Gene Therapy, RevisitedBy GRETCHEN REYNOLDS Published: December 13, 2007 In decisions followed closely by experts in performance-enhancing drugs, the Food and Drug Administration and the National Institutes of Health both ruled in the past two weeks that the death of an Illinois woman receiving gene therapy to treat her rheumatoid arthritis was not related to the therapy itself. The woman had developed a life-threatening infection that the regulators decided was due to other drugs she was taking.
As PLAY reported in June, gene doping -- or the attempt to alter athletes' genetic code to make them stronger, faster, bigger, more durable or otherwise inhumanly good -- piggybacks on legitimate gene therapy for ideas. Although there are no known cases of gene doping, many drug experts believe that dopers are squirreled away right now in underground labs, consulting published data about gene therapy to create their own home-brewed versions.
Which is why, in theory, the F.D.A.'s findings about the gene trial in Illinois are heartening. Gene therapy, in this case, didn't kill. Christopher Evans, a professor at Harvard Medical School, who's preparing his own gene therapy trial for osteoarthritis, speculates that dopers would have been less interested in the women's death than the promising early results from the trial. "Everything I've learned about the psychology of high-performance athletes is that they'll try anything to get an edge," he says. Last month, Evans's gene therapy human trial was pushed back by at least a year, to allow for more safety studies in animals. Gene dopers aren't likely to be so scrupulous. "Safety," Evans says dryly, "is not their main concern."
The Illinois gene therapy trial is expected to resume soon.