Goofle

Spot on Chula.

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Frownland

It would have to pass the first phase of clinical trials, yes. That first phase is testing the medicine on healthy humans to see if it is toxic in the short term. The second level of testing is on the efficacy of the drug, which is infinitely more important. The legislation opens the doors for snake oil because you can pass phase 1 and never pursue subsequent trials while still profiting off of your product.

They're a non-profit organization with crazy strong lobbying powers, placing them amongst organizations such as the NRA and Greenpeace. But who endorses it is not important to me, I'm discussing the actual content of the bill.

The last close to unanimous vote I remember was the Iraq war approval.

And even though I came to my own conclusions when I read about the legislation and what it did, I am far from alone in my views.

“This bill is inherently deceptive,” Alison Bateman-House, a medical ethicist at New York University who led the charge against Johnson’s bills, wrote in an email. “What [patients] have a right to (and did long before this bill) is to ask drug companies for permission to use their experimental drugs outside of clinical trials. If the drug company says no, both before and after this legislation, that's the final word: neither the FDA nor the courts have to power to make companies provide access to their experimental drugs-in-development.”

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Studies show that when a given norm is changed in the face of the unchanging, the remaining contradictions will parallel the truth.

Chula Vista

The Senate vote on the Iraq war was 77 to 23.

Listen, this person is going to die in a short while. They've exhausted every possible option. There's no hope left. At that point do whatever you want to do. If it's an experimental drug, go for it. Don't restrict them from trying.

If nothing else, it might speed up some FDA approvals.

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“The fact that we live at the bottom of a deep gravity well,
on the surface of a gas covered planet going around a nuclear fireball 90 million miles away
and think this to be normal is obviously some indication of how skewed our perspective tends to be.”

Frownland

I'm not saying that we should restrict them from trying, I'm saying that there options that should not present themselves as medicine that can do just that because of this bill without repurcussion. The terminally ill can already exhaust their options by being a part of clinical trials for legitimate experimental medicine. There might be a few underfunded companies who can benefit from this and streamline their funding process with money from the terminally ill as opposed to paying the terminally ill to participate in their trials, but this is a window for creators of ineffective and potentially unsafe medicines to exploit the desparate.

And how often are people barred to begin with?

What makes you say this? From where I'm sitting this is an attempt to move away from the FDA.

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Studies show that when a given norm is changed in the face of the unchanging, the remaining contradictions will parallel the truth.

The Batlord

Might also create a secret pharmaceutical side business of deliberately developing bogus medicine that they know will never pass the FDA. Since there'll be no massive time and money commitment then they can just sprinkle as much as of both as they absolutely need to, jack up the prices anyway (as usual), and have themselves a quick buck whenever they need it. That's just off the top of my head.

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Frownland

Exactly. All they have to do is establish that it's not toxic and they can start selling it.

Any terminally ill cancer patients want to try out my magic cinnamon?

The unanimous vote is entirely political btw. Imagine explaining the nuance of why you voted against FREEDOM to your constituents.

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Studies show that when a given norm is changed in the face of the unchanging, the remaining contradictions will parallel the truth.

Chula Vista

Your assumptions conclusions. And a very cynical one - as usual.

Ineffective - how do you know this? Again, snake oil salesmen are not going to be included in this.

Potentially unsafe - duh. The person is already slated to die. Roll the dice.

Re: FDA

It normally takes about 10 years to get FDA approval. If a bunch of people try a drug that's on the waiting list and it hurts them, then that drug takes a bunch of steps backwards.

If a bunch of people try a drug that's on the waiting list and they show some positive results, the FDA will pay attention.

__________________

“The fact that we live at the bottom of a deep gravity well,
on the surface of a gas covered planet going around a nuclear fireball 90 million miles away
and think this to be normal is obviously some indication of how skewed our perspective tends to be.”

Frownland

Dude. It takes up to ten years to get FULL FDA approval. The bill allows for unapproved drugs to hit the market so long as they pass preliminary safety tests. Snake oil can absolutely get involved with this. There is a massive difference between passing phase one and being FDA approved. They have not tested for efficacy. They have not tested for safety on the sick. They have only established that it is not immediately toxic for entirely healthy people.

Someone who knows what they're talking about take over for Chula.

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Studies show that when a given norm is changed in the face of the unchanging, the remaining contradictions will parallel the truth.

Chula Vista

Extremely naive statements. This bill doesn't just bust the doors wide open for every Tom, Dick, and Harry pharmaceutical company to dump junk into the market.

Stop posting with your hair on fire.

__________________

“The fact that we live at the bottom of a deep gravity well,
on the surface of a gas covered planet going around a nuclear fireball 90 million miles away
and think this to be normal is obviously some indication of how skewed our perspective tends to be.”

Goofle

What exactly is the incentive for bogus pharmaceutical products to be made for and sold to terminally ill people that will be tested and proven to not work, leading to whatever punishment that entails?

Let people decide what they want to do with their lives. We don't need the government deciding if your dying father should be able to try an experimental treatment under the premise that it might not "pass the snake oil test".

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