I didn’t wanna hijack this messy thread, but it’s something I wondered about. I’m not asking for specific proofs of their effectiveness, so much as the process itself. Let’s say for the US/FDA, just to make it easier.
So…100 people take a sugar pill, 100 take a Triflixatrab: extra strength. Counting how many people in each group say they feel better, and measuring the surplus in group number two. Something vaguely similar to that?
In order to “prove” that something is an effective painkiller, does a product such as Tylenol or Advil or Aspirin have to show the process by which it prevents pain? I would assume simple qualitative analysis of the patient is insufficient, if for no other reason than because the medicine must be analyzed to ensure its contents aren’t toxic or what have you.
Furthermore, do these products need to be re-tested periodically with new procedures to ensure that they are still safe and effective?
It’s a long question, I know, but I really would like to know what process has been used to scrutinize drugs moreso than, say, acupuncture.
I can’t answer any of your questions specifically for painkillers, but I have participated in a drug study for a drug called Mirapex. It was already on the market as a Parkinson’s Disease drug and was being studied for additional labeling for treatment of Restless Leg Syndrome. In the trial I participated in - after reading mountains of paperwork and getting a complete physical(with bloodwork) - I was given tablets to take at bedtime. Not even the doctor conducting the local study knew if I received the drug or the placebo. I was required to come in for bloodwork at regular intervals and fill out questionaires concerning the effectiveness of the drug - did it relieve the symptoms? Completely, partly, slightly? Did I notice any other effects? If I remember correctly, it was a 3 - month study.
I knew the first night I hadn’t received the placebo.
As for showing “how” the drug relieves the symptoms, I’m not sure that is possible with Restless Leg - because they don’t know what causes it.
Again, I know this was not strictly on topic but I hope it was even slightly helpful.
Most of the OTC painkillers (and also lots of prescription drugs of all classes) have this wonderful phrase in my drug book: Action Unknown.
Yes, even Tylenol. We just don’t know how it works. We have some theories about how maybe it works, but we really don’t know. It may inhibit prostanglandin production.
Let me look up Advil…yep, Action Unknown. (We think maybe it inhibits prostaglandin production, too.)
Aspirin… As a painkiller: inhibits prostaglandin production. As a fever reducer: Action Unknown
Makes me want to point and laugh at people who claim acupuncture cannot work because no one can explain how it works. It may or may not work, true, but ignorance of the mechanism of action is no reason to conclude something doesn’t work.
I think the best place for you to start is the wiki on clinical trials, which is the process all drugs must go through to gain approval and reach the market.
In the case of painkillers and other “subjective” medications, double-blind studies attempt to eliminate the placebo effect and a form of grading criteria is established to try and get trial subjects to all be responding to the same scale/criteria. In some cases, there might also be objective measurements, such as reduction of inflammation or related factors in blood tests, so that gets considered too.
Long-term data based on actual patient use does get periodically reviewed and evaluated; that’s how you end up with cases where it’s only after some extended use that risks of certain side effects occur (for example).
And Aspirin has been around in it’s present form since the 1800’s (but is similar to and derived from a drug known by the Ancient Greeks), when regulation of drugs was much much looser, and I believe quite a number of drugs were “grandfathered” when governments started clamping down.
I’ve spoken to several pharmacists and physicians who share the opinion that, were it developed today, aspirin would be prescription only, and used primarily as a cardiac drug, not a pain killer or fever reducer.
Wikipedia has a page on the history of aspirin. The oldest documentation it mentions is, “the Ebers Papyrus, an Egyptian medical text from ca. 1543 BC, likely a copy of a text from around the time of the Ur tablet.” It has a reference to a book to support that claim.
A friend of mine participated in a clinical trial for a painkiller while he was in college. He kinda paid for college by participating in drug trials and selling his plasma (not it that order).
Process was take drug, wait X minutes, put your hand in a bucket of ice and see how long you can stand it. Come back another day, take placebo (you aren’t told it’s a placebo) and repeat ice process.
