Journal editor overstated safety of asthma drug, FDA says

Article Abstract:

'The New England Journal of Medicine' editor Jeffrey Drazen made misleading statements over the value of the asthma drug levalbuterol, made by Sepracor Inc, which employed him as a consultant, according to the FDA. In a 'notice of violation' issued in Mar 1999 against Sepracor, the FDA said Drazen overstated the safety and effectiveness of levalbuterol in comments made in a drug company news release. Drazen has contradicted the FDA's accusation, saying he made his evaluation based on the facts made available to him by Sepracor.

Product quality

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Claims of 'first real advance' cited by FDA

Article Abstract:

The FDA ordered Sepracor Inc to withdraw its press release issued on Mar 26, 1999, concerning regulatory approval for the new asthma drug levalbuterol for making exaggerated claims. The FDA said two remarks made by Jeffrey Drazen, editor-in-chief of 'The New England Journal of Medicine' were cited as violations of federal drug law and regulation. The remarks were unsubstantiated and misleading while overstating the efficacy and safety of levalbuterol, which is being sold as Xopenex.

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FDA advisers tied to industry

Article Abstract:

A study shows that more than 50% of the experts hired to serve on an FDA advisory committee that evaluates the safety and effectiveness of a drug have financial relationships with pharmaaceutical companies that will be affected by their decisions. The financial conflicts usually include consulting fees, stock ownership and research grants. The study is based on 159 FDA advisory committee meetings from Jan 1, 1998 through Jun 30, 2000.

Pharmaceutical and Medicine Manufacturing, Drugs & Pharmaceuticals

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