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

#231

Post by Given_47 » Sat, Jul 22, 2023, 6:40 PM UTC

MostlyStable wrote: post #198

lucianbr wrote: post #187

Earlier quoted context omitted.

You say this now, but after your son, sister or mother dies after choosing snake oil, you will likely not say "I accept that they chose wrong and that's all there is to it". You will cry bloody murder and blame the system that didn't protect them from the snake oil salesmen, and demand that something be done. Well, I of course don't know what you personally would do. But some people would do this, and it turns out, a…

I agree with your description of reality. That doesn't mean that we have to accept it or say it's ok. It may be politically infeasible for the suggested policy (allowing people to choose treatments even if some people _will_ choose unwisely), or, if enacted, it may be impossible to keep it. But I will continue to advocate for it anyways. I believe in and advocate for _many_ policies that I have close to zero hope wil…

I share the same mindset as u and I’ve been told countless times something to the effect of “yea but that’s not realistic” yet I never stop. I’ve often wondered why that is; I assume it’s just some psychological thing/on principle of not simply accepting this thing I perceive as stupid.

Additionally, I think it’s partly me just wanting to spread awareness about and possibly engage smarter people than me to devise better resolutions/implementations as well.

Wondering if u have any thoughts or I’m just galaxy braining it

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

#232

Post by tux3 » Sat, Jul 22, 2023, 6:40 PM UTC

haldujai wrote: post #162

tux3 wrote: post #128

Earlier quoted context omitted.

It may help to not view the options as a binary choice between drugs approved under the current process and any drug not currently approved. What constitutes the acceptable tradeoff is the heart of the matter. On the one hand, even the current approval process does not always guarantee efficacy (Aduhelm to mention it by name). Medical trials work with considerable uncertainty, and the risk/benefit tradeoff is always…

I don’t understand your overall point here as this is pretty much how the current system works. > It is possible to take those probabilities and to talk about the expected number needed to treat (NNT) for a medication, the expected side effect profile, how many people might live and how many might die. NNT > NNH = efficacy. To calculate these the trials need to be done, which is not the case for experimental therapie…

Trials are done in multiple phases, with a progressively wider population. There is a point where we consider a drug to still be unproven, but safe enough for human trials.

I think that situations like TFA make a compelling case for selectively broadening access, for some drugs and some pathologies. The characterization of a choice between something proven and something with unknown values is too coarse and not a good model.

Clinical trials are very expensive, drug development as a field tends to move forward with what it thinks will have a chance of making it through. While most new drugs indeed fail (the large majority of them), in diseases with very poor prognosis like OP's cancer, I think we would benefit from still looking at the tradeoff as a decision under uncertainty, instead of a complete unknown. Even with less data than we would otherwise want.

Looking at experimental therapies as completely undetermined leads to a binary choice. There is supporting evidence that allows those therapies to move forward with experimental trials in the first place. The counterfactual of not treating patients with poor prognosis being what it is, my overall point is that treating experimental drugs as total unknowns with benefits and harms that cannot be quantified until the full process is finished is not consistent with the knowledge that, even after all trials are completed, this is still a uncertain statistical result, only with slightly more data than before.

In other words, we are always working with partial unknowns so when the prognosis is bad a larger unknown may be good overall and save lives, even though it wouldn't be acceptable otherwise.

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

#233

Post by npsomaratna » Sat, Jul 22, 2023, 6:40 PM UTC

tux3 wrote: post #3

There seems to be a growing sentiment that FDA delenda est , but if we don't fix the underlying problem that led to this situation, it will just come back. As the author says, no one ever blames the FDA for the people it failed to save. But approve something without the certainty that it isn't potentially going to kill someone, and there will be hell to your doorstep. Even if you want the experimental treatment, you…

Going on a tangent here: there's a reason medicine is heavily regulated—because of the lessons we've learned the hard way. The same reason law is also heavily regulated. Some of these lessons have become obscured by time, unfortunately. Other lessons may not be fully applicable to the modern state of the field. (I say this as a qualified doctor and lawyer with some appreciation of the history of both fields.)

Are the current regulation regimes perfect? No. Would we be better off without it? I doubt it. Should we try to strike a balance between regulation and innovation? Yes—but doing so is devilishly tricky. No matter what you do, someone somewhere will be unhappy.

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

#234

Post by [deleted] » Sat, Jul 22, 2023, 6:40 PM UTC

tux3 wrote: post #3

There seems to be a growing sentiment that FDA delenda est , but if we don't fix the underlying problem that led to this situation, it will just come back. As the author says, no one ever blames the FDA for the people it failed to save. But approve something without the certainty that it isn't potentially going to kill someone, and there will be hell to your doorstep. Even if you want the experimental treatment, you…

[deleted]

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

#235

Post by WalterBright » Sat, Jul 22, 2023, 6:41 PM UTC

tux3 wrote: post #3

There seems to be a growing sentiment that FDA delenda est , but if we don't fix the underlying problem that led to this situation, it will just come back. As the author says, no one ever blames the FDA for the people it failed to save. But approve something without the certainty that it isn't potentially going to kill someone, and there will be hell to your doorstep. Even if you want the experimental treatment, you…

Sam Peltzman goes into this and the statistics in his book Regulation of Pharmaceutical Innovation:

https://www.amazon.com/Regulation-Pharmaceutical-Innovation-...

