Purdue Pharmaceutical within the first few years of launching the prescription opioid OxyContin knew about "significant" misuse of the drug, but it continued to market the drug as a safer opioid option, according to a confidential Department of Justice report examined by the New York Times.

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The previously undisclosed documents obtained by the Times detail findings from a four-year investigation led by then-U.S. attorney for the Western District of Virginia John Brownlee into Purdue's marketing and sales tactics for OxyContin. Those documents were used by DOJ in 2007 to bring felony charges against Purdue and a misdemeanor charge against three Purdue executives for "misbranding" the drug and downplaying the drug's addictive risk and potential for misuse. However, under the settlement, which required the company and executives to pay a combined $634.5 million in fines, most of DOJ's findings were never released to the public.

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Purdue, which along with other opioid manufacturers is facing a new wave of lawsuits from states and cities, has maintained that officials did not learn about of OxyContin's potential for misuse until the early 2000s, after the drug had been on the market for several years, the Times reports.

But the DOJ report paints a different picture, disclosing emails and other evidence that shows Purdue executives prior to 2000 were sent reports about misuse of OxyContin and another Purdue opioid, MS Contin. In fact, according to the Times, some former government officials said DOJ's evidence called for a stronger penalty than the 2007 settlement.

Terrance Woodworth, a former Drug Enforcement Administration official who investigated Purdue Pharma in the early 2000s, said more severe charges "would have sent a message to the entire drug industry." He added, "It would have been a turning point" for the opioid epidemic.

Robert Josephson, a spokesperson for Purdue Pharma, declined to comment on the claims in the report. He said in a statement, "Suggesting that activities that last occurred more than 16 years ago are responsible for today's complex and multifaceted opioid crisis is deeply flawed."

Inside the documents

According to the Times, Purdue Pharma in 2007 admitted that it had trained sales representatives to market OxyContin as being less addictive and prone to misuse than competing opioids. According to the Times, that marketing tactic actually focused on findings from FDA, which in its 1995 approval of the drug said OxyContin's long-acting formulation was "believed to reduce" the appeal to drug misusers, compared with shorter-acting painkillers like Percocet and Vicodin. FDA based that phrasing on a theory that drug misusers preferred shorter-acting painkillers that delivered a faster "'hit,'" the Times reports.

But within five months of FDA's approval, prosecutors said Richard Sackler and Howard R. Udell, who at the time was Purdue's general counsel, received an older medical journal article that showed drug misuser were extracting morphine from MS Contin tablets to inject the drug.

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In 1998, a Canadian study was published that found MS Contin tablets fetched a high price on the street. In an accompanying editorial, Brian Goldman, a Canadian physician who at the time was also a paid speaker for Purdue, wrote that the findings were at odds with the assumed lower risk of long-acting opioids. "This should ring alarm bells," he wrote.

However, that study never made its way to FDA, the Times reports. Josephson said the company viewed the findings as insignificant because it was well known that morphine could be misused. He noted that the company was under no legal obligation to inform FDA about the study or editorial.

According to the Times, emails show the number of reports Purdue received regarding misuse, addiction, and crimes related to OxyContin continued to rise through the late 1990s and early 2000s as sales of the drug soared. The documents show several sales representatives for Purdue also raised concerns about the drug during that time. From 1997 through 1999, prosecutors found 117 internal notes from sales representatives that used the words "street value," "crush," or "snort."

After the arrest of one Jacksonville provider for illegal prescribing in late 1999, J. David Haddox, a Purdue executive, suggested after the company adopt a crisis-response plan, but according to the DOJ documents, Purdue's then-CEO Michael Friedman dismissed the idea.

According to the documents, Udell in early 1999 in an email to another company official wrote, "We have in fact picked up references to abuse of our opioid products on the internet."

Despite that evidence, the prosecutors in 2006 wrote that the drugmaker continued "in the face of this knowledge" to market OxyContin as less prone to abuse and addiction than other prescription opioids.

According to the Times, Udell and other company executives in testimony before Congress maintained that the drugmaker did not learn about OxyContin’s growing abuse until early 2000, when Maine's attorney general issued an alert.

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In 2001, Goldenheim testified, "Everyone was taken by surprise by what happened," adding, "We launched OxyContin in 1996, and for the first four years on the market, we did not hear of any particular problem."

DOJ prepares case

In mid-2006, DOJ prosecutors alerted Purdue Pharma and the three executives—Friedman, Paul Goldenheim, the top medical officer at the time, and Udell, who passed away in 2013—about the charges they planned to seek. The prosecutors sent their recommended indictments to DOJ officials in later September 2006, which according to the Times included felony charges that could have sent the executives to prison if convicted.

According to the Times, defense lawyers representing Purdue and the three executives met with top DOJ officials to present their case, including evidence that they said showed the executives had no knowledge about OxyContin's misuse before 2000.

Andrew Good, a defense lawyer who represented Goldenheim, in a statement said, "We made a presentation of evidence and advocacy to DOJ without having seen the prosecution memo." He added, "No charge of false testimony or concealment of abuse was brought because none of that happened."

Former government lawyers said top DOJ officials in the George W. Bush administration signaled they did not support the initial indictments and began discussions to resolve the case through a plea bargain.

Brownlee, who is now in private practice, declined to comment on the article, but Joseph Rannazzisi, a former DEA official, told the Times that Brownlee said he had been "outgunned" and had little choice but to settle the case (Meier, New York Times, 5/29).

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