British Medical Journal Blasts FDA on Lotronex

The Food and Drug Administration, charged with guarding the health of all Americans, is compromised by funding from the drug industry and pressure from Congress, the editor of a top British medical journal said Friday.

Richard Horton of the journal The Lancet accused the world’s most powerful drug watchdog, which regulates a market worth more than $1 trillion, of endangering lives in its handling of GlaxoSmithKline’s controversial bowel drug, Lotronex, and of being a servant of the pharmaceutical industry.

The FDA approved Lotronex in February 2000, but the company voluntarily withdrew it from the market nine months later after the deaths of five patients who had been taking it.

“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 in particular--has become a servant of the industry,” Horton wrote in an editorial in the British journal.

The FDA said it had been holding discussions with GlaxoSmithKline concerning issues surrounding Lotronex.

“If Lotronex was to be introduced in any manner, FDA safety concerns would have to be adequately addressed,” said Victor Raczkowski, the deputy director of the Office of Drug Evaluation III, which oversees the department that reviewed Lotronex.

He said the editorial was a misrepresentation of the FDA and how it works, and he denied that the review process was secretive or that opinions had been suppressed.

“The FDA is a large scientific organization. We have many people who have worked in the review. We expect and encourage them to be frank about their scientific opinion,” Raczkowski said.

The Lancet said scientists within the FDA who raised concerns about the drug’s safety were sidelined and excluded from future discussions.

“The FDA is not only compromised because it receives so much funding from industry but because it comes under incredible congressional pressure to be favorable to industry. That has led to deaths,” Horton said in an interview.

The FDA monitors the safety, labeling, import, transport, storage and sale of food ingredients, drugs, cosmetics and surgical supplies.

GlaxoSmithKline confirmed the company was in discussions with the FDA, but it refused to discuss the timing of any decision.

“We are in discussions with the FDA over Lotronex,” a spokesman said.

Lotronex was developed to treat irritable bowel syndrome, which can cause disabling bouts of constipation, diarrhea, abdominal pain and bloating.