Fw: Esteemed Medical Editor of Lancet Rips Into FDA

[Guest guest]

Of course, the FDA was responsible for giving saline breast implants the

" all clear " for marketing in the USA last year, despite the horrific

problems associated with them.

Patty

From: " Ilena Rose " <ilena@...>

Sent: Friday, May 18, 2001 10:28 AM

Subject: Esteemed Medical Editor of Lancet Rips Into FDA

> EXCERPT:

> " 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.

>

>

> http://www.wired.com/news/print/0,1294,43891,00.html

>

> Medical Editor Rips Into FDA

>

> Reuters

>

> 11:54 a.m. May 17, 2001 PDT

>

> 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.

>

> 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

>

> In an editorial, he slammed the FDA for its handling of GlaxoKline

> 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.

>

> GlaxoKline 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

> 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.

>

>