Purdue knew this and lied to the medical community.
Unless doctors ran their own studies they couldn't know that Purdue's dosage recommendations were pure garbage.
So they mounted a campaign to convince doctors to increase dosages instead. This was apparently the more harmful of the 2 options.
Here's an article on the subject: http://www.latimes.com/projects/oxycontin-part1/
First and foremost, it illustrates that drug regulation is basically a failure, and that the FDA and physicians cannot be trusted as sole authorities on drug safety. There needs to be more diversity of authority.
You say "unless doctors ran their own studies" as if it is not the responsibility of physicians to be thinking critically about scientific information about drugs, in terms of who is providing the information and how to respond as scientists. Your statement basically assumes that doctors are not competent to evaluate and conduct scientific research. Why shouldn't doctors run their own studies? Maybe not each physician, by why don't they as a group? Why doesn't a large hospital run a trial? A conglomerate? It's not that difficult given the magnitude of the consequences involved and the frequency of prescription.
It is the job of the medical community to be proactive participants in scientific process, especially when clinical consequences are on the line. That we've reached a point where we lay the responsibility of critical evaluation at the lap of the corporation says as much about the fault of the physicians and FDA as it does about the corporations.
It's kind of like saying that an individual who knows a child is being abused but goes out of their way to transport the kid day after day to the abuser without reporting it bears no responsibility because they weren't abusing the child themselves.
Anyone involved in the healthcare system knew that oxy was an addictive substance and there were rampant problems. The idea that someone with an MD shouldn't have a clue that increasing the dose would lead to greater problems is absurd--it's like claiming that a chemical engineer shouldn't understand that adding jet fuel to a fire wouldn't increase the blaze. Acting like physicians were innocent victims is a joke.
The corporations and physicians were both complicit. Either that, or they were incompetent. It can't be neither. The FDA and physician groups need to be dethroned from their perches.
Purdue knew full well that 24 hour effectiveness was the factor that distinguished Oxy from other drugs on the market, despite the fact that their own studies showed the drug did not offer 24 hours of relief in many cases.
Upon hearing that doctors were shortening the dosage schedules, they could have left well enough alone. Doctors prescribe off label all the time. There was no need for Purdue to step in.
But that's exactly what they did. Purdue actively fought the doctors and lobbied to convince them to stick to the marketed dosage schedules because otherwise Oxy would have no perceived benefit in the marketplace over other opiods. There is documented evidence as reported by the LA Times that supports this.
This has absolutely zero to do with regulation. The only way you could convince yourself of that is if you've already got a conclusion ("big government regulations bad!") and are you simply trying to find an explanation that fits it.
If Oxycontin didn't work with a 12 hour interval, why did the FDA approve it for that? Why is it in the label if it couldn't be supported by clinical trial data? Was the FDA asleep at this switch?
“There is no Q8 dosing with OxyContin,” one sales manager told her reps, according to a memo cited in an FDA filing. She added that 8-hour dosing “needs to be nipped in the bud. NOW!!”
Is a great example of creating the narrative the LA Times wants to spin. Take a look at the documents that are in the article. The reason for the Q12h dosing is: 1) insurance companies won't pay for it [since it's not in the label], 2) some pharmacies won't fill a script for anything but Q12h dosing [because it's not in the label], 3) FDA/DEA oversight [because it's not in the label], 4) minimize diversion and abuse.
Those seem like real good reason to me!
Sinister plot? It's very simple economics: Our drug has one distinguishing factor from other drugs: 12 hour dosing. If our drug loses that distinguishing factor, no one will prescribe it.
It's a basic economic incentive.
No one is claiming Purdue wanted to addict patients. They're not that evil. They're just a massive corporation focused on making money.
If Oxycontin didn't work with a 12 hour interval, why did the FDA approve it for that? Why is it in the label if it couldn't be supported by clinical trial data? Was the FDA asleep at this switch?
Three obvious explanations immediately spring to mind: Fraud, incompetence, and/or corruption.
It's not as though the FDA hasn't approved many drugs over the years with dubious efficacy.
1) insurance companies won't pay for it [since it's not in the label], 2) some pharmacies won't fill a script for anything but Q12h dosing [because it's not in the label], 3) FDA/DEA oversight [because it's not in the label], 4) minimize diversion and abuse.
The first three are problems for doctors doing the prescribing, not Purdue. None of those explain Purdue's actions, save that it might reduce the number of pills sold... which is exactly what I'm claiming is their motivation for pushing their dosage schedule.
The fourth is literally the problem caused by the dosing schedule pushed by Purdue... so you'll forgive me if I struggle to believe they were especially concerned about addiction or abuse.
The first three are problems for doctors doing the prescribing, not Purdue.
I used to work in biotech, those three problems are exactly what pharma companies spend their time trying to solve. Writing a script is just the first step in the process. Insurance needs to agree to pay for it, pharmacies need to fill it and you don't want the FDA/DEA closing you down.
I have to say, the doctors have some plausible deniability. When the drug company tells you how to prescribe, there are good reasons to listen. Pharmokinetics is heinously complex and unpredictable. Unfortunately in this case the drug manufacturer outright lied.
I do feel like doctors should have questioned the notion that these drugs were completely safe.
But who else do we trust? These drugs have the government's approval (FDA) as being safe, and a very large cooperation who makes the drug says it's safe. Did I mention the FDA approved it? What's the alternative here? I know my family doctor can't just run his own studies with drugs, he'd never have the resources for that.
I only took them for less then 3 days - even that was longer then needed (not that I knew this, you don't know how painful the results of the surgery are until you stop the painkiller, which could cause incredible pain you are in pain (physically).
Let's say the doctor doesn't have many client complaints, reads journals and memos that promote opiates (this is called advertising, something J&J spent 3x more money on then research), it seems like there should be an independent organization that researches, tests (or validates studies), and validates the results and usage instructions. Oh wait that's the FDA job.
I want to emphasize my criticism of the FDA's current performance of what I believe their job is: to make sure that the drugs sold do what they say they do, don't cause serious side effects unless they are clearly listed, have dosages that do as they are supposed to (without purposely causing addiction).
They seem to be not addictive if used to treat short term pain for a few days. They seem to be strongly addictive, and ineffective to treat pain, if used for longer.
If we accept your point; which I do; why the fuck didnt the doctors catch on for 10 years w/ similar generics.