First US Hub For Experimental Medical Treatments Is Coming (technologyreview.com) 37
Montana has passed a bill allowing licensed clinics to offer experimental medical treatments that haven't been approved by the FDA, provided the drugs have passed phase I safety trials. MIT Technology Review reports: The bill, which was passed by the state legislature on April 29 and is expected to be signed by Governor Greg Gianforte, essentially expands on existing Right to Try legislation in the state. But while that law was originally designed to allow terminally ill people to access experimental drugs, the new bill was drafted and lobbied for by people interested in extending human lifespans -- a group of longevity enthusiasts that includes scientists, libertarians, and influencers. These longevity enthusiasts are hoping Montana will serve as a test bed for opening up access to experimental drugs. [...]
Supporters of the bill say it gives individuals the freedom to make choices about their own bodies. At the same event, bioethicist Jessica Flanigan of the University of Richmond said she was "optimistic" about the measure, because "it's great any time anybody is trying to give people back their medical autonomy." Ultimately, they hope that the new law will enable people to try unproven drugs that might help them live longer, make it easier for Americans to try experimental treatments without having to travel abroad, and potentially turn Montana into a medical tourism hub.
But ethicists and legal scholars aren't as optimistic. "I hate it," bioethicist Alison Bateman-House of New York University says of the bill. She and others are worried about the ethics of promoting and selling unproven treatments -- and the risks of harm should something go wrong. [...] At any rate, the clinics are coming to Montana, says [Dylan Livingston, founder and CEO of the Alliance for Longevity Initiatives]. "We have half a dozen that are interested, and maybe two or three that are definitively going to set up shop out there." He won't name names, but he says some of the interested clinicians already have clinics in the US, while others are abroad."
Mac Davis -- founder and CEO of Minicircle, the company that developed the controversial "anti-aging" gene therapy -- told MIT Technology Review he was "looking into it." "I think this can be an opportunity for America and Montana to really kind of corner the market when it comes to medical tourism," says Livingston. "There is no other place in the world with this sort of regulatory environment."
Supporters of the bill say it gives individuals the freedom to make choices about their own bodies. At the same event, bioethicist Jessica Flanigan of the University of Richmond said she was "optimistic" about the measure, because "it's great any time anybody is trying to give people back their medical autonomy." Ultimately, they hope that the new law will enable people to try unproven drugs that might help them live longer, make it easier for Americans to try experimental treatments without having to travel abroad, and potentially turn Montana into a medical tourism hub.
But ethicists and legal scholars aren't as optimistic. "I hate it," bioethicist Alison Bateman-House of New York University says of the bill. She and others are worried about the ethics of promoting and selling unproven treatments -- and the risks of harm should something go wrong. [...] At any rate, the clinics are coming to Montana, says [Dylan Livingston, founder and CEO of the Alliance for Longevity Initiatives]. "We have half a dozen that are interested, and maybe two or three that are definitively going to set up shop out there." He won't name names, but he says some of the interested clinicians already have clinics in the US, while others are abroad."
Mac Davis -- founder and CEO of Minicircle, the company that developed the controversial "anti-aging" gene therapy -- told MIT Technology Review he was "looking into it." "I think this can be an opportunity for America and Montana to really kind of corner the market when it comes to medical tourism," says Livingston. "There is no other place in the world with this sort of regulatory environment."
Test cancer treatments on dying cancer victims (Score:1)
That option should be available to everyone ( of sound mind ).
Re:Test cancer treatments on dying cancer victims (Score:5, Informative)
Did you actually read TFS?
They already had a law on the books for people looking for actual last-ditch efforts to treat deadly diseases. This is just people with far shallower ambitions.
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Did you actually read TFS?
They already had a law on the books for people looking for actual last-ditch efforts to treat deadly diseases. This is just people with far shallower ambitions.
If a bunch of longevity luddites want to freeze themselves in Montana, who are they to turn away good tax revenue for the state?
And for those professionals that “hate” this idea, I’m pretty sure all the adults in the room wanting to become infamous ice cubes can be convinced to do so with a standard liability waiver absolving everyone else. Even the guy refilling the ice machine.
