Six Gene Therapy Deaths Kept From NIH, Public-Post
Reuters Online ServiceMittwoch, 3. November 1999 08:51:00
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WASHINGTON (Reuters) - Scientists and drug companies did not
notify the National Institutes of Health about six people who
died during gene therapy experiments in the past 19 months, in
the latest sign of a possibly finance-driven shift toward
secrecy in the research area, the Washington Post reported
Wednesday.
The deaths are the first in gene therapy to come to light
that were purposely withheld from the NIH, one of two federal
agencies charged with overseeing the safety of the controversial
field of medical research that seeks to cure diseases by giving
patients new genes, the Post said.
Federal regulations have long held genetic treatments to a
higher level of public scrutiny than conventional new therapies
because of public discomfort with the idea of manipulating
people's genetic makeup, the report said.
But as the field has become increasingly dominated by
private industry, drug companies and scientists with a financial
stake in their research are challenging the broad interpretation
of that rule. They are filing reports with demands for
confidentiality, the Post reported, or maintaining that they do
not have to file them with the NIH at all.
Confirmation of the six deaths follows revelations last week
of a death and two serious illnesses in gene therapy patients
that were reported to the NIH with the unprecedented insistence
that they be kept confidential, defying a long-standing agency
policy of public disclosure.
In the case of the six deaths, all of the people died during
heart studies headed by two leading gene researchers -- Ronald
Crystal of the New York Hospital-Cornell Medical Center in
Manhattan and Jeffrey Isner of Tufts University in Boston, the
Post said, citing interviews with researchers and scientists.
The two founded competing gene therapy companies -- Isner's
Vascular Genetics of Durham, North Carolina, and Crystal's
GenVec of Rockville, Maryland -- and are racing to be the first
to grow new blood vessels around blocked ones as an alternative
to heart bypass surgery, the report said.
The Post said Crystal was the first to request
confidentiality from the NIH for a patient death report in May
1998, just two weeks after his company GenVec announced its
initial public offering of stock.
The report reported that NIH staff said at the time Crystal
cited concerns about the impact on his business if the death
were made public. But Crystal has in the past week, according to
the Post, said the public offering had no bearing on his
confidentiality request.
Crystal and Isner told the Post they believe the
fatalities in their studies were not directly caused by the gene
therapy but by complications stemming from the patients'
underlying illnesses.
Because they decided the deaths were not caused by gene
therapy, they argued, federal regulations do not require them to
notify the NIH -- a new interpretation of those regulations that
stands in sharp contrast to the one held by NIH officials and a
decade of practice, according to the Post report.
The researchers told the Post they reported the deaths to
the Food and Drug Administration, which keeps such information
secret.
But NIH officials in the federal office that oversees gene
therapy were adamant that even deaths not initially believed to
have been caused by the therapy must be reported to the NIH and
made public, because often it is not clear until later whether
the therapy actually caused the deaths.
"It may take five, six, seven patients ill, or 20 patients,
before you find out, 'Hey, this is also happening in other
people's trials,"' Amy Patterson, who heads the NIH Office of
Recombinant DNA Activities, which oversees gene therapy studies,
told the Post.
"And if you don't know what's going on in other people's
trials, then you can't put two and two together," she said.
Most of the new deaths are coming to light only because
federal officials put out a plea for gene researchers across the
country to report any undisclosed deaths or illnesses.
They issued the plea after the death of a teenage patient at
the University of Pennsylvania in September. His death is
thought to be the first directly caused by gene therapy, and NIH
officials are looking for indications of similar problems in
other studies that may not have been attributed to the
treatments themselves.