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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

#111

Post by rz2k »

sfRattan wrote: post #81

On the flip side, many drugs approved by governments in the rest of the Western world languish in the FDA's queue for years. I contracted a common illness while living in Germany as an exchange student, and was prescribed medication by a doctor there which I had to fight over with my insurance (then my parents' family plan) for reimbursement because the drug had not yet been approved by the FDA. We got the reimbursem…

The US market is so lucrative that drug companies will go through FDA certification, but it is definitely more costly. It is arguable that disasters such as prescribing Thalidomide to pregnant women for morning sickness, and even selling it over the counter, is less likely with a more rigorous agency.

> Thalidomide was first marketed in 1957 in West Germany under the trade-name Contergan. [...] Primarily prescribed as a sedative or hypnotic, [...] Afterwards, it was used against nausea and to alleviate morning sickness in pregnant women. Thalidomide became an over-the-counter drug in West Germany on October 1, 1957. Shortly after the drug was sold in West Germany, between 5,000 and 7,000 infants were born with phocomelia (malformation of the limbs). Only 40% of these children survived. Throughout the world, about 10,000 cases were reported of infants with phocomelia due to thalidomide; only 50% of the 10,000 survived. Those subjected to thalidomide while in the womb experienced limb deficiencies in a way that the long limbs either were not developed or presented themselves as stumps. Other effects included deformed eyes and hearts... [1]

In practice, there are a lot of problems that prevent it from only being a more rigorous quality control, but it also isn't entirely bad.

[1] https://en.wikipedia.org/wiki/Thalidomide

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

#112

Post by sfRattan »

da02 wrote: post #109
sfRattan wrote: post #81

On the flip side, many drugs approved by governments in the rest of the Western world languish in the FDA's queue for years. I contracted a common illness while living in Germany as an exchange student, and was prescribed medication by a doctor there which I had to fight over with my insurance (then my parents' family plan) for reimbursement because the drug had not yet been approved by the FDA. We got the reimbursem…

What was the illness? Did you ask the doctor why he was using a Commodore 64?

I deliberately didn't specify the illness for privacy reasons, though it was an airborne contagious disease. I did not ask him why he was using such an old machine, but it seemed to work and he was rather old also. The detail only sticks out because it was so odd.

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

#113

Post by dfsegoat »

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…

Your stats are a tad dated - the FDA has far better (in terms of granularity) stats lately that show a pretty steady trend towards 'more approvals' in the past few years - this includes biosimilars and new molecular entities (novel drugs): https://www.fda.gov/downloads/aboutfda/centersoffices/office...

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

#114

Post by grandalf »

maxerickson wrote: post #56
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.

Insurance companies all evaluate drugs before putting them on their formulary and doctors do at least a little bit before they start writing a prescription. So there ya go.

Right, so why is the FDA the bottleneck to drugs coming to market? It makes no sense and creates a massive, overly risk-averse bureaucracy.

There are tradeoffs involved for allowing a drug too soon, failing to take it off market fast enough in the face of new evidence, and for needlessly delaying time to market.

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

#115

Post by cariaso »

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 genotyping a prerequisite for some medications.

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

#116

Post by dkural »

WalterBright wrote: post #108
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…

Sam Peltzman goes into great detail on this issue in his book "Regulation of Pharmaceutical Innovation."

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.

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

#117

Post by dkural »

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…

vaccines, antibiotics etc. are pretty big improvements upon the natural order. Brings the famous New Yorker cartoon about cavemen observing their life spans to mind.

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

#118

Post by valuearb »

dkural wrote: post #116
WalterBright wrote: post #108

Earlier quoted context omitted.

Sam Peltzman goes into great detail on this issue in his book "Regulation of Pharmaceutical Innovation."

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?

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

#119

Post by valuearb »

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…

Let me guess, you are a MLB pitcher? Toradol was famously used to help pitchers deal with arm pain before starts, starters put a lot of stress on their pitching arms. It helped them get loose to pitch, until people noticed a pattern of severe injuries from pitchers being able to pitch through pain.

My Doc wanted to shoot it into me for a bad back (muscle spasms). I passed.

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