Merck did not want Vioxx label changes

So finally FDA is starting to take some responsibility for 140,000 injuries (as many as 55,000 Americans dead) in the United States due to its failure to point out the risks of Vioxx to doctors and patients. In a presentation before a Senate committee, FDA officials admitted that they found it extremely difficult to work with Merck, the maker of Vioxx, when they wanted to make changes in the label. (Related article: Merck does not cooperate with Health Canada either)

As has been disclosed before, Merck did everything possible to hide the adverse side effects of Vioxx for years, and as far as changes in the label is concerned, in negotiations with the FDA, it simply dragged the process so that Vioxx could be on the market as long as possible. (Related article: Why Merck did not recall Vioxx earlier?)

It is very unfortunate that Merck and FDA did not consider informing patients and doctors a priority and continued to go back and forth on label language. All this while, Americans continued to die or suffered from heart attacks, strokes, and other serious side effects. The question that needs to be asked is if Merck was not cooperating with the FDA, why did the FDA not do something about it early on? Why did it wait for disaster to happen? Why did FDA not approach the lawmakers for the powers that it needed? Why did it not issue an advisory? Was it because FDA has been hijacked by the drug industry? Or because pharma industry lobbyists control what the FDA does? Or FDA simply too busy helping drug companies by making sure that Americans could not import prescription drugs from Canada?

These disclosures by the FDA can be a major problem for Merck which is now facing as many as 800 lawsuits from Vioxx victims. Merck was very combative in its approach at the FDA panel hearings in February. Dr. Peter S. Kim, who represented Merck at the hearings, said, "We made the decision to voluntarily withdraw VIOXX from the market in September (2004) based on the clinical data available at that time." (Related article: Merck wants to sell Vioxx again)

Many investigations by newspapers have shown that in reality Merck may have known Vioxx risks for years. Casey Stavropoulos, a Merck spokeswoman, is quoted in the New York Times as saying, "We worked diligently with F.D.A. to do all requested analyses and develop labeling that provided physicians with the most accurate and appropriate information." A similar statement was made by Merck Frosst (Canada) which is also being accused by the Canadian Health Minister of not cooperating with the authorities there.

FDA is asking Congress to give it more authority and Sandra Kweder, deputy director of the FDA's Office of New Drugs said that "A strong ability to require changes in labeling would be helpful." This is a very contentious issue and may face strong opposition from drugmakers and conservative think tanks that do not want FDA to have more powers to make drugs safer for Americans.

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