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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

#71

Post by dcolgan »

hnhg wrote: post #64
dcolgan wrote: post #57

Earlier quoted context omitted.

A good hypothesis can be used to make predictions. I'm just saying with my foot issues that the heuristic of "subtractive medicine is better than additive medicine" was able to predict that removing padding from my shoes would make my problem go away. And it did. That does not prove anything but it worked here.

Say that the padding had worked, you might have rationalised it to to be that it's unnatural to walk on hard surfaces ("our ancestors never walked on concrete"). There are also probably many instances in your life where this hasn't worked, but you've cherry picked the example that does. It's very likely that your body healed itself regardless of the padding. You might have just needed time. You've figured that it's r…

That's fair enough, but also why I looked for other people who had similar experiences. I'm definitely not always right, that is true. I am not a doctor, lawyer, or accountant.

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

#72

Post by Alex3917 »

amyjess wrote: post #66
Alex3917 wrote: post #47

Earlier quoted context omitted.

> how many drugs never get to the public None. FDA approval isn't required to manufacture, sell, or purchase drugs. It's only required for companies that want to make marketing claims about the ability of drugs to treat various illnesses and conditions. As long as the drug you want isn't scheduled by the DEA, you're free to go online and order however much you want.

If it's not a controlled substance, you can buy all you want, but it's illegal to sell it unless it's been approved by the FDA. Sure, if you want to order your meds from online pharmacies based in India and Vanuatu, you can (and I personally know people who order cyproterone acetate from these pharmacies because it's the best oral anti-androgen in existence but hasn't been approved by the FDA mostly out of laziness/c…

> it's illegal to sell it unless it's been approved by the FDA.

Source? I'm pretty sure this is only true if you advertise the product as being for human consumption. The U.S. has basically zero restrictions on selling random chemicals. C.f.:

http://www.pbs.org/newshour/updates/it-could-take-centuries-...

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

#73

Post by Pfhreak »

Naively, I feel like the same could be said about appliances, or kitchen items, or software, or food, or vehicles, or ...

"Significant safety issue" seems both poorly defined, and doesn't address the rate of incidence or the conditions necessary to create that issue. Many drugs have safety concerns when not used correctly, for example. Or in small populations.

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

#75

Post by njarboe »

dcolgan wrote: post #51
criley2 wrote: post #35

Earlier quoted context omitted.

>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 think some nuance here is needed. My understanding of "natural" primarily comes from an understanding of evolutionary history. If humans have been doing something for millions of years, it is likely to be more "natural" and therefore not cause harm compared to recently invented things. But it is not a black and white thing, but rather a spectrum. Some examples: Trans fats were invented because they thought saturate…

I'm pretty sure the early hydrogenated oils were created (Crisco, 1911) because they had similar and in some cases superior properties to animal fats and butter, but were cheaper and had a longer shelf life. The idea they were healthier came later.

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

#76

Post by shriphani »

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…

Irrationalism? Err no.

Taleb expounds on his definition of the natural - anything that man has done for 100s of years without observing downside.

There is reasonable cause to believe that people are very interventionist in a lot of cases where all that is needed is letting the system sort itself out. Diabetes medication for instance (again - not in all cases): https://www.youtube.com/watch?v=da1vvigy5tQ

A lot of openness to low quality scientific work done in a lot of domains and our eagerness to think that anything with numbers slapped on it is better has given us wonderful gifts like high-fructose corn syrup, trans-fat, thalidomide (all within the last century).

The Taleb metric is just that a lot of systems don't respond in a linear fashion to random input. High levels of consumption of a substance only materialize with a delay of a few decades in horrible ways and the negative result can undo all the positives over the duration of the use of said substance. Thus is it important to err on the side of those things that have been (i) well tested over centuries and (ii) strong evidence doesn't exist that said substance is actually dangerous (tobacco for instance).

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

#77

Post by cc439 »

orblivion wrote: post #38
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.

The free market has made this work in the realm of electronics and electrical devices (UL), as well as the automobile industry (TS16949). The risks posed by bad products in the healthcare sector are perceived as far more dangerous but the sheer ubiquity of theoretically dangerous, yet completely trusted products produced with nothing but private party testing lends credence to the argument that we wouldn't be worse off without the FDA.

The safety of US made nutraceuticals is also a testament to that fact although they have become increasingly regulated by the FDA and FTC despite a lack of prominent examples to back the need for further regulation.

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

#78

Post by chiefalchemist »

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…

But rare is relative to usage, yes. It's also a function of the side effects. I mean, if 1M ppl use X and 1% get a rash, that's not the same as .5% of 10M having some sort of major organ reaction.

That said, America loves drugs. Patients expect them. Doctors prescribe them. Big Pharma counts the money. Everyone is happy.

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

#80

Post by chiefalchemist »

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).

Yes. Good point. It's also that all the easy diseases have been solved. Now we're into that hard stuff. And of course some are just by accident. Viagra, for example, didn't start as a solution to ED. So often it's a solution in search of a problem. Gotta keep the shareholders happy, eh.

And we wonder why healthcare is so expensive, obesity aside.

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