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“Agency says U.S. researcher was consultant to Crestor maker” Newsday - July 10, 2004 BY DELTHIA RICKS One week after cholesterol-reducing Crestor was approved last year, a top government researcher published a scientific paper praising the medication, but failed to mention he was a consultant to the drug's maker, a watchdog group has charged in a letter to the nation's top health agency. Dr. Sidney Wolfe, director of Public Citizen's Health Research Group in Washington, D.C., said not only was Dr. H. Bryan Brewer a consultant to AstraZeneca, he led a company-financed symposium during a meeting of the American Heart Association about eight months before the drug's approval. The paper and symposium focused on the drug's benefits, but not its side effects, said Wolfe, who added that favorable drug reports by high-ranking government researchers can sway prescribing habits of physicians. Wolfe's letter was delivered this week to Dr. Elias Zerhouni, director of the National Institutes of Health. "NIH has received the letter and is reviewing it," spokesman Don Ralbovsky said. Brewer, chief of the molecular disease division of the National Heart, Lung and Blood Institute -- one of the 19 institutes at the NIH -- was not accepting telephone calls. A spokeswoman for the division said because the letter was addressed to the NIH director, calls were being directed to his office. Friday an AstraZeneca spokeswoman confirmed that Brewer is a paid consultant. Wolfe charged that Brewer "delivered the goods for AstraZeneca in his article because he clearly omits very important information. This fortuitously comes out eight days after the FDA approved the drug and three weeks before it appears in drug stores. So the timing could not have been better," Wolfe said. Crestor was approved last August. The report appeared in a supplement to the American Journal of Cardiology. Publication of the supplement was paid by AstraZeneca, Wolfe said. Crestor is a member of the popular statin family of drugs that reduce cholesterol by limiting the amount of the compound produced by the liver. AstraZeneca spokesman Gary Bruell said Crestor is as safe as similar drugs and added that Wolfe is crusading to discredit the medication. Six statins are on the market and are taken by about 36 million people in the United States. Statins earn drug companies an estimated $20 billion a year. Wolfe said neither Brewer's paper nor the symposium over which he presided emphasized a serious muscle deterioration problem -- rhabdomyolysis -- that occurred at an 80-milligram dose. Problems at that dosage were detected during clinical trials. Although that dose was never approved, Wolfe said identical muscle wasting and kidney failure have been detected at 10 to 40 milligram doses. "Sidney Wolfe keeps talking about a dose of the drug that doesn't even exist," Bruell said. "It's alarming that this is being communicated to health care providers and patients." Wolfe's allegations come as the NIH and the FDA are investigating government researchers who have lucrative side jobs as consultants for pharmaceutical, biotechnology and medical device companies. The agencies began a joint probe in May of government scientists on payrolls of many influential companies. Two weeks ago, Canadian drug regulators tightened guidelines on how Crestor should be prescribed following reports of muscle deterioration in that country. European drug regulators also have changed their label on Crestor, citing muscle deterioration in some patients. SOURCE: |
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