Texas Stem Cell Controversy: Treatment or Trial?. When people have life-threatening or debilitating diseases for which there are few cures, or even none at all, is it right to let them undergo stem cell therapies that have not been proven safe and effective? Is it ethical or legal?
The answer to those questions is a resounding “no,” according to a number of pre-eminent scientists and institutions — including the influential scientific journal Nature and the International Society for Stem Cell Research (ISSCR). The scientists have come out in the past week to express their strong disapproval of adult stem cell regulations proposed by the state of Texas, which are up for approval this month.
The scientists say the new regulations circumvent the United States Food and Drug Administration’s oversight functions by making the experimental stem-cell therapies commercially available even before they’re proven safe and effective. The Texas Medical Board is scheduled to consider the proposed policy — believed to be the first of its kind.
“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,” Nature writes in its editorial. “Texas officials should take the FDA’s regulatory power over stem cells more seriously.”
Dr. Irving Weissman of the ISSCR says the policy violates the ISSCR’s guidelines for clinical use of adult stem cells. Dr. Weissman, who is also the director of Stanford University’s Institute for Stem Cell Biology and Regenerative Medicine, calls the draft “a clever way around the FDA’s appropriate role overseeing clinical trials.”
Texas Stem Cell Draft Policy. The draft policy was developed by the Texas medical board following the highly publicized stem-cell treatment Texas Gov. Rick Perry received last year for his back problem. It would allow Texas doctors to provide the unlicensed therapy — for as long as they have approval from a review panel that assesses the cells’ use for patient safety. This practice is customary in clinical trials. But unlike in clinical trials, where experimental therapy is provided free, the policy allows Texas doctors to charge for it — and these therapies typically cost tens of thousands of dollars.
What’s worse, experts say, the policy allows for-profit review boards to oversee doctors’ use of stem-cell therapies. This means that boards risk losing business if they don’t approve clinical research proposals, the scientists point out.
Adult stem cells are cells in the body that multiply to replenish dying cells. Unlike embryonic stem cells, they can’t transform into any kind of body tissue — blood, brain, bone and organ tissue. But after scientists have shown in recent years that many different tissue types can be derived from adult stem cells, they’ve become the focus of potential treatments for a variety of medical conditions. Such therapies, however, are mostly in early-stage clinical trials and the scientific community agrees that these are about five to 10 years away from FDA approval.
Texas Stem Cell Redundant? Critics say the proposed policy sets up a process that is redundant to the one already set 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,’ Douglas Sipp, head of Science Policy and Ethics Studies at Japan’s RIKEN Center for Developmental Biology tells the United Press International, Inc.
“Essentially, Texas is saying research can be done as treatment — that patients can be charged to participate in research,” an outraged Sipp says.
The gold standard of research is using a control in randomized– while patients receive the therapy, others receive a placebo. But the new Texas board policy will make it difficult to conduct these trials since patients paying tens of thousands of dollars for therapy wouldn’t accept a 50-50 chance of getting a placebo, Sipp points out.
Alternative path for seriously ill Texas Medical Board Executive Director Mari Robinson denies that the proposed policy circumvents the FDA. The proposed policy represents an alternative path to that of the FDA, she argues.
Claiming that there’s an absence of definitive direction from the federal regulator, Robinson says 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,” Robinson says. “The board wants to let the field come forward and grow but in a safe manner,” she claims.
But Robinson says the FDA doesn’t need to approve every therapy a doctor provides. There are there already plenty of alternative and complementary medicines regulated by the state, not the FDA, she asserts.
Stem Cell Clinics Flourish. Nevertheless, the promise stem cells holds for many debilitating or untreatable diseases — diabetes, spinal cord injuries, cerebral palsy, brain injuries, stroke, cancer and Alzheimer’s disease, to name a few — has spawned a thriving, unregulated industry in stem cell therapies that are unproven and potentially dangerous. Desperate patients are often willing to pay tens of thousands of dollars in a last ditch attempt to restore sight or other functions lost to disease.
The lucrative industry has been thriving for years — but an increasing number of clinics are popping up in the U.S. The head of a Houston stem cell bank involved in Perry’s procedure tells the Houston Chronicle, for instance, that it stored the stem cells of more than 100 customers — and as many as 50 have had the stem cells reinjected in various therapies.
Because of this, the Texas Medical Board has grappled with the issue and in February, after months of “stakeholder” discussions, public comment and revision, it approved the proposal tentatively. But numerous experts in bioethics, stem-cell science and health law last week strongly criticized the finished version.