Watching Over Clinical Trials

The death of Jolee Mohr, a participant in a gene therapy trial, was a horrible tragedy ["Death Points to Risks in Research," front page, Aug. 6]. We in the biotechnology industry are terribly saddened by her family's loss.

Biotechnology innovations, such as gene therapy, have tremendous potential to extend and save the lives of patients suffering from a variety of diseases. As with all clinical trials, gene therapy research must be regulated in a rigorous but efficient manner that ensures patient safety and expedites the delivery of innovative therapies to patients who so desperately need them.

To that end, in 2000, the Biotechnology Industry Organization successfully urged harmonizing proposed National Institutes of Health guidelines with existing U.S. Food and Drug Administration regulations overseeing the reporting of serious adverse events during clinical trials. The FDA can at any time during a clinical study require the sponsor to provide full information on all observed adverse events. FDA regulations also cover events in which the medical official overseeing the study does not think the serious adverse event was caused by the therapy under study. Under these regulations, reporting of such unrelated adverse events should be submitted in an information amendment or annual report from the study's sponsor.

Since the NIH had no regulations on this issue and sought comments from stakeholders, our proposal in 2000 was not a "rule" change, as reported in your story, but simply a recommendation to make NIH guidelines consistent with existing FDA regulations.

There is nothing in the tragic facts of this case, as reported in the media, that makes this harmonization relevant to Mrs. Mohr's death. The cause of her untimely death, and whether it resulted from the experimental treatment, is under investigation by the FDA and is, as yet, undetermined.

JAMES C. GREENWOOD

President and Chief Executive

Biotechnology Industry Organization

Washington