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Nearly 400 medical devices, procedures and practices found ineffective in study

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Re: Nearly 400 medical devices, procedures and practices found ineffective in study

#71

Post by la_barba »

naringas wrote: post #16

[flagged]

> I believe that the efficacy of many of them should be put to the test.

https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolesc...

Here's the list. Which ones do you have a problem with?

>I believe that profit-motivated pharmaceutical companies have incentives to make new vaccines -- more sales, and if they're also cheap to make, more profit.this together with some corporate ethics, political regulators, and greedy humans and I think you can see where I'm going with this.

Does this also not apply to Silicon Valley? Insurance? Automobiles? Entertainment? No industry is exempt from human greed and the resulting malfeasance.

> I am just advocating we review how truly necesary they all are. maybe not everybody needs the same set of vaccines? (thou I don't doubt there's a subset everyone needs)

Well, no vaccine is truly necessary. Its preventative, to reduce harm from potential exposure to disease causing antigens. You could go through life without encountering any of those pathogens. Also, its not like a random idiot bureaucrat that lists a vaccine as "needed" because his palms got greased. This is a public committee whose meetings and work you can easily follow https://en.wikipedia.org/wiki/Advisory_Committee_on_Immuniza...

>second note: unwritten rule of HN, do not question vaccines.

Can you provide a rationale for your questioning?

Re: Nearly 400 medical devices, procedures and practices found ineffective in study

#72

Post by la_barba »

teh_infallible wrote: post #10
hirundo wrote: post #4

I think it's bad policy for the FDA to screen medicines not just for safety but also efficacy. From this study it appears to be frequently unjustified but it gives the drug a seal of approval that has a tendency to replace the judgement of doctors and patients. It's not that the FDA decision makers are corrupt or incompetent. These are wildly complex issues that nobody can get right consistently. Better not to concea…

You lost me when you made the assertion that the FDA isn’t corrupt.

Is this a general assertion that "government" is corrupt, or do you have any specific assertions? Can you describe how you think drugs are approved and at what stage the "corrupt" FDA manifests itself?

Re: Nearly 400 medical devices, procedures and practices found ineffective in study

#73

Post by bilbo0s »

gumby wrote: post #24
dannykwells wrote: post #18

Everyone yelling about how the FDA is corrupt or should only screen for safety are completely ignorant of history and basic facts. Medicine is not like trying out a new coding framework - in some cases, like cancer: i) There is no ability to "try it out for your self" - you are either all in or not ii) There are extreme risks to taking the drug (most cancer drugs are actually somewhat to extreme toxic...just less tox…

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 who took their duty to protect the public from me seriously.

I took no offense at all.

Re: Nearly 400 medical devices, procedures and practices found ineffective in study

#74

Post by bilbo0s »

rscho wrote: post #62
Macross8299 wrote: post #42

Earlier quoted context omitted.

>Do they get it wrong? Yes, occasionally. Not frequently. Occasionally. But that also, is science. The FDA follows rigorous statistical procedures, but even p The issue is that there is a huge lack of transparency. When a third of the studies involved in approval of anti-depressants were withheld from the public [0] and even some withheld at the insistence of the FDA [1], what good do low P-values do? Hard to trust t…

Well, current medical research is not really science, more of a sort of office politics with added prestige and financial incentive. Actually you can read all the papers you want, you have no guarantee that what's on paper is what happened. Academic and industrial misconduct and epidemiological ignorance are so prevalent in the field that it's more akin to a religious cult. No, unfortunately I'm not being pessimistic…

>you have no guarantee that what's on paper is what happened....

Can't speak for others, but we were deathly afraid of submitting anything dependent on papers that we had not verified ourselves to 100% satisfaction. This actually held us up a lot, but it was safer than taking a chance that you would get it by those people at the FDA. Now of course, we were making software, and when you deal with computer science research, there are a lot of BS papers out there. I remember reading through papers on ray tracing, which had supposedly been peer reviewed, but were presenting arithmetic that was entirely incorrect. Literally every paper we found on this particular algorithm was riddled with almost identical mathematical errors. It was crazy. (I would say that computer scientists have got to be the worst mathematicians I've seen during my time in the sciences.) In any case. I knew that one of the people we were dealing with was a pretty good math guy. Yeah, we decided not to chance it.

Having bogus research out there is one thing, getting lucky enough to slip it by the FDA is something entirely different. Don't mistake those two things for the same issue, it could cost your company. Or worse, if you do manage to slip it by the FDA, it could cost your freedom when your bass ackwards ortho normal basis calculation switches left and right, and the surgeon goes in after the wrong kidney.

