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

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


FreeRepublic.com “A Conservative News Forum”


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


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


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

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

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

“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

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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