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Texas board approves controversial stem-cell therapy
April 13, 2012 Updated: April 13, 2012 11:05 p.m.
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Texas board approves controversial stem-cell therapy
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."
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.
The therapy gained increased attention after Perry received it last summer. The governor's cells were stored by Houston company Celltex Therapeutics, then injected during his July 1 back surgery by Houston orthopedist Dr. Stanley Jones .
Celltex attorney Nathan Kottcamp , testifying in favor of the rule, downplayed board members' fear of new stem cell labs running rampant. He could not answer questions about the number of injections Celltex has been involved in, but after the meeting stressed that harvesting stem cells is a complex process that few companies can manage.
David Eller , Celltex's co-founder, said last month that the company has stored the stem cells of about 100 patients, and as many as 50 have been injected. The numbers at the state's other major stem cell bank, in Dallas, are not known.
During the public comment period, University of Minnesota bioethicist Leigh Turner called it "worrisome" that Texas is becoming known as the No. 2 place to get stem cell therapy after Mexico. Turner lodged a complaint with the FDA regarding Celltex last month.
He warned that the regulations' allowance of independent, for-profit review boards would result in doctors shopping around for boards that would approve their project.
One for-profit Colorado board , Coastal IRB, in 2009 was caught approving bogus, falsified application materials in a congressional sting.
In adopting the policy, the board said it didn't want to keep the status quo for another four months that revision would require under agency rules.
Dr. Scott Holliday , an anesthesiologist from Arlington, called it "the wild, wild West right now" and Dr. Stanley Wang , an Austin cardiologist, added, "Right now we've got essentially an emergency state."
Smythe, a Temple surgeon who said he's against giving patients false hope that empties their bank accounts, responded that if it's truly "an emergency state out there, we can put a moratorium on these stem-cell therapies."
The board said it will establish a registry to track the outcomes of each stem cell treatment performed on a patient. Details of that have not yet been worked out.
Todd Ackerman was a veteran reporter who covered medicine for the Houston Chronicle. A graduate of the University of California at Los Angeles, he previously worked for the Raleigh News & Observer, the National Catholic Register, the Los Angeles Downtown News and the San Clemente Sun-Post.
Texas board approves controversial stem-cell therapy
April 13, 2012 Updated: April 13, 2012 11:05 p.m.
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Texas board approves controversial stem-cell therapy
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."
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
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