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...