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

#236

Post by [deleted] » Sat, Jul 22, 2023, 6:41 PM UTC

chroma wrote: post #185

maxbond wrote: post #171

Earlier quoted context omitted.

Maybe part of the reason that the Canadian and UK drug regulators are competent, is because we haven't created a sufficiently large system of incentives to undermine them. Maybe if approving a drug in Canada got you access to the entire world, we would have a very different scenario. A rubber stamping scheme removes redundancy from the system. Approving drugs faster sounds like a great idea, but there was a reason so…

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…

[deleted]

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

#237

Post by zer8k » Sat, Jul 22, 2023, 6:42 PM UTC

light_hue_1 wrote: post #45

Blaming the FDA is popular but the problem is not the FDA itself. Drug manufacturers are part of the problem. 1. When the FDA has fast-tracked drugs, drug makers have taken advantage of this to hide data, lie, and refuse to comply with timelines for proving those drugs work. https://www.npr.org/sections/health-shots/2022/07/22/1110830... 2. When these accelerated drugs are found to not work or cause harm, the manufac…

You're missing the part where the FDA has a revolving door with the biggest pharma companies. To think the FDA is some flawed, but impartial, judge of drugs is the key problem. The FDA is controlled by big pharma. No more, no less.

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

#238

Post by lucianbr » Sat, Jul 22, 2023, 6:42 PM UTC

MostlyStable wrote: post #198

lucianbr wrote: post #187

Earlier quoted context omitted.

You say this now, but after your son, sister or mother dies after choosing snake oil, you will likely not say "I accept that they chose wrong and that's all there is to it". You will cry bloody murder and blame the system that didn't protect them from the snake oil salesmen, and demand that something be done. Well, I of course don't know what you personally would do. But some people would do this, and it turns out, a…

I agree with your description of reality. That doesn't mean that we have to accept it or say it's ok. It may be politically infeasible for the suggested policy (allowing people to choose treatments even if some people _will_ choose unwisely), or, if enacted, it may be impossible to keep it. But I will continue to advocate for it anyways. I believe in and advocate for _many_ policies that I have close to zero hope wil…

IMHO, the solution is not advocacy for policies where people get to choose and take the risk and get whatever results they get. Because there will generally be more people advocating for forced "good" choices.

The solution, I think, is to teach people to understand risk, choices and consequences better. With enough teaching, maybe the advocacy for the forced good will decrease.

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

#239

Post by robomartin » Sat, Jul 22, 2023, 6:42 PM UTC

Trump got a federal Right to Try experimental drugs act passed in 2018:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7309195/

Not sure how this intersects with the author's reality. It is sad to see article after article spewing nothing but hatred towards Trump --almost purely from an ideological perspective-- when something like this could help so many.

This, in more ways than one, demonstrates how difficult of a problem this is. When people's lives become game pieces in political battles, the people lose and politicians, well, use them to score points towards their own career objectives.

I read in a comment that the author lives in NY, where, apparently, Right to Try isn't available. If find this interesting when a federal law has been in place since 2018.

This is one of the things that can be perplexing about the US system of government. Here we have a state preventing people from having access to treatments that could materially affect their illness when federal laws allow it.

While I do understand the many advantages of the independence granted to states by the US constitution, sometimes it feels like the US has devolved into a fifty regions pretending to be united as a nation when they are actually not and, as a result, end-up conspiring to damage the very societies they claim to protect.

Education is another example of this. All nations with excellent systems of education (and the results to prove it) have national-level planning, management and standards. In the US, not only is our system of education fragmented at the State level. Our schools are run by fucking unions organized as districts, each with their own axe to grind. It is no surprise the results are what they are.

We somehow manage to extend some of this "excellence" (sarcasm) into every level of healthcare.

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

#240

Post by haldujai » Sat, Jul 22, 2023, 6:42 PM UTC

User23 wrote: post #195

GuB-42 wrote: post #154

Earlier quoted context omitted.

> The incentive isn't to cure but to treat. The Market wants (repeat) customers. I am fed up with this argument. Compared to a recurring treatment, a cure will: - destroy the competing recurring treatment - sell particularly well initially, when you still have the patent, potentially at a high price - not stop the influx of repeat customers, since as long as people are alive, they will need medicine, and people who a…

Gilead’s hepatitis cure is a real example of this[1], so it’s not some hypothetical. The sales plummeted and wall street dinged them for it. [1] https://www.investors.com/news/technology/can-gilead-withsta...

Wall Street dinged them because Gilead is a one trick pony and the street overestimated revenue, not because Gilead cured HCV rather than just treating it.

Additionally, if their drug didn’t work as well they wouldn’t have gotten away with charging 100k for a course and wouldn’t have made 40B+ in revenue.