Purdue’s internal files reveal that the Sacklers thought their star drug could transform their company into one of the country’s most profitable pharmaceutical firms. Even if that was just wishful thinking, or mentioned to motivate employees, it explains in part why they were not satisfied when Oxy broke a billion dollars in sales. That was only the first milestone. They wanted much more. Marketing files show that 75 percent of the $400 million Purdue spent promoting OxyContin came after 2000. That is the year that executives from the company later claimed in congressional testimony they first learned of reports about the drug’s abuse.1
A few pharmacists had alerted Purdue nearly two years earlier about a Myrtle Beach pain clinic operating as a pill mill (usually a cash-only doctor or clinic where narcotic prescriptions are dispensed to anyone for any reason).2 Purdue did nothing to investigate those reports although the volume of sales to that clinic was far greater than what it needed for treating the local population. Purdue did not even question why sales in Myrtle Beach had surged by an extra million dollars in the first quarter of 2001, by far the largest increase in OxyContin revenue in the nation.3 As its executives later contended, the company had no legal obligation to alert the FDA or any law enforcement agency.
It was December 2001 before the DEA raided that Myrtle Beach clinic and suspended the license of six doctors who had written thousands of OxyContin prescriptions weekly.4 What no one outside the company then knew was that the three sales representatives responsible for that pill mill continued to collect bonuses based on the sales it had produced. Raymond Sackler and a senior executive made that decision personally. They reasoned that Purdue had earned its profits on pills sold to the shuttered clinic, even if Oxy had been dispensed improperly. It was out of the question that they might return those profits, so withholding the sales reps’ bonuses might demoralize the team.5
The detail team understood the top priority was how many pills they sold. The Sackler-family directors and their top executives supported plans to persuade more doctors to prescribe more OxyContin at ever-higher doses and for longer periods. The stars at Purdue were not the scientists in the research lab looking for new medications. The stars were those detail squad members who managed to crush their quarterly sales quotas.
Going forward, there were very few instances in which the detail squad reported an incident where they thought a doctor or clinic in their sales territory improperly dispensed Oxy. Instead, the detail squad concentrated on the “high value target” prescribers, internally listed as SP (super prescribers). Courting the super prescribers paid off with spectacular results for the company’s bottom line and the detail team’s annual bonuses. In OxyContin’s thirteen top markets a few hundred SPs wrote more prescriptions than there were people.6 Nationally about 55 percent of all opioids were prescribed by 3 percent of all physicians.7
Purdue was not blind to overprescribing. It had identified the sales territories where it suspected that illegal dispensing contributed to the outsized volume of sales in relation to the population. That area was internally dubbed “Region Zero.” Law enforcement would eventually arrest some of the most reckless prescribers and shut down pill mills, but never as a result of a tip from Purdue. The company did not warn any state or federal agency that a West Virginia doctor wrote 335,000 prescriptions over eight years, a rate of 130 daily, seven days a week.8 Purdue was silent about its star prescriber in Massachusetts who penned 347,000 OxyContin prescriptions over five years. He stopped only when the state stripped him of his medical license.9 Purdue instead awarded both those doctors, and others like them, lucrative speaker’s contracts at sponsored symposiums about pain and pharmaceutical treatments.10 Some eventually lost their licenses. Others went to prison.
