"We need to be certain that the safety and dignity of patients who volunteer to help advance medicine are fully protected by the law," Rep. Henry Waxman, D-Calif., tells WebMD. Waxman agrees with the OIG report and says he plans to introduce legislation addressing the issue.
Nonetheless, one of the country's leading gene therapists takes issue with the report. W. French Anderson, MD, of the University of Southern California, says overall, patients in research studies are very well protected. "It's not appropriate when you're already doing an excellent job, but you can see that there's room for improvement to say, 'Oh, it's a grim situation. We've all these problems,'" Anderson tells WebMD. Anderson points out that of thousands of gene therapy patients, Gelsinger's death was the only major adverse event.
The government investigators did praise the FDA, as well as the NIH, for efforts to follow up on safety and enforcement questions as well as offering education and training services. In the last three years, the NIH and its Office for Protection from Research Risks have significantly increased their on-site investigations, as has the FDA, according to the report.
Finally, the report points out the need to streamline the so-called Common Rule that governs treatment of human subjects over 17 federal agencies. While the Rule provides consistency, says the OIG, it makes it difficult to change things quickly.
Well-placed sources tell WebMD that within six months the Clinton administration will propose major changes in the IRB structure aimed at improving patient protection.