Could Merck Be About to Stumble Over Gardasil Adverse Event Reports?

July 28, 2008

Some time ago I took a strong stance in favor of Gardasil, the HPV vaccine that also prevents certain cervical cancers (which can be fatal). I believe I called critics of the vaccine “the anti-science/pro-cancer crowd.” The most vocal opposition to this vaccine has been from religious parents who think that protection against HPV will make their daughters slutty.

In the last two years there has been a drumbeat of reports about the number of adverse events, and a handful of deaths, reported to the FDA after young girls were administered Gardasil. The conservative group Judicial Watch obtained an FDA database detailing 10 deaths and 140 serious events associated with Gardasil.

I was going to write yet another post urging people to put those reports in the context of the thousands and thousands of girls who have received the vaccine and not experienced any problems. But someone has done a much better job of that for me: Jeff Bercovici at Portfolio. You should read his post.

A couple of side-thoughts, however: First, it’s worth downloading the FDA files at Judicial Watch’s web site, because reading adverse events reports in the original is very, very different from reading about them in Sharyl Attkisson’s report on CBS. None of these reports ever put the adverse event numbers in context of the number of girls who have actually received the injection in total: It was at least 1 million in 2007, and obviously well north of that now.

Here’s a couple more examples of reporters who thought the adverse events were news but couldn’t be bothered to give you the total number of girls unharmed by the jab. One is at CBS, the other is at US News & World Report.

Worse, they rarely describe how lousy the adverse event reports are. Just by skimming them myself I noticed that even in death cases the autopsy physician sometimes concludes that Gardasil played no role. So why are they in there? Because adverse event reports can be sent in by anybody for any reason, and the FDA has a duty to collect them. There are no standards for information collecting — and so the reports fill up with junk, basically.

The only thing that gives me pause for thought here is that Susan Edelman at the New York Post thinks it’s news. Edelman was one of the first reporters to jump on the J&J Ortho Evra birth control patch story. (Basically, the patch administers an unexpectedly high level of estrogen, giving girls heart attacks and strokes in unusual numbers.) The one thing that the patch and Gardasil have in common is they are both administered to young girls who rarely drop dead for no reason. This fact turned out badly for J&J, which has quietly stopped promoting the patch as a result.


8 Responses to “Could Merck Be About to Stumble Over Gardasil Adverse Event Reports?”

  1. […] this week, Mr. Edwards wonders if Merck is about to stumble over Gardasil adverse event reports, although he points out just how lousy the adverse events reports actually are. And check him out […]

  2. […] the current VAERS. Jim Edwards comments on mainstream media clumsiness in presenting the numbers: Could Merck Be About To Stumble Over Gardasil Adverse Event Reports?. August 4: Orac weighs in: Germ theory denialism and antivaccination myths on Medscape. There is an […]

  3. […] Jim Edwards comments on mainstream media clumsiness in presenting the numbers: Could Merck Be About To Stumble Over Gardasil Adverse Event Reports?. […]

  4. […] Jim Edwards comments on mainstream media clumsiness in presenting the numbers: Could Merck Be About To Stumble Over Gardasil Adverse Event Reports?. […]

  5. […] Look at slide 2, where he notes that the FDA recorded 32,000 cardiac events related to Vioxx. (Side thought: see here for a brief critique of why relying on FDA adverse event reports isn’t the wisest thing). […]

  6. […] The Times is finally bringing down the hammer on one of the most controversial drug launches ever, just like I predicted … […]

  7. I would asppreciate any data relating to the effects of Gardasil on females.

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