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

Thu, 10 Nov 2005

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

http://www.dailyherald.com/business/businessstory.asp?id=116664#

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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