FDA To Hold COX-2 Advisory Committee In Early 2005, Woodcock Says
FDA will hold an advisory committee in early 2005 to discuss the cardiovascular safety profile of COX-2 inhibitors, Acting Deputy Commissioner of Operations Janet Woodcock, MD, said.
“We plan a public advisory committee to discuss how to evaluate the cardiovascular safety issue sometime early next year,” Woodcock said at an American College of Rheumatology meeting Oct. 18 in San Antonio, Texas.
“Part of it will be what type of evaluation should be done pre-market and potentially post-market for these products,” she added.
Woodcock noted that the cardiovascular events occur so infrequently that even large scale trials (containing many thousands of patients) are not adequately powered to detect a significant difference between the two arms.
“The FDA is going to have to look at the size and safety database and the kind of safety database in the future for these agents,” Woodcock said. “However, we have trade-offs between getting products on the market and determining their adverse event profile” she said.
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Meine Meinung: Mir kommt diese Einstellung von Merck
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Merck believes that such trials cannot be conducted due to ethical concerns of giving patients placebo for their pain over a long-term period.
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plausibel vor. Hoffen wir, daß die FDA keine Verlängerung der üblichen Testzycklen verlangen wird, denn dieses würde finanziell alle forschenden Pharma-Firmen langfristig belasten.