Avorn J. Dangerous deception — Hiding the evidence of adverse drug effects. N Engl J Med 2006; 355(21):2169-2171.
Excerpt: September 30 is becoming a day of infamy for drug safety. On that date in 2004, Merck announced that rofecoxib (Vioxx) doubled the risk of myocardial infarction and stroke, and the company withdrew the drug from the market after 5 years of use in more than 20 million patients. On September 30, 2006, a front-page article in the New York Times reported that the Food and Drug Administration (FDA) had issued a warning that the antifibrinolytic drug aprotinin, widely used to reduce perioperative bleeding in patients undergoing cardiac surgery, could cause renal failure, congestive heart failure, stroke, and death. Free Full Text Interview with Jerry Avorn
Hiatt WR. Observational studies of drug safety — Aprotinin and the absence of transparency. N Engl J Med 2006; 355(21):2171-2173.
Excerpt: The full safety profile of a new drug is rarely known at the time of approval by the Food and Drug Administration (FDA). Most drug-development programs designed for treatments of symptomatic indications are underpowered to detect any increased risk of rare drug reactions or change in background event rates attributable to the drug. Large, post-marketing, randomized, controlled trials provide robust data on drug safety but may be subject to multiple sources of bias. Observational studies of a drug’s effects in clinical practice can offer additional information on risks. The recent discussions of aprotinin (Trasylol, Bayer) by the Cardiovascular and Renal Drugs Advisory Committee of the FDA, which I chair, provide insight into the strengths and weaknesses of using observational data to assess drug safety and highlight the importance of using a transparent and open process when reviewing such data. Free Full Text
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