Well, since they don’t, this is a silly hypothetical.
Basic human right not to be scammed, I think is the real issue.
I don’t think that quite captures my argument, no.
From what I understand the idea that the mean FDA is blocking drugs because of bureaucratic red tape is mostly a myth and waivers were already available. Essentially this law was a Conservative “feel good” legislation that doesn’t really do anything that couldn’t already be done (in a slightly different way). Basically now Drug companies can sell their drugs without FDA testing (or at least while they are still testing them) which is probably not great.
A terminally ill patient already can try any means to survive. They can use folk remedies, they can buy homeopathic water, they can mail-order some leeches, they can volunteer for therapeutic waterboarding, they can subject themselves to whatever anybody can convince them to try as a last resort.
What they don’t have the right to do is subvert the ethical and regulatory safeguards of the medical system that exist to protect patients in general. If they want to request a compassionate waiver from some of those safeguards, that’s fine. But being terminally ill doesn’t entitle them to demand that the safeguards be entirely deactivated in their case.
Laws like this won’t force physicians or drug developers to prescribe or supply the experimental treatments that some terminally ill patients are hoping might benefit them. All they will do is give a free pass to predatory quacks who don’t care whether or not they benefit sick people as long as they can get money from them without risk of a prosecution or lawsuit if the results are catastrophic.
Did you read the bill? Did you read the part below?
What you are saying is that the FDA is approving for trial remedies from predatory quacks who don’t care whether or not they benefit sick people as long as they can get money from them without risk of a prosecution or lawsuit if the results are catastrophic. If that is the power of the FDA then maybe it needs to be weakened in other ways.
Before this bill, there was no reason to enter phase 1 trials unless you believed they were the first step to getting FDA approval. With this bill, you can now complete phase 1 trials with quack medicines and the sell them to a gullible public.
Before this bill, drug companies paid people to participate in trials because they wanted to learn whether their drugs worked. With this bill, some may never bother to complete later stages of research to determine whether their drugs work because they can commercialize their drugs after phase one. Further stages of research might only prove that the drug is worthless. Why would they want to do that? Reputable companies won’t. Charlatans will.
You’re just doubling down on the bad ideas. If the FDA is approving phase 1 trials for charlatans the solution is not sentencing people to death.
They are* already* sentenced to death. Consuming quack nostrums will only give them false hope and empty their pocketbooks, hurting their loved one.
You and the others are justifying the need for this law that the snake oil salesmen behind it have claimed. The FDA is acting incompetently if they are allowing quack nostrums to proceed into trials. Where are you guys getting these ridiculous notions? There is nothing in the bill that allows this kind of nonsense. If you worry about a slippery slope then don’t join the people who are icing down the slope. It says that treatments earlier in the process of FDA approval can be used when there is no other choice. Why do you want to take away the last hope from even one person who may benefit from it, and no one who could be seriously harmed by it because they will be dead soon anyway? You should be jumping up and down complaining about the FDA’s failure to provide proper oversight for all sorts of treatments that are harming people who weren’t dying and keep`shyster lawyers rolling in dough from class actions suits that may not benefit the victims of FDA incompetence at all.
Do you have any info that says that the FDA routinely stops drugs from going into Phase 1 trials? Phase 1 is simply a test to make sure it’s not immediately dangerous. Not that it works.
I*t’s much worse than that, however, because these laws are actively anti-patient, the claims of their supporters notwithstanding. The only requirements these laws have for testing of the drugs being “tried” are (1) that they have passed phase I clinical trials and (2) that they are still under development and undergoing further clinical trials. Anyone out there who is familiar with clinical trials knows that passing phase I is an incredibly low bar for safety. Phase I trials are “first in human” trials in which a small number of patients test the drug. Basically, the dose is escalated until unacceptable toxicity is encountered. … Phase I trials are not designed to determine if a drug has any efficacy. Saying that a drug that’s passed phase I testing is safe, as I’ve heard many right-to-try advocates claim, is utter and complete bullshit. Phase I trials do not prove safety. They merely show that the drug is not too toxic to continue with efficacy testing…These laws also immunize companies providing right-to-try drugs and physicians overseeing their administration from liability. Right-to-try laws also limit what patients can do in the event of malpractice or negligence. All of them broadly immunize physicians advising or administering right-to-try medications or using right-to-try devices against malpractice suits or actions against their medical license by the state medical board related to their participation in right-to-try. All of them also immunize companies providing experimental therapeutics under right-to-try from liability. … As Jann notes, even if state authorities believe, for example, that an elderly person is being exploited for financial gain by a physician, presumably this provision would prohibit their acting.
