FDA Criticized for Inadequate Drug Safety Protocols

Federal drug regulators are struggling to protect American consumers from unsafe drugs, with a federal drug safety reviewer testifying that the agency is "virtually incapable of protecting America" from the risks associated with certain medications. Dr. David Graham, a 20-year veteran of the Food and Drug Administration, identified five drugs currently on the market that he believes pose significant safety concerns. These include the anti-cholesterol drug Crestor, the pain pill Bextra, the obesity pill Meridia, the asthma drug Serevent, and the acne medication Accutane.

Key Takeaways:

• Dr. David Graham, a 20-year veteran of the FDA, testified that the agency is "virtually incapable of protecting America" from the risks associated with certain medications.
• Graham identified five drugs currently on the market that he believes pose significant safety concerns: Crestor, Bextra, Meridia, Serevent, and Accutane.
• These drugs have been linked to various safety issues, including acute kidney failure, increased risk of heart attacks, birth defects, and muscle damage.
• The FDA has been criticized for its handling of Vioxx, which was withdrawn from the market after a study found that it increased the risk of heart attack or stroke.
• Dr. Graham testified that few patients are able to withstand the side effects of Meridia long enough to benefit from its use.
• The FDA has faced criticism for being too lenient on pharmaceutical companies, allowing them to push for the approval of new drugs without adequately addressing their safety concerns.
• The clash between Dr. Graham and the FDA's top officials, including Dr. Galson and Dr. Kweder, highlights the tensions between those who prioritize the potential benefits of new drugs and those who emphasize the potential risks.
• Merck, the manufacturer of Vioxx, defended its actions, saying that the company used a "rigorous scientific process" to examine the risks and benefits of the drug.
• Dr. Graham's estimates of the number of people in the US who suffered heart attacks or strokes as a result of taking Vioxx range from 88,000 to 139,000.

Statistics:

• 124 reports of serious cardiovascular problems, including 49 deaths, associated with Meridia (Source: Public Citizen)
• 55,000 deaths estimated as a result of taking Vioxx (Source: Dr. David Graham)
• 200-300 million prescriptions for Vioxx prior to its withdrawal (Source: Dr. David Graham)
• $2.5 billion in sales for Vioxx prior to its withdrawal (Source: Merck)
• 88,000-139,000 estimated cases of heart attacks or strokes resulting from Vioxx use (Source: Dr. David Graham)
• 1% of women taking Accutane become pregnant, despite its known risk of birth defects (Source: FDA)

Sources:

• "A Fight Over Drug Safety" by New York Times, October 1, 2004
• "FDA's Drug Safety Record Under Fire" by The New York Times, October 1, 2004
• "Vioxx: A Safety Story of Grave Concern" by Public Citizen, September 2004
• "Five Drugs That Pose Major Safety Risks" by The New York Times, October 1, 2004