Conflicts of Interest in
Lancet editorial critical of FDA
29 May 2001
-------- Original Message --------
Subject: Lancet editorial on FDA (Newton)..
Date: Sun, 27 May 2001 10:12:15 -0500
From: Roy Beavers <email@example.com>
Organization: EMF-L List
I have not yet seen the Lancet editorial -- but let me add that they "missed the boat" if they didn't point out that the FDA pattern exists more or less the same THROUGHOUT THE U.S. GOVERNMENT.....!!! Particularly throughout AMERICA'S RICH $$$$$$$ HEALTH BUREAUCRACIES .......guru..... (Including the NIEHS, which is about to undertake the new $10 million dollar toxicology study on EMF health risks...... There is little reason to have high expectations about that.)
-------- Original Message --------
Subject: Lancet editorial on FDA
Date: Fri, 25 May 2001 09:44:05 -0700
From: JNewton at EMRNetwork <JNewton@emrnetwork.org>
Medical journal slams FDA as "servant of industry"
By Pat Reaney
LONDON (Reuters) - The U.S. Food and Drug Administration, guarding the health of 274 million Americans, is compromised by funding from the drugs industry and pressure from Congress, the editor of a top British medical journal said Friday.
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.
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.
"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."
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.
Janet Newton, Executive Officer
EMR Network, P.O. Box 221, Marshfield VT 05658
Tel: (802) 426-3035 FAX: (802) 426-3030
Web Site: www.EMRNetwork.org