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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

#81

Post by sfRattan »

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 reimbursement eventually, and the price was eminently reasonable anyway: something like 70-ish Euro. But drug prices in the United States are another can of worms entirely...

I recall the incident well because the computer the doctor used to enter information in the late 2000s was a Commodore 64 with that distinctive lighter band around the display edge.

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

#83

Post by chiefalchemist »

amyjess wrote: post #66
Alex3917 wrote: post #47

Earlier quoted context omitted.

> 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.

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…

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' blood/piss tested positive for drugs they had no script for. Lol

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

#84

Post by chiefalchemist »

orblivion wrote: post #38
noir_lord wrote: post #7

A more interesting question would be how many would have a significant safety issue without FDA approval. Given the complexity of the drugs, the body and the interaction with other medication I'm impressed it's only 1 in 3 particulary since as mentioned down thread only 1.3% get taken off the market (1 in 77).

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.

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

#85

Post by rayiner »

conanbatt wrote: post #31
noir_lord wrote: post #7

A more interesting question would be how many would have a significant safety issue without FDA approval. Given the complexity of the drugs, the body and the interaction with other medication I'm impressed it's only 1 in 3 particulary since as mentioned down thread only 1.3% get taken off the market (1 in 77).

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.

There are two sides to that. People die because they can't get effective medicines that are kept out of the market by FDA approval. People would also die if they took ineffective drugs instead of effective ones because the FDA was too lax about letting things into the market.

It's really hard to tell what works and what doesn't. Drug companies spend tens or hundreds of millions on a drug even before it gets to FDA testing, and most still fail final clinical trials. Most drugs just don't do what the developers think they will do.

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

#86

Post by mveety »

chiefalchemist wrote: post #83
amyjess wrote: 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…

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.

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

#87

Post by EGreg »

theseatoms wrote: post #60
dzdt wrote: 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?

You likely lose your job and your healthcare insurance, at least after some period of time, I'm assuming. (Fortunately I can't speak from experience.) So you did not, in fact, have insurance against a very bad situation. All the more reason to eliminate employer-based health insurance tax incentives. I don't buy anything else through my employer. Why should I be insuring against my future medical bills through them?…

Single Payer. Medicare for all.

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

#88

Post by rayiner »

cc439 wrote: post #77
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.

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

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

#89

Post by openasocket »

dzdt wrote: post #50
theseatoms wrote: post #23

Earlier quoted context omitted.

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

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 qualify for disability it can go for 29 months. And you do have to pay the full price for the plan because your employer is no longer providing it for you, though you may get government assistance.

Also relevant is the Family and Medical Leave Act. Also, if you're unable to do your job due to a medical issue you may qualify for https://en.wikipedia.org/wiki/Social_Security_Disability_Ins... , along with Medicare. And there's regular disability insurance: https://en.wikipedia.org/wiki/Disability_insurance

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

#90

Post by DougWebb »

theseatoms wrote: post #23
fictioncircle wrote: post #20

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.

Therein lies the difference of opinion between the Democratic and Republican points of view on US healthcare. Democrats want a system where insurance companies have to cover everyone regardless of their health, and (most) Republicans want (or have voted for) a system where the unhealthy are off in one pool with insurance they can't afford, while the healthy are in another pool with insurance that's cheap but doesn't cover any actual healthcare.
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