If the sceptics are worried due to ethics, then we should find every one of them vehemently against plastic sur
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Yes. That option should be available to everyone ( of sound mind ). As I wrote.
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When I get a terminal cancer diagnosis, I will be happy to have experimental treatments tested on me
Yes, and people do that all the time right now. But those are experimental treatments that have shown some efficacy through initial scientific research, not just any old thing that a huckster can sell. It seems this will likely make Montana the snakeoil capital of the world, with the primary goal of separating the desperately sick from their money rather than developing new therapies for disease. The law should come with the stipulation that you cannot charge patients or their families or insurance for any
Geeesh this isn't what we meant (Score:5, Funny)
When we joked about the world ending in 2025 we meant it would be because Trump starts a nuclear war not because Montana starts the zombie apocalypse!
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When we joked about the world ending in 2025 we meant it would be because Trump starts a nuclear war not because Montana starts the zombie apocalypse!
Montana... where you can be implanted with pig kidneys and given untested pharmaceuticals but perfectly safe birth control is banned.
However Montana is the perfect place if you wanted to start a zombie outbreak as no-one will notice the difference until the horde reaches British Colombia.
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These trials should be televised and have odds boards in Vegas.
A reason to bring back ESPN 8 - The OCHO!
Phase I is not enough. (Score:5, Informative)
Re: (Score:2)
Then stop preventing them from testing their new drugs on dogs, cats, pigs, cows, and other animals.
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The FDA was created to address snake oil. The rules are that you must prove efficacy(the drug does what it says it's going to do) and safety. Uncommon side effects will only rarely be found in phase I trials. The opportunity to take small studies and wildly extrapolate will be exploited to someones benefit. That someone may or may not be the patient. I hope there is at least a documentation burden that makes them keep track of side effects.
Undortunately the ethics of the FDA died with snake oil.
(Post-COVID lawsuit-free America) ”Documentation? The fuck would I need that for?”
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The FDA was created to address snake oil. The rules are that you must prove efficacy
Only for new drugs. For variants of old drugs, which are still considered new as far as patent protection goes, you only have to prove that they do not kill statistically significantly more people than the drug they're based on. Then you market the new drug and allow some papers to be published saying the old drug is unsafe and that gets you to step 3, profit.
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This is a horrible plan on so many levels.
An investigational treatment that has passed Phase I only has the most basic pharmacokinetic and safety data gathered. There's virtually no efficacy data. The layman who thinks that patients with serious and unmet medical needs should have access to such treatments before efficacy is established, believes so because "what other options do they have?" Their logic is that they should be "free" to try anything.
But the primary reason why this logic is flawed is becau
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> The FDA was created to address snake oil. The rules are that you must prove efficacy(the drug does what it says it's going to do) and safety.
FDA was created to address fraud and improper labeling. Food and Cosmetics Act.
The Safteyism Regime popped up after a media psyop about Thalidomide in the 60's which was only ever marketed in Europe. To noone's surprise it cemented power and profit in the hands of the richest Pharma companies.
There are Type I and Type II errors in this field, both of which can b
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Birth defects due to thalidomide approval outside of the US were extensive, and you conveniently ignore this. That wasn't some media psyop: 20000 affected embryos for a drug marketed to prevent morning sickness is not something to trivialize, and the fact that it was not approved in the US meant that many American families were spared this horror.
It's ironic that you mention Type I and Type II errors, yet conclude--without any apparent consideration of such errors as they apply to the establishment of eff
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The FDA was created to address snake oil.
Ya, but RFK, Jr. is now in charge of HHS and he's "Mr. Snake Oil" ... who (literally) swims in sewage runoff.
Germ-theory skeptic RFK Jr. goes swimming in sewage-tainted water [arstechnica.com]
witch doctors (Score:2, Insightful)
medicine men, ratfucks and brainworm
the USA of the 21 century
Is it going to be called The Darwin Clinic (Score:4, Insightful)
Re: (Score:2)
No, it will be called The Darwin Clinic because of the weird resistant bacteria that will escape out of there.
