Comment by exmadscientist
3 years ago
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.
> 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.
That would never happen for good reason. Drug companies would have every incentive to bias the results towards approval by giving the drugs to detain patients. I’m not exaggerating when I say this might be the worst idea I’ve read in this entire thread.
7 replies →
This plan seems to have excellent incentive alignment and basically mirrors the system in place, but without the need to be approved for clinical trials.
Experimental treatments being available to people with no options (there must be no applicable option with a proven probability of success or this becomes very questionable) could save drug companies millions-billions in the off chance that it proves to be incompatible with human testing or fails to produce the expected effects in humans.
I would take this up a notch or two for patients in a short-range situation that is certainly fatal, opening the door for them to try treatments that have just barely crossed en-vidrio and seem to have acceptable toxicity in mouse models. This would essentially be donating one’s body to science but in a much more useful form, with the side benefit of a slim chance of life extension.
This could benefit humanity by significantly reducing time to market for some drugs and cutting costs on eventual dead-ends.
2 replies →
No, that does not set the right incentives. You have completely written off the harm of dangerous or deadly drugs.
The HepC drug Sovaldi brought in around $50B-100B in sales, but probably costs less than $50 to administer. Under your scheme it would make economic sense for a company to kill 1,000,000,000 people testing variants until they chance upon the right one because they incur no costs for administering deadly experiments.
The problem with your scheme is that human lives are valuable. A unsafe drug that causes harm or death is immensely destructive. If we want to be completely reductive, the actuarial value of a human life is around $10,000,000. A unsafe drug could kill the person resulting in a $10M loss to society. Therefore, the company should be required to escrow $10M per person until the treatment is done, paid out proportionally to any potential death or harm in excess of the gold standard treatment. Only then would the incentives be reasonably aligned.
This is obviously a very reductive treatment, but it helps illustrate the problems with unrestricted testing.
2 replies →
> 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.
Hell I'd even approve my tax money to go to those companies which end up saving lives as reward.
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.
I mean, this is just a “sufficient misinformation” argument that could be levied against literally any kind of policy. No policy can survive sufficient misinformation.
1 reply →
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.
If I knew I were going to die, I'd at least want to try something new even if the chances were slim. If it didn't work out, at least it'd be a new data point for those that come after. That means something.
True. But speeding up the search for a treatment saves many future people.
The ethical tradeoff between definitely saving a life now or probably saving many lives later is an age old problem, but one which society hasn't properly converted into laws and processes in medicine.
> 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.
It should be a escrow release when a patient is cured.
This just winds up being cruel. We don't understand a number of diseases, and we don't know how to cure them.
But we can treat symptoms, and sometimes prevent them even if it isn't a cure. It's OK to make Insulin Plus that keeps diabetics alive longer. I have MS, and freaking trust me, I want my non-cure medicine. Without that medicine, my chances of having a very poor quality of life full of discomfort increases pretty dramatically. Lots of things are like this: No real cure, but we make folks lives better by treating symptoms or preventing some damage and things like that.
The only way to not be cruel is to give treatments that work even if they aren't a cure.
3 replies →
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)
It should also be free after it's approved by the FDA.
2 replies →
> 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.
woosh
Steve Jobs got into alternative medicine to treat his pancreatic cancer, including trying a fruitarian diet. Since he had a rare form that isn’t as fatal as pancreatic cancer usually is, there’s a chance he could have survived significantly longer if he had instead treated it with traditional, non-experimental medicine.
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.