First, do no harm (side effects may include death)

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nicole
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First, do no harm (side effects may include death)

Post by nicole » 05 Jun 2017, 10:32

A thread for the medical industrial complex.
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nicole
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Re: First, do no harm (side effects may include death)

Post by nicole » 05 Jun 2017, 10:33

Amazing.
To understand Mylan’s culture, consider a series of conversations that began inside the company in 2014. A group of midlevel executives was concerned about the soaring price of EpiPens, which had more than doubled in the previous four years; there were rumors that even more aggressive hikes were planned. (Former executives who related this and other anecdotes requested anonymity because they had nondisclosure agreements or feared retaliation. Aspects of their accounts were disputed by Mylan.)

In meetings, the executives began warning Mylan’s top leaders that the price increases seemed like unethical profiteering at the expense of sick children and adults, according to people who participated in the conversations. Over the next 16 months, those internal warnings were repeatedly aired. At one gathering, executives shared their concerns with Mylan’s chairman, Robert Coury.

Mr. Coury replied that he was untroubled. He raised both his middle fingers and explained, using colorful language, that anyone criticizing Mylan, including its employees, ought to go copulate with themselves. Critics in Congress and on Wall Street, he said, should do the same. And regulators at the Food and Drug Administration? They, too, deserved a round of anatomically challenging self-fulfillment.
https://www.nytimes.com/2017/06/04/busi ... -much.html
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Re: First, do no harm (side effects may include death)

Post by dhex » 05 Jun 2017, 10:57

having literally no competition in that sphere makes for a significant multiplier to any innate fuckfacedness one might have.

the single payer brigade couldn't ask for better help.
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Re: First, do no harm (side effects may include death)

Post by Highway » 05 Jun 2017, 11:02

It's definitely atrocious corporate behavior. But the article never mentions that it's the law that allows them to get away with their atrocious corporate behavior. What's the pressure to change? Like the article makes clear, public opinion doesn't do it. Even lawmakers don't really do it. Not when the profits are still there, the stockholders get their dividend, and everyone's making money.

They created a system where they're just hoping against hope that the people involved are good actors, but where the primary mechanism that creates good actors is completely cut off.
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Re: First, do no harm (side effects may include death)

Post by Andrew » 06 Jun 2017, 09:00

http://slatestarcodex.com/2017/06/05/is ... an-chance/

So millions of users experimenting on their own were more effective at finding useful drugs than pharma companies conducting tiny trials under FDA scrutiny? Let me find my shocked face...
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Re: First, do no harm (side effects may include death)

Post by Aresen » 06 Jun 2017, 10:26

Andrew wrote:http://slatestarcodex.com/2017/06/05/is ... an-chance/

So millions of users experimenting on their own were more effective at finding useful drugs than pharma companies conducting tiny trials under FDA scrutiny? Let me find my shocked face...
Drugs are not supposed to be fun. The FDA frowns on fun.
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Re: First, do no harm (side effects may include death)

Post by JasonL » 06 Jun 2017, 10:31

Andrew wrote:http://slatestarcodex.com/2017/06/05/is ... an-chance/

So millions of users experimenting on their own were more effective at finding useful drugs than pharma companies conducting tiny trials under FDA scrutiny? Let me find my shocked face...
I'm skeptical of this as any kind of durable or generalizable result. Things with a billion variables and no control groups or blinding tend not to be answerable with "try random things".

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Re: First, do no harm (side effects may include death)

Post by Mo » 06 Jun 2017, 10:53

How is this different than the Viagra story? Viagra was originally a failed blood pressure drug that people didn't want to give back after the trial was ended.
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Re: First, do no harm (side effects may include death)

Post by JD » 06 Jun 2017, 10:56

Andrew wrote:http://slatestarcodex.com/2017/06/05/is ... an-chance/

So millions of users experimenting on their own were more effective at finding useful drugs than pharma companies conducting tiny trials under FDA scrutiny? Let me find my shocked face...
Maybe I'm missing the irony, but this was kind of funny:
I’m a little suspicious trying to calculate the odds of a single chemical having two forms, one of which is a really exciting analgesic, and the other of which is a really exciting antidepressant, by two different mechanisms.
Yeah, that would be as weird as a single chemical having two forms, one of which is a vasoconstrictor and nasal decongestant, the other of which is is a central nervous system stimulant.
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Re: First, do no harm (side effects may include death)

Post by JasonL » 06 Jun 2017, 11:03

If the story is something like after the ground work has been done for theory and safety and a drug has been released into use, it's best to let people experiment outside of primary uses, yes I totally agree with that as a way to discover potential new uses - which should then be confirmed with real studies.