Employees who reported likely overprescribing met resistance. Purdue executives rejected a plea from one employee that the company do the “right and ethical thing” by providing insurance companies with a list of likely illegal prescribers. “If it reduces abuse and diversion of opioids,” she wrote in an email, “then it seems like something we should be doing.”11 In another instance, a member of the detail team, Mark Ross, alerted his sales manager that one doctor’s office in his territory was packed with drug addicts. The manager’s response was fast and direct: Ross’s job was to sell the company’s drugs, not to play detective to determine if a “doctor was a drug pusher.”12
As if Purdue’s failure to act on the warning signs from the sales data it compiled were not egregious enough, internal files show the detail squad sometimes pressed those suspect doctors to write prescriptions for drug addicts who had been turned away by other physicians.13
In January 2002 the problems posed by OxyContin abuse drew increased attention from the country’s politicians. A government advisory committee concluded that opioid pain medication abuse was on the verge of becoming a public health crisis. In February, the Senate Committee on Health, Education, Labor and Pensions held public hearings on “Balancing Risks and Benefits of OxyContin.” In the coming decades, as OxyContin worsened from a “problem” to an “epidemic,” the Senate and House held more than a dozen hearings into the causes of the crisis and to discuss possible solutions. The Government Accountability Office produced multiple reports that provided detailed snapshots that in retrospect are a sad commentary on the slow bureaucratic response to the most lethal prescription drug scourge in modern American history.14
The DEA’s Laura Nagel, meanwhile, had arranged for an extraordinary summit meeting with representatives from Purdue and the FDA at Drug Enforcement’s Washington headquarters. Nagel was joined on April 12, 2002, by the DEA’s senior science officer, David Gauvin, Frank Sapienza, chief of the Drug & Chemical Evaluation Section, and Christine Sannerud, the senior scientific advisor in the Diversion Control Division. The FDA sent Deborah Leiderman, director for controlled substances in the Center for Drug Evaluation and Research. Purdue again dispatched Friedman, Goldenheim, and Udell.
The Purdue executives were unaware that behind the scenes Nagel and Leiderman were at odds about how to best respond to the OxyContin problems. As far as the FDA was concerned, it had approved Oxy as effective and the drug demonstrated real-world usefulness for many patients. Issues of diversion and abuse were the DEA’s job. The problem, though, at Drug Enforcement was that its authority was limited to go after drug dealers and syndicates, pill mills, and doctors who had broken the law. Nagel was convinced that arrests and enforcement alone could not resolve the crisis. Only the FDA had the power to restrict the otherwise legitimate production and distribution of a controlled substance. Nagel wanted the FDA to restrict how OxyContin was dispensed, as it had previously done for barbiturates, amphetamines, and benzodiazepines. Leiderman had shown no interest yet in that.
Unable to reach an understanding on how to proceed before the meeting, Nagel hoped that at least the two government agencies would present a united front to Purdue. If they did that, she hoped, the company might agree to some voluntary restrictions on OxyContin to avoid more stringent federal regulation. Nagel had something she expected would help push the parties toward an agreement: the DEA’s science team had completed its internal review of the autopsy reports and the results showed that previous estimates of nearly three hundred OxyContin overdose deaths nationwide were significantly understated.15
As the meeting got under way, Gauvin distributed a forty-five-page PowerPoint presentation of their findings (the author obtained a printout of that unpublished presentation).16 Medical examiners had sent 1,304 autopsies during the previous two years in which there had been “oxycodone positive toxicologies.”17 Gauvin presented the methodology used by the science team. That was critical since overdose-death autopsies that flagged the presence of OxyContin often included a combination of other legal and illegal drugs as well as alcohol. He and Sapienza had filtered the information to exclude those autopsies not verifiable as being “directly” or “most likely” associated with OxyContin.I18
The DEA’s presentation was a damning overview of the deepening OxyContin crisis. The science team had reevaluated all the laboratory data, toxicology reports, and therapeutic drug profiles to confirm their accuracy. Included in the PowerPoint were five-year charts that tracked the number of emergency room visits that coincided with the increase in OxyContin sales. The DEA had also obtained Veterans Administration data showing that a quarter of all patients treated with Oxy for pain ended up abusing the drug. Primary care doctors said the abuse number was closer to a third of their civilian patients. Police departments provided information demonstrating that OxyContin was among the top ten most popular street drugs in the nation’s fifteen largest cities.
Gauvin told the stone-faced Purdue representatives that he had begun a review of a number of OxyContin deaths across the nation that had been classified as suicides. They could add to the total number of overdose deaths attributed to the drug.
