AUSTIN The Texas Medical Board approved rules regulating adult stem cell therapy Friday, concerned that the proliferation of the experimental treatment Gov. Rick Perry received last year constitutes "an emergency state."
Despite opposition from some board members who said the action could put more patients at risk of harm from the unproven, unlicensed therapy, the board adopted a policy that allows doctors to use it as long as they get the patient's consent and the approval of a review board that evaluates clinical research for safety.
"We know this is far from a perfect policy, but our hope is that this affords people in Texas seeking this therapy some protection," said Dr. Irwin Zeitler, president of the board. "The wheels of federal government move so slowly - we're not willing to wait to protect our patients."
The board voted 10-4 to approve the regulations and pledged to consider improvements as soon as its June meeting. No date was set for the policy to take effect, but it will be at least 30 days, staffers said.
Zeitler, a San Angelo family practitioner, said the board couldn't afford to wait to perfect the policy because "the cat's out of the bag." Board member Dr. W. Roy Smythe responded that the policy "doesn't put the cat back in the bag - it just allows more cats to proliferate."
No embryos involved
Smythe said the intent behind the policy is good, but in practice it likely will give more doctors permission to use the therapy. He called the policy "a facade of protection."
The policy, thought to be the first of its kind, has drawn criticism nationally and internationally for seemingly circumventing the Food and Drug Administration and for making the therapy commercially available before it has been proved safe and effective. Patients typically must pay tens of thousands of dollars for the treatment, which the FDA last year filed an injunction to stop a Colorado clinic from using.
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.
They are considered five to 10 years away from FDA approval.
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Medical board approves controversial adult stem-cell rules
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