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posted by Fnord666 on Sunday June 18, @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: 0) by Anonymous Coward on Sunday June 18, @05:28AM

    by Anonymous Coward on Sunday June 18, @05:28AM (#527355)

    Trumpland for Coal Miners

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

    by kaszz (4211) on Sunday June 18, @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.”

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

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

      by Anonymous Coward on Sunday June 18, @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, @03:43PM

        by Anonymous Coward on Sunday June 18, @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.

  • (Score: 3, Interesting) by n1 on Sunday June 18, @06:38AM

    by n1 (993) Subscriber Badge on Sunday June 18, @06:38AM (#527381) Journal

    Been a while since i've seen 'sanctions' used in it's permissive context, rather than the usual fare in regard to Russia, Iran, North Korea and the like.

  • (Score: 4, Informative) by stormwyrm on Sunday June 18, @06:59AM (2 children)

    by stormwyrm (717) Subscriber Badge on Sunday June 18, @06:59AM (#527385) Journal

    Looks like this is going to really put the steam into Stanislaw Burzynski [scienceblogs.com], despite repeated attempts by the FDA and the Texas Medical Board to shut his cancer quackery operation down over the years. Here's a rundown [csicop.org] of what this bozo has been doing up to around 2014. Seems that this new law might make stopping him from bilking the most desperate of their money even harder.

    --
    The right to believe whatever you want does not mean that whatever you want to believe is right.
    • (Score: 0) by Anonymous Coward on Sunday June 18, @05:57PM

      by Anonymous Coward on Sunday June 18, @05:57PM (#527536)

      i'm not reading all of that bullshit but the only thing that matters if if he's lying to people or not. if he's not, then i don't give a shit. people can choose their own goddamn medical quackery. if you think the establishment western medicine is not at least a certain percent barbaric quackery, you're a dumb ass.

    • (Score: 2) by PartTimeZombie on Monday June 19, @01:33AM

      by PartTimeZombie (4827) on Monday June 19, @01:33AM (#527678)

      That Stanislaw Burzynski fellow seems an awful lot like Milan Brych [wikipedia.org] who killed an awful lot of people with his brand of quackery.

  • (Score: 2) by bzipitidoo on Sunday June 18, @02:23PM (2 children)

    by bzipitidoo (4388) Subscriber Badge on Sunday June 18, @02:23PM (#527463) Journal

    I like the idea of clearing away bureaucratic obstacles. But in this case, better be real careful.

    Desperately ill and dying people are among the ripest for scams, medical and otherwise, and I'm not at all sure this provides sufficient protection from that. Stem cell treatments could become the snake oil of the 21st century. Real snake oil from the right kinds of snakes actually works [scientificamerican.com], the problem was that so many con artists sold the wrong kind or just faked it.

    • (Score: 0) by Anonymous Coward on Sunday June 18, @04:38PM (1 child)

      by Anonymous Coward on Sunday June 18, @04:38PM (#527517)

      What I'd like to see is less regulation on the products themselves and more on the market of the products. Snake oil salesmen are not a problem. Snake oil salesmen claiming things about the oil that have no real justification in reality are the problem.

      For instance imagine if when you bought a drug you were granted a unique token enabling you to provide input on a site managed by a third party - likely government. Users would be able to provide text feedback as well as rating the efficacy of the product. No genuine feedback would ever be removed. And anybody could go to this site and see user feedback as well as the total number of users that could have left feedback (leaving it up to them to judge what the unspoken would have said). The next thing would be to stop the whole burn one businesses' rep and just start another with a clean slate. Drugs would be listed not just by company but by primary investors in the company (as well as anybody else with a compelling financial interest) that created them as well as the entire executive board.

      Really it's just taking Amazon reviews to a new level. Amazon, for instances, sells a lot of poorly made Chinese crap on their site and it's not a problem at all. It gets a reputation as such incredibly quickly. The reason this is so hard for other industries is a lack of centralization. Amazon's scale generally enables a rapid approach on meaningful reviews for even the most esoteric products. If it works, why not apply it elsewhere?

      • (Score: 2) by leftover on Sunday June 18, @10:23PM

        by leftover (2448) on Sunday June 18, @10:23PM (#527623)

        Excellent idea! This could completely bypass the role of many industry-captured government regulators and good riddance. The next step would be to give these mechanisms some enforcement teeth without involving the federal government. Something like the Interstate Commerce Commission that would itself be monitored by feedback from those directly affected.

        One required capability would be to block industry shills or, better yet, expose them to ridicule or stoning as appropriate.

        --
        Bent, folded, spindled, and mutilated.
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