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President Trump signs right to try law

tygeezy

Senior member
Aug 28, 2012
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Today trump signed into law given terminally ill patients the right to try experimental drugs:

"The "right to try" measure will let patients who have exhausted other options access drugs in early stages of FDA review. Trump has frequently noted his support for the idea, most recently during his State of the Union address in January. "

https://www.wfmynews2.com/mobile/article/news/nation-now/president-trump-signs-right-to-try-law-to-get-experiment-drugs-for-terminal-patients/465-c036ce19-f1be-4ba9-b70d-b1ed9e8479a6
 

TheVrolok

Lifer
Dec 11, 2000
23,463
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Agreed, I don't think anybody would have qualms with someone trying something experimental as a last ditch effort.
Maybe. I'm not entirely sure how I feel about it yet. There are some more complex ethical elements here than it may seem on the surface. There may also be some risk of muddying the waters of scientific research. I hope these are all issues that could be hammered out in the law (although my faith in congress is limited) as I I think my gut favors this law.
 
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jackstar7

Lifer
Jun 26, 2009
11,679
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I'm baffled that this needed to be legislated, and now kinda concerned what else might be in there, but overall, glad it's law.
 

zinfamous

No Lifer
Jul 12, 2006
105,910
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Good. There are situations where I find the burdensome, delayed demand for highly controlled, double-blind, insurance-mandated qualifications for terminally ill patients to be wholly unnecessary..

And from a data standpoint, I'm sorry, but randomly assigning sugar pills to some of the patients that will be dead anyway isn't going to tell you anything you don't already know and, in the end, makes no difference for these patients either way. Humans aren't rats or mice, regardless of what I think about the necessity of significant data--if you have a drug that shows 70% or more success in such patients, then I find it wholly unethical to withhold that from a randomized population that would otherwise survive, if not given a placebo.

....now that probably isn't specifically related to this measure, as it's just part of the study models, but this measure is a start.
 
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SMOGZINN

Lifer
Jun 17, 2005
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Maybe. I'm not entirely sure how I feel about it yet. There are some more complex ethical elements here than it may seem on the surface. There may also be some risk of muddying the waters of scientific research. I hope these are all issues that could be hammered out in the law (although my faith in congress is limited) as I I think my gut favors this law.
To be all serious, the real problem here is that there is real question about how desperation affects the choice of treatments. Experimental treatments are experimental because we don't know if they work, and how well they do. Who exactly is going to get to decide what is a legitimate 'experimental treatment' that has some chance at helping and what is profiteering off of desperation.

Desperate people can be easy marks for unethical people, and they can do a lot of harm to desperate people and their families, not the least by convincing them to attempt ineffective 'treatments' that at best do nothing, and at worst are actively harmful to their condition. You might think it doesn't matter because they are already terminal, but believe me to them and their family those extra weeks or months matter.
 
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TheVrolok

Lifer
Dec 11, 2000
23,463
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To be all serious, the real problem here is that there is real question about how desperation affects the choice of treatments. Experimental treatments are experimental because we don't know if they work, and how well they do. Who exactly is going to get to decide what is a legitimate 'experimental treatment' that has some chance at helping and what is profiteering off of desperation.

Desperate people can be easy marks for unethical people, and they can do a lot of harm to desperate people and their families, not the least by convincing them to attempt ineffective 'treatments' that at best do nothing, and at worst are actively harmful to their condition. You might think it doesn't matter because they are already terminal, but believe me to them and their family those extra weeks or months matter.
I agree and this is just a part of the ethical discussion. Even if a patient is volunteering for a treatment, if we do not know it to be helpful (even if we don't know it to be definitively harmful physically) there can still be harm. Volunteering does not remove the ethical obligation to do no harm. Patients volunteer for harmful stuff all the time and we still say no. Certainly there are arguments on both sides of even this point, but it's not nearly as clear as I wish it could be.
 

Ken g6

Programming Moderator, Elite Member
Moderator
Dec 11, 1999
15,427
2,485
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Life is a terminal condition. I can smoke the weeds now?
Not according to federal law. This law requires the drug to have completed phase 1 trials, and to at least have phase 2 trials planned, as I understand it.

Of course, state law is a different story. ;)
 

Amused

Elite Member
Apr 14, 2001
53,924
7,048
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Just fucking great. This combined with the disastrous FDA disclaimer abdication of responsibility given to snake oil salesmen will make it even MORE open season on the desperate and scientifically illiterate.

Trump seems to feel that the government should never stand between a con man and his mark.

FFS November cannot come soon enough.
 
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GoodRevrnd

Diamond Member
Dec 27, 2001
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Didn't it kind of already work this way. Does the law just bypass the requirement for case by case FDA approval?
 

Hayabusa Rider

Admin Emeritus & Elite Member
Jan 26, 2000
50,872
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Maybe. I'm not entirely sure how I feel about it yet. There are some more complex ethical elements here than it may seem on the surface. There may also be some risk of muddying the waters of scientific research. I hope these are all issues that could be hammered out in the law (although my faith in congress is limited) as I I think my gut favors this law.
The details matter but IMO it unethical to refuse treatment to a terminal patient when there is a scientific basis for a possible benefit. It's like denying them pain relief because they die with a possible addiction.
 

Hayabusa Rider

Admin Emeritus & Elite Member
Jan 26, 2000
50,872
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Just fucking great. This combined with the disastrous FDA disclaimer abdication of responsibility given to snake oil salesmen will make it even MORE open season on the desperate and scientifically illiterate.

Trump seems to feel that the government should never stand between a con man and his mark.

FFS November cannot come soon enough.

I am completely opposed to your viewpoint if this legislation if it is as billed, something which allows treatment with things that have not passed all FDA tests. What's going to happen, they die?
 
