Medical Journal Blasts FDA

May 21, 2001 — LONDON — A top medical journal in England is taking on the U.S. Food and Drug Administration, calling it a ‘servant of the industry.’

In a recent editorial in The Lancet, Editor Richard Horton accused the FDA of endangering the lives of 274 million Americans, saying the agency was compromised by funding from the pharmaceautical industry, according to a Reuters report.

Specifically, Horton cites the FDA’s handling of the bowel drug Lotronex, made b GlaxoSmithKline Plc. The product was approved by the FDA, but after five people patients who were taking the drug died the company withdrew it from the market after nine months.

“This story reveals not only dangerous failings in a single drug’s approval and review process but also the extent to which the FDA, its Center for Drug Evaluation and Research (CDER) in particular, has become a servant of the industry,” Horton wrote in the editorial.

Horton alleges that scientists who voiced concern about the drug’s safety were excluded from future discussions about the product.

“The FDA is not only compromised because it receives so much funding from industry, but because it comes under incredible Congressional pressure to be favourable to industry. That has led to deaths,” Horton wrote.

An FDA spokesperson declined comment on the editorial, according to Reuters.


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