Dispute highlights pitfalls in drug review process

Aprotinin's safety profile remains in question in absence of full data disclosure

Karen Pallarito
Nov 29, 2006
Two months have lapsed since the FDA warned that the antifibrinolytic drug aprotinin (Trasylol) could cause renal failure, congestive heart failure, stroke and death. Yet significant questions about the drug's safety profile continue to swirl, stoked in part by one researcher's alleged failure to provide full access to his data and looming questions about Bayer HealthCare's admitted blunder in not immediately sharing data from a retrospective study.The aprotinin flap plays out in a provocative collection of writings published in the Nov. 23 issue of the New England Journal of Medicine. Taken together, the two "Perspective" pieces, two letters to the editor and editorial highlight continuing difficulties in assuring that data from relevant drug studies are fully disclosed to the FDA and that methods used to obtain those findings are made transparent."This is yet another example of why there has to be full clinical trial registry and full releases of...

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