‘Sell Baby Sell!’

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A dozen years ago, the federal government came down hard on Purdue Pharma, fining the drugmaker and three of its executives a record $634 million for misbranding its blockbuster OxyContin pill as safer and less addictive than other painkillers.

In the decade leading up to the 2007 fine, Purdue helped change the culture of prescribing opioids through an extensive marketing campaign that persuaded the medical community that addiction was rare and patients were suffering needlessly, according to recently unsealed corporate documents and plaintiffs attorneys suing two dozen drug companies in a landmark federal case in Cleveland.

The attorneys argue that other drug manufacturers continued the aggressive marketing even after the Purdue fine, leading to a surge in opioid overdoses. The number of pills made with oxycodone — the main ingredient in OxyContin — rose from 2.5 billion in 2006 to 4.5 billion in 2012, a 55 percent increase.

“Purdue created a market for the use of opioids for a range of common aches and pains by misrepresenting the risks and benefits of its opioids, but it was far from alone,” lawyers for the nearly 2,500 cities, counties and Native American tribes suing the drug companies alleged in the Cleveland case. Subsequently, other drug manufacturers “positioned themselves to take advantage of the opportunity Purdue created, developing both branded and generic opioids to compete with OxyContin, while, together with Purdue and each other, misrepresenting the safety and efficacy of their products.”

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New details about the marketing campaigns are revealed in the corporate documents and internal emails unsealed in the Cleveland case after a year-long legal fight by The Washington Post and the owner of the Gazette-Mail in Charleston, W.Va.

Drug manufacturers paid doctors and movie stars to promote more aggressive pain treatment. The companies also created campaigns for their sales forces, tying bonuses to opioid sales and holding contests to reward top earners.

As the marketing campaigns unfolded, representatives from industry-funded groups that advocate for pain patients fanned out across the country to speak on TV shows, at conferences and dinners and to doctors at continuing medical education seminars, the court documents show. The groups included the American Pain Foundation and the American Pain Society, which have since gone out of business.

Drug manufacturers have rejected the plaintiffs’ arguments. They said that their sales and marketing teams did not misrepresent the safety of opioids.

A spokesman for Johnson & Johnson, and its opioid-manufacturing subsidiary Janssen, said in a statement to The Post that its products had been approved by the Food and Drug Administration and that its sales representatives were properly trained.

Representatives from industry-funded groups that advocate for pain patients fanned out across the country to speak on TV shows, at conferences and dinners and to doctors.

“Janssen did what a responsible pharmaceutical company should do with medicines that play an important role in the lives of patients with severe pain,” the company said. “Janssen provided extensive compliance training for its salesforce so they could educate doctors based on the FDA-approved labels for its medications.”

In August, a judge in a lawsuit in Oklahoma ruled that Johnson & Johnson and its subsidiary Janssen had engaged in “false, misleading, and dangerous marketing campaigns” and caused “exponentially increasing rates of addiction, overdose deaths” and opioid-addicted babies.

Johnson & Johnson also provided incentives for its sales force. The company produced a PowerPoint presentation that promised prizes for those who sold the highest amounts of Nucynta, an extended-release opioid. The prizes included a Caribbean cruise, “His and Hers” Tourneau watches and a Sony home theater system.

In its statement, Johnson & Johnson said, “In the Oklahoma trial, the State did not produce a single doctor who testified that they were misled by a Janssen marketing communication.”

Oklahoma Judge Thad Balkman ultimately ordered Johnson & Johnson to pay $465 million to abate one year’s worth of damage done by opioids in the state. The company is appealing.

The first case in the Ohio lawsuit, involving Summit and Cuyahoga counties, was recently settled for more than $325 million by multiple drug companies, including McKesson Corp., Cardinal Health, AmerisourceBergen, Johnson & Johnson, Mallinckrodt and Teva Pharmaceutical Industries. The remaining 2,500 cases, as well as lawsuits filed by most of the state attorneys general, are still pending.

In the Ohio case, the newly unsealed documents delve deep into the marketing strategies of the manufacturers.

