GENE THERAPY: NIH Kept in the Dark About Deaths
Defying federal reporting regulations, scientists and drug companies have failed to notify NIH about six deaths among gene therapy patients occurring over the last 19 months, the Washington Post reports. Confirmation of the six deaths follows "revelations last week" of a death and two serious illnesses" among gene therapy patients that were reported with the insistence that the information be withheld from public record. The discovery marks the first time in the history of gene therapy research that adverse effects are known to have been purposely withheld from the NIH, one of two federal agencies with oversight of the research field. The lack of disclosure "provides new evidence of a shift toward secrecy" in gene therapy, formerly considered one of the more "open fields" of medical research, and also reflects increased efforts by research firms to weaken federal reporting standards.
Competition Driving Secrecy?
The six deaths occurred in heart studies headed by two leading gene therapy researchers -- New York Hospital-Cornell Medical Center's Ronald Crystal and Tufts University's Jeffrey Isner -- in competition to grow the first new blood vessels in an alternative to bypass surgery. They contend that, unlike the September death of an 18 year-old patient at the University of Pennsylvania, the fatalities occurring in their studies were not believed to be caused by the gene therapy. Consequently, Crystal and Isner determined that they did not have to report the incidents to 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." Although the researchers reported the deaths to the FDA, gene therapy research's other oversight body that keeps such information confidential, NIH officials are "adamant" that deaths not initially believed to be caused by the therapy be made public. NIH Administrator Amy Patterson notes that adverse effects information is vital to reduce research fatalities, saying, "if you don't know what's going on in other people's trials, then you can't put two and two together." But as more private companies enter the research field, drug firms and scientists with a financial stake in the projects are "challenging the historically broad interpretation" of the reporting rule. The firms are filing reports and demanding confidentiality from the NIH, or not reporting at all. This week, Schering-Plough requested confidentiality regarding adverse effects occurring in one of the firm's gene therapy experiments. The secrecy and reporting guidelines surfaced in the September meeting of the Recombinant DNA Advisory Committee (RAC) -- the NIH group in charge of gene therapy report reviews -- and are scheduled to be discussed further when the group reconvenes in December (Nelson/Weiss, 11/3).