Re: Nearly 400 medical devices, procedures and practices found ineffective in study

#75

Post by gumby »

geggam wrote: post #44
gumby wrote: post #37

Earlier quoted context omitted.

You pay hardly anything to the agency -- their fees are a rounding error compared to all your other costs. And while it's valuable for some jobs to have on your resume that you used to work there, so many people have done so over the years that it doesn't raise any salaries; it's merely that for certain regulatory roles it's good to have someone who knows what it's like to receive the filings so you can make them cle…

When employees at the FDA leave and take positions at one of the companies they had a hand in approving something for, at an increased salary. The appearance of impropriety is blatant. Regardless of it actually happening or not it looks terrible. This should never happen

“Hand in approving” is an important factor: approval is such a complex process no one person is really decisive, except possibly at the very very beginning.

Drug companies used to hire multiple trucks simply to deliver their submissions.

Re: Nearly 400 medical devices, procedures and practices found ineffective in study

#76

Post by adam »

dannykwells wrote: post #18

Everyone yelling about how the FDA is corrupt or should only screen for safety are completely ignorant of history and basic facts. Medicine is not like trying out a new coding framework - in some cases, like cancer: i) There is no ability to "try it out for your self" - you are either all in or not ii) There are extreme risks to taking the drug (most cancer drugs are actually somewhat to extreme toxic...just less tox…

Thank you for this. So often we rip on government agencies from our perch on...Hacker News, when we really have no idea what's going on.

We do work with the Government in a different context, and I've found nothing but professionalism and deep expertise. In fact the people I've met in the agencies we're working with are some of the smartest I've encountered in my entire career.

Re: Nearly 400 medical devices, procedures and practices found ineffective in study

#77

Post by ehnto »

geggam wrote: post #58
jstarfish wrote: post #55

Earlier quoted context omitted.

You were never going to be convinced otherwise by a rational argument. You've literally dismissed the credibility of the American government and the entire field of medicine in a single comment.

Of course I did. After watching the govt and the FDA in action for 5 decades, detassling corn for Monsanto, watching Monsanto sue farmers into submission, seeing increased rates of cancer autism and other issues. Being told everything is ok. Then I travel the world eating food in other countries and notice the difference in my health. I see the cancer rates in Africa. You say I am uneducated and stupid. I say I have…

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.

Re: Nearly 400 medical devices, procedures and practices found ineffective in study

#78

Post by PakG1 »

homonculus1 wrote: post #52
michaelbuckbee wrote: post #8

Earlier quoted context omitted.

Efficacy is important as many drugs have significant side effects. If a drug is not going to actually reduce your chance of heart attack or help treat aggressive cancer it's likely not worth the trade-off with side effects.

Not to mention cost, and the opportunity costs that emerge from it.

Part of the opportunity cost being that you could have chosen a more effective treatment if the bar had been set higher. Difficult for patients to be able to correctly determine whether a treatment would actually be good for them. They're not in a good place to decide, for the same reason why lawyers should never represent themselves if possible.

Re: Nearly 400 medical devices, procedures and practices found ineffective in study

#79

Post by jschwartzi »

LitFan wrote: post #60
criley2 wrote: post #29

Earlier quoted context omitted.

With respect to cancer drugs, while generally no one can be prescribed medication that has not passed clinical trials, in the case of terminal patients who could potentially be saved by a drug currently in trials, there is a system for allowing them access to the medication. It's called "Expanded Access" (also known as "Compassionate Use") https://www.fda.gov/news-events/public-health-focus/expanded... The other reas…

This is a good argument for government funded R&D, and government owned drugs. They cost a ton of money and take forever to create, so the product becomes very expensive, and rights to it are owned by the creating company. The government empowers a body to regulate the flow of new drugs on the market, and once the drug meets regulatory requirements, the government - in many cases - pays on behalf of the patient. A co…

A good argument against government funded R&D is that several of our modern medical challenges have been deeply embroiled in political debates.

AIDS/HIV(originaly called GRID) was originally considered a punishment for gay men who were seen in the 80's as being immoral and sinful by the establishment. Government-funded R&D for AIDS drugs would have been unlikely for decades.

Another example is hormonal birth control. Birth control in general is a huge political football with portions of the establishment wanting no access to birth control at all. If R&D were government funded it's possible for these people to prevent access simply by making funding of certain lines of research illegal.

I think you have to look beyond the price of treatment to really see the benefit of a healthy private enterprise here. There are still a ton of ways that government contributes to new treatments, like grant funding for basic research and development. But I can see your proposed future becoming a dystopia, where whoever is in power in government makes it illegal to sell certain patented drugs to their particular underclass of the week.

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