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I am dying of squamous cell carcinoma, and potential treatments are out of reach

jakeseliger.com

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Re: I am dying of squamous cell carcinoma, and potential treatments are out of reach

#371

Post by meristem »

bhhaskin wrote: post #362
knodi123 wrote: post #357

Earlier quoted context omitted.

Devil's in the details. Suppose Pfizer wants to test a new acne drug based on radium nanoparticles fused to asbestos. It might work, and hey, if you can give a homeless guy $100 and a bottle of vodka to "voluntarily take it into his body" and let you watch to see what happens- that's so cheap! Why not give it a shot!

If the person is mentally able to make that decision for them selfs, then why not?

Mentally able =/= intellectually sophisticated to parse the legalese in the offer

Re: I am dying of squamous cell carcinoma, and potential treatments are out of reach

#372

Post by chroma »

maxbond wrote: post #364
chroma wrote: post #361

Earlier quoted context omitted.

At this point I don’t know what could change your mind. Your response to any criticism of the FDA or any proposed fix is to say that we need to make the FDA more competent, as if that’s not what people have been trying to do since the FDA was created. Unless you provide details about what would be different from what we’re already doing, you’re just arguing for the status quo. It’s as if I were pointing out the usele…

> Your response to any criticism of the FDA or any proposed fix is to say that we need to make the FDA more competent... [Emphasis added] You've only proposed one fix. I'm only opposed to one idea. You aren't under any obligation to try and convince me of anything, but surely you don't have to put words into my mouth.

What hypothetical evidence would cause you to change your mind about allowing American doctors to prescribe drugs approved by the EU?

Re: I am dying of squamous cell carcinoma, and potential treatments are out of reach

#373

Post by Veserv »

krisoft wrote: post #298
londons_explore wrote: post #169

Earlier quoted context omitted.

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 s…

> 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 manufactu…

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.

Re: I am dying of squamous cell carcinoma, and potential treatments are out of reach

#374

Post by haldujai »

kortex wrote: post #313

Why don't we just have a schedule/tier system? Category A - approved by the FDA, basically what we have right now Category B - approved by some other established regulatory body (EU). Comes with all the warnings, doctors can write it off-label, insurance companies may not cover it but doctors can ask for a variance Category C - approved by some non-OECD body. Insurance companies under no obligation to cover Category…

> Category B - approved by some other established regulatory body (EU). Comes with all the warnings, doctors can write it off-label, insurance companies may not cover it but doctors can ask for a variance

We can already prescribe off-label if the FDA has approved it for at least 1 indication, and it mostly gets reimbursed.

> Category C - approved by some non-OECD body. Insurance companies under no obligation to cover

There's very little that's approved by a non-US body and approved by the EU or non-OECD body that warrants clinical use, and if it is it gets reviewed quickly. The US is the largest market for manufacturers so they almost always start here.

> Category D - experimental, this is stuff maybe still only in animal models, but pharmacies can still order and dispense it

Pharmacists and physicians are ethically bound to prescribe to the best of their ability and avoid harm, by prescribing something only validated in animal models it means we are not prescribing/dispensing something validated in humans and therefore not meeting or exceeding the standard of care.

This sounds like a recipe for killing people.

> The latter category also opens the door for custom therapies (gene/mRNA) that you basically can't test the active pharmaceutical ingredient for efficacy on.

Huh? There are many ongoing gene-directed and mRNA studies being tested.

Re: I am dying of squamous cell carcinoma, and potential treatments are out of reach

#375

Post by HWR_14 »

jstummbillig wrote: post #358
HWR_14 wrote: post #277

Earlier quoted context omitted.

If it were for science alone, it might be fine. The problem is when Steve Jobs is sick and I walk up to him and sell him an experimental cure for $2,000,000,000. He can trivially pay it, but I have a huge incentive to lie. At a smaller scale, a more efficient conman can take all of someone's assets. And not just the dying person's. How many people wouldn't sacrifice everything to save a spouse's life or their child's…

Could the former be fixed by requiring experimental drugs to be free of charge, or would that break how drug roll-out works? Somebody suggested an escrow account in this thread, which also seemed interesting.

I mean, the experimental drugs are already provided free of charge to the group participating in the study. I have no idea how it would change the economics if the ones given under any kind of "right to try" were also required to be free.

As of now, "right to try" drugs are supplied by the manufacturer under whatever terms they want at their discretion.

Re: I am dying of squamous cell carcinoma, and potential treatments are out of reach

#376

Post by PostOnce »

bhhaskin wrote: post #362
knodi123 wrote: post #357

Earlier quoted context omitted.

Devil's in the details. Suppose Pfizer wants to test a new acne drug based on radium nanoparticles fused to asbestos. It might work, and hey, if you can give a homeless guy $100 and a bottle of vodka to "voluntarily take it into his body" and let you watch to see what happens- that's so cheap! Why not give it a shot!

If the person is mentally able to make that decision for them selfs, then why not?

Additionaly, medicine companies aren't going to waste money trying stuff they know is likely to fail (like the example "radium asbestos")

Re: I am dying of squamous cell carcinoma, and potential treatments are out of reach

#377

Post by maxbond »

chroma wrote: post #372
maxbond wrote: post #364

Earlier quoted context omitted.

