Medical Editor Rips Into FDA
Reuters
11:54 a.m. May 17, 2001 PDT http://www.wired.com/news/medtech/0,1286,43891,00.html
LONDON -- The editor of a top medical journal on Friday accused the U.S.
Food and Drug Administration, the world's most powerful drug watchdog, of
endangering people's lives.

Richard Horton of The Lancet said the FDA, which safeguards the health of
274 million people and regulates over $1 trillion worth of products, was
compromised by funding from the drugs industry and pressure from Congress.

In an editorial, he slammed the FDA for its handling of GlaxoSmithKline
Plc's controversial bowel drug Lotronex.

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 journal.

According to Horton, serious side effects were evident during the
pre-approval process and shortly afterwards but the FDA kept the product on
the market. "The decision was to prove fatal," said Horton.

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.

"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.

A spokesman at the FDA said he could not comment on the editorial but added
that the agency was formulating a response to the allegations.

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
refused to discuss the timing of any decision.

"We are in discussions with the FDA over Lotronex," spokesman Martin Sutton
said. "Both the FDA and ourselves are trying to find a resolution that will
benefit and protect patients."

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 ischaemic 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 added.

Copyright 2001 Reuters Limited.