Gene Therapy Adverse Effects

mikalra at my-deja.com mikalra at my-deja.com
Wed Feb 9 15:40:42 EST 2000


Congress Told of More Injuries in
Gene Therapy Trials


WASHINGTON, Feb 02 (Reuters Health) -- At a congressional
hearing Wednesday looking into reporting irregularities by gene
therapy researchers, a National Institutes of Health (NIH) official
said the agency had recently received reports of 40 new adverse
events that occurred in the 157 or so studies supported by NIH
in 1999.

These reports were made only after the NIH in November urged
federally-supported researchers to comply with rules requiring
immediate notification of adverse events, said Amy Patterson,
director of the NIH's Office of Biotechnology Activities.

Patterson testified at a hearing held by Sen. Bill Frist's (R-TN)
Subcommittee on Public Health of the Committee on Health,
Education, Labor, and Pensions.

The new reports were in addition to 100 the NIH already had for
1999, Patterson said. And they come on top of 652 reports
received as a result of a letter sent in October to researchers
working on adenovirus-related protocols.

Frist was dumbfounded. "The fact that NIH received 652
previously unreported serious adverse events is inexcusable," he
said. "Clearly, our oversight system is failing."

The NIH is investigating why reports were not submitted on a
timely basis. The 652 events were not just for one year, but for 7
years, and encompassed roughly 372 studies that had been
funded by the NIH over the years, Patterson said.

Frist asked why researchers would suddenly begin reporting.

"I think the death of Jesse Gelsinger galvanized the scientific
community," Patterson said. Gelsinger was the Arizona teenager
who died September 17, 1999, four days after receiving an
infusion of corrective genes introduced with an adenovirus in a
University of Pennsylvania-led study.

The trial was halted by the Food and Drug Administration (FDA)
in mid-January, after an agency inspection found substantial
lapses in reporting, record-keeping, and informed consent.

Gelsinger's father, Paul, testified that after his son's death, he was
belatedly told of problems with the study, including adverse
events and the deaths of some monkeys in similar trials.

"I learned, after Jesse's death, that Penn had removed from the
information they gave Jesse and me any reference to deaths of
monkeys, which had previously appeared in their documents,"
said a tearful Gelsinger.

He called on the government to increase trial oversight, and to
ensure patients had enough data to make truly informed decisions
about participating in studies.

NIH's Patterson said the agency is building a website for the
public and scientists that will provide information on gene therapy
studies, including adverse events.

In addition, the FDA will soon propose that researchers disclose
more to the public about the dangers of gene therapy, said Jay
Siegel, director of the FDA's Office of Therapeutics Research
and Review.

The FDA had been receiving adverse event reports as required,
but its rules are different than NIH's, Siegel said. And, the agency
does not generally release such reports to the public unless there
is an imminent health threat.


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