141–150 of 153 posts
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Here is one example https://ivn.us/2013/02/11/the-revolving-door-fda-and-the-mon...
Revolving doors between regulators and industry can raise conflict of interest concerns, but this is not at all the same problem that you alluded to above.
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This. Having been through the FDA process myself (though we didn't make it to NDA, sob ) I have to say that dealing with the Agency was great. Tedious, but great, and nothing seemed stupid except some trivialities at the margin (e.g. certain formatting issues). Honestly the worst parts of dealing with them are direct consequences of people trying to game the system. We went out of our way to make sure nothing we did…
Same. Been through that process with a couple products from a medical imaging software startup. Extreme professionalism and competence was the lasting impression I got from my time interacting with them. We were making software that could be used in oncology for diagnosis, analysis, and treatment planning, so yeah, we got the regulatory proctology exam. But I wasn't annoyed at all. They were highly competent people w…
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If you keep posting unsubstantive comments or flamebait to HN, we will ban you. https://news.ycombinator.com/newsguidelines.html
Banning someone for expressing opinions you disagree with falls in line with some very bad history. My comment wasnt unsubstantive by any definition of the word. There are countless examples of the govt doing things to lose trust and that is the root cause of many of societies issues. Banning people from a forum for expressing that thought seems counter to the guidelines you post.
The comment was against the site guidelines. Provocative, grandiose claims on controversial topics are flamebait.
I found this one from the table of reversals to be interesting: Article: Efficacy of infant simulator programmes to prevent teenage pregnancy: a school-based cluster randomised controlled trial in Western Australia Summary: The infant simulator is an example of persuasion technology or captology, where the use is intended to prevent teenage pregnancy.26 Their use is widespread in developed countries27 and is expandin…
That would only explain part of the effect. It wouldn't explain why the number of abortions went up by 50%.
- child gets pregnant
Then
- parents find out, recommend terminating pregnancy
- friends find out, recommend terminating pregnancy
- doctor finds out, recommends terminating pregnancy (“you are not ready for this”)
- unpleasant side effects set in, child decides she is not ready to handle pregnancy, or
- reality sets in, child decides she is not ready to be a mother/wants to finish school
- boyfriend abandons her
Basically increasing the number of pregnancies will necessarily increase the number of abortions.
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My argument would be to look into the studies made by numerous universities from all around the world, not just American ones. I have no business telling you whether or not you should trust American government entities, it's not my country. But the world has had medicines and universities for longer than the United States has existed.
You do realize the EU has banned many many things allowed by the FDA because of their studies ?
My point was that if you don't trust the FDA, there are literally hundreds of other medical and educational institutions you could look to for information.
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You make public health care with fixed prices to contain the capitalism incentive. Worked for us in france: hospitals get pressure from the state and must justify their refundable expenses. It's not perfect, there are still abuses, but it's nowhere the circus we see in the US.
How about outpatient prescriptions? Does a GP (or group thereof) get a budget of expenditures on prescriptions that they have to stay within?
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The lack of safety would affect those who can't afford the "approved" options. :/
Which is more likely to cause an issue, a treatment with no FDA safety approval (but also no history of problems, and possibly safety approval from some other trusted organization) or going without treatment altogether because you can't afford the one with FDA approval and everything else is prohibited? The existence of uncertified, or just differently certified, options should also put some downward pressure on the…
Downward pressure is nice from unapproved/unknown stuff, but any kind of price stratification inevitably leads to harm for those who are at risk the most.
People already order generics on "ebay" and a lot of those shipments are seized at customs, etc.
We know why prices are high in the US. And that's not because the need to go through FDA approved trials, but because of patents and because every other developed market got their shit together and negotiates in bulk with suppliers. (Thus the US market is what pays for most of R&D.)
> FDA approval there is no incentive to minimize the cost
Do you mean the cost of going through the approvals? I think it should be largely subsidized (and ratio should be computed from a reputation score of the requester - of course using the lower bound of the Wilson score interval, or something similarly fast converging).
> established incumbents to make approval as expensive as possible
True. But there are quite a lot of newcomers. VC money is pouring into medical tech. (Though usually small promising research projects [and sometimes the labs themselves too] are bought up wholesale by bigger companies that then do the preclinical and clinical trials and the FDA approval.) This of course incentivizes incumbents to consolidate.
Keeping the approval sane is largely the job of watchdog organizations (NGOs, other civil advocacy groups, expert groups). Of course filtering the lobbyist bullshit should be the job of everyone's beloved dear leaders. The incentives are not stacked in the common man's favor, as we already know it for some time.
Pushing for safety is of course the usual think of the children argument, but I'm not pushing for more. I'm pushing for the same amount that is currently there.
Furthermore, the FDA costs are almost negligible compared to the development cost of new drugs. (Seriously, it's less than one percent.) And running clinical trials themselves cost a lot of money. Which is something that cannot be simply avoided. Because human biology is very complex, and even with these trials getting the signal from the noise is not easy. Just look at the mess in psychiatry ( https://slatestarcodex.com/2019/05/07/5-httlpr-a-pointed-rev... how basically targeting one gene is [almost?] completely uselss)
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Public servants are not compensated for that higher standard.
I’m not “compensated” financially when I pick up litter I encounter when walking around but that doesn’t dissuade me from doing so.
Abstract: > The ability to identify medical reversals [practices that have been found, through randomized controlled trials, to be no better than a prior or lesser standard of care] and other low-value medical practices is an essential prerequisite for efforts to reduce spending on such practices. Through an analysis of more than 3000 randomized controlled trials (RCTs) published in three leading medical journals (th…
Supplementary File 2 contains the full list of reversals: https://elifesciences.org/articles/45183/figures#supp2 I don’t know if this is a permalink due to the hash parameter but I’ll try: https://elifesciences.org/download/aHR0cHM6Ly9jZG4uZWxpZmVzY...
Challenging chemo: https://www.icnr.com/articles/ischemotherapyeffective.html Australia has a study that's pretty damning. Is that one of these practices listed?
the website you linked reads like homeopathic conspiratorial junk. I would be wary of anything they cite
The pharmacological industry resistance to these findings is unsurprising.