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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

#121

Post by exergy »

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?

AEI operates with so much of an agenda that it would be impossible for me to pick up that book and read it without the filter of AEI published it. I'd constantly be on guard for where the authors tries to inject "Regulation? Booooo, hisss" sentiments.

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

#122

Post by weq »

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…

You mean like opiods? Or nexium? with a 50% addiction rate once proscribed for longer then 2 weeks???

I think u will find that most of the top selling drugs approved by the FDA have a host of side-effects that are VERY common, and then they themselves have a host of other drugs specifically to counter those side-effects.

Essentially the FDA is no different to how russia is run. If u have enough money for the approval process, u have enough money to rig all the trial data in your favour and surpress anything else, including research into competing drugs.

The industry itself is the keeper to all drugs, they decide what the most profit will be made off and then research that, get a patent, then do everything int here power protect that patent including not researching better drugs. Only in the worse cases of drug company fraud will the FDA step in to stop a drug.

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

#123

Post by weq »

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…

You mean like opiods? Or nexium? with a 50% addiction rate once proscribed for longer then 2 weeks???

I think u will find that most of the top selling drugs approved by the FDA have a host of side-effects that are VERY common, and then they themselves have a host of other drugs specifically to counter those side-effects.

Essentially the FDA is no different to how russia is run. If u have enough money for the approval process, u have enough money to rig all the trial data in your favour and surpress anything else, including research into competing drugs.

The industry itself is the keeper to all drugs, they decide what the most profit will be made off and then research that, get a patent, then do everything int here power protect that patent including not researching better drugs. Only in the worse cases of drug company fraud will the FDA step in to stop a drug.

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

#124

Post by aaron695 »

I'd fucking hope so.

Drugs should do stuff.

They are used to stop bad things, if lesser bad things happen they are still great. And if greater bad things happen to some people they are also great.

Whats next, study finds chainsaws can cause harm.

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

#125

Post by DanBC »

ploxiln wrote: post #67
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...

I hope no one minds if I copy some choice quotes from his comments here: > Only three of the events were withdrawals, meaning that only 1.3% of approved drugs were recalled off the market. > In 2006, the FDA added a boxed warning to warfarin, a blood thinner which at that time had been out 52 years, saying that if you took too much of it, it could make your blood too thin. > Another example: antipsychotics are not FD…

I didn't like his comments about the warning against combining opioids and benzos, because the US has seen a large increase (admittedly of small numbers) of deaths from this combination since 2000.

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

#126

Post by orblivion »

chiefalchemist wrote: post #84
orblivion wrote: post #38

Earlier quoted context omitted.

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.

It's a cost of doing business. They know there will be "error" and they accept that. That said, most are not in health business. They are in the manufacturing, distribution, and sales business. That is what they do. And they will act in ways that fulfill that model. That's just human (business) nature.

> They know there will be "error" and they accept that.

But that's always the case. The OP is about an amount of error the FDA is accepting. The only question is the right amount of acceptable error.

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

#127

Post by Qantourisc »

You want to introduce drugs/foreign molecule in a body? and hope everybody will respond perfectly to this ? Better change the body and not the drug ;)

So imo the most important thing for the FDA: 1) Does it actually do what it's intended to do ? 2) Determine conditions before you can take the drug. Drugs that have very rare side-effect -> over the counter. Dangerous drugs -> pretesting/screening of the patient before even considering given the drugs.

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

#128

Post by cgmg »

exergy wrote: post #121
valuearb wrote: post #118

Earlier quoted context omitted.

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

AEI operates with so much of an agenda that it would be impossible for me to pick up that book and read it without the filter of AEI published it. I'd constantly be on guard for where the authors tries to inject "Regulation? Booooo, hisss" sentiments.

You didn't answer the question.

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

#129

Post by jcranmer »

mikeyouse wrote: post #26
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 devel…

> 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.

The actual cost to develop a single successful drug, if you pass all the clinical trials, is in the ballpark of $500M or so. Dividing the total cost by success rate isn't an accurate number since the cost varies based on where you fail: the expensive bits are the clinical trials at the end, so finding out that the drug is a failure sooner cuts your costs considerably. The Phase III clinical trial by itself is well over $100M, much more if you're doing a large, long-term clinical study for a difficult problem (say, Alzheimer's or cancer). Something like 50% of all drugs fail in phase III.

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

#130

Post by pokemongoaway »

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…

277 days ago you wrote, "Medical research sucks as it is, and longevity research is inherently time-consuming. There are ways to ease this, like testing treatments on mice first, but I don’t see an easy way around the need to apply the test to humans and wait many years to see the results."

Why the change in heart?

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