7/23/2000 – FDA officer advised diet-drug clinic about Fen-Phen

In case any of you missed this last fall when it broke in the Philadelphia
Inquirer and the Wall Street Journal, here it is again so you have it for
reference.

Notice that this FDA official is also the doctor who is credited with
starting the Fen-Phen craze with a medical study he published suggesting the
use of this deadly combination of drugs.

Ann Blake-Tracy

http://www.FreeRepublic.com/forum/a37f02e3073c5.htm

FreeRepublic.com “A Conservative News Forum”

Crime/Corruption

News Source: AP
Published: 9/27/99 Author: AP
Posted on 09/27/1999 19:55:44 PDT by Joe Montana

CROOKED FDA WORKS HAND IN HAND WITH DRUG COMPANIES THEY ARE SUPPOSED TO
“REGULATE”–

Ex-FDA officer advised diet-drug clinic about fen-phen

9/27/99

PHILADELPHIA (AP) – A high-ranking U.S. Food and Drug Administration official
helped a small businessman in Florida promote the popular diet drug fen-phen
in 1995, during the height of the pill combination’s popularity, newspapers
reported.

Though the FDA never approved or endorsed fen-phen, which has since been
linked with heart-valve problems, Dr. Michael Weintraub provided advice and
patient referrals to a fledgling chain of weight-loss clinics dispensing
fen-phen, The Philadelphia Inquirer reported Sunday and The Wall Street
Journal reported Monday.

Weintraub suggested a list of doctors who might endorse the diet drug
combination, talked to at least three potential clients and allowed his name
to be used in advertising, said Tampa, Fla., attorney John Trevena, who
founded Advantage Weight Control in 1994. Weintraub denies allowing his name
used in advertising.

Weintraub, who left the FDA in 1998 after five years and is now a
pharmaceutical consultant, has not been investigated by the FDA for
wrongdoing. Weintraub said his activities were similar to assistance he
offered to other people who sought advice about fen-phen.

“I couldn’t reject talking to people who called me up,” Weintraub told the
Inquirer. “I believed that the drugs could help people.”

Weintraub is largely credited for launching the fen-phen fad with a 1992
medical study that suggested combining fenfluramine, sold under the brand
names Pondimin and Redux, and phentermine in an “off-label” combination
use. Each drug was FDA approved, but the cocktail was not.

American Home Products Corp. marketed Pondimin and Redux until September
1997, when the FDA pushed for their withdrawal after a study linked the drugs
to potentially fatal heart valve damage. [And after an August 1997 National
Institute of Health study linked the drugs to brain damage.] American Home
Products now faces thousands of lawsuits from patients who claim to be hurt
by them and is negotiating a settlement estimated at $4 billion.

Weintraub joined the FDA in 1993, and eventually became director of
over-the-counter-drug evaluation. Weintraub agreed to advise Trevena
beginning in 1995, though he refused to be paid, citing government ethics
policies.

In the months that followed, Trevena recommended names of prominent obesity
experts who might serve as the center’s medical director. He testified before
the state medical board urging it not to ban fen-phen – though he explained
his remarks were not on behalf of the FDA – and praised Trevena’s centers to
the Florida news media.

Weintraub also personally advised at least three prospective Trevena clients
who were considering joining the program, Trevena said. After speaking with
Weintraub, all three signed up.

In one case, a client asked Weintraub for a referral to a weight-loss
physician in her area. Weintraub’s reply, written on FDA letterhead dated
February 1995, gave her the name of Trevena’s marketing consultant – not a
physician.

“He enthusiastically assisted us,” Trevena told the Journal.

He said his business, which has since filed for bankruptcy, relied heavily
on Weintraub’s advice on such matters as how to monitor patients. Its
publicity materials said the center used the “Weintraub Protocol.”

Weintraub said he did suggest a name or two as possible medical directors and
referred at least one patient to Trevena. He said that to anyone who asked
about fen-phen he explained the possible side effects, “potential and
real,” and stressed the need for a full physical exam and medical
monitoring.

In one of their three conversations, Trevena said he asked Weintraub whether
his advice and help with the weight-loss clinic were ethical.

“Dr. Weintraub indicated that because of his high-level position and
contacts within the FDA, he wasn’t concerned about it,” Trevena said. “He
said it wasn’t a problem.”

