Comment by riffraff
3 years ago
I remember at least three instances in my country where the authorities were forced to allow people to use experimental treatments due to media clamor.
In all three instances, the result was that the treatments were snake oil and people died that might have lived otherwise.
It's easy to say "people who have no other options should get access to experimental treatments" but the problem is that people who have other options want those too, because nobody wants to go through chemotherapy or whatever.
Medical authorities have a shitty job.
To sibling commenters: immunotherapies aren't the only problem. There are a ton of truly evil companies out there pushing therapies that do not work, have never worked, and will never work, because they literally have no possible mechanism to ever do anything. This is a crime, but it's very very hard to prove.
And these companies get very good at gaming the system, because that is their product. They are mechanisms to commit fraud, stealing all their patients' money and all their families' hope. This is a very bad thing. And, no, I am not making any of this up, but I dare not name names here. These companies also tend to be litigious!
The impact of this is extremely severe. First, people die because they choose a truly worthless treatment that can never work, over bad ones that at least had a snowball's chance. Second, people lose faith in The System, because they think that the fraudulent treatments should have worked, so they lose faith in the good ones too. And third, R&D efforts can get redirected away: rare condition X already has a treatment, so let's put our efforts elsewhere (oh wait, no it doesn't, that was fraud, now there will never be a treatment).
We will not untangle the experimental treatments issue until we confront this problem. Just do not think that it is all in "good faith" here, or even "best effort": there is real fraud going on, committed by monsters that know exactly what they are doing to take their profit.
A simple way to stem most snake oil is to put all payments for snake oil treatments into escrow till the treatment is approved.
Then the snake oil manufacturer can peddle their unapproved treatment to as many people as they like, but they are losing money on every dose unless the treatment turns out to be safe and effective.
Obviously you need a big team of scientists on the approval panel to make sure no snake oil salesmen are faking trial data to get their payday, but that seems solvable.
> A simple way to stem most snake oil is to put all payments for snake oil treatments into escrow till the treatment is approved.
Even simpler is to prohibit payments for these experimental treatments, but let people who whould die anyway participate in them as long as it is free for them. In return the drug companies could use the outcomes as data points towards their aproval applications.
Why would a drug manufacturer do that? Why would they offeir their advanced but as of yet unaproved drugs for free? It is true it would cost them the manufacturing cost of the drug, but what they get in return is data on how efficient/safe the drug is. Assuming the drug works well they could use that data to prove their case and get approval. And if it is safe and has the desired effect they get their aproval and they could then charge for their drug as usual.
This sets the right incentives for the drug company. If they know they are selling snake oil they would be crazy to offer it for free, especially because all it would do is to prove that it does not work. If they think it can work they gamble with their own money. Which is good because the drug company knows the most about their own drug. The patient in general is not knowledgeable enough to evaluate the chances of an experimental therapy, but the drug company is.
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I love the innovative thinking here but I can easily think of a way to game this system. Snake Oil LLC mounts a PR campaign claiming the governmen is trying to shut them down by delaying approvals so they can't get their money so they can't undercut Big Pharma. If Snake Oil (TM) doesn't work, why have patients ponied up $X billion in fees over the years?
You have enough stories like this (plus there will inevitably be some mistakes by the FDA that will be shown to be proof of government perfidy) and the conspiracy theories will have a field day and fuel a black market.
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But at the end of the day, failed treatments still kill people. Some may choose the experimental treatment, and die, over the crappy chemo, which gives them a chance to live. Escrow won’t bring them back.
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> A simple way to stem most snake oil is to put all payments for snake oil treatments into escrow till the treatment is approved.
I doubt any company anywhere (legitimate or not) would provide drugs under such conditions. It would make much more sense to just focus on getting approval instead.
>A simple way to stem most snake oil is to put all payments for snake oil treatments into escrow till the treatment is approved.
It should be a escrow release when a patient is cured. Let the science and knowledge speak for itself instead of statistic doing the talking.
The problem is these drugs companies are the stealth chemical weapons development program for the military.
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There's a trivial well-regulated market solution: medical company A registers treatment B with the FDA; patients can try experimental B from A on A's dime: let them out their money where their medicine is.
Exactly, a treatment should be free until approved by FDA.
The team would try to make the treatment an experiment useful for science. They would have no incentives to kill prematurely patients that would otherwise have lived longer. They would work in good faith.
Disclaimer: I actually had had a treatment (surgery) not yet approved, it saved my foot from amputation. This was in Europe.
The doctor was adding me to the long lists of patients he saved. He also trained other doctors to perform the surgery. Eventually the procedure was approved by FDA and in Europe. I'm glad to have contributed.
Before going on that I read all the articles related to my problem (many thanks to sci-hub) and then send a email to the surgeon. He said "I can indeed help you" (best day of my life) I didn't pay anything (only the plane tickets to get where he was)
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> First, people die because they choose a truly worthless treatment that can never work, over bad ones that at least had a snowball's chance.
Like Steve Jobs.