If OTOH we are saying something like the pharma company following protocol did nothing that could have have been done better by people just randomly trying things, that I'm skeptical of. People say lots of things and perceive lots of things and there are lots of variables. People trying things don't have controls or any real ability to measure effects most of the time.

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Re: First, do no harm (side effects may include death)

Post by Andrew » 06 Jun 2017, 11:21

JasonL wrote:If the story is something like after the ground work has been done for theory and safety and a drug has been released into use, it's best to let people experiment outside of primary uses, yes I totally agree with that as a way to discover potential new uses - which should then be confirmed with real studies.
This is kinda what I was driving at, but more that this little story could almost be a just-so story in an econ textbook. Researchers discover that the invisible hand actually works, and drugs that millions of people have used to feel good... can make people feel good.
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Re: First, do no harm (side effects may include death)

Post by nicole » 06 Jun 2017, 11:38

JasonL wrote:If the story is something like after the ground work has been done for theory and safety and a drug has been released into use, it's best to let people experiment outside of primary uses, yes I totally agree with that as a way to discover potential new uses - which should then be confirmed with real studies.

If OTOH we are saying something like the pharma company following protocol did nothing that could have have been done better by people just randomly trying things, that I'm skeptical of. People say lots of things and perceive lots of things and there are lots of variables. People trying things don't have controls or any real ability to measure effects most of the time.
I would say it's more like "pharma companies and drug users are trying to solve different problems."
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Re: First, do no harm (side effects may include death)

Post by JasonL » 06 Jun 2017, 11:48

That's totally valid too. I'm just pushing back against a view you hear from naturopaths all the time - this thing where if you try things (that are natural whatever that means) it's just as good as what pharma does. There's a subsect of home remedy types who encourage "experiments" with different herbs and the like. But, there's no measurement and no control and no way to isolate variables. So people may not have been saying that but it had a bit of that smell to me in the article.

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Re: First, do no harm (side effects may include death)

Post by Aresen » 06 Jun 2017, 11:55

The question is: Which method does more harm (including both death by commission and death by ommission)?
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Re: First, do no harm (side effects may include death)

Post by Warren » 06 Jun 2017, 12:17

nicole wrote:
JasonL wrote:If the story is something like after the ground work has been done for theory and safety and a drug has been released into use, it's best to let people experiment outside of primary uses, yes I totally agree with that as a way to discover potential new uses - which should then be confirmed with real studies.

If OTOH we are saying something like the pharma company following protocol did nothing that could have have been done better by people just randomly trying things, that I'm skeptical of. People say lots of things and perceive lots of things and there are lots of variables. People trying things don't have controls or any real ability to measure effects most of the time.
I would say it's more like "pharma companies and drug users are trying to solve different problems."
That doesn't address Jason's point. You need clinical trials to determine whether, and to what extent, they've solved anything.
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Re: First, do no harm (side effects may include death)

Post by nicole » 06 Jun 2017, 12:24

Warren wrote:
nicole wrote:
JasonL wrote:If the story is something like after the ground work has been done for theory and safety and a drug has been released into use, it's best to let people experiment outside of primary uses, yes I totally agree with that as a way to discover potential new uses - which should then be confirmed with real studies.

