Hacker News Board Hacker News, browsed like a classic message board
Live data from Hacker News

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

jakeseliger.com

Post reply on HN
Print view View original

41–50 of 486 posts

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

#41

Post by chroma »

maxbond wrote: post #27
tb_technical wrote: post #6

What I don't understand is why the FDA doesn't automatically rubber stamp approvals on medicine approved in Canada and the European Union. We all know their medicine is good - so why can't I get it?!

Thalidomide was widely approved, and I'm glad the FDA didn't rubber stamp it.

But that’s the problem. No regulatory body has perfect judgement, so they’ll all approve some harmful things and ban some helpful things. If you’re so strict that you don’t allow thalidomide, you’ll also ban stuff like beta blockers for an extra decade, causing 80,000 deaths. The argument in favor of loosening restrictions is that it would reduce overall death and suffering.

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

#43

Post by kepler1 »

Another topic for discussion related to this (and I hope we can be detached enough to discuss the intellectual side of this impersonally):

Even if the drug/treatment method were approved, how much would this cost, would the author even be able to pay for / have the insurance company pay for the treatment?

And by the way, what limits are there on the price of a drug that an insurance company or the government will cough up the money to pay, for one person's extension to life for a couple years?

If someone has a very rare or just very advanced cancer, how much should the rest of us (as individuals paying taxes/premiums/etc) be on the hook for paying for last ditch efforts to prolong that person's life?

These are genuine questions I think are legitimate to ask, if not in polite conversation, then at least at the level of policymaking bodies in govt or insurance companies. I'm sure that people in the UK are quite familiar with this concept or debate.

You cannot just say you'll pay whatever it takes to save someone's life no matter what the circumstances.

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

#45

Post by light_hue_1 »

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 manufacturers continue to push for them and the FDA has tremendous trouble trying to their approval revoked. https://apnews.com/article/science-health-medication-busines...

3. Accelerated drug approval gets mired in advertising. The general public has no idea how to judge if a drug works or not. Plenty of people believe that homeopathy works. The FDA gets massive pushback when trying to take a drug that is worthless away, because people think it works. This hurts us all and creates an incentive for companies to hide data and deceive customers.

4. The FDA is as fast or faster than the Canadian or EU equivalents. The FDA is not specifically slow, bureaucracy everywhere has become much slower because there are no incentives to be fast but countless incentives to be slow.

5. Lawsuits. It's easy to say "I'm hurting, I'll take anything". But, then, there are rights you cannot give away. If a drug harms you, you will sue. If it kills you, your family will sue. The whole system is bogged down by lawsuits with massive disproportionate payouts. The early biotech companies and scientists involved often cannot deal with even a mistaken lawsuit.

We need a much more comprehensive overhaul of the system, starting with open access laws to all data pertaining to any drugs that are on the market (no manufacturer can keep anything secret for a drug that people take), an FDA that has much more authority and much less industry capture, medical tort reform, to create a system where in exchange it actually makes sense to provide fast tracked approval.

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

#46

Post by yieldcrv »

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…

> Even if you want the experimental treatment, you cannot get it.

fortunately, Baja California seems to have everything. Or specifically, a different drug approval strategy that is right in the middle of this.

The FDA's main limitation is that it gives a one to one relationship in approvals. A substance is seemingly evaluated for a single narrow ailment. While evaluation process is a threshold of side effects as well as efficacy in treating that single narrow ailment. This process could be expanded to recognize that fulfilling the side effect issue could expand its use in other ways, more easily than whatever semantical distinction of easier the FDA uses now. There could be more possibilities for one to many approvals.

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

#47

Post by batch12 »

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…

> Killing someone in an attempt to help is deeply unethical, while merely letting them die is not your fault.

If a train is coming with someone pinned to the tracks, and they are begging you to hand them an axe so they can remove their own leg-- knowing they may die from blood loss, do you just do nothing?

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

#48

Post by janeway »

gburt wrote: post #32

Regulators are, in general, too sheltered and disconnected from the impact of their actions. Incentives matter. When you get to make decisions that impact others, but not feel any of the costs associated with that, you do not have the correct incentives. I hope the staff of FDA read this and can’t sleep tonight. We can hope they feel some emotional pain, even if it is only some small subset of the pain they have and…

I would disagree with this. Regulators that I have worked with in US and EU knew what it meant. Maybe not the most amazing technical people I’ve ever worked with, but they were as competent as any random sample of pharma/tech types. Their jobs is to verify that you have completed all the valid documentation to demonstrate that your drug does what you claim it does. Their opinion on personal emotions are irrelevant. They are supposed to be guideline checkers.

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

#49

Post by nextos »

riffraff wrote: post #14
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…

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…

Immunotherapies are still immature but far from snake oil at this stage. They routinely achieve miraculous remissions but also lead to many adverse events. For most late stage tumors, chemotherapy will only, at best, increase life expectancy a bit. In my opinion, the choice is obvious.

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

#50

Post by adrr »

lr4444lr wrote: post #28
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…

The FDA could create a standard consent form for nonapproved treatment that patients and doctors would sign, which would indemnify the physician from legal repercussions, but they don't, and they bear full blame for that. The AMA would still have its own regulations about the limits of ethical experimentation, with the revocation of a medical license as punishment to serious offenders, and malpractice safeguards coul…

You can get get experimental drugs/treatments that aren’t approved by getting them under the clinical trial for that drug. The question is who pays for it? Cancer treatments are millions of dollars.
Post reply on HN