The NY Times today published 4,100 words on Merck’s Gardasil under the rubric “The Evidence Gap.” the Times touts the story this way: “this series will explore medical treatments used despite scant proof they work and will consider steps toward medicine based on evidence.”
Scant proof that Gardasil works? Oh boy! This is the big one. The Times is finally bringing down the hammer on one of the most controversial drug launches ever, just like I predicted … right?
The piece has a number of problems that will leave drug industry folk scratching their heads as to why it was published. Doubtless the folks at Drug Wonks are already banging furiously at their keyboards in outrage at the Times’ anti-pharma bias.
More seriously, it’s long, boring, and filled with old news and non-news. So that you don’t have to read it yourself, here’s a users’ guide:
First, despite the bug-line, there’s no evidence in the article that the drug doesn’t work. Merck has never marketed Gardasil as a vaccine for all HPV, just some of the major strains.
Second, the Times’ math as explained in the story doesn’t add up. (Regular readers will be familiar with the fact that the Times is not great at explaining its numbers.) The drug costs $400-$1000 for a complete treatment, but the Times then says “Health economists estimate that depending on how they are used, the two cervical cancer vaccines will cost society $30,000 to $70,000, or higher, for each year of life they save in developed countries — a cost commonly seen in treating people already suffering from deadly cancers.” There is no explanation of how these economists got from $400 to $70,000, which would be nice, because on its own the claim makes no sense. Readers are asked to speculate that perhaps because patients who have Gardasil will be less likely to die of cervical cancer they will live longer and use more healthcare resources for different chronic diseases? Who knows. I’m just guessing.
Third, the story claims that “experts worry about the consequences of the rapid rollout of the new vaccines without more medical evidence about how best to deploy them.” Then it admits a few grafs later that Gardasil and Cervarix between them have been through eleven and a half years of trials. Gardasil alone has been through 16 million doses. From all that, there are only 9,749 adverse event reports at the FDA and 20 deaths. Even of the fatalities, there’s “no indication that the deaths or serious side effects were caused by the shot,” the Times reports.
The most inflammatory part of the story goes like this:
Phillip and Barbara Tetlock, both professors at the University of California at Berkeley, are asking whether Gardasil shots that their daughter, Jenny, received last year contributed to her illness, an extremely rare form of progressive paralysis that has left her bed bound and needing assistance to breathe at age 14.
The Tetlocks, who are not pursuing legal action, are appealing to the C.D.C. and Merck for more data and searching for other girls with similar conditions through their blog (www.jenjensfamily.blogspot.com). “Her parents are scientists – they know better than to assume Gardasil caused her disease,” said Terry Murray, a close friend speaking for the family. “But you have to explore the possibility.”
[Dr. Diane Harper, a professor of medicine at Dartmouth Medical School ] said she believed the vaccine was generally safe. She vaccinated her own children. But with Gardasil’s use having grown so fast, she added, … “The Tetlocks are right to ask these questions.”
Well, sure, but by the evidence presented by the Tetlocks, their friends, their blog and the Times itself, there’s zero connection whatsoever to Gardasil other than the fact that this poor girl got sick around the time she had the injections.
Most of the rest of the story is about two years old — there’s a complete rehash, for instance, of Merck’s clumsy and cynical lobbying campaign in Texas and Virginia, which was widely reported in both local and national media at the time.
Did the Times get anything right? Credit where it’s due: It was certainly worth reporting this conflict of interest:
Gregory A. Poland, a vaccine expert at the Mayo Clinic, was a nonvoting member on the C.D.C. panel that recommended Gardasil in 2006 and has publicly defended the panel’s decision. Records show he received at least $27,420 in expenses and consulting fees from Merck from 1999 to 2007. Both the C.D.C. and Dr. Michael Camilleri, chairman of the Mayo Clinic Conflict of Interest Review Board, speaking on Dr. Poland’s behalf, said the payments complied with institutional requirements.
But beyond that, I am mystified as to why this deserved such massive airtime this late in the day.