of Societal Issues, American Cultures Center, Disability Studies Program, Disabled Students Program, Center for Reproductive Rights and Justice, and the Center for Race and Gender.
Co-coordinators: Marcy Darnovsky (firstname.lastname@example.org) Alexandra Minna Stern (email@example.com)
Advisory committee: Miroslava Chávez-García, Troy Duster, Tony Platt, Sue Schweik
They look like models from a Cialis ad: healthy, prosperous, white, late thirties or early forties. If you were guessing, you’d say the man was an executive in a nonmedical field, that the wife has a professional degree but scaled her career back for family, and that they drove to the office together in a silver Lexus SUV. His hobby is golf, hers is scrapbooking. You see them over the doctor’s shoulder – he’s a blurred white coat in the foreground – and they look concerned but reassured, as if they have just received good news about a solvable problem. The husband’s arm is positioned supportively behind the woman’s chair. There are no markers of political and religious affiliation: their story is a matter of suggestion and erasure, underpinned by the certain fact of an extra chromosome. In this way, at least, it resembles the story of the condition they are clearly there to prevent.
That condition is Down syndrome, and the product isn’t a pill. It’s Sequenom’s MaterniT21plus, an early-pregnancy test described as “an in-office, noninvasive laboratory-developed test for trisomy 21, 18, and 13.” Perhaps because trisomies 18 and 13 are both rarer and incompatible with long life, only Down syndrome is described below the photograph. It’s a standard description, and it is a more than superficial improvement upon the slanted language, factual errors, and long lists of possible disease features that are fading, but still common, in contemporary descriptions of the condition. In this, the description, like the test itself, is very much of our time: over the past several decades, even as our ability to detect Down syndrome has increased, so has our acceptance of people with the condition, a fact reflected in the way we describe it.
And yet that description, like most descriptions of Down syndrome, has a context and a purpose. As such, it is inflected, ever so lightly, with the negative. The word “risk” (as opposed to, say, the neutral “chance”) appears four times, and in a way which subtly expands the pool of potential consumers: “The risk to have a child with Down syndrome does increase with the mother’s age, but mothers of all ages can have a child with Down syndrome.” “Your doctor may also recommend screening for Down syndrome if you have other risk factors such as a family history of Down syndrome.” The condition being risked, though initially identified as a “variation,” is also associated with “birth defects”; and the sense of risk is amplified by an insistence on randomness: “It is important to know that most cases of Down syndrome are not inherited. In fact, most cases of Down syndrome happen randomly by chance.”
It is, in other words, less a factual document than an act of persuasion. Though it speaks with the bland rhetoric of health and choice, and though it’s subtly done, at root it works the way most advertisements work: it engages our fears, then seeks to allay them. Down syndrome, in the world of the ad, is an abstract world of randomness and risk; MaterniT21plus is the answer.
What, then, is left out?
As ever, the actual lives of people with Down syndrome. It is not reasonable, of course, to ask Sequenom – whose continued profitability depends on the wishes of prospective parents to avoid Down syndrome – to show pictures from the latest Buddy Walk®. However, the likely effect of tests like MaterniT21 is to depopulate the Buddy Walks of the future. This isn’t a matter of evil, or prejudice; it’s just economics, and individual decisions adding up to social change.
It is crucial to note that those individual decisions are not lightly taken. Nor are they as common as is thought. As the writer Amy Julia Becker points out, the frequently-cited statistic that 90% of all fetuses with Down syndrome are aborted is factually incorrect. In fact, around 90% of all fetuses positively diagnosed are aborted – which is to say, women willing to undergo the invasive procedure of amniocentesis, with its small but real risk to the fetus, and to contemplate a second-trimester abortion. And yet the numbers of those with Down syndrome are considerably lower than they would otherwise be.
At present, an estimated 100,000 women a year have prenatal genetic tests. A recent article in Nature reports that the Sequenom test is expected to expand that number as much as thirtyfold – to 3,000,000. It is difficult to imagine that this will not affect the numbers of those with Down syndrome in the world. It is also likely that the widespread use of the test will affect our sense of what Down syndrome is.
For parents, advocates, and people with the condition, Down syndrome is not a mistake or a defect; it is a way of being human. But the very fact of a test, combined with the medical authority behind it, implies a different view. Its focus on whole-chromosome disorders strongly associates Down syndrome with other disorders which are either different, or more severe. More generally, as a prenatal test, it associates Down syndrome with other conditions which can be tested for –which is why, in discussions of prenatal diagnosis and selective abortion, it is common to see Down syndrome lumped in with utterly unlike conditions, including thalassemia, cystic fibrosis, PKU, Tay-Sachs, and Huntington’s disease.
These may seem like specialized concerns: matters for parents of children with Down syndrome like myself, for disability rights activists, and for all those of us miscast as Luddites. In fact, we should all be concerned, because Down syndrome is at the leading edge of prenatal genetic diagnosis – just as it was at the dawn of prenatal (non-genetic) testing. In the age of genomics, whole-chromosome conditions are only the beginning. Our ability to sample fetal DNA from maternal blood means that not only Down syndrome, but before long any condition with a genetic component, any “risk,” can be forecast.
How such advances will affect our understanding of human health remains to be seen, but the questions they raise are far from easy. When everything can be tested for, how will we determine what is pathological, and what is normal? For that matter, what will happen to the troubled idea of “normal” itself? When the interpretive ground is shifting, how will patients interpret complex results? What sense will they make of the avalanche of data, and in a failing health system, who will have the time to help them make that sense? When inheritable conditions are discovered, what obligations, legal and ethical, obtain between the patient, the doctor, and the company selling the test? The presence of difficult questions should not preclude the test’s existence or use: difficult questions are always present. But if the test is to be a genuine benefit to human health, the questions need to be faced.
In its webpage for health professionals, Sequenom describes its product with three adjectives: clear, convenient, compelling. The test is undeniably convenient, and will be compelling for many. Its implications, however, are anything but clear.
George Estreich received his M.F.A. in poetry from Cornell University. His first book, a collection of poems entitled Textbook Illustrations of the Human Body, won the Gorsline Prize from Cloudbank Books. His memoir about raising a daughter with Down syndrome, The Shape of the Eye, was published in SMU Press’ Medical Humanities Series. Praised by Abraham Verghese as “a poignant, beautifully written, and intensely moving memoir,” The Shape of the Eye was awarded the 2012 Oregon Book Award in Creative Nonfiction. Estreich lives in Oregon with his family.
Harriet Washington, author of the award-winning Medical Apartheid and most recently Deadly Monopolies, just published an article in Slate(and New Scientist) on new fetal gene tests that can give expecting parents voluminous information about their fetus after only seven weeks. Others have discussed the ethical issues involved with non-invasive prenatal diagnosis; Washington cogently articulates the pressing nature of these developments:
Before using such a test, parents must ask themselves, "What can we do with the information?" If abortion is not an option, perhaps because the fetus is past the maximum gestation period or because of moral beliefs, the information can be useless—or worse than useless, thanks to the needless anxiety. Moreover, the dearth of treatment options for some disorders makes the information medically useless, but potentially risky if insurers use it to hike rates or deny coverage.
