Lipitor,Jarvik,Dracula
Lipitor and The Dracula of Medical Technology
by Jeffrey Dach MD
Perhaps you have seen the Direct-to-Consumer TV and print advertisements with Robert Jarvik, the inventor of the Jarvik Heart, speaking on behalf of the Pfizer's anti-cholesterol drug, Lipitor. With 13 billion dollars in sales last year, Lipitor was the best selling statin drug, the best selling drug in the world, and most prescribed drug in the U.S.
Barney Clark, Jarvik Heart Recipient
Jarvik is best known from the media circus surrounding the 1982 implantation of his Jarvik-7 into the Seattle dentist, Barney Clark. Although the artificial heart continued to beat, Barney died of multi-organ failure 112 days after the operation, tethered to a dishwasher sized air compressor. The heart device acted as a blender which chewed up the blood cells. Recipients of the Jarvik-7 suffered horribly for months, finally succumbing to infections, strokes, convulsions and immune system failure with progressive decline in T cells, thus making the Jarvik-7 another cause of HIV negative AIDS.(1)(2)
The Dracula of Medical Technology
Left Images: Bella Lugosi in Dracula 1931, and Robert Jarvik selling Lipitor on TV 2007.
During the ensuing media coverage, the New York Times dubbed the Jarvik Heart the "Dracula of Medical Technology" (link). (3)(4)
Jarvik-7 patients had the Kevorkian option of assisted suicide, a small on-off button which allowed the mechanical heart to be stopped when too unbearable. About 90 people received the Jarvik heart before its use was curtailed by the FDA.
A revised version of the mechanical heart called the AbioCor® Implantable Replacement Heart was approved September 5, 2006 for heart transplant candidates, intended for temporary humanitarian use to prolong the terminal patient while awaiting a suitable donor. (5)
Why would Pfizer select an MD like Jarvik as spokesman for their Direct to Consumer (DTC) campaign? Jarvik himself doesn't have the strongest of professional credentials, and apparently had difficulty gaining admission to a US medical school.(6) Instead, he enrolled for the first two years at the University of Bologna in Italy, later returning for the MD degree at the University of Utah.(6) Jarvik never did an internship or residency, and never actually practiced medicine.
Around the time of the Barney Clark story, some of the news media reports erroneously credited Paul Winchell the ventriloquest, with the design for the first artificial heart citing his patent which was filed in 1961 The patent rights were later donated by Winchell to the University of Utah in 1972. The patent history is explained more completely here.
Why is Jarvik an Expert on Statin Drugs?
Why does Jarvik's "Dracula of Medical Technology" make him an expert on statin drugs? Eight controlled clinical trials have shown that statin drugs cause Coenzyme Q10 depletion by inhibition of HMG-CoA reductase, which is the rate limiting step in cholesterol and Coenzyme Q-10 biosynthesis.(8) Coenzyme Q10 serves in the mitochondria as an electron carrier to cytochrome oxidase, the major system for cellular energy production. Heart muscle requires high levels of Co-Q10. Side effects of Co-Q10 deficiency include muscle wasting, muscle pain, heart failure, neuropathy, amnesia, and cognitive dysfunction.(9) Deaths from heart failure have doubled nationwide since the introduction of statin drugs in 1987.(10) Statin induced heart failure can be prevented by supplementing with Co Enzyme Q10, a form of intervention considerably less expensive and less traumatic than an artificial heart operation followed by cardiac transplantation.
Jarvik May not be the Best Choice for Spokesman
Duane Graveline MD
Perhaps Jarvik is not the best choice for the Lipitor campaign which has had mixed reviews.(11) Instead of Jarvik, a more convincing yet unlikely spokesman would be the popular Duane Graveline MD MPH, a former NASA astronaut, and author who was started on Lipitor during an annual astronaut physical at the Johnson Space Center, and 6 weeks later had an episode of transient global amnesia, a sudden form of total memory loss described in his book.(12)(13) Graveline points out that 50 percent of the dry weight of the cerebral cortex is made of cholesterol, an important substance for memory and cerebral function.
