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In December of 2002, Purdue Pharmaceutical executives received a subpoena from the office of the United States Attorney for the Western District of Virginia. Federal prosecutors were notifying Purdue that the Department of Justice had formally opened an investigation into how the company marketed OxyContin. Two assistant U.S. Attorneys had become aware of the false marketing claims made by Purdue sales reps for OxyContin “and they began to wonder if high-ups in the company had orchestrated that campaign.” The two men noticed that since Purdue had begun marketing OxyContin the cases they were getting had changed drastically. “By 2001, virtually all of them—robberies, fraud, assaults, and pill-mill cases—had a connection to Purdue’s drug.”
Over the next four years a team of federal prosecutors and investigators worked through thousands of Purdue emails, records and other documents. “They called former Purdue sales reps, marketing executives, researchers medical officers, and chemists to testify under oath before a federal grand jury.” While going through the subpoenaed documents, they discovered how Purdue misrepresented data in order to minimize OxyContin’s addictive potential. “The FDA has told Purdue that data was bogus, but the company trained its reps to use it anyway.”
They also discovered Purdue had concealed information that contradicted a claim made when OxyContin was first marketed, namely that patients on low doses (less than 60 mg daily) “could stop it abruptly without going through the anxiety and discomfort associated with opioid withdrawal.” This claim had been based on a Purdue-funded study that low dose patients exhibited “no overt withdrawal syndrome.” A Purdue researcher re-examined the study’s underlying data in 2001 and found that 25% of patients showed symptoms consistent with withdrawal. “But prosecutors found emails showing the company allowed sales reps to give the questionable study to doctors, apparently with the blessing of senior executives.”
Some Purdue medical officers wanted the company to notify the FDA about the withdrawal issue; to admit that tapering a dose was a “more prudent medical recommendation than stopping low dose OxyContin abruptly. “In grand-jury testimony, FDA officials said the agency never got that report.”
Prosecutors discovered that by 2000 Purdue has begun receiving calls from patients on low doses, who were experiencing significant withdrawal symptoms. Soon, Purdue officials were sending one another emails about the “risk management” implications if the study’s findings were inaccurate.
To this day, Purdue insists it first became aware of abuse problems with OxyContin in early 2000, “as a result of articles in Maine newspapers and when the U.S. Attorney there sent out an alert to doctors in the state.” But during their investigation prosecutors came across emails indicating that senior executives at Purdue “learned about wider abuse of OxyContin well before they said they did.” Prosecutors believed they had more than enough evidence to show that three senior company executives had misrepresented when they first learned of OxyContin’s abuse. They recommended the men be indicted on charges that included conspiracy to defraud the United States. In late September 2006 they sent a 120-page memo to their boss, the U.S. Attorney for the Western District of Virginia, with the recommended indictments. It was then forwarded to officials at the Justice Department headquarters for review and approval. The following excerpt is from the memo:
Had the conspirators provided Congress and their sales representatives with the truth, that is that PURDUE had been aware, at least as early as 1997-1998, that both MS Contin and OxyContin were subject to widespread abuse and diversion but continued to market OxyContin as less addictive, abusable and subject to diversion in the face of this knowledge, the sales representatives would have lost all credibility with health care providers, and PURDUE’s conduct would likely have been subject to much greater regulatory and Congressional scrutiny.
The above was gleaned from the expanded and updated edition of Barry Meier’s book, Pain Killer. Coinciding with the publication of the expanded edition of Pain Killer, two articles by Meir appeared in The New York Times, where he has been a reporter since 1989. Those articles are: “Origins of an Epidemic: Purdue Pharma Knew Its Opioids Were Widely Abused” and “Every Time I Thought the Purdue Pharma OxyContin Story Was Over, I Was Wrong.” In “Origins of an Epidemic,” Meir gave further details of how Purdue Pharma knew about serious abuse in the first years after OxyContin was put on the market. Even members of the Sackler family had been alerted about abuse problems with OxyContin and MS Contin.
Company officials had received reports that the pills were being crushed and snorted; stolen from pharmacies; and that some doctors were being charged with selling prescriptions, according to dozens of previously undisclosed documents that offer a detailed look inside Purdue Pharma. But the drug maker continued “in the face of this knowledge” to market OxyContin as less prone to abuse and addiction than other prescription opioids, prosecutors wrote in 2006.