If abortion is an option, new problems emerge: Which disorders justify abortion? For some conditions the choice is perhaps clearer. For example, children with the infantile form of Tay-Sachs or Canavan disease go into an immediate, inexorable decline. There is no cure or effective treatment and most children with the disease die in childhood.
Do you have the right to know if the food you buy contains genetically modified ingredients (GMOs)? That's the question behind California's Proposition 37, which will be on the ballot in November. If it passes, the ripple effects may well change the whole country, and perhaps the world.
A YES vote on this measure means: Genetically engineered foods sold in California would have to be specifically labeled as being genetically engineered.
That's essentially it. The official summary [pdf], prepared by the state Attorney General, also notes that Prop. 37 prohibits calling GMO food "natural" and includes various exemptions: the law will not apply to food that has been certified organic; restaurant food; accidentally contaminated food; food from livestock fed on genetically engineered material (if they are "not genetically engineered themselves"); and alcoholic beverages. The Yes campaign is focusing on the Right to Know and who could disagree with that?
Yes on 37 is defending the popular position. A California Business Roundtable poll released in August showed it leading 65-22, and winning [pdf] in every age group and all political affiliations. A national poll in March [pdf] showed labeling supported by 91–5, which is fairly typical and consistent over many years. A KCBS poll in California in March also found 91% support. Which is why proponents managed to gather almost double the signatures needed to put the proposition on the ballot: 508,000 were required, and nearly a million were turned in.
But that is no guarantee of victory. The No campaign has raised at least $27 million and might spend as much as $50 million. The full money trail is not yet on the reporting website, but Monsanto has kicked in $7 million and other major opponents include DuPont, BASF, Bayer, Dow, Pepsico, Nestle, Coca-Cola, Del Monte, General Mills, Kellogg and a raft of others. Included are the corporate parent companies of Horizon Organic, Kashi, Muir Glen and other organic brands.
The Yes campaign is badly behind on money. They have Whole Foods, Nature's Path, Dr Bronner's, and many smaller enterprises, as well as the American Public Health Association, California Nurses Association, United Farm Workers, Sierra Club, Public Citizen, California Certified Organic Farmers, Consumer Federation of America, Center for Food Safety, Food Democracy Now! and thousands of other groups and individuals. They have raised over $3 million so far, launched one TV ad and a new series of radio ads.
Will the avalanche of cash overwhelm the initial public support? Well, it might. Fear of that is why a number of major food-safety organizations were at first reluctant to get on board with the grassroots campaign (initiated by Pamm Larry, a "grandma on a mission") that gathered those signatures. But they're all on board now. This is a struggle worth winning, and it's important not to lose. Ronnie Cummins of the Organic Consumers Association (an early supporter and still a major advocate) writes:
We are entering the home stretch of the most important food policy fight in your lifetime. ... Major food companies have already conceded that if we pass Prop 37 in California, we may as well pass a national GMO labeling law. If this law passes, food manufacturers will take GMOs out of their products, rather than risk losing sales by slapping a label proclaiming "This product contains GMOs" on every package. They admit that from a production standpoint, it makes no sense to reformulate only the products they sell in California, the eighth largest economy in the world - they'll be forced to reformulate all of their products for all US markets.
The same day that his appeal dropped into mailboxes all over the country, so did this extraordinary news, in a Reuters report (via MSNBC):
New GMO study finds tumors in rats fed genetically modified corn
The study itself was published in Food and Chemical Toxicology, and is available here [pdf]. The lead author has been a vocal critic of GMOs, so some people (the Council for Biotechnology Information, for instance) are reflexively skeptical; others (such as Criigen's Michael Antoniou) leapt to the study's defense. It's about time there were long-term studies on the effects of eating GMOs. The agritech companies have systematically blocked such research from being performed or published, as Scientific Americancomplained in 2009. It seems that they really don't want us to know either what we are eating or what it may do to us.
In a special en banc hearing yesterday, eleven judges of the Ninth Circuit Court of Appeals considered the constitutionality of a California law mandating that felony arrestees – people who have merely been arrested but not charged or convicted of a crime – provide a DNA sample to law enforcement. The law was put in place by a 2004 state ballot initiative that took effect in 2009.
As reported by the San Francisco Chronicle and Associated Press, a number of the judges seemed skeptical of the law. Judge Harry Pregerson called police-mandated DNA swabbing "a terrible intrusion on privacy." Once police take a DNA sample, said Judge Raymond Fisher, "your whole history is ... in possession of the government." Judge N. Randy Smith stated matter of factly that "the government doesn’t lose anything by putting off DNA collection" until a judge or at least a prosecutor has had a chance to review the case.
One of the main targets of the judges’ unease was the tenuous distinction the Assistant Attorney General drew between the government’s use of DNA for identification versus investigatory purposes. The state attorney stated that the DNA samples are used only for identification purposes, and argued that because arrestees have no constitutional right to conceal their identity from police, the sample collection does not violate Fourth Amendment protection against unreasonable searches and seizures.
But ACLU attorney Michael Risher denounced this argument as factually and legally incorrect. First, the DNA sample isn’t even taken until the arrestee has been identified via fingerprinting. Second, the ACLU’s voluminous record includes reports from state agencies attesting to the fact that it is standard practice to compare the samples to forensic databases of crime scene samples. In other words, the DNA samples are being used to investigate whether the arrested individual may have been involved in past unsolved crimes, and this search is conducted without probable cause or a warrant.
Contrasting the California law with the Maryland DNA collection law currently under fire in other federal courts, Judge N. Randy Smith noted that the California statute seems to deviate from the norm that a judge must issue a warrant to initiate a search. He questioned whether police in California now have total discretion when it comes to launching a criminal investigation, whereas in Maryland a person’s DNA sample cannot be taken and compared to unknown crime scene samples until after an arraignment hearing.
The Assistant Attorney General argued that under current law, arrestees can be subject to a strip search based purely on police officers’ discretionary determination of sufficient probable cause, and a simple swab of the cheek is much less invasive than a strip search. Judge Fisher disagreed, noting that while the search itself may be less invasive, the information gleaned – which includes intimate details of one’s health and heritage – is not. The state attorney emphasized that under the statute, the government can only examine 15 genetic loci that are not currently known to code for any such traits. And though the government does have access to the entire genetic sample, this is also the case when they draw blood to test an arrestees’ blood alcohol content (BAC).
The important difference, however, is that the government doesn’t keep a drunk driving suspect’s blood after they determine his BAC. They do keep a felony arrestee’s.
In a memorable analogy, Michael Risher argued that in the United States, citizens are not in the habit of turning over all their most personal documents to the government under the promise that the government will only look at the name on those documents.
This sparked an extended discussion about the appropriateness of the analogy, given that people don’t usually leave their private papers strewn about in public, whereas they do abandon their DNA everywhere they go. Since police are permitted to search abandoned property, the judges wondered whether there would be a difference if police just picked up a piece of hair off the ground and used the DNA they retrieved from that. Risher replied that the US Supreme Court has clearly established that what matters is how the search actually occurred. That the information in question could have been otherwise gleaned doesn’t justify the more intrusive means. In this case, the fact that police could have found an arrestee’s abandoned hair doesn’t justify swabbing the inside of his or her cheek.