Graveline also points out that statins are useful for secondary prevention of heart disease in patients with significant pre-existing coronary artery disease, however the benefit is independent of cholesterol response during statin use.
Contrary to the secondary prevention findings, no statin primary prevention study has ever shown a benefit in terms of all cause mortality in healthy men and women with only an elevated serum cholesterol, and no known coronary artery disease (link). Patients with known heart disease are customarily placed on statin drugs by the medical system with no need for direct to consumer (DTC) advertising to this group. DTC ads for Lipitor are clearly directed at the larger group of untreated primary prevention patients, for which there is no benefit in terms of all cause mortality.(15)
Studies Cast Doubts
The J-Lit study actually showed higher mortality at the lowest serum cholesterol (both total and LDL-C), a paradox called the J-Shaped Curve.(16) The highest mortality was found at the lowest total cholesterol of 160 mg/dl, and lowest mortality at serum cholesterol around 240 mg /ml, exactly the opposite one would expect if cholesterol lowering was beneficial for health. The authors state that the increased mortality at the lower cholesterol levels was due to increased cancer. Another statin trial, CARE (Cholesterol And Recurrent Events), showed 1500 % increase in breast cancer among women in the statin treated group, explained as merely a statistical aberration.(17) This is disputed by Uffe Ravnskov who feels that the difference is significant, and points to rodent studies showing statin drugs cause cancer in animals.(18)(19)
The Honolulu Heart Study of elderly patients showed the lowest serum cholesterol predicted the highest mortality.(20) A study by Krumholz found lack of association between cholesterol and coronary heart disease mortality and morbidity in persons older than 70 years.(21) Jenkins (BMJ) states that no statin drug study has ever shown an all cause mortality benefit for women.(22)
DTC Advertising- A Bad Idea
The Jarvik-Lipitor ad campaign is a perfect example of why prescription drug ads are dishonest, do not promote public health, increase unnecessary prescriptions, increase costs to taxpayers, and can be harmful or deadly to patients. New Zealand and the US are the only two industrialized nations to allow direct-to-consumer advertising for prescription drugs. Here in the USA, thirty nine public interest groups have proposed congressional legislation to ban DTC prescription drug ads.(23)(24)
Mary Enig and Uffe Ravskov- Unlikely Lipitor Spokesmen
Two more unlikely spokesmen for the Lipitor ad campaign include Mary Enig and Uffe Ravnskov. Should either one be selected as Lipitor spokesman, I myself would run down to the corner drug store to buy up the drug. It seems unlikey that even Pfizer's deep pockets could ever induce them to recant their opposing position on the cholesterol theory of heart disease. Mary G. Enig writes, "hypercholesterolemia is the health issue of the 21st century. It is actually an invented disease, a problem that emerged when health professionals learned how to measure cholesterol levels in the blood.(25)
Uffe Ravnskov MD PhD, a critic of the Lipid Hypothesis, is spokesman for Thincs, The International Network of Cholesterol Skeptics, and written extensively about Cholesterol, and its relation to heart disease. He is the author of a number of
on the topic. His controversial ideas have angered loyal cholesterol theory supporters in Finland who demonstrated by burning his book on live television. (26)
Condolence Call
I once made a condolence call to a dear friend who just lost her mom to Alzheimer's. Our kids have grown up together and we shared family events for the last 15 years. A few months ago, during one such occasion, the conversation touched on her mom's mental decline in a nursing home, and I mentioned that sometimes treatment for B12 deficiency or hypothyroidism can help. They had already tried that to no avail. During the condolence call, we chatted about her mom's life and the reason for the cognitive decline. Apparently, her mom had been taking Lipitor for 15 years, and her daughter recalled in painful detail the initial episodes of transient global amnesia, followed by progressive dementia, and death attributed in retrospect to the drug. How many demented nursing home patients will suffer from the adverse side effects of statin drugs? We will never know. People experiencing adverse side effects from statin drugs may share their experiences in discussion groups. (27) One such group has 3800 messages.(28)
Articles With Related Content:
The Art of the Curb Side Cholesterol Consult
Getting Off Statin Drug Stories by Jeffrey Dach MD
Cholesterol Lowering Statin Drugs for Women Just Say No
Healthy Men Should Not Take Statins Says JAMA
More Articles on Cholesterol, Statins and Heart Disease
References and Links
(1) http://www.ncbi.nlm.nih.gov/pubmed/3261735?dopt=Abstract
Wellhausen SR, Ward RA, Johnson GS, DeVries WC.
