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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

#21

Post by kanzure »

opencl wrote: post #19
kanzure wrote: post #11

Earlier quoted context omitted.

> 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?

Well, the one that says medical procedures are only practiced on people.... and that embryo editing is not editing a person. But anyway, we really do need a way for people to let themselves opt out of the FDA's regulatory regime for all sorts of reasons- chronic pain, euthanasia, pick your poison there's thousands.

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

#24

Post by gumby »

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 could give that impression and got excellent guidance and response.

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

#25

Post by richardthered »

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…

Without some kind of efficacy standard, you could sell water as a cancer cure. That would be very bad for health outcomes.

However, I do agree that it's a difficult topic, in general. Off-label drug uses is one example.

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

#26

Post by testpostpls »

geggam wrote: post #22

Frankly, Me and most of America think the FDA approves things according to the highest bidder. This is one of the biggest contributing factors to the anti vax movement. | The trust in our govt and all govt agencies is simply gone.

That really isn’t the truth though. What should be done?

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

#27

Post by avip »

geggam wrote: post #22

Frankly, Me and most of America think the FDA approves things according to the highest bidder. This is one of the biggest contributing factors to the anti vax movement. | The trust in our govt and all govt agencies is simply gone.

Highest bidder of what?

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

#28

Post by ims »

geggam wrote: post #22

Frankly, Me and most of America think the FDA approves things according to the highest bidder. This is one of the biggest contributing factors to the anti vax movement. | The trust in our govt and all govt agencies is simply gone.

> Me and most of America think the FDA approves things according to the highest bidder.

Why do you think this?

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

#29

Post by criley2 »

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…

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 reason why data sharing is hard is because it costs on average over $1,000,000,000 (1 billion USD) and 10 years of time to whittle over 10,000 drug candidates into a single new FDA approved NME (new molecular entity).

If you spent a billion dollars and a decade on a project, you will consider the data you collected to be a trade secret and would protect it with everything you can, because you have to now take this drug to market and make up the billion you spent making this drug. If you simply shared all your results, foreign competitors will simply copy your work without paying you, and will then offer your product without the cost of R&D and regulation built in: AKA they will charge 1/10 or less than you and you will struggle to profit anywhere they are in the market.

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

#30

Post by geggam »

testpostpls wrote: post #26
geggam wrote: post #22

Frankly, Me and most of America think the FDA approves things according to the highest bidder. This is one of the biggest contributing factors to the anti vax movement. | The trust in our govt and all govt agencies is simply gone.

That really isn’t the truth though. What should be done?

Transparency, in all levels of government.

And quit equating money to speech. Lobbying is legalized bribery and everyone knows it.

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