Texas Medical Board approves new rules on the use of stem cells
The Texas Medical Board voted and approved new guidelines for experimental adult stem cell research last Friday. Their decision comes after Governor Rick Perry was injected with his own stem cells for his recovery after back surgery in July 2011; Perry appoints all members of the medical board and has strongly encouraged new guidelines for adult stem cell research.
In a letter to the medical board, Perry wrote that he hopes Texas will "become the world's leader in the research and use of adult stem cells." He also believes it will create growth for Texas by creating jobs and economic opportunity.
The new rules do not come without controversy. Critics believe they will give doctors too much freedom to practice procedures that are not wholly safe and proven, and are not federally approved.
In a letter to the medical board, Perry wrote that he hopes Texas will "become the world's leader in the research and use of adult stem cells."
The guidelines 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 Food and Drug Administration hasn’t approved using adult stem cells to help people heal from surgery, but experimentation is common.
Some scientists tout possible benefits of stem cell treatments, including treatment for heart disease, diabetes and some cancers. Others argue adult stem cell experimentation actually increases the risk of cancer and can cause blood clots.
Many scientists said the evidence of success of stem cell injections thus far is anecdotal, and advocate waiting for large, multicenter controlled clinical trial results before allowing doctors to charge patients for the procedures, which typically cost many thousands of dollars. Medical researchers agree that stem cells offer the hope that one day they will be able to cure a huge range of disorders, but that too many people are promising those cures to patients now, long before there is any solid, long-term evidence that they work.
“I think there are some real problems with these rules,” Leigh Turner, a professor at the University of Minnesota's Center for Bioethics (who commented on the rules before the board) told the New York Times. “The protective mechanism that they’re focusing on isn’t going to do very much.”
Supporters acknowledged the need for changes, like a better definition of stem cells, but they said the rules would protect Texas patients more effectively since procedures are being performed now without any oversight in medical facilities.
Of note, 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.
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.”
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, attracted criticism from Nature, a well-respected international scientific journal, who wrote 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, the medical board reportedly 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 said they improved upon 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,” Dr. Stanley Wang, a board member, stated in the New York Times report. In addition, he said, the new rules add at least the layer of institutional review board approval before a doctor can act.