PIKEVILLE, Ky. — STAT’s multiyear legal battle to unseal secret Purdue Pharma files in a Kentucky court has produced dozens of documents that lay bare new details about the company’s marketing strategy and the role of Dr. Richard Sackler, a member of the family that founded and controls Purdue, in making OxyContin a top-selling pain pill.
Starting in the early 1990s, the internal emails and other documents describe Purdue’s preparation for the opioid’s launch in 1996, its plans for targeting OxyContin to non-cancer patients with chronic pain, and how the company aggressively fought off threats to its blockbuster’s sales, even as the opioid epidemic took hold.
Below is a timeline of Purdue’s activities as revealed by the newly released documents (and some that were already public), and excerpts from those records. Click on the links to read the full documents.
June 15, 1993 to April 15, 1994: Purdue conducted a clinical trial in elderly patients with osteoarthritis to test the safety and efficacy of OxyContin. It enrolled 133 patients, but only 63 completed the trial. About 82% of the patients had some sort of adverse event related to the treatment. Yet Purdue concluded that the study “demonstrated that [controlled-release] Oxycodone is a safe and effective analgesic for the control of osteoarthritis-related pain.”
Dec. 29, 1994: Sales and marketing executive Michael Friedman (who would later become Purdue’s CEO) sent a memo marked “very confidential” to three members of the Sackler family, including Richard, outlining the planned marketing strategy.
“Our current MS Contin business has created ‘a franchise’ with certain physicians who routinely write prescriptions for the drug,” Friedman wrote. These family physicians, general physicians, and internists “may be the bridge that we can use to expand the use of OxyContin beyond Cancer patients to chronic non-malignant pain” — a market that he noted accounted for 68.7 million prescriptions a year.
“We do not want to position OxyContin in a way that will discourage physicians from using OxyContin for chronic non-malignant pain, especially when we have studies available that demonstrate efficacy and safety for this indication.”
March 31, 1995: In the minutes of a marketing team meeting on the impending launch of OxyContin in the U.S., Purdue staff emphasized that the drug needs to be used for a broad group of pain patients, and that the twice-daily dosing of OxyContin is its “most important benefit.”
“It was reinforced that we do not want to niche OxyContin just for cancer pain,” the minutes stated.
The team conducted focus groups and one-on-one interviews with more than 500 health professionals to gauge their attitudes about prescribing OxyContin: “Seventy six percent of those questioned would use OxyContin on opioid naive patients.”
May 6, 1996: Executives of Purdue and the Sacklers’ global drug company Mundipharma met with the pharmacology group at Geneva University Hospital in Switzerland in an effort to enlist an influential doctor in the group to conduct a study of OxyContin. A report on the meeting was shared with Richard Sackler.
It described “good cooperation” with Pierre Dayer, “a most important person in the Swiss medical area,” a development viewed as being “decisive for the future.” Although he did express interest, Dayer raised some concerns, according to the memo, including how low back pain “is not regarded a suitable indication for opioids in Europe. This indication is accompanied by a psychological factor which holds a risk for addiction if opioids are used for treatment.”
Among the subjects Dayer considered important and worthy of further investigation is “information about the abuse/addiction potential vs. other opioids because of the rapid onset of action of OxyContin.”
Sept. 3, 1996: Richard Sackler, in an email string with Purdue executives about how best to promote the successful launch of OxyContin — first-year sales goals were reached four months early — described his aggressive approach to expanding the drug’s market, including internationally. He wrote that he “wants to get an audience for our patent infringement suits so that we are feared as a tiger with claws, teeth and balls, and build some excitement with prescribers that OxyContin Tablets is the way to go.”
Oct. 23, 1996: In another email exchange with executives, Richard Sackler shows his attention to detail, in this case about whether dinner programs Purdue hosts for doctors are “cost-effective” in driving an increase in attendees’ prescribing of OxyContin.
“Physicians who attended the dinner programs or the weekend meetings wrote more than double the number of new Rxs for OxyContin compared to the control group,” Sackler noted, quoting from the minutes of an OxyContin team meeting. ”Weekend meetings had the greatest impact, increasing new prescriptions for OxyContin by a factor between 2.16 and 2.62.”
