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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

#101

Earlier quoted context omitted.

> Insurance companies are the most aligned with your wellness financially. They want as many healthy people to pay in as possible. That is only true if they are forced to accept people blindly and without screening. Otherwise, they simply create a screening process centered around removing unhealthy people and preventing unhealthy people from enrolling.

If an insurance company can "remove" you when you become unhealthy, then they weren't providing insurance in the first place.

> If an insurance company can "remove" you when you become unhealthy, then they weren't providing insurance in the first place.

Yup, hence Obamacare with mandatory enrollment and the removal of all the tools they used to it. Then people complain about prices going up. :/

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

#102
These decisions are huge and uncertain tradeoffs between how many will die from a drug being stopped or delayed and how many will die from it being approved.

If no drugs ever were recalled or had significant safety issues after approval, that would be a certain sign the process is erring on the side of non approval.

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

#103
post #50

Earlier quoted context omitted.

What do you think happens when insurance is provided through your employer and you develop a health problem that interferes with your ability to do that job?

In that case, assuming you are fired from your work, you can get a continuation of your insurance under COBRA. See https://en.wikipedia.org/wiki/Consolidated_Omnibus_Budget_Re... The short answer is you can get a continuation of your same health plan for a certain period of time, but you have to pay more because your employer isn't subsidizing your premiums. Generally this extension lasts for 18 months, though if you…

Probably worth keeping in mind that many SSDI requests are denied and the process can take 18 months.

So pretty much everyone needs an 18 months of savings + COBRA costs. Even then its quite likely not enough unfortunately.

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

#104
post #66

Earlier quoted context omitted.

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-...

You and the grandparent are correct. That's why you have the DEA doing "emergency scheduling" of various analogues of controlled substances. Otherwise, they have no legal recourse to stop the sale of the chemical.

That said, if you start claiming your "chemical" has health benefits, then the FDA will get all over you for making unproven health claims.

The one exception is the supplement market in the US. If you can trace the chemical back to a natural source, then you are allowed to sell it, and I believe make claims based on what data is available, but you still can't make unproven claims.

It's a jungle of regulations out there.

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

#105
I fear this is one of those subjects where querying any 5 people will yield 10 opinions, and in the end the issues remain poorly illuminated.

FWIW I've been prescribing medications for a number of decades and pretty well understand the general benefits and limitations of pharmocotherapy as a treatment method.

To save you a lot of time and trouble studying this very complex field, let me boil it down to these few words: any medication can cause any side-effect at any time.

All drugs cause side multiple effects. The ones we like we call "benefits" or therapeutic effects, those we don't like are "adverse effects" (AEs). Useful drugs will have few troublesome AEs vs. good benefits, but it's a relative matter, a judgement call about what's good, bad or ugly.

It partly depends on the condition the drug is used for. In life-threatening situations we'll accept bad AEs, for example, cancer chemotherapy agents. For merely annoying, self-limiting problems, like a common cold, we wouldn't take big risks.

However, no drug is absolutely safe. All are capable of causing serious problems in at least a few people. Therefore we must use all drugs carefully and with thorough knowledge of the risk/benefit trade-offs, but there are never any guarantees of outcomes.

Another aspect is that often severe AEs are quite uncommon. Think of a side-effect that occurs in 1/100000 recipients. What are the odds this will be detected in drug registration trials? Most drugs are tested on a perhaps a few thousand people before approval, and often fewer subjects than that. The chances of encountering these outcomes is remote until drugs have been around for years, even decades before the harmful effects can be gleaned.

One drug that became notorious for incidents of fatality in the late 90's was nefazodone (Serzone), an antidepressant. I was peripherally involved with research on the matter. Basically what came to light was that in people with rare (like 1 in a million) mutations in certain liver enzymes, the drug was metabolized along a pathway that produced compounds causing fatal liver necrosis. After 18 deaths around the world became known, the association was made and the drug was withdrawn from the market. There was no way to predict this would be an effect of the drug when it was approved.

Of course AEs are very seldom fatal. The point here is that AEs (serious or not) are quirky, inevitable and randomly distributed. The benefits are always intertwined with finite risks. It's not surprising in the least that a high proportion of drugs are associated with troublesome AEs (with varying definitions of "troublesome").

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

#106
post #98
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.

> 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 saying hot showers are a good habit - which one is objectively right?

Yes, there are people who decide to use drugs instead of making simple changes (e.g. my friend who drank a large bottle of Jack in a day and needed to get his stomach pumped - he should have just vented to a friend about his girl issues). But there are so many other people out there who don't fit that description, and there isn't any true scottsman with objectively perfect behaviors and habits. So I don't think it's unreasonable to help people out with more options for drugs that may be better for some people than what we already have.

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

#107

Earlier quoted context omitted.

Or harder still, how many drugs never get to the public because of the expensive process of FDA approval that skyrocket costs and kill people without getting reasonably priced low-risk medicine.

> 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.

I dont know the details of the us health system and correct me if im wrong, but lacking FDA approval probably restricts a lot of things you can do, aside from doing unprovable claims, though the last one is also allowed for many things that are health and non-health related.

I can be swayed , but i do subscribe to the concept that there is an availability bias in FDA approval: the fda has the incentive to be overly cautions, because punishment hurts fda, but banning potentially good medicine does not cause FDA any problems.

That, and the potential of regulatory capture make me dubious of any positive claim about the existence of the FDA.

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

#108
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."

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

#109

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?

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

#110
post #98
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.

There's definitely more that can be done behaviorally - the solution to obesity today probably looks more like eating better than taking diet pills. But this is the anti-technological solution that can only be pushed so far, like trying to solve the energy crisis by telling everyone to drive smart cars.

Also, there's often nothing you can do behaviorally. Even people with near perfect behavior will eventually get Cancer or Alzheimer's or Heart Disease. Most of the drugs approved to treat these diseases are something like band-aids that decrease your risk 10% or allow you to live a couple months longer. Maybe too many people are making drugs that work barely well enough for the side effects to be worth it. But almost anything that can get past the FDA will work economically, since there are usually very few alternatives from the buyer's perspective.

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