President Trump signs right to try law

[Amused]

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?

No.

Pharmaceuticals in the United States are regulated by the FDA. When a drug company develops a new compound intended for patient use, the medication goes through three phases of clinical trials that often take years to complete.

The first phase of trials requires a company to prove the drug is relatively safe for humans – that the drug itself will not poison the patient. These phase 1 trials are often conducted on as few as 30 patients.

In later phases, the clinical trials test whether the drug is effective at treating the condition for which it is intended without problematic side effects. It is at this stage that the vast majority of drugs fail to pass approval, because many drugs turn out to be ineffective or to cause severe side effects.

The right to try legislation the Trump administration pushed for would authorize doctors to administer drugs that have cleared the first phase, but which have not yet completed these later human clinical trials.

In other words, NO EFFICACY need to be proven whatsoever.

It means any quack can sell sugar pills as a cancer cure to desperate patients.

Even poison like Latril could be sold if they stage the phase one trial with small enough doses.

Fucking no. This is a con man's dream.

Signed by an anti-vaxxer.

Fuck this shit. You guys have no idea just how bad the alt-med con is here in the states. Go down that rabbit hole. It makes anti-vax look innocent.

 

[SMOGZINN]

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?

The law only requires phase 1 tests. Passing Phase 1 FDA testing only requires that the drug not be actively harmful to the patient. That is all Phase 1 testing requires, that the drug not be a poison. Phase 1 is normally conducted on healthy individuals to show that it does not make them unhealthy. Phase 1 testing is a joke. A glass of water is eligible for Phase 1 FDA.

 

[zinfamous]

No.

Pharmaceuticals in the United States are regulated by the FDA. When a drug company develops a new compound intended for patient use, the medication goes through three phases of clinical trials that often take years to complete.

The first phase of trials requires a company to prove the drug is relatively safe for humans – that the drug itself will not poison the patient. These phase 1 trials are often conducted on as few as 30 patients.

In later phases, the clinical trials test whether the drug is effective at treating the condition for which it is intended without problematic side effects. It is at this stage that the vast majority of drugs fail to pass approval, because many drugs turn out to be ineffective or to cause severe side effects.

The right to try legislation the Trump administration pushed for would authorize doctors to administer drugs that have cleared the first phase, but which have not yet completed these later human clinical trials.

In other words, NO EFFICACY need to be proven whatsoever.

It means any quack can sell sugar pills as a cancer cure to desperate patients.

Even poison like Latril could be sold if they stage the phase one trial with small enough doses.

Fucking no. This is a con man's dream.

Signed by an anti-vaxxer.

Fuck this shit. You guys have no idea just how bad the alt-med con is here in the states. Go down that rabbit hole. It makes anti-vax look innocent.

I didn't appreciate that this was about approving all Phase I drugs for use. So ah, yeah, a good no there. But honestly, if they removed the profit motive out of this, it wouldn't bother me. I'm honestly not too concerned about Phase I type tests, on whatever substance, as long as it passes a rigorous protocol and medical merit review, even if it is highly, highly experimental. And these type of tests can not be attached to any kind of payment to the entity that wants to submit them for testing.

I wonder if it's possible to restructure the profit-taking, in some manner through the trial system, so that companies are more willing to both test a slew and different methods and remove the illegitimacy of the charlatans that only need to seek $$$ for intentionally feeding poison past the most limited standards of review. If there is no profit to be had from this particular phase (say, you submit for Phase I with the understand that you are providing samples free of charge), I think it would eliminate this nonsense, no? And of course I understand that it is exceedingly expensive to bring a drug even to Phase I, let alone Phase III. It's what, a billion or more per drug that makes it to Phase I, and only something like 10% or less ever make it past Phase III? My thought would certainly be highly unpopular in the industry, but also fuck the industry. How about the scale back on the advertising and stop trying to turn regular patients in to their own doctors, endlessly demanding drugs that they don't need, or are addicted to, because the happy couple on the football ad told them that it would improve their lives and they'll be damned if they don't find a doctor that will hook them up (because they will).