Gauvin finished his presentation with an unexpected finding. Only twelve of the deaths were attributed to injecting, snorting, or chewing Oxycodone. Ninety-eight percent of those who had died had taken it orally, as approved by the FDA and as intended by Purdue.19 That made the point, according to the DEA, that the overdose deaths did not measure the full extent of OxyContin abuse. The chronic opiate abusers would have developed a tolerance to the drug that would make it far less likely for them to die of an oral overdose. That meant the hard-core abusers were still driving the market for Oxy’s diversion and illicit trade.
Goldenheim, as Purdue’s senior medical officer, made an abbreviated rebuttal. He complained that Purdue had not been given full access to all the DEA data. That made it impossible, he said, for Purdue to uncover any errors or misjudgments by the medical examiners. He also contended it was not possible to determine “OxyContin verified” deaths since the toxicology reports usually did not list exact levels of the other drugs at the time of death.20
Drug and Chemical chief Frank Sapienza reminded Goldenheim that the DEA marked a death as “OxyContin verified” only if the level of OxyContin in the bloodstream was high enough to be deadly on its own.21
“Assuming the measurements were accurate, how do we know that?” asked Goldenheim.
Gauvin leaned forward. “Do you think patients have a legal right to opiates? Or an inalienable right to be drug dependent?”
All three Purdue executives agreed with the right to opiates but said the second question was moot since patient dependence was not a widespread problem with Oxy.
Gauvin directed them to a copy of the World Health Organization and U.N. treaty in which “everyone had a right to reduced pain,” but “pain by opiates was not an inalienable right.” Pointing to a several-inch-thick stack of data from the autopsies, Gauvin said, “It is a direct attack on modern pharmacology to promote opioids as you do in the United States.”22
That is when, according to one of the DEA officials in attendance, Deborah Leiderman surprised everyone by declaring she tended to agree with Purdue. The autopsy results were inconclusive, or at least not as definitive as the DEA had presented them. The FDA also, she said, had not received copies of all the data the DEA had analyzed.23 Nagel and Gauvin looked at each other in disbelief. The meeting broke up soon after that.
A retired DEA officer familiar with what transpired next told the author that Nagel and Gauvin were so incensed by Leiderman’s intervention on the side of Purdue that they discussed whether she might have sabotaged their investigation. They had no evidence of any wrongdoing and did not think she was in Purdue’s pocket.24 Instead, they wondered if it was Leiderman’s way of pushing back against the DEA for overreaching its authority by seeking prescription restrictions.
Nagel’s backup plan in case Drug Enforcement did not get the FDA’s backing was to release the science team’s conclusions publicly: “Recent media reports of ‘hundreds of deaths’ attributed to OxyContin can now be substantiated by credible scientific evidence.” Few outlets picked it up. What did make news, however, was when the FDA publicly took issue with the DEA conclusions.
Three days after the failed meeting, a front-page New York Times story was headlined “OxyContin Deaths May Top Early Count.” Barry Meier reported the DEA findings. The paragraph that got attention was: “But an F.D.A. official said that agency had not reviewed the reports underlying the D.E.A. analysis and appeared to express caution about it. That official, who spoke on the condition of anonymity, said the Food and Drug Administration’s own review of data involving OxyContin was continuing but so far had not produced evidence that the drug posed a threat to people who took it as prescribed. ‘We don’t believe there is cause for panic,’ the F.D.A. official said.”25
“We knew where it had come from,” an ex-DEA official told the author. “It was as if they were going out of their way in giving Purdue a free pass. What the hell was going on over there [at the FDA]?”26
The DEA team knew after the Times article that they had to win not only the tug-of-war with the FDA but also the fight for public and professional opinion. For a month they drafted an article setting out their evidence that OxyContin was proving increasingly lethal. They submitted it that summer to The New England Journal of Medicine. One of the DEA officials involved in that article told the author the NEJM rejected it as “too alarmist.” An editor said it “was too early in post marketing surveillance to make claims of risks/hazards.”27
While Nagel, Gauvin, and others huddled to decide their next move, the issue of OxyContin abuse and diversion had finally drawn the interest of the Justice Department. John Brownlee was the recently appointed U. S attorney for the Western District of Virginia. Neighboring West Virginia was one of the hardest-hit OxyContin states. The thirty-six-year-old Brownlee had been an assistant U.S. attorney in Washington, D.C., before George W. Bush had nominated him.
