The Texas Medical Board today approved controversial new rules on the use of adult stem cells that have raised concerns over the possibility that Texans could receive therapies that have not yet been proven to work and that could be unsafe.
Researchers say the evidence of success of stem cell injections is anecdotal, and they advocate waiting for clinical trial results before allowing physicians to charge patients — typically tens of thousands of dollars — for the procedures.
The new guidelines allow for stem cell procedures as long as they are done for research and receive approval from an institutional review board, which can be private and for-profit. The rules also require that patients sign informed consent forms.
“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, such as better defining “stem cells,” but they said the rules would better protect Texas patients. 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 that “this is just the first step.”
Gov. Rick Perry has been a strong supporter of the adult stem cell industry, and he received a stem cell injection last July to treat his back pain. That same month, Perry sent a letter to the Medical Board chairman noting the “revolutionary potential that adult stem cell research and therapies have on our nation’s health, quality of life and economy.” The rules approved today do not address the use of embryonic stem cells — a far more controversial procedure that has drawn moral and religious objections.
Though bone marrow transplants, which use blood-forming stem cells, have been used effectively as treatment for decades, experts say other procedures remain experimental. The Medical Board’s proposed rules, published last month in the Texas Register, attracted criticism from the international journal Nature, 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 Texas Register and stakeholders had provided input, the Medical Board could not make major changes today and faced a simple choice today: accept the rules or reject them.
Even some board members who voted for the rules agreed that they weren’t perfect. But they said the rules improved on the current situation by adding a layer of protection for Texas patients.
“Right now, we’ve got essentially an emergency state, where there are a lot of concerns about the way stem cells are being used,” said Stanley Wang, a board member. “Our rule adds in at least the layer of [institutional review board] approval before a doctor can act.”
William Smythe, a board member who voted against the rules, agreed that guidelines are needed, but objected to the use of the procedures without additional research.
He added: “If Texas wants to be a leader in this area, there are other ways to do this. You want to add a layer of protection? Put a moratorium on the use of these agents until they’re proven.”