Immunologic complications of long-term implantation of a total artificial heart. J Clin Immunol. 1988 Jul;8(4):307-18. PMID: 3261735
Bacterial infections are a significant complication of long-term total artificial heart implantation. We evaluated the functional capabilities of host defense mechanisms in two patients sustained long-term by a total artificial heart. Although serum complement and polymorphonuclear leukocyte function remained intact, both patients became B and T lymphopenic and there was an initial decrease in the ratio of helper/inducer to suppressor/cytotoxic cells. Histologic examination of their lymphoidal tissue at autopsy further revealed reduced numbers of germinal centers and atrophy of the T lymphocyte-dependent areas. In addition, the reticuloendothelial system was engorged with degenerate erythrocytes. We hypothesize that blockade of the reticuloendothelial system was induced by multiple blood transfusions necessitated by device-associated hemolysis and coagulopathy. This blockade may have led to a progressive loss of content of the antigen-specific lymphoidal elements and, perhaps, to a reduced ability to ingest microbe-antibody complexes.
(2) http://www.ncbi.nlm.nih.gov/pubmed/3566584?dopt=AbstractPlus
Stelzer GT, Ward RA, Wellhausen SR, McLeish KR, Johnson GS, DeVries WC.
Alterations in select immunologic parameters following total artificial heart implantation. Artif Organs. 1987 Feb;11(1):52-62.
We examined select immunologic parameters in three recipients of a total artificial heart and correlated changes with the clinical course. Two patients remain alive and were studied for 320 and 240 days, respectively; the third died 10 days after implantation. All patients demonstrated transient complement activation immediately postoperatively, as indicated by an increase in plasma levels of C3a des Arg. In the two long-term survivors, C3a des Arg levels again increased, concomitant with intravascular hemolysis associated with high blood shear rates imposed by the drive system of the heart. All three patients had a marked lymphopenia immediately postoperatively, and the two long-term survivors demonstrated marked fluctuations in total lymphocyte count. There was a progressive decline in the number of peripheral blood helper/inducer T cells in the two long-term survivors. A large number of activated (HLA-DR positive) suppressor/cytotoxic T cells were also noted in these two patients. A progressive decrease in B cells was also observed; however, total IgG and IgM levels were not decreased. No changes in neutrophil phagocytic or respiratory burst capacities were identified. The cause of these changes in lymphocyte populations is not clear; however, they may have impact on the use of this device as a bridge to transplantation and may lead to decreased immunocompetence during long-term use.
(3) http://query.nytimes.com/gst/fullpage.html?res=940DE7DB143CF935A25756C0A96E948260
The Dracula of Medical Technology Published: May 16, 1988 New York Times, The Federal project to create an implantable artificial heart is dead. During its 24-year life this Dracula of a program sucked $240 million out of the National Heart, Lung and Blood Institute. At long last, the institute has found the resolve to drive a stake through its voracious creation. ''The human body just couldn't seem to tolerate it,'' explains Claude
(4) www.time.com/time/magazine/article/0,9171,44039,00.html
Time Magazine, Reviving Artificial Hearts Sunday, Apr. 30, 2000 By MICHAEL D. LEMONICK
Nobody has talked much about artificial hearts in recent years, and no wonder. It took Washington dentist Barney Clark 112 miserable days to die after being fitted with the Jarvik-7 heart back in 1982--four months of suffering that included convulsions, kidney failure, respiratory problems, a wandering mind and, finally, multi-organ system failure. In the aftermath of that debacle, the New York Times nicknamed artificial-heart research the "Dracula of Medical Technology."
