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President Trump signs right to try law

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Mandres

Senior member
Jun 8, 2011
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The fairest thing would for the cost of manufacturing alone to be reimbursed, but again I think this should be paid by Uncle Sam.
That's the dream scenario for the drug makers also. If Medicare ends up covering the cost then they can charge the taxpayers (us) anything they want without having to fight the insurers. Who's going to enforce price controls, the congressmen they've bought and paid for?

I think it's incredibly foolish to allow drug companies to start marketing products without any proof-of-efficacy requirements at all. The terminal disease medications market might start looking just like the "supplements" market very soon.
 

SMOGZINN

Lifer
Jun 17, 2005
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All medications would ALREADY have gone through FORMAL FDA Phase I trials.
As has been pointed out Phase 1 trials is nothing more than 20-100 people took this drug and it did not kill many of them.

These investigations ARE to be evaluated for efficacy and not discontinued.
This is more promising. I would like to know how they are going to regulate this. How do you make sure that the makers of the drugs go though good-faith Phase 2 and 3 trials to show that the drug is effective? Phase 1 testing is frankly a joke. It requires basically nothing but filling out a form to get approval for Phase 1 testing, and passing Phase 1 requires nothing more than the drug be not too toxic. I was not kidding when I said that a glass of water could be approved and pass Phase 1 testing. I would much have preferred the bill to say something along the lines of 'Have passed or been approved for Phase 2 testing' That would show good-faith attempt at making sure these drugs are not scams since it takes much more to get approval for Phase 2 testing.
 

Hayabusa Rider

Admin Emeritus & Elite Member
Jan 26, 2000
50,872
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That's the dream scenario for the drug makers also. If Medicare ends up covering the cost then they can charge the taxpayers (us) anything they want without having to fight the insurers. Who's going to enforce price controls, the congressmen they've bought and paid for?

I think it's incredibly foolish to allow drug companies to start marketing products without any proof-of-efficacy requirements at all. The terminal disease medications market might start looking just like the "supplements" market very soon.
A couple things. First they've had trials on critters before they can be tried on humans. There's no guarantee it works for people, but there's hundreds of millions more to spend on human trials. Seems only the best candidates would be put forward. If a company loses it's out more than a billion dollars these days. "Supplements" doesn't fit the criteria of the law and each drug allowed risks a loss of hundreds of millions to over a billion. No one takes that financial risk no matter how evil people think pharma is.

Generally speaking experimental drugs aren't going to be covered and Medicare pays what it wants (if that's the mechanism of payment), not what the company wants. I'm for direct reimbursement limited to cost of manufacture alone. R&D costs? No.
 

Darwin333

Lifer
Dec 11, 2006
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I have no idea why this wasn't already the case. As long as patients are given all the facts, they are already dying FFS so if some new treatment might help them and they understand the potential downsides then let them go for it. As a side bonus but in no way should be the deciding factor, although I can all but guarantee that it was, the drug companies get real data faster so hopefully successful treatments will be on the market sooner.
 

Hayabusa Rider

Admin Emeritus & Elite Member
Jan 26, 2000
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I didn't finish or did before I should have.

s has been pointed out Phase 1 trials is nothing more than 20-100 people took this drug and it did not kill many of them
Wait, what? "Didn't kill MANY"? Who came up with that? Phase I means that the test returned a verdict of "safe" as far as that goes. That doesn't mean there weren't temporary side effects but outright kill? Nope. That's like saying that the FDA allowed trials to proceed on vaccines because "not many" became autistic.

As far as later drug phases, any company who enters this agreement and doesn't follow through with the commitment it agreed to will wish it was Michel Cohen by the time the lawyers and maybe the DOJ is finished with it. There will be no limit to liability when violating such things. They are open to everyone who has a bad case of flu. The FDA exemption is limited not erased.
 

SMOGZINN

Lifer
Jun 17, 2005
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As a side bonus but in no way should be the deciding factor, although I can all but guarantee that it was, the drug companies get real data faster so hopefully successful treatments will be on the market sooner.
Actually it probably won't work out that way. Any data they get from non-clinically-controlled use of their drug will be worse than useless. Drug trails have to be carefully controlled for variables for the data to be of any use.
 

SMOGZINN

Lifer
Jun 17, 2005
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I didn't finish or did before I should have.



Wait, what? "Didn't kill MANY"? Who came up with that? Phase I means that the test returned a verdict of "safe" as far as that goes. That doesn't mean there weren't temporary side effects but outright kill? Nope. That's like saying that the FDA allowed trials to proceed on vaccines because "not many" became autistic.
Anytime you are testing something like drugs intended to treat fatal diseases you are going to have some fatalities. It is all but impossible to completely rule out the drug as a contributor in the death. Science most often deals in statistics, not absolutes.

As far as later drug phases, any company who enters this agreement and doesn't follow through with the commitment it agreed to will wish it was Michel Cohen by the time the lawyers and maybe the DOJ is finished with it. There will be no limit to liability when violating such things. They are open to everyone who has a bad case of flu. The FDA exemption is limited not erased.
Then why would any company offer their drug up if they are going to get sued if they decide not to move forward with trials? Think about that. By offering their drug up to terminal patients they are committing themselves to 10's of millions of dollars of trials, even if they decide they don't want to peruse that avenue of research any further. It seems foolish to do especially if it offers almost no benefit to the company.
 

