FDA Calls for accuracy in Clinical Trials

Article by HairlossTalk.com

A new proposal was announced by U.S. health officials which would give the public better access to information on all new or ongoing clinical trials involving Gene Therapy or Xenotransplantation (a process involving the transplantation of animal tissue into humans)...To date, most clinical trial information is revealed in post trial documentation, but the goal is to extend this into the future of Genetic research for all ailments including hair loss research. Most of the necessary information is already being provided for this type of research as well, but the agency's goal is to help build more confidence in the public's eye with this risky new treatment methods resulting from genetic research.

"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.

As part of HairlossTalk's ongoing involvement in helping find better treatments and potentially a cure, we will be announcing any new and upcoming research projects which may include genetic research. 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 extends to making sure the FDA follows all the rules that are implemented for other government agencies performing research, who currently keeps many aspects of studies confidential. 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.

Naturally, some companies are against such public display of trial information. They use the argument that it violates the privacy of the trial participants (I guess they missed the part about names being confidential) and (surprise?) that it compromises the companies' trade secrets. They also feel there is a risk that too many listed side effects will unnecessarily scare people away from treatments, whereas under current laws, they can omit certain side effects which may not be prevalent enough to mention. "Disclosing data on all adverse events in clinical trials without first investigating the causes could unnecessarily frighten patients and the public," says Carl Feldbaum, president of the Biotechnology Industry Organization, a trade association.

HLT

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