(5)http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=H040006
FDA Approves First Totally Implanted Permanent Artificial Heart for Humanitarian Uses P06-125 September 5, 2006
http://www.faqs.org/health/bios/93/Robert-K-Jarvik.html
Robert K. Jarvik Biography, Jarvik began premedical course work and graduated in 1968 with a bachelor's degree in zoology. His immediate plans were stalled when mediocre grades prevented him from acceptance into an American medical school. As an alternative, he attended medical school at the University of Bologna in Italy. After two years he returned to the United States to pursue a degree in occupational biomechanics at New York University, receiving an M.A. in 1971.
(7) deleted
(8) http://www.fda.gov/ohrms/dockets/dailys/02/May02/052902/02p-0244-cp00001-02-Exhibit_A-vol1.pdf
The clinical use of HMG CoA-reductase inhibitors (statins) and the associated depletion of the essential co-factor coenzyme Qlo; a review of pertinent human and animal data. BY Peter H. Langsjoen, M.D., F.A.c.c.
(9) www.tga.gov.au/pdf/aadrb-0504.pdf
Australian Adverse Drug Reactions Bulletin Volume 24, Number 2, April 2005, ADRAC has received 281 reports of peripheral neuropathy or symptoms consistent with this diagnosis attributed to statins (see Table), and first highlighted this association in 1993.1 Thirteen of the 281 cases were confirmed by nerve conduction studies. Both sensory and mixed sensorimotor peripheral neuropathies were reported. The time to onset ranged from one dose to 4.5 years.
(10) September 1996, National Heart, Lung, and Blood Institute, National Institutes of Health NIH,Data Fact Sheet,
Congestive Heart Failure in the United States: A New Epidemic,
An estimated 4.8 million Americans have congestive heart failure (CHF). Increasing prevalence, hospitalizations, and deaths have made CHF a major chronic condition in the United States. It often is the end stage of cardiac disease. Half of the patients diagnosed with CHF will be dead within 5 years. Each year, there are an estimated 400,000 new cases. The annual number of deaths directly from CHF increased from 10,000 in 1968 to 42,000 in 1993 (figure 1), with another 219,000 related to the condition.
CHF is the first-listed diagnosis in 875,000 hospitalizations, and the most common diagnosis in hospital patients age 65 years and older. In that age group, one fifth of all hospitalizations have a primary or secondary diagnosis of heart failure.
(11) http://www.msnbc.msn.com/id/16039753/
Is this celebrity doctor's TV ad right for you?
Despite past failures, Dr. Robert Jarvik succeeds hawking statin drug Lipitor By Robert Bazell, Chief science and health correspondent, NBC News, March. 1, 2007
(12) http://www.spacedoc.net/
Duane Graveline MD SpaceDoc,Statin Drug Side Effects, Transient Global Amnesia
(13) http://www.spacedoc.net/lipitor_thief_of_memory.html
Lipitor Thief of Memory, the Book by Duane Graveline MD
(14) deleted
(15) http://www.cmaj.ca/cgi/content/full/173/10/1207-a
CMAJ • November 8, 2005; 173 (10). Letters, Questioning the benefits of statins, Eddie Vos* and Colin P. Rose, *Sutton, Que.; Cardiologist, McGill University, Montréal, Que.
(16) http://www.jstage.jst.go.jp/article/circj/66/12/1096/_pdf
J-Lit Study, Large Scale Cohort Study of the Relationship Between Serum Cholesterol Concentration and Coronary Events With Low-Dose Simvastatin Therapy
in Japanese Patients With Hypercholesterolemia and Coronary Heart Disease Secondary Prevention Cohort Study of the Japan Lipid Intervention Trial (J-LIT)
(17) http://www.annals.org/cgi/content/full/131/2/155-b
Cholesterol Lowering in Older Patients Sandra J. Lewis, MD; Frank Sacks, MD; and Eugene Braunwald, MD 20 July 1999 | Volume 131 Issue 2 | Pages 155-156
(18) http://www.thincs.org/unpublic.UR3.htm
Uffe Ravnskov, MD, PhD, Letter to the editor of Lancet, sent 10. December 2002, Evidence that statin treatment causes cancer
(19) http://www.ncbi.nlm.nih.gov/pubmed/8531288?dopt=Abstract
Newman TB, Hulley SB. Carcinogenicity of lipid-lowering drugs. JAMA. 1996 Jan 3;275(1):55-60. Review.