Invalidating California’s DNA collection law would have enormous significance for similar policies across the country and the world.
An exciting gathering of academic scholars, healthcare reformers, consumer organizations / advocates and progressive health journalists will gather next February in Washington, DC at Selling Sickness 2013: People before Profits.
The conference will focus on "disease mongering," which one medical journalist has defined as "trying to convince essentially well people that they are sick, or slightly sick people that they are very ill." And it will take up the challenge of developing strategies and coalitions that can turn this "global tide."
Topics will include
misleading marketing, journalistic standards, over-treatment,
over-diagnosis, whistleblowers, new roles for advocates,
pharmacovigilance, clinical trials, activist narratives, new conflict of
interest areas, evidence-based screening, igniting citizen outrage, and
The pilot opens with an extremely sweet video in which one of the main characters, Bryan, talks to his future child, explaining how badly he/she is wanted. The best part of the show can be wrapped up with his teary line, “Oh god, I think I would just die if you call me Daddy.” Within these first minutes, the show successfully makes the case that gay men (whether they’re biological fathers or not) can be great and loving parents. Considering that this is still something for which many gay couples have to fight (and the fact that Utah actually banned the show), there is a lot to admire in presenting this as “normal.”
It’s almost enough to make one overlook the tired stereotypes of every character in the show.
The gay couple’s relationship, almost sickeningly perfect, is dramatically contrasted with the female characters' complete failure at family formation. Goldie, the woman who becomes Bryan and his partner David’s surrogate, got pregnant at fifteen and spent years living with her deadbeat, cheating boyfriend. Goldie’s grandmother, a loud-mouthed bigot who also appears frequently on the show, credits her overt homophobia to her marriage to a man who turned out to be having affairs with men.
Goldie’s character fits the archetype of the American surrogate: she’s a young, healthy, sweet, and pretty blond from the Midwest who, because of the cards life has dealt her, is down on her luck and searching for a way out and up.
The relationship that emerges between the couple and Goldie is another stereotype – this one of an ideal, with nothing but mutual understanding and respect between them. Goldie has specifically asked to carry a gay couple’s child due to her belief that “a family is family. And love is love.” And while she helps Bryan and David fulfill their dream of starting a family, the $35,000 they’re offering gives her the financial ability to go to law school and fulfill her own dreams. It is clear that the three of them will be close throughout the pregnancy and that the parents-to-be are invested in Goldie’s well-being as well as that of their baby.
As recent news reports demonstrate, however, not all surrogates fare as well. The danger of this rosy portrayal is that it downplays the risks real women face when they enter a surrogacy agreement. Many couples go abroad to hire surrogates in order to save on costs, which leads to a markedly different situation from the one portrayed in the show. In these cases, bonding between parents-to-be and a surrogate is purposefully stunted to keep the arrangement in the commercial realm and to minimize personal attachments. Such dynamics arguably dehumanize women acting as surrogates, as their bodies are viewed only as a vehicle to produce an end product. In some cases, women must agree to give up control over their living conditions and medical decisions in order to be hired as a surrogate. People with 35 grand to spare may be able to buy their way out of the sleazy or unpleasant parts of real-world surrogacy, but that is a luxury only available to some.
The New Normal also trivializes the long and fraught process many gay couples go through to have a child. It pegs the decision to have a baby on Bryan’s realization that he “wants to have baby clothes. And a baby to wear them.” He and David pick an egg donor by clicking through photos of carefully pre-selected women in a “platinum” egg donor database, choosing one entirely for her looks. And the perfect surrogate lands at their doorstep and gets pregnant instantly.
Huffington Post blogger and gay parent Frank Bua had high hopes for the show but couldn’t stomach the false portrayal of the situation he went through himself.
This looks nothing like my life, or the lives of dozens of gay parents whom my partner and I count as friends. We have waited years to create our families, jumped through legal hurdles as if doing so were an Olympic sport, fought our employers for equal childcare leave, and even paid for our surrogate's birth-related insurance because our own health plans refused to cover them. We also considered adoption as an equally viable alternative to surrogacy.
Such thoughtful consideration is notably missing from The New Normal.
As any comedy necessitates obstacles, I’m sure Bryan and David will have a fair share come their way. But I doubt I’ll make it through this rose-tinted view of ease and “normalcy” to find out.
Though the legitimacy of race as a biological concept has been largely discredited, racial categories (often as crude proxies for genetic differences between populations) are currently ubiquitous in medicine and medical research. Drugs are marketed to particular racial communities; researchers describe varying effects of a drug in different races; in some cases severity of diseases are even measured differently for different races. How are these categories determined? Is there uniformity from one study to another? Is it ever ethical to use these categories to address health disparities, or does it only increase discrimination and further misinterpretations about racial difference?
Though these questions have extremely critical impacts on the way that race is used in medicine, and the way people receive healthcare, they do not seem to have much traction within the medical field. All too often, race is used as though it were an unproblematic, static, and scientific fact of life. In many cases, researchers do not explain how people come to be categorized the way that they are, or even the reason for separating people out by race. When they find differences between the categories they have made, all too often they are not careful to disentangle social conditions from biological conclusions.
Scientific American blogger Ilana Yurkiewicz, a student at Harvard medical school, argues that “while sensitive consideration of race may sometimes be justified, the burden is on the medical researcher to explain why that is.” Given the lack of uniformity and appropriate consideration, guidelines for the medical community are clearly needed. Yurkiewicz’s most recent blog draws attention to seven guidelines that were proposed by Judith B. Kaplan and Trude Bennett in a 2003 paper in JAMA (protected by a paywall). Here are their conclusions, as Yurkiewicz cites them:
“1. When race/ethnicity is used as a study variable, the reason for its use should be specified.
2. In citing race/ethnicity data from any source, authors should describe the way in which individuals were assigned to racial/ethnic categories. If racial/ ethnic identification was self-reported, authors should specify whether individuals answered an open-ended question or chose from a fixed set of categories.
3. Race/ethnicity should not be used as a proxy for genetic variation. Statements about genetic differences should be supported by evidence from gene studies. Genetic hypotheses should be firmly grounded in existing evidence, clearly stated, and rigorously tested.
4. In stating hypotheses and describing study results, authors should distinguish between race/ethnicity as a risk factor and race/ethnicity as a risk marker.
5. In the interpretation of racial/ethnic differences, all conceptually relevant factors should be considered, including racism and discrimination, [socioeconomic status] SES, social class, personal or family wealth, environmental exposures, insurance status, age, diet and nutrition, health beliefs and practices, educational level language spoken, religion, tribal affiliation, country of birth parents’ country of birth, length of time in the country of residence and place of residence.
6. Because lack of adjustment for [socioeconomic status] SES or social class is the most important potential source of bias in studies of racial/ethnic differences, researchers should make every effort to adjust for conceptually relevant measures of SES or social class when comparing racial/ethnic groups. Unadjusted findings should be clearly labeled as such, and in general they should be reported in conjunction with adjusted findings for comparison purposes.
