Journal Uses Out-of-Date Info to Bash Merck's Gardasil

Pharmalot and the Wall Street Journal both used outdated information in items they published on Merck’s Gardasil today. That’s a shame, because having accurate, up-to-date information is crucial in sorting fact from squeamishness about the controversial HPV vaccine that is now mandatory for many schoolgirls. The WSJ and Pharmalot pointed to this opinion article in the Journal of Law, Medicine and Ethics which concludes:

The long-term safety and effectiveness of the vaccine are unclear, and serious adverse events reported shortly after the vaccine’s approval raise questions about its short-term safety as well. … In light of these potentially adverse public health, economic, and societal consequences, we believe that it is premature for states to add HPV to the list of state-mandated vaccines.

That sounds scary and serious … until you realize that this article was published in the summer of 2008 – months before the CDC released new information about the actual, to-date safety record of Gardasil. You can read a summary of that data here and here and here. Briefly:

• After looking at 370,000 doses of the drug, the CDC concluded it was safe.
• Gardasil has been given in more than 16 million does so far.
• Gardasil and a similar vaccine, Cervarix, have been studied for 11 and a half years.
• There have been only 10,326 adverse events reported.
• Of those, only 6 percent were serious.
• There have only been 27 deaths reported following Gardasil use; none have so far been linked to the drug.

The WSJ semi-apologized for writing the item:

The article was published online in June, but we have to admit that we didn’t see it until the medical journal got around to publicizing it this week. Even after the delay, we found the arguments thought-provoking and worth sharing.

Ed Silverman at Pharmalot did note that the information was old compared to the CDC study, but only low down in his item after he had highlighted the opinions in the JLME piece.

There are good reasons to criticize Merck’s marketing of Gardasil. (See here, for instance.) But outdated opinions on the safety of the product are not one of them.