By MINJAE PARK
Published: April 13, 2012
AUSTIN, Tex. — 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. Mr. 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.”
Mr. 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 on Friday 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 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, a state publication, 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 Texas Register and stakeholders had provided feedback, the medical board could not make major changes on Friday and faced a simple choice: accept or reject the rules.
Even some board members who voted to accept the rules agreed that they were not 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 Dr. Stanley Wang, a board member. He added that the new rules add at least the layer of institutional review board approval before a doctor can act.
Dr. 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.
“If Texas wants to be a leader in this area, there are other ways to do this,” Dr. Smythe said. “You want to add a layer of protection? Put a moratorium on the use of these agents until they’re proven.”
Minjae Park writes for The Texas Tribune, which produces a twice-weekly local section in the Texas editions of The New York Times.