Richard Sackler proposed plan to play down OxyContin risks – STAT

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PIKEVILLE, Ky. — In the early days of OxyContin, Dr. Richard Sackler, a member of the billionaire family that founded and controls Purdue Pharma, learned about concerns that the potent opioid could lead to abuse in chronic pain patients, and he then proposed executives aggressively push back, according to newly unsealed documents obtained by STAT after a four-year court battle.

An email chain from January 1997 — just a year after Purdue launched the drug — shows that Merck Medco, then one of the nation’s largest pharmacy benefit managers, had begun cautioning doctors that use of OxyContin to treat chronic pain patients could lead to abuse. That news set off alarms among executives at the Connecticut-based Purdue because it threatened to derail the company’s strategy to tap a lucrative non-cancer pain market.

Sackler urged a robust response, writing that the “addiction” objection could be “obliterated.” Specifically, he said executives should consider giving a “convincing presentation” that controlled-release products like OxyContin are “less prone to addiction potential, abuse or diversion” than other opioid pain pills. “I think that can be done,” he wrote, but deferred to the company’s experts about whether it could.

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By that time, Purdue sales representatives were falsely marketing the drug to physicians as “less addictive and less subject to abuse and diversion,” according to federal court records — conduct that would lead to Purdue pleading guilty in 2007 for the misleading way it sold OxyContin.

The email exchange is included in more than 1,000 pages of Kentucky court records that are now being made public, offering the most complete picture to date of Sackler’s commanding presence inside Purdue. They show that Sackler, who was a senior vice president at the time of OxyContin’s launch in 1996 and became president in 1999, was directly involved in guiding Purdue’s promotional strategy for OxyContin and responding to the concerns raised by Merck Medco. Given an early chance to examine these worries about abuse, he and other executives focused on how to protect OxyContin sales and, in Sackler’s words, chronic-pain patients’ “right to effective opioid treatment.”

The documents show a ferociously competitive side of Sackler, who has shunned the spotlight as his family became known for its large philanthropic gifts to museums, elite universities, and charities. In one email, Sackler wrote that he wanted Purdue to draw attention to its patent infringement lawsuits so that “we are feared as a tiger with claws, teeth and balls.”

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Alex Hogan/STAT

When asked in a 2015 deposition about the presentation he suggested in the Merck Medco email exchange, Sackler said he “was basically just trying to ask the question. And if the answer were yes, we can put together a good, medically correct presentation, I thought it would be useful to do so … obviously, if we had contrary information or data, then obviously I couldn’t do that.”

The new documents don’t say what Purdue ultimately told Merck Medco and similar companies about potential abuse of OxyContin and addiction. In his deposition, Sackler said he did not think any presentation was ever produced. “[B]ut I don’t remember how this came to an end,” he said, adding that he marked the email “low” on importance “to indicate it was not something that was urgent.”

Portions of this email chain were referenced in that deposition, which was included in the sealed files but disclosed earlier this year by ProPublica and STAT. The newly released documents, however, provide context and details missing from the deposition.

A lawyer for the family of Raymond Sackler, Richard Sackler’s father, provided a statement in response to questions for this article, saying “there is nothing improper in the emails” cited by STAT. “The emails discuss how doctors who prescribed OxyContin were upset that insurance companies wanted to avoid paying for their patients’ medicine,” wrote the lawyer, Daniel S. Connolly. “Dr. Sackler responded by asking whether it would be accurate to make a presentation to the insurance companies, specifically saying that he deferred to Purdue’s in-house experts on the proper way to proceed if at all.”

Sackler also called for a marketing campaign to counter the Merck Medco objections, according to the documents. “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,” Sackler wrote “… I think that this is something that we should start this year.”

The company’s efforts to boost sales of OxyContin continued even after reports of drug diversion and addiction problems began flooding in from around the country between 1999 and 2001 amid rising tallies of overdoses and deaths — the start of what’s become an addiction epidemic that’s now been blamed for the overdose deaths of more than 218,000 Americans from all prescription opioids.

STAT initially sought the secret Purdue documents in March 2016, filing a motion to unseal records that had been gathered during a lawsuit the commonwealth of Kentucky pursued against the company over allegedly improper marketing, before settling in late 2015 for $24 million. In May 2016, Pike County Circuit Judge Steven Combs ruled in STAT’s favor. After years of unsuccessful appeals by Purdue, Combs ordered on Nov. 19 that “the entire file shall be unsealed due to public interest.”

