Friday, February 25, 2005

FDA Votes Vioxx Back on the Market


This blogger is curious about the FDA's recent decision to allow the arthritis pain killer Vioxx back on the market despite evidence that the drug has been linked to as many as 100,000 heart attacks and strokes.

You may remember that pharmaceutical giant Merck voluntarily pulled Vioxx from the market back in September 2004 following a study in the British medical journal
The Lancet, authored by Dr. David Graham, that linked Vioxx to between 88,000 and 140,000 excess cardiovascular incidents. By the time the drug had been withdrawn, over 80 million people had taken the pain killer worldwide, grossing Merck some $2.3 billion per year in sales.

The story took a twisted turn when e-mails surfaced from Merck, some dating back to 2000, indicating that the company knew about the dangers of Vioxx but chose to cover them up. The drug giant apparently launched what they called a "dodge ball" strategy when touting the popular pain killer, providing its sales staff with instructions on how to artfully dodge the increasing number of questions about the drug's safety. One report indicates Merck knew Vioxx was dangerous as long ago as 1996.

The Vioxx scandal once again rasises questions about the FDA. Is the government watchdog agency protecting physicians and patients, or are they in the pockets of the drug companies?

This week, at the request of the New York Times, a study of the affiliations of the FDA experts who voted on Vioxx was conducted by the Center for Science in the Public Interest. This study found that 10 of the 18 experts who elected to keep Vioxx on the market had connections to Merck and other pharmaceutical companies that make the COX-2 inhibitors like Vioxx. The final tally was 18 to 14 to put this deadly drug back on the pharmacy shelf.

A report from CBS says that if these 10 FDA experts had abstained from voting, then the FDA panel would have decided 14 to 8 to keep Vioxx off the market. The FDA has responded to these stories saying they properly screened all members and found no significant conflicts.

Whatever the merits of the FDA's exercise in self-screening, this blogger believes that in the case of Vioxx, a drug that was withdrawn from the market because of its link to thousands of deaths, no members of the FDA panel with any connections to the companies that make these drugs should have been voting. Period.

Even if these 10 FDA experts were not influenced in any way by their affiliations to the drug companies, the appearance of impropriety should have prompted any decent men on the FDA panel to recuse themselves from the proceedings and abstain from voting on Vioxx.

What can curious bloggers do?

With a click of the mouse on the form letter links below, you can send a handful of earnest Senators this blog with a note demanding to know how all this happened. These men work for you. When enough people contact them, they have to start investigations. E-mails do work.

Senator Edward Kennedy (D-Mass), Senate Health Committee

Senator John McCain (R-Arizona), Senate Commerce Committee

Senator Charles Grassley (R-Iowa), Senate Finance Committee
This fellow has started asking the FDA questions about Vioxx. He needs your support.

If you can't spare the minute to compose an original letter, then copy and paste this link to direct these men to this blog: http://www.TheCuriousBlogger.blogspot.com/

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5:23 PM  

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