311–320 of 486 posts
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...why?
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If you wouldn't mind reviewing https://news.ycombinator.com/newsguidelines.html and taking the intended spirit of the site more to heart, we'd be grateful.
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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…
> 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…
Hell I'd even approve my tax money to go to those companies which end up saving lives as reward.
Category A - approved by the FDA, basically what we have right now
Category B - approved by some other established regulatory body (EU). Comes with all the warnings, doctors can write it off-label, insurance companies may not cover it but doctors can ask for a variance
Category C - approved by some non-OECD body. Insurance companies under no obligation to cover
Category D - experimental, this is stuff maybe still only in animal models, but pharmacies can still order and dispense it
Category E - experimental and basically limited run from pharmaceutical companies. These essentially need to be tailor-made or produced by a GMP kilo lab. There are plenty of drugs in this category - I worked on them - and the intended recipients are entirely animals, QA, and regulatory agencies. But maybe if some crazy S.R. Hadden type (billionaire in Contact) wants to guinea pig themselves, let em.
The latter category also opens the door for custom therapies (gene/mRNA) that you basically can't test the active pharmaceutical ingredient for efficacy on.
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Couldn't agree more. There is literally nothing to lose, and potential to save a life. Blocking this is effectively murder.
My dad recently died. There are always new treatments being studied and some day one of those treatments might actually be able to cure people with the same disease. That day didn’t come early enough for my dad. That sucks but it doesn’t change the fact that drug policy is made for society as a whole and not only for my dad. This isn’t some conspiracy where a cold bureaucracy is letting people die. Sometimes your luck just runs out.
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You're right that there are alternatives, and there is an existing standard of care. I don't think I'm ignoring that. Let me clarify, I am not saying that patients with poor prognosis are being offered nothing. They are being offered standard of care. I think sticking with standard of care until new drugs have gone through the full, current process may be net negative under the current process, and considering the co…
Current standard of care includes experimental therapy. What you are describing is once again how novel cancer treatments are being implemented today. Furthermore, Step 1 of the NCCN treatment guidelines for these kinds of cancers (i.e. advanced and/or poor responders to conventional chemo) is always that the patient is enrolled in a clinical trial. In this authors case he does not meet inclusion criteria for the the…
I'll take your point, and I appreciate the time you took to write a good response, though I've read about enough examples other than the current article that I feel this may be rejecting a wider pattern on the details of the current submission (but maybe I'm wrong, and they all happened to be incorrect for similar reasons).
But I'd like to hear your thoughts on the broader argument of being more aggressive with trials in general. What sticks with me each time this argument comes up, regardless of the particular situation, is this idea that despite some mechanisms for accelerated approvals, we are still far slower than we could be, if we take into account the number of people saved by bringing therapies sooner.
There is a cost to letting people take dangerous medication. I hate the idea of peddling dubious cures to vulnerable people as much as I'm sure you do. It's the counterfactual that makes the argument, the people who do not receive treatment due to delay seems to vastly outnumber the people harmed by experimental treatments. And the difference seems large enough that it would remain true even if we went much faster. I think that's the strongest objection to the current system.
My Dad was dying of IPF and I was always on the hunt for anything that may help. Of course there are countless quack "cures" but I came across a study that said metformin may help. Metformin is what people with type 2 diabetes use to help to control blood lipids among other things. My Mom actually takes metformin since she has type 2 diabetes. My Dad's doctor wouldn't even discuss it and dismissed it outright. Dad di…
Given metformins safety and cost profile, your dads doctor sucked. They should put it in the water of the 60+ crowd.
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…
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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 doubt any company anywhere (legitimate or not) would provide drugs under such conditions. It would make much more sense to just focus on getting approval instead.
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For those who are curious, the term was coined on this blog post[1]: > The Copenhagen Interpretation of quantum mechanics says that you can have a particle spinning clockwise and counterclockwise at the same time – until you look at it, at which point it definitely becomes one or the other. The theory claims that observing reality fundamentally changes it. > The Copenhagen Interpretation of Ethics says that when you…
So, observing a problem is no more complicated than becoming aware that it exists. That's the only interaction necessary to invoke ethical liability. How does then pretending you didn't observe it release you from anything?
One aspect of the problem here is the difficulty in running a clinical trial, particularly at the recruitment stage. The covid-19 trials all had a surfeit of participants because of a pandemic, but with modern cancer treatment trials the qualification requirements significantly cut down on the eligible population. This, in itself, isn't a huge obstacle. The problem is the state of healthcare data systems. It's next t…