Comment by londons_explore
3 years ago
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.
> Drug companies would have every incentive to bias the results towards approval by giving the drugs to detain patients.
What do you mean “detain” patients? Remember we are talking about people who have a terminal illness with no known cure. How can drug companies “bias the results”? Obviously I’m not saying we take anything they say as gospel, but in short order these patients are expected to die. If a drug managed to cure them that would be quite hard to falsify don’t you think?
> I’m not exaggerating when I say this might be the worst idea I’ve read in this entire thread.
Well, thank you. I aim to please. Are you sure that you understood the idea well? If you are, could you please explain with more words what is the misbehaviour you are worried the drug companies would commit?
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What do you mean with "by giving the drugs to detain patients"? Is that a typo? I don't see how companies holding on to terminally-ill patients makes the trial results look more favourable. Are you suggesting that companies might not release the bodies of the patients that died during the trial?
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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.
I don’t think these people would be useful. Pharma needs controlled double blind studies to actually tell if the therapies work.
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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.
> You have completely written off the harm of dangerous or deadly drugs.
I was only talking about testing on people who we know are going to die fast because of their condition, and we do not have a way to save them in any other way. And naturally only with their consent. People who have a ticking clock and therefore willing to try anything.
This is the context the article in question talks about.
I think you forgot to price in the fact that some people live with what is effectively a time limit sometimes counted in months or weeks (like the person from the linked article).
> 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.
The point I am making is not a rebuttal to this specific proposal but that any such change will have an attack vector. Hell, the reason we are having this discussion is because of the (unfortunate) case of someone not being served by the current policy. Any new change to the policy will have such cases which will lead to this same discussion.
Creating an equitable drug approval process is a true dilemma.
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.
Symptoms are used to diagnose, ergo is a treatment of symptoms a cure?
Lets not forget the expansion of the DSM which pretty much incorporates every human being as having a mental health issue or sexual deviancy fetish. There is no normal in the DSM, so would some medical experts start dialling back on diagnosing new conditions to pad out their careers and income?
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