Hayabusa Rider

Admin Emeritus & Elite Member
Jan 26, 2000
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Anytime you are testing something like drugs intended to treat fatal diseases you are going to have some fatalities.
No, that's not how any of this works.

From the NIH fact site

The phase 1 study is used to learn the "maximum tolerated dose" of a drug that does not produce unacceptable side effects.
The first few volunteer subjects receive low doses of the trial drug to see how the drug is tolerated and to learn how it acts in the body. The next group of volunteer subjects receives larger amounts. Phase 1 studies typically offer little or no benefit to the volunteer subjects.

These are perfectly healthy tested with great care. Someone dies from taking the med? That's "HOLY SHIT" level.
 

Amused

Elite Member
Apr 14, 2001
53,987
7,201
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No, that's not how any of this works.

From the NIH fact site

The phase 1 study is used to learn the "maximum tolerated dose" of a drug that does not produce unacceptable side effects.
The first few volunteer subjects receive low doses of the trial drug to see how the drug is tolerated and to learn how it acts in the body. The next group of volunteer subjects receives larger amounts. Phase 1 studies typically offer little or no benefit to the volunteer subjects.

These are perfectly healthy tested with great care. Someone dies from taking the med? That's "HOLY SHIT" level.
It was already explained to you just how limited phase 1 trials are. In full with links to in depth explanations from an oncologist. With as few as 30 subjects it is barely a cursory safety check. Many drugs have proven highly toxic and fatal eve after passing phase one trials.

Your continued touting of this as though it were something significant is now nothing more than willful ignorance.
 
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Hayabusa Rider

Admin Emeritus & Elite Member
Jan 26, 2000
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It was already explained to you just how limited phase 1 trials are. In full with links to in depth explanations from an oncologist. With as few as 30 subjects it is barely a cursory safety check. Many drugs have proven highly toxic and fatal eve after passing phase one trials.

Your continued touting of this as though it were something significant is now nothing more than willful ignorance.
Your expertise has earned you two internets.
 

Darwin333

Lifer
Dec 11, 2006
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Everyone ask yourself this: Why is it no medical association or significant group of doctors is asking for this. Why is it a libertarian think tank, right wing billionaires, and a whole host of naturopaths, homeopaths, chiropractors and snake oil salesmen are backing this?

Why?

Why does virtually EVERY patient advocacy group oppose these laws?

http://thehill.com/policy/healthcare/372600-40-patient-advocacy-groups-oppose-right-to-try-drug-bill

Because this has nothing to do with helping patients. It's all about making money off the desperate.

https://www.thenation.com/article/the-right-to-try-unproven-pharmaceuticals-is-a-right-wing-scheme/

It's a right-wing scheme to sidestep the scientific process and make bank. Nothing more.

All one need do is look who supports it. Is it doctors? No. Patient rights groups? Nope. Then who? Who backed this?

Right-wing think tanks long known for being anti-science.
Wow, I initially thought it was a great idea but after reading those two links I am starting to question it. I didn't realize that the FDA already had a program in place and approved of over 99% of requests and it's usually the manufacturers that say no.
 
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Darwin333

Lifer
Dec 11, 2006
19,946
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Yep. Companies already have a few hundred or more million out of pocket already. Considering there's very few who would qualify then no one is going to make a profit. The fairest thing would for the cost of manufacturing alone to be reimbursed, but again I think this should be paid by Uncle Sam.
Don't drug makers usually pay or provide for free drugs that are in the trial phase?
 

Hayabusa Rider

Admin Emeritus & Elite Member
Jan 26, 2000
50,872
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Don't drug makers usually pay or provide for free drugs that are in the trial phase?
For trials? Sure. This isn't part of one though. Regarding the existing approved rate there's something not mentioned, which is that the practice of medicine is regulated at the state level. There is no Federal Medical Board. Most states already have a "right to try" equivalent, but not all. If someone agrees to provide an experimental treatment then they have no federal or state protection and if anything goes wrong, which it certainly can then what? They've caused an unapproved med to be given with harmful or fatal consequences and that the patient wanted a chance would be scarce protection.
 

Darwin333

Lifer
Dec 11, 2006
19,946
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Actually it probably won't work out that way. Any data they get from non-clinically-controlled use of their drug will be worse than useless. Drug trails have to be carefully controlled for variables for the data to be of any use.
Boy I'd like to find me a nice drug trail! Kidding, well not really but I know what you meant. Although the data isn't nearly as controlled as in actual trials I can't imagine that the data is absolutely useless, especially if they get a good 30 or 40 patients.
 