 

[SMOGZINN]

So after reading about this I am still against it. It provides no protection from profiteering by unethical groups, and ethical groups will have little to no reason to give their experimental drugs to people other than naked profiteering.

• Giving drugs to people outside of controlled trials is going to produce unexpected outcomes that could end up being harmful to the drug's approval process.
• It could end up exposing the company to lawsuit. (The law gives some protection but those protection are not expected to hold up in court)
• No insurance will cover the costs of the drugs, the administration and oversight of the procedures, or treatment of the side effects. Side effects will be common since nearly 70% of all drugs that pass Phase 1 fail Phase 2 because of side effects.
• That leaves us with the fact that only a very few people will be able to afford to take these drugs even if they can get them.

 

[Hayabusa Rider]

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.

You've got this entirely wrong. This isn't Jobs or McQueen. This isn't "fake cancer cure industry".

From the NYT

Scientists would need to complete the first phase of clinical research on a drug before it could be made available under the bill. Phase 1 trials typically assess the safety and toxicity of a drug in a small number of volunteers.

It has ALREADY PASSED THE FIRST HUMAN TRIAL FOR SAFETY. You might at least look at the facts before becoming outraged.

 

[Amused]

You've got this entirely wrong. This isn't Jobs or McQueen. This isn't "fake cancer cure industry".

From the NYT



It has ALREADY PASSED THE FIRST HUMAN TRIAL FOR SAFETY. You might at least look at the facts before becoming outraged.

LO fucking L

Dude. I covered this already. Phase one simply means the drug must not cause direct harm. It need not show ANY FUCKING efficacy WHATSOEVER. Meaning con men could sell sugar pills to the desperately ill.

Ask yourself why this was backed by all the usual suspects in the medical con game. Alt-med gurus, snake oil salesmen, naturopaths, homeopaths and chiropractors.

 

[Hayabusa Rider]

LO fucking L

Dude. I covered this already. Phase one simply means the drug must not cause direct harm. It need not show ANY FUCKING efficacy WHATSOEVER. Meaning con men could sell sugar pills to the desperately ill.

Ask yourself why this was backed by all the usual suspects in the medical con game. Alt-med gurus, snake oil salesmen, naturopaths, homeopaths and chiropractors.

Phase one means that it has already passed other tests that show efficacy, but not yet in humans. If it passed all the tests then it would be on the market and these people dead.

Hey if you want to deny someone a chance of treatment that has science behind it but not gone through more testing then apply it to yourself and your loved ones.

 

[mect]

I would support this if the treatments had no costs attached. If they dying are being used as beta testers for the drugs, they are providing a benefit to the company, not the other way around. If anything, the companies should pay the dying for being their lab rats.

 

[Hayabusa Rider]

I would support this if the treatments had no costs attached. If they dying are being used as beta testers for the drugs, they are providing a benefit to the company, not the other way around. If anything, the companies should pay the dying for being their lab rats.

I agree that they should pick up the tab.

 

[SMOGZINN]

Phase one means that it has already passed other tests that show efficacy, but not yet in humans.

No it does not. All that is actually required for a Phase 1 trial is that a IND has been submitted. INDs require information on the chemical compound of the drug and that it be manufacturable (we know of a method to produce the drug), data to permit an assessment as to whether the product is reasonably safe for initial testing in humans, and detailed protocols for proposed clinical studies. There is no requirement that they have any evidence that it will have any efficacy.

Until now it has been pretty much assumed that no one wants to go to trials with a drug that they don't have some reason to think will work because clinical trials are expensive. But now they could be profitable!

 

[Amused]

Phase one means that it has already passed other tests that show efficacy, but not yet in humans. If it passed all the tests then it would be on the market and these people dead.

Hey if you want to deny someone a chance of treatment that has science behind it but not gone through more testing then apply it to yourself and your loved ones.