Of course, the ideologues at the Goldwater Institute knew all along that state laws weren’t going to do anything to make access to experimental therapeutics easier for terminally ill patients. Indeed, not surprisingly, they haven’t; basically right-to-try thus far has been a miserable failure, with almost no one accessing drugs through it. There’s a reason why I refer to state right-to-try laws as “placebo” legislation. They give the appearance of doing something but really don’t do anything to address the issue of making experimental drugs more widely available to terminally ill patients. *
I didn’t say they worked. But they are not immediately dangerous according to the FDA, so certainly not a concern for someone about to die.
Would a bill like this seem like a better idea if it required drug companies to provide, at cost, any medicine they are currently testing that is not yet approved for general sale, but is intended to cure or treat a terminal illness? So that someone whose prognosis with all tested medicines is ‘you’re going to die’ can demand that a drug company that is testing a medicine for their condition provide it to them, but without a significant profit motive for the company since it would be required to be at cost rather than including a profit? At most, the company would profit from the data gathered from the patient’s reaction that way.
This requires:
The patient to be dying already, and there being no approved cure or treatment.
The company to be testing a medicine intended to cure or treat the patient’s condition.
And the company must then provide it without making a profit.
It would seem that would solve most of the issues people have brought up with the law, while even further expanding access to it so that when the first two conditions are met, the company cannot refuse the treatment if the patient chooses to ask for it.
Edit: Obviously, once they complete trials and the medicine is approved, they can then profit off it. Or if it is rejected, then it can no longer be tested/sold, whether for profit or not, because there’s then evidence that it does not work.
NO! *Phase I trials are “first in human” trials in which a small number of patients test the drug. Basically, the dose is escalated until unacceptable toxicity is encountered. … Phase I trials are not designed to determine if a drug has any efficacy. Saying that a drug that’s passed phase I testing is safe, as I’ve heard many right-to-try advocates claim, is utter and complete bullshit. Phase I trials do not prove safety. They merely show that the drug is not too toxic to continue with efficacy testing…
*
The bill doesn’t say anything about Phase I trial drugs being safe. I’m glad you’re so worried that someone about to die might die as a result of taking such a drug. We can’t let that happen. We have to let them die from not taking a drug,
No, not to me, because manufacturers profiting is not my major problem with this law. Manufacturers should be permitted to refuse to participate before their drugs are fully tested and on the market.
They are.
for the whole “weakening the fda " argument
joe weider and the gnc crowd already shit all over the FDA almost 2 decades ago and got away with it so what’s the diff ?
only thing keeping anyone from doing it anyways is to get around the FDA you have to claim " we claim pill x doesn’t treat or cure any disease”
in this case you cant claim that ….
You’ve hit the jackpot there. This argument is between two corrupt lobbies, Big Pharma and Big Useless Supplements. Neither side gives a rat’s ass about sick and dying people except to soak them or us for all the money they can get. This bill may not even help anyone but it is harmless and sits right in the middle of these greedy SOBs ulterior motives. As I said before, it’s remarkably well written for the the US Congress. I assume they got some help from a High School Civics class or something like that.
The FDA is as corrupt and incompetent as any other government agency. In a another thread, I noted how the 60 year old topical creme tretinoin widely known as Retin-A used to fight acne and wrinkles is OTC in other countries and costs one tenth of what it costs in the United States. There is no legitimate reason for this drug to be prescription only other than to fatten Big Pharma profits.
Some of these “Right To Try” drugs are available in other countries and the fact that other government bodies have approved the drugs to some level should weigh on its availability in the United States.
I recommend reading the Respectful Insolence article, and considering what it has to say about “right to try” being part of an effort to essentially strip the FDA of regulatory authority over drugs (solely requiring “safety” testing, without any means of assuring efficacy). More from the article:
“…these (“right to try”) laws explicitly state that insurance companies are under no obligation to pay, even though such a statement is unnecessary given that insurance companies don’t reimburse for experimental therapies. As a result, the only people who would potentially be able to access right-to-try are the rich or people who are very good at fundraising. A terminally ill person trying to access right-to-try can easily spend away his estate or even go bankrupt before dying. It’s even worse than that. The language in many of these laws can be interpreted to mean not just that insurance companies don’t have to pay for right-to-try but that they don’t have to pay for medical care as a result of complications suffered from using a drug under right-to-try…compar(e) what happens when a patient accesses an experimental therapeutic under the FDA expanded access program to what happens when another patient accesses one under a right-to-try law. Under FDA expanded access, patients retain full protections under federal and state laws. They can sue for malpractice if there is any, and their care is still monitored by an institutional review board (IRB), with any adverse events recorded and considered by the FDA. Moreover, the FDA approves nearly all such requests (99%). In contrast, under right-to-try, there is no IRB oversight. It’s all between the company and the patient, a libertarian paradise!”
It should be possible to take steps like making it easier for terminally ill patients to get into proper clinical trials, without enabling mass exploitation of them while weakening regulatory protections.