In 2012, Endo Pharmaceuticals stated on its website for its opioid Opana, a formulation of morphine, that “most healthcare providers who treat patients with pain agree that patients treated with prolonged opioid medicines usually do not become addicted,” according to the court documents.

The extended-release version of Opana was pulled from the market in 2017 because “the benefits of the drug may no longer outweigh its risks,” the FDA said at the time.

Endo declined to comment, citing the ongoing litigation.

At Mallinckrodt, the largest manufacturer of oxycodone, the sales team had a mantra. “You only have 1 responsibility,” a senior sales manager wrote in a 2013 email now part of the Cleveland court file. “SELL BABY SELL!”

Mallinckrodt declined to comment, citing the ongoing litigation.

Independent of the court cases, The Post obtained copies of internal company training videos that show the lengths companies went to motivate employees to sell more pain pills. One 2008 video is a spoof of the TV show “The Office,” replete with a Dwight Schrute-like character running in a frenzy from cubicle to cubicle, pledging to sell more Kadian, a morphine capsule.

“I’ve gotta be a lean, mean selling machine to sell Kadian to all kinds of doctors,” the character said. The company that produced Kadian, AlPharma, paid a $42 million fine to the Justice Department in 2010 to resolve allegations related to the marketing of Kadian. AlPharma was acquired by King Pharmaceuticals, which was later acquired by Pfizer. A Pfizer spokeswoman declined to comment, saying the company was not involved in the AlPharma video.

In 2006, Cephalon introduced a new fentanyl tablet called Fentora to its sales force during a corporate stage show that included fireworks and the U2 song “Beautiful Day” playing in the background. “The first and only” tablet, the announcer said, that “utilizes effervescence to improve the rate and extent of fentanyl absorption.”

Teva purchased Cephalon in 2011. A Teva spokeswoman said the company was not involved in the video or Cephalon’s marketing strategies.

In addition to describing internal company efforts, the Cleveland documents also highlight the industry’s external marketing targeted at doctors.

Former FDA commissioner David A. Kessler, a paid expert for the plaintiffs, said in a recently unsealed deposition in the Cleveland case that this “highly sophisticated” and overwhelming marketing of opioids “changed American medicine.”

The efforts “range from regional advisory boards to the speaker’s bureaus, to the e-marketing to doctors, to the alternative channels, to the advocacy groups, to the unbranded publication plans,” Kessler said, referring to materials that did not disclose they were funded by drug companies.

Kessler said that the paid appearances on television and at conferences usually featured the highest-prescribing doctors and were meant to transform the public perception of opioids and encourage other doctors to prescribe them more freely.

Paul T. Farrell Jr., a co-lead plaintiff’s lawyer in the Cleveland case, said the federal government was not policing the interactions between the drug manufacturers’ sales teams and doctors.

“Neither the FDA nor the [Drug Enforcement Administration] had the ability to go inside the doctor’s offices when the sales reps were pushing their pills,” Farrell said. “The companies weren’t on television running commercials. It was more insidious. They were normalizing the use of opium to treat pain. And they were very effective at it. And it just so happens that the more effective they became in convincing doctors to prescribe more opium, the more money they made.”

‘Less than one percent’

Privately owned Purdue was founded in 1892, and purchased by the Sackler family in the 1950s. Arthur M. Sackler pioneered aggressive marketing techniques that the company would later incorporate in splashy ads in medical journals and literature targeting doctors.

Sackler died in 1987, nearly 10 years before the introduction of OxyContin and his share of the company was sold to his brothers.

Purdue introduced OxyContin in 1996 and began promoting it as a wonder drug for all kinds of pain — a powerful, extended-release version of oxycodone. But the company had to overcome a major stigma: Most doctors were loath to prescribe opioids, fearing their patients could become addicts. Doctors had been taught for decades that opioids should be reserved for severe pain, for cancer or surgery patients, and not for back pain, headaches or osteoarthritis.

Purdue worked hard to change the perception about the treatment of pain.

