The FDA vs. Science on Merck HPV Vaccine

Seeking Alpha

June 16, 2009

It’s funny how there are some groups of people who campaign against anything that makes sex less risky, fearing the new form of protection promotes negative behavior. It’s like being against seat belts because you think more people will drive drunk. Anyhow, Merck’s (MRK) Gardasil HPV vaccine has been under fire for awhile now from some groups in the US, and oddly has even been asked to carry a safety warning by the FDA, despite science showing the warning should not be there. Hopefully scientific facts win out, for the US, for the FDA’s reputation… and of course for Merck, given that its stock is near its 52-week lows.

The FDA has demanded Merck add a new warning to its Gardasil HPV vaccine: That it may cause fainting… Let’s update that information to see just how ravaged America’s fragile female youth has been by this fainting epidemic that the liberal media conspiracy is refusing to cover…

Do the math: 13 percent of 13,758 adverse events = 1,788 girls. There are three shots to complete a Gardasil vaccine, so divide 24 million by three and get 8 million. Of those 8 million girls, just 1,788 fainted. That’s 0.02 percent — or 2 in 10,000 — who faint when getting the jab.

Now ask yourself: If you line up a bunch of giddy 13-year-old girls for an injection that has something to do with sex, cancer and genital warts, would you expect more or fewer than 2 in 10,000 to faint during the process? A true cynic — employed by Merck! — might argue that the fainting rate is so low that Gardasil contains some sort of anti-fainting protection, based on these numbers.

Comment from Leslie

You are absolutely right – the number of girls (I will omit the reference to “giddy” since that is an unfair, biased and sexist judgement) actually fainting within 15 minutes of receiving the HPV injection is relatively low.  However, only 1% of adverse reactions are being reported as noted by NVIC.  That really skews the numbers that the author is referring to.

The labeling is a smokescreen for a much larger problem. There are those who think it is the first admission of guilt by the FDA.  Their documents show that they were aware of this problem.

Only time will tell what the final stats will be.  But until then, there is no doubt that the numbers of girls affected will also rise.  Unless of course, information on the Internet and through the media (except for this blog, of course) is giving these intelligent young women pause to rethink their choices.

This issue is not about stocks and market rise and falls – it is about lives shattered and forever changed for parents and and their daughters who trusted in the medical and pharmaceutical industries.


Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.