GENE THERAPY: NIH Seeks Public Disclosure of Deaths
The NIH's Office of Recombinant DNA Activities (ORDA) has proposed public disclosure of adverse patient reactions to gene therapy treatments, much to the dismay of some field researchers and companies who want to keep the data confidential, the Wall Street Journal reports. NIH insiders are becoming increasingly concerned about the growing number of secrecy requests from gene therapy researchers. In one case, noted the Washington Post, a leading scientist provided the NIH with "sketchy details of a patient's recent death" and asked that the information "be kept confidential and not part of the public record." In another instance, Madison, New Jersey-based Schering-Plough Corp. requested that some of its patient data remain confidential. The NIH "would still get everything," explained company spokesperson Ronald Consalvo. He said, "It's a matter of what would be available to the public." Currently, NIH requires that any serious illnesses or deaths involving patients getting gene therapy be reported to ORDA, the FDA and local review boards at the institution where the research was conducted (Washington Post, 10/30). Last month, researchers at the University of Pennsylvania reported the first publicly acknowledged death thought to be cause by gene therapy.
Tougher Rules to Come?
To alleviate public worries, NIH officials created an ORDA advisory committee and a Recombinant DNA Advisory Committee (RAC), consisting of geneticists, theologians, patient advocates and others to review every proposed gene therapy protocol and any adverse outcomes. Confidentiality has become a major issue for RAC, which "has watched over the years as gene therapy has shifted from a publicly funded venture led by university and government scientists to a field largely sponsored by private companies with strong proprietary interests." Government lawyers have concluded that the regulations insisting on research becoming public record were so imperfectly worded that they may not be enforceable. But ORDA members recently proposed new language for the NIH guidelines that would eliminate any ambiguities about public access to gene therapy research. The language is to be finalized at an RAC meeting in December. ORDA official Amy Patterson stated, "This field is a new science where the experience with one patient should inform the experiments performed on the next. And in this day and age when we can communicate in a nanosecond, there's no excuse to keep repeating the same adverse event if we can prevent them" (Weiss and Nelson, 10/30).