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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

#21

Post by raverbashing »

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…

Sugar is natural (though HFCS is not)

The first cartoon tells everything I think about this: http://www.newyorker.com/cartoons/bob-mankoff/cave-cuisine

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

#23

Post by theseatoms »

fictioncircle wrote: post #20
EGreg wrote: post #17

Earlier quoted context omitted.

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.

If an insurance company can "remove" you when you become unhealthy, then they weren't providing insurance in the first place.

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

#24

Post by [deleted] »

fictioncircle wrote: post #18
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.

[deleted]

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

#25

Post by pasbesoin »

(In the U.S.,) It's government funding and research that turns up most novel drugs (as opposed to tweaking existing formulae and mechanisms).

And, there needs to be government funding (e.g. to an independent academia) and research that follows and studies the commercial as well as research lives and implementations of these drugs.

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

#26

Post by mikeyouse »

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's a very industry-friendly number with a very industry-friendly calculation;

> CSDD’s finding, a bellwether figure in the drug industry, is based on an average out-of-pocket cost of $1.4 billion 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.

Backing some figures out then, the actual cash cost is $1.4 billion to develop a drug. They rely on a 11.8% clinical success rate for that figure, so if you back out the drugs that were abandoned along the way (since they won't need late-stage human safety studies), it's more like $165M to develop a self-originated drug if you believe the self-supplied pharma figures.

It's even more suspect when their $2.6 billion headline figure for increased from $800M in 2003 when the cost of capital has decreased since then and average approval times have been halved: http://www.raps.org/uploadedImages/Site_Setup/Regulatory_Foc...

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

#27

Post by grandalf »

The idea that we should all simply trust one entity to "approve" drugs is pretty farfetched.

I think there should be multiple "stamps" of approval from a variety of entities that consumers can use to determine whether they want a particular drug...

Why not have stamps from the FDA, insurer groups, physicians groups, etc.

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

#28

Post by csours »

throwaway91111 wrote: post #14

I'm a little shocked it's that low. What medication doesn't have significant safety issues?

"Poison is in everything, and no thing is without poison. The dosage makes it either a poison or a remedy." - Paracelsus

The same fentanyl that a junkie might overdose on was used as a general anesthetic in my surgery.

All drugs can be used UN-safely, but some drugs cannot be used safely or cannot reliably be used safely.

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

#30

Post by taeric »

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…

While I love that and the related books, I think this is somewhat silly. At a base level where you are depriving your body of everything, food is medicinal in nature. Without it, you die.

Now, I get that being cognizant of what you add to your body seems beneficial. And, to a large extent, adding extra burden to your liver and other organs is not a good idea. However, to think that you should avoid all medicine unless acutely sick seems disingenuous. And to modify that for allowing chronically sick people opens a wide door to a ton of chronic states.

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