New York Times / May 4, 2000 / By PHILIP J. HILTS
BOSTON, May 3 -- Researchers at St. Elizabeth's Medical Center here failed
to report the death of a patient in gene therapy experiments and might have
contributed to the growth of cancer in another patient, whose condition was
also reported improperly, investigators for the Food and Drug
Administration have said.
Their accusation were made in April in a letter to the hospital and the
chief researcher in the experiment, Dr. Jeffrey M. Isner, and was recently
posted on the agency's Web site.
The experiment has been stopped.
The news comes as scientists, hospitals and companies sponsoring gene
therapy experiments have been working to assure the public of the safety of
the experiments after the death of a patient in a gene experiment at the
University of Pennsylvania last year.
Jack Cumming, president of the Vascular Genetics Inc. of Durham, N.C., the
company sponsoring the experiment at St. Elizabeth's, acknowledged today
that there had been some "problems" in the gene therapy experiment. Mr.
Cumming said the company would do everything it could to satisfy the F.D.A.
in correcting the problems. He said he was "very optimistic" that positive
results would be presented to the agency this summer.
Mr. Cumming said he would not dispute the agency's findings and said that
his company had hired two outside groups to audit and monitor all the
experiments it had begun around the country, including the one at St.
Elizabeth's. The groups were hired after the company learned that the
federal agency was writing a warning letter, he said.
Sonia Hagopian, a spokeswoman for the St. Elizabeth's, said the hospital
took the warning letter very seriously, and added: "We are focusing all our
resources on producing a thorough and thoughtful response to the F.D.A."
The hospital's public relations office said Dr. Isner would not be
available for comment at this time.
The problems in the experiment were reported on Tuesday in The Washington
Post and The Boston Herald.
In the experiment at St. Elizabeth's, which was jointly sponsored by Tufts
University, a gene that makes a substance called V.E.G.F. (for vascular
endothelial growth factor) was injected directly into the hearts of
patients with blocked heart vessels. Researchers hoped the gene would start
making the growth factor, which is the body's natural substance to make
blood vessels grow.
Inspectors for the federal agency said they found several violations of the
rules of the experiment in a routine check in March. One patient in the
experiment died two months after receiving the experimental therapy, but
the researchers failed to report the death to the agency. The agency is
investigating to determine if the treatment was the cause of the death.
In another case, a patient was included in the study although he should
have been kept out under the rules of the experiment. The patient was a
heavy smoker and a small mass had appeared in one lung, the agency said. Because the experimental therapy used a chemical designed to increase the
growth of blood vessels, the agency said, it was possible that it increased
the supply of blood to the growing tumor.
The agency's warning letter noted that the St. Elizabeth's researchers saw
the mass when it was less than a centimeter in July 1999, then again in
August when it was two centimeters in diameter, but went ahead with the
treatment on Sept. 21, 1999. Two months later, the agency said, the patient
was hospitalized with chest pain, and the mass was found to have grown to
five centimeters.
There was no evidence in the patient's records or the experiment records
that either the patient or his doctor was notified of the growth of the
mass, investigators said.
The hospital and the researchers have 15 days to tell the agency how they
will correct the problems in the experiment. The F.D.A. has the authority
to ban the researchers from future work using federal money.
This and three other experiments carried on by Dr. Isner were stopped when
the agency first began its inspection in February and have not resumed.
Dr. Isner is a founder of the company leading the trials and is a major
stockholder in it.
(posted without permission)
