I am dying of squamous cell carcinoma, and potential treatments are out of reach • Hacker News Board

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

#381

Post by chroma » Sat, Jul 22, 2023, 9:52 PM UTC

citruscomputing wrote: post #323

joak wrote: post #254

Earlier quoted context omitted.

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…

It should also be free after it's approved by the FDA.

How would that work? Would the government use money from taxes to pay the drug companies for their costs, plus some profit margin?

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

#382

Post by kromem » Sat, Jul 22, 2023, 9:53 PM UTC

can16358p wrote: post #173

There should be a universal law in human rights stating anyone can take anything into their own bodies and governments can never, ever prevent them. Governments/regulators deciding what you can put into your body is beyond ridiculous: applies to all substances and drugs. Inform about the potential risks and effects: sure. Prevent: never.

The problem with your scenario is when the consequences are unknown.

People who aren't in medicine really have a hard time understanding just how grisly the things the human body can go through might be.

Medical staff saw during COVID the mismatch between the degree of fear the average Joe had about the consequence of intubation and the degree of fear and panic of the average Joe when actually getting a tube down their throats.

A drug that goes wrong in a bad way can go REALLY wrong in a bad way. Dying from cancer sucks, but it's still several degrees less horrible than dying from your CNS being eaten away from an autoimmune response to an experimental drug which somehow leads to opiate-resistant neuropathic pain.

But if we simply caution "we don't know if this drug will cause horrible side effects" versus "this drug may likely cause unthinkable pain that we can't control in your last conscious moments" that's a very different level of informed consent.

You might be surprised by the number of doctors who privately lament how patients and patient families in general will so often choose to shoot for low odds outcomes that mean terrible conditions for the patient in their last months of life. Even when risks are known, people tend to be bad at actual risk assessment, and will downplay risks and focus on potential rewards, and this extends into medical care. And I'm skeptical that descriptions of what might go wrong versus actually seeing firsthand what it looks like when things go wrong still represents adequately informed.

So while in spirit I agree that completely criminalizing personal choice around consumption is not ideal, when there's insufficient data for truly informed consent I'm not sure I still see eye to eye on the topic.

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

#383

Post by SanderNL » Sat, Jul 22, 2023, 9:56 PM UTC

can16358p wrote: post #200

hotpotamus wrote: post #181

Earlier quoted context omitted.

I mean, fentanyl? Obviously it's a whole subject that could be unrolled/debated, but I don't have any interest in doing that today. Really, I thought I'd just point out one interesting and often unknown aspects of US/State law (assuming this is mostly a US-based forum; I know you said universal human right) - taking drugs isn't a crime anywhere that I'm aware of. Possession of them certainly is, but just having taken…

Yeah. It should be legal too. I'm not defending the use of it in any way, this is not about drugs but a more fundamental problem: governments deciding what you can and cannot put into your own body. They should inform people about potential dangers and effects of substances, and try to prevent the underlying reasons for people to, say, do heroin or fentanyl. But if someone wants to do it anyway, making it illegal jus…

It’s not about any one person in particular. It’s about whole communities descending into hell for what could be multiple generations.

I know that in theory we all should be free and take whatever we want, but I know that in practice this doesn’t end well.

There are good reasons to control consumption of some classes of drugs that don’t have anything to do with religion and/or fake sense of morality. Some things just mess us up too hard and especially some people who are susceptible to it for various reasons.

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

#384

Post by Kamq » Sat, Jul 22, 2023, 10:02 PM UTC

abecedarius wrote: post #211

Kamq wrote: post #114

Earlier quoted context omitted.

I still think they need another category than what they have now. My understanding of the current categories of drugs are you have "banned" and "has this specific therapeutic effect that costs billions of dollars to prove". A category of "this doesn't kill you" in the middle would probably alleviate most of this. Insurance only has to pay for things with proven therapeutic effects, but you can shield people from pois…

The requirement to test for efficacy and not just safety was only added in response to Thalidomide (which disaster had nothing to do with testing for efficacy). So what you're asking for is very not radical.

> So what you're asking for is very not radical.

Shame. Radical seems to be all the rage these days.

Maybe I can brand it as radically conventional.

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

#385

Post by maxbond » Sat, Jul 22, 2023, 10:02 PM UTC

wbl wrote: post #365

maxbond wrote: post #149

Earlier quoted context omitted.

