Faced with prescriber fears of OxyContin misuse, Purdue sales reps misleadingly played up drug’s safety, documents show

PIKEVILLE, Ky. — A year and a half after the opioid painkiller OxyContin went on the market, a Purdue Pharma sales representative documented a physician’s concern about the burgeoning drug that would come up again and again.

“Dr worried re addiction w/ Oxy,” the sales rep wrote in a memo summarizing a visit with a Kentucky physician on Aug. 12, 1997.

The representative had a ready message to deflect such concerns: “Oxy is long-acting, has fewer peaks than other oxycodone combos, less addictive value.”

More than two dozen other notes from sales agents show they delivered a similar message to doctors as OxyContin was becoming a best-seller in the late 1990s and early 2000s. “Pushed hard on no buzz, less abuse,” one from the following day said. “Seemed to hear the Oxy mesage [sic] better on no buzz potential,” another note from the following week read.

Together, the selection of memos make clear that when some prescribers raised fears of OxyContin misuse, including in the early days of its availability as the drug was gaining a foothold in the market, the sales force consistently batted those concerns away with misleading assertions that the drug would cause less euphoria and was less prone to misuse than competing opioids.

Excerpts of a handful of sales memos were read during a deposition of Dr. Richard Sackler, a onetime Purdue president and member of the family that built and controls the company, that was reported on last year by ProPublica and STAT. But the memos themselves were recently obtained by STAT following a yearslong legal battle.

The sales reps’ claims about OxyContin’s safety profile were in many cases false — assertions that in part led to the company pleading guilty in 2007 in federal court to understating the risk of addiction to OxyContin, a “controlled-release” drug designed to last longer than immediate-release opioids. The drug’s label at its launch, as approved by the Food and Drug Administration, said that “delayed absorption, as provided by OxyContin tablets, is believed to reduce the abuse liability of a drug.” But Purdue at the time did not have any studies “demonstrating that OxyContin was less addictive, less subject to abuse and diversion, or less likely to cause tolerance and withdrawal than other pain medications,” according to a statement of facts from the 2007 plea.

The sales team’s messaging was crucial to ensuring a smooth takeoff for OxyContin in its first years on the market. Another newly obtained document, Purdue’s 83-page launch plan for OxyContin, describes the 351-person sales force as “our most valuable resource.” Dated Sept. 27, 1995, it details how Purdue had prepared a full court press to blast OxyContin onto the market. The company had sweeping plans to reach hospitals, doctors, nurses, patients, distributors, pharmacy benefit managers, and pharmacists: Upon OxyContin’s approval, Purdue intended to send a fax “to every retail pharmacy in the United States” that would “list the reasons why pharmacies will profit by stocking this new product.”

The documents were gathered as part of a lawsuit by the state of Kentucky against Purdue over its marketing of OxyContin. They were sealed as part of a 2015 settlement between the state and the company, but STAT filed a motion to make them public in March 2016 — initiating a case that ultimately went to the Kentucky Supreme Court and resulted in the release of the records late last year. STAT previously reported on the contents of many of the unsealed files, but recently discovered these additional records.

The 26 sales call notes contained in the Kentucky documents, stretching from 1997 to 2001, provide in-their-own-words examples of Purdue’s selling of OxyContin that it admitted in 2007 was done “with the intent to defraud or mislead.” The 2007 court document states that sales representatives were trained to “tell health providers that OxyContin potentially creates less chance for addiction than immediate-release opioids” and that “patients who took OxyContin would not develop tolerance to the drug,” which, sales representatives told prescribers, “had less abuse potential [and] was less likely to be diverted than immediate-release opioids.”

Purdue paid $600 million in fines and penalties as part of the 2007 plea agreement. Three executives also pleaded guilty to related charges.

In a statement this week, Purdue said: “The call notes in question were written over 18 years ago and represent an exceedingly small sample compared to the millions of notes written during this period that aligned with FDA-approved materials. Even so, we deeply regret any misstatements that were made and we accepted responsibility for these actions as part of the Agreed Statement of Facts in our 2007 settlement.”

Other documents included in the Kentucky cache and previously reported on by STAT include the 2015 deposition of Sackler and emails that showed Sackler proposed Purdue executives aggressively push back against concerns about the misuse potential of OxyContin.

During the deposition, when Sackler was asked about the memos from the company’s sales representatives and their messages about OxyContin’s safety profile, he said: “They are fragments of fragments of fragments of a conversation that are designed to remind the rep of a conversation that he or she had two, three, four, five, six weeks prior. So they mean a lot, but without asking the person who wrote them what it meant, we don’t, sitting here, have any idea what it means.”

At varying points during the deposition, Sackler defended the comments made by sales representatives to minimize the euphoric qualities of OxyContin, but he also acknowledged that excerpts read to him during the questioning were “inappropriate.”

Purdue is now working to settle more than 2,000 lawsuits from states, local governments, and tribes accusing it and other companies in the opioid supply chain of overwhelming communities with opioids while misleading the public about the risks and benefits of the drugs. Members of the Sackler family are also named as defendants in some of those lawsuits, most of which have been bundled into a federal multidistrict litigation.

