GENE THERAPY: Reports Disclose 691 Deaths and Illnesses
Gene therapy reports that have swamped the NIH reveal a total of 691 "serious adverse events" resulting from gene therapy. Of those, 652 have never before been seen by the NIH, as required by federal law. This means that less than 6% of those cases were properly reported on time. Since the uproar surrounding the University of Pennsylvania's gene therapy experiments, the NIH has cracked down on researchers who fail to report serious adverse events and hopes to shed some light on the death of UPenn volunteer Jesse Gelsinger. Many of these tardy reports fail to explain the causes of death, implying that Gelsinger might not be the first to die from gene therapy experiments, but rather the first to have been reported to the NIH.
Confusion Over Law?
Under federal law, all deaths and illnesses attributed to gene therapy must be reported to the FDA, as well as the NIH. The NIH then makes the information available to other scientists and the public. The information obtained shows that patients undergoing such treatments suffered from fevers, serious drops in blood pressure and clotting abnormalities. Vera Hassner Sharav of Citizens for Responsible Care and Research chastises scientists for not properly reporting their studies and leaving the cause of death for many patients to remain unknown. She said, "You have to find out what [the cause of death] is before you can rule out what it's not. That's just logic. Otherwise it's basically a denial of responsibility." In their defense, researchers say they thought the NIH reporting requirement ended in 1996 when the agency lost its authority to approve or disapprove of gene therapy experiments. But the NIH mandate is "stated plainly on every letter of approval that goes out to researchers when they first gain permission to start their experiments." Others candidly admitted that public disclosure of such deaths and illnesses, even those not related to new genes, can "shake investor confidence in a gene therapy company" (Nelson/Weiss, Washington Post/Philadelphia Inquirer, 2/1).