> Your response to any criticism of the FDA or any proposed fix is to say that we need to make the FDA more competent... [Emphasis added] You've only proposed one fix. I'm only opposed to one idea. You aren't under any obligation to try and convince me of anything, but surely you don't have to put words into my mouth.

What hypothetical evidence would cause you to change your mind about allowing American doctors to prescribe drugs approved by the EU?

I haven't made the counterclaim to that. That's not the same as saying that the FDA should rubber stamp all European approvals.

Should doctors be able to prescribe drugs approved elsewhere? When we're talking about lifesaving treatment that isn't available in the US, yeah probably there should be some process to do that. I imagine insurance companies will make this next to impossible, but that's not a reflection on your argument, just a shitty reality.

What would convince me that the FDA should rubber stamp European drug approvals? I don't know, but it would be evidence about the structure of the pharmaceutical market and the incentives in place, not a recitation of misses by the FDA.

Your evidence they aren't approving drugs fast enough is convincing, I absolutely buy that a problem exists. But that evidence doesn't address my separate concerns.

Let's say we do go ahead and rubber stamp everything coming out of Europe. What is going to happen?

There's going to be more pressure on European regulators. How are they going to respond to it?

Possibly by being corrupted and subverted and failing open. That would be bad.

The alternative is that they becoming more careful, more plodding, they start taking into account the views of stakeholders the FDA would otherwise have represented, and the process gets gummed up anyway.

Re: I am dying of squamous cell carcinoma, and potential treatments are out of reach

#378

Post by porejide »

haldujai wrote: post #374
kortex wrote: post #313

Why don't we just have a schedule/tier system? Category A - approved by the FDA, basically what we have right now Category B - approved by some other established regulatory body (EU). Comes with all the warnings, doctors can write it off-label, insurance companies may not cover it but doctors can ask for a variance Category C - approved by some non-OECD body. Insurance companies under no obligation to cover Category…

> Category B - approved by some other established regulatory body (EU). Comes with all the warnings, doctors can write it off-label, insurance companies may not cover it but doctors can ask for a variance We can already prescribe off-label if the FDA has approved it for at least 1 indication, and it mostly gets reimbursed. > Category C - approved by some non-OECD body. Insurance companies under no obligation to cover…

> This sounds like a recipe for killing people.

Do you know what else sounds like a recipe for killing people? Not allowing people to access therapeutics that might save their life because it hasn't yet gone through regulatory approval yet for whatever reason (delays, too expensive to submit), etc.

> There's very little that's approved by a non-US body and approved by the EU or non-OECD body that warrants clinical use, and if it is it gets reviewed quickly

LOL. What are you talking about. There are so many examples.

One of the most tragic is amisulpride. Amisulpride is an antipsychotic medication used to treat schizophrenia and other psychiatric conditions. Some key notes about its regulatory status:

- Amisulpride was first approved in France in the 1980s and is widely used in Europe.

- It was never approved by the FDA for use in the United States, and at this point there's not organization that can afford to go through the approval process because there's no patent.

- The reason often cited is that the manufacturer did not apply for approval with the FDA. It was likely not considered commercially viable for the US market at the time.

- Amisulpride is believed to have comparable efficacy to other second-generation antipsychotics like olanzapine and risperidone, but with a lower side effect burden according to some studies.

- In Europe, amisulpride is considered a first-line treatment option for schizophrenia, but American psychiatrists do not have access to it. According to some sources, it is literally recommended as the best antipsychotic in other countries.

Re: I am dying of squamous cell carcinoma, and potential treatments are out of reach

#379

Post by Google234 »

gabea wrote: post #75

There is a clear problem, and a good idea here. (i.e. Right to Try) What needs to happen to make this move forward? I am getting so mentally exhausted learning about a specific problem, and then experiencing the helplessness of not knowing how to push on driving towards some mutually agreeable resolution. Add in the fact that there is no way to seemingly coordinate the push towards a resolution. Individuals taking ac…

What about the right to refuse? I don’t think there actually is a problem here, there’s no reason for this Pharma company to provide an expensive untested drug- only potential negatives

Re: I am dying of squamous cell carcinoma, and potential treatments are out of reach

#380

Post by Veserv »

bhhaskin wrote: post #362
knodi123 wrote: post #357

Earlier quoted context omitted.

Devil's in the details. Suppose Pfizer wants to test a new acne drug based on radium nanoparticles fused to asbestos. It might work, and hey, if you can give a homeless guy $100 and a bottle of vodka to "voluntarily take it into his body" and let you watch to see what happens- that's so cheap! Why not give it a shot!

If the person is mentally able to make that decision for them selfs, then why not?

Because they almost certainly can not. They almost certainly have no idea what the consequences of their actions are as the drug company almost certainly did everything in their power to obscure, obfuscate, and downplay the risks as literally every company is legally allowed to do.

The principle at play here is “informed consent”. Unfortunately, modern society has little interest in the “informed” part which is why it is probably not a good idea to let people imbibe untested drugs even if they are giving “consent” unless they can demonstrate they are “informed”.

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