7. In describing racial/ethnic groups, authors should use terminology that is not stigmatizing, does not reflect unscientific classification systems, and does not imply that race/ethnicity is an inherent, immutable attribute of an individual.”
“The bottom line?,” asks Yurkiewicz. “Be comprehensive; be as precise as possible; be respectful. I applaud and thank the authors for these guidelines. The ultimate goal of medical research is to help patients. In the discussion over whether there is a place for race in doing so, it would help all sides to make their cases with such care.”
Posted by Anna Hamilton, Biopolitical Times Guest Contributor on September 6th, 2012
Julian Savulescu, the Oxford University professor of ethics who has kept busy for a decade or more promoting his vision of “breeding better babies,” has taken his campaign to the UK edition of Reader’s Digest. His short article in the September issue, titled “It’s Our Duty to Have Designer Babies,” casts the bad-boy argument he relishes in a conventional and reassuring tone.
Savulescu’s vision is a genetic pick-and-mix in which parents choose to edit out certain “personality flaws” in order to obtain “ethically better children.”
Fancy a child who’s likely to be altruistic? Then look for a version of the COMT gene. Want them to be faithful and enjoy stable relationships? Avoid a variant of AVPR1A. Steer clear of a certain type of the MA0A gene, too—it’s linked to higher levels of violence in children who often suffer abuse or deprivation.
Indeed, when it comes to screening out personality flaws, such as potential alcoholism, psychopathy and dispositions to violence, you could argue that people have a moral obligation to select ethically better children. They are, after all, less likely to harm themselves and others.
One tired argument that Savulescu marshals is that to order up a future child’s personality and character is no big deal, since we’re already doing similar kinds of selection:
We’re routinely screening embryos and foetuses for conditions such as cystic fibrosis and Down’s syndrome, and there’s little public outcry.
This is an odd statement from a literate person who lives in a country in which a government agency – the Human Fertilization and Embryology Authority – has conducted a number of “public consultation” on controversial matters such as embryo screening, and the media regularly reports on them. And it’s difficult to believe that Savulescu is unaware of the many articles, books and conferences in which disability rights activists have voiced their concerns about prenatal testing. (See, for an early and classic example, The Disability Rights Critique of Prenatal Genetic Testing).
Savulescu takes head on, as from a Rhetoric 101 standpoint he must, the question of whether breeding smarter babies or ethically superior babies should be considered a form of eugenics. He answers that “what was especially objectionable about this [20th-century eugenics] movement was the coercive imposition of a state vision for a healthy population.”
But a new eugenics would be different, he says: “Modern eugenics, from testing for diseases to deciding whether you want a girl or boy, is voluntary.”
Here is where Savulescu’s oscillation between two kinds of language – “choice” and “fancy” on one side, “obligation” and “duty” on the other – becomes especially perplexing, and more than a little problematic. He says that parents should have the choice to select against possible flaws, but also argues that when genetic selection (or genetic engineering) become more widely available, parents will have an obligation to use them to improve society.
How and when does an apparently optional “choice” become an “obligation?” I hate to get all Handmaid’s Tale here, but I cannot help wondering how such an obligation might be enforced. Intense social pressure? Insurance company requirements? Will prospective parents have to assess their reproductive plans to make sure their children will be “ethical” and able to contribute to society?
Given mainstream culture’s past and current attitudes toward a variety of differences and disabilities, it seems likely to me that Savulescu’s vision could lead us to incredibly dark places.
Race-based medicine has been one of the more contentious issues in pharmaceutical research and development over the past few years. Some argue that drugs specifically labeled to treat particular racial groups offer an invaluable way to fight racial disparities in health by targeting at-risk populations. Others claim that race-based medicine inappropriately treats race as a biological cause of racial disparities when broader social and environmental factors may offer better explanations.
Much of this debate involves the FDA’s 2005 approval of BiDil, which became the first drug to be labeled for a specific racial group – African Americans with heart failure. The heat generated from this debate has largely faded due to BiDIl’s market failure. But, it seems like a new drug may reignite a few flames.
Tradjenta was developed by Boehringer Ingelheim Pharmaceuticals and Eli Lilly to treat Type 2 diabetes. But results from a Phase III clinical trial recently showed that Tradjenta was particularly beneficial for controlling African Americans’ blood sugar levels. The press release notes
African American adults are disproportionately affected by diagnosed diabetes. In the U.S., the risk of diabetes is 77 percent greater for non-Hispanic black adults, when compared to non-Hispanic white adults, with an estimated 18.7 percent (4.9 million) of all non-Hispanic black adults living with the disease.
John Smith, senior VP at Boehringer Ingelheim, praised these results in the same press release by noting that Tradjenta may “provide black or African American adult patients with another option to improve control of their blood sugar.”
Is another BiDil on the horizon? It’s important to acknowledge that Tradjenta had already received FDA approval to treat type 2 diabetes in the general population prior to the announcement of these race-specific results. This is different from BiDil, where investigators sought a race-specific indication from the FDA because they could not otherwise win regulatory approval as a race-neutral drug. Despite these differences, treating racial disparities in diabetes as a naturally observed group
difference that can be at least partially resolved with a pill shares
some similarities with the BiDil saga. In both cases, there is a
tendency to naturalize racial disparities as a function of group
difference rather than having a deeper engagement with the social determinants of health.
This leads to an important question: if Tradjenta already received approval for use in the general population, why would it not be effective in African Americans? Put differently, why go through the time and expense of conducting a clinical trial to demonstrate efficacy in a particular racial group when the drug has already been approved for everyone regardless of race?
It’s unclear how these recent clinical trial results might be used. Perhaps this is another example of using a clinical trial as a marketing device in the hopes of capturing a larger share of the market. What is clear, however, is that this probably isn’t the last word that we’ll hear about Tradjenta.
The new high-profile digital series H+ portrays a world in the not-so-distant future in which transhumanism has moved from the fringe it currently inhabits to become a mainstream ideology and reality. The transhumanist link is explicit; in fact, the series opens with a definition of transhumanism. Before I watched the program, which debuted in August, I had somehow gotten it into my mind that the show’s focus on transhumanist technologies implied a pro-transhumanist bent. Fortunately, I was wrong, although I’ve come across some disappointed transhumanists whose remarks suggest I’m not the only one who made this assumption.
H+ is somewhat of an experiment for Warner Premiere, which has invested $2 million in producing the show to see if a fast-paced action/drama web series can become profitable. So far, H+’s financial success is at best up in the air with some episodes pulling in only 20,000 viewers.
The series of 48 episodes, each 4 to 7 minutes long, is directed by Bryan Singer (X-Men: First Class and The Usual Suspects, and executive director of House MD). It is based on this premise:
In the future, 33% of the human population will retire their cell phones and laptops in favor of a new technology which connects the human nervous system to the Internet. But something dark is coming to threaten this path of accelerating progress.
In the first episode, we learn that hackers have found a way to infect the neural implants with a virus, causing a huge proportion of the world to drop dead in an instant. (Though the teaser says only 33% have the implant, the numbers of the dead seem much higher.) The rest of the series that has aired to date fits squarely within the dystopian sci-fi genre with a feel similar to films like GATTACA, In Time, and AI.
