I suggest you go do a little research about what Purdue did before commenting further. Other commenters have already provided links to the LA Times investigation. Read it.
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.
I've read the LA Times article. It's full of misleading information and sensationalism. I'm not saying Purdue acted like an angel, but their actions are twisted into a sinister plot.
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.
I'm not saying Purdue acted like an angel, but their actions are twisted into a sinister plot.
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.
We'll just have to agree to disagree, but one last point:
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.
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.