Author: Jon Merz
Date: 04-21-05 11:06
Source: Houston Chronicle
URL: http://www.chron.com/cs/CDA/ssistory.mpl/topstory/3145795
Date published: April 21st 2005
from Haavi Morreim:
April 20, 2005, 11:53PM
FDA investigating clinic where patient died
Agency considers closing the facility it contends violated research protocol
By TODD ACKERMAN
Copyright 2005 Houston Chronicle
Federal regulators are investigating whether to shut down a Houston research
clinic after one of its patients died during a drug trial.
The Food and Drug Administration notified the Fabre Research Clinic that it
has started proceedings to disqualify it as a clinical investigator after an
investigation into the 2002 death of a psychiatric patient.
"The FDA's Center for Drug Evaluation and Research believes you have
repeatedly or deliberately violated regulations governing the proper conduct
of clinical studies," Dr. Joanne Rhoads, director of the center's division
of scientific investigations, wrote Dr. Louis Fabre, the head of the clinic,
in a Jan. 19 letter.
The patient, who was receiving the antipsychotic drug Clozaril (clozapine),
died of a heart attack brought on by inflammation of the heart, a known risk
of the drug. The FDA letter said clinic staff failed to recognize or
evaluate the patient's worsening condition.
The patient's name was removed from the FDA letter.
Fabre declined an interview request, but said in a written statement that
the clinic is "working with the FDA to achieve an early and mutually
acceptable resolution to this matter." He said the clinic "answered and
corrected the issues raised by the FDA" but a subsequent FDA investigation
revealed documentation deficiencies.
He said the clinic recently submitted a response addressing those
deficiencies.
FDA officials would not comment because the matter is under investigation.
Its letter to Fabre is posted on its Web site.
The Fabre clinic, which is located near the Texas Medical Center, conducts
research on mostly psychiatric conditions for pharmaceutical companies.
Founded in 1973 by Fabre, a psychiatrist and graduate of Baylor College of
Medicine, it owns inpatient and outpatient facilities. Its Web site says
Fabre has contributed to more than 350 clinical trials.
Private, for-profit clinics such as Fabre are popular with pharmaceutical
companies because their trials typically involve less bureaucracy than
university drug testing.
In an early 1990s lawsuit against Upjohn Co., Fabre was accused of
falsifying some of the earliest clinical studies that resulted in approval
of the once-popular sleeping pill Halcion, after some users reported amnesia
and hallucinations. Fabre's lawyer denied the charge. Upjohn agreed to
reduce the recommended dose.
In Fabre's 2002 patient death, the FDA's letter cited seven major
violations, the most prominent of which detailed how the clinic failed to
protect the rights, safety and welfare of human subjects.
It said Fabre had little personal involvement in the study, delegating
conduct of it to medically unqualified staff rather than being present
himself.
It laid out a 22-day timeline of the patient's worsening symptoms ‹
including a rapid heart rate, diarrhea, hypotension, kidney failure and
electrolyte imbalances ‹ during which staff never appropriately intervened.
The letter noted that the labeling for Clozaril features a warning about the
association between the drug and fatal myocarditis (heart inflammation).
The letter notes that despite the volume of clinical evidence consistent
with drug-induced myocardial injury and drug toxicity generally, Fabre's
progress note shortly after the patient died said, "This patient was awake
and well at 7:30 ... We feel that this death is not related to the
medication."
The letter also charged Fabre with submitting false information to the
trial's sponsor, failing to provide informed consent and failing to conduct
the study according to approved protocol.
The FDA's January letter was written after receiving Fabre's November
response.
A spokesman for Novartis, the maker of Clozaril, was not aware of the FDA
investigation of the Fabre trial Wednesday afternoon.
He noted that though there is no requirement it only be used in a hospital,
it requires very close monitoring and medical supervision. It is used to
treat seriously ill schizophrenic patients, often at risk of recurrent
suicidal behavior.
todd.ackerman@chron.com
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