Yet H+ is distinct in an important way. Unlike some of its dystopian precedents [1,2] that focus on the futuristic oppression of white men, H+ draws continuities between contemporary and future modes of inequality. This is most clearly seen when the series introduces Leena, an Indian woman who agrees to be a surrogate for a wealthy, white Western couple. The episode gives the racial, socioeconomic, and geopolitical inequalities of the present a futuristic twist: in order to get the job, Leena must agree to the neural implant in order to provide the parents-to-be with the ability to monitor her throughout the pregnancy. She is apprehensive and explains that she will be the first woman in her town to receive one but accepts the implant anyway. This storyline will clearly continue in later episodes.
The total footage that’s aired so far amounts to less than an hour; that and the very short episodes have made it a bit difficult to follow the plot or get attached to any of the characters. But in content, H+ shows promise. It challenges the transhumanist movement’s fervent belief in the Singularity; it encourages viewers to question the wisdom of faithfully trusting the biotech industry (it’s pretty clear already that the company that created H+ is tied to the virus); and it uses a dystopian imaginary to criticize the persisting inequalities we face today.
As election season heats up, so does the discussion of what drives that elusive creature, the voter. Political scientist professors Peter K. Hatemi of Penn State University and Rose McDermott of Brown University add their two cents in an article published in Trends in Genetics titled “The genetics of politics.”
Looking back at previous media stories, Hatemi and McDermott write
Media claims that ‘Researchers find the Liberal Gene’ (Fox News) or that ‘Some Politics May be Etched in the Genes’ (New York Times) serve to both exacerbate and reflect the epistemological divide between the social and life sciences.
Indeed, the authors argue that there is no single “liberal gene,” but rather that thousands of genetic variables combine to influence political preferences. They also argue that genes play no critical role in individuals' political lives until they leave home and the “powerful social pressures” of their families of origin.
In fact, throughout much of the article they are careful to stress the mutual importance of social and genetic factors in determining political identity, arguing that politics are only “in part genetically informed, interacting with the environment in countless and reciprocal ways.”
But Hatemi and McDermott eventually do make an explicit case for the importance of genes to political identity. Their argument largely relies on previously conducted twin studies, the logic of which is that by looking at both identical and fraternal twins, one can determine variation between environmental and genetic causation. But many holes have been poked in this methodology (1, 2, and 3).
And despite their rhetoric that looking to single genes is a simplistic understanding of genetics largely employed by social scientists, they do in fact include a table in their article that lists individual genes as responsible for specific traits. For example, they list MAOA and 5-HTT as the genes that are correlated with voter turnout. This is based on a 2008 study by University of California, San Diego professors James H. Fowler and Christopher T. Dawes, which was later determined to be false. In the words of Duke University professors in a disparaging press release
The same two genes that Fowler and Dawes claimed would predict voter turnout are also said to predict, according to other recently published studies, alcoholism, Alzheimer's disease, anorexia nervosa, attention deficit hyperactivity disorder, autism, depression, epilepsy, extraversion, insomnia, migraines, narcolepsy, obesity, obsessive compulsive disorder, panic disorder, Parkinson's disease, postpartum depression, restless legs syndrome, premature ejaculation, schizophrenia, smoking, success by professional Wall Street traders, sudden infant death syndrome, suicide, Tourette syndrome, and several hundred other behaviors. They point to a number of studies that attempted to confirm these findings and could not.
And while Hatemi and McDermott mention many other gene-based tools that may become increasingly important in the years to come, such as genetic pathway analysis and next-generation sequencing (but interestingly, not epigenetics), their rehash of previous studies does not provide any particularly new or meaningful way of thinking about the interplay of genetics and political leanings.
Thus, despite the extensive media coverage, the study already feels like old news.
In fact, we saw a remarkably similar round of claims and simplistic headlines four years ago, just in time for the 2008 election season. In February of that year, an article in New Scientistasked “Are political leanings all in the genes?” This, too, was a summary of research (also largely based on twin studies) suggesting that genetics influence our behavioral characteristics, which in turn influence our political preferences. Biopolitical Times contributor Jesse Reynolds covered the article at the time, pointing to the circular logic of asking politically charged questions in an effort to gauge genetic predisposition to political preferences, and expressing concern that, “accepting that genes determine political orientation could cause deepening political apathy.”
I’d like to second this concern – not to discredit genetic research, or to say that genetics and epigenetics play no role at all in our political preferences, but to caution against overly simple interpretations that seem to pop back up no matter how many times they're swatted down.
Hatemi and McDermott, for example, argue that contemporary political attitudes “encompass fundamentally the same issues of reproduction and survival that confronted group life in ancient humans because they involve the same interpersonal traits.” They note that “modern questions about immigration are similar to the primal need to deal with out-groups.” Do they really believe that xenophobic immigration policies today are best understood as a necessary by-product of our evolutionary past?
In one news article about their new study, Hatemi commented that “this research can help the public and policy makers recognize that people see the same thing differently, and at times no amount of yelling or 'proof' will sway them.” He seemed to find this a liberating prospect.
But I can think of far more liberating possibilities. Our country – and any functioning democracy – needs in-depth debate about pressing social issues, not a call to apathy based on a slightly updated version of genetic reductionism.
A U.S. Federal Appeals Court determined on August 16 that Myriad Genetics may keep its patent on the BRCA1 and BRCA2 genes, variants of which show heightened risk of breast and ovarian cancer in women.
The previous July 2011 Federal Circuit’s ruling in favor of Myriad’s patent had come under scrutiny after the U.S. Supreme Court ruled against Prometheus Laboratories five months ago, on the grounds that companies cannot patent observations about natural phenomena.
The Prometheus ruling had been hailed as a step in the right direction by many across the country. However, the Federal Appeals Court’s new decision on Myriad marks a significant backtrack.
The American Civil Liberties Union filed a lawsuit in 2009 against Myriad on behalf of plaintiffs including women’s health groups, research organizations, and breast cancer patients. They argue that human gene patents violate the First Amendment because genes are “products of nature.” Myriad and other defenders of gene patents argue that because they isolate the genes, changing their chemical structure, they have transformed genes from elements of our bodies to “products of human ingenuity.” Circuit Judge Alan Louris voiced his agreement last week, writing that, “The compositions here are not natural products. They are the products of man.”
The court did not grant Myriad everything it wanted though. It determined that Myriad’s processes for analyzing the genes, its “method claims”, cannot be protected under its patent. This means that other biotech companies can study the BRCA genes without infringing on Myriad’s patent, but it doesn’t benefit patients, who still can’t be informed what other companies’ tests have found.
As some journalists have noted, patents do not result in literal ownership of a gene, but they do lead to effective ownership for the duration of their patent agreement. Myriad now maintains its monopoly on all BRCA testing in the United States; its BRACAnalysis test is the only tool available to women who want to look into their genetic risk of breast and ovarian cancer.
