I’ve heard it opined (by a doctor) that acetylsalicylic acid is an extremely powerful drug, and, had it been discovered today, it would never be cleared for over-the-counter sales.
Is this true, do you suppose, and why? Is it because of the gastric bleeding it induces? The risk of Reye’s Syndrome?
Perhaps this is far too vague a question and belongs in IMHO, on second thought.
The FDA is somewhat of a political organization. The decision to schedule drugs can have basis in everyday politics as much as science. Is the FDA of 2009 more likely to ban aspirin than 1999 or 1989 or 1979? Who knows. I really doubt this question can have a real concrete answer.
Considering how many dangerous OTC substances there are, it doesnt seem anymore risky than anything else, but then youre question suggests that anything short of vitamin C tablets would also be banned in this alternate past.
I’ve heard the same thing from some of my professors. It’s that the side effect of stomach problems is too large for the benefit of mild pain relief. There are better options out there now.
FWIW the quote that is in essence “if it were discovered today, it would be prescription only” I’ve heard applied to tobacco, alcohol, acetaminophen, ibuprofen, and even capsaicin.
Part of this comes from the recent issues with developing and approving a class of drugs called COX-2 inhibitors (Wiki has a pretty good overview if you want more detail). These were pretty much painkillers that work on the same mechanism that drugs like ibuprofen and aspirin, but were designed to be more selective and thus have fewer side effects. Early in their development, they looked to be exactly as advertised: like aspirin, but no stomach issues, and more effective. So they were approved, and the pharmaceutical companies aggressively marketed them to the elderly and other groups that would be much better off without the stomach issues.
Shortly thereafter, reports came in that these new drugs had significant cardiovascular side effects. Not something you want to have for a drug given to arthritis patients in generally poor health… which is what the marketing managed to accomplish. Big controversy ensued, which was IMO a bit of an overreaction. The FDA pulled the approval for some of the drugs, and others were pulled off the market by their manufacturers.
This whole episode in particular prompted the observation by many that aspirin could not be approved today. This is perhaps a bit of an exaggeration, but the FDA was suddenly much more conservative for the next few years. Still, it’s entirely possible that if aspirin was rolled out en mass in the same way, the sudden detection of its side effects could derail its approval.
Now, some of the COX-2 inhibitors have been re-approved after further study, but now have a long list of side effects and indications. I believe current consensus is that they do have small cardiovascular side effects, which means they’re mostly safe for most people, but shouldn’t be given to people with bad cardiovascular health.
ETA: In regards to side effects of aspirin and other NSAIDs, I wouldn’t be surprised if some of them actually carried the same cardiovascular risk of the newer COX-2 inhibitors. We just can’t see them because nobody bothers with the massive double-blind tests for over-the-counter drugs. Without such a study, it’s next to impossible to pick out small but significant side effects when so many people constantly take an OTC drug.
Hardly. Another NSAID- Naproxen- was prescription only 1976- 1994, when it was approved OTC. It has many of the same issues as asprin.
So, Aspirin would likely be approved OTC after 20 years or so of use, which it certainly has had.
Yeah, and I’d heard it applied to cane sugar, comparing it’s deleterious health effects, to other non-nutritive sweeteners. IMHO (which is where this thread may end up) talk like that is just random criticism of the FDA approval process, and not a useful way to discuss the risks.
I have heard the same statement for 30 years. Aspirin is an amazing drug and certainly would be a fantastic advance if it were invented today. As to whether it would be regulated by the FDA I suspect it would, but we will never know.