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 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,” Nature said in an editorial. “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 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,” Robinson said. “The board wants to let the field come forward and grow but in a safe manner.”
Robinson, a lawyer, said the courts ultimately might provide the answer about the FDA’s jurisdiction. The agency last year filed an injunction to stop a Colorado clinic from treating patients with their own stem cells, arguing that 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.
Nevertheless, clinics that claim adult stem-cell therapy can treat conditions from Parkinson’s disease to multiple sclerosis are proliferating, mostly in other countries but increasingly in the United States. The head of a Houston stem cell bank involved in Perry’s procedure says it has stored the stem cells of more than 100 customers, as many as 50 of whom have had them reinjected.
The Texas Medical Board has grappled with the issue since before a Houston surgeon treated Perry last July. Its policy was tentatively approved in February, after months of “stakeholder” discussions, public comment and revision.
But numerous experts in bioethics, stem cell science and health law last week criticized the finished version. Most expressed concern about why Texas feels the need to set up a process they described as redundant because of the one already run by the FDA.
“It also confuses clinical research, which is conducted to find out generalized information about new therapies’ safety and efficacy, with the practice of medicine, which is about using safe, proven methods to treat ailments,” said Douglas Sipp, head of Science Policy and Ethics Studies at Japan’s RIKEN Center for Developmental Biology. “Essentially, Texas is saying research can be done as treatment, that patients can be charged to participate in research.”
Robinson disputed the suggestion that every therapy a doctor provides requires FDA approval. She said there already are plenty of alternative and complementary medicines regulated by the state, not the FDA.
Sipp said the policy would make it difficult to conduct randomized trials, the gold standard of research in which some patients receive the therapy and some receive a placebo. Patients paying tens of thousands of dollars for therapy likely wouldn’t accept a 50-50 chance of getting a placebo, he noted.
Experts also questioned the policy’s allowance of for-profit review boards to oversee doctors’ use of stem cell therapies, claiming such boards risk losing business if they don’t approve clinical research proposals. In 2009, a congressional sting operation caught such a board approving bogus and falsified application materials.
The Texas Medical Board is scheduled to consider the proposed policy Friday. The board must either adopt it or start its policy publication process over if it finds a need for further revision.
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