That's sort of a different situation. Thalidomide did what it was supposed to, but ended up having horrible unknown (at the time) side effects. The FDA correctly didn't approve it based on the lack of safety data.
Opiates also do what they're supposed to, but the fact that they're addictive wasn't a mystery. They're safe if taken and prescribed as instructed. The failure is more on the DEA and other enforcement bodies for not dealing with the obvious prescription abuse. The FDA doesn't make controlled substance decisions.
There's lots of controversy about opiates being excessively addictive even when used 'on label'. I didn't find it with a bit of searching, but I remember an article about the 'extended release' aspect of Oxycontin tending to encourage addictive use patterns (because it didn't really work for 6 hours).
Figuring that out wouldn't necessarily be an up front trial kind of thing though.
A while ago I posed a similar question and the answers/downvotes made it clear to me why; Americans have a broken model of pain management. Americans think that opiates are necessary to manage the pain from most surgeries, back pain, headaches etc., so, they get opiates to do that, with the obvious and foreseeable catastrophic consequences.
A friend of mine was very briefly hooked. He had pretty serious leg surgery after an accident at an air force base, and the Veterans Affairs doctor basically wrote him out a prescription for a massive quantity of pills with the instructions to take as needed.
So, naturally, he sat around with nothing to do during recovery but to play video games, drink beer and pop pills.
Pain management is definitely not taken seriously enough by some doctors, and too many people are too trusting that their overworked doctors and nurses know better.
Both myself and my wife also have chronic pain from past injuries (back pain mostly, plus some arthritis for me) but we manage with stretching, liberal amounts of tiger balm, and the occasional ibuprofin.
I had relatively routine surgery last year that affected my kidneys. It took a few days to recover, and after a few days I wasn't getting any better so they sent me to the ER. I had Percocet that they prescribed me after the surgery, but the ER doctor wrote me a prescription for straight oxycodone because he was concerned that the acetaminophen in Percocet is sufficiently damaging to the kidneys that I really shouldn't be taking them.
I have to be honest, I was really hesitant to fill that prescription. I did after a few hours when the pain got unbearable (at 1 in the morning, they filled it in 5 minutes which also makes me worried that pharmacy would be an easy robbery target...), and damn they did work quite well. I only needed them for 2 days, and I didn't get the sense of being high that I expected, and had no issues stopping them. I can't say I didn't wonder what would have happened if I needed them for a week or more, or if I had previously been addicted to opiates.
It just seems hard to believe in modern times there's nothing in between NSAIDs/Tylenol and full on opioids for managing pain, especially for this sort of post-op temporary use case.
No kidding. Years ago I had a collapsed lung and surgery to repair it, and they sent me home with some kind of opioid. I took one and felt great for about a half an hour. Then the room started spinning and I spent about 4 hours trying not to puke, which would have been really painful with a bunch of stitches in the side of my abdomen. Once that passed, I threw the rest of those things away and just took some tylenol and tried to just move carefully to avoid pain.
This highlights something I think more people should do: be as careful as possible while healing, and accept the fact of enduring some amount of pain. Sure, there are people with chronic pain problems, and extreme acute pain that probably calls for the big guns, but the fact that you were able to deal with it using tylenol and some self-care is IMO a good thing.
A bunch of years ago I broke two ribs, and decided not to go see a doctor, after a doctor friend told me they wouldn't be able to do anything about it, aside from prescribing pain medication and telling me to try not to move much (with the caveat that if at any point I started to have trouble breathing, I must call 911 and get myself to the ER). It wasn't a particularly fun 6-8 weeks of healing, and I took the max recommended dose of OTC ibuprofen many of the days, but I got through it. Would it have been nicer to have zero pain? Sure. But I don't think the addiction risks of something like an opiate would have been worth it, and the healing process serves as a reminder to me to take better care of my body.