No, No it doesn't. No efficacy trials by phase one. Full stop.

I do every fucking day. It's called not falling for snake oil, naturopaths, homeopaths, chiropractors and anti-vaxxers.

There is a reason this testing is in place. This bill is a massive case of Dunning Kruger backed by con men seeking to profit off the suffering of the terminally ill who are also scientifically illiterate.

If you cannot see this bill as being yet another extension of the growing anti-science/anti-intellectualism movements and the further death of expertise, you're as duped as any alt-med mark.

 

[Hayabusa Rider]

No, No it doesn't. No efficacy trials by phase one. Full stop.

I do every fucking day. It's called not falling for snake oil, naturopaths, homeopaths, chiropractors and anti-vaxxers.

There is a reason this testing is in place. This bill is a massive case of Dunning Kruger backed by con men seeking to profit off the suffering of the terminally ill who are also scientifically illiterate.

If you cannot see this bill as being yet another extension of the growing anti-science/anti-intellectualism movements and the further death of expertise, you're as duped as any alt-med mark.

Yeah, about Dunning-Kruger...

Anyway, we're done.

 

[Amused]

Yeah, about Dunning-Kruger...

Anyway, we're done.

Yeah about that. Of course you're done. You had your ass handed to you by repeatedly not grasping the subject matter and going on emotion rather than fact.

I'll take the advice of David Gorski, a practicing oncologist over you, the Koch brothers and the snake-oil salesmen that backed this bill.

https://respectfulinsolence.com/201...to-pass-the-cruel-sham-known-as-right-to-try/

 

[Amused]

This is the most insidious part of this bill right here:

(b)No liability or use of outcomes

(1)No liability. Notwithstanding any other provision of law, no liability shall lie against a producer, manufacturer, distributor, prescriber, dispenser, possessor, or user of an experimental drug, biological product, or device for the production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that is in compliance, with subsection (a).

(2)No use of outcomes. Notwithstanding any other provision of law, the outcome of any production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that was done in compliance with subsection (a) shall not be used by a Federal agency reviewing the experimental drug, biological product, or device to delay or otherwise adversely impact review or approval of such experimental drug, biological product, or device.

The second part means if a patient uses an experimental drug under right-to-try and suffers a serious adverse reaction, the FDA cannot consider that reaction in its deliberations over approval of the drug. This clause is obviously intended to address the concern of drug and device manufacturers that if they provide an experimental therapeutic to a patient under right-to-try and the patient suffers complications due to the treatment, the approval of its product might well be jeopardized. T this clause goes way, way too far. Basically, it means that even if a patient death is clearly due to use of an experimental drug under right-to-try, that death cannot be considered by the FDA in deciding whether to approve the drug.

So not only are the drug makers and snake oil salesmen immune from any and all responsibility, negative outcomes don't even get counted.

This is a con man's dream.

 

[tweaker2]

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.

Didn't read through the whole thread yet so it may have already been mentioned in reference to "health directives" where a third party is involved in the decision making process of how an individual wants to be treated should they lose their faculties in the process of passing on. I'm guessing this is one of those ethical elements you were referring to?

 

[interchange]

This isn't my area, so I'm not sure of the real-world implications. In principle, this sounds like a no-brainer, but my concern is people profiteering off of it. We already have a huge problem with spending massive amounts of $ on people in end of life care that isn't driven by trying to make $. Salvage chemotherapy, ICU interventions, feeding tubes, etc. Often there is logical reason for things but they are done without evidence to support them. Mostly I have seen failure to clearly communicate the condition and prognosis to a patient and family, and to have these discussions proactively before the interventions are being offered. It should come as no surprise that, even when communication is given, doctors do a poor job of generating real understanding and appreciation of what's going on. When there are ventilators, arterial lines, continuous renal replacement, sedatives, pressors, etc. involved the language is technical, detached, and overwhelming. Same for complicated chemotherapy regimens, radiation, etc. I would hope to bracket this with interventions to improve communication and promote proactive discussions.

