Feb. 28, 2000 (Washington) -- Genetic researchers have not always followed r
Feb. 28, 2000 (Washington) -- Genetic researchers have not always followed rules requiring them to report to the National Institutes of Health (NIH) side effects seen during their human trials. However, in the majority of cases, they have reported these side effects to the FDA.
But the NIH, with its eye toward future public disclosure of such information, is flexing its oversight muscle and now adopting a strategy designed to get this information from researchers.
As part of this strategy, Lana Skirboll, PhD, the NIH's Director of Science Policy, tells WebMD the NIH plans to conduct a retrospective analysis of researchers' records while also "actively working with the FDA to see what they receive vs. what we receive."
If the FDA received reports of an unfavorable event that was not reported to the NIH, then that clinical investigator will now be getting a call from the NIH to find out what happened, she says.
All of this information eventually will be posted on a Web-based database for public inspection. "We haven't set a deadline," Skirboll tells WebMD. But full public disclosure definitely is a big part of the agency's mission.
Most likely, the NIH review also will find that a large percentage of unfavorable events are a result of the patients' underlying disease, which could be a difficult message to explain in a public database, says LeRoy Walters, PhD, a past chairman of the NIH's Recombinant DNA Advisory Committee. As a result, whether this disclosure will do more public harm than good, he tells WebMD, largely will "depend upon the quality of the analysis."
"I don't think [full public disclosure] is absolutely necessary," says Arthur Caplan, PhD, a medical ethicist at the University of Pennsylvania in Philadelphia. "I have no problem at all saying that subjects should have the right to know about [unfavorable] events. I am just not sure what is the best answer is," he tells WebMD.
However, both Walters and Caplan agree that submitting to additional accountability measures can only help the industry's credibility. Genetic research has come under a lot of scrutiny recently, whether justified or unjustified, and submitting to some form of further supervision can only help these researchers' image, Walters tells WebMD.
The NIH policy is a major step in the right direction, Caplan says. In general, he tells WebMD, patients thinking about participating in any clinical trial should have the right to know about possible side effects. "In the end, the real question is [whether you're] going to sacrifice safety for secrecy," he says.
But public accountability should not be the NIH's top priority, Walters says. The top priority should be to set up a system that can accurately record and properly analyze these unfavorable events. The present system is a mess, he says.
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