Tuesday, August 26, 2008

The Politics of Merck’s Gardasil

Another tough week for Merck.

First, the Annals of Internal Medicine takes the company to task for running a "seeding" study of Vioxx at the start of the decade, a charge Merck disputes--but of course that only means more negative headlines.

Then, the New York Times upbraids the company for pretty much everything it has ever done with the HPV vaccine Gardasil—up to and including developing a vaccine for cervical cancer prevention in the first place.

The very next day (quite a coincidence, no?) the New England Journal of Medicine publishes an an article affirming the cost effectiveness of the vaccine in its currently indicated population of adolescent girls, but questioning the cost-effectiveness of vaccinating young women (aged 21-26). Not what you want to read when you have a supplement pending for use in the 27-45 population.

And, last but not least, another chapter in the Vytorin saga, with FDA issuing a public declaration that it is looking into the apparent association between the cholesterol drug combo and an increased risk of cancer seen in the SEAS trial. (And, no, as far as we know Merck has no studies suggesting that Gardasil prevents Vytorin-associated cancers.)

In that context, we think Merck may have dodged a bullet on Saturday morning, when Barack Obama issued the text message heard round the world, announcing Delaware Senator Joe Biden as his Vice Presidential running mate.

What does this have to do with Merck? We think the good news for the company is who Obama didn’t select—Virginia Governor Tim Kaine (pictured above). Kaine was an early front-runner for the pick, but was eclipsed in the home stretch when the Obama campaign decided to place a greater emphasis on foreign policy experience.

And Kaine is also featured in the New York Times piece, as a champion of mandatory vaccination as a condition of school entry. And, according to the Times, Merck did all kinds of stuff to make that happen, like (gasp!) investing in Virginia, and also (say it ain't so!) hiring lobbyists who used to work for the governor.

All kidding aside though, we’re guessing that Merck is just as happy not to have Gardasil so directly interjected into the Presidential campaign. At least, not right after the Times piece.

But we're betting that Gardasil will be talked about on the campaign trail this fall--and probably not in a context that Merck (or the rest of the industry) will welcome.

The HPV vaccine is, quite simply, a politically volatile project. Merck knows that better than anyone. During development, the company reached out to right-leaning religious organizations to help head off the perception that Gardasil would be a “sex vaccine.” But the company’s aggressive push for coverage mandates backfired with some negative publicity about the lobbying campaign—and even drew fire from politically liberal organizations that viewed coverage mandates as paternalistic or even patronizing.

And, somewhere along the way, Merck managed to alienate many in the public health community who you would think would welcome the vaccine with open arms. Including, for example, Diane Harper--one of the principal investigators on the Gardasil trials. Here is what the Times reports:

“Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people — it created a sense of panic that says you have to have this vaccine now,” said Dr. Diane Harper, a professor of medicine at Dartmouth Medical School. Dr. Harper was a principal investigator on the clinical trials of both Gardasil and Cervarix, and she spent 2006-7 on sabbatical at the World Health Organization developing plans for cervical cancer vaccine programs around the world.

“Because Merck was so aggressive, it went too fast,” Dr. Harper said. “I would have liked to see it go much slower.”
(Conflict of interest mavens take note: The Times carefully chronicals some relatively modest payments by Merck to various experts who have spoken up on Gardasil's behalf, but does not offer any estimate of payments from Merck to Harper.)

Harper is not alone in expressing discomfort with Merck's sales approach. Public health advocates are excited to have so much investment in vaccines. But they are terrified that Big Pharma marketing tactics could taint the whole sector, and undermine the notion of vaccination altogether. (We've written extensively about this attitude before. Start here.)

Ironically, Merck's investors are having the exact opposite reaction. They are concerned that Gardasil sales are slowing down--as if the brand should replicate the Januvia-style growth curve, rather than the historic vaccine model. Imagine how disappointed they would be if Merck had taken the go-slow approach some of the public health advocates wanted!

So Merck finds itself in a bind: marketing a well-recognized pharmaceutical brand that raises red flags with some historically conservative groups (who still see a "sex" vaccine) and other traditionally liberal voices (who see in Merck's marketing of Gardasil all the worst of industry practices they want to change). Commercially, it is full steam ahead (because, after all, what choice does Merck really have except to make the most of its brands?)

There is some good news. Obama's health care reform agenda includes initiatives to expand insurance coverage to recent college graduates, an objective one Obama advisor described at a recent health policy forum sponsored by the National Journal as critical "now that we have things that are critical for young people, like HPV vaccines."

The question is: will that talking point be retired now that Gardasil may be just another short-hand for the problems of Big Pharma?

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