(20) http://www.ncbi.nlm.nih.gov/pubmed/11502313?dopt=AbstractPlus
Schatz IJ, Masaki K, Yano K, Chen R, Rodriguez BL, Curb JD.
Cholesterol and all-cause mortality in elderly people from the Honolulu Heart Program: a cohort study. Lancet. 2001 Aug 4;358(9279):351-5.
BACKGROUND: A generally held belief is that cholesterol concentrations should be kept low to lessen the risk of cardiovascular disease. However, studies of the relation between serum cholesterol and all-cause mortality in elderly people have shown contrasting results. To investigate these discrepancies, we did a longitudinal assessment of changes in both lipid and serum cholesterol concentrations over 20 years, and compared them with mortality.
METHODS: Lipid and serum cholesterol concentrations were measured in 3572 Japanese/American men (aged 71-93 years) as part of the Honolulu Heart Program. We compared changes in these concentrations over 20 years with all-cause mortality using three different Cox proportional hazards models.
FINDINGS: Mean cholesterol fell significantly with increasing age. Age-adjusted mortality rates were 68.3, 48.9, 41.1, and 43.3 for the first to fourth quartiles of cholesterol concentrations, respectively. Relative risks for mortality were 0.72 (95% CI 0.60-0.87), 0.60 (0.49-0.74), and 0.65 (0.53-0.80), in the second, third, and fourth quartiles, respectively, with quartile 1 as reference. A Cox proportional hazard model assessed changes in cholesterol concentrations between examinations three and four. Only the group with low cholesterol concentration at both examinations had a significant association with mortality (risk ratio 1.64, 95% CI 1.13-2.36).
INTERPRETATION: We have been unable to explain our results. These data cast doubt on the scientific justification for lowering cholesterol to very low concentrations (<4.65 mmol/L) in elderly people.
(21) http://jama.ama-assn.org/cgi/content/abstract/272/17/1335?ijkey=d2fe4b0874ba7917
Lack of association between cholesterol and coronary heart disease mortality and morbidity and all-cause mortality in persons older than 70 years
H. M. Krumholz, T. E. Seeman, S. S. Merrill, C. F. Mendes de Leon, V. Vaccarino, D. I. Silverman, R. Tsukahara, A. M. Ostfeld and L. F. Berkman
Department of Internal Medicine, Yale University School of Medicine, New Haven, CT 06520-8017.
OBJECTIVES--To determine whether elevated serum cholesterol level is associated with all-cause mortality, mortality from coronary heart disease, or hospitalization for acute myocardial infarction and unstable angina in persons older than 70 years. Also, to evaluate the association between low levels of high-density lipoprotein cholesterol (HDL-C) and elevated ratio of serum cholesterol to HDL-C with these outcomes.
DESIGN--Prospective, community-based cohort study with yearly interviews.
PARTICIPANTS--A total of 997 subjects who were interviewed in 1988 as part of the New Haven, Conn, cohort of the Established Population for the Epidemiologic Study of the Elderly (EPESE) and consented to have blood drawn. MAIN OUTCOME MEASURES--The risk factor-adjusted odds ratios of the 4-year incidence of all-cause mortality, mortality from coronary heart disease, and hospitalization for myocardial infarction or unstable angina were calculated for the following: subjects with total serum cholesterol levels greater than or equal to 6.20 mmol/L (> or = 240 mg/dL) compared with subjects with cholesterol levels less than 5.20 mmol/L (< 200 mg/dL); subjects in the lowest tertile of HDL-C level compared with those in the highest tertile; and subjects in the highest tertile of the ratio of total serum cholesterol to HDL-C level compared with those in the lowest tertile.
