Purdue Pharma justifies pushing Oxycontin by citing FDA rules it helped write
Jamie SatterfieldPurdue Pharma has one message for states such as Tennessee complaining that their top-selling drug – Oxycontin – is killing thousands of people every year: Talk to the FDA.
Newly unsealed records show the FDA listened to operatives secretly paid by Purdue Pharma and its fellow opioid makers when the agency refused to put limits on how much Oxycontin could be prescribed and for how long.
Purdue: We're FDA approved
Tennessee’s attorney general is suing Purdue Pharma on behalf of taxpayers in Knox County Circuit Court for the deadly opioid epidemic plaguing the state and the nation. USA TODAY NETWORK-Tennessee and the Tennessee Coalition for Open Government sued to make that lawsuit public.
More:Coverage of the Purdue Pharma case
It contains internal records from the Oxycontin maker that had been kept under wraps – despite a plethora of similar lawsuits. The complaint was unsealed last week.
Purdue told USA TODAY NETWORK-Tennessee via a spokesman last week the firm would be filing a response to Tennessee Attorney General Herbert H. Slatery III’s lawsuit. In the meantime, Purdue pointed to its stock response, using its latest answer to a lawsuit in Alaska as an example of its expected defense in the Tennessee case.
In it, Purdue says the Physicians for Responsible Opioid Prescribing tried to get the FDA to regulate Oxycontin in 2012 but failed. Purdue is simply following FDA guidelines in how it markets the deadly opioid.
“FDA rejected these proposed restrictions,” the document stated. “Despite FDA’s conclusion that opioid medications should continue to be available for the treatment of chronic pain, the state brings this lawsuit.”
Records reveal secret ties
But Purdue’s own records – turned over to the Tennessee attorney general under seal in 2015 – show the family-owned firm was paying doctors to downplay the addictive properties of Oxycontin and funding advocacy groups, including the American Pain Society.
More:Purdue Pharma pushed opioids as 'hope in a bottle,' records show
The FDA three years earlier had relied on the American Pain Society and a half-dozen others now linked to Big Pharma in deciding whether to place tighter controls on the prescribing of Oxycontin.
The FDA credited the interest groups' claimed expertise over that of doctors in refusing to limit how much Oxycontin could be prescribed daily and for how long, according to the FDA’s own summary of its decision.
The FDA also gave its approval to the use of prescribing “guidelines” drafted by the Purdue-funded American Pain Society.
The FDA rejected nearly every proposal the physicians’ group sought to curb the opioid epidemic. The FDA cited the work of the American Pain Society and other groups now tied to Purdue and other opioid makers as sources in footnotes included in its decision.
Doctors vs advocacy groups
The physicians' group in 2012 asked the FDA to essentially ban the use of Oxycontin for “moderate” pain sufferers.
The group asked the FDA to limit the drug's approved uses to cancer patients and those non-cancer patients experiencing “severe” and “acute” pain – such as car crash victims and surgery patients.
The group argued Oxycontin is too powerful, too dangerous and too addictive to safely treat conditions such as chronic back and neck pain. It noted pill mills – clinics that swap cash for opioid prescriptions – thrive on claims of chronic pain that can’t be easily diagnosed.
Pill-mill doctors:Records show Purdue Pharma pushed pill-mill doctors to shell out OxyContin, hid evidence
The group asked the FDA to limit the daily dosage of an extended-release opioid such as Oxycontin for non-cancer patients and to limit the supply of those opioids for non-cancer patients to a maximum of 90 days.
The recommendations – if approved – could have cost Purdue Pharma millions. Its internal records show the firm made most of its profits from pushing high-dose Oxycontin to repeat customers, so much so that its sales staff targeted pill mills to win bonuses.
FDA: Word change will do
The FDA, citing to the American Pain Society among other groups, concluded there simply wasn’t enough proof that Oxycontin and similar opioids were especially dangerous for chronic pain suffers.
The FDA used phrasing in its decision about a non-cancer patient’s “quality of life” – language Purdue’s internal records show was part of the Oxycontin makers own marketing campaign.
Instead of a limit on dosage, the FDA ordered a change in the wording on the box Purdue uses to package Oxycontin for shipment to prescribers – dropping “moderate” from the language.
It now reads, "(Oxycontin) is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”
The agency also ordered studies on whether Oxycontin and other high-dose, extended-release opioids are indeed too dangerous for non-cancer patients. The FDA put Purdue and other “sponsoring” opioid makers in charge of those studies.
“More data are also needed on the point at which the risks of opioid use at escalating doses and longer durations of treatment may outweigh the benefits of opioid analgesic therapy,” the summary stated.
The FDA in 2013 allowed Purdue to market via labeling a “reformulation” of Oxycontin the drug maker claimed made it tougher for addicts of its drug to “abuse” by inhaling because the outer shell couldn’t be crushed or chewed open – even though the FDA itself noted the most common form of abuse of Oxycontin is simply popping the entire pill – outer shell and all – into the mouth.
Purdue: We spent billions
Purdue is now using that FDA approval to defend itself in lawsuits. The Alaska response provided by Purdue to USA TODAY NETWORK-Tennessee makes that clear.
“Purdue has helped reduce the misuse of and overdose deaths from prescription opioid medications,” the Purdue response stated.
The firm contends it spent “nearly a billion dollars” to make a form of Oxycontin “designed to make crushing and injection much more difficult.”
Tennessee’s lawsuit alleges Purdue records show the firm’s sales staff lied to medical providers, claiming the reformulated Oxycontin was nearly “abuse” proof.
“In sales calls with Tennessee health care providers, Purdue misrepresented the extent of the abuse-deterrent properties of its opioids that went beyond a limited acknowledgement (approved by the FDA),” the lawsuit stated.
Purdue: Drug addicts to blame
Purdue contends in its Alaska response that taxpayers need to stop blaming Big Pharma for the opioid epidemic and instead blame the users of their drugs.
“The state contends that (it) is faced with an opioid abuse and overdose problem,” the response stated. “Yet the problem is driven largely by the unlawful use of illegal drugs, such as heroin and illicit fentanyl.
“While the abuse of unlawfully obtained prescription medications is a public health concern, the epidemic surge in overdose deaths due to opioids is not being driven by FDA-approved prescription opioids that are properly prescribed by physicians and used by patients.”