The release of the records comes at a perilous moment for Purdue and particularly the Sackler family. Two dozen states and Washington, D.C., are vigorously opposing a tentative national settlement that Purdue and the Sacklers have reached with 24 other states and about 2,000 cities, counties, and Native American tribes, saying the deal would leave family members with too much of the profits they have derived from OxyContin’s sales.

Under the proposed settlement, the Sacklers — who have received $12 billion to $13 billion in profits from Purdue, according to the company’s bankruptcy court filings — would eventually pay the plaintiffs $3 billion and have to sell another family-owned drug company that markets opioids globally. They would also give up control of Purdue, which has filed for bankruptcy but would continue to operate — with its revenues from OxyContin and other products going to the plaintiffs.

In pursuing OxyContin’s success, no detail was too small for Sackler, who is now 74: In one 1996 exchange with Purdue executives, he questioned the meaning of numbers showing that physician attendance at dinners was associated with a doubling of prescriptions, asking whether they truly yielded a “commercially significant” increase.

The documents also show Sackler’s satisfaction in the close relationship the company formed with doctors and medical organizations that write treatment guidelines for pain patients. Testimonials from pain patient advocates about the value of OxyContin were pivotal in Purdue’s marketing materials.

In a 1999 email, Sackler wrote that it is “soo encouraging to see and experience how happy the key pain specialists are for me.”

“I intend to invite the President of the Pain Society to our Gala night at the end of the kickoff meeting,” Sackler continued. “It is unusual to have customers at company functions. But we have such [a] good relationship with them that in some cases I know they would like to join us.”

Purdue donated money to the American Pain Society and in early 2000, Purdue distributed the organization’s 1999 treatment guidelines to its sales force, according to an internal memo in the court records. “The guidelines can be an effective tool for selling our products,” the memo says. The society’s president at the time was Dr. Russell Portenoy, who frequently argued that chronic pain was being undertreated in the United States and later acknowledged exaggerating the benefits of opioids and understating the risks.

In his statement, the lawyer for Sackler said the invitation to the dinner was not an attempt to exert influence. “Dr. Sackler suggested inviting colleagues from the medical community who had previously been supportive,” he wrote.

Purdue has derived most of its profits over the past two decades from OxyContin, a brand-name drug for which the company could charge far more than competing generic opioids. It was born in part from concern that its MS Contin opioid painkiller was going off patent. To get doctors and insurers to buy into the notion of prescribing — and paying for — a much more expensive version of existing oxycodone products, Purdue pushed several misleading claims: OxyContin was less addictive than other opioid products; resulted in less euphoria and less potential for abuse; and could be abruptly stopped without causing withdrawal symptoms. Those claims were central to its ultimately successful push to expand use of the drug among chronic pain patients and increase sales — and they eventually caught the attention of the U.S. Department of Justice.

In 2007, the company agreed to plead guilty to a felony charge involving misleading marketing of OxyContin and acknowledged falsely promoting OxyContin as “less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other pain medications.” Three senior executives — its former top lawyer, Howard Udell, former medical director Dr. Paul Goldenheim, and onetime CEO Michael Friedman — pleaded guilty to a related misdemeanor charge. Purdue paid $600 million in fines and penalties. (The company is now facing new federal criminal investigations.)

The unsealed documents show that Richard Sackler, who at various times served as senior vice president, president, and co-chairman of the board, was directly involved in discussions about marketing and other business decisions with Goldenheim and Friedman. Neither Sackler, nor any other member of his family, is mentioned in the records of the 2007 government settlement with the executives and Purdue.

STAT and ProPublica previously reported that Sackler embraced a plan to conceal OxyContin’s strength from doctors by failing to correct their false impression that the drug was weaker than morphine — because the myth was boosting prescriptions and sales for non-cancer patients with chronic pain. In fact, OxyContin is twice as strong as morphine.

“It would be extremely dangerous at this early stage in the life of the product to make physicians think the drug is stronger or equal to morphine,” Friedman wrote Sackler in a May 1997 email that was included in a 2015 deposition of Sackler. “… We are well aware of the view held by many physicians that oxycodone [the active ingredient in OxyContin] is weaker than morphine. I do not plan to do anything about that,” Friedman continued.

“I agree with you,” Sackler responded. “Is there a general agreement, or are there some holdouts?”

A month later, according to an internal memo, a sales executive, Mike Cullen, communicated this messaging to the team overseeing the rollout of OxyContin. “We can show that we are as ‘effective’ as morphine, but do not want to say OxyContin is as ‘powerful’ as morphine,” he said, according to minutes of the meeting. “Words such as ‘powerful’ may make some people think the drug is dangerous and should be reserved for the more severe pain.”

