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medpundit |
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Sunday, October 03, 2004The FDA could take a simple step that would improve clinical trial quality before it approved drugs, observers say. Drug companies with products comparable to Vioxx could be required to conduct longer clinical trials. "If you're the FDA, you'll say `OK, all bets are off. We're going to make you do studies lasting 18 months,'" said Dr. Sidney Wolfe, director of Public Citizen. At the time of approval, the FDA had data from clinical trials on Vioxx that lasted for 12 months. The increased risk of heart attack and stroke that prompted Merck to pull Vioxx did not begin to appear until older patients had taken took the drug for 18 months. It's a valid criticism that drugs that are used long-term (like birth control or arthritis medication) should be tested longer than six or twelve months. But then, what about drugs whose long-term side effects only manifest themselves after two or three or five years, or even longer? No time frame is going to be perfect. And no drug is going to have zero side effects. Every doctor and every patient has to ask themselves if the potential risk is really worth the benefit. posted by Sydney on 10/03/2004 08:35:00 AM 0 comments 0 Comments: |
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