When Brownlee got to the Virginia prosecutor’s office he was at first surprised it was “a pretty small shop.”28 That was true by the standards of Washington where he had been one of 350 attorneys with a support staff of nearly 400.29 The Western District of Virginia had only 23 of the country’s 5,300 federal prosecutors.30 Four worked civil cases and the 22-person support staff included only two investigators. Its size, though, did not dissuade Brownlee from opening two ambitious preliminary investigations a month after taking charge. One was a national security probe into whether the ITT Corporation might have illegally transferred classified technology to other countries. The second was into Purdue and OxyContin. Brownlee wanted to find out whether the drug’s maker had any legal responsibility for the budding epidemic.31 Over the next few years he directed his Oxy task force, eventually composed of nine state and federal agencies, from a strip mall.II32
No one at Purdue’s Stamford headquarters initially paid much attention to the investigation operating from the heart of Appalachia and with a prosecutor who had never directed a major case. Purdue was getting accustomed to aggressively defending itself on simultaneous fronts. It prevailed that year (2002) with dismissals and winning jury verdicts in the first wave of private lawsuits claiming OxyContin made them addicts.33 Howard Udell boasted, “We have not settled one of these cases, not one. Personal injury lawyers who bring them in the hopes of a quick payday will continue to be disappointed.”34III
Raymond Sackler and his son Richard were not so sanguine. The DEA was a problem. However, it could not bring an indictment or cause the type of legal havoc that a U.S. attorney hell-bent on a mission might produce.
“Who better to represent Purdue?” Raymond Sackler asked at an informal meeting at the firm’s Norwalk headquarters.35 Rudy Giuliani was “America’s mayor.” He was riding high after two terms as New York’s mayor and just months after he was widely praised for his calm leadership in the aftermath of the 9/11 terror attacks on the World Trade Center. His 9/11 role had earned Giuliani Time’s Man of the Year and an honorary knighthood from Britain’s Queen Elizabeth. When he returned to private life in January 2002, he opened Giuliani Partners, a consulting firm. Giuliani was selling access and influence. As a former United States attorney for the prestigious Southern District of New York, he was friendly with many top-ranking Justice Department officials. He knew Asa Hutchinson, the Drug Enforcement Administration director, for twenty years. Maybe, thought the Sacklers, Giuliani might find a way to put a check on Brownlee’s Virginia probe.
There was no dissent from Purdue’s directors or the top executives. In May 2002, the company retained Giuliani Partners. It was the ex-mayor’s first major client. While the fee agreement remains a secret since both Purdue and Giuliani Partners refuse to disclose it, documents produced later by Purdue in litigation reveal it was paying about $3 million a month to all its high-powered attorneys.36 It could certainly afford it. Oxy was bringing in $30 million per week, about 90 percent of its profits.37
Purdue was direct with Giuliani: it had hired him to extinguish the brewing firestorm in Washington.38 When Laura Nagel heard the news, “My reaction was that they went around me. They went and got Rudy.… They thought they were buying access and insight into how to manage things politically.”39
Giuliani assigned Bernard Kerik, New York’s former police commissioner who had also joined Giuliani Partners, to oversee a security appraisal of Purdue’s Totowa, New Jersey, manufacturing plant. That was the plant where unaccounted-for Oxy had attracted police attention. And Giuliani set an August meeting with the DEA.