Conman central. (Score:5, Interesting)
I'm waaaay less concerned about unproven treatments going terribly wrong than about the shear volume of outright con-jobs that this will produce. People with a terminal prognosis are easy targets that have bee preyed upon for time immemorial. This is going to be a crime hub, not a medical hub.
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Exactly this. I have no problem with a terminal patient wanting to try a Hail-Mary experimental treatment. I'm concerned about the entire industry of conmen trying to sell fake cures in place of actual medicine.
You know what would make this work? Require that any treatment given under this program be free, cost covered entirely by the clinic and/or whatever company is developing the treatment. If it's truly an experimental treatment, something intended to eventually get approval and be made generally ava
Most drugs are useless .. (Score:3)
“It is no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines.”
“I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor at the New England Journal of Medicine. But I am convinced that the case for the superiority of [many] drugs has not been proven.”
Re:Most drugs are useless .. (Score:5, Insightful)
This is throwing the baby out with the bathwater. The problems Horton describes in the second quote are "small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance". Every single one of those issues is going to be made worse by this move.
Absolutely not (Score:5, Informative)
If women don't have control over their bodies, neither should men. There's a woman who is bain dead being kept alive, so far for three months, because she happened to be pregnant and Georgia state law will not allow the doctors to do their job [newsweek.com]. Essentially, the state is treating this dead woman as a vessel to force out a baby, all the while burdening the family with the cost of keeping her alive AND the subsequent cost of the child. That child has large amounts of fluid on its undeveloped brain which means it probably won't even survive once its forced out of the dead body, but that financial burden will also fall on the family.
The same thing would happen in Montana if the situation arose. If women can't do what they want with their bodies, a bunch of whiny cunts shouldn't be able to either.
Re:Absolutely not (Score:5, Interesting)
Well that's a difficult case, and you're going to have people angry either way...
You have no idea yet if the baby would be viable, nor is it possible to tell what the mother's wishes would be.
Re:Absolutely not (Score:4, Insightful)
You have no idea yet if the baby would be viable
If the baby lives, and if it lives long enough to grow up, it's going to grow up to be the kind of person that Donald Jakov Trump mocks at rallies. The kind of person that Cheeto Benito is cutting funding for so the family won't be able to afford their necessary medical care.
It's not a "case", it's a travesty. People who think it's okay to do this are "cases".
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Clearly the GP thinks that the brain isn't important. He also appears to be being true to his views with the quality of his comments too.
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It's just a trial run of Axlotl tanks.
Sounds like the Hoffman Center (Score:2)
Alan E Nourse wrote about the Mercy Men
Snake oil (Score:2)
My elixir will cure all ills! It will make men virile and women irresistible. It will cure gout and arthritis. It will soothe pustulating ulcers. It will cleanse and regulate the liver. It will add 15 years to your lifespan!
Guaranteed safe by Montana state law, which requires a Phase I trial involving 20 people. All my friends and relatives have used it, and they are still alive!
Pill Mills (Score:2)
Thalidomide (Score:2)
I guess it's been over 60 years, and everyone has forgotten about babies born with deformed limbs...
Phase 1 is a super low safety bar to clear. (Score:2)
Phase 1 trials can consist of as few as twenty subjects, although fifty is more common. It's basically there to make sure you don't kill or injure hundreds of test subjects in the larger trials with the dosage and protocol you intend to use. Only about a quarter of drugs which are rejected as unsafe are rejected at Phase 1. There have been drug trials halted because they killed dozens of people *in phase 3*.
Ultimately just 10% of drugs that pass Phase 1 get approved. The rest are either too dangerous o
Snake Oil for sale (Score:2)
Get your Marvelous Magical Mystery Oil here! One spoonful a day is guar-an-teed to cure what ails you. It will put the pep in your step, the will-do in your willy, and hair on your head. Step right up sir, and get yours before supplies run out and prices go up. This formula is straight from our lab. So advanced that the FDA doesn't understand how it works, and were not gonna tell 'em! This is just between you and me. Today only!