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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

#21

Post by melling »

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…

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, then when we, or someone we know, eventually ends up with some horrible disease, (cancer(s), Alzheimer’s, Parkinson’s, etc) we’ll know that we at least we made significant effort, and gave everyone a better chance, rather than settle for a “Hail Mary” drug near the end.

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

#22

Post by kepler1 »

I think the consideration that an article like this misses is the unintended consequences of speeding a process up / reducing the criteria for review, approval, etc.

I think we can all see incidents of where some oversight process is loosened because of some legitimate desire to help some, but then you learn that the bad / incompetent / exploitative actors come out of the woodwork to test and take advantage of the changing of rules. Not even saying intentionally, but just by sheer numbers, the change you made allowed things that were being held back by (hopefully proper) regulation to now happen.

Anyway, not saying that the FDA and other bodies couldn't move faster -- that is always the case. And there will always be examples of people/cases stuck in the cracks with legitimately sad situations.

But I would hope that people reading such stories think about why there is a process. It's not like the FDA's purpose in life is to stop people from benefitting from new treatments. It's to prevent the flood of bad effects of companies/individuals from being able to say they offer some drug that doesn't work in the way it says it does.

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

#23

Post by shuckles »

Arainach wrote: post #11
changoplatanero wrote: post #4

I get that the FDA is bad but how come there is no country anywhere on earth where these treatments are legal and available?

The FDA is not bad. The world has never had a shortage of liars, scammers, or snake oil salesmen. The term snake oil itself hearkens back to salesmen who would promise "medicines" to desperate people to con them out of their money. Allowing trials to be bypassed and allowing people to pay for early access to unproven drugs would bring a flood of such be vendors and be bad for society, bad for medicine, and bad for et…

No one is advocating for "pay for access" or a means of bypassing trials that facilitate a "flood of [scammers]", so this is a straw man. You'd have to show why any design for relaxing regulation of trials is necessarily bad in aggregate.

The article even cites a case where the bureaucrats are confident in the safety of a trail drug but unable to approve for political reasons.

Not to mention the FDA allows plenty of snake oil supplements, etc. to be sold, so it's not particularly good at the goal you claim it's optimizing for.

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

#24

Post by Latty »

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?!

Somewhat famously the US not doing this stopped Thalidomide being such a large issue in the US, but of course one example of it failing doesn't mean it is inherently bad policy.

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

#26

Post by WarOnPrivacy »

etothepii wrote: post #7
changoplatanero wrote: post #4

I get that the FDA is bad but how come there is no country anywhere on earth where these treatments are legal and available?

This is a very interesting question. Why are medicines regulated federally? As I understand it (and IANAL) doctors, pharmacists and nurses are regulated on a state by state basis.

> Why are medicines regulated federally? As I understand it (and IANAL) doctors, pharmacists and nurses are regulated on a state by state basis.

Dr's typically practice in ~1 state while drugs are available in all states simultaneously.

Fifty states - of varying ability - trying to independently qualify all available drugs would be a nightmare of redundancy.

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

#27

Post by maxbond »

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.

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

#28

Post by lr4444lr »

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 could still be there. State laws about gross medical negligence are also an option.

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

#29

Post by prmoustache »

The author seems to forget that entering a trial doesn't necessarily give you access to the treatment. You have as many chances to be in the control group receiving a placebo.

And as bad, sad and frustrating as it sounds to someone in a desperate situation, it is for the greater good of many more human beings, protecting us from snake oil.

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

#30

Post by Glawen »

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?!

Because it then becomes a kind of race to the bottom, where all manufacturers will approve medecine in the easiest country, a bit like flag on convenience for ships
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