If OTOH we are saying something like the pharma company following protocol did nothing that could have have been done better by people just randomly trying things, that I'm skeptical of. People say lots of things and perceive lots of things and there are lots of variables. People trying things don't have controls or any real ability to measure effects most of the time.
I would say it's more like "pharma companies and drug users are trying to solve different problems."
That doesn't address Jason's point. You need clinical trials to determine whether, and to what extent, they've solved anything.
Seems like Jason thought it addressed his point perfectly well.
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Re: First, do no harm (side effects may include death)

Post by D.A. Ridgely » 06 Jun 2017, 16:43

At most, the FDA's role should be vetting drugs for safety. Keeping them off market until vetting them for effectiveness reduces the chances of discovering serendipitous uses as well as the possibility of effectiveness within the margin of error. Mind you, I have no problem with the FDA reporting it found a drug to be ineffective for its intended purpose; I just think that's insufficient grounds for the state to tell you or your physician you can't try it.

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Re: First, do no harm (side effects may include death)

Post by nicole » 06 Nov 2017, 15:38

Hahahahhaahhahaahha what
The Defense Department — and not FDA — would have the power to approve drugs and medical devices under the defense policy bill that’s being hammered out by a conference committee, alarming congressional staff and Health and Human Services officials who say it would undermine medical safety and potentially put soldiers at risk.

Section 732 of the Senate’s version of the National Defense Authorization Act creates a new regulatory structure that would allow the Pentagon to sign off on unapproved devices and drugs for emergency use on military personnel and others in harm’s way. The bill is in conference committee with final language expected as early as this week.

FDA currently has sole authority to authorize drugs and devices for emergency use.

“It’s unprecedented,” said one Democratic aide who works on medical safety issues. “We’ve never had a process for where an individual agency could [approve] drugs and devices ... for its own use” and outside of the FDA. “It’s a massive shift.”

The language states that the Defense Department would be able to approve “emergency uses for medical products to reduce deaths and severity of injuries caused by agents of war.” For instance, the Defense Department could approve the use of freeze-dried plasma, which the department has repeatedly said can save the lives of military personnel who have suffered blood loss on the battlefield. While a small number of elite soldiers currently are deployed with access to freeze-dried plasma, the product is still awaiting full FDA approval, which isn’t expected until 2020.
https://www.politico.com/story/2017/11/ ... ary-244604
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Re: First, do no harm (side effects may include death)

Post by Highway » 06 Nov 2017, 15:41

"So I was reading this book, and there was this guy that they injected with a super serum, and then he became this awesome soldier. I think we need to approve these kinds of treatments so that we can get these elite soldiers out there!"

"You were reading a comic book, weren't you."

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"It was Captain America, wasn't it."

"... maybe..."
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Re: First, do no harm (side effects may include death)

Post by thoreau » 06 Nov 2017, 16:08

Trump loves when he lands at an Air Force Base so that he can tweet a photo of himself with OUR GREAT MILITARY!!! He would totes sign a bill putting the military in charge of anything.
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Re: First, do no harm (side effects may include death)

Post by lunchstealer » 06 Nov 2017, 16:09

Only some of them would be Hydra, we promise!
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Re: First, do no harm (side effects may include death)

Post by Aresen » 06 Nov 2017, 17:24

lunchstealer wrote:
06 Nov 2017, 16:09
Only some of them would be Hydra, we promise!
Trump is not a Hydra agent. Hydra has standards.
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Re: First, do no harm (side effects may include death)

Post by Warren » 06 Nov 2017, 18:39

Hang Glider!
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Re: First, do no harm (side effects may include death)

Post by Kolohe » 06 Nov 2017, 19:17

I thought some of the battlefield blood clotting agents were introduced early in the Iraq war under something like this i.e. bypassing the FDA.

(Though I think it also turned out that the quick tourniquet was a better mechanism when that could be used)
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Re: First, do no harm (side effects may include death)

Post by Number 6 » 06 Nov 2017, 22:47

Kolohe wrote:
06 Nov 2017, 19:17
I thought some of the battlefield blood clotting agents were introduced early in the Iraq war under something like this i.e. bypassing the FDA.

(Though I think it also turned out that the quick tourniquet was a better mechanism when that could be used)
Hard to tourniquet off a torso or abdomen wound.
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