Fruit juice kills people.
clarification: fruit juice is basically pure fructose which cancer loves and your organs can't handle.
actual fruit has fiber and you're unlikely to eat enough to cause harm.
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Maybe someone should create a throwaway and provide a list of they’re concerned about retribution. People not calling out scum because they are afraid of the consequences of outing criminals makes the world a crappier place for everyone.
This is a crime, but it's very very hard to prove
Then how do you know it's prevalent?
> Then how do you know it's prevalent?
Let's just say I have a personal blacklist of therapeutics companies I will NEVER seriously work for (though I have done a couple things for them that satisfied my conscience), and a few electrical schematics squirreled away should I need to defend myself someday....
Would you email me? I'm really interested in learning about this. I have similar intuitions about places to avoid.
Id let people use unaprooved treatments labeling them with big warnings in red that this is not approved and may be snakeoil or something like that. Whoever attempts to hide, remove such labels fined severely, possible jail time. Couple of scandals of unaprooved treatments wreaking havok and very few would risk it afterwards.
> It's easy to say "people who have no other options should get access to experimental treatments" but the problem is that people who have other options want those too, because nobody wants to go through chemotherapy or whatever.
I reserve for myself the right to try to save my own life, even if that means some people who can't handle that responsibility make things worse for themselves. I can't get from, "but other people might hurt themselves" to "therefore you simply have to die, sorry."
No, I think we just have to be straightforward about this; I don't want anybody to purchase snake oil, but that possibility does not move me to eliminate options for myself or my family.
You say this now, but after your son, sister or mother dies after choosing snake oil, you will likely not say "I accept that they chose wrong and that's all there is to it". You will cry bloody murder and blame the system that didn't protect them from the snake oil salesmen, and demand that something be done.
Well, I of course don't know what you personally would do. But some people would do this, and it turns out, actually a lot of the people in that situation would do that. And so something gets done.
This is the same thing as crypto, people "reserving the right to take risks with their own money", and after the money is lost asking why the government didn't protect them. And the same as many other things. Humans suck at accepting the consequences of their own choices.
Nobody has a fetish of taking your choice away from you. People ask for things to be this way, because people are just human.
I agree with your description of reality. That doesn't mean that we have to accept it or say it's ok. It may be politically infeasible for the suggested policy (allowing people to choose treatments even if some people _will_ choose unwisely), or, if enacted, it may be impossible to keep it. But I will continue to advocate for it anyways. I believe in and advocate for _many_ policies that I have close to zero hope will ever be enacted.
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Let's say a treatment kills 9 out of 10 people. Maybe those 9 were terminally ill & that's why they died, but maybe the company was just lying and their treatment was doing nothing or killing people more quickly. How do you determine that? When would you shutdown a "death factory"? Would you require mandatory disclosures of the death rate & risks, or could a company hide those facts from prospective patients, only talking about the patients who survived? If they can't show efficacy, should they still be allowed to sell to patients?
I think the ideal of regulation is to try to remove the guesswork & expertise required for the end user to do due diligence. It's not perfect, but at least some minimum level of regulation, such as mandatory efficacy disclosures, would be needed.
I don't fundamentally disagree with you, I just understand why, as a society we may choose a different thing.
One of the reasons my father died of cancer quickly is that he was convinced by a chiropractor/osteopath that he had trouble with his back which could be cured with manipulation.
He was not an idiot, but sick people will make bad choices.
The abstract world of "either I die or I try this experimental treatment" is far more blurry, and there lies the problem, in my very humble opinion.
Why do you think you could always evaluate the options properly? What if that is not the case?
I accept the responsibility and all that it entails.
Just because a treatment doesn’t work doesn’t make it snake oil. Snake oil implies intent to deceive. Untested drugs can be based on a strong theoretical foundation and still not work. I expect the majority of experimental treatments won’t work. We should be trying regardless, not just for the sake of the people taking the treatment, but for the countless people in the future who can benefit from the same treatment when it does works.
Also we should stop patronizing everyone. If someone understands the risk and their doctor agrees, just treat them.
And how do we assess whether "someone understands the risk"? Often, I suspect nobody really "understands" the risk of some minimally-tested, experimental treatment.
This is a fully generalized argument against personal autonomy.
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Immunotherapies are still immature but far from snake oil at this stage. They routinely achieve miraculous remissions but also lead to many adverse events. For most late stage tumors, chemotherapy will only, at best, increase life expectancy a bit. In my opinion, the choice is obvious.
Imminotherapies very quickly kill a significant percentage of the people who try them. So it’s a complicated balancing act when someone is likely to die in say 1-2 years but also likely to survive another 6 months.
For people who are likely to die very soon the case is more clear cut, but the people developing these treatments don’t have the resources or infrastructure to try and treat more than a tiny handful of people. Allowing people to pay for such treatments also opens the door for a huge range of bad actors which also costs lives. I am not saying the current system is great, just that there’s a lot more complexity than is obvious on the surface.
Your comment makes something that happens quite rarely (1-5% based on agent, and not quickly) seem like it happens quite frequently.
