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Gene Transfer Data to Go Public
Reuters

3:45 p.m. Sep. 15, 2000 PDT

A U.S. federal advisory committee has unanimously approved recommendations that would change the system for reporting adverse events in clinical gene transfer research and make the information more readily available to the public.

The changes, approved at a meeting on Thursday, were developed by a working group within the National Institutes of Health's (NIH)Advisory Committee to the Director and submitted to NIH Acting Director Dr. Ruth L. Kirchstein on July 12.

The Working Group on NIH Oversight of Clinical Gene Transfer Research was formed last year in response to the death of Jesse Gelsinger, an 18-year-old patient enrolled in an adenoviral vector gene transfer clinical protocol at the University of Pennsylvania.

Among other changes, the advisory committee approved a recommendation that a standing body of scientists, clinicians, patient advocates and ethicists should be established to conduct ongoing analyses of adverse events.

Under the recommendations, data on adverse events would be released to the public once they have been analyzed and interpreted. This would give people considering enrolling in trials "the best possible information," according to working group co-chair Dr. Christine K. Cassel of the Mount Sinai Medical Center.

"All reasonable measures must be taken to protect the privacy of the individual(s) who suffered the adverse event, without compromising the health of others in similar trials," the working group recommended.

The recommendations do not specify the criteria that would trigger an adverse event report. Cassel acknowledged that a guideline "needs to be developed."

In addition, the timeline for reporting adverse events has not been established, Cassel said, but she noted that the Recombinant DNA Advisory Committee (RAC) is "working on that right now." There has been "some talk of 7 days or 2 weeks," she added. "Ideally, it would be the same as the (U.S. Food and Drug Administration )."

The recommendations urge the Food and Drug Administration (FDA) to move quickly "to make public some information regarding serious adverse events in gene transfer." The working group also recommended that the FDA and the NIH "must work together to simplify, streamline and harmonize reporting of serious adverse events."

The recommendations "now come to me ... and I will do what I feel is needed," NIH's Kirchstein said, adding that she will "report back" at a December 7 meeting.

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