In 2001, the Joint Commission on Accreditation of Healthcare Organizations, a nonprofit that evaluates hospitals, urged the medical community to consider pain as the “Fifth Vital Sign.” Health care providers were encouraged to ask their patients to rank their pain from 1 to 10 and not worry about treating them with opioids.

Among those who promoted the wider use of opioids for pain were Russell Portenoy, then an anesthesiologist at Memorial Sloan Kettering in New York City, and major health associations such as the American Academy of Pain Medicine and the American Pain Society. All of them received funding from opioid manufacturers, according to the court documents.

“AAPM has always advocated that opioids are only one of many pain treatments available and that they should be prescribed in a responsible manner as part of a patient’s individualized treatment plan,” the president of the American Academy of Pain Medicine, Tim Lamer, said in a statement to The Post.

The plaintiffs attorneys in Cleveland, using internal company studies, marketing materials and emails, are presenting their own account of the evolution of pain treatment in the United States.

The plaintiffs single out the conclusion of a one-paragraph letter to the editor of the New England Journal of Medicine in 1980 that Purdue and later other companies relied on in their marketing. The letter was written by Hershel Jick, a doctor and drug specialist at Boston University School of Medicine, and Jane Porter, his assistant. They analyzed hospital patients who were provided opioids. Their finding was summed up in the headline that accompanied their letter: “ADDICTION RARE IN PATIENTS TREATED WITH NARCOTICS.” They found only four cases of addiction out of 11,882 patients.

Purdue repeatedly cited the finding in its marketing and “educational” material about OxyContin, including a 1998 promotional video, “I Got My Life Back,” in which a doctor says, “In fact, the rate of addiction amongst pain patients who are treated by doctors is much less than one percent.” The video was sent to 15,000 doctors that year, according to a 2003 Government Accountability Office report.

Jick would later say publicly that the data was contained in a letter because it was not strong enough to be included in a study.

“Only years and years later, that letter was used to advertise by new companies that were pushing out new pain drugs,” Jick told NPR in 2017. “I was sort of amazed. None of the companies came to me to talk to me about the letter, or the use as an ad.”

Jick said the assertion that pain pills had a vanishingly small risk of addiction was “not in any shape or form what we suggested in our letter.”

The one percent statistic spread quickly — on national television, in promotional videos and in pain literature. But the National Institute on Drug Abuse found that at least 8 to 12 percent of patients prescribed opioids experience problems with addiction.

Between 1996 and 2002, Purdue funded more than 20,000 pain-related education programs and encouraged long-term use of opioids for chronic non-cancer pain, plaintiffs attorneys allege in court documents. The Justice Department’s inspector general stated in a recent report that OxyContin prescriptions for non-cancer related pain increased from about 670,000 in 1997 to about 6.2 million in 2002.

By 2001, communities in southern Virginia and eastern Kentucky were starting to see growing addiction and mounting deaths.

By 2001, communities in southern Virginia and eastern Kentucky were starting to see growing addiction and mounting deaths.

“These pills, I mean, they’re killing our people in our county and our communities,” Maj. Jimmy Woodard of the Lee County Sheriff’s Office in Virginia told “CBS Evening News” that year. “It’s worse than any disease that I can think of, cancer, AIDS. I mean, it’s just like an epidemic.”

In May 2007, in federal court in Virginia, Purdue and three executives, including the company’s president and top lawyer, were fined $634 million for misleading the public about OxyContin’s risk of addiction and claiming the opioid was less subject to abuse than other pain medications.

“We accept responsibility for those past misstatements and regret that they were made,” Purdue said in a statement at the time.

The three executives also received misdemeanor convictions.

“The genesis of OxyContin was not the result of good science or laboratory experiment,” then-U.S. Attorney John Brownlee said in a statement announcing the fine and the guilty pleas. “OxyContin was the child of marketeers and bottom line financial decision making.”

Ten years later, on June 1, 2017, another letter was published in the New England Journal of Medicine as an editor’s note, describing the way Jick’s letter had been “heavily and uncritically cited as evidence that addiction was rare.”

