Jan. 18, 2001 (Washington) -- U.S. health officials proposed a rule Wednesday that would give the public better access to information on all new or ongoing clinical trials involving either gene therapy or xenotransplantation, which involves transplanting animal tissue into humans.
Much of that information already is disclosed during the public meetings of the agency's expert advisers. But the proposed rule "is an important step in ensuring greater public confidence in these revolutionary therapeutic technologies," says FDA Commissioner Jane E. Henney, MD, in a prepared statement.
"Both of these technologies [gene therapy and xenotransplantation] hold great promise, but they may also pose a remote, but unique risk to the individuals who have volunteered to participate in these types of studies. Our proposal will ensure that the public is fully informed as we investigate these new public health opportunities and challenges," Henney says.
The plan is part of a series of steps the government has taken to bolster the public's confidence in these technologies since the September 1999 death of study participant 18-year-old Jesse Gelsinger. His death was the first directly attributed to gene therapy.
The proposal also will ensure the FDA's policies for public access to this information are compatible with those of other government agencies that oversee this type of research. At present, this information is often made publicly available by the National Institutes of Health, although it is kept confidential by the FDA.
But under the proposed rule, researchers would have to make public details about the side effects seen during these trials, including deaths. However, the names of the participants would remain confidential and companies would be able to edit out commercial secrets.
Still, the research industry is up in arms. Industry representatives maintain that the proposed rule would violate patients' right to privacy as well as compromise the companies' trade secrets.
"Although the FDA has said such data would be [edited] from publicly disclosed materials, there are no assurances some sensitive information would not be revealed," says Carl Feldbaum, president of the Biotechnology Industry Organization, a trade association.
Industry representatives also say the disclosures would be misleading since most of the adverse events reported during a clinical trial are not related to the experimental therapy. "Disclosing data on all adverse events in clinical trials without first investigating the causes could unnecessarily frighten patients and the public," Feldbaum says.
Industry representatives will get a chance to air their concerns. Under federal rules, the FDA must now open the proposed rule for public comment before passing a final regulation.
Comments on the proposed rule, which has been published in the federal register, can be emailed to the FDA at [email protected] These comments will be considered in the development of any final rule, the FDA says.