‘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.’

- RICHARD HORTON

The Lancet RICHARD HORTON of The Lancet accused the world’s most powerful drug watchdog, which regulates products worth over $1 trillion, of endangering the lives of people in its handling of GlaxoSmithKline Plc’s controversial bowel drug Lotronex and 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.

Senior FDA officials are now trying to reintroduce it, Horton said. "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," he wrote in an editorial in the British journal. Horton cited a 1998 survey by Public Citizen that found that since 1992, when legislation enabled the FDA to utilize $329 million of drug industry funding to hire almost 700 more medical officers to review new products, standards for drug approval have declined.

According to Horton, serious side effects from Lotronex were evident during the pre-approval process and shortly afterward, but the FDA kept the product on the market.

"The decision was to prove fatal," Horton said. In response to Horton’s accusations, the FDA told Reuters that it had been holding discussions with GlaxoSmithKline about 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 Office of Drug Evaluation III which oversees the department that reviewed Lotronex.

"MISREPRESENTATION" OF FDA 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. An independent review of research found serious flaws, but calls for more studies were ignored.

Advertisement "That is where there has been a terrible failure in evaluating the safety of this drug," Horton told Reuters.

"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," he added. The agency 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. "Both the FDA and ourselves are trying to find a resolution that will benefit and protect patients."

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Lotronex was developed to treat irritable bowel syndrome which can cause disabling bouts of constipation, diarrhea, abdominal pain and bloating. But soon after its launch, reports of side effects such as severe constipation and ischemic colitis, a restriction of blood flow to the colon, began to surface. "It is an impossible conflict for safety issues to be overseen by a center that receives funding from industry to review and approve new drugs," Horton said.

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