Doctors lose trust in FDA after Vioxx recall mess

While a FDA panel recently recommended that Vioxx sales be allowed to resume in the United States, and Celebrex and Bextra be allowed to stay on the market, despite serious concerns about their safety, it is not just the American people or consumer rights groups or Senator Charles Grassley that are concerned about FDA being in bed with the pharmaceutical industry. Even doctors and scientists are now seriously concerned that they may be putting their patients at risk because the FDA is not disclosing all that it knows. (Related article: Americans run away from Vioxx, Celebrex, and Bextra after safety in doubt)

Dr. Susan Okie in an article in the New England Journal of Medicine entitled "What ails the FDA?" has expressed her frustration with the way the FDA works. As anyone would expect, she discusses the story of renowned epidemiologist at the FDA, Dr. David Graham, who was pressured to change his findings about Vioxx because his superiors at the FDA did not want to make Merck unhappy. It is estimated that as many as 140,000 Americans have been injured after taking Vioxx and as many as 50,000 may have died. (Related article: FDA tries to protect Merck and Pfizer)

Dr. Jeffrey M. Drazen, in an accompanying editorial in the Journal entitled "COX-2 Inhibitors — A Lesson in Unexpected Problems," discusses that the enthusiasm that the drugmakers demonstrated for "clinical investigation to show their gastrointestinal safety was not evidenced by studies designed to show their cardiovascular safety." It is now known that most injuries from Vioxx were as a result of side effects on the heart.

Two other doctors that have been engaged in the discussion on safety of Cox-2 drugs, Bruce M. Psaty and Curt D. Furberg, have written another editorial "COX-2 Inhibitors — Lessons in Drug Safety" highlighting the importance of an integrated approach to drug safety once a study shows disturbing results. (Related article: Is Mobic a safe alternative to Vioxx, Celebrex, and Bextra?)

The FDA has become "very pro-business, anti-regulatory" and "there's been a tendency to manage all of these agencies from the top with a kind of pro-business stance," according to Dr. Okie. Since President Bush came to power, the FDA has not had proper leadership and most of the energy of the FDA was directed towards helping the drug companies, including their efforts to make it impossible for American people to import prescription drugs from Canada.

Things are not changing though in any way at the FDA despite the recent controversy. There is no push from the White House which is too absorbed with pushing Social Security privatization. And the FDA continues to do its part in helping the drug industry even if it comes at the expense of American lives. In recent weeks, FDA has refused to recall Adderall (that was recalled in Canada). While criticizing the misleading ads about Crestor, FDA refused to recall Crestor as well.

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Source: NEJM