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Previous Volume 355:2261-2262 November 23, 2006 Number 21 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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To the Editor: I was troubled by the recent, near-unanimous decision of the Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee publicly advocating the safety of aprotinin¹ — despite considerable evidence to the contrary,^2,3,4 including our recent study² and the FDA's own initial 1993 warning regarding "kidney toxicity."⁵ We learned after the Advisory Committee's meeting of newly disclosed records of 67,000 patients, yielding data that were consistent with our warnings (renal failure, stroke, and heart failure)² and that were inconsistent with the positions of the committee and Bayer.^1,6

In defending the committee's decision, Dr. Hiatt makes allegations . . . [Full Text of this Article]

This article has been cited by other articles:

• Drazen, J. M. (2006). Research replication.. NEJM 355: 2252-2253 [Full Text]