FDA Gifts Merck’s Garasil With Broader Market Access

FDA advisory panel recommends approval of Gardasil to prevent genital warts in young men

Bonus Lobbying Victory: European regulators give Gardasil nod for use in women up to the age of 45

Last week was good to Merck’s hopes for an improved bottom line next quarter. It was a very a disappointing week for those of us who feel the HPV vaccine has the potential to do more harm than good, and continues to preempt scarce public health funds better used for more effective programs, like universal access to PAP Tests.

Merck’s FDA and European Gardasil market-expansion victory was some what muted by its potential competitor, GSK’s Cervarix own good news as it inches  closer to FDA approval. Merck has used all of its Federal regulatory lobbying influence to delay FDA approval of Cervarix for the American market.

Merck actively sought new indications for Gardasil to help combat falling sales of their human papillomavirus shot

Merck’s Garasil vaccine, promoted to prevent cervical cancer and genital warts, roared onto the market in 2006, but since then has decelerated sharply. Merck has been lobbying to increase its potential market to boys and mature women. It failed to persuade FDA to broaden use to older women–up to the age of 45–but now has convinced an agency advisory committee that Gardasil would be useful for boys and young men.

A few panelists–and at least one analyst–point out that approval for use in males doesn’t necessarily mean males will use it. The series of three shots is expensive, around $400, and will require three visits to the doctor over a six-month period…to prevent a nonfatal venereal disease. “Pretty much no healthy teen would ever do that,” Tim Anderson, analyst with Sanford C. Bernstein, told the New York Times.  (Good point Tim. The more cynical amongst those of us, who have fought use of Garasil  since the beginning, are wondering if, even now, the Merck marketing team is not trying to whip up false scare tactics that will herd fathers into take their sons in to doctor’s offices in massive numbers — after all, those catchy, cute commercials worked to move hundreds of thousands of well meaning mothers to contribute to those fat bonuses Merck Execs passed out in 2006 and 2007.)

Merck is expected to argue for vaccination of boys and young men in part to help protect girls and young women. But it remains to be seen whether that “herd immunity” argument will work on parents and insurers who have to pay for the shot.

The European approval, meanwhile, addresses cervical cancer, which is potentially fatal. [Sandi note: Merck’s phasing, not mine. Cervical cancer is potentially, but rarely fatal if women have regular PAP tests after they become sexually active.] In Europe, the vaccine is marketed by Sanofi Pasteur MSD, a joint venture between Merck and Sanofi-Aventis. European regulators gave the nod to expand use of Gardasil to women up to age 45, when previously it was only indicated for those up to age 26.

This new expansion gambit is a complete mystery. In 2006 the rational used by Merck lobbyists for vaccinating school-girls as young as age 10 was that the HPV-vaccine Gardasil was not effective once the girls were exposed to HPV via sexual activity. Hundreds of thousand of girls have been herded into doctor’s offices by mothers and State regulators on the promise of lifetime protection from cervical cancer.  As more non-marketing information became available, questions that should have been asked and answered BEFORE approval began to be discussed. Dr. Diane Harper, one of the designers of the early trials, questioned the long-term effectiveness of the vaccine and raised the possibility of booster shots needed just at the age when young women became sexually active.  Based on Merck rational for expanding Gardasil usage for women up to their mid-forties, why do we continue to put young girls at risk with a vaccine with a history of adverse effects and has been tied to the deaths of young healthy girls.

In the U.S., the FDA has asked Merck for more data on Gardasil use in women 27 to 45 years old; the company expects to provide that info by the end of this year. Mother’s need to watch this like hawks. Read the FDA rational and the Merck aguments for expansion.  The money spent enriching Merck executives is far better used expanding access to PAP tests.

Sources:

Read Full NYT story: Two Giants Vie for Billions in S.T.D. Vaccine Market:

Read Full Story from CNNHealth.com: FDA panel urges HPV vaccine be given to boys

Read Wall Street Journal article: FDA Panel Backs Cancer Vaccines

PG

Author: H. Sandra Chevalier-Batik

I started the Inconvenient Woman Blog in 2007, and am the product of a long line of inconvenient women. The matriarchal line is French-Canadian, Roman Catholic, with a very feisty Irish great-grandmother thrown in for sheer bloody mindedness. I am a research analyst and author who has made her living studying technical data, and developing articles, training materials, books and web content. Tracking through statistical data, and oblique cross-references to find the relevant connections that identifies a problem, or explains a path of action, is my passion. I love clearly delineating the magic questions of knowledge: Who, What, Why, When, Where and for How Much, Paid to Whom. My life lessons: listen carefully, question with boldness, and personally verify the answers. I look at America through the appreciative eyes of an immigrant, and an amateur historian; the popular and political culture is a ceaseless fascination. I have no impressive initials after my name. I’m merely an observer and a chronicler, an inconvenient woman who asks questions, and sometimes encourages others to look at things differently.