Besides the obvious pitfalls of monopolies, including the likelihood of higher prices and less accountability, the court’s ruling perpetuates other problems. Myriad’s test itself is limited; it looks at only a few rearrangements of the BRCA genes so it cannot test for all of the potential causes of hereditary cancer. Though Myriad has developed an extra test, the BRAC Analysis Rearrangement Test (BART), it offers it for free only to a small proportion of patients. The majority have to pay an extra $700 for it, though it ought to be part of the overall test as it simply provides more accuracy.
Myriad and its advocates have denied that its patents will result in restricting women’s access to care. Runi Limary would disagree. After being diagnosed with invasive breast cancer at age 28, she wanted to know whether she had the BRCA variation in order to decide whether to have a prophylactic mastectomy on her left breast. The $3,000 for the Myriad test required her to wait several years to be able to afford it. When she finally received her long-awaited results, she learned that she did have an unusual variant of the BRCA1 gene, but that Myriad could not tell her whether the variant was dangerous or benign.
Because of Myriad’s patents on the genes, there was nowhere else Limary could turn for a second (or actually helpful) opinion.
“I was dumbfounded,” Limary said. “I understand that companies take out patents on things they create, but it seemed really weird that they could patent something in my body – and everyone else’s... My health is largely in Myriad’s hands – it feels really unfair to be in this position.”
Joseph Merrick (1862-1890) is arguably the most famous sideshow freak. After Merrick acquired his disfigurement in his youth, his family abandoned him as a teenager, eventually leading him into the sideshow as “the elephant man” until a surgeon at the London Hospital offered him an alternative path that still included being surveyed and examined. His story has been told many times over, as a Tony Award-winning play and Academy Award-winning film by Director David Lynch. Its most recent rendition, starring Bradley Cooper, is on track to make it to Broadway this fall.
As was common for most sideshow performers, Merrick’s life story was largely an open book, but one element remains a private mystery – the medical explanation for his condition. Ever since Merrick spent time in the London Hospital, doctors and scientists have searched for answers. Some believe it to be elephantitis, which earned him his nickname, while others have recently suggested that it was caused by a rare disease called “Proteus syndrome.”
This week brought news that University of London scientists are hoping to find answers by analyzing DNA extracted from a piece of Merrick's skeleton, which has been preserved and publicly displayed by the Royal London Hospital. The announcement is not surprising since many people have been tempted to try to solve riddle. But the project can claim no real medical justification or social benefit.
While the sideshow fell out of fashion by the early twentieth century, historians have argued that the voyeurism that drove them has continued in a new realm – the hospital (1,2,3). Just as Merrick was taken in by the physicians who wanted to fully examine and document his anomalous body, many other famous sideshow performers ended up on display in hospitals, a process that continues today. Is the quest to diagnose Merrick’s condition about improving medical knowledge and practice or is it a reminder that curiosity is not neutral and can sometimes lead us to put our own desires to know above all else?
Keeping Charles Byrne’s skeleton on display sends a terrible message about the modern-day relationship between physicians (especially surgeons) and people with unusual anatomies. It says that such people do not have an equal say in their fate, that they can be readily exhibited to the public as symbols of nature’s freakery or medicine’s miracles, whether or not they wish to be. Moreover, it says that being considered a freak is enough to exempt a person from the social norm of respect, especially in dealings with medical and scientific professionals (138).
Even in death, the spectacle of physical difference continues. Some people with physical anomalies have gone so far as to ask their loved ones to bury their remains in cement, knowing the risks of being exhumed. Their fears are confirmed in Merrick's case. As the lead scientist in the efforts to extract DNA from his skeleton explained, “We can’t just mash a whole amount of it up. We have to preserve it for future generations because it’s an important historical record.”
Grinding up a piece of Merrick’s skull may satisfy a bit of scientific curiosity, but I fear it will tell us much more about our unceasing desire to gawk at bodily difference without respecting the fact that these bodies were once inhabited by real people.
The American Society for Reproductive Medicine (ASRM), the professional organization of the assisted reproduction industry, sets guidelines for its members on a range of practices including third-party egg providers, sex selection, and multiple embryo implantation. Unfortunately, these guidelines are routinely ignored, even by many members of ASRM, and sometimes even selectively quoted to justify practices they are meant to discourage.
An article in Fertility and Sterility by Klitzman et al. (abstract) is the latest piece of evidence. The title describes it:
Recruiting egg donors online: an analysis of in vitro fertilization clinic and agency websites' adherence to American Society for Reproductive Medicine guidelines
The full article is behind a paywall, but it is summarized in this Reuters piece:
A sizable share of the U.S. organizations recruiting egg donors online don't adhere to ethical guidelines, including failing to warn of the risks of the procedure and offering extra payment for traits like good looks, according to a U.S. study.
Reuters also mentions that "[e]thical standards set forth by the ASRM specify that donors should be at least 21 years old," but that "[m]ore than 40 percent of the sites [visited by the study's authors] also recruited women between the ages of 18 and 20."
Websites that recruit women to provide eggs are more likely to offer higher amounts to those with (for instance) better grades or specific ethnicity if the organizations are not affiliated with ASRM, but so do more than a quarter of those that claim to follow the guidelines. And, says the report (behind the paywall):
Websites that pay more for traits were more likely to refer to or quote ASRM's guidelines on compensation, but often just mentioned the $5,000–$10,000 compensation range that ASRM deems acceptable given justification-not the stipulations discouraging trait-based payment variation. In this way, websites not following this aspect of the guidelines may gain credibility to website users simply by quoting the section of the guidelines that they do follow.
The ASRM ethics committee report on financial incentives [pdf] not only states that "payments to donors in excess of $5,000 require justification and sums above $10,000 are not appropriate" but urges compensation less than that, as well as counseling for donors, a minimum age of 21, and making a good-faith effort "to avoid accepting women who have already made a high number of donations." Nevertheless, according to the study, some websites "increased their payment to donors by $500 for each successful prior donation"; almost half recruit women who are under 21; and only about 8% even mention risks to future fertility, at least in their public presentations.
This unfortunate news should not be a surprise. A 2009 Associated Press piece summed up the situation on multiple embryo implantation with this headline:
Most Fertility Clinics Break the Rules
The ASRM guidelines on this issue [pdf] state that, for women under 35 years old, no more than two embryos should be transferred, and "consideration should be given to transfering only a single embryo." That recommendation has been in effect since at least 2006. According to the Centers for Disease Control (CDC), the number of embryos transferred has indeed been declining. In 2010, for which preliminary data are now available, transfers for women under 35 averaged 2.0, down from 2.1 the year before and 2.2 in 2008.
In 2009, the last year for which full statistics are available, well over half of reporting clinics exceeded the guidelines: 60% transferred an average of more than 2.0 embryos for women under 35 using their own eggs and fresh embryos; 13 out of 441 averaged 3.0 or more. (Rates for use of non-donor frozen embryos and donor eggs were marginally lower.) Since the average in 2010 was what is supposed to be the maximum, it is fair to say that an awful lot of clinics are still not following guidelines.
So with regard to at least two matters that significantly affect women's health – recruiting women to provide eggs for other people's fertility treatment, and deciding how many embryos to transfer into a woman trying to become pregnant – the ASRM's own members fail to follow best practices and ethical guidelines.