 

[sdifox]

Wait what phase ones? Err, no, I thought it was about phase threes.

 

[Hayabusa Rider]

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?

There are several steps taking a number of years and real money to go through a process. It's formalized and goes from discovering a chemical entity to post marketing followup. In this process as explained we're following Phase I trials. It's small in scale and it's to evaluate safety and toxicity in humans. There are larger scale trials and ones for efficacy in humans. Those take a very long time which is why there's this initiative.

Before Phase I begins, there aready animal studies which show promise, and those are extensive in their own right so this isn't throwing darts beginning with human trials.

A comment was made about adverse effects and liability. That makes perfect sense. There are no human efficacy or large scale safety studies, so there is a risk in allowing unapproved drugs. The patient needs informed consent so they know that there are risks and no guarantees. Adverse effects? These aren't studies, not scientifically controlled. How does one know that a substance causes an effect when the methods which are used to determine causation vs correlation do not exist. Anything would be noted but "adverse effect" would be speculation. If you didn't know, most of my formal education and degrees are in pharmacy and pharmacology so I have some idea how the process works.

This isn't my area, so I'm not sure of the real-world implications. In principle, this sounds like a no-brainer, but my concern is people profiteering off of it. We already have a huge problem with spending massive amounts of $ on people in end of life care that isn't driven by trying to make $. Salvage chemotherapy, ICU interventions, feeding tubes, etc. Often there is logical reason for things but they are done without evidence to support them. Mostly I have seen failure to clearly communicate the condition and prognosis to a patient and family, and to have these discussions proactively before the interventions are being offered. It should come as no surprise that, even when communication is given, doctors do a poor job of generating real understanding and appreciation of what's going on. When there are ventilators, arterial lines, continuous renal replacement, sedatives, pressors, etc. involved the language is technical, detached, and overwhelming. Same for complicated chemotherapy regimens, radiation, etc. I would hope to bracket this with interventions to improve communication and promote proactive discussions.

In principle it's a no brainer but the details of costs are my biggest concerns. IMO the pharma companies should write these costs off.

 

[Amused]

In principle it's a no brainer but the details of costs are my biggest concerns. IMO the pharma companies should write these costs off.

And this is why you're duped. This is all about sidestepping the FDA (the one agency that stands between you and snake oil salesmen) and making money off the desperate selling drugs that would and could more than likely never pass human trials.

Your delusion is that this has anything to do with helping the terminally ill.

This country already has a booming snake oil industry because of the FDA disclaimer rule passed in 94. This law takes off yet another handcuff from the fraudsters to help snake oil salesmen make even more money from the desperate and gullible.

 

[Hayabusa Rider]

And this is why you're duped. This is all about sidestepping the FDA (the one agency that stands between you and snake oil salesmen) and making money off the desperate selling drugs that would and could more than likely never pass human trials.

Your delusion is that this has anything to do with helping the terminally ill.

This country already has a booming snake oil industry because of the FDA disclaimer rule passed in 94. This law takes off yet another handcuff from the fraudsters to help snake oil salesmen make even more money from the desperate and gullible.

Well thank goodness I'm not a climate scientist. I'd be guilty of not understanding anything because all I'd be interested in is grant money.

 

[Amused]

Well thank goodness I'm not a climate scientist. I'd be guilty of not understanding anything because all I'd be interested in is grant money.

Nice try at a completely irrelevant, desperate response rather than just capitulating.

The scientific process exists for a reason. Drug regulations exist for a reason. This entire law is designed to give con men a side step around that process. It is anti-science and pro-snake oil.

And you're falling for it because it's been disguised as libertopian.

 

[Hayabusa Rider]

Nice try at a completely irrelevant, desperate response rather than just capitulating.

The scientific process exists for a reason. Drug regulations exist for a reason. This entire law is designed to give con men a side step around that process. It is anti-science and pro-snake oil.

And you're falling for it because it's been disguised as libertopian.