But top Justice Department officials did not believe the felony charges against Purdue executives were justified. Instead, the case was settled through a plea bargain. “When the case was settled, the memo and the evidence within it were sealed and forgotten.”
In 2007, Purdue Pharma pleaded guilty to a felony charge of “misbranding” OxyContin while marketing the drug by misrepresenting, among other things, its risk of addiction and potential to be abused. Three executives — the company’s chief executive, Michael Friedman; its top medical officer, Dr. Paul D. Goldenheim; and Mr. Udell, who died in 2013 — each pleaded guilty to a misdemeanor “misbranding” charge that solely held them liable as Purdue Pharma’s “responsible” executives and did not accuse them of wrongdoing. The company and the executives paid a combined $634.5 million in fines and the men were required to perform community service.
In “Every Time I Thought the Purdue Pharma OxyContin Story Was Over, I Was Wrong,” Meier described how the complete Purdue OxyContin story told in Pain Killer came to him in spurts. He became interested in the back-story to Purdue Pharma and OxyContin after a 2001 interview he had with the Purdue CEO, Michael Friedman. This led to his 2003 edition of Pain Killer. Meir heard rumors of the Justice Department investigation, but when nothing happened, he assumed it just ran out of steam. Then he heard of the plea bargain, where “Purdue Pharma and the three executives I had interviewed were about to plead guilty to charges connected to the company’s deceptive marketing of OxyContin.” He received a tip about the sentencing from the U.S. Attorney for the Western District of Virginia because his writing on the issue for The New Times and in Pain Killer helped inform the original investigation documented in the 2006 memo.
Once again, Meier thought the OxyContin story was over. That is until he was given a copy of the 2006 Justice Department memo. After reading it, he realized just how much he hadn’t known back then. He even discovered that he was mentioned in the memo. Prosecutors found a tape recording of his 2001 interview with the Purdue CEO and planned to use it as an example of how the Purdue executives publically misrepresented the company’s knowledge of early OxyContin abuse. “Now, with the report in hand, I finally had the chance to bring the story of Purdue Pharma and OxyContin full circle, both in The Times and in an expanded edition of Pain Killer.”
Then on May 15, 2018 Reuters noted that six states, Nevada, Texas, Florida, North Carolina, North Dakota and Tennessee filed lawsuits against Purdue Pharma LP, accusing the company of “fueling a national opioid epidemic by deceptively marketing its prescription painkillers to generate billions of dollars in sales.” Sixteen other U.S. states and Puerto Rico have already filed lawsuits against Purdue, with New York and California preparing similar lawsuits. Fierce Pharma announced Massachusetts would be the first to not only file suit against Purdue, but also against its current and former executives and board members. This group includes members of the Sackler family that owns the stable of privately held Purdue Pharma companies.
On July 5th Purdue Pharma dropped its effort to keep the Tennessee lawsuit sealed. The Tennessee Coalition for Open Government and the Knoxville News Sentinel were successful in their efforts to make public the details of the 274-page lawsuit against Purdue Pharma. The Tennessee Attorney General told the News Sentinel: “The state’s complaint contains specific examples of defendant’s unlawful conduct, its scale and impact on the state, the company’s knowledge of activities and financial gain.” He said there is proof the firm lied about the addictive properties of the drug OxyContin and actively marketed it to addicts.
The New York Daily News reported the unsealed lawsuit said Purdue called on two providers 48 times after the company had been told by law enforcement they were responsible for “significant interstates OxyContin diversion.” The lawsuit further states:
Purdue continued to make sales calls in spite of credible reports of patient overdoses, indictments, adverse licensure actions, a provider admitting he was addicted to heroin, a knife fight outside a provider’s office, muggings over controlled substances outside of a pharmacy linked to a specific provider, a clinic that had no examination tables or equipment, an admission by a provider that he was running a pill mill, a provider changing the name of his practice shortly after he was notified of a state investigation into his practice, a patient being coached in the waiting room about how to fill out intake forms, armed guards in provider waiting rooms, high numbers of patients who purchased OxyContin in cash, high numbers of out-of-state or out-of-county tags in providers’ parking lots, accusations of insurance fraud, choreographed urine screenings and pill counts, standing-room-only waiting rooms, and additional signs of problematic high volume practices.
It sounds like one of the devils in the opioid epidemic may just get its due.