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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

#141

Post by narrowrail »

raverbashing wrote: post #21
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

While sugar (a really generic term usually referring to sucrose) is natural, it occurs in the highly fibrous stalks of sugar cane. Most sugars naturally occur within fiber, while modern food practices extract and/or refine leaving the fiber behind.

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

#142

Post by Apfel »

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…

For the record, the 2 billion dollars figure is from the notorious tufts centre for the study of drug development, which is heavily pharma-backed.

It's a very, VERY controversial figure in the pharmacoeconomic literature, but has been accepted as gospel due to continuous repetition in shitty reporting.

Fairly good article discussing this: https://www.washingtonpost.com/news/wonk/wp/2014/11/18/does-...

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

#143

Post by pas »

Noseshine wrote: post #136
Broken_Hippo wrote: post #131

Earlier quoted context omitted.

Yes, he did. It was specific. I have a similar opinion. Because the publisher also engages in climate change denial and other such thing, it is hard to trust anything in This book - even though it is a different subject. I couldn't read it and trust any factual bits presented to me - the worst case scenario is that I get these "facts" mixed up with things that are from more credible places without having the time or…

> Yes, he did. It was specific. It was specific about the authors , but the question was about specifics of the book. Still not one bit of information about the book in sight in this sub-thread. I don't care either way, as a bored HN reader going through this and that thread I just noticed the discrepancy, and while I have nothing to say about the subject being discussed I am able to see that the discussion itself do…

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 others think of the book, it's pretty good to go by what one knows of the publisher.

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

#144

Post by pas »

cancelNYTimes wrote: post #137
Broken_Hippo wrote: post #131

Earlier quoted context omitted.

Yes, he did. It was specific. I have a similar opinion. Because the publisher also engages in climate change denial and other such thing, it is hard to trust anything in This book - even though it is a different subject. I couldn't read it and trust any factual bits presented to me - the worst case scenario is that I get these "facts" mixed up with things that are from more credible places without having the time or…

Yes, this is why I cancelled my New York Times subscription, and have been recommending everyone else do as well. They are now in the business of publishing climate denial propaganda for profit. Don't support it.

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

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

#145

Post by chiefalchemist »

mveety wrote: post #86
chiefalchemist wrote: post #83

Earlier quoted context omitted.

My understanding is, if you possess a prescription drug without a script then that is, at that point, relative to you, an illegal drug. Sure, no one is going to do time for, say, thyroid meds, but opoids is a whole other story. This is why is cracks me up when people want to tie public services (e.g., food stamps) to drug testing. Imagine how many (white) middle class kids would be denied school is their parents' blo…

That depends. AFAIK, if its prescribed to you and you give it to someone else, that's illegal whether or not its scheduled. Otherwise, if it isn't scheduled, there's no real legal issue there. Drug testing in the US is insane.

Yes. If it's OTC and you possess it but have no script (for you) then that's "illegal drugs." I'd like to see a study/figure for illegal drug use using that proper definition.

P.s. Script and illegal use of prescription opioids are the gateway to street opiods (e.g., heroin).

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

#146

Post by vitorbaptistaa »

Not directly related to the OP's story, but can be useful for someone reading these comments.

We've scraped the Drugs@FDA data as part of OpenTrialsFDA [1], a project aimed to make it easier to search their documents. It contains data from about Oct/2016, because they changed their website's layout just after we finished the scraper (if you'd like to contribute, it shouldn't be difficult to update the scraper [2]). All the data is available in a Postgres database at https://explorer.opentrials.net/data, or via https://fda.opentrials.net.

I'm happy to talk with anyone interested in this kind of data via https://gitter.im/opentrials/chat.

[1]: https://opentrials.net/opentrialsfda/ [2]: https://github.com/opentrials/opentrials/issues/705

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

#147

Post by Noseshine »

pas wrote: post #143
Noseshine wrote: post #136

Earlier quoted context omitted.

> Yes, he did. It was specific. It was specific about the authors , but the question was about specifics of the book. Still not one bit of information about the book in sight in this sub-thread. I don't care either way, as a bored HN reader going through this and that thread I just noticed the discrepancy, and while I have nothing to say about the subject being discussed I am able to see that the discussion itself do…

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 eye on the latter. I won't read it either, but I don't have an opinion about it that I'm trying to share.

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

#148

Post by lr4444lr »

pas wrote: post #144
cancelNYTimes wrote: post #137

Earlier quoted context omitted.

Yes, this is why I cancelled my New York Times subscription, and have been recommending everyone else do as well. They are now in the business of publishing climate denial propaganda for profit. Don't support it.

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 appropriate response, as if the NYTimes had never pushed politically biased interests before.

[0]https://www.nytimes.com/2017/04/28/opinion/climate-of-comple...

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

#149

Post by azernik »

cariaso wrote: post #115
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…

Stevens–Johnson syndrome seems to occur as a response to several different drugs, but apparently only to people with a specific HLA genotype. Part of the solution here is that currently we only approve a drug if it is safe for nearly 100% of the population, even if it is useful for far fewer (see statins) and the path forward needs to give more consideration of the differences in people, and having suitable genotypin…

Agreed on the general principle, but note that the incidence of SJS varies by drug. For example, lamotrigine causes SJS in 10-30% of people taking it, depending on how fast the dosage is increased.

There they don't address it by trying to predict who will show SJS symptoms and who won't; they just put people in it slowly (which reduces incidence) and take people off the drug (or hold at a given dose until the body accepts the drug) if they show symptoms.

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

#150

Post by lostboys67 »

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…

Quite all drugs have said effects I have to take BP pills and a couple of Christmas's ago I was doing a full roast dinner for the family, I accidently took a double dose and fainted at the table due to low blood pressure - that's a safety issue but a fairly trivial one compared to the benefits of controlling hyper tension
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