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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

#31

Post by conanbatt »

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).

Or harder still, how many drugs never get to the public because of the expensive process of FDA approval that skyrocket costs and kill people without getting reasonably priced low-risk medicine.

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

#32

Post by Theodores »

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…

I could not agree with you more! Today is my last day clutching a frothy latte, ever! I gave up on chocolate recently due to Cadbury's being bought by Kraft and since then I have moved to the equally sugary fruits for my treats.

So now I am going to eat what I eat when I am not well - fruit, salads, fruit and more salads. No beige foods and not necessarily cooked meals. So no chips either.

I also happen to be vegetarian so I really just want to fine tune what I eat rather than go on a diet, which rarely works for people who do such things.

I also think there is something cool about being 'powered by fruit, nuts and vegetables' with only a bicycle for transport.

I am not convinced about any medicines, particularly pain killers, I will save those and the antibiotics until I get past 8 on the A+E pain scale.

https://www.fastcompany.com/3050319/how-giving-up-refined-su...

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

#33

Post by afarrell »

bhalperin wrote: post #13

Scott Alexander [1] has some useful (critical) comments: "significant safety issue" is not necessarily what it sounds like. [1] https://slatestarscratchpad.tumblr.com/post/160559317596/kit...

It is worth noting that Scott Alexander is an MD who is currently finishing his residency.

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

#34

Post by DanBC »

conanbatt wrote: post #31
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).

Or harder still, how many drugs never get to the public because of the expensive process of FDA approval that skyrocket costs and kill people without getting reasonably priced low-risk medicine.

People say this, but the evidence from the UK Cancer Drugs Fund (a pot of money used to pay for expensive, new, not yet approved by NICE meds) tells us that the drugs "had no meaningful benefit" and are fantastically expensive.

http://www.bmj.com/content/357/bmj.j2097

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

#35

Post by criley2 »

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…

>if you want to be healthy, remove unnatural things from your body (sugar, medicines, sitting too much, etc),

?? What is "natural"? How do you define "natural"? Is there a single point in human evolution that you call "done" and emulating that discrete point is natural, and anything before or after is 'unnatural'?

I always struggle to understand "natural" woo because it is, at its core, an undefined and meaningless word with absolutely no scientific or medical relevance.

>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.

So, basic modern medicine? If your general doctor is recommending unnecessary medications or not doing cost/benefit for you, then medicine isn't broken, your doctor is.

>Especially since hearing more about more about how the American health system is not exactly incentivized to always look out for the best interest of the patient, I'm inclined to agree with him.

Why on earth would you conflate the profit motives of healthcare middlemen to imply that the science behind medicine isn't credible?

This is a shockingly ignorant statement openly peddling ludditeism and implicitly denouncing science in favor of the pitiful naturalism fallacy.

Really surprised to see such irrationalism on this forum.

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

#36

Post by criley2 »

grandalf wrote: post #27

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.

It's not farfetched in the least to have one entity approve the drugs based on roughly $1 billion dollars over 10 years[1] worth of research.

What's more farfetched to me is allowing private, profit-motivated corporations the unfettered ability to produce this expensive research.

Fortunately the all-but-oppressive regulation of the FDA from GLP and GMP to insanely rigorous science-based four phase system of testing is IMO the greatest achievement in science-based regulation in human history.

People simple do not understand or respect the awesome power of the scientific method being the basis of government regulation.

[1] http://onlinelibrary.wiley.com/doi/10.1002/9780470403587.ch1...

or go to https://www.amazon.com/Drugs-Discovery-Approval-Rick-Ng/dp/0... and use the "look inside" feature to see page 4: "It is estimated that, on average, a drug takes 10-12 years from initial research to reach the commercialization stage. The cost of this process is estimated to be over $1 billion USD" (2005)

Another fun tidbit you'll find in the book: On average, for every 10,000 NME's that begin research, 1 NME will receive FDA approval. (where NME is a new molecular entity, a novel new drug).

So you've got a market where you have to begin development on 10,000 products to get 1 product into the market, on a 10 year runway. Could you imagine that in tech? 9,999 pivots per product!

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

#37

Post by scrollbar »

criley2 wrote: post #35
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…

>if you want to be healthy, remove unnatural things from your body (sugar, medicines, sitting too much, etc), ?? What is "natural"? How do you define "natural"? Is there a single point in human evolution that you call "done" and emulating that discrete point is natural, and anything before or after is 'unnatural'? I always struggle to understand "natural" woo because it is, at its core, an undefined and meaningless w…

I will reflect your outrage back to you now:

Why on earth would you NOT assume that institutionalized greed affects the results of medical science?

Who is funding the science? What are their financial motives? Who conducts the research? What are their financial motives? Are incentives aligned to produce quality medical research with the patient's best interests in mind, or the bottom lines of medical companies (pharma, medtech, even hospitals, etc.)?

I'm shocked and surprised at your shock and surprise. I don't think your arguments are irrational. I simply think they are naïve.

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

#38

Post by orblivion »

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).

You would also have to consider whether the drug companies would choose an alternate route for validating safety. I think they would care at least some amount about their reputation for safe products.

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

#39

Post by c3534l »

refurb wrote: post #4

As someone who works in the industry, this shouldn't be much of a surprise. Most drugs have a very low incidence of serious side effects. Even over the counter products do. The reason they are approved is that they are so rare. A great example of a serious side effect is Toxic epidermal necrolysis (TEN) and Stevens–Johnson syndrome (SJS). There are many everyday drugs (ibuprofen, antibiotics, etc) that can cause this…

Not to mention there's a risk-benefit thing going on. Serious side-effects are something to really care about for a drug that treats allergies. But if it's meant to treat terminal cancer, then you're more likely to let the potential of adverse side-effects slide.
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