Challenges of...
Challenges of independent assessment of potential harms of HPV vaccines
BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3694 (Published 24 September 2018) Cite this as: BMJ 2018;362:k3694
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Re: Challenges of independent assessment of potential harms of HPV vaccines
I note in regard of these concerns the new paper by Shardlow, Mold and Exley: 'Unraveling the enigma: elucidating the relationship between the physicochemical properties of aluminium-based adjuvants and their immunological mechanisms of action' [1]. The conclusion reads:
"Human exposure to aluminium is burgeoning...with significant implications for human health.... ABAs [aluminium based adjuvants] are effective and cheap but are they safe? Confirmation of their safety remains to be addressed and will only come from further research on their biological activities at injection sites and beyond. All ABAs currently in use in vaccination and sub-cutaneous immunotherapy require further validation of their safety, which means that the manufacturer of AAHS [a sulphate salt present in the novel Gardasil adjuvant AdjuPhos®] should release this ABA so that its safety can be verified independently. Burgeoning knowledge regarding the biological activities of ABAs now dictates that their safety should be evaluated independently of their presence in vaccine formulations."
[1] Emma Shardlow, Matthew Mold and Christopher Exley, 'Unraveling the enigma: elucidating the relationship between the physicochemical properties of aluminium-based adjuvants and their immunological mechanisms of action,', 7 November 2018, Allergy, Asthma & Clinical Immunology201814:80 https://doi.org/10.1186/s13223-018-0305-2
UK Editor
London N22
HPV vaccine: news management vs. public safety and the right to know?
Seven weeks after its courageous publication, this paper [1] has received relatively little attention even in these columns, but I thought of it when I saw an article in the Mail on Sunday a couple of days ago: 'Outcry as boys' HPV 'catch-up' is rejected by the government as Health Secretary and Vaccines Minister stop the extension'. People are being told they desperately need this product, pressure is brought to bear on government ministers, it is even - horror of horrors - an issue of gender equality. Under the article I left the two line comment (which remarkably has survived):
"A greater right than having this vaccine would be knowing about it. The medical research world is in upheaval over this vaccine - the Cochrane Group has split and yet the public must not be told."
To an earlier generation of journalists the split in Cochrane [3] and the attack on HPV vaccine safety by senior scientists [1,4] would be attention grabbing headlines, and rightly so. As it is, can health professionals - if they have managed to inform themselves adequately - properly tell their patients that these products are "safe" or even that "the benefits greatly outweigh the risks" (the usual rubric)? If the news media was not in breakdown everyone would be told, and not just those who have their noses buried in medical journals: ordinary citizens have a right to know - it affects them. Indeed, with this amount of justified doubt should not the products simply be withdrawn?
[1] Lars Jørgensen, Peter Doshi, Peter Gøtzsche, Tom Jefferson, 'Challenges of independent assessment of potential harms of HPV vaccines', BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3694 (Published 24 September 2018)
[2] David Rose, 'Outcry as boys' HPV 'catch-up' is rejected by the government as Health Secretary and Vaccines Minister stop the extension', 10 November 2018, https://www.dailymail.co.uk/health/article-6375239/Outcry-boys-HPV-catch...
[3] Nigel Hawkes, 'Cochrane director's expulsion results in four board members resigning', BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3945 (Published 17 September 2018)
[4] Jørgensen L, Gøtzsche PC, Jefferson T.'The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias', BMJ Evid Based Med. 2018 Oct;23(5):165-168. doi: 10.1136/bmjebm-2018-111012. Epub 2018 Jul 27
Without transparency, there can be no trust.
I applaud Lars Jørgensen, Peter Doshi, Peter Gøtzsche, and Tom Jefferson for publishing this in-depth look at the lack of transparency and accessibility of clinical data, and revealing the volumes of suppressed data.
The average parent--indeed, the average doctor who administers vaccines, and the average public health employee promoting vaccination--has no idea that this is happening.
Parents are bombarded with messages to vaccinate their children with HPV vaccines. Many millions are spent annually by Merck and GSK to saturate public health messages and silence any whisper of risk.
If it were simply the manufacturers pushing, it would be bad enough, but our government agencies push even harder. Campaigns are waged with tax-dollars and pharmaceutical company grants channeled through "non-profits", coercive scripts are provided by the CDC (a patent-holder that profits from the sale), to convince "hesitant" parents, and the mantra of "safe and effective" is trumpeted along with "mountains of studies showing they are safe." None of it is true because, as this article explains, the full clinical trial data--generated by the companies that stand to profit-- has never been reviewed.
I recently attended a WA State Vaccine Advisory Committee meeting at which a CDC program was gleefully announced-- "HPV Vaccine is Cancer Prevention Champion Award for clinicians, clinics, or health systems who meet certain criteria for fully immunizing their adolescent patients against HPV." This news was followed by an hour-long presentation by a researcher on vaccine hesitancy and communication research. The DOH intends to educate vaccine providers how to use the researchers "presumptive" approach to drive rates higher. There was not a single word of caution, of contraindication, of adverse reactions, of prescreening for previous infection, of providing full information for informed consent to be respected.
In fact, it was also announced at this meeting that WA State's Immunization director is now chair-elect of AIM, the Association of Immunization Managers. This is a collaboration between every single US state immunization director and vaccine makers. They have a memo of understanding that ensures pharmaceutical reps are allowed phone calls, meetings, and access to policy information. At their annual conference in June, materials boasted that "Leadership Development Training was made possible through a Merck educational grant", and in a presentation, Informed Consent organizations were labelled as their opposition. How have we come to this? In a country that is supposed to be the leader of the free world-- yet our state public health officials are being trained by Merck to oppose those of us protecting our human right to fully informed consent?
Trust in government vaccine policy is swiftly vanishing as details emerge from all angles. I agree most emphatically with the authors that "Urgent changes are essential for open and transparent assessment of the harms and benefits of interventions." The entire system needs changing.
It has been made clear from this article and many others that HPV vaccines cannot be claimed to be safe or effective and we cannot wait for our public health agencies to do the right thing. The vaccines must be pulled from the market, and something must be arranged to support those who were harmed by them, and the health of all recipients closely monitored for many years to come. If justice is served, this cost will be borne by Merck and GSK and the CDC from the profits made from HPV vaccine sales.
Bernadette Pajer
writer/co-president, Informed Choice WA
WA State, USA
In the light of this information [1] what are the ethical grounds for the continued prescription of these products which seem to be neither properly tested or monitored? How can we look to some long term nebulous benefit when public agencies are apparently so negligent of safety? And what do we do about those agencies?
I have also been reading with dismay the shortly to be published 'The HPV Vaccine On Trial: Seeking Justice for a Generation Betrayed' [2] which parallels and augments much of what has been said here.
[2] Mary Holland, Kim Mack Rosenberg and Eileen Iorio, 'The HPV Vaccine On Trial: Seeking Justice for a Generation Betrayed' with an introduction by Luc Montagnier, Skyhorse, 2 October 2018
Lars Jørgensen researcher,, Peter Doshi assistant professor, Peter Gøtzsche professor, Tom Jefferson researcher
Jørgensen Lars, Doshi Peter, Gøtzsche Peter, Jefferson Tom. Challenges of independent assessment of potential harms of HPV vaccines BMJ 2018; 362 :k3694
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