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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

#361

Post by chroma »

maxbond wrote: post #264
chroma wrote: post #185

Earlier quoted context omitted.

There is no reason because it wasn’t a deliberate choice. Different countries created their own standards bodies and didn’t try to coordinate until later. The same thing happened with safety regulations around automobiles and aircraft. Fortunately in those cases, most countries have coordinated and manufacturers can sell the same vehicle in different countries with little extra effort. But for rare diseases with chea…

Again, this is a fine argument for making the FDA more effective and for coordinating with international partners, but full of holes as an argument for rubber stamping. And I still don't see why a rubber stamp serves your purposes better. If you think the UK, European, and Canadian regulators are competent, then you must believe in the possibility of a competent regulator, right? Let's just have one of those, instead…

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 uselessness of most TSA screening and someone replied that the solution is to make the TSA more competent.

I’d change my mind if there were more examples of harmful drugs in Europe or Canada that the FDA blocked in the US. The thalidomide scandal was over 60 years ago and caused around 4,000 deaths and 6,000 birth defects. You’d need a dozen thalidomide scandals to equal the FDA’s delays in approving beta blockers.

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

#362

Post by bhhaskin »

knodi123 wrote: post #357
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.

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?

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

#363

Post by tremon »

CogitoCogito wrote: post #322
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…

> 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 pati…

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?

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

#364

Post by maxbond »

chroma wrote: post #361
maxbond wrote: post #264

Earlier quoted context omitted.

Again, this is a fine argument for making the FDA more effective and for coordinating with international partners, but full of holes as an argument for rubber stamping. And I still don't see why a rubber stamp serves your purposes better. If you think the UK, European, and Canadian regulators are competent, then you must believe in the possibility of a competent regulator, right? Let's just have one of those, instead…

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.

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

#365

Post by wbl »

maxbond wrote: post #149
wbl wrote: post #131

Earlier quoted context omitted.

Why doesn't it mean that?

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.

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

#366

Post by kromem »

Terr_ wrote: post #349
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.

> anyone can take anything into their own bodies and governments can never, ever prevent them. Thought experiment: There is a magic drug or parasite where any dosage (whether deliberate, accidental, or fraudulent) will force the person into a single-minded violent quest to get another dose. For the next month, another hit is the most important thing in their world, even if that means selling everything they own, cutt…

Not OP, but laws against distribution? Absolutely.

Laws against consumption? A terrible idea.

What we should want to do as a society is funnel people interested in trying things we think they really shouldn't do towards legal chokeponts that are less onerous than DIY access under controlled distribution but still allow for attempts at prevention of the end outcome.

The clearest example of this even more than your drug scenario would be a drug that just immediately kills the user.

There's a lot of people every year that seek out that end result. While some can fall under a narrow scope of legal options under dignity laws when faced with terminal situations, there's many who seek out that outcome without physical ailments.

If there were a legal way to seek it which was overall less traumatic of a route, but which was also only on the other end of intervention measures like counseling, how many lives might be saved as compared to the rather ineffective prohibition that we see today which largely fails to prevent access and use, but whose illegality does prevent aspects of both research and prevention that might otherwise occur if distribution was the only thing targeted in laws and not attempted consumption?

If people are aware of the life ruining consequences of a drug but value their own lives so poorly that it doesn't deter them from throwing them away to seek out a drug, then society doesn't have a drug problem as much as it has a human experience problem.

There's few things more cruel in concept than ensuring people keep living under conditions where they'd rather not live at all. Whether they are seeking that result all at once or gradually throwing their life away, criminalizing their seeking rather than the conditions that motivate their seeking is wildly messed up.

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

#367

Post by xk_id »

adamredwoods wrote: post #335
youssefabdelm wrote: post #104

There was a drug called Rapamycin discussed in this Radiolab episode https://radiolab.org/podcast/dirty-drug-and-ice-cream-tub The drug supposedly helped delay the doctor's cancer and extend his lifespan until he stopped taking it, then it came back "with a vengeance" and he passed away. He wanted to stop taking it to verify whether it was actually working or not. I wonder if it might help this person? He might have…

This is an mTOR inhibitor, I believe there are others already in clinical trials. I know PIK3 inhibitors are used to block some cancers. Most inhibitors stop cancer for "a while" but cancer cells have the ability to circumvent pathway disruptions. https://en.wikipedia.org/wiki/Sirolimus https://en.wikipedia.org/wiki/MTOR_inhibitors

PI3K inhibitors only work if the tumour tests positive for that special mutation.

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

#368

Post by haldujai »

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 haven't been tried yet. In this post he only describes locoregional therapy and it appears he has not tried anything systemic yet.

The closest I've seen is we at least try a very short attempt of something in clinical use and then say patient refused/intolerable side-effects/treatment failure and move on. I can't imagine a circumstance where medical ethics would allow to skip a trial of validated therapy for something without even phase I data. It's not like this mRNA by Moderna is known to actually work.

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

#369

Post by croisillon »

ayewo wrote: post #295
sgseliger23 wrote: post #226

This is my brother. I love you. Anyone who has suffered through this disease or has a loved one that experienced it knows the feeling of helplessness. More on Jake’s story below, and a link to the fundraiser to support him and his wife: https://www.gofundme.com/f/help-the-fight-against-cancer-wit... Be kind and good to your loved ones. Life is short and no one knows how much time we have left. While the FDA’s antiqua…

The surname is very familiar. I checked and Jake is in fact a long-standing member of this community as jseliger [1]. I’m sorry for the very difficult times your brother is going through. I hope and pray that his situation improves. 1: https://news.ycombinator.com/user?id=jseliger

more specifically, this topic has been brought here https://news.ycombinator.com/item?id=36393383

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

#370

Post by Google234 »

K0balt wrote: post #334
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…

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 incompati…

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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