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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?


Original Submission

Related Stories

President Trump Signs "Right to Try" Bill 36 comments

Trump signs 'right to try' drug bill

President Trump signed a bill Wednesday allowing terminally ill patients access to experimental medical treatments not yet approved by the Food and Drug Administration (FDA). Dubbed "right to try," the law's passage was a major priority of Trump and Vice President Pence, as well as congressional Republicans.

"Thousands of terminally ill Americans will finally have hope, and the fighting chance, and I think it's going to better than a chance, that they will be cured, they will be helped, and be able to be with their families for a long time, or maybe just for a longer time," Trump said at a bill signing ceremony at the White House, surrounded by terminally ill patients and their families.

Trump thanked lawmakers sitting in the audience who sponsored the bill, including Sen. Joe Donnelly, a vulnerable Democrat up for reelection in Indiana.

Also at CNN.

Related: What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
Texas Sanctions FDA-Unapproved Stem Cell Therapies
Drug Approvals Sped Up in 2017

Also submitted by mrpg


Original Submission

Politics: Koch-Backed Groups Urge Congress to Pass "Right to Try" Legislation 56 comments

Groups funded by Charles and David Koch have launched ad campaigns aimed at urging Congress to pass legislation that would make it easier for terminally ill patients to try experimental treatments. The bill passed the Senate unanimously, but FDA Commissioner Scott Gottlieb told the House in October (archive) that the FDA already approves 99% of requests for expanded access/compassionate use, and that the primary roadblock is not the FDA, but drug supply constraints. He said that pharmaceutical companies do not continuously manufacture a drug undergoing clinical trials, but instead produce "discontinuous batches":

Several deep-pocketed political advocacy groups founded by Charles and David Koch are ramping up their advocacy before Congress on a niche issue: access to experimental drugs.

On Monday, several Koch-backed groups, including Freedom Partners and Americans for Prosperity, launched an ad campaign urging Congress to pass so-called "right-to-try" legislation, which aims to help terminally ill patients access experimental treatments that haven't yet been approved by the Food and Drug Administration. The Senate unanimously passed a right-to-try bill from Sen. Ron Johnson (R-Wis.) last August, but it has since stalled in the House. Supporters, including lawmakers on Capitol Hill and other off-the-Hill advocates, are focusing their efforts this month on the Energy and Commerce Committee, which would likely have to clear the legislation before the full House could vote on it.

The new ad campaign — also sponsored by Generation Opportunity and The LIBRE Initiative — directly addresses Congress, saying at the end of one commercial, "Congress, give patients a chance. Pass right to try." In addition to a series of digital ads focused on D.C. and key congressional districts, the campaign will include lobbying efforts by the groups, according to a press release. In a letter sent Monday to Committee Chairman Greg Walden (R-Ore.), executives wrote, "We strongly urge your committee to act expeditiously to approve Right to Try legislation and send the bill to the House Floor for a full vote."

Johnson told STAT he's doing everything he can this month to get the legislation passed, and suggested the vice president might become even more engaged. Vice President Mike Pence has supported right-to-try efforts since he signed a similar law as governor of Indiana.

S.204 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017

Related: What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
FDA Nominee is a Proponent of "Adaptive Trials"
Texas Sanctions FDA-Unapproved Stem Cell Therapies
University Could Lose Millions From "Unethical" Research Backed by Peter Thiel
"Black Hole" of Accountability for Drug Trials Flouting FDA Oversight?
Drug Approvals Sped Up in 2017


Original Submission

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  • (Score: 0) by Anonymous Coward on Sunday June 18 2017, @05:28AM

    by Anonymous Coward on Sunday June 18 2017, @05:28AM (#527355)

    Trumpland for Coal Miners

  • (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.”

    • (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.

  • (Score: 3, Interesting) by n1 on Sunday June 18 2017, @06:38AM

    by n1 (993) on Sunday June 18 2017, @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 2017, @06:59AM (2 children)

    by stormwyrm (717) on Sunday June 18 2017, @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.

    --
    People don't like to think. If one thinks one must reach conclusions. Conclusions are not always pleasant.
    • (Score: 0) by Anonymous Coward on Sunday June 18 2017, @05:57PM

      by Anonymous Coward on Sunday June 18 2017, @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 2017, @01:33AM

      by PartTimeZombie (4827) on Monday June 19 2017, @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 2017, @02:23PM (2 children)

    by bzipitidoo (4388) on Sunday June 18 2017, @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 2017, @04:38PM (1 child)

      by Anonymous Coward on Sunday June 18 2017, @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 2017, @10:23PM

        by leftover (2448) on Sunday June 18 2017, @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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