Medical board’s proposed stem-cell policy under fire

Texas' proposed adult stem-cell regulations, up for approval this week, are under fire for circumventing the Food and Drug Administration and making the experimental therapy commercially available before it's been proven safe and effective.

The criticism of the Texas Medical Board draft policy, developed in the aftermath of Gov. Rick Perry receiving stem-cell treatment for his back problems, is coming from a host of pre-eminent scientists and institutions, including the influential scientific journal Nature and the International Society for Stem Cell Research.

"Texas officials should take the FDA's regulatory power over stem cells more seriously," editorialized Nature. "If the medical board were to act according to its stated pledge to protect patients, then it would make clear the need for clinical validation of adult stem cells before use and rescind the medical licenses of any doctors in breach of rules about using unapproved treatments."

Dr. Irving Weissman of the ISSCR called the draft "a clever way around the FDA's appropriate role overseeing clinical trials." Weissman, director of Stanford University's Institute for Stem Cell Biology and Regenerative Medicine, said the policy violates the ISSCR's guidelines for clinical use of adult stem cells.

The policy, thought to be the first of its kind, would allow Texas doctors to provide the unlicensed therapy as long as they have approval from a review panel that assesses the cells' use for patient safety, as is customary in clinical trials. But unlike most clinical trials, in which experimental therapy is provided free, the policy would allow Texas doctors to charge for it, typically tens of thousands of dollars.

Mari Robinson, executive director of the Texas Medical Board, denied that the proposed policy represents an alternative path than the FDA. She said that in the absence of definitive direction from the FDA, the board simply wants to ensure that "new and expanding areas of medicine" are safe for patients.

"The FDA has provided no definitive statement about the medical use of adult stem cells, including whether it even has jurisdiction if the cells are taken from patients and given back within the state," said Robinson. "The board wants to let the field come forward and grow but in a safe manner."

Robinson, a lawyer, said the courts ultimately may provide the answer about the FDA's jurisdiction. The federal agency last year filed an injunction to stop a Colorado clinic from treating patients with their own stem cells, arguing its failure to comply with FDA regulations "puts the public's health at risk."

Adult stem cells are cells in the body that multiply to replenish dying cells. Though they lack the ability of embryonic stem cells to morph into any kind of tissue, they have shown much promise in recent research treating a variety of conditions. Still, the therapy is mostly in early-stage clinical trials and considered five to 10 years away from FDA approval.

Clinics popping up

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Medical board's proposed stem-cell policy under fire