“The mayor and I met with Asa Hutchinson, the director of the DEA; his staff; and people from Purdue [general counsel Udell],” Kerik told New York magazine a few weeks later. Karen Tandy, the associate attorney general responsible for Drug Enforcement oversight, also attended.40 “We don’t want Purdue put in a position where it winds up being taken over by the courts,” said Kerik. “Or they get put out of business. What I’d like to see come out of this is we set model security standards for the industry.”41
A week before the first anniversary of 9/11, Giuliani joined Hutchinson and Attorney General John Ashcroft at the opening of a DEA exhibit on terrorism and drug trafficking. Giuliani gave a speech that raised $20,000 for the Drug Enforcement Museum Foundation. When he finished, Hutchinson asked Laura Nagel to join him with the ex-mayor. A week later they gathered in Giuliani’s twenty-fourth-floor office overlooking Times Square. The OxyContin team that Giuliani had assembled ran through a thirty-minute PowerPoint they had developed “to keep OxyContin out of the wrong hands.” It was built around the concept that Purdue had a good drug and was doing its best to abide by all the necessary rules and regulations. What was needed were better tools to earlier spot abuse and diversion. The DEA pair said little. “We were receivers of the information,” Hutchinson later said.
Nagel was anxious to return to headquarters. When she did, colleagues recall that she railed against that “dog and pony show.”42 She soon took notice that Purdue had adopted another tactic popular with pharmaceutical companies: silencing critics by hiring them. Dr. Louis Sullivan, former chief of Health and Human Services, became a Purdue consultant developing courses for medical schools about pain treatment. Jay McCloskey, the Maine prosecutor who had been the earliest federal critic of Purdue’s promotion and extravagant doctors’ junkets, was a legal consultant. The FDA official who oversaw the OxyContin approval process, Dr. Curtis Wright, had become Purdue’s senior medical director.43
That autumn, Purdue confronted a wide-ranging investigation under way at the Florida attorney general’s office.44 Richard Sackler, Michael Friedman, and J. David Haddox planned a counterstrategy. Mortimer, eighty-five, and Raymond, eighty-one, kept abreast of the developments.45
In November, Purdue made its second “big hire” in its counteroffensive to the ongoing government investigations. Burt Rosen was a familiar and well-connected pharmaceutical lobbyist in the corridors of D.C. power. The Sacklers had lured Rosen from Novartis where he was senior vice president for communications and governmental relations. The amiable, backslapping Rosen had gotten his taste for politics as a law student at the University of South Carolina, where he clerked as an aide to the state’s long-serving senator Fritz Hollings. After getting his law degree, he became Pfizer’s youngest ever director of government relations. Rosen had a talent for the socializing and dealmaking required to navigate Washington agencies and lawmakers. After Pfizer, he ran Government Relations for three years at Bristol-Myers Squibb, then for eight years ran “Government Affairs” at SmithKline Beecham before joining Novartis. Purdue created a new position for him: vice president of federal government affairs.
Rosen joined the company at a time the Sacklers were increasing their own contributions to politicians ($2.3 million since 1996 to over three hundred candidates and political groups; the author discovered even Arthur Sackler is listed on public records as having made contributions after his death, sometimes Marietta Sackler donating in her deceased husband’s name).46 As Purdue and other opioid manufacturers came under increasing scrutiny, the companies opened up their wallets to lobby Congress and statehouses. Over a decade, drug companies selling an opioid product spent $746 million on state and federal lobbying. They spent another $80 million on state and federal candidates; that was split almost equally between Democrats and Republicans.47 Rosen directed Purdue’s lobbying. He oversaw a little-publicized group, the Pain Care Forum, a group of pharma companies that spent more than $700 million in a decade on lobbying for expanded opiate dispensing and for the FDA to loosen dispensing regulations.48
