Texas Governor Greg Abbott yesterday signed a bill allowing clinics and companies in the state to offer people unproven stem cell interventions without the testing and approval required under federal law. Like the “right to try” laws that have sprung up in more than 30 states, the measure is meant to give desperately ill patients access to experimental treatments without oversight from the U.S. Food and Drug Administration (FDA).
In a state where unproven stem cell therapies are already offered widely with little legal backlash, bioethicists and patient advocates wonder whether the state’s official blessing will maintain the status quo, tighten certain protections for patients, or simply embolden clinics already profiting from potentially risky therapies.
“You could make the argument that—if [the new law] was vigorously enforced—it’s going to put some constraints in place,” says Leigh Turner, a bioethicist at the University of Minnesota in Minneapolis, who last year co-authored a study documenting U.S. stem cell clinics marketing directly to consumers online, 71 of which were based in Texas. But “it would really be surprising if anybody in Texas is going to wander around the state making sure that businesses are complying with these standards,” he adds. Either way, Turner says there’s “powerful symbolic value” in “setting up this conflict between state law and federal law.”
The law, effective 1 September, will allow people with severe chronic or terminal illness to be treated at a clinic that purports to isolate therapeutic stem cells from adult tissue—such as a patient’s own fat—if their doctor recommends it after considering all other options, and if it’s administered by a physician at a hospital or medical school with oversight from an institutional review board (IRB). It also requires that the same intervention already be tested on humans in a clinical trial. The law sanctions a much broader set of therapies than federal rules, which already exempt certain stem cell interventions from FDA’s lengthy approval process, provided the cells are only “minimally manipulated” and perform the same function they normally have in the body.
The Texas bill’s clinical trial and IRB requirements seem to weed out some dubious therapies, but the language is too nebulous to protect patients, says Beth Roxland, a bioethicist at New York University’s Langone Medical Center in New York City. The bill doesn’t specify that a trial be conducted in the United States or that the therapy get clearance from FDA for human testing. “You could gain access to something [as long as it’s] being studied in a human … somewhere on the planet,” she says, “which in the stem cell area makes it really very scary.”
Awareness about the risks of unproven stem cell therapies is growing. A case report published in The New England Journal of Medicine earlier this year documented three women who lost their vision after receiving purported “stem cell” injections meant to treat age-related degeneration of the retina. Such risks are also the subject of a news conference today at the annual meeting of the International Society for Stem Cell Research in Boston.
Roxland is also unnerved by a provision in the Texas law that would prevent any state government entity from interfering with a patient’s access to treatment. “Hypothetically, if a state officially gets wind of nefarious doings at a for-profit clinic … the state officials are now restrained from doing anything.” She notes that that language mirrors a proposal in a federal bill known as the Trickett Wendler Right to Try Act, introduced in the Senate in January, which would prevent the federal government from interfering with a terminally ill patient’s access to an experimental drug outside of a clinical trial, and would prevent FDA from considering those patients’ outcomes in its drug approval decisions. Vice President Mike Pence signaled his support for the law in February and met with the family of Trickett Wendler, who advocated for right to try laws before her death from amyotrophic lateral sclerosis in 2015.
Others also believe that the Texas law’s approval might signal a coming thaw in federal regulation of stem cell clinics. “The FDA obviously doesn’t have the manpower to watch over these people,” says David Bales, chairman of the advocacy group Texans for Cures in Austin, which pushed for more patient protections in the new bill. “We really feel like they’re trying to open up the floodgates.”