DON’T mess with Texas? The US government may have little choice now that the Lone Star State has adopted stem cell rules that seem to clash with federal regulations. Critics say the new rules could put patients at risk.
On 13 April, the voted to intended to give doctors “a reasonable and responsible degree of latitude” in using experimental stem cell therapies.
This latitude is too broad, critics argue. “They seem to have taken experimental research and swept it into the practice of medicine,” says , a bioethicist at the University of Minnesota in Minneapolis who had urged the board to . He worries that they will “provide cover” for clinics that sell unproven therapies.
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“They seem to have taken experimental research and swept it into the practice of medicine”
The new rules state that stem cells can be used if they are part of a study approved by the federal government, or if the protocol has been approved by an Institutional Review Board that provides ethical review for research involving human volunteers. That is a worry, says Turner, given concerns about the , especially those with commercial ties.
The rules may also bring Texas into conflict with the US Food and Drug Administration, which says that, in most cases, stem cell trials must be part of an application to bring a new drug to market.