To be sure, the ASRM is in a bind. They cannot get too far ahead of their members, and yet they have to rein their members in or they may face the kind of government intrusion many of them vigorously oppose. Moreover, ASRM's ability to affect non-members is "pretty limited," as Sean Tipton, their Director of Public Affairs, admits:
"There's no question that there are some agencies that don't seem particularly interested in what our guidelines are, and we don't know how to impact their behavior."
The ASRM probably could impact the behavior of their members by rescinding the membership of clinics that don't follow the agreed-upon rules. And that might well have some effect, by way of public opinion, even on non-members. But whether or not a particular clinic or recruiter is a member of ASRM, perhaps it's time to acknowledge that voluntary guidelines are not working, and start seriously considering binding regulations.
This past year has seen a particularly dramatic increase both in the collection of DNA for forensic purposes, and in controversy over its ethical and social implications. DNA forensics can be an extremely useful tool for identifying perpetrators as well as exonerating people who have been wrongly convicted or accused. However, its use carries significant risks as well. 25 states currently allow pre-conviction DNA testing, but most are now stuck in battles over its legality. As states struggle to balance effective law enforcement and protecting individuals’ rights and privacy, the debate over the appropriate use of DNA is likely to intensify.
In Maryland, the controversy has pit the state’s highest court against the U.S. Supreme Court. Maryland’s DNA Collection Act allows the collection and retention of genetic material from those who are arrested, even if never convicted. In 2010, Alonzo Jay King was convicted and sentenced to life in prison without the possibility of parole based on a DNA sample that was taken from him the previous year without a warrant, and that ended up linking him to an unsolved 2003 rape. But Maryland’s Court of Appeals ruled earlier this year (Maryland v. King) that this violates the Fourth Amendment as an unreasonable search and seizure.
The Supreme Court is currently deciding whether to hear Maryland’s appeal, but in the meantime, Chief Justice John Roberts has allowed state police to carry on unobstructed. He ruled that the state will suffer “irreparable harm” without this “valuable tool for investigating unsolved crimes.”
Yet, last year in Maryland, less than one-tenth of one percent of DNA samples collected led to convictions.
The Vermont Supreme Court is similarly deciding on the constitutionality of a 2009 law allowing the collection of DNA from those who have not yet been convicted. Although, in Vermont, the lower court rulings have managed to largely restrict the state from carrying out the law until a greater consensus has been reached.
California, too, has been struggling with its laws on DNA forensics. In 2004, voters approved Proposition 69, which authorized the collection of DNA from everyone arrested on suspicion of a felony. In February, a panel of the Ninth U.S. Circuit Court of Appeals voted to uphold this law, arguing that the DNA is used only to identify individuals and that the state’s interest in solving crimes outweighs privacy concerns. However, a majority of judges at a federal appeals court have decided to have an 11-judge panel review the case to determine if these results are unconstitutional.
Several states have recently heavily expanded their efforts to preemptively collect DNA samples. New York became the first state to allow the collection of DNA from those convicted of any crime, no matter how minor, when its legislature and Governor Andrew Cuomo cleared an “all-crimes DNA” program earlier this year. The new law also gives lawyers greater access to the DNA database for use in trials.
In July 2011, Ohio passed a law requiring everyone arrested on a felony charge to provide a DNA sample, expanding the previous practice of limiting collection to those convicted of a felony. In the year since the law’s inception, the number of samples in the state’s database has more than doubled. While Ohio law enforcement previously collected around 2,800 samples per month, it now obtains around 6,000 monthly, with nearly a half million samples currently in the database.
Proponents of such expansions compare the forensic use of DNA samples to standard fingerprinting; they argue it is merely a means for establishing identity. Many also contend that DNA is only used to help solve the most serious of crimes, and that large databases are worthwhile because those who commit major crimes are more likely to be repeat offenders.
But the use of DNA forensics has some major drawbacks that poke holes in the fingerprint metaphor. DNA databases are increasingly being used for more than individual identification. Searching for partial matches can find that a suspect is likely to be the family member of someone in the database. This brings extended families, including many people who have never broken the law in their lives, under direct police surveillance.
And though a cheek swab constitutes a relatively low level of physical invasion, the intrusion of privacy represented by being forced to surrender DNA to a police database is high. DNA is qualitatively different from a fingerprint; it holds extremely personal information about lineage, propensity for disease, and countless other traits.
Despite the insistence that DNA is only used for serious and violent crimes, only six percent of cases for which DNA is sought are homicides; and 20 percent are for sexual assaults. As many as 32 percent of cases involve property crimes, mainly burglaries and robberies.
With popular culture regularly featuring DNA forensics in crime investigations, juries often misunderstand DNA evidence as infallible. This phenomenon is so widespread that it has been given a name: the “CSI effect.” But DNA findings are far from infallible. Contamination, clerical errors, and misinterpretation are common and have led to false convictions in the past and recently (see here and here.)
Earlier this year, for example, Cleveland Barett was brought to trial for the sexual assault of a nine-year-old girl. Prosecutors claimed that his DNA “matched” DNA found on the girl. Shockingly, crime lab analyst Lisa Fallara acknowledged that the genetic profile in question would match 1 in 4 African-American males, 1 in 8 Hispanic males, and 1 in 9 Caucasian males - in other words, hundreds of thousands of men in the Chicago region.
The most troubling aspect of DNA forensics is the way that it plays into an already deeply unequal and problematic criminal justice system. The number of people incarcerated in this country has risen dramatically over the past several decades and has disproportionately affected certain communities. A Black American is five times more likely to be in jail than a White American. African Americans now make up roughly 40% of the national DNA database. The overrepresentation of Blacks and Latinos in the criminal justice system means that DNA forensic practices are not affecting all equally, but have become yet another way to disproportionately police particular groups. These communities will experience greater genetic surveillance and be subject to more injustice from inaccurate interpretations of DNA.
Many victims’ rights organizations, including one called DNA Saves, are pushing states to pass laws further increasing DNA collection on the grounds that it “pinpoints suspects more quickly, gets predators off the streets sooner and clears suspects who have been wrongly accused.” This is a dangerous over-simplification. DNA evidence is not infallible, nor is it a neutral scientific advance. Misuse of DNA forensics threatens our civil liberties and promotes injustice for specific communities. We should work towards ensuring that DNA forensics is used for the common good - without allowing misuses in an already deeply flawed system to become a national norm.
Posted by Mike Beitiks, Biopolitical Times guest contributor on August 17th, 2012
Due to several factors (mostly incredibly poor time management), I have developed a certain scholarly expertise in Internet viral videos over the course of my lifetime.
As such an expert, I can inform you that in the canon of viraldom, there's an entire class of cinéma-vérité videos that companies create to generate buzz for their products. These are staged videos intended to be taken as real, presumably in hopes that the verisimilitude will carry potential customers through the entire advertisement.
Knowing of this advertising technique, when I saw the Mentos-sponsored video promoting Singapore's "National Night," in which the mint company with the tagline "The Freshmaker" encourages Singaporeans to make some fresh babies, I knew such trickery was afoot.