RESULTS--Elevated total serum cholesterol level, low HDL-C, and high total serum cholesterol to HDL-C ratio were not associated with a significantly higher rate of all-cause mortality, coronary heart disease mortality, or hospitalization for myocardial infarction or unstable angina after adjustment for cardiovascular risk factors. The risk factor-adjusted odds ratio for all-cause mortality was 0.99 (95% confidence interval [CI], 0.56 to 2.69) for the group who had cholesterol levels greater than or equal to 6.20 mmol/L (> or = 240 mg/dL) compared with the group that had levels less than 5.20 mmol/L (< 200 mg/dL); 1.00 (95% CI, 0.59 to 1.70) for the group in the lowest tertile of HDL-C compared with those in the highest tertile; and 1.03 (95% CK, 0.62 to 1.71) for subjects in the highest tertile of the ratio of total serum cholesterol to HDL-C compared with those in the lowest tertile.
CONCLUSIONS--Our findings do not support the hypothesis that hypercholesterolemia or low HDL-C are important risk factors for all-cause mortality, coronary heart disease mortality, or hospitalization for myocardial infarction or unstable angina in this cohort of persons older than 70 years.
(22) http://www.bmj.com/cgi/content/full/327/7420/933-b
BMJ 2003;327:933 (18 October), Letter Might money spent on statins be better spent? Arnold J Jenkins
I have yet to find a paper showing a significant reduction in mortality in women for groups treated with statins. It therefore seems that any benefit, if found, will be minimal. Yet we are almost compelled by protocols such as the national service framework for coronary heart disease4 and local prescribing incentives to prescribe for this subgroup.
(23) http://www.commercialalert.org/news/news-releases/2006/05/39-health-seniors-groups-call-on-congress-to-end-to-dtc-prescription-drug-ads
39 Health & Seniors Groups Call on Congress to End to DTC Prescription Drug Ads Thirty-nine medical, health and seniors' organizations are urging Congress to stop the advertising of prescription drugs to consumers, Commercial Alert and the National Women's Health Network announced today.
"Prescription drug ads are dishonest and dangerous," said Gary Ruskin, executive director of Commercial Alert. "They hype the benefits and cloak the risks of prescription drugs."
As Robert A. Schoellhorn, former chairman of Abbott Laboratories warned more than two decades ago, "We believe direct advertising to the consumer introduces a very real possibility of causing harm to patients who may respond to advertisements by pressuring physicians to prescribe medications that may not be required."
(24) http://www.commercialalert.org/phpa.pdf
Public Health Protection Act. We call on Congress to enact the Public Health Protection Act to prohibit direct-to-consumer marketing of prescription drugs. Background: In 2004, pharmaceutical companies spent more than $4 billion in advertising for prescription drugs. This advertising does not promote public health. It increases the cost of drugs and the number of unnecessary prescriptions, which is expensive to taxpayers, and can be harmful or deadly to patients.Provision 1: Direct-to-consumer advertisements of prescription drugs are prohibited, including "reminder advertisements," and "help-seeking advertisements" that direct people to websites that are intended to promote the sale of particular prescription drugs.
http://www.westonaprice.org/modern-diseases/dangers-of-statin-drugs-what-you-havent-been-told-about-popular-cholesterol-lowering-medicines/
Dangers of Statin Drugs: What You Haven't Been Told About Popular Cholesterol-Lowering Medicines By Sally Fallon and Mary G. Enig, PhD Hypercholesterolemia is the health issue of the 21st century. It is actually an invented disease, a "problem" that emerged when health professionals learned how to measure cholesterol levels in the blood.
(26) http://www.ravnskov.nu/uffe.htm
The Cholesterol Myths by Uffe Ravnskov, MD, PhD
(27) http://search.yahoo.com/search?p=lipitor+message+boards&fr=yfp-t-501&toggle=1&cop=mss&ei=UTF-8
Message Boards for Statins
(28) http://mb.rxlist.com/rxboard/lipitor.pl?
Lipitor Message Board, adverse events
(29) http://qjmed.oxfordjournals.org/content/96/12/927.full
Q J Med 2003; 96: 927-934; High cholesterol may protect against infections and atherosclerosis U. Ravnskov I
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