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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

#151

Post by lostboys67 »

amyjess wrote: post #61
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…

Last month, my doctor gave me a shot of toradol (for reasons I don't want to go into). The allergic reaction I got from that shot had me terrified I was experiencing the early symptoms of TEN at first. I had hives all over my body, plus muscle pains all over my arms and legs (at its worst, I could barely hold a razor and needed a cane in order to shuffle around). You know what comes up when you search for bumps all o…

How much where you on? I have had to take pred (40mg /d) and did not have any major side effects apart from one incidence of mood swings went from stressed to giggling inside of 10 min (I told my boss I think I had better go home and have a lie down).

It did ramp up my appetite "mmm doughnuts" and my aggression a bit.

I do know there are some funkier side effects but I did not get those

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

#152

Post by dekhn »

shriphani wrote: post #76
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…

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 open…

Note that thalidomide is still used as a medicine; it is a very effective drug when other drugs don't work. The issue was that it was given to pregnant women, when it was known that it shouldn't have been.

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

#153

Post by WalterBright »

Noseshine wrote: post #147
pas wrote: post #143

Earlier quoted context omitted.

The book is tained by the publisher. It's a perfectly valid reason in a very complex and delicate debate, such as climate change and pharma innovation regulation. Even if the book is fine, it might not be the total picture, thus it could mislead you by omission. And it can be totally in good faith, it's just bias. So, even if the book is a good overview, it's just a voice in a discussion, and without hearing what oth…

> Even if the book is fine There is the crux of your... argument. How about you read the book and then come back? You sure have a lot to say about something you never looked at. You can't improve how "the other side" is arguing (or not arguing), but you sure have 100% control over your own behavior and discussion habits. Attacking the people instead of the work is as bad as it gets, especially if you never even set e…

Looks like I'm the only person who ever read the book :-(

https://www.amazon.com/Regulation-Pharmaceutical-Innovation-...

BTW, it was published in 1987, long before climate change became a thing.

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

#154

Post by dkural »

valuearb wrote: post #118
dkural wrote: post #116

Earlier quoted context omitted.

Which is published by the American Enterprise Institute, a conservative think tank, known among other things, for climate change denialism of all sorts: 1) saying it will be minor / non-existent, 2) if it is real, it won't cost much to mitigate 3) bribing scientists as a last resort to get their alternative facts out.

We aren't talking about climate change or the AEI. What specific criticisms of the book to you have?

I read books to gain information. Books are convenient collections of facts where ideally the author has gone through the trouble of scholarship and synthesis. Thus, when I read any book, I like starting with a high bayesian prior of being able to trust the information in it, without having to fact check the statements. Indeed, this is the primary value I get from reading a book as opposed to looking stuff up myself.

Now, when the publisher is known for publishing lies and distortions, it reduces my bayesian prior that their publications are any good, particularly given the explicit stated mission of this institution is to push a given political viewpoint. It is not about the flavor politics: I don't read anything by left-wing think tanks either. It is hard to distinguish fact from fiction when one reads propaganda from an organization whose purpose is to produce intellectualized propaganda.

Thus, my criticism of the book is - I am not able to trust the author or the publisher, due to the publisher having broken that trust earlier by lying to me. The author made a bad choice by choosing a publisher who publishes propaganda. Too bad. Trust is a pre-requisite I have for taking someone's writing seriously. So there you go.

This is why we have reviews/ratings etc. We trust our fellow readers too, and try to extend the chain of trust.

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

#155

Post by dkural »

Noseshine wrote: post #147
pas wrote: post #143

Earlier quoted context omitted.

The book is tained by the publisher. It's a perfectly valid reason in a very complex and delicate debate, such as climate change and pharma innovation regulation. Even if the book is fine, it might not be the total picture, thus it could mislead you by omission. And it can be totally in good faith, it's just bias. So, even if the book is a good overview, it's just a voice in a discussion, and without hearing what oth…

> Even if the book is fine There is the crux of your... argument. How about you read the book and then come back? You sure have a lot to say about something you never looked at. You can't improve how "the other side" is arguing (or not arguing), but you sure have 100% control over your own behavior and discussion habits. Attacking the people instead of the work is as bad as it gets, especially if you never even set e…

reading a book is a significant investment of time. when published by untrustworthy institutions, i am not willing to make that investment.

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

#156

Post by jamescostian »

Mikushi wrote: post #134
jamescostian wrote: post #106

Earlier quoted context omitted.

> too many people rely on [drugs] to an absurd extent rather than changing behaviors and habits It's not that simple. If I go to school and someone gets me sick, you wouldn't "this is your fault, you shouldn't have such bad habits like going to school." Furthermore, what are these good behaviors and habits? I can find a million articles on the internet telling me that cold showers are a good habit and another million…

> can find a million articles on the internet telling me that cold showers are a good habit and another million saying hot showers are a good habit - which one is objectively right? The one that works for you? We are all different, depending on ethnicity, medical history, and a million other factor your diet, life style and life choices will affect your health differently.

How do you define "works for you"? For example, say I take cold showers and decide "this makes me cold; I don't like it" and then start taking hot showers everyday. But then imagine that one day, we find a link between hot showers and cancer.

How was I supposed to know that cold showers would have been better for me? Should my "bad habit" really be blamed?

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

#157

Post by pas »

lr4444lr wrote: post #148
pas wrote: post #144

Earlier quoted context omitted.

Can you expand on this? Links? Sources? What did they publish that was climate change denialism?

They published an op-ed from Bret Stephens[0] that was largely focused on criticizing the elite's hubristic over-reliance on probabilistic data models as a justification for not dignifying skepticism of less well-informed people. It was construed as a promotion of climate change denialist FUD. That charge was fair to make, but a certain subset of people prone to dramatic gestures figured unsubscribing was the appropr…

Thanks!

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

#158

Post by omarchowdhury »

rayiner wrote: post #88
cc439 wrote: post #77

Earlier quoted context omitted.

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 o…

The difference between UL and a automobiles and drugs is that it's obvious if an electronic product or automobile works. It's very hard to tell if a drug works--and most don't. Nutraceuticals are a great example of the problem: they're safe because they're bogus and don't do anything. But because they're not regulated people waste tons of money (and suffer because they don't take drugs that do actually work). The

Saying nutraceuticals don't do anything is quite a claim on your behalf.

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

#159

Post by GuB-42 »

warent wrote: post #98
tvural wrote: post #93

Negative press like this probably contributes to the FDA being so conservative. They get none of the benefits when a great new drug is approved, but get scapegoated when they approve something dangerous even to small numbers of people. So they just approve as few drugs and medical devices as they can get away with - it's a massive misalignment of incentives. One might think drugs would be more dangerous if the FDA we…

"The far bigger problem than drugs with side effects is a lack of drugs." I'm not so sure about that. Arguably the market is actually oversaturated with drugs, and too many people rely on them to an absurd extent rather than changing behaviors and habits to improve overall health.

More like saturated with endless variations of the same drug.

The pharmaceutical industry likes to release a new variants of popular drugs in order to keep them patented. They then advertise to doctors and other involved parties in an attempt to convince them that the "new" drug is better than the old one.

It is possible to have too many and not enough drugs at the same time.

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

#160

Post by upvotinglurker »

Shinchy wrote: post #138
throwaway91111 wrote: post #14

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

Jewish Penicillin?

Somewhere there must be a few people severely allergic to some ingredient in chicken soup.
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