Let's say I give you 10 tasks. You're going to have to go back and forth with external stakeholders, and a given task will be blocked much of the time waiting for a response. So you can do each of them concurrently, but it's gunnuh take a year to do each of them. But the next day I come to you with an 11th task. I tell you this is the only one that matters. I give you full license to blow through your budget, harass…

The external stakeholders in the FDA are extremely motivated to get approval quickly. If this is a resource problem then the case for increasing the budget is clear.

> If this is a resource problem then the case for increasing the budget is clear.

Agreed.

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

#386

Post by oaktrout » Sat, Jul 22, 2023, 10:03 PM UTC

Hopefully he makes it into a clinical trial. In case anyone is interested in reading what trial options are available for this type of cancer you can find the trials here: https://www.clinicaltrials.gov/search?cond=Squamous%20Cell%2...

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

#387

Post by HWR_14 » Sat, Jul 22, 2023, 10:05 PM UTC

haldujai wrote: post #368

HWR_14 wrote: post #263

I would hate to ask the author this, as it seems cruel, but is the FDA denying him access? As he points out, Moderna has two drug trials going. The FDA "right to try" page[0] clearly spells out that Moderna could give him unproven medicine currently in a clinical trial under the right to try laws. So Moderna could let him into one of the two studies, or give him the medicine under the right to try laws if it rejects…

Actually the Moderna trials are recruiting metastatic and treatment resistant disease. From his description he has not met inclusion/exclusion criteria for the studies due to treatments received and not received rather than being too advanced in stage. It's highly highly highly unusual to be offering an experimental therapy on compassionate grounds when conventional options that have potential to actually work well h…

Are there conventional therapies that he has not tried that could be effective? It seems he has never had chemotherapy, but he implies at this point that's a long, almost impossible, shot.

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

#388

Post by abeppu » Sat, Jul 22, 2023, 10:07 PM UTC

porejide wrote: post #378

haldujai wrote: post #374

Earlier quoted context omitted.

> 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 us…

> 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.

Should we at least demand more specific criteria than "X _might_ save their life", like threshold of suggestive evidence? There will always be lots of stuff that hasn't been closely studied, the effects of which we can only partially describe. You could isolate any new molecule from some previously unknown bacterium and say it "might" be a treatment for any disease, but that's just a statement of our own ignorance right?

If we say, "so long as it hasn't been conclusively shown to _not_ beneficial for the patient's disease, then it _might_ help them, so it should be fair game", then that seems to open the door to quacks selling snake oil to desperate dying people and their families. And of the unenumerable list of potential "it might work because we haven't yet shown that it doesn't" chemicals, why shouldn't unethical practices pick the most expensive options available?

"Of course you must understand there can be no guarantees with any treatment, and this may be a long shot, and precisely because of the lack of prior studies we cannot even give you any efficacy numbers. But we're at the cutting edge of medical science! Please make out a check for $500k and sign this waver and we can begin treatment as soon as possible."

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

#389

Post by haldujai » Sat, Jul 22, 2023, 10:08 PM UTC

porejide wrote: post #378

haldujai wrote: post #374

Earlier quoted context omitted.

> 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 us…

> 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.

You're assuming a therapeutic not tested in humans has a better chance of saving someone's life than something tested and available. Do you have any evidence to support this?

> 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:

There is little randomised evidence comparing amisulpride with other second generation antipsychotic drugs. We could only find trials comparing amisulpride with olanzapine, risperidone and ziprasidone. We found amisulpride may be somewhat more effective than ziprasidone, and more tolerable in terms of weight gain and other associated problems than olanzapine and risperidone. These data, however, are based on only ten short to medium term studies and therefore too limited to allow for firm conclusions.

This review compared the effects of amisulpride with those of other so called second generation (atypical) antipsychotic drugs. For half of the possible comparisons not a single relevant study could be identified. Based on very limited data there was no difference in efficacy comparing amisulpride with olanzapine and risperidone, but a certain advantage compared with ziprasidone. Amisulpride was associated with less weight gain than risperidone and olanzapine.

What's so tragic about this? Equally efficacious antipsychotics are available. Once again the alternative to non-approved drug isn't nothing or inferior substance.

I will concede that legacy off-patent drugs are part of the "very limited" gap with the FDA, this doesn't hold for new drug discoveries as discussed in the article.

Even then, there is an ongoing US trial for amisulpride and the substance is approved for nausea/vomiting (granted not in oral form).

[0] https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD...

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

#390

Post by krisoft » Sat, Jul 22, 2023, 10:10 PM UTC

Veserv wrote: post #373

krisoft wrote: post #298

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. 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…

> 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.