The bitter pill

A drug with fatal side-effects may be reintroduced in the US

Published: Saturday 30 June 2001

the us Food and Drug Administration ( fda ) is planning to reintroduce Lotronex, a drug that was withdrawn from us markets in November 2000 because of its fatal side-effects. The drug is used to treat Irritable Bowel Syndrome ( ibs ), a debilitating disease characterised by excruciating pain in the abdomen.

The drug can damage the intestine by reducing the flow of blood to it. In some cases it can also lead to death. The disease affects nearly 15 per cent of the us population, most of whom are women. After reports of the drugs' adverse side-effects, the drug was withdrawn from the markets. Now, GlaxoSmithKline ( gsk ), the multinational pharmaceutical company that manufacturers Lotronex, is negotiating with fda to reintroduce the drug in the market.

This move has been severely criticised by Richard Horton, editor of The Lancet , a medical journal published from the uk . Horton has cited the us Prescription Drug User Fee Act as the cause of the problem in his editorial. "Since the implementation of the act, whereby, fda receives direct funding of us $329 million from pharmaceutical industry to hire almost 700 medical officers to review new products, the standards for drug approval have declined," writes Horton. "Senior fda officials pressurise many researchers to approve new drugs. They receive inappropriate calls from the sponsor about the drug under review and they opine that fda too often interferes on the company's behalf in the drug approval process," states Horton.

fda had earlier approved Lotronex after a seven-month review as part of a "fast track" approval process. Ignoring the scientists' warnings about the side-effects of the drug, fda officials had approved it. They also excluded the scientists from further discussions. fda had warned that the usage of the medicine must be discontinued when the patient experiences abdominal pain. As pain is a symptom of ibs too, the fda scientists felt that the patient or the doctor would not be able to ascertain the cause of the abdominal pain -- the drug or ibs . Horton said that fda is a "servant of the industry" and blames it for covert behaviour totally against the set procedure of drug approval. fda has not yet commented on the allegations. "We regard the editorial as misleading. There have been discussions between fda and gsk officials according to the usual regulatory and industry practices," says Martin Sutton, spokesperson of gsk

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