(Just to be clear, because I'm sure someone will put words in my mouth otherwise: no, I don't think this "grin and bear it" method works for all situations! When it's possible and reasonable to get by with minimal pain medication, I think people are better off. But I think many people -- aided and abetted by overzealous prescription-writing by some doctors -- go too far in trying to remove all pain, to their detriment.)
This is my same reaction to opiates. After telling my doctors I didn't want anything opiate-related for anything. I had a year and a half of really bad colds and strep that was probably at-that-point undiagnosed asthma, and the docs kept giving me codeine syrup. After getting ignored for so long, I switched to telling them I'm allergic to opiates. Now it's in my records and now it doesn't come up anymore.
Ibuprofen was already a huge step up from Paracematol, which is another step up from Aspirin. The fact that ibuprofen is also much better tolerated, has fewer side effects, and has to be dosed less often means you're taking the best non-opioid painkiller we know of as your first-line option.
Well, lucky for you, both (in fact, all three) are still available. But, as a statistical matter, Ibuprofen is safer. Not only because the liver is such a contentious point for drug elimination, including alcohol, but due to the ability to fix overdoses. Even with minor overdoses (such as mixing with alcohol), paracematol causes permanent liver damage, whereas stomach ulcers can be repaired. More than 100,000 people die annually from Paracematol overdoses. Ibuprofen is sold more, and has fewer than 16,000 deaths.
Kidneys cannot be repaired. You'll need hemodialysis if you overdose on ibuprofen. I don't know the state of the research on the topic, but I expect locations offering OTC NSAIDs to have issues with acute and chronic kidney injury that goes pretty much unnoticed. Especially in populations with high diabetes prevalence. One of the reasons for higher paracetamol mortality is because people commit suicide using it (especially common among teenagers).
"More than 100,000 people die annually from Paracetamol overdoses."
The fact is we seem to be damned if we do or damned if we don't. We desperately need a reasonably effective and safe painkiller. If 100,000 actually die from paracetamol per year then there's a reasonable excuse for banning it. But what do we replace it with given that many cannot take NSAIDs for various reasons?
- Pharmacists and doctors repeatedly say paracetamol/acetaminophen is very safe if taken according to directions, the trouble is, that in excess, it shuts the liver down and it cannot recover/clear the drug in time before real trouble sets in. Moreover, it's not very effective as a painkiller.
- NSAIDs, ibuprofen and aspirin, cause bleeding of the stomach and other major issues, even hearing loss in high doses.
- The newer COX-2 selective NSAID Rofecoxib, aka Vioxx, was very effective at certain forms of pain relief but was banned by the FDA after it was found to cause cardiac effects in susceptible people including heard attacks. (Another criticism I have of the FDA is the inordinate length of time it took for the FDA to remove Vioxx from the market after its cardiac effects became known—this was around three years. (I recall reading a paper in the AAAS journal Science that outlined Vioxx's cardiac effects and thinking to myself that the drug would have to be banned. That was some three years before the FDA actually banned it).
- Celecoxib, also a newer COX-2 selective NSAID that is in the same class as Vioxx, hasn’t yet been banned but it still has the potential to cause cardiac effects. Moreover, it is not as effective a painkiller as Vioxx was.
- Then there's the dangerously addictive opioids.
- Once we had another rather effective painkiller but it too has been long banned. APC was a mixture of aspirin, phenacetin and caffeine and it was rather effective except for the fact that it rotted one's kidneys, many instances of kidney disease were attributed to its use
Alas, there's precious little else, especially anything that's safe.
Unfortunately, my wife has very unpleasant reactions to acetaminophen / paracetamol, and I notice roughly zero reduction on pain from it. Fortunately, neither of us has stomach issues, so we stick to ibuprofen.
TBF, they should stop selling most things OTC. In the current US system that would mean massive additional costs to the consumer, but that is really a policy problem and not a medical one.
Where would you draw the line? Being unable to buy something simple like ibuprofen OTC would (as you point out) mean massive costs for people, and to what benefit? Is there really a huge problem with people overdosing on ibuprofen and suffering permanent damage or death?
