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Nearly 1 in 3 drugs have a significant safety issue after FDA approval

latimes.com

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Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval

#11

Post by tgb »

Cozumel wrote: post #9
helloweirld wrote: post #6

Only three of the events were withdrawals, meaning that only 1.3% of approved drugs were recalled off the market. Consider that this is a really impressive error rate. Scientific studies are allowed to be wrong 5% of the time; the FDA is wrong 1%. The others were “boxed warnings” and “safety communications”. These are often pretty minor. I can’t read the full study you linked, so I don’t have their examples, but some…

> 'I can’t read the full study you linked, so I don’t have their examples' Then you go on to cite tumblr ?! Just read the actual paper: http://sci-hub.cc/10.1001/jama.2017.5150

That is, at least, the tumblr of a psychiatrist resident who writes a lot on the subject of FDA regulations. I really recommend his blog posts on the subject, like this one about how different countries (Russia and US particularly) use different drugs and for the most part don't even seem to be so interested in trying the drugs available elsewhere: http://slatestarcodex.com/2014/08/16/an-iron-curtain-has-des...

Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval

#12

Post by Retric »

aantix wrote: post #10

It already costs 2.5 billion to bring a medication to market.. https://www.scientificamerican.com/article/cost-to-develop-n... Adding additional quality measures only stands to increase that number.

That number includes : "and an estimate of $1.2 billion in returns that investors forego on that money during the 10-plus years a drug candidate spends in development."

The math on that seems wacky as 1.4 billion assuming it's close to valid is spent over 10+ years and is not a 100% up front investment for 10 years. So, they are saying if you invest ~140 million / year after 10 years you will have ~2.5 billion from your expected 13% annual ROI which is crazy talk. Even 70m/year over 20 years is only 2.5b if you assume 6% ROI which is hardly 'safe'.

Given that, I suspect the other numbers are also inflated such as including 'failed' drugs which is classic Hollywood accounting.

PS: One of the classic ways Drug companies mislead is what they bundle under the Research part of R&D vs the Development part of R&D.

Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval

#15

Post by hfourm »

dcolgan wrote: post #2

In one of my favorite books, Antifragile, Nassim Taleb argues that health is largely subtractive - if you want to be healthy, remove unnatural things from your body (sugar, medicines, sitting too much, etc), and only undergo surgery, go to the hospital, or take medicine in very serious cases where the harm of not doing something outweighs the potential complications. Especially since hearing more about more about how…

Further, try to take only what medicine you need, maybe just a Sudafed instead of a SUDAFED DM X + PAIN

Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval

#16

Post by adrr »

dcolgan wrote: post #2

In one of my favorite books, Antifragile, Nassim Taleb argues that health is largely subtractive - if you want to be healthy, remove unnatural things from your body (sugar, medicines, sitting too much, etc), and only undergo surgery, go to the hospital, or take medicine in very serious cases where the harm of not doing something outweighs the potential complications. Especially since hearing more about more about how…

Infant mortality and life expectancy are improving with modern medicine and diet. Most of our problems today stem from the over consumption of food and lack of physical activity. Cancer rates are at an all time low even though media makes it seem like everything(non caloric sweeteners, plastics, herbicides) around us causes cancer.

https://www.cdc.gov/cancer/dcpc/data/race.htm

Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval

#17

Post by EGreg »

dcolgan wrote: post #2

In one of my favorite books, Antifragile, Nassim Taleb argues that health is largely subtractive - if you want to be healthy, remove unnatural things from your body (sugar, medicines, sitting too much, etc), and only undergo surgery, go to the hospital, or take medicine in very serious cases where the harm of not doing something outweighs the potential complications. Especially since hearing more about more about how…

My grandfather used to tell me about a Chinese king who paid his doctors only when he was well, not the other way around.

I used to really dislike private insurance companies but after teaching about Charles Babbage using math for "Comparative View of the Various Institutions for the Assurance of Lives" I realized something:

Insurance companies are the most aligned with your wellness financially. They want as many healthy people to pay in as possible.

And thus a government health insurance system with universal coverage would be even more financially aligned with increasing health.

I think one of the greatest things you can do as a startup is to improve health for people, through diet and exercise apps and preventative checkups etc. and the insurance companies will PAY YOU to do it!

Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval

#18

Post by fictioncircle »

noir_lord wrote: post #7

A more interesting question would be how many would have a significant safety issue without FDA approval. Given the complexity of the drugs, the body and the interaction with other medication I'm impressed it's only 1 in 3 particulary since as mentioned down thread only 1.3% get taken off the market (1 in 77).

https://www.bio.org/sites/default/files/Clinical%20Developme...

> A more interesting question would be how many would have a significant safety issue without FDA approval.

tl;dr

> FDA approval (LOA) reveals that only 9.6% (n=9,985) of drug development programs successfully make it to market

The FDA strikes a good balance I think. Its never going to be 100% successful but it does screen out many dangerous drugs.

Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval

#19

Post by helloweirld »

Cozumel wrote: post #9
helloweirld wrote: post #6

Only three of the events were withdrawals, meaning that only 1.3% of approved drugs were recalled off the market. Consider that this is a really impressive error rate. Scientific studies are allowed to be wrong 5% of the time; the FDA is wrong 1%. The others were “boxed warnings” and “safety communications”. These are often pretty minor. I can’t read the full study you linked, so I don’t have their examples, but some…

> 'I can’t read the full study you linked, so I don’t have their examples' Then you go on to cite tumblr ?! Just read the actual paper: http://sci-hub.cc/10.1001/jama.2017.5150

Sorry, I wasn't clear -- the text is quoted from the tumblr post. Thanks for the original link though

Re: Nearly 1 in 3 drugs have a significant safety issue after FDA approval

#20

Post by fictioncircle »

EGreg wrote: post #17
dcolgan wrote: post #2

In one of my favorite books, Antifragile, Nassim Taleb argues that health is largely subtractive - if you want to be healthy, remove unnatural things from your body (sugar, medicines, sitting too much, etc), and only undergo surgery, go to the hospital, or take medicine in very serious cases where the harm of not doing something outweighs the potential complications. Especially since hearing more about more about how…

My grandfather used to tell me about a Chinese king who paid his doctors only when he was well, not the other way around. I used to really dislike private insurance companies but after teaching about Charles Babbage using math for "Comparative View of the Various Institutions for the Assurance of Lives" I realized something: Insurance companies are the most aligned with your wellness financially. They want as many he…

> Insurance companies are the most aligned with your wellness financially. They want as many healthy people to pay in as possible.

That is only true if they are forced to accept people blindly and without screening.

Otherwise, they simply create a screening process centered around removing unhealthy people and preventing unhealthy people from enrolling.

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