After several months of talks, Giuliani managed to settle the Florida investigation. The Florida attorney general agreed to drop the probe in return for Purdue agreeing to pay up to $2 million to develop a “prescription monitoring program” that allowed the state to maintain digital records of all doctors who dispensed narcotic prescriptions and the patients who filled them.49 Purdue, however, never developed that software. And inexplicably Florida returned the money the company advanced toward the project. Letting Purdue off so lightly turned out to be a great error. Over the next eight years, law enforcement nicknamed the high concentration of pill mills in Florida’s Broward County as the Oxy Express. Over a thousand dispensing clinics sold more OxyContin than any other county in the nation (at its peak, 89 percent of all the OxyContin in America).50 “The illegal sale of prescription drugs, and oxycodone in particular,” concluded the New York Times in 2011, “boomed in Florida because of the absence of a widely used prescription drug monitoring system.” That was the software Purdue had failed to deliver after agreeing to do so in its 2002 deal with the state’s attorney general.51
Giuliani also helped Purdue emerge unscathed from hearings called by Ted Kennedy before his Health, Education, Labor and Pensions Committee. Physicians and patients urged government intervention to stop the “misprescribing and overprescribing of this drug.”52 The committee, though, had no appetite for singling out OxyContin. Christopher Dodd, the senator from corporate Purdue’s home state, Connecticut, seemed to help Purdue whenever the questioning got too heated. He insisted that the counties reporting the highest levels of OxyContin abuse were places that had long-standing prescription drug problems.53
As the Senate probe finished without any breakthroughs, Bernard Kerik announced rigorous changes at Purdue’s New Jersey OxyContin plant. Laura Nagel had built a damning case against the cavalier way the company handled the manufacturing of a controlled substance. It was the only one of the 257 OxyContin abuse and diversion cases she initiated over two years connected directly to Purdue.54 Still, Giuliani had managed to make certain Purdue faced only civil charges. Once the feds signed off, Purdue paid a $2 million civil penalty for its lapses in security and failure to enforce regulations that allowed the drug to be diverted to the black market. By then, OxyContin sales were up twentyfold since its introduction and it was on its way to $2 billion in annual sales. Two million dollars was not an insignificant amount, but it was, as one Purdue executive boasted, “less than a day’s [OxyContin] revenue.”55 IV 56
I. One hundred and thirty-four of the autopsies were deaths from gunshots, traffic accidents, AIDS, and cancer. Although oxycodone was present in each, Gauvin excluded them. He also omitted another 221 in which the “summary statements” from the medical examiner were “incomplete.” As for the remaining 949, Gauvin had “464 deaths linked to single entity oxycodone products.” He split those into “OxyContin verified” and “OxyContin-likely.” The uncategorized remainder all showed medium to high blood levels of oxycodone. Although the science team believed those were also OxyContin-related, the directive from Nagel had been to err on the side of a conservative analysis to make it tougher for Purdue to ignore the data.
II. To learn more about how OxyContin had hit West Virginia like a plague, Brownlee read Barry Meier’s Pain Killer. He later heard that Purdue had complained bitterly to the Times and that resulted in Meier being taken off that story (he was not allowed to cover it for four years). That piqued Brownlee’s interest in what the drug company might have to hide. Purdue’s general counsel, Howard Udell, had convinced the Times public editor that Meier’s reporting cast the company as the villain since it guaranteed more coverage by the newspaper. Meier’s byline had appeared on fourteen stories, many on the front page, since the first ran on February 9, 2001. His 2003 book was evidence, Purdue claimed, that Meier had a financial interest in keeping the story alive by concentrating on the most sensational and damaging news. “Their agenda was to shut me down,” Meier later said.
III. Until 1978, Udell had been the law partner of Myron and Martin Greene, the brothers who were attorneys and proxy owners of companies that formed the basis of the Sackler labyrinth of companies in the 1950s and 1960s. Martin Greene went into a solo legal practice in 1978 after Myron Greene died of a heart attack. The address and telephone number listed in the Manhattan yellow pages for his solo law firm was the same as half a dozen Sackler-owned businesses. Udell went to Purdue Pharmaceutical that same year (1978) and became its general counsel.
IV. Kerik resigned from Giuliani Partners the following year. President George W. Bush had nominated him to become the secretary of homeland security on Giuliani’s recommendation. Kerik later pled guilty in 2010 to eight felonies, including lying to White House officials and tax fraud, and was sentenced to four years in prison.