I understand that the best you can do is yell snake oil and anti-science without much of an idea of the realities. I've encountered anti-vaxxers and they used precisely the same "logic" and accusations as you.

If I were supporting "snake oil" (it's not, there's science going into this WHICH THE FDA ALREADY HAS) or else we wouldn't have gotten past Phase I. If this were a means of evading the approval process then you would have an argument. You don't. Every process will have to be followed, every application fulfilled exactly the same before approval. That you didn't understand why adverse events couldn't be deemed scientifically valid was obvious, and obviously "snake oil". No, that's science.

The difference is that someone has a chance to live or live better when there would be no hope otherwise. There is oversight, but not a completion of the process, done long after the corpse is worm food.

Risks? Yes. Should the companies pay? Yes. If someone tries to try "snake oil" or treatments which have no scientifically determined potential? No.

Stop being a climate denying anti-vaxxer type thinker. Or, continue on.

No one cares either way, certainly not me. Usually you are reasonable but this time? Off the wall without a factual basis, just an automatic latching onto a conspiracy.

Once particulars come out I may revise my opinion. I don't see an indication on your part that you are interested in facts as you have your mind already made up.

Chill and think, or again refuse.

 

[Amused]

I understand that the best you can do is yell snake oil and anti-science without much of an idea of the realities. I've encountered anti-vaxxers and they used precisely the same "logic" and accusations as you.

If I were supporting "snake oil" (it's not, there's science going into this WHICH THE FDA ALREADY HAS) or else we wouldn't have gotten past Phase I. If this were a means of evading the approval process then you would have an argument. You don't. Every process will have to be followed, every application fulfilled exactly the same before approval. That you didn't understand why adverse events couldn't be deemed scientifically valid was obvious, and obviously "snake oil". No, that's science.

The difference is that someone has a chance to live or live better when there would be no hope otherwise. There is oversight, but not a completion of the process, done long after the corpse is worm food.

Risks? Yes. Should the companies pay? Yes. If someone tries to try "snake oil" or treatments which have no scientifically determined potential? No.

Stop being a climate denying anti-vaxxer type thinker. Or, continue on.

No one cares either way, certainly not me. Usually you are reasonable but this time? Off the wall without a factual basis, just an automatic latching onto a conspiracy.

Once particulars come out I may revise my opinion. I don't see an indication on your part that you are interested in facts as you have your mind already made up.

Chill and think, or again refuse.

Wow, that's a whole lotta tu quoque bullshit repeated over and over again.

Like I said, let's see what an expert says:

https://respectfulinsolence.com/201...to-pass-the-cruel-sham-known-as-right-to-try/

Nope, I don't sound like an anti-vaxxer. I'm not trying to support laws that allow hucksters to skirt the scientific process. In fact, I am exactly the opposite.

Fact: The "right to try" law allows drug sellers and people selling them to skit the scientific process. Period. Full fucking stop.

You are literally supporting the most anti-science president in history signing a law that allows the side stepping of the scientific process in medicine to sell desperate people unproven, untested drugs, the vast majority of which, would and could never pass testing.

 

[IJTSSG]

Hopefully this will open the door for TDS treatment. Some of you need it badly.

 

[Hayabusa Rider]

Wow, that's a whole lotta tu quoque bullshit repeated over and over again.

Like I said, let's see what an expert says:

https://respectfulinsolence.com/201...to-pass-the-cruel-sham-known-as-right-to-try/

Nope, I don't sound like an anti-vaxxer. I'm not trying to support laws that allow hucksters to skirt the scientific process. In fact, I am exactly the opposite.

Fact: The "right to try" law allows drug sellers and people selling them to skit the scientific process. Period. Full fucking stop.

Well this expert disagrees and I didn't have to go with Pence and the Koch brothers.

Dunning Kruger unless one knows their subject and then a shill. I want to see particulars but if the NYT is correct that's already above "snake oil".

Fork in this thread, topic is over as far as useful discussion.