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 Texan rules could put patients at risk.

On 13 April, the Texas Medical Board voted to accept rules 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 Leigh Turner, a bioethicist at the University of Minnesota in Minneapolis who had urged the board to reject the proposed rules. He worries that they will “provide cover” for clinics that sell unproven therapies.

In December, the FBI made a series of arrests in Texas in connection with the sale of unproven stem cell treatments. Controversy over experimental treatments has even reached the office of Texas governor Rick Perry, who last year received injections of his own stem cells during surgery on his back.


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 (IRB) that provides ethical review for research involving human volunteers. That is a worry, says Turner, given concerns about the quality of some IRBs, 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, treatments involving stem cells count as experimental drugs. This means that trials must be part of an application to bring a new drug to market.

“We have regulatory authority over stem cells,” says Rita Chappelle, a spokeswoman for the FDA. “We don’t comment on state regulations. However, they have to be as stringent as the FDA’s or more so.”