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.
But contrary to the Chronicle's suggestion that Weissman was speaking for the ISSCR, the society says in its statement that it "has not endorsed a position on the draft language." The society is concerned about how untested stem cell treatments are marketed—it even created a Web site to educate patients—and supports rigorous testing. "We've generally heard positive things about the intent" of the Texas draft rule, says ISSCR Science Director Heather Rooke.
Sean Morrison, an ISSCR member at the University of Texas Southwestern Medical Center in Dallas, says that even if it wanted to, the board could not require FDA oversight, because the agency doesn't regulate all experimental therapies: Many legitimate U.S. clinical trials, including some stem cell trials, test treatments that don't meet FDA's definition of a regulated product. But the draft rule wouldn't stop the FDA from stepping in, he says, because "federal laws trump state laws."
Morrison does share concerns that the draft rule's requirements for IRB review are "weak" because, for example, the IRB would not have to be affiliated with a Texas hospital or academic institution. The regulations "are not perfect," Morrison says. But he says the medical board "should be congratulated for trying to impede the proliferation of unproven stem cell therapies." Texas, he says, "has done more to address this problem than most other states."
Celltex itself dislikes the rule: It argues in comments to the board (see p. 3) that its stem cells should be exempted because they are "not more than 'minimally modified' " or combined with another drug and so don't meet the FDA's (and therefore the board's) definition of an investigational agent. (Celltex's premise may be in doubt, however: The U.S. government has sued a similar company in Colorado, arguing that the stem cells it offers qualify as a regulated product.)
The medical board will either decide to pass the draft policy, pull it down for more tweaking, or scrap it altogether, says board spokesperson Leigh Hopper.
UPDATE, 13 April: Today the Texas Medical Board passed the draft rule by a vote of 10 to 4 after "a lot of debate," said board spokesperson Leigh Hopper. Some members feared the rule would open the door to abuses (physicians charging patients large sums of money for unproven treatments), Hopper says. Others noted that some physicians are already treating patients and felt that, in the absence of clear FDA guidelines, the rule was a reasonable if imperfect start. She said the board has assigned a subcommittee to refine the rule with input from Leigh Turner and others.
Turner, the University of Minnesota, Twin Cities, bioethicist who spoke at the meeting, told ScienceInsider by e-mail from the Austin airport that he continues to feel the policy "has numerous flaws" and that what's needed are "more robust and coherent guidelines."