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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

#11

Post by kanzure »

avar wrote: post #6
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…

Not screening for efficacy will result in both legitimate cancer medication and homeopathic medicine having an FDA stamp of approval. Nothing is stopping decentralized decision making, you just need to market whatever non-effective but safe remedy you're selling as a food supplement, a tea or whatever. You just can't advertise that it's a drug.

> Nothing is stopping decentralized decision making, you just need to market whatever non-effective but safe remedy you're selling as a food supplement a tea or whatever. You just can't advertise that it's a drug.

Unfortunately, this is false. The FDA will still intervene in situations where it doesn't like what you're doing even if you don't advertise your work as a drug, medical procedure, or as having any particular efficacy.

https://www.technologyreview.com/s/603530/a-biohackers-plan-...

On another note, see the sensor pads story here: http://www.fdareview.org/devices.shtml

"We rarely get to try products that the FDA fails to approve, and we never get to try products that are never brought into existence because FDA rules and regulations have made research and development uneconomic. As a result, the public remains ignorant of the true costs of FDA power."

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

#12

Post by komali2 »

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…

Typically the efficacy stamp does come with whatever caveats came up during FDA approval - for example, my SSRIs came with two sheets of double sided paper listing in excruciating detail the potential side effects, and reminding me on every page that the pills may just make me want to kill myself so watch out for that.

SSRIs being top of the list of drugs that "sometimes work sometimes don't" I think are a good example of why the FDA rubber stamping efficacy are still good. I'm not convinced I'd had those sheets of paper if drug makers had the run of the market.

I've never actually seen evidence that a "free market" (i.e. drug market with no FDA) results in a better world for consumers, unilaterally.

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

#13

Post by sysbin »

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…

Please, let's not kid ourselves about what actually is life saving intervention for a person. It downplays the need for funding and we're already dealing with a lot of suicides per day.

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

#14

Post by maxxxxx »

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…

“Therefore decision making should be as decentral and computationally parallel as we can make ”

This may work if the decentralized decisions were made based on results. But they are often made based on profits and there is a lot of money to be made in doing useless therapies.

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

#17

Post by sametmax »

Scoundreller wrote: post #9
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…

> The efficacy of a particular molecule for a particular patient isn't much easier than that to determine. How do you handle situations where the provider doesn’t know/care which is best either and just chooses the intervention that was the most heavily marketed to them? Why do we see new patent drugs replace the “old and boring” generics without any proven efficacy benefit?

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.

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

#18

Post by dannykwells »

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 toxic than cancer)

iii) You only get a few tries (since, you know, cancer will kill you).

iv) People are very desperate and will try anything

v) Data sharing is very very hard given the sensitivity of the information (patient data) - making it effectively impossible to have an open data exchange. (This is also due to the billions of dollars at stake on the pharma side).

Try designing a system to overcome those challenges...and you will likely end up with a central governing body that looks like the FDA. Anything else you are going to get way way more drugs that don't work, which waste time and money and kill people, which endanger patient privacy, or which are not satisfactory to pharma or, ...

The fact is, the FDA is full of many of the smartest and hardest working doctors and scientists in all of medicine. They take their jobs extremely seriously. They are far more careful and rigorous than most academic or even pharma-level researchers.

Do they get it wrong? Yes, occasionally. Not frequently. Occasionally. But that also, is science. The FDA follows rigorous statistical procedures, but even p<0.05 (or <0.001) still means false positives can happen.

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

#19

Post by opencl »

kanzure wrote: post #11
avar wrote: post #6

Earlier quoted context omitted.

Not screening for efficacy will result in both legitimate cancer medication and homeopathic medicine having an FDA stamp of approval. Nothing is stopping decentralized decision making, you just need to market whatever non-effective but safe remedy you're selling as a food supplement, a tea or whatever. You just can't advertise that it's a drug.

> Nothing is stopping decentralized decision making, you just need to market whatever non-effective but safe remedy you're selling as a food supplement a tea or whatever. You just can't advertise that it's a drug. Unfortunately, this is false. The FDA will still intervene in situations where it doesn't like what you're doing even if you don't advertise your work as a drug, medical procedure, or as having any particul…

What kind of bizarre definition of the term "medical procedure" would exclude using CRISPR gene editing to get rid of an inherited disease?

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

#20

Post by avar »

kanzure wrote: post #11
avar wrote: post #6

Earlier quoted context omitted.

Not screening for efficacy will result in both legitimate cancer medication and homeopathic medicine having an FDA stamp of approval. Nothing is stopping decentralized decision making, you just need to market whatever non-effective but safe remedy you're selling as a food supplement, a tea or whatever. You just can't advertise that it's a drug.

> Nothing is stopping decentralized decision making, you just need to market whatever non-effective but safe remedy you're selling as a food supplement a tea or whatever. You just can't advertise that it's a drug. Unfortunately, this is false. The FDA will still intervene in situations where it doesn't like what you're doing even if you don't advertise your work as a drug, medical procedure, or as having any particul…

The story you've linked to is where the FDA shut down some private individual selling genetically modified dogs to the public.

But yes, the FDA aren't complete morons. If you're selling genetically modified dogs you're obviously selling the results of an unapproved medical procedure to the public, even if all you say about it is that you're selling fluffy friends to the public.

The second story you've linked to is one where someone was clearly trying to sell a replacement for breast examinations to the public.

I've never heard about the "sensor pad" before, and there's probably a good case to me made for such a device being more beneficial than not, and that the FDA made a mistake etc.

But I think their process is more sound than not in demanding clinical trials of these sorts of products. This is because in practice people will use them as a replacement for going to their physician, so having some DYI breast cancer scanning kit doesn't just need to be harmless in isolation. You also need to consider the increased death rate from people not going to their doctor for an examination as a result.

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