Would the FDA even allow that? You are talking about reps deliberately advising to prescribe outside the package insert - they could be prosecuted for that if the drug was only indicated for 12- hour dosing.
And the author of this article should know that
Sorry - they could not recommend shorter dosing, because that would be out of indication.
but owners* - I think RogerStrongâs statement has itâs merits, even when itâs not totally correct for Purdue Pharma
* according to this article the Sackler family
The research showed that it wasnât lasting 12-hours and the physicians were reporting back to Purdue that it wasnât lasting 12 hours. Purdue lied, itâs sales force lied, and almost worse, the physicians acquiesced. Itâs all in the article.
Edited to add: we had a case kinda like this in Canada, part of a study on deferiprone, but with a different outcome.
Dr. Olivieri was finding that deferiprone was bad for her patients. The pharma company wanted to prevent her from revealing this information, citing the confidentiality agreement. They threatened court action. She responding by not backing down, and she did go to the court - of public opinion. She won, hands down.
Now, deferiprone is approved for use in over 50 countries, but not in Canada.
Karen Ann Quinlan and DEA Schedule 1.
Itâs approved use was 12 hours. presumably, the FDA had good data for 12 hour approval. Now, docs can prescribe a drug at any dose or use they want. But drug reps can only talk about approved use - which presumably includes a higher dose.
If the drug really didnât work efficaciously, that is the FDAâs fault for approving it. And if Purdue reps were restrained from giving the best possible advice - that is because of the FDA also, who has gone out of its way to gag sales reps.
This is NOT to say that Purdue did not do anything wrong here - just that this article was carefully worded to not even give a hint of Purdueâs side of the story.
ZZ1111
You also say that Purdue lied - I do not read that in the article.
And notice:
" The Connecticut attorney general had complained to the FDA that doctors prescribing OxyContin every eight hours, rather than the recommended 12, were unintentionally fueling black market use of the drug."
Purdue can not win here - they are damned if their drug is used every 8 hours by the Ct AG, damned by the author of this article if used 12 lower dose (not efficacious) AND 12 hour higher dose( supposedly more addictive - the opposite of the CT AGâs argument.
The authorâs article also includes this gem
âBut from the earliest clinical trials, it was clear that Oxycontin didnât work for 12 hours in most patients. Purdue massaged the numbers, lobbied the FCC, and got its drug approved as a 12-hour dose of effective pain relief. This led to hundreds of millions in advertising and direct marketing by pharma reps to doctors to prescribed Oxycontin for all manner of long-term pain relief. Billions in revenue followed.â
You canât âmassage the numbersâ to correct lack of efficacy. Lobbying the FCC has absolutely nothing to do with FDA approval. Maybe the author meant the FDA - but you canât âlobbyâ them and get an inefficacious drug approved. You have to resubmit NEW data to their exact specification - and this is done ALL THE TIME in the industry. The article makes the process sound underhanded. This is huge bias and the highest irony for an author castigating Purdue for lack of honesty and disclosure.
So whatâs worse? The Mexican drug cartels or the âlegalâ drug companies the US has?
FTA: âEven before OxyContin went on the market, clinical trials showed many patients werenât getting 12 hours of relief. Since the drugâs debut in 1996, the company has been confronted with additional evidence, including complaints from doctors, reports from its own sales reps and independent research.
The company has held fast to the claim of 12-hour relief,âŚâ
I suppose you and I have a different definition of that verb, eh.
In any case, the oxycontin epidemic[every letter links to a different articleâŚ], even if just limited to people who have had it prescribed by physicians, gives lie to Purdueâs (and other entitiesâ) claims that, used as prescribed, oxycontin was safe.
âMisbrandingâ, indeed.
Judging by this article, you are correct
Purdue, 100% owned by the Sacklers, has generated estimated sales of more than $35 billion since releasing its time-released, supposedly addiction-proof version of the painkiller oxycodone back in 1995. Its annual revenues are about $3 billion, still mostly from OxyContin. The Sacklers also own separate drug companies that sell to Asia, Latin America, Canada and Europe, together generating similar total sales as Purdueâs operation in the United States.
Do you still work for Purdue?
Perhaps someone else already pointed this out, but there is a typo in the third paragraph. Iâm sure they didnât lobby the FCC; it would have been the FDA.
No, they fired me for beating my wife. ;D
It was approved by the FDA for 12-hour dosing, right? That means they presented enough quality clinical trials to convince the FDA of its efficacy and safety.
No doubt it didnât work perfectly in some patients. That doesnât mean they lied about anything. No product works 100% of the time in 100% of patients.
Evidently, what Purdue did NOT do, was present data to the FDA for a 8 hour dosing indication => which means they are NOT allowed to promote its use with 8-hour dosing, because they have no FDA indication for its use.
If you think they SHOULD be presenting 8-hour dosing to Docs, then you are saying they SHOULD break the law. See why they are damned if they do, and damned if they donât?
Meanwhile, as I said, doctors can prescribe any med they want in any way they want. Seems to me THEY have more responsibility for their patients problems than Purdue.
Or they presented enough selected results of clinical trials to convince the FDA.
?
Quinlan took Valium (Diazepam) not Qualaudes (Methaqualone).
No justification for any investigation.
Maybe because âmany patientsâ is neither here nor there. People like you complain about hundreds of patients having serious side effects in antibotics used on millions and millions of people worldwide.
Incidentally, neither documentaries nor random webpages are scientific evidence.
Whaaat? Youâve obviously not gone through all my comments on various topics here, eh.
Well, to address that straw man:
Some would argue that corporate-funded and corporate-conducted research barely qualifies as scientific evidence. You did read the article(s), no? Besides, science doesnât only happen in in labs, and not just by people wearing lab coats.
