Texas stem cell rules may impede clinical research

The Lancet, Carrie Arnold, Volume 379, Issue 9828, May 12, 2012.
Stem cell researchers in the USA and abroad are reeling from new laws in Texas that commercialise experimental procedures and could attract patients away from clinical trials. Carrie Arnold reports.
New regulations on the experimental use of adult stem cells recently passed by the Texas Medical Board has returned the ethos of the Wild West to the Lone Star State. Supporters of the rules believe they offer patients seeking stem cell therapies a modicum of protection in a semi-lawless environment, but opponents believe that these regulations actually put patients at greater risk. What is more, critics say, these guidelines could actually hold back progress in stem cell research.
“I think it’s outrageous”, said Leigh Turner, a bioethicist from the University of Minnesota, MN, USA, who testified at the medical board’s hearings. “Some of what takes place may not be credible research. It’s going to be unproven interventions sold for profit with the veneer of a clinical trial.”
The regulations give Texas doctors “a reasonable and responsible degree of latitude in the use of investigational agents”, which allows them to offer experimental stem cell procedures without first getting formal approval from the US Food and Drug Administration (FDA). Texas doctors will have to seek approval from an Institutional Review Board (IRB) and obtain informed consent from patients about the experimental nature of the procedure before they can begin. Read more