Texas stem-cell bill won’t end controversy over safety, efficacy
Published 10:30 am Wednesday, June 7, 2017
- test tube
AUSTIN — Wiping away tears, Rep. Drew Springer made a dramatic speech in the last days of the just-ended legislative session, urging lawmakers to approve “investigational” stem-cell treatments in Texas.
The Muenster Republican told House members that such therapies might offer folks such as his wife, who suffered a spine injury and has for decades used a wheelchair, a chance to walk again.
But critics say that by becoming the first state to approve the procedures, Texas may expose vulnerable patients to snake-oil salesmen instead of opening the door to a better life.
“For non-FDA approved offerings of for-profit clinics that often have no real data behind them and sometimes not even common sense, what are the odds of them being both safe and effective? Near zero,” Paul S. Knoepfler, a professor of cell biology and human anatomy at the University of California Davis School of Medicine said in an email. “I can understand from a patient perspective that more access can seem like a good thing, but going the non-FDA approved route is also very risky and there’s a definite financial reason the clinics like it.”
Gov. Greg Abbott’s office has not yet announced a signing date, but Abbott — a wheelchair user since a 1984 back injury — has signaled his approval of House Bill 810.
Often called “master cells,” stem cells develop into blood, brain, bones and other organs.
“Their promise in medical treatments is that they have the potential to repair, restore, replace and regenerate cells that could then be used to treat many medical conditions and diseases,” according to a U.S. Food and Drug Administration consumer update. “But the … FDA is concerned that the hope that patients have for cures not yet available may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful.”
An FDA spokeswoman said in an email that the agency did not “have comment/perspective to provide regarding the legislation in Texas,” but Preston Walker, 47, said stem-cell treatments he received in Costa Rica cleared the “cognitive cloud” that multiple sclerosis cast over him.
In the U.S., the only stem cell-based product approved by the FDA is “a cord blood-derived product manufactured by the New York Blood Center and used … in patients with disorders affecting the body’s blood-forming system,” according to the FDA consumer update.
Physicians used stem cells derived from fat in his own body to treat Walker, a 27-year Fort Worth Police Department veteran.
“Nobody promised a cure,” Walker said. “But some of the symptoms lessened.”
The first treatment cost Walker about $20,000, which wasn’t covered by insurance.
A series of benefits helped defray the cost.
Springer said that clearing the way for Texas physicians to perform similar procedures here would help those who can’t or won’t leave the U.S. for treatment, even if they outcome isn’t a cure, but improved quality of life.
“You can’t just say no because some people might lose their money,” Springer said. “Sometimes perfection gets in the way of good.”
Springer plans to travel to Washington, D.C., to lobby federal officials “not to interfere” with Texas when the law takes effect.
Still, the president of the International Society for Stem Cell Research, in a letter to Texas lawmakers, cautioned that the law could cost more lives than it saves.
“Patients have been harmed as a result of receiving unproven cell therapies from physicians in the United States, with serious outcomes including blindness and paralysis,” Sally Temple, the ISSCR president, wrote.
Leigh Turner, a professor at the University of Minnesota’s Center for Bioethics, School of Public Health and College of Pharmacy, said the Texas law “is not as bad as it could be,” because legislators listened to “meaningful internal criticism.”
Yet Turner’s reservations remain.
“Choice is important, but some protections are also important to curb the worst excesses of the marketplace,” Turner said. “We don’t make individual consumers get on an airplane and test everything themselves.”
John Austin covers the Texas Statehouse for CNHI’s newspapers and websites. Reach him at jaustin@cnhi.com.