In his deposition, Sackler denied there was any attempt to deceive doctors. “The term ‘stronger’ in Friedman’s email,” Sackler said, “meant more threatening, more frightening. There is no way that this intended or had the effect of causing physicians to overlook the fact that it was twice as potent.”

The unsealed records show that, by the time of their exchange, Friedman and Sackler had already been alerted to the abuse concerns raised by Merck Medco and others.

On Jan. 3, 1997, a sales employee sent an email notifying executives that a doctor was complaining that Merck Medco had sent two letters expressing concerns of “abuse potential” in pain patients treated with OxyContin and MS Contin.

“Dr. McGinnis was mad about this and he believes in using our products in the chronic non-malignant pain patient,” the employee wrote. “He asked me, ‘Is Purdue Frederick doing anything to enlighten these folks at Merck-Medco(?)’”

The email quickly climbed through the ranks of the company and set off alarms among executives who noted that Merck Medco was not the only pharmacy benefit manager raising red flags.

“Our success with OxyContin is starting to create concerns amongst the large PBM’s as you already know because they recognize we are targeting non cancer pain,” James Lang, a Purdue sales executive, wrote a week later. “This goes beyond their initial perception that it was primarily a cancer pain medication.”

Sackler, Friedman, and Goldenheim chimed in that the PBMs were expressing worries both about the cost of OxyContin’s expansion to chronic pain patients as well as the potential for abuse.

On Jan. 14, Sackler wrote that “we should consider that ‘addiction’ may be a convenient way to ‘just say “No”’ and when this objection is obliterated, they will fall back on the question of cost. Unless we can give a convincing presentation that c.r. [controlled release] products are less prone to addiction potential, abuse or diversion than i.r. [immediate release] products. I think that this can be done, but I defer to [the company’s experts].” (Immediate release refers to short-acting opioid products taken more frequently.)

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Alex Hogan/STAT

The drug’s label at the time, approved by the Food and Drug Administration, included the statement that delayed absorption, as provided by OxyContin tablets, was believed to reduce abuse liability, but Purdue had done no studies supporting this claim, or that it was less addictive, according to the 2007 plea agreement.

As STAT previously reported, Merck Medco eventually became an ally of Purdue, helping it thwart the West Virginia state employee health plan from requiring prior authorization for OxyContin prescriptions amid a surge of deaths. Purdue paid Merck Medco higher rebates in return for the PBM agreeing to keep the drug widely available without restrictions.

West Virginia suffers now the highest per-capita drug overdose death rate in the country, according to the National Institute on Drug Abuse. Not far down the list is Kentucky.

In 1999 — as law enforcement officials were starting to notice a wave of overdoses linked to OxyContin — Purdue sales reps were told their bonuses would be calculated in a way that made the incentive for selling the drug much greater than for selling MS Contin.

“As we continue to drive more business toward OxyContin, each of you will benefit significantly,” Russ Gasdia, the company’s national sales manager, wrote in a January 1999 memo. “As pointed out, your priority is to Sell, Sell, Sell OxyContin.”

While the company’s chief focus was on selling OxyContin to the large chronic pain market, Sackler was assertive in combating questions raised about the drug’s effectiveness in treating cancer pain.

In April 1997, Sackler wrote an email to Friedman expressing concern that focus groups convened by the company surfaced a perception among oncologists that OxyContin had a “ceiling effect,” a phenomenon in which a drug reaches a dosage beyond which increasing the dose does not provide an additional benefit.

“I am somewhat surprised that 18 months into marketing, significant groups of experts … believe that oxycontin has a ceiling effect,” he wrote. “What materials could we pull together that would smash this critical misconception?”

Friedman wrote back a few hours later that such aggressive action could end up backfiring on the company and undermining OxyContin sales. In a lengthy email, Friedman explained that drug substances develop personalities independent of their chemical qualities, and that the company had carefully cultivated OxyContin’s image to differentiate it from other painkillers.

“Marketing is not only about what you are. It is also about what you are not,” Friedman wrote. “We have success beyond our expectations that is, in part, due to the unique personality of OxyContin. Even as we seek to increase the use of the drug in higher doses, we should be very careful. As far as I know, the strength of the drug is principally a barrier in malignant pain. We do not want to change the image in a way that will discourage non-malignant use. A barrage would be ill advised.”

The following day, Sackler replied, “excellent points.”

“[W]hat about rifle shots?”

Contributors to this story: Shraddha Chakradhar of STAT and David Armstrong of ProPublica, who began pursuing the sealed Kentucky records while a reporter at STAT.

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