4 ms·

>The 21st Century Cures Act—a rare bipartisan bill, pushed by more than 1,400 lobbyists and signed into law in December—lowers evidentiary standards for new use

by skolos 10y ago

>The 21st Century Cures Act—a rare bipartisan bill, pushed by more than 1,400 lobbyists and signed into law in December—lowers evidentiary standards for new uses of drugs and for marketing and approval of some medical devices. It shows again that we will not have sane healthcare system when there are thousands of lobbyist working to keep it insane.

makomk 10y ago
Not to mention all the "patient advocacy groups" funded by the pharmaceutical industry: https://theintercept.com/2016/12/01/new-report-exposes-patient-advocacy-groups-as-a-big-pharma-scam/ https://theintercept.com/2016/12/01/new-report-exposes-patie...
Symmetry 10y ago
Here's a semi-random blog post with a handful of examples[1]. Generally speaking European countries are much quicker to approve most drugs and tend to have better health outcomes on average even though you can point to individual disasters like Thalidomide. But on the other hand beta blockers were available in Europe about a decade before they were in the US and would have saved about 10,000 lives a year during that time. [1]http://www.advicegoddess.com/archives/2017/01/11/the_fda_protect.html http://www.advicegoddess.com/archives/2017/01/11/the_fda_pro...
- maxerickson 10y ago
  The article discusses beta-blockers. The overall picture of beta-blockers is complex. For example, some beta-blockers have been shown clearly to reduce the chance of a stroke or heart attack in patients with heart failure. But the latest review of beta-blockers from the Cochrane Collaboration—an independent, international group of researchers that attempts to synthesize the best available research—reported that they “are not recommended as first line treatment for hypertension as compared to placebo due to their modest effect on stroke and no significant reduction in mortality or coronary heart disease.”
  - Symmetry 10y ago
    Well, that'll teach me to post in Hacker News without reading all parts of an article.
- karlkatzke 10y ago
  Are you taking into account the recent studies of the effectiveness of beta blockers, which the OP article discusses? "the latest review of beta-blockers ... reported that they 'are not recommended as first line treatment for hypertension as compared to placebo due to their modest effect on stroke and no significant reduction in mortality or coronary heart disease.'"
jerf 10y ago
What the article is talking about and what that bill seems to address are two separate issues. Whether you have high or low evidentiary standards for a new treatment is, under our current system and almost any system I've ever seen proposed, independent from whether doctors will end up completely correctly using those new systems. Doctors already have that responsibility and are already failing in that responsibility for a variety of complicated reasons, apparently, but it's easy to construct "solutions" that make it even worse. How do you out-expert the very people you've trained to be experts in the first place? That may not be unsolvable but it surely isn't a trivial problem to be fixed with some regulation here and some pamphlets there. We've frequently discussed on HN the idea that sky-high evidentiary standards for new treatments may have passed the point where they are doing more harm than good. While I'm sure there are disagreeable details in the new bill, the broad strokes of the bill are things that the HN gestalt has at least been talking about for a while. It's not like it's a sudden out-of-the-blue idea that nobody's ever heard of before.
- Hnrobert42 10y ago
  The term "sky-high" means the evidentiary standards are by definition harmful. One wouldn't describe them as sky-high if one thought they were reasonable. If one starts with the premise that existing standards are sky-high, then of course one will conclude they should be lowered.
  - jerf 10y ago
    I am obviously speaking about the end result of that debate and my personal opinion, which I won't try to hide. The debate itself was substantial, however, not merely word games.
hinkley 10y ago
It'll make a great pejorative some day. "No thanks, grandma. We don't want none of your 21st Century cures here."
BurningFrog 10y ago
How exactly does it show that? Because it was supported by many lobbyists? Or because it lowers evidentiary standards?
kolinko 10y ago
On the other hand, you had situations where people were smuggling drugs into the country for HIV treatment. Or you have drugs that we know are safe, and initial research shows a lot of promise, but are unavailable. A patient with a serious condition should not be denied a possible treatment, as long as it's proven that it won't hurt him.

by skolos 10y ago

makomk 10y ago

Not to mention all the "patient advocacy groups" funded by the pharmaceutical industry: https://theintercept.com/2016/12/01/new-report-exposes-patient-advocacy-groups-as-a-big-pharma-scam/ https://theintercept.com/2016/12/01/new-report-exposes-patie...

Symmetry 10y ago

Here's a semi-random blog post with a handful of examples[1]. Generally speaking European countries are much quicker to approve most drugs and tend to have better health outcomes on average even though you can point to individual disasters like Thalidomide. But on the other hand beta blockers were available in Europe about a decade before they were in the US and would have saved about 10,000 lives a year during that time. [1]http://www.advicegoddess.com/archives/2017/01/11/the_fda_protect.html http://www.advicegoddess.com/archives/2017/01/11/the_fda_pro...

maxerickson 10y ago
The article discusses beta-blockers. The overall picture of beta-blockers is complex. For example, some beta-blockers have been shown clearly to reduce the chance of a stroke or heart attack in patients with heart failure. But the latest review of beta-blockers from the Cochrane Collaboration—an independent, international group of researchers that attempts to synthesize the best available research—reported that they “are not recommended as first line treatment for hypertension as compared to placebo due to their modest effect on stroke and no significant reduction in mortality or coronary heart disease.”
- Symmetry 10y ago
  Well, that'll teach me to post in Hacker News without reading all parts of an article.
karlkatzke 10y ago
Are you taking into account the recent studies of the effectiveness of beta blockers, which the OP article discusses? "the latest review of beta-blockers ... reported that they 'are not recommended as first line treatment for hypertension as compared to placebo due to their modest effect on stroke and no significant reduction in mortality or coronary heart disease.'"

jerf 10y ago

What the article is talking about and what that bill seems to address are two separate issues. Whether you have high or low evidentiary standards for a new treatment is, under our current system and almost any system I've ever seen proposed, independent from whether doctors will end up completely correctly using those new systems. Doctors already have that responsibility and are already failing in that responsibility for a variety of complicated reasons, apparently, but it's easy to construct "solutions" that make it even worse. How do you out-expert the very people you've trained to be experts in the first place? That may not be unsolvable but it surely isn't a trivial problem to be fixed with some regulation here and some pamphlets there. We've frequently discussed on HN the idea that sky-high evidentiary standards for new treatments may have passed the point where they are doing more harm than good. While I'm sure there are disagreeable details in the new bill, the broad strokes of the bill are things that the HN gestalt has at least been talking about for a while. It's not like it's a sudden out-of-the-blue idea that nobody's ever heard of before.

Hnrobert42 10y ago
The term "sky-high" means the evidentiary standards are by definition harmful. One wouldn't describe them as sky-high if one thought they were reasonable. If one starts with the premise that existing standards are sky-high, then of course one will conclude they should be lowered.
- jerf 10y ago
  I am obviously speaking about the end result of that debate and my personal opinion, which I won't try to hide. The debate itself was substantial, however, not merely word games.

hinkley 10y ago

It'll make a great pejorative some day. "No thanks, grandma. We don't want none of your 21st Century cures here."

BurningFrog 10y ago

How exactly does it show that? Because it was supported by many lobbyists? Or because it lowers evidentiary standards?

kolinko 10y ago

On the other hand, you had situations where people were smuggling drugs into the country for HIV treatment. Or you have drugs that we know are safe, and initial research shows a lot of promise, but are unavailable. A patient with a serious condition should not be denied a possible treatment, as long as it's proven that it won't hurt him.