Canadian researchers had found that the Jick letter had been cited more than 600 times in the 37 years since its publication. “It’s difficult to overstate the role of this letter,” David Juurlink, a doctor of internal medicine at the University of Toronto, who led the analysis, told the Associated Press at the time. “It was the key bit of literature that helped the opiate manufacturers convince front-line doctors that addiction is not a concern.”

Purdue said it ended its opioid marketing and sales practices in February 2018.

“In the early 1990s, there was a widespread recognition among doctors, medical and scientific experts, and government agencies that pain was not being adequately treated, causing millions of people to suffer needlessly,” the company said in a statement to The Post.

“Between January 1996 and June 2001, certain Purdue employees improperly marketed and promoted OxyContin as less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other opioid pain medications. Purdue takes full responsibility for its misconduct.”

Other companies follow

Purdue’s tactics helped to create a market that other companies could emulate: the use of opioids for common pain, including back pain and osteoarthritis. In the Cleveland lawsuit, lawyers for the plaintiffs allege that drug companies followed Purdue’s marketing strategy to create “a series of misperceptions in the medical community and ultimately reverse the long-settled understanding of the relative risks and benefits of opioids.”

In 2006, Endo introduced a generic extended-release oxycodone pill to compete with OxyContin. The same year, the company began to market another opioid, an oxymorphone pill called Opana. By 2010, the company’s extended-release version of Opana was generating more than $1 billion in annual revenue, according to court records.

A website funded in part by Endo said: “Did you know? Most chronic pain patients do not become addicted to the opioid medications that are prescribed for them,” documents in the Cleveland case show. An Endo patient education pamphlet, “Understanding Your Pain: Taking Oral Opioid Analgesics,” told patients that “taking opioids as prescribed for pain relief is not addiction.”

Endo “incentivized” its sales reps to meet the goal of “pushing higher doses” to another one of its opioids, Percocet, which contains oxycodone, Kessler, the former FDA commissioner, said in a report written for the plaintiffs. The rewards “increased steeply” along with sales. Endo held a “Grand Prix Contest” where the top prize was a BMW for use as a company car.

In the Oklahoma case, Judge Balkman said in his ruling that Johnson & Johnson sales reps visited medical professionals in Oklahoma “hundreds of thousands of times” on opioid sales calls over two decades.

In their “call notes,” the reps recorded doctors raising concerns about abuse of opioids, including Duragesic, a fentanyl-based patch for chronic non-cancer pain. They brushed aside the concerns, with one calling abuse a “myth,” according to the court documents.

The reps were told to “Avoid the Addiction Ditch” and refocus on “the barrier contributing to the undertreatment of pain,”according to a training PowerPoint now part of the court file. The reps brought breakfast, lunch, coffee and snacks to Oklahoma doctors and offered paid-speaking roles as part of their pitch, the judge said in his ruling.

“The pharmaceutical industry targeted primary care physicians with their marketing efforts in order to convince these doctors to prescribe opioids for chronic non-cancer pain,” Balkman said.

An attorney for Johnson & Johnson and Janssen said company employees complied with the law.

“Counting up the number of sales representative visits, as the State did at trial, says nothing about how doctors made treatment decisions for their patients,” Sabrina Strong said in a statement. “Janssen sales representatives were trained to act according to company standards and in compliance with regulations and, like employees in many industries, were eligible for performance-based incentives.”

‘Nice-sounding names’

Jennifer Grey became famous for her co-starring role in the 1987 romantic drama “Dirty Dancing.” At the height of the opioid epidemic, the actress took on a far less publicized role: a pitch woman for Purdue Pharma.

Grey, who suffered a severe neck injury following a car crash the year the movie was released, made television appearances as part of a “Partners Against Pain” campaign. On Jan. 22, 2012, Grey appeared on a CBS-affiliate talk show in San Francisco.

“It’s called PartnersAgainstPain.com, and it’s a really interesting educational program,” Grey said during her appearance on Bay Sunday. “It’s a campaign that was meant to help people become advocates for themselves who are in chronic pain and because chronic pain is such an insidious syndrome.”