And even if there is, would we really expect requiring a prescription to fix that problem? That doesn't seemed to have kept opiates from ruining people's lives.
Codeine is metabolized to morphine, so it's not really 'in-between'. Plus it's a bad painkiller due to variability in pharmacokinetics. Good practice would be to not use it anymore.
Now, there also is stuff such as tramadol (WHO ladder step 2). But it also can be abused, and is indeed sold on the streets.
"Codeine is metabolized to morphine, so it's not really 'in-between'. Plus it's a bad painkiller due to variability in pharmacokinetics."
Right, and as you say it'd be a good practice to stop using it, especially if it's OTC, which, as mentioned above, it still is in some countries.
It used to be OTC where I am but it's now only available by script. I recall decades ago taking combination codeine/paracetamol (aka acetaminophen) for headaches and the codeine definitely exacerbated them, moreover it was not very effective as a painkiller.
It turned out that whilst paracetamol wasn't very effective by itself the headaches didn't rebound as they did with the codeine mixture. All up, NSAIDs—aspirin, ibuprofen—were better even though they caused minor stomach upset.
Yup. Tried gummies and hemp cigarettes both. I thought the hemp cigs helped the back pain a bit, but not so much the joint pain. The effect was small enough that it wasn't worth the money to keep doing it. We get much more mileage out of stretching and tiger balm- especially the back patches and arthritis lotion formulations.
6 months at most, I think. CBD products are becoming trendy out here, but actual flower is much harder to come by, hence attempting the hemp cigarettes (hempettes?).
Maybe I'll try again this spring or summer when I get back into doing some light forestry, but I almost prefer to not mask the pain so I know I'm not making things worse.
There is a great Freakonomics podcast on the opiate crisis. If you want to get some food for thought about the American approach to pain management, how it is done elsewhere, and some background on the opiate crisis.
(Looks like episodes 402 and 403, from a quick search.)
Many American regulatory institutions have crumbled in the past few decades, the FAA being a particularly jarring example.
In some cases it seems like peoples' trust in those regulators may be fueled by nostalgia, but the FDA does seem like one of the few agencies that has retained some measure of independence.
Looking at what has happened in this nation's other industries and institutions, only one crippling decades-long medical crisis doesn't seem all that bad.
That's not an explanation for why the FDA has failed to address the regulatory aspects of the opioid crisis, but an argument for why we should discount or ignore that failure. At the very least – this is a non sequitur.
I disagree. Regulatory capture is a clear and present danger to the United States, and it is contributing to a breakdown in accountability across all sectors of the nation's economy and society.
So I offered it as an explanation for why the FDA could be well-respected and reasonably functional, while the United States fails to address some acute public health issues.
Things could be much worse; at least they don't turn a blind eye when huge sums of money are not involved. It's still very rare for a drug's approval to be pushed through via fraud, and there are a lot of diseases that need treating. They have a solid track record, even now.
The FAA are the ones responsible for stopping shit like the 737Max fiasco. Yes, Boeing did it, and many people there deserve to go to prison, but the FAA is supposed to be the guardrail ensuring they can't get away with it in the first place. It was an objective failure, and it has eroded the trust in them - point in case, most other aviation regulators did their own checks on the 737 Max before allowing it back to service, which usually doesn't happen ( EASA trusts FAA's ratings and vice versa).
The US opiate crisis has its roots deep in US healthcare culture and the blame lies on both sides of the doctor-patient fence. US docs used to prescribe opiates like candies, but US patients expect to feel no pain at all and are extremely aggressive legally speaking. Those two aspects go hand in hand.
Exactly, the FDA was not only completely incompetent but indirectly responsible for the deaths of thousands. It should have pounced on Purdue at the very outset.
Unlike much medical/drug research, knowledge about opioids and opioid addiction is well known.
The FDA irresponsibly failed to act on a no-brainer.