The family and the company have broadly denied the allegations. Purdue has filed for bankruptcy protection as it works to reach a resolution of the lawsuits.

OxyContin was meant to provide longer pain relief than other opioid medications by packing into each pill more oxycodone — a type of opioid — that would be released over 12 hours. But the drugs were able to be crushed and snorted or dissolved in liquid and injected. According to experts, Purdue’s alleged aggressive promotion of high-dose opioids in large numbers contributed to the opioid crisis by funneling more pills into communities that could be misused or diverted. Stronger doses are also associated with an increased risk of addiction and overdose.

From 1999 to 2017, more than 200,000 people in the United States died from overdoses tied to all prescription opioids, according to federal data.

In the call notes, when physicians cited specific cases of misuse, the sales representatives stressed the purported safety of OxyContin and sometimes took a blame-the-user approach.

In January 2000, one doctor during a visit from a sales rep “discussed that some of her pts may be crushing tablet to inject or snort the oxycodone.” The representative in turn told the doctor that “Oxy is less likely to be abused than Percocet or Vicodin,” which are other pain medications.

And when a different doctor in 1997 raised concerns about the potential misuse of pain medications, another sales rep “talked about Oxy less abusive potential. Helps weed out the addicts.” As for patients who were misusing OxyContin, one sales rep offered the idea of “removing abusive patients” from that prescriber’s practice.

According to the Centers for Disease Control and Prevention, “anyone who takes prescription opioids can become addicted to them.” Studies have found that from about 8% to up to 25% of pain patients on opioids become addicted.

Meanwhile, Purdue rewarded top sales representatives with trips to Bermuda and London, according to the deposition of Sackler.

Some Kentucky doctors embraced OxyContin, according to the memos. One, Dr. Harry Kennedy, “enthusiasticly [sic] told me that he would use Oxy for all pain patients,” a sales representative wrote in a 1997 memo, after noting he told Kennedy that OxyContin came with “less euphoria, less abuse, and fewer side effects.” A Walmart pharmacist, according to another sales rep’s memo, said Kennedy “is writing Oxy with both hands” and then “rolled her eyes.”

Messages left at Kennedy’s office were not returned.

The OxyContin launch plan shows how Purdue, while initially intending the drug as a treatment for cancer pain, was already looking beyond that to the much larger “chronic non-malignant pain market.” That meant reaching the clinicians most inclined to prescribe the drug. As the launch plan says, “oncology/hematology represents the primary target for promoting OxyContin. The primary care physicians, however, must also be considered a primary target, and physician-prescribing information by decile must be used to target the highest potential physicians.”

Purdue had ambitious goals for its new drug. It saw the audience for its promotional efforts as “all 1,200 cancer centers, all 1,200 major teaching institutions, all 2,500 community hospitals” with at least 100 beds.

The plan states that “one of the major strategies in launching OxyContin will be to replace all prescriptions for MS Contin,” an earlier Purdue product that was set to face generic competition. “Overall, the $462 million Class II opioid market presents an excellent opportunity for the introduction of OxyContin tablets,” the plan says.

According to the statement of facts from the 2007 plea agreement, Purdue made about $2.8 billion in revenue from OxyContin from January 1996 to the middle of 2001. Bankruptcy filings from last year show members of the Sackler family have made $12 to $13 billion from Purdue.

The large majority of launch plans for new medicines would look broadly similar to the OxyContin report, with market analyses and detailed promotional plans, said Erik Gordon of University of Michigan’s Ross School of Business, who studies the pharmaceutical industry. But in hindsight, a few points stood out to Gordon as ground for critics to use against the company. One of the objectives listed, for example, is “to increase the number of prescriptions for strong opioids by 10%.”

“If it was a new statin, it would say to increase the number of prescriptions for this class of statins by X%,” Gordon said. “But in light of the opioid crisis, I think this language could be interpreted in a way that hurts them looking backward.”

Other details from the OxyContin launch plan include:

• Purdue recognized the influence nurses had, despite not being able to prescribe drugs themselves. “They are the people who rate the patients’ pain and make a recommendation on the type of opioid and dosage for pain control,” the plan says.
• The company intended to reach patients directly. It proposed “a consumer awareness program … to educate consumers about the tragedy of needless suffering that occurs in millions of cancer patients every year.” It raised the idea of partnering with a group like the American Cancer Society for such a campaign. A spokeswoman for the society said it had no record of such a partnership ever happening.
• Purdue planned to target — and incentivize — consultant pharmacists, who would then teach providers at long-term care facilities about pain treatment. “Pricing to the consultant pharmacist should be offered at a discount off the wholesale acquisition price. This will allow them to increase their profit margin, commonly referred to as the spread, thereby encouraging them to recommend OxyContin as the drug of choice in the long-term care market.”

Andrew Joseph reported from Boston, and Shraddha Chakradhar from Pikeville.