It's the Wild West of modern medicine.
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At a time when many researchers have voiced concern about a proliferation of clinics offering unproven stem cell therapies, Texas lawmakers have gone in the opposite direction: This week they approved a bill explicitly authorizing such treatments. The bill now goes to Governor Greg Abbott, who supports it; by signing it into law, he would make Texas the first state to authorize experimental stem cell treatments.
Supporters of the bill have argued that it opens up potentially life-saving therapies, even if results are not guaranteed. Right now, stem cell therapy exists in a kind of regulatory limbo. Despite the claims of "miracle cures," the Food and Drug Administration has approved only one kind of stem cell treatment. That's in part because science moves slowly, and proving efficacy and safety in human trials can take years, if not decades.
In the meantime, though, hundreds of clinics around the world have begun offering stem cell treatments for all manner of ailments. Typically they use fat cells harvested from the patient's body, which are then treated and injected back into another area of the body. The FDA has generally taken a hands-off approach; it considers this relatively basic procedure outside its regulatory purview.
In the absence of strong regulation, clinics have multiplied in the United States. It's no longer necessary to go on "stem cell pilgrimages" to Tijuana or China; STAT reports that there are at least 71 clinics in Texas.
Researchers, meanwhile, caution against the false hope that can be summoned simply with the phrase "stem cell treatment." But it's not just that the treatments aren't proven to do any good. In some cases, they've caused actual harm, as with three women blinded at a South Florida clinic. The International Society for Stem Cell Research (ISSCR) opposed the bill, saying it would "put patients at serious risk of harm from unproven treatments."
The debate in Texas mirrors a larger national conversation about patient access. Lawmakers there offered a trio of bills that would enable patients to try unproven therapies at their own expense—and risk. Two of those failed in the state Senate; the stem cell bill passed after amendments were added requiring that a doctor deliver the treatments at a hospital or ambulatory medical center. It also mandated approval of an institutional review board (a panel that approves research involving human subjects), a change that brings the procedure more in line with typical clinical trials. Patients also retained the right to sue if things go wrong.
The amendments may temper scientist's concerns, while still providing the access that lawmakers seek. By allowing patients—many of whom may be desperate for any possible cure—to seek out untested treatments, legislators are deferring to their constituents. The choice, they're saying, is yours. As are the consequences.
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