Darwin333

Lifer
Dec 11, 2006
19,946
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For trials? Sure. This isn't part of one though. Regarding the existing approved rate there's something not mentioned, which is that the practice of medicine is regulated at the state level. There is no Federal Medical Board. Most states already have a "right to try" equivalent, but not all. If someone agrees to provide an experimental treatment then they have no federal or state protection and if anything goes wrong, which it certainly can then what? They've caused an unapproved med to be given with harmful or fatal consequences and that the patient wanted a chance would be scarce protection.
Have there been a lot of malpractice suits due to doctors getting FDA waivers to use experimental treatments?
 

Hayabusa Rider

Admin Emeritus & Elite Member
Jan 26, 2000
50,872
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Have there been a lot of malpractice suits due to doctors getting FDA waivers to use experimental treatments?
Where legal? No. There's protection there. In other states where there's no law it would likely constitute malpractice. Numbers? No idea.

As simple as some want to make this there's more to medicine than the FDA. There's a lot of laws, a number of people who have ethical problems administering meds when others would not. "First do no harm" If one believes that giving a medicine that has no human proof of benefit is wrong then they won't participate. Then there's a view that if there's scientific data which has safety data and might help, then denying treatment would be unethical. I'm not an MD so I can't say how I'd opine and I'm simplifying things a great deal in a field outside my expertise so physicians can opine or correct as they see fit.

Then there are standards of practice and "what would a reasonable and prudent physician do". Then there's state law and regs, and then there's federal law. Personally I'd not like to be caught up in this if things turned south especially when there is no legal refuge.

There's a lot of speculation as I'm not a legal expert in malpractice or what's taught in medical ethics courses.
 
Apr 27, 2012
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I hope you're the first volunteer to swallow the turmeric, juniper, and nightshade "cancer cure" pills that this bill authorizes scammers to distribute to you, at massive profits to them, of course.
I dont have cancer or a terminal illness. What you are talking about is crap that is pure junk and a scam. There are other treatments but the pharmaceutical industry wants to shut them down since they would lose money.
 

sdifox

No Lifer
Sep 30, 2005
84,755
9,300
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I dont have cancer or a terminal illness. What you are talking about is crap that is pure junk and a scam. There are other treatments but the pharmaceutical industry wants to shut them down since they would lose money.

Example?
 

Darwin333

Lifer
Dec 11, 2006
19,946
2,325
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I dont have cancer or a terminal illness. What you are talking about is crap that is pure junk and a scam. There are other treatments but the pharmaceutical industry wants to shut them down since they would lose money.
If you are talking about stuff said pharmaceutical companies make then this bill will do nothing to help. They can't actually force a company to produce and supply a drug that they have shut down.

If you are talking about stuff they don't make, then yes please, examples!
 

SNC

Platinum Member
Jan 14, 2001
2,166
200
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Are you joking? Do you have any idea how much it costs to lobby the White House/Congress to get a rule change like this pushed through? The treatments won't be free ... lol I can barely type the word without starting to laugh at what an absurd notion that is.

They'll be incredibly expensive, and the next battle will be over whether or not insurance or medicare/medicaid has to cover the costs. We'll see which group (pharma or insurance) has the better lobbyists to get that particular question settled.
What do you think that? How much money do those involved in the final series of trials before FDA approval pay to be involved in the trial? These people that would be issued these trial drugs would be nothing more then individual trials and not a group with placebos.
I can not imagine that a group of trial goers would be willing to pay to much to be guinea pigs.
 

Jhhnn

No Lifer
Nov 11, 1999
62,149
14,361
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I dont have cancer or a terminal illness. What you are talking about is crap that is pure junk and a scam. There are other treatments but the pharmaceutical industry wants to shut them down since they would lose money.
Back in the 60's there was a conspiracy theory that the oil companies had bought the patent rights to a super sekrit carburetor that would double your gas mileage...
 

SMOGZINN

Lifer
Jun 17, 2005
13,289
2,926
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These are perfectly healthy tested with great care. Someone dies from taking the med? That's "HOLY SHIT" level.
That is the normal procedure, but when dealing with drugs designed for terminal conditions they often test the drugs on people with those conditions even in Phase 1. Think about it, they are not going to test chemotherapy drugs on healthy patients, even in phase 1. Those drugs simply are not safe for a healthy person in any dose. Most of them are known carcinogens and all of them are metabolistic poisons.

Back in the 60's there was a conspiracy theory that the oil companies had bought the patent rights to a super sekrit carburetor that would double your gas mileage...
You might be thinking of the Garrett Carburetor the magical device that would let a IC engine run on tap water.
 
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fskimospy

Elite Member
Mar 10, 2006
72,594
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Wow, I initially thought it was a great idea but after reading those two links I am starting to question it. I didn't realize that the FDA already had a program in place and approved of over 99% of requests and it's usually the manufacturers that say no.
I had a similar reaction to this, at first it seemed like a no-brainer. Now I am less sure.
 

Hayabusa Rider

Admin Emeritus & Elite Member
Jan 26, 2000
50,872
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I had a similar reaction to this, at first it seemed like a no-brainer. Now I am less sure.

There's program where people have potential access and are absolutely free to hold the manufacturers legally liable if things don't work out. Will actual access increase? I don't know, but we have "good samaritan" laws for a reason.
 

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