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Houston (UPI) Apr 9, 2012
Proposed stem-cell regulations in Texas would make the experimental therapy commercially available before it's been proven safe and effective, critics say.
A Texas Medical Board draft policy on adult stem-cell treatments is coming under fire from a number of scientists and institutions, including the scientific journal Nature and the International Society for Stem Cell Research, the Houston Chronicle reported Monday.
Critics say the proposed regulations circumvent Food and Drug Administration oversight.
"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."
The Texas policy would allow doctors in the state to provide the unlicensed therapy as long as they have approval from a review panel, as is customary in clinical trials.
But whereas most clinical trials provide experimental therapy for free, the policy would allow Texas doctors to charge tens of thousands of dollars for treatments.
Texas Medical Board Executive Director Mari Robinson has denied the proposed policy circumvents the FDA.
"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."
Critics say the policy sets up a process 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," 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."
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