Garry Polsgrove received two Purple Hearts as a Marine in Vietnam. Three decades after that war ended, Polsgrove, 55, was homeless and unemployed...
Garry Polsgrove received two Purple Hearts as a Marine in Vietnam. Three decades after that war ended, Polsgrove, 55, was homeless and unemployed. 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, she says. Polsgrove enrolled in a clinical trial for clozapine, a schizophrenia drug being tested for Ivax, the largest U.S. maker of generic drugs based in Miami.
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 treated, according to the FDA. The next day, lab tests showed life-threatening kidney failure.
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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 Polsgrove’s death — before telling clinic owner Louis Fabre it would move to shut down his testing center.
Fabre had 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 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 procedures for tests, and not promptly reporting serious side effects.
Fabre, who now runs a drug-development company, declined to comment. His lawyer, Douglas Farquhar, wrote to the FDA that Fabre did nothing wrong.
The institutional review board that was to protect patients from harm was the Human Investigation Committee in Houston. That board received an FDA warning letter in 1992 saying it had conflicts of interest: It was run by Fabre himself.
Members included his business partner, psychiatrist Stephen Kramer, and his lawyer, Bruce Steffler.
The FDA also wrote last January that the consent form Fabre gave Polsgrove “failed to describe clozapine’s risk of fatal myocarditis.” Four months before Polsgrove began the test, the FDA required a warning for clozapine about that risk.
Until April 2005, when Fabre closed his trial center, its Web site said he had tested drugs for leading companies, including Abbott Park, Abbott Laboratories; Bristol-Myers Squibb; and Pfizer.
The FDA wrote in the January letter that Fabre used unlicensed employees to run the Ivax trial, failed to supervise them and falsified the circumstances of the death.
“We have no responsibility”
“It was no issue with the FDA,” Ivax spokesman David Malina says. “I think we have no responsibility for the unfortunate thing that happened to this man.” He says the FDA approved its version of clozapine after Polsgrove’s death.
Fabre left Polsgrove in the care of John Rodriguez. In its letter to Fabre, the FDA said Rodriguez “is reported to have had medical-school training in Mexico; he is neither licensed nor credentialed in the United States.”
Six days before Polsgrove joined the Ivax test, Andrea Branche, an FDA inspector, visited Fabre and found clinic records illegible. Branche reported Rodriguez had screened subjects, performed physicals and conducted electrocardiograms.
Fabre falsely presented Rodriguez as a licensed physician assistant, and the inspector believed him.
Psychiatrist Kramer says Fabre’s review board met in restaurants around Houston. Kramer says he offered Rodriguez tips on caring for Polsgrove. “When that patient had trouble, he called me, and we discussed what to do,” says Kramer, who blames Fabre’s predicament on bad luck.
“Its unusual that the patient died, and it was on his watch, so he’s screwed.”
FDA contradicts Fabre
Shortly after Polsgrove died, Fabre wrote that Polsgrove’s low blood pressure wasn’t related to the medication.
The FDA said Fabre’s conclusion was contradicted by the high level of clozapine in Polsgrove’s blood. Fabre should have suspected Polsgrove’s heart irregularity was clozapine-related and provided appropriate medical care, the FDA wrote.
The agency found Fabre failed to properly protect participants during inspections in 1980, 1993 and 1999 and twice in 2002, yet it never stopped him from doing trials. Fabre was cited again last March. The confidential FDA process of banning a clinician can take years to complete.
Twenty-five years ago, the FDA found that dozens of pages of records were missing for a Fabre test, and investigators questioned whether all of Fabre’s patients existed. “They are there, and if some of the data is missing, the patient is still real,” Fabre said, according to the report.
Charles Arledge, 50, participated in several of Fabre’s trials during 1974. Arledge says he helped his girlfriend, a nurse at the clinic, concoct phony paperwork describing nonexistent patients at the clinic. “If you look at this as science, you’re in trouble,” Arledge says. “This is science fiction.”
In 1992, drug maker Upjohn checked Arledge’s claims, finding Fabre had enrolled himself and employees in tests.
After the FDA documented Polsgrove’s death, Fabre did experiments on humans for Eli Lilly and Wyeth. Gerald Burr, Wyeth spokesman, says the company halted its trial with Fabre in January after learning of the FDA’s action against him.
Wyeth found the January FDA letter to Fabre on the Internet, Burr says.
“Lilly was not aware of the seriousness of the FDA’s concern with Dr. Fabre in 2002, nor were we aware of the death of the patient in the clozapine trial until February 2005,” Lilly spokesman Phil Belt says. Lilly stopped using the clinic.
Gatlin first saw the FDA findings on her brother’s death in August. She says the FDA should have barred Fabre from running tests years ago. “People like this should be stopped,” Gatlin says. “They slapped his little hand and let him go on.”