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4/14/2000 – FDA Doc Claims Fen-Phen Cover-Up

More “hanky-panky” in the pharmaceutical industry. Did you see
this article posted this week on the CBS news site? There is a
link on our site to the class-action lawsuit suit if you or someone
you know has been effected by fen-phen. Mark

http://cbsnews.cbs.com/now/story/0,1597,181616-412,00.shtml

FDA Doc Claims Fen-Phen Cover-Up

* Says Drug Maker Altered His Findings
* Diet Drug Linked To Heart, Lung Maladies
* Company Agreed To $4.8 Billion Settlement Last Year

WASHINGTON
CBS
Fen-phen

(CBS) The drug company that manufactured “fen-phen,” a diet
medication linked to heart ailments, covered up problems with
the drug that emerged during Food and Drug Administration
testing, a former FDA scientist tells CBS News.

Fen-phen was removed from the market in 1997. Thousands of
people who took the drug have sued American Home Products
of Madison, N.J., for health problems they claim the drug caused.

In an Eye on America investigation, CBS News Correspondent
Sharyl Attkisson reports the FDA’s key reviewer of fen-phen, Dr.
Leo Lutwak, claims the company knew about the problems long
before the drug was pulled.

“I felt from the very beginning the drug companies were covering
up. I felt from the very beginning that these drugs were
dangerous,” said Lutwak.

He claims American Home Products twisted the meaning of his
research to make it seem as if there was no way to predict
fen-phen’s hazards.

“What I had actually written was, that in view of the covering up of
information by the drug company, the FDA had no way of
predicting some of these side effects,” he said.

One of those who sued American Home Products was Patricia
Buol, who developed severe heart problems after taking
fen-phen. She’s now in line for a life saving heart-lung transplant.

The company settled with Buol this week.

“Being part of my kids’ lives and doing their everyday activities is
a struggle,” said Buol. “But I just take one day at a time and do
the best I can.”

Dr. Lutwak’s testimony is crucial to fen-phen cases like Buol’s.
But the FDA won’t let him testify. Now Lutwak says he’s planning
to retire, making him free to testify at will.

“I followed the rules and regulations, I didn’t go public. I tried to
work within the system, it didn’t work. People died as a result of a
dangerous deadly drug being released,” he said.

Defendant American Home Products would not be interviewed,
but has said in the past it “acted responsibly and lawfully.”

FDA Commissioner Jane Henney refused a CBS News request
to answer the allegations.

The agency’s last commissioner, Dr. David Kessler, criticized the
agency’s current approach to drug regulation.

“I have some concerns that we may be losing sight of what the
FDA is all about,” said Kessler. “The question is, who’s the
agency’s customers? Who’s the agency partner?”

Consumer advocates say the FDA is constantly keeping
damaging information from the public.

“They view the drug industry in many ways as their customers, at
least the bosses do, as opposed to viewing the public as the
customers they need to protect from some of the excesses of the
drug industry,” said Sidney Wolfe of Public Citizen.

Concerns about the FDA also emerged during the controversy
over the diabetes drug Rezulin.

Kessler said the agency needs to realize the American
consumer is its customer.

American Home Products also makes such drugs as
Caordarone, Sectral, Protonix, Synvisc and Pnu-Imune.

Fen-phen is actually a combination of two drugs, fenfluramine
and phentermine, which work by suppressing the appetite of a
person who is trying to lose weight.

It was estimated that in 1996, 18 million Americans took the
drugs.

FDA: Under The Micriscope
Click here to read CBS News Correspondent Sharyl Attkisson’s
reports on the FDA and the diabetes drug RezulinBut a report in
the August 1997 New England Journal of Medicine found that
fenfluramine can in some cases lead to pulmonary
hypertension, a rare, almost always fatal, disease. It was also
linked to heart valve malfunction.

In September, 1997, the FDA, saying it was “acting on new
evidence about significant side-effects,” asked the
manufacturers to voluntarily withdraw both medications,
marketed under the names Pondimin (fen-phen), and Redux, a
similar medication.

Wyeth-Ayerst Laboratories, a subsidiary of American Home
Products, complied.

However, the company continued to deny the drugs caused the
alleged problems. In November, 1998, Wyeth-Ayerst published a
study that compared heart function in people who had taken
fen-phen and a group who hadn’t, and concluded there was “no
significant differences in cardiovascular clinical outcomes.”

But that didn’t stop the fen-phen fallout.

A February, 1999 60 Minutes II investigation with U.S. News &
World Report revealed that Wyeth-Ayerst knew more than it told
about the pulmonary hypertension risks, a charge the company
denied.

In September 1999, the Wall Street Journal reported that the FBI
was investigating the FDA’s approval of Redux.

A month later, American Home Products agreed to pay up to
$4.83 billion to settle the more than 11,000 fen-phen lawsuits,
one of the biggest product liability settlements ever.

As part of the settlement agreement, the company admitted no
wrongdoing.

Copyright 2000, CBS Worldwide Inc., All Rights Reserved.

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