Gene Therapy Firms Resist Publicity

"Adverse events are, by definition, trade secrets."

By Rick Weiss Washington
Post Staff Writer
Saturday, December 11, 1999;

Federal officials overseeing the field of gene therapy searched in vain yesterday for common ground between drug companies that want to keep details of their experiments secret and advocates who favor a more open airing of the field's recently revealed problems.

On the final day of an emotionally exhausting gene therapy conference at the National Institutes of Health in Bethesda, federal officials wrangled over the difference between "serious" and "severe" side effects, biotechnology company officials pushed for less burdensome regulations, and parents of sick children pleaded for more help from both the regulators and those who hope to profit from gene therapy.

The three-day meeting was prompted by the awkward confluence of two events: the September death of a teenager in a University of Pennsylvania gene therapy experiment, and recent efforts by some gene therapy companies to scale back the amount of information about side-effects they must submit to the NIH.

Researchers and companies testing genetic therapies on people are required by the NIH to release to the public more details of their work than are researchers who test conventional drugs. Those rules were devised to ensure that subtle side-effect trends are noticed more quickly, and to foster public confidence in the novel field that seeks to cure diseases by giving people new genes.

Gene therapy has yet to cure anyone. But as the field has grown from one dominated by academic researchers to one driven by companies with millions of dollars at stake, pressure has built to trim the NIH public disclosure rules ...

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