Tomorrow the Texas Medical Board will decide whether to sign off on what's said to be the first state-level policy imposing oversight on the medical use of experimental treatments using adult stem cells. The hotly debated plan has drawn mixed views from the scientific community over whether it's a good way to raise standards—and has generated confusion in the media.
Some experts say the rule will allow unscrupulous doctors to evade review by the Food and Drug Administration (FDA) because it may clear methods that haven't been rigorously examined. But others say the rule, while imperfect, is a good-faith effort to bring oversight to these controversial, unproven treatments, which clinics around the world offer for diseases ranging from arthritis to multiple sclerosis. At present, the board's rules require that doctors offering stem cell therapies in Texas comply only with general standards for the practice of medicine. The International Society for Stem Cell Research (ISSCR) issued a statement today clarifying that, contrary to newspaper reports this week, it has not taken a position on the Texas draft rule.
Texas has become a flashpoint for concerns about stem cell clinics in part thanks to Governor Rick Perry, who has taken steps to promote a stem cell industry in the state and last summer, as treatment for a back injury, received an injection of his own fat stem cells from a Houston physician. Meanwhile, a Sugar Land, Texas, company called Celltex Therapeutics that prepared Perry's cells has recently come under fire for allegedly charging patients for stem cell treatments that had not been validated in clinical trials.
Last summer after Perry asked for a review, the Texas Medical Board began drafting a rule that would impose new oversight over physicians' use of investigational agents, including stem cells. The latest draft, published in the Texas Register in March, would, among other things, require that stem cell treatments either be part of a National Institutes of Health or FDA-approved protocol or study (all of which undergo an ethics review), or have approval from a local research ethics review board known as an Institutional Review Board (IRB).
Critics say the draft rule would allow doctors to avoid rigorous oversight. "It opens up a lot of opportunities for abuse or fairly lax regulation," says science policy expert Douglas Sipp of the RIKEN Center for Developmental Biology in Kobe, Japan. In a like-minded comment to the board (see p. 9), University of Minnesota, Twin Cities, bioethicist Leigh Turner warns that the proposed rule would permit review by private, for-profit IRBs. Turner opposes this because he argues that such IRBs can be under financial pressure to approve protocols. And stem cell researcher Irving Weissman of Stanford University in Palo Alto, California, told the Houston Chronicle that the draft rule is "a clever way around the FDA's appropriate role overseeing clinical trials" and violates ISSCR guidelines.
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