The talk show did not disclose that the campaign was underwritten by Purdue, which had signed up Grey the year before.

Grey told The Post she thought she was helping chronic pain patients.

“When this unbranded [Purdue] Pharma campaign was brought to me in 2011, I was excited by the opportunity to help people who, like myself, suffered from chronic pain by giving them practical tools to advocate for themselves and manage their pain in a safe, responsible way,” she said in a statement issued by her manager. “I never suspected I was being used to potentially advance a darker agenda.”

Drug manufacturers also funded patient advocacy groups, professional medical societies and coalitions that distributed educational materials, treatment guidelines and programs promoting opioid use, according to lawyers for the plaintiffs.

The American Academy of Pain Medicine and the American Pain Society issued treatment guidelines in 2009, recommending opioids for treating chronic pain. A 2018 investigation led by the Senate Homeland Security & Governmental Affairs Committee found that opioid manufacturers gave $9 million over five years to groups that advocate for pain patients.

“You see these nice-sounding names and these organizations and you don’t realize that many of them are being funded by the very people that manufacture opioids,” then-Sen. Claire McCaskill (D-Mo.), the ranking Democrat on the committee, told “NBC Nightly News” at the time.

The U.S. Pain Foundation has been one of the largest recipients of contributions from the manufacturers, collecting nearly $3 million, according to the Senate investigation.

The organization defended its sources of funding in a statement to The Post.

“The U.S. Pain Foundation receives funding from individual donors and private companies, including pharmaceutical companies, for its free programs and services for people with chronic pain,” the foundation said.

Another advocacy group, the Alliance for Patient Access, was founded in 2006 as “a national network of physicians dedicated to ensuring patient access to approved therapies and appropriate clinical care.”

The alliance in 2015 was one of the groups that signed a letter supporting legislation seeking to curb the DEA’s ability to immediately suspend the operations of drug companies suspected of failing to report suspicious orders of drugs.

The alliance noted that the legislation received unanimous approval from Congress and was signed into law by President Barack Obama.

In June 2017, the alliance list of associate members and financial supporters included Johnson & Johnson, Endo, Mallinckrodt, Purdue Pharma and Teva, all opioid manufacturers.

In his ruling against Johnson & Johnson and Janssen in Oklahoma, Balkman singled out the pain groups.

“Defendants made substantial payments of money to a variety of different pain advocacy groups and organizations that influenced prescribing physicians and other health care professionals,” he said.

In their marketing plans that are now part of the court file, the companies referred to the doctors and other pain experts who promoted opioids for pain as “Key Opinion Leaders.”

The attorney for Johnson & Johnson and Janssen defended its relationship with pain advocacy groups.

“Janssen from time to time supported and collaborated with pain patient advocacy groups, just as it does with groups focused on other medical conditions, like heart disease and cancer,” Strong said in the statement. “These interactions occur continually in the health care industry and are essential to knowledge sharing, the advancement of treatment and ultimately improving patient care.”

Portenoy, the prominent New York pain specialist, received tens of thousands of dollars from drug manufacturers as he appeared on national television news programs as far back as 1997, court exhibits show. He crisscrossed the country to appear at conferences. It wasn’t until 2012, after hundreds of thousands of people had died, that Portenoy had a change of heart.

Portenoy, who is named as a defendant in the Cleveland case, did not return requests for an interview from The Post. He told the Wall Street Journal in December 2012 that he had unwittingly provided incorrect information about opioids in the past. In a videotape the Journal cited, Portenoy told another doctor that he gave “innumerable lectures in the late 1980s and ‘90s about addiction that weren’t true.”

“We didn’t know then what we know now,” Portenoy said.

“Clearly, if I had an inkling of what I know now then, I wouldn’t have spoken in the way that I spoke,” Portenoy said in a video made by the Physicians for Responsible Opioid Prescribing. “It was clearly the wrong thing to do.”

Stephen Rich contributed to this report.

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‘Sell Baby Sell!’