The commercial is a three-minute rap song that combines the Singaporean government's rigid pro-procreation policies with a caliber of pickup lines usually reserved for bachelor party dares. Up until the mid-1980s, Singapore’s eugenic policies entailed actively promoting reproduction only among the nation’s most educated, and providing financial incentives for poor, uneducated parents to undergo sterilization. Singapore has switched gears in recent years and begun to prioritize population growth in any form rather than from only one sector, but a eugenic undertone still remains in policies specifically targeting certain classes.
Mentos’ idea was clearly to make the video shocking enough to be entertaining, but real enough to be confusing. It presents itself as an accompaniment to Singapore’s National Day on August 9, the parade-and-firework celebration of the country’s independence from Malaysia in 1965. It can be assumed that Mentos wanted viewers to question whether Singapore's government was behind the commercial.
Spoiler Alert: The video was not funded by the Singaporean government (if you enter the URL provided in the video, you're taken to Mentos' Facebook page). However, the city-state has been involved in the ad campaign's success. Slate notes that the government's notoriously itchy censorship fingers have uncharacteristically allowed the video to air on TV in the country.
The song lampoons the Singaporean government's notoriously eugenic reproductive policies by over-embracing them. While generally crass, it is legitimately clever at points, subtly skewering the irony in the country's "Merlion" hybrid-animal mascot, vaporizing romance by rhyming "patriotic wife" with "manufacture a life," and likening intercourse to the ever-so-sexy work of a government scholar.
The problem is, where the song is intended as a send-up of Singapore's desperation to raise its birthrate while keeping its bloodlines pure, it falls short. General rule of thumb: If your satire doesn't make its subject at least a little angry, it's not good work. The Singaporean government's complicity demonstrates that the laughs Mentos has popped out are in line with government policy. The song references "National Duty," in several forms suggesting that the ultimate intention of the sex act is to "make a little human that looks like you and me," and explicitly narrows its message's intended audience to "financially secure adults in stable, long-term committed relationships."
In an attempt to be controversial while still pleasing the censors, Mentos has not made a clever viral video as much as it's provided the kind of entertainment to which court jesters used to aspire. The jester is as cheeky as he wants to be while entertaining dinner guests, but when it's all over, he's bowing to the king.
The symbol for intersexed implies a range of possibilities beyond male and female.
As I approach the third trimester of my first pregnancy, I’m more aware than ever of how early we begin gendering our children. My husband and I decided at the outset to wait until our child is born to learn whether we’ll have a daughter or son – a decision we made in part to avoid getting overwhelmed with lacy pink dresses if we’re set to have a girl, and partially motivated by my father’s caution that as soon as you know the sex, you start building expectations about what you want the baby to be like. Though it’s not easy to push aside the curiosity, we’re attempting to focus instead on what kind of parents we will be. Yet, I must admit that it’s harder than I expected. I recently purchased a pack of “boy’s bibs” because it included all the primary colors (seriously, boys get all the primary colors?).
So I deeply sympathize with women who are told they have a high likelihood of having a child with congenital adrenal hyperplasia (CAH), a genetic condition that can cause female fetuses to develop genitals that appear somewhat masculine. Gendering is, unfortunately, central to the process of having a baby and “What’s the sex?” gets asked hundreds of times in any pregnancy. Knowing that your child will not easily fit into these socially built boxes can be deeply disheartening.
Hoping to help expectant parents avoid this struggle, many doctors have been prescribing an off-label use of dexamethasone (DEX) for women at risk of having a child with CAH. However, the recent findings highlighted in an essay by Alice Dreger, Ellen K. Feder, and Anne Tamar-Mattis make a convincing case that in these efforts to help, doctors are irresponsibly and unethically encouraging women to risk their own health and that of their baby-to-be [for news coverage, see: 1, 2, 3].
In this month’s issue of Bioethical Inquiry, Dreger et al. describe in detail an upsetting number of reasons not to promote this use of DEX and report their struggles since 2010 to elicit equal concern from the Office of Human Research Protections and the Food and Drug Administration. Many clinicians may be responsible for this increasingly standardized application of DEX, but the authors focus their study on one particularly egregious offender, pediatric endocrinologist Maria New at the Mount Sinai School of Medicine, who has used this “treatment” on somewhere between 600 and 2,144 fetuses.
Dreger et al.’s essay really must be read in full rather than summarized because the authors work meticulously to document both the serious risks of this usage of DEX and the ethical lapses of judgment by Dr. New. Much of the essay is based upon data obtained using the Freedom of Information Act, but even still, Dreger has had to sue (a case that is ongoing) to obtain remaining files from the OHRP and FDA.
Largely, the risks of DEX treatment are unknown, and Dreger et al. detail the inadequacy of previous clinical studies and the complete lack of reliable long-term data. A Swedish team recently terminated its study of this application of DEX, finding the adverse effects too worrisome to overlook. In a study of 43 children:
… eight severe adverse events were noted in the treated group, compared with one in the control group. Three children failed to thrive during the first year of life; in addition, one had developmental delay and hypospadias; one had hydrocephalus; two girls were born small for gestational age, and one of these girls was later diagnosed with mental retardation; and one child had sever mood fluctuations that caused hospital admission.
Other effects included reduced scholastic ability, increased social anxiety, and more feminized behavior in boys. This study should not be taken as a proof in and of itself, but the findings are certainly alarming enough to demand more rigorous studies before DEX use continues.
The point not to miss is this: yes, CAH can cause serious medical problems in some cases, but DEX doesn’t eliminate CAH, it merely aims to prevent the appearance of masculine genitalia in females, and for some clinicians like New, non-heteronormative behavior. In her past work, Alice Dreger has traced the history of medical treatment of the intersexed, arguing that too often what gets deemed “medical necessity” is more accurately about social norms – what we expect the male and female body to look like and what forms of sex we are expected to have. Despite the successes of intersexed activists in raising questions about medicalization, this latest update suggests that our efforts to help through medical treatment may still be causing more harm than good.
One could argue that the uncertainty surrounding risks is outweighed by the need to prevent ambiguous or masculinized genitalia. However, this assumes that the fetus being treated is guaranteed to have CAH, which is not the case. Many clinicians, New included, put women at risk of having a child with CAH on DEX as soon as they find out they are pregnant. Then, if it turns out that the fetus is male or is not affected by CAH, the treatment is stopped. That pregnant women who may not even have an affected child are being encouraged to add “60 to 100 times the normal level of glucocortoicoids” should leave us deeply concerned.
Apparently, we have learned very little from the historic misuse of DES, which put girls and young women whose mothers had been encouraged to use diethylstilbestrol (DES) during their pregnancies to prevent miscarriage at greatly increased risk of cancer. This too was a practice that continued despite early research suggesting the inefficacy and risks of the treatment.
Yet, Dreger et al. point out that there’s something even more unsettling here; the intention of DES treatment was preventing fetal death, but DEX seems more tied to treating social and behavioral difference than medical problems.
Normalcy still has a powerful pull, and the rise of this dangerous method for fetal engineering suggests that treatment for the intersexed still needs to sort out when “medical necessity” and aesthetic preferences get murkily mixed together.