Austin, TX, February 10, 2012 (Houston Chronicle) - The Texas Medical Board Friday approved a tentative policy regulating the use of adult stem cells, the experimental therapy Gov. Rick Perry drew criticism for undergoing for his ailing back last year.
Under a policy that will come up for final approval April 13, Texas doctors would be authorized to provide stem cell therapy only if an independent review committee that assesses research trials for patient safety grants permission. Perry's therapy had no such oversight.
"This policy will afford the public protection that doesn't exist now for products not approved by the Food and Drug Administration," said Dr. Irwin Zeitler, president of the board. "At the same time, it doesn't hinder progress. Hundreds of studies have shown the promise of adult stem cells."
Zeitler said the policy could be tweaked at the April meeting, but added that it's unlikely major changes will be made, given the consensus among "medical stakeholders" and the board. All 19 members of the board are Perry appointees.
The policy likely would head off potential conflict with the FDA, which recently began cracking down on unregulated stem cell businesses. Experts say the agency hasn't approved therapy using adult stem cells because their effectiveness and safety haven't been established. The agency has declined to comment on Perry's therapy.
Adult stem cells, which multiply to replenish dying cells, have long been used to treat leukemia and other cancers, but in the last decade they have shown promise for tissue repair in many other diseases. Less versatile than embryonic stem cells, they are championed by many as a more ethical alternative because no embryo is destroyed.
The therapy gained national attention after it was revealed Perry received it last summer. Houston surgeon Stanley Jones injected the governor during his July 1 back surgery and intravenously in follow-up appointments. A spokeswoman for Perry has said the results were positive.
Little discussion preceded the vote on the new policy. Board Member Dr. Charles Willeford said he was proud of the board for coming together, despite controversy, to produce a policy that will protect the public and not stifle doctors.
Experimental therapies used in hospitals, typically by academic researchers, already require review committee oversight. The proposal would make doctors who want to provide adult stem cells in practice or clinics enlist what's known as an independent review board, which follow all state and federal laws involving research on human subjects. Zeitler said such boards "aren't free," but shouldn't pose any great hardship on doctors.