Sackler was somewhat skeptical, however: “This is very encouraging although I must allow that a proportion or a % without the associated absolute numbers is inherently meaningless. Was the number of increased Rx’s commercially significant?” he asked. “If so, what would the cost per increased Rx be assuming that the absolute difference persisted?”
Jan. 3, 1997: A Purdue sales representative begins a string of emails after hearing from pain clinic doctors about two letters from the pharmacy benefit manager Merck Medco. The PBM raised concerns about the “abuse potential” of using OxyContin and MS Contin in two chronic pain patients. The email was shared all the way up the ladder to Richard Sackler.
The doctor, the sales rep wrote, “is concerned that in the future he will receive more pressure from them to not use our products.”
A number of Purdue executives saw Merck Medco’s letters as a sign of growing concern among managed care insurance plans over the financial cost of the expanding use of OxyContin for non-cancer patients, a threat they argued Purdue needed to confront if it wanted to avoid being shut out of HMOs and to stay in business.
Jan. 11, 1997: “This is becoming a more common comment,” wrote Friedman, who was then head of sales and marketing for Purdue.
That evening, Sackler replied that there are two issues. One is the need to provide economic justification for OxyContin’s cost. “The second issue is the chronic non-malignant pain patient, and his/her right to effective opioid treatment. … We may need to start a campaign to focus attention on the untreated patient in severe pain who is mobilized and given his life back by our products. … I think that this is something that we should start this year.”
Jan. 14, 1997: Dr. Paul Goldenheim, Purdue’s medical director, refocuses the conversation on addiction, and noted that the email that started this “has little to do with pharmacoeconomics. We need to talk to Medco and others about addiction.”
Sackler replied: “Why don’t you guys plan a presentation about addiction,” adding that they should “give a convincing presentation that [controlled-release] products are less prone to addiction potential, abuse or diversion than [immediate-release] products. I think this can be done but I defer to BK and RR and other experts.”
Jan. 16, 1997: “We are swamped,” Goldenheim emailed Friedman, and proposes adding another physician to the OxyContin effort, including “the massive non-cancer pain program. We have a tiger by the tail, and I wonder if we should add more muscle. Let’s discuss over live sushi!”
April 22, 1997: Friedman tries to quell suggestions from Richard Sackler that Purdue engage in messaging that pushes back against negative perceptions by some oncologists that OxyContin has a “ceiling effect,” meaning increasing the dose beyond a certain point doesn’t make it more effective. “What materials could we pull together that would smash this critical misconception?” Sackler asked Friedman.
In response, Friedman said, “Even as we seek to increase the use of the drug in higher doses, we should be very careful. … The strength of the drug is principally a barrier in malignant [cancer] pain. We do not want to change the image in a way that will discourage non-malignant use. A barrage [of messaging] would be ill advised.”
Sackler’s response the following day: “what about rifle shots?”
June 13, 1997: Minutes from a meeting of the OxyContin team spells out in greater detail the messaging balancing act for the drug, given Purdue’s keen interest in not scaring off the non-cancer pain market, which is much larger than the cancer-patient market.
“We can show that we are as ‘effective’ as morphine, but do not want to say OxyContin is as ‘powerful’ as morphine” a marketing and sales executive said. “Words such as ‘powerful’ may make some people think the drug is dangerous and should be reserved for the more severe pain.”
Jan. 25, 1999: A memo to the prescription sales force team at Purdue shows just how aggressively the company was pushing OxyContin sales. Sales representatives are told their bonuses will be calculated in a way that makes the incentive for selling OxyContin much greater than for selling MS Contin.
“Your priority is to Sell, Sell, Sell OxyContin,” the memo said, pointing out specific pain conditions to emphasize and sell for. It concluded, “Finally, continue to highlight the advantages of OxyContin, specifically for use in the elderly.”
May 30, 1999: One way that Purdue encouraged prescriptions of OxyContin was to cultivate pain professionals and position the drug as helping to solve an “epidemic” of chronic pain in the U.S. In one email, Sackler referenced his strong relationship with pain doctors.
“It is also soo encouraging to see and experience how happy the key pain specialists are for me,” he wrote, referring to his untiring efforts to “make OxyContin a huge success.” He added, “I intend to invite the President of the Pain Society to our Gala night at the end of the kick off meeting. It is unusual to have customers at company functions. But we have such good relationship with them.”
