Vioxx critic may lose his job for criticizing FDA

One fails to understand why the FDA will be so eager to help Merck in the Vioxx recall case even if it means working against the interests of Vioxx victims in general, and Americans in particular. The evidence that is emerging indicates that Merck may have made several mistakes in how it got Vioxx approved, how aggressively it was marketed to consumers, and how it failed to recall it once data started to show that it was hurting arthritis patients.

One theory that is being circulated is that the Merck CEO and others in the pharmaceutical industry are very close to the Administration and have very close friends in powerful positions. Plus, Merck and others in the drug sector have contributed enormous sums of money to 2004 political campaigns. (Related article: Vioxx recall and Washington politicians)

For a while it has been known that the FDA has been harassing Dr. David Graham, an expert at the FDA, who had the courage to expose the inner workings of the agency and tell Congress that there are many other drugs like Vioxx on the market and that the FDA is not really capable of ensuring the health and safety of Americans. His bold approach has not made him many friends at the Agency and since then he has been fighting to keep his job.

Members of Congress have tried to come to his help, specifically Senator Grassley, and now Congressman Bart Stupak. In response to reports that the Food and Drug Administration (FDA) had asked Dr. Graham to leave his position and move elsewhere in the agency, Congressman Stupak and 21 other congressional members have demanded assurance the whistleblower will keep his job. The members also asked in the Dec. 10th letter to FDA Acting Commissioner Lester M. Crawford that he investigate the smear campaign conducted by some within the agency against Dr. David Graham.

According to reports, Crawford had asked Graham to leave his position within the Office of Drug Safety and move to another part of the agency soon before Graham testified before the Senate Finance Committee about FDA oversight on certain prescriptions drugs, such as Vioxx. Graham, a 20-year veteran at the FDA, was asked by members of the Committee, based on his expertise, if there were any other drugs that should be pulled from the market. Graham named five: the acne drug, Accutane; the weight loss drug, Meridia; the anti-cholesterol drug Crestor; the pain reliever Bextra; and the asthma drug, Serevent.

"Dr. Graham has been a dedicated public servant, working to ensure the safety of America's drug supply. If these reports are true, then this latest action is out of line, and very well may be illegal," the members wrote. "Dr. Graham was asked to testify before Congress at the request of the Committee Chair and was under obligation to answer questions posed by the Committee based on his expertise. The public’s interest is not served when he is asked to leave for doing his job."

The letter also stated that the treatment of Graham will have a chilling effect on FDA employees to speak up and disagree when they believe the public's health is at risk. In addition, Stupak and members said they were concerned by reports that some FDA managers launched a smear campaign to discredit Graham. The House members have asked Crawford what plans the FDA has to take disciplinary or other action against those individuals who may have attempted to discredit Graham.

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