War hero's death in clinical trial follows years of FDA neglect

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Thu, 10 Nov 2005 20:35:19 -0500

[sSRI-Research] War hero's death in clinical trial follows

years of FDA neglect_Bloomberg News

 

 

 

 

War hero's death in clinical trial follows years of FDA

neglect_Bloomberg News

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

 

FYI

 

Bloomberg News reports that a decorated veteran of the Vietnam war was

killed in 2002, in a clinical drug trial at the FABRE Research Clinic

in Houston, Texas.

The FDA had found the Fabre Clinic in violation of federal research

protection regulations since 1980.

Despite serious safety violations, the FDA allowed Fabre to continue

operating:

Fabre " conducted more than 400 clinical trials involving 20,000 people

for at least 50 drug companies since 1973. "

 

Garry Polsgrove, the veteran who received two Purple Hearts, but wound

up homeless without income, volunteered as a human test subject in

Aprill 2002, for the cash.

 

He died 22 days after enrolling in a trial testing the antipsychotic

drug, Clozapine.

" The mistakes at the clinic included enrolling people who weren't

qualified to be in medical tests,

offering what it called free treatment when it was actually testing

unapproved drugs,

failing to follow drug company-ordered procedures for tests,

keeping illegible notes and not promptly reporting serious side effects. "

 

The FDA waited three years after his death to make any move against

the facility--thereby endangering other lives.

How many other such drug trial mills are operating with FDA full

knowledge of violations--

How many are operating in this country? How many are operating off-shore?

Did the FDA accept the tainted data from trials conducted at Fabre and

treat that data as " scientific evidence " of efficacy and safety ?

 

 

 

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

 

 

http://www.dailyherald.com/business/businessstory.asp?id=6664#

War hero's death at clinic follows years of FDA neglect

By David Evans

Bloomberg News

 

Posted Thursday, November 10, 2005 Garry Polsgrove received two Purple

Hearts for his service as a Marine in Vietnam. Three decades after

that war ended, Polsgrove, 55, was homeless and unemployed. In order

to have a bed and earn some money, he entered an experimental drug

test at the Fabre Research Clinic in Houston in April 2002, says his

sister, Nancy Gatlin.He was healthy when he signed on for the medical

trial, she says.

 

Polsgrove enrolled in a clinical trial for clozapine, a schizophrenia

medication being tested for Miami-based Ivax Corp., the largest U.S.

maker of generic drugs. A day after he took the first dose,

Polsgrove's heartbeat became irregular, according to a January 2005

letter to Fabre from the U.S. Food and Drug Administration.A few days

later, he developed diarrhea.

 

A clinician misdiagnosed his condition as a virus unrelated to the

test, the FDA wrote.

A week after that, Polsgrove developed low blood pressure that was

never explained, evaluated or treated, according to the FDA.

 

The next day, lab tests showed he had life threatening kidney

failure.Polsgrove died of myocarditis, or swelling of the heart, 22

days after he enrolled in the trial.

 

The FDA waited until January 2005 - nearly three years after his death

- before telling Louis Fabre, 64, the clinic's owner, that it would

move to shut down his testing center.

 

Fabre has conducted more than 400 clinical trials involving 20,000

people for at least 50 drug companies since 1973.

The FDA found human protection failures in six inspections since 1980.

The mistakes at the clinic included enrolling people who weren't

qualified to be in medical tests, offering what it called free

treatment when it was actually testing unapproved drugs, failing to

follow drug company-ordered procedures for tests, keeping illegible

notes and not promptly reporting serious side effects.

 

The institutional review board that was supposed to protect patients

from harm was the Human Investigation Committee in Houston.

 

That IRB received an FDA warning letter in 1992 saying it had

conflicts of interest: It was run by Fabre himself.

Members include his business partner, psychiatrist Stephen Kramer, and

his lawyer, Bruce Steffler.

The FDA said in a January 2005 letter that the consent form Fabre gave

Polsgrove " failed to describe clozapine's risk of fatal myocarditis, "

the disease that killed him.

 

It said Fabre used unlicensed employees to run the Ivax trial, failed

to supervise them and then falsified the circumstances of the death.

 

Fabre, who now runs a drug development company, declined to comment.

His lawyer wrote to the FDA that Fabre did nothing wrong.

 

Gatlin, 61, says the FDA should have barred Fabre from running

experimental tests years ago.

" People like this should be stopped, " says the retired postal clerk.

" They slapped his little hand and let him go on. " .

 

 

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