The government of Texas will allow clinics across the state to market unapproved stem-cell therapies, in a move that has met with criticism from bioethicists.
Last week Governor Greg Abbott signed off on the new legislation that allows clinics to by-pass FDA approval for investigational stem cell treatments for patients with certain severe chronic diseases or terminal illnesses. Like “right to try” laws in other States, the Texas legislation will give desperate patients access to therapies that provide hope after traditional medical treatments have failed.
Currently, most patients wishing to have stem-cell therapy have to travel out of the country to receive it. The new law will allow people with severe chronic or terminal illness to be treated at a clinic that purports to isolate therapeutic stem cells from adult tissue—such as a patient’s own fat—if their doctor recommends it after considering all other options, and if it’s administered by a physician at a hospital or medical school with oversight from an institutional review board (IRB). It also requires that the same intervention already be tested on humans in a clinical trial.
The law sanctions a much broader set of therapies than federal rules, which already exempt certain stem cell interventions from FDA’s lengthy approval process, provided the cells are only “minimally manipulated” and perform the same function they normally have in the body.
Bioethicists have expressed their concern at the move, which they say puts patients at risk of the effects of dangerous, untested therapies.
University of Minnesota bioethicist Leigh Turner said he was sceptical about whether the clinics would be adequately monitored, while NYU Langone Medical Center bioethicist Beth Roxland said it was insufficient to have the therapies tested in clinical trials while by-passing FDA approval. “You could gain access to something [as long as it’s] being studied in a human … somewhere on the planet,” Roxland told Science, “which in the stem cell area makes it really very scary.”
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