[Akinato]

There's a lot of great arguments presented in the article for why we shouldn't go "balls to the wall on experimentation". The drug costs $56k a year, can cause some severe brain bleeding and swelling, and requires regular MRIs which can put quite a strain (and cost) on the system. These are some significant negatives for a drug that hasn't been proven to be effective at all.

[ALittleLight]

I think that makes the case for balls to the wall experimentation. Let whoever is interested and can afford it try this drug. If they have good results, lets cover it with medicaid. If not, try something else.

If we cut out regulations and trials and requirements and so on for what medical treatments people can try, then a bunch of stuff will be tried. Most of it will be bad, but some may show effect and we can iterate on that and get better medicines.

I don't advocate this style for every possible treatment. If we already have good treatments or if the illness isn't too bad, then we definitely should not risk things on trials. However, in this case, it is a disease that kills old people and we don't have any good treatments for it. Why not let people who want to experiment aggressively.

[ethanbond]

One problem is that it’s actually extremely difficult to derive meaningful information from data collected outside of the context of a clinical trial.

So you’d be giving greenlight to tons of fraudsters, exposing people to potentially way more suffering than their baseline disease causes, AND not learning anything from doing so.

[Akinato]

On top of that, we currently have a grossly overburdened healthcare system that in no way could support this. This presents so many clear problems that I wonder if the people are thinking critically about the long term effects of an unregulated drug market.

1. Knowledge -> How will doctors possibly keep track of the knowledge of all of these new drugs? If they don't need to be verified beyond a claim, they could be getting thousands of options. How do they pick between one drug with no proof, and another drug with no proof -- especially if they all have negative side effects?

2. Data -> All of the data for these drugs will be extremely if not impossible to derive. This will probably result in it taking even longer for evidence of the drug's efficacy to be built.

3. Resources -> Hospitals across North America are understaffed and overworked. How could they possibly find time to not only learn the entire treatment path for new drugs and all the necessary information, but to do this countless times across all their patients? MRI machines are already backlogged quite a bit, do we really think they could weather the storm of an unregulated drug market?

4. Liability -> Whether we like it or not, this adds quite a bit of liability to a hospital. Insurance will absolutely be against this, and would likely greatly increase the number of people trying to sue the hospital.

5. Fallout/Complications -> Can you imagine the strain of the additional complications that arise out of allowing free use of untested drugs? Imagine how much more expensive a patient would be if they got a brain bleed from a medication that they would never have had previously. This isn't just like "I tried a drug and it did nothing", it's more like "I tried a drug that had the potential to kill me. I had severe complications that required me to be in the hospital for 2 months but the drug still did nothing to help my problem."

Effectively, we'd be breaking our own healthcare system by breaking down our regulations. Regulations are written in blood. They're there for a reason.

[ethanbond]

Yeah, the level of thought behind proposals like this leaves something to be desired. Benefit of living a life downstream of a mostly functional drug safety regime...

[mchusma]

The drug only costs $56k because medicare can't negotiate. The parent was saying the bar for medicare paying for it should be decoupled from the bar for banning it. I agree.

[ethanbond]

Parent is saying very clearly that you should not need FDA approval to sell a drug that claims to treat some specific diseases.