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I have a good friend who went through Immunotherapy on a Stage 4 lung cancer and had an impressive recovery (all the metastasis tumours disappeared in the scan pictures I've seen). Not cured of course, but has a much longer life expectancy. So I've seen at least one anecdotal evidence that they work.
Keytruda, and other PD-1 blockers, have good science behind it. Many oncologists believe this is the true path to defeating many cancers.
While PD-1 blockers may cause the immune system to attack another part of a patient's body, we have quite a few ways to treat those autoimmune issues.
I'd say that people should be allowed to try whatever treatments they agree to have, in order to save their lives, and also in other cases. One cannot say with a straight face that a woman has sovereignty over her body and thus contraception and abortions should not be banned, and preclude that same woman from getting a treatment that can possibly save her life but has not been approved yet.
My friends mom bought a fancy light for 2000€ that was supposed to cure her cancer. Spoiler: it did not.
Now, that wasn't in the US, and I'm pretty sure the quack device wasn't approved as a medical device. But the fact is that fraudsters will sell their fake medical products to desperate patients who have nothing left to try. These people should rot in jail.
I'm sorry to hear this.
My idea is not about quack medicine. People should be discouraged from using quack medicine, and made abundantly informed that it's guaranteed not to work, while consuming their precious time alive which other treatments might extend.
My idea is about something that has promising results in scientific trials, but may carry unknown risks, and so is not yet approved. The risks may be worth it, because the alternative is a certain and quick death.
The patients should, of course, be also abundantly informed about the risks, the odds of success, etc.
Of course, some people would do things that we would find irrational, no matter how we try to persuade them against that. This may of course be painful to see, but I don't see why should we curtail the free will of an adult in their sane mind, as long as nobody's rights are being infringed. Certain new things always look crazy even though they have merit: see vaccines, blood transfusion, etc.
C’mon, it’s extremely disingenuous to compare abortion and contraception with untested treatment.
Assisted suicide and euthanasia are better examples. If you have autonomy to die, you should have autonomy to die trying not to.
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It’s unfair to call treatments untested. Medications are tested extensively. The FDA could work with sponsors to come up with a range of risk profiles and expand access.
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I don't have an issue with people taking magic beans to heal themselves; it's the sellers who knowingly (whole other kettle of fish there) sell snake-oil that are the immoral ones.
If the treatment needs to be administrated by a doctor, it demands the resources of the hospital and connected system, for a novel process. It does introduce a real risk factor for the rest of the healthcare provider’s system and the other people counting on it. I don’t see the comparison you’re making at all, really - a novel treatment has completely different context from an abortion.
Talking about immunotherapies feels like oh yes of course it would be worth it…but should you also be able to print out a blog article about holistic medicine and demand the hospital follow that treatment plan for your illness? Should a person insisting their illness be treated with an untested therapy from a disreputable company get a hospital bed instead of you for the same condition because they arrived first?
IMO this seems like something where the burden on the medical system is at least as much of a factor as the risk to the patient.
If I’m terminal and my doctor and I want to try the treatment, who are the feds to tell me no?
Screw ‘em
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Yes, and the FDA often does get pressured into approving treatments of dubious efficacy: https://arstechnica.com/science/2021/06/a-disgraceful-decisi...
It's easy to understand the logic of desperate patients who will try anything but it doesn't seem right to allow manufacturers to profit hand over fist selling treatments that may not even do anything, or worse, outright cause harm.
> In all three instances, the result was that the treatments were snake oil and people died that might have lived otherwise.
It seems like you're claiming that people who were given medical treatment after media attention weren't down to their last option(s)?
If they were down to their last options, then they made their choice and it didn't work out.
Couldn't this be solved by getting doctors' opinions? If docs says "This person's only chance of survival at the moment is chemotherapy, and it has a good chance of saving their life.", then, refuse the experimental treatment.
But if the docs say "With our current medical knowledge, this person is destined to die within $TIMEFRAME.", then, if the patient consents to try anything, even if it kills them earlier, why not?
Do you have the citations for the three instances where "people died that might have lived otherwise."?
In this person's case, he will not live otherwise, so he has nothing to lose by trying an experimental therapy, although it appears to be too late anyway. Very sad.
I guess the FDA has a role in minimizing the market for snake oil.
>but the problem is that people who have other options want those too
So, why can't one go through its own choice of treatment? Disregarding if its a good choice or a bad one.
That is an interesting and relevant point, but it does not apply in case of Jake and others like him -- he has no alternative where he might live.
In my opinion, the FDA ought to be more open to allowing experiments in cases where it is clear the patient is aware of the untested nature of the treatment.
It would result in tragic cases like the three you describe. During COVID-19 it would have resulted in people taking Ivermectin which was ineffective and even harmful.
But during COVID-19 it would also have resulted in determining 6 or more months earlier that the vaccines we made were safe and effective and the number of lives saved in that single instance would have greatly outnumbered the losses from 100 years of experiments.
Maybe the fact that these are the ones you remember is an indication of the problem, rather than evidence that it is wrong.