Governor Rick Perry lends a hand to stem cell therapies. Credit: Jeff Malet Photography/Newscom

On April 13, the Texas Medical Board by a vote of 10–4 approved guidelines for the use of investigational drugs, including stem cells, in the practice of medicine. The state is positioning itself as “the world's leader in the research and use of adult stem cells,” wrote Governor Rick Perry to his medical board last July after receiving a stem cell treatment for an ailing back. The letter was part of an effort on the part of the governor and his henchman in the state legislature, Rick Hardcastle, who suffers from multiple sclerosis and wishes to have stem cell treatments himself, to support such treatments by creating an adult autologous stem cell bank in the state. An amendment calling for such a bank and tasking the state's Health and Human Services Commission with establishing basic rules regarding its work was passed last July as part of an omnibus Medicaid cost-containment bill (Article 14, SB 7 Medicaid Efficiency Bill). Details of such a bank have yet to appear, but the Sugar Land, Texas–based company Celltex, which provided the cells for Perry's treatment, may be angling for the job. It was reported in Newsweek that the governor's office changed the wording of the bill from the establishment of “banks” to “a bank.” Although it is not the only stem cell bank in the state, it is arguably the best connected, with the CEO David Eller a Perry contributor, and the physician who gave Perry stem cells, Stanley Jones, chief medical officer. Meanwhile, the newly approved regulations appear to break new ground by allowing physicians to use protocols approved by local institutional review boards in lieu of US Food and Drug Administration (FDA) review. Whereas those members of the board who voted for the regulations believe that they provide needed patient protection, others, like Stanford University stem cell researcher Irv Weissman, see them as “a clever way around the FDA's appropriate role of overseeing clinical trials.” University of Minnesota ethicist Leigh Turner, who testified before the board prior to the final vote, sees many reasons for concern, among them, the loose use of terminology with regard to stem cells (adult stem cells are not mentioned, let alone any discussion of the kinds of preparations that would be allowed), the varied qualifications and quality of work of institutional review boards, particularly for-profit ones, and the lack of clear rules prohibiting payment for experimental treatments. “What you end up with is kind of [a] tearing away of regulatory review and patient–research subject protections,” says Turner. Members of the board who voted for the measure stand by their decision. “We're trying to be safe. It's the wild, wild west right now,” Scott Holliday, an anesthesiologist from Arlington, Texas, told the Washington Post.