Questioning vaccines doesn’t make someone anti-vaccine.
Doing a poor job of it and making folks scared to get vaccinated and protected?
I’ll let you decide what to call them…
Slate Investigates the Gardasil Clinical Trials
So after an eight-month long investigation, a journalist for Slate thinks he has evidence that the clinical trials that helped get Gardasil approved by the European Medical Agency were flawed.
What was the problem?
The way that they recorded possible side effects after folks were vaccinated.
“To track the safety of its product, the drugmaker used a convoluted method that made objective evaluation and reporting of potential side effects impossible during all but a few weeks of its years long trials.”
What made the method convoluted?
“In an internal 2014 EMA report about Gardasil 9 obtained through a freedom-of-information request, senior experts called the company’s approach “unconventional and suboptimal” and said it left some “uncertainty” about the safety results.
…
Merck, which is known as Merck Sharp & Dohme outside the U.S. and Canada, did not address the EMA’s safety concerns.”
When you read the internal 2014 EMA report about Gardasil 9, it is clear that Merck has a thorough response to each and every question that the EMA asked.
And those other quotes?
The EMA does state that:
- “At all other time points in the study medical events were reported as “new medical history”. This is an unconventional and suboptimal study procedure.”
- “While it is considered that the required safety data eventually has been made available for assessment, this feature of the study protocol brings some degree of uncertainty into safety assessment.”
So the EMA got the required safety data they were looking for, which is likely why Gardasil was approved in Europe.
They also said that “As the AE reporting procedure as seen at the inspection sites was in line with the approved protocol, the inspectors did not comment on it in the inspection reports. It was discussed with assessors during the course of the inspections, as in the inspectors’ opinion it is not an optimal method of collecting safety data, especially not systemic side effects that could appear long after the vaccinations were given.”
But if it was suboptimal, how come they were able to record someone getting diagnosed with POTS 1,389 days after their third dose of vaccine?
I’m starting to understand why Dr. Yehuda Shoenfeld wasn’t quoted in the piece. He likely knew how it was going to be perceived…
“Imagining a link between HPV vaccination and CFS is not all that far-fetched, according to Dr. Jose Montoya, a professor of medicine at Stanford University and a CFS expert.”
Not far-fetched at all, which is why studies are done to see if there really is a link.
So even if part of the study design was suboptimal, the Slate piece shouldn’t have cherry picked those quotes and should have included these other big pieces of information:
- A study in the UK using the MHRA’s Yellow Card passive surveillance scheme found no increase in reports of chronic fatigue syndromes following the introduction of Cervarix (another HPV vaccine)
- In 2015, the EMA confirmed evidence that HPV vaccines do not cause complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS)
- A large, nationwide register-based study from Norway found no indication of increased risk of chronic fatigue syndrome/myalgic encephalomyelitis following HPV vaccination
- A large cohort study of over 2 million young girls in France found no risk for autoimmune diseases (including neurological, rheumatological, hematological, endocrine, and gastro-intestinal disorders)
- A large cohort study of girls in Sweden with pre-existing autoimmune diseases found that HPV vaccination was not associated with increased incidence of new-onset autoimmune disease (49 types of autoimmune diseases)
- A review of VAERS reports that “did not detect any unusual or unexpected reporting patterns that would suggest a safety problem” with HPV vaccination
The Slate piece does mention two of these studies, but just barely. One gets a single sentence and the other, half a sentence.
We see page after page of anecdotes of folks with supposed vaccine injuries, but the evidence that shows the vaccine is safe is almost buried and easy to miss. Many of the other studies seem to be left out.
And just because these patients have agonistic auto-antibodies, it doesn’t mean that they are from a vaccine.
“Five of the 14 POTS subjects and 2 of the 10 “healthy controls” recalled a respiratory infection in the 6 months prior to onset of their symptoms or inclusion in the study for the healthy controls.”
Li et al on Autoimmune Basis for Postural Tachycardia Syndrome
Lastly, what’s with calling cervical cancer uncommon???
“Cervical cancer is the 4th most common cause of cancer death in women worldwide, with tens of thousands of deaths in Europe each year despite the existence of screening programmes to identify the cancer early.”
European Medicines Agency
Downplaying the risks of vaccine-preventable diseases, while trying to scare folks about vaccines – that’s what gets you labeled as anti-vaccine.
The HPV vaccines are safe. They work and they are necessary. Don’t skip them.
What to Know About the Slate Gardasil Investigation
Although the study design for Gardasil used for licensing in Europe might have been suboptimal, that doesn’t really come across in this Slate piece, as it seems clear that it didn’t result in safety data being missed, and as post-licensure tests have confirmed, Gardasil is safe.
More on the Slate Gardasil Investigation
- HPV vaccine side effects – unrelated to chronic fatigue syndrome
- Gardasil HPV Vaccine Safety Assessed In Most Comprehensive Study To Date
- HPV vaccines: EMA confirms evidence does not support that they cause CRPS or POTS
- EMA HPV Safety Review
- The media’s MMR hoax
- The MMR story that wasn’t
- WHO – Impact of rumours and crises
- Public Health Takes on Anti-Vaccine Propaganda: Damage done, Challenges Ahead
- How the Media Fed the Anti-Vaccine Movement
- The Autism-Vaccines Myth: The Impact of the Media
- How vaccine scares respect local cultural boundaries.
- How the Toronto Star massively botched a story about the HPV vaccine — and corrected the record
- Jabs “as bad as the cancer”
- Beware of false balance: Are the views of the scientific community accurately portrayed?
