Farcical Study of Gardasil Safety: Medscape Gives CME Training Credit for It

As apparent adverse effects from the Gardasil vaccine mount, Merck decided to do some public relations control. They initiated, controlled, and paid for a piece of pseudo science to trot out as proof that the vaccine doesn’t cause harm. We’d expect them to do that. Buying the appearance of science is a typical Big Pharma method for selling its products.

But Medscape is giving away a Continuing Medical Education (CME) online class in support of the study. There isn’t a single word in the brief course to indicate that the study might be questionable. Though there’s a statement of conflicts of interest, cut and pasted from the study, tacked on at the end, there’s no requirement that the course takers actually read it.

The Study

Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine was published by the journal Internal Medicine in November 2011. The authors claimed that the only disease increase that showed up was for Hashimoto’s disease, a severe autoimmune disorder of the thyroid. Even that they softened by claiming that no evidence of “temporal relationship and biological plausibility revealed no consistent evidence for a safety signal for autoimmune thyroid conditions”.

So what’s wrong with the study? First, we always need to determine how it was funded, who controlled the study, and what relationship the researchers have with anyone who might profit from the results. In this study, the blatancy of conflicts of interest is astounding:

• Merck, the Gardasil vaccine’s manufacturer, funded the study.
• Merck controlled how the study was done.
• The lead authors,  C. Chao and S. J. Jacobsen, plus J. M. Slezak, have received research funding from Merck in the past.
• S. J. Jacobsen served as a Merck consultant.
• N. P. Klein currently receives Merck funding.
• C. M. Velicer and K. L. Liaw are Merck employees.
• Merck was involved in the analysis, and manuscript drafting and revision.

We could stop right here and know that this study is a farce. But we’ll delve into it just a bit more.

They followed 189,629 women and girls, aged 9-25, for 180 days after the date of Gardasil vaccination. They recorded 1,014 cases of new onset disease. They reported that 719 were “eligible for case review”, determined by whether they had been members of the Kaiser plan (where the study was done) for at least a year prior to being given the Gardasil vaccine.

A significant question is: Why didn’t they separate out the number of subjects who had been in the program for at least a year before, rather than after, determining the number diagnosed with illness? In this computerized age—and Kaiser is most assuredly computerized—it wouldn’t have been difficult. But they didn’t do it, and at no point do they tell us how many actual subjects were involved. As a result, we have no idea how many subjects were actually involved in the study! We only know how many subjects they started with before eliminating an unknown number of them.

Of the 719 subjects determined to be eligible for case review, 31-40% were confirmed as new onset.

How did the authors determine the rate that diseases struck nonvaccinated girls and women? They estimated! Certainly, they used sophisticated methods. However, the fact is that they did not include unvaccinated girls and women in the study.

Only a certain set of diseases was considered. They were:

• Immune thrombocytopenia
• Autoimmune hemolytic anemia
• Systemic lupus erythematosus
• Rheumatoid arthritis
• Juvenile rheumatoid arthritis
• Type 1 diabetes
• Hashimoto’s disease
• Graves’ disease
• Multiple sclerosis
• Acute disseminated encephalomyelitis
• Other demyelinating diseases of the central nervous system
• Guillain-Barré syndrome
• Optic neuritis
• Uveitis

The Truth About Gardasil reports on a different set of adverse effects, including “seizures, strokes, dizziness, fatigue, weakness, headaches, stomach pains, vomiting, muscle pain and weakness, joint pain, auto-immune problems, chest pains, hair loss, appetite loss, personality changes, insomnia, hand/leg tremors, arm/leg weakness, shortness of breath, heart problems, paralysis, itching, rashes, swelling, aching muscles, pelvic pain, nerve pain, menstrual cycle changes, fainting, swollen lymph nodes, night sweats, nausea, [and] temporary vision/hearing loss.”

That list doesn’t have too much correlation with the carefully circumscribed list developed by the Merck study, does it? Just examining the study’s list shows how bizarre it is. Only type 1 diabetes is listed. Why not type 2? Notice how specific the conditions are. Only two thyroid disorders are included. They could have given two broad descriptions, hyperthyroid and hypothyroid, which would have included most thyroid disorders. Instead, they limited it to just two of several. Why would they do this, if not to obscure the truth?

The study’s list, by itself, clearly demonstrates that the Merck study is useless for anything but spin. But when you also consider:

• The range of disorders that The Truth About Gardasil has noted
• That many conditions simply aren’t touched on by the study
• That the actual number of subjects is never revealed
• That there were no unvaccinated subjects in the study

Well, it’s difficult to see it as qualifying as even pseudo science. It looks more like outright fraud.

So why did Medscape produce a CME course based solely on such nonsense? Worse, why did they just go along with the virtually manufactured claims? Are the producers of Medscape completely unaware of how absurd the study is, or are they complicit in promulgating a fraud, the idea that Gardasil is safe? Not only are they accepting blatant pseudo science, they are using it as the basis of training doctors.

I’ll leave it to the reader to decide what Medscape’s intentions are.

Tagged big pharma, conventional medicine, gardasil, gardasil adverse effects, gardasil pseudo science, hpv4, medscape gardasil, medscape merck, merck, merck pseudo science, pharmaceutical drugs, pseudo-science, vaccine, vaccines