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Subject: Medical Editor Rips Into FDADate: Fri, 29 Jun 2001 09:41:36 -0700
Dear Members and Friends -
Trusting the FDA can be VERY dangerous to your health...
Medical Editor Rips Into FDA Reuters
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 drug 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.
Sheri Nakken, R.N., MA Vaccination Information & Choice Network, Nevada City CA & UK 530-478-1242 Voicemail in US http://www.nccn.net/~wwithin/vaccine.htm "All that is necessary for the triumph of evil is that good men (& women) do nothing"...Edmund Burke