Feb 4, 2009
30,224
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The details matter but IMO it unethical to refuse treatment to a terminal patient when there is a scientific basis for a possible benefit. It's like denying them pain relief because they die with a possible addiction.
I *think* this bill addresses the language for what is considered for what is reasonable scientific basis.
 

SMOGZINN

Lifer
Jun 17, 2005
13,285
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I am completely opposed to your viewpoint if this legislation if it is as billed, something which allows treatment with things that have not passed all FDA tests. What's going to happen, they die?
I would like to put a disclaimer that I have not yet read this bill, and so I might change my mind, but I am going to just toss some potential pitfalls of this sort of legislation.

As I said earlier, the last days and months of a terminal patient matter to them and their family. Desperate dying people make for easy marks for profiteering. Snake oil is already a major problem, this has the potential of legitimizing it.

Consider this scenario: I am the CEO of a small drug company. My company is in need a cash infusion to finish our R&D on bonerex the new designer male enhancement drug. So, I decide to hold trials on another drug my team has spitballed, a drug intended to treat leukemia based off of the chemical compounds found in rhinoceros horn and homeopathy. I fill out the proper FDA forms and get phase 1 FDA trials, because that takes little more than just filling out forms. We then produce an almost certainly useless pill that is mostly just water, advertise it heavily on late night TV and Alex Jones as a potential revolutionary cure for common types of cancer that the other administrations didn't want you to have that is just now available to you because of Trump, and sell it for $100,000 a pill.

Still think this is harmless?
 
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Puffnstuff

Lifer
Mar 9, 2005
15,365
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From what I understand this sounds like a good decision
I had to do an ethical case study on pharmaceutical companies where I learned that many conduct their clinical trials overseas to mitigate liability versus conducting them here. This sounds like its giving big pharma the green light for this at home under the guise of patient privilege.
 

Hayabusa Rider

Admin Emeritus & Elite Member
Jan 26, 2000
50,872
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I would like to put a disclaimer that I have not yet read this bill, and so I might change my mind, but I am going to just toss some potential pitfalls of this sort of legislation.

As I said earlier, the last days and months of a terminal patient matter to them and their family. Desperate dying people make for easy marks for profiteering. Snake oil is already a major problem, this has the potential of legitimizing it.

Consider this scenario: I am the CEO of a small drug company. My company is in need a cash infusion to finish our R&D on bonerex the new designer male enhancement drug. So, I decide to hold trials on another drug my team has spitballed, a drug intended to treat leukemia based off of the chemical compounds found in rhinoceros horn and homeopathy. I fill out the proper FDA forms and get phase 1 FDA trials, because that takes little more than just filling out forms. We then produce an almost certainly useless pill that is mostly just water, advertise it heavily on late night TV and Alex Jones as a potential revolutionary cure for common types of cancer that the other administrations didn't want you to have that is just now available to you because of Trump, and sell it for $100,000 a pill.

Still think this is harmless?
The report I saw is that there was already FDA testing going on with these potential candidates, which show some promise. Rhino horn, no. Something that hasn't fully gone through all stages of testing, but is science-based isn't just anything? Sure. Now consider this. Cannabis is not FDA tested and approved but people are mostly in favor of medical use regardless. On what grounds could one deny something that shows promise to a dying person and argue for medical cannabis? Is it that cannabis rarely has serious effects but people who are going to die may die?
 
Feb 4, 2009
30,224
10,753
136
I had to do an ethical case study on pharmaceutical companies where I learned that many conduct their clinical trials overseas to mitigate liability versus conducting them here. This sounds like its giving big pharma the green light for this at home under the guise of patient privilege.
I'm OK with that provided it works something like that, not an opt in and pay 3 million a year to be a test subject or opt in because we want faster drug approval or some other shenanigans.
I'm fine with someone waiving their rights in some desperate circumstances.
 

Stokely

Senior member
Jun 5, 2017
922
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I agreed with Trump on something! I agreed with Trump on something! I agreed with---*bam* killed by a meteor
 
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Amused

Elite Member
Apr 14, 2001
53,924
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I am completely opposed to your viewpoint if this legislation if it is as billed, something which allows treatment with things that have not passed all FDA tests. What's going to happen, they die?
Steve McQueen and Steve Jobs.

Both bamboozled by the fake cancer cure industry, and both died. Jobs could have lived. McQueen probably would have died either way. BOTH were bamboozled by the same scam (latril, repackaged as vitamin b17 which is basically cyanide), decades apart.

No. Just fucking no. It is opens the door for even more rampant alt-med fraud.

The FDA disclaimer is already bad enough. This country is filthy with medical scams already. And you want to make it easier for the con men? Fucking seriously???

Just look at David Wolfe's fucking Facebook page.

There is a reason the snake oil salesmen and anti-vaxxers are backing this bill. When the con men back something, you know it's shady as fuck.

You know what they call alternative medicine that works? Medicine.
 
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zinfamous

No Lifer
Jul 12, 2006
105,910
20,833
136
Just fucking great. This combined with the disastrous FDA disclaimer abdication of responsibility given to snake oil salesmen will make it even MORE open season on the desperate and scientifically illiterate.

Trump seems to feel that the government should never stand between a con man and his mark.

FFS November cannot come soon enough.
I'm assuming this has to do with FDA-approved, or at least properly-sanctioned (meaning, approved by an NIH board, medical board, meets various standardized protocols for drug development, meets proper biochemical, medical efficacy, etc) drugs and regimens. Not just that any Joe Sixpack can mix a potion of rootbeer, sorghum extract, and (dilute) methanol and legally administer it to terminally ill patients.

....Right?
 

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