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

jakeseliger.com

201–210 of 486 posts

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

#201
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…

I remember at least three instances in my country where the authorities were forced to allow people to use experimental treatments due to media clamor. In all three instances, the result was that the treatments were snake oil and people died that might have lived otherwise. It's easy to say "people who have no other options should get access to experimental treatments" but the problem is that people who have other op…

That is an interesting and relevant point, but it does not apply in case of Jake and others like him -- he has no alternative where he might live.

In my opinion, the FDA ought to be more open to allowing experiments in cases where it is clear the patient is aware of the untested nature of the treatment.

It would result in tragic cases like the three you describe. During COVID-19 it would have resulted in people taking Ivermectin which was ineffective and even harmful.

But during COVID-19 it would also have resulted in determining 6 or more months earlier that the vaccines we made were safe and effective and the number of lives saved in that single instance would have greatly outnumbered the losses from 100 years of experiments.

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

#202
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…

Vaccines aren't a cure. They require repeat customers. You're making my argument for me.

Most vaccines only require 1-3 injections.

This example is poorly chosen for a different reason explained in my comment.

Alternatively, we can look at novel curative intent therapies for cancer like focal ablation or stereotactic radiation.

The recurring customer alternative of chemo/immunotherapy or the conventional surgical option are at least an order of magnitude more expensive.

You won’t find much novel systemic therapy that’s curative intent because it’s really hard (?impossible) to do, not because the system wants to make more money slowly killing patients.

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

#203

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.

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…

If buying, selling, and possessing are all illegal, it's illegal for all practical purposes.

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

#204

There are "right to try" laws both Federally and in 40+ states. It's unfortunate the author doesn't address those, I'm curious how they interact with his case.

It appears that he is in New York, which doesn’t have a right to try law on the books.

If that is the reason, perhaps temporarily moving to another state might help? The author appears to still be mobile.

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

#205

There's a very easy regulatory solution: Roll the drug approval process back to the way things were done prior to 1962. Back then, safety testing was all that was required. Efficacy testing -- which is difficult, expensive, arguably unethical in itself, and in some cases effectively impossible -- was not required. Drugs cost ~20-50x less to bring to market, and were brought to market faster. Indeed the 40s and 50s ar…

Ah yes, let’s go back to the days of Thalidomide. For those that don’t know, the 1962 change is the Kefauver–Harris Amendment, which was a response to one of, if not the, largest overall global crisis of conscience in the medical field. From Wikipedia: “When first released, thalidomide was promoted for anxiety, trouble sleeping, "tension", and morning sickness.” After some time it became increasing obvious that while…

Everything you said has absolutely nothing to do with what GP said.

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

#206

There's a very easy regulatory solution: Roll the drug approval process back to the way things were done prior to 1962. Back then, safety testing was all that was required. Efficacy testing -- which is difficult, expensive, arguably unethical in itself, and in some cases effectively impossible -- was not required. Drugs cost ~20-50x less to bring to market, and were brought to market faster. Indeed the 40s and 50s ar…

I’m fine with that as long as insurance does not pay for any drugs without efficacy testing. Also no advertising of any sort.

generally, insurance companies do require efficacy. many of them have decided not to cover aducanumab for that very reason. though this also gives insurance an additional excuse to deny stratospherically-expensive gene therapies and other life-saving new treatments, since even the most effective new drugs won't have e.g. 10 year survival rates until they're a decade old.

agreed on advertising though.

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

#207
post #177

Earlier quoted context omitted.

Assisted suicide and euthanasia are better examples. If you have autonomy to die, you should have autonomy to die trying not to.

Well, those are pretty controversial topics, so I'm not sure how much the analogy helps.

It helps underline the hypocrisy of the current moral norms.

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

#208

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.

Should be, yes, I agree, however, we are extremely far from this, I don't even know how many hours I would need to travel to legally buy and smoke a pack of menthol cigarettes.

Agreed. The regulations are beyond ridiculous and definitely not for the greater good of the society, only to clear the names of bureaucrats and regulators.

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

#209

Earlier quoted context omitted.

To sibling commenters: immunotherapies aren't the only problem. There are a ton of truly evil companies out there pushing therapies that do not work, have never worked, and will never work, because they literally have no possible mechanism to ever do anything . This is a crime, but it's very very hard to prove. And these companies get very good at gaming the system, because that is their product. They are mechanisms…

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…

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.

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

#210
post #146
post #21

Earlier quoted context omitted.

This has been a common complaint for decades. We always want to try rush experimental drugs/procedures that “show promise”. How often do these drugs, etc turn out to effective? 25 years ago we wanted to rush gene therapy and that didn’t turn out well. Someone died. It probably set back gene therapy: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC81135/ I think the solution is to invest more into medical research now, t…

>I think the solution is to invest more into medical research now, The author is arguing that terminally ill people (with a few months left to live) -- like him -- would be willing participants in trials to help medical research . They already know that mRNA drug or whatever likely won't cure them. It's possible some new scientific knowledge of the drugs' effects can still be gained even when it doesn't cure them. Gi…

There's a lot of problems with it, though. Even if advancing medical research was the main goal-- ad hoc use in dying patients provides unclear data. Medical research wants clear inclusion criteria, metrics, reduced statistical noise from similar patients, predeclared outcome measures, and economies of scale in running trials.

We already let terminal patients participate in medical research, but only inviting patients at times and meeting criteria that optimizes the research. Also, only where IRBs have found it to be ethical-- this means not replacing a drug with proven benefit with an experimental treatment with unknown benefit recklessly.

But terminally-ill patients push for inclusion beyond this: to be dosed when there is not an active trial, or to be dosed when they are so sick that the outcome would be difficult to interpret or compare, etc. This isn't for medical research, this is for self-preservation.

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