Nov. 30, 1999: A sales representative emailed Dr. J. David Haddox, a Purdue executive, about the growing concern among physicians about news reports of the diversion and abuse of OxyContin, including people extracting the oxycodone in the tablet for “mainlining” illegally.
“While many sales people have sold controlled release opioids as having less abuse potential, the current situation has put us in an awkward situation,” the sales rep wrote. “I feel like we have a credibility issue with our product. Many physicians now think, OxyContin is obviously the street drug all the drug addicts are seeking.”
March 13, 2000: Purdue sent its sales force 50 copies each of the 1999 American Pain Society treatment guidelines to use in promoting OxyContin to physicians. That’s the same group whose president Sackler planned to invite to the gala because of their “good relationship.”
“The guidelines can be an effective tool for selling our products,” the memo said.
Aug. 3, 2001: The Kentucky OxyContin Task Force issues recommendations to eliminate illegal use of the drug. A year earlier, the report said, state officials had begun to see an uptick in problems related to OxyContin. By fall 2000, the problem had “grown to epidemic proportions” and in November 2000, federal, state, and local law enforcement joined forces to try and tackle the problem.
The report noted that “representatives from Purdue Pharma have joined the task force and have committed time and money for education on diversion aspects.”
Aug. 29, 2001: Representatives from Purdue spoke at a meeting of the Kentucky Department for Medicaid Services’ Drug Management Review Advisory Board and offered to help train health professionals on pain management.
Dr. Ruth Plant from Purdue told the board: “We know physicians and pharmacists traditionally, to this date anyway, don’t get a lot of pain management education in school. And if we can help supply third-party, nonprofessional pieces that might help with that educational process, that’s why we’re coming to you all to see if you’d like to work with us with a mailing.”
Feb. 28, 2002: An email about working with institutions that are requesting grants from Purdue, apparently to support educational programs, advised sales reps not to write grant requests on behalf of an institution. It goes on to list statements that should not be included in a grant letter. They include: “Jane Doe, sales representative promised me $5,000 in support of this program”; “We have sold more OxyContin than ever. This program will ensure that our sales will increase”; and “Purdue will definitely get ‘a bang for their buck’ if they support this program.”
Jan. 3, 2003: A Purdue position paper intended for medical directors and pharmacy directors of insurance plans argued against requiring prior authorization for OxyContin, which would restrict access to the drug.
“In our view, facilitating patient access to pain management therapies without imposing prior authorization specific to OxyContin … will serve the medical needs of the patients for whom this analgesic is appropriate therapy.” Prior authorization, it argued, “may only extend the period of suffering for patients, but also lead to greater expenses in the long term” due to additional staff time. If prior authorization is necessary, it continued, it should only be if the daily dose of OxyContin tablets exceeds 320 milligrams.
Feb. 12, 2004: A Food and Drug Administration letter responding to proposed promotional material submitted by Purdue for OxyContin cites numerous misleading or unsubstantiated marketing claims.
Among the items that the FDA takes issue with is that Purdue claims OxyContin is more effective than a hydrocodone and acetaminophen combination “when such has not been demonstrated by substantial evidence”; that it presents a case study of a truck driver taking the drug without noting that OxyContin can impair abilities needed for driving; and that it didn’t adequately explain that OxyContin isn’t for everyone. “This presentation is misleading because you fail to present important risk information that describes patient populations where OxyContin use is contraindicated,” the FDA wrote.
April 30, 2013: Documents from the Commonwealth of Kentucky’s lawsuit against Purdue show that Purdue had 78 sales representatives assigned to Kentucky alone who promoted OxyContin in some form through 2010.
July 2014: Dr. William T. Fannin, a licensed physician in Kentucky, swears an affidavit as part of Commonwealth of Kentucky v. Purdue Pharma.
Fannin stated: “I was advised by the manufacturer of Oxycontin, through its employees and marketing materials, that Oxycontin was less addictive, less prone to tolerance, and less prone to abuse than other opiates.” As a result of these representations, he added, “I prescribed Oxycontin to patients who suffered adverse health consequences.”
He further said: “It is my belief … the marketing of Oxycontin in the above-stated manner resulted in numerous health consequences to patients and other individuals in Kentucky, especially those in Eastern Kentucky.”
David Armstrong of ProPublica, who began pursuing the sealed Kentucky records while a reporter at STAT, contributed to this story.