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posted by Fnord666 on Sunday June 18 2017, @05:21AM   Printer-friendly
from the because-Texas dept.

Texas has approved a "right-to-try" law that will allow patients access to experimental treatments as a last resort, but without FDA oversight:

Texas Governor Greg Abbott yesterday signed a bill allowing clinics and companies in the state to offer people unproven stem cell interventions without the testing and approval required under federal law. Like the "right to try" laws that have sprung up in more than 30 states, the measure is meant to give desperately ill patients access to experimental treatments without oversight from the U.S. Food and Drug Administration (FDA).

In a state where unproven stem cell therapies are already offered widely with little legal backlash, bioethicists and patient advocates wonder whether the state's official blessing will maintain the status quo, tighten certain protections for patients, or simply embolden clinics already profiting from potentially risky therapies.

"You could make the argument that—if [the new law] was vigorously enforced—it's going to put some constraints in place," says Leigh Turner, a bioethicist at the University of Minnesota in Minneapolis, who last year co-authored a study documenting U.S. stem cell clinics [DOI: 10.1016/j.stem.2016.06.007] [DX] marketing directly to consumers online, 71 of which were based in Texas. But "it would really be surprising if anybody in Texas is going to wander around the state making sure that businesses are complying with these standards," he adds. Either way, Turner says there's "powerful symbolic value" in "setting up this conflict between state law and federal law."

But are the rights of stem cells being protected?


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  • (Score: 2) by kaszz on Sunday June 18 2017, @05:47AM (3 children)

    by kaszz (4211) on Sunday June 18 2017, @05:47AM (#527363) Journal

    This kind of experimentation only makes sense if at least theoretical analysis is complete, cell culture testing is done and animal trials are complete. There seems to be some support for this in the Texas law [sciencemag.org]:

    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.

    There are some really big risks however:

    The bill doesn’t specify that a trial be conducted in the United States or that the therapy get clearance from FDA for human testing. “You could gain access to something [as long as it’s] being studied in a human … somewhere on the planet,” she says, “which in the stem cell area makes it really very scary.”

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  • (Score: -1, Troll) by Anonymous Coward on Sunday June 18 2017, @06:15AM

    by Anonymous Coward on Sunday June 18 2017, @06:15AM (#527369)

    Get behind me satan! Rape me up the anus until my prostate explodes with love of evil!

  • (Score: 0) by Anonymous Coward on Sunday June 18 2017, @06:53AM (1 child)

    by Anonymous Coward on Sunday June 18 2017, @06:53AM (#527383)

    theoretical analysis is complete

    Theoretical analysis complete in biomed? What does this consist of?

    • (Score: 0) by Anonymous Coward on Sunday June 18 2017, @03:43PM

      by Anonymous Coward on Sunday June 18 2017, @03:43PM (#527492)

      That's a huge problem right there and it's not one that's easily solved. It will eventually be solved when scientists are able to create simulators for the cells that are most important. Things like that heart on a chip that was linked a while back that can be used to verify the toxicity of treatments without having to actually expose anybody. Better computer modeling and more computing power also plays a role in all of this.

      FWIW, the toxicity issue is big, but so are the efficacy and ethical considerations. These bills are a huge problem as people with serious health problems aren't in the same position that the rest of us are when evaluating treatments. In some cases these treatments are the only glimmer of hope that these patients have and there should be controls on it.

      There's already programs for rare diseases that largely waive the requirements as the number of test subjects you would need to conduct research is pretty much the same as the population that needs the treatment.