The Texas Medical Board on Friday approved controversial new rules on the use of adult stem cells, raising concerns that Texans could receive therapies that have not yet been proven to work and that could be unsafe.
The new rules allow doctors to perform stem-cell procedures as long as they are done for research and receive approval from an institutional review board, which can be private and profit-making. The rules also require that patients sign informed consent forms.
The approval process, which took months, was set off by Gov. Rick Perry, who reported relief from back pain after being injected with his own stem cells last summer before he began his presidential bid. Perry directed his staff to help push through the legislation on which the new rules are based.
Researchers said the evidence of success of stem-cell injections is anecdotal, and they advocate waiting for clinical trial results before allowing doctors to charge patients for the procedures, which typically cost tens of thousands of dollars.
I think there are some real problems with these rules, said Leigh Turner, a professor at the University of Minnesota's Center for Bioethics, who commented on the rules before the board. The protective mechanism that they're focusing on isn't going to do very much.
The rules' supporters acknowledged the need for changes, like a better definition of stem cells, but they said the rules would protect Texas patients more effectively. Procedures are being performed now without oversight.
Doing something at this point is better than doing nothing, said Mario Salinas, director of Texans for Stem Cell Research, adding, This is just the first step.
Perry received a stem-cell injection in July to treat his back pain. That same month, he sent a letter to the medical board chairman commenting on the revolutionary potential that adult stem-cell research and therapies have on our nation's health, quality of life and economy. The rules approved Friday do not address the use of embryonic stem cells a far more controversial procedure that has drawn moral and religious objections.
Although bone-marrow transplants, which use blood-forming stem cells, have been used effectively to treat a variety of ailments for decades, experts say other procedures remain experimental. The medical board's proposed rules, which appeared last month in the Texas Register, attracted criticism from Nature, the international journal, which wrote in an editorial that the board should make clear the need for clinical validation of adult stem cells.
Because the rules had already been published in the state register and stakeholders had provided feedback, the medical board could not make major changes Friday and faced a simple choice: Accept or reject the rules.
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Rules on use of adult stem cells get approval
