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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?
(Score: 0) by Anonymous Coward on Sunday June 18 2017, @04:38PM (1 child)
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
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.