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Comment by kurthr | Hacker News Reader

This drug was approved after Phase II trials largely failed and a second review panel was convened to override the first. Now it has failed again in Phase III after being given to many hopeful patients at great cost.

The last lines rang true:

   You need what you've always needed: efficacy and safety. Boring, tedious,
   expensive efficacy and safety. Desire and despair don't figure in much - in a
   much different universe, one whose physical laws respected and validated human
   emotions and human suffering, they would. But we don't live in that world.

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How about we fix that with this?

https://www.congress.gov/bill/118th-congress/senate-bill/190...

Give patients access and do the right science. Make sure it is safe and allow people the right to try.

Can you expand on this? This bill seems to enable exactly what the author is attacking: exploiting the desperate hopes of terminally ill patients to sell ineffective drugs.

I agree with removing red tape and allowing accelerated trials when the drugs are for these purposes, but it seems like today, drug companies can make a profit off of selling snake oil. They already stand to benefit from the reduced regulations, so why allow them to sell the drug at all under these circumstances? If they're so confident in the efficacy, they should be willing to give the drug away for free to benefit from an accelerated path to approval.

This bill seems to allow drug companies to continue to sell under these regulations, and in fact goes even further by removing most liability from them.

You could compromise by allowing a doctor to sign off if they feel the expected benefits outway the costs. That would put up a barrier for useless treatments but leave the door open for people to try stuff without 10 years of beaucracy.

If it's a "trial", the patients shouldn't be paying for it, the drug company should. Is that not what's in the bill?

> but it seems like today, drug companies can make a profit off of selling snake oil

anybody can sell sugar pills or any 'generally approved as safe' consumptive good, repackaged as something big pharma is hiding from you

You can't make specific claims like "cures Alzheimer's" without a clinical trial. You have to use weasel words like "boosts immunity".

You don’t seem to understand the bill and perhaps people are downvoting because they don’t understand either.

I recommend you read it yourself and understand what it is saying. Not to make broad assumptions that “snake oil” will be allowed.

Here is a summary I wrote about this bill based on a condition I have that can benefit from it:

https://www.lctreatments.com/legislation

In the case of the parent article drug, it claims it was the pressure of patient advocacy groups that got the drug approved. Giving people the right to try unfortunately at present means everyone else paying for it (or paying for the harm it causes), unless unapproved drugs were required to be covered by the individual on their own.

" But ALS patients (or their insurance companies) had the chance to pay for a drug ($158,000/yr list, who knows what the real price was somewhere below that) for what is in the end a combination of two generic medicines. And they might as well have been given peppermint candy for all the good it did. ... patient advocacy groups took victory laps after Relyvrio was approved, and they were a big part of the pressure that made the FDA reverse its initial correct decision "

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