- Impartial journalism is laudable. But false balance is dangerous
- Facts vs. opinions: Beware of false balance in your reporting
- Study – The HPV vaccine and the media: How has the topic been covered and what are the effects on knowledge about the virus and cervical cancer?
- Study – Bivalent human papillomavirus vaccine and the risk of fatigue syndromes in girls in the UK.
- EMA to further clarify safety profile of human papillomavirus (HPV) vaccines
- Study – HPV vaccination and risk of chronic fatigue syndrome/myalgic encephalomyelitis: A nationwide register-based study from Norway.
- Study – Human papillomavirus vaccination and risk of autoimmune diseases: A large cohort study of over 2million young girls in France.
- Study – Incidence of new-onset autoimmune disease in girls and women with pre-existing autoimmune disease after quadrivalent human papillomavirus vaccination: a cohort study.
- Study – Reports of Postural Orthostatic Tachycardia Syndrome After Human Papillomavirus Vaccination in the Vaccine Adverse Event Reporting System.
- Study – Autoimmune Basis for Postural Tachycardia Syndrome
- The cranks pile on John Ioannidis’ work on the reliability of science
- Are Most Medical Studies Wrong?
- CDC – Possible Causes of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Gardasil is safe, for almost everybody. For a very small fraction of people, it can trigger serious illness. This action of triggering is not going to be easy to catch in population studies, which look for a cause, not a trigger. It would be sad to let the anti-vaxxers win: to have to say, the people who say they got sick are liars. Yet our own group health depends on the illness of just a few people: we should pay those people the respect of believing them. And keep vaccinating.
Anti-vaxxers are the great enemy of the chronically ill: their stupidity prevents others from looking with nuance at how the immune system works in different individuals.
The cervical cancer vaccines are a major achievement. They will save many thousands of lives every year for many years. The discussion of cases of CFS was never about whether or not to vaccinate, and it shouldn’t be treated that way.
Anyone runs a far greater risk of cancer by not vaccinating against HPV than they risk illness by vaccinating. How can this not be obvious? The vaccines will save many thousands of lives, and there’s just no case not to vaccinate. This is a completely different question altogether from the problem of CFS: let’s not confuse science (looking a possible side effects) for pseudoscience (anti-vaxxers).
Wow, reading my comments two years ago I was in a difficult space: no one believed the women who got sick from Gardasil, and everyone was hating on anti-vaxxers. My aim was to get the injuries taken seriously. At the time I was really really sick with Chronic Fatigue Syndrome, and to me reading now, it looks I had poor judgment about how to get the injuries taken seriously.
I haven’t reread the article, but I would say now that: new scientific studies are raising the possibility of such injuries happening; the profile of ME/CFS (chronic fatigue syndrome) is changing, so that patients are no longer being blamed for their illness (you’re just making it up, or it’s psychosomatic, or you’re not actually sick), as happened to the women who got sick from Gardasil; and it’s becoming clear that mainstream medicine has not been listening to women on serious chronic illness. I don’t have links to hand at the moment — I’m still sick and have limited capacity. But I do want to return to these comments and say that if it’s considered unscientific to believe the women who say they got sick from Gardasil, obviously it’s equally unscientific to disbelieve them. We should listen to these women and try to work out what happened.
My point in my comments above two years ago was simply that it’s not anti-vax to suggest that sometimes people get seriously ill from vaccination, and to try to work out why. To my mind that is a pro-vax position (how can we make vaccinations work better?). I think it is a more cogent and persuasive pro-vax position than trying to argue, unconvincingly, that no one ever gets seriously injured by a vaccination. If it turns out to be only a trigger, not a cause per se, it’s still a trigger for lifelong disability in a previously healthy person, and we should respect those women. And the men who are affected.
I’ve now reread the article, but I can’t now reread all the links. I’ve previously read or skimmed most of them I think. There are new scientific studies as of June 2017 that revisit the question of ME/CFS in relation to these vaccines. With the earlier studies, before that date, basically no one has any idea of the prevalence of ME/CFS in the general population so that could make conclusions difficult. I can’t remember the studies well enough now to go into any detail. But it’s an epistemological bind: we can’t work out why the women are sick, and it’s pretty hard to use a population head count to make conclusions about individual cases (“it didn’t happen, dear, because it doesn’t happen” — I used to get this line from doctors all the time! But things are changing now). So, what to do? More research, and more questioning, I would say. In that vein, the critical review of the Slate article thta’s offered in the article here above is welcome, and more of it is needed — and my own critical response to this article is that I think it closes down a few questions that I think are still open questions in the research, particularly around that epistemological bind.
It’s good that it’s clear that Merck were terrible in the way they conducted the trial, both on the count of not logging some effects and on the count of not managing to get a proper placebo group, even though that second flaw is pretty standard. My comments are not a source of references, for which apologies, but a source of questions for which we still don’t have answers. Hopefully the new biomedical research into ME/CFS will eventually provide some answers on the untouchable topic of vaccine adverse reactions.
*NB: I briefly got sick from a single dose of Cervarix, then recovered; my ME/CFS was caused by a different, unnecessary, medical test, not by the HPV vaccine; without that trigger, I’d still be healthy (still a walking potential disaster just like every human on this planet, but not triggered and so, not disabled, and still paying taxes.) So I did choose to get vaccinated against HPV as an adult: I’m not anti-vax. Also, I’ve had several procedures and two general anaesthetics to remove pre-cancerous lesions on my cervix, so I’m not unaware of how rough that screening program is or what the risks of lesions are.