Although the Sacklers and Purdue executives knew about early reports of abuse with OxyContin in late 1997 or early 1998, the first media stories—mostly in rural newspapers—did not appear until 1999. Small-town police forces scattered across six Appalachian states stretching from Kentucky to Maine reported a surge in drug dealers arrested with OxyContin and pharmacies robbed at knife- or gunpoint.1 There was also a spike in Oxy-related hospital admissions.2 The drug had begun showing up in toxicology reports of overdose autopsies (although it varied by year, on average there were twenty-five emergency room visits related to opioids for every lethal overdose).3
Steven Passik was then a clinical psychologist in pain management and palliative care at the University of Kentucky’s School of Medicine. He had written about pain and opioids. Kentucky was one of the states hard hit early on by OxyContin. There would soon be nine counties in America that had an opioid-related overdose death rate greater than 20 per 100,000. Four of those were in eastern Kentucky. Passik described it as a region “marked by poverty and 20 percent unemployment among laborers with lots of chronic pain. This environment was ripe for prescription drug abuse.”4
Passik had no idea then of the extent to which Purdue had targeted poverty-scarred working-class whites in rural America as a prime market. Although a few small towns felt under siege from OxyContin, there was little evidence the problem extended much beyond a dozen counties in a handful of states. Health and Human Services’ “Drug Abuse Warning Network,” which relied on reports from hospital emergency rooms and medical examiners, reported a 93 percent jump in “oxycodone mentions” in 1998. It was written off as a cyclical spike common with illegal drug supply and demand.5 No one could have then imagined they were witnessing the national opioid epidemic in its infancy.
In the fall of 1999, Jay McCloskey, Maine’s U.S. attorney, noticed state police arrests for illegal possession or distribution of prescription narcotics had jumped ninefold in four years. McCloskey was the first public official to realize that OxyContin was behind the surge; it was involved in more than half the arrests. He met that October in Washington with a group of citizen advocates who were trying to raise awareness of what they claimed were OxyContin’s unrecognized dangers.6 They included parents of addicted children and others who themselves had become dependent on the drug. Three months later McCloskey sent a letter to all Maine’s practicing doctors “warning them about the increasing problems with illegal diversion and abuse of OxyContin.”7 That got the attention of the Sacklers and Purdue.
OxyContin had become Purdue’s best-selling drug ever. Just a few months earlier, chief operating officer Michael Friedman had sent Richard Sackler an email with the news that its sales exceeded $20 million weekly. It was well on its way to becoming a billion-dollar drug. Sackler’s semisatirical response? “Blah, humbug. Yawn.”8 In fact, the Sacklers were ecstatic at the numbers. And when they learned of McCloskey’s letter, they wanted to make certain that any bad press was nothing more than a public relations speed bump.9
In a strategy meeting, the Sackler-family directors and their top executives decided to confront the problems in Maine. A few weeks later, J. David Haddox, Purdue’s medical director, called McCloskey. Haddox seemed genuinely interested to learn more about what had prompted the warning letter to the state’s doctors. He asked if he and several Purdue colleagues could meet McCloskey but the U.S. attorney declined. “I found it difficult to envision how the manufacturer could help stop the illegal diversion and abuse of OxyContin,” he later testified before the Senate.10
It took several months before McCloskey concluded that “traditional law enforcement techniques alone would have very little impact.” Counties in northern Maine had reported 2.5 times as many arrests for prescription narcotics as the rest of the state. There were a lot of first-time offenders. Breaking and entering and strong-arm robberies were up 70 percent.11 McCloskey asked Purdue if it would help “reach an audience of health care providers to whom law enforcement generally did not have access.”12 Purdue dispatched Haddox, its chief operating officer, Michael Friedman, and legal counsel Howard Udell to meet with prosecutors, federal and state law enforcement officials, and local police chiefs at a conference McCloskey arranged.
McCloskey thought the trio seemed sincerely surprised at the “extent of the diversion.” They told the conference that during the thirteen years in which Purdue had sold a “similar product,” MS Contin, they “had not experienced any serious diversion problems.”13 That was not true, but no one besides the three Purdue executives knew that. Internal documents that became public years later as part of a 120-page Justice Department report revealed that in the late 1980s Purdue’s management knew there was a diversion and abuse problem with MS Contin. Michael Friedman received a memo that showed a $51 prescription of MS Contin (thirty tablets of 60 mg each) sold on the street for $1,050 (about $35 a pill).14 In 1990, Cincinnati police reported that MS Contin had surpassed heroin as the city’s most abused opioid. Other cities reported addicts either chewing the tablets or liquefying them for injection.15
“They pledged that they would do whatever they could to assist the efforts of law enforcement officials to address the illegal diversion of OxyContin,” McCloskey later recalled. Howard Udell told the conference, “We want to do what is right.”
“I remember these words very distinctly,” McCloskey later recalled, “and although I did not give any special weight to them at the time, I later recalled them on several occasions as I observed all that Purdue Pharma later did, and offered to do, in an effort to reduce OxyContin abuse.”16 Within a month, Purdue hired half a dozen consultants and instructed them to devise better ways for physicians to identify addicts and potential abusers. The detail team was told to end their sales pitches by reminding doctors that opioid-based painkillers such as Oxy were “common targets for both drug abusers and drug addicts.”17
Richard Sackler had become Purdue’s president the previous year, (evidently over the objections of Mortimer Sr.).18 The board promoted Mortimer D., Jonathan, and Kathe to vice presidents. The second generation was in charge. Purdue needed to be publicly as concerned as anyone in America at reports about OxyContin abuse.19 There was no contradiction in assuring public officials that the company would do its best to prevent diversion at the same time it aggressively marketed the drug. Those twin strategies would inevitably collide. The more successful the promotion and sales, the greater the likelihood of abuse and diversion. Yet, in 2000, Purdue believed it could have it both ways.
While the public relations department went into high gear with its “we are all in this together” message, Purdue applied for approval to the FDA for a 160 mg pill, double its then maximum dose.20 The FDA gave its okay that spring, intending it to be dispensed to a small number of patients who had developed tolerance to lower-dose opiates because of long-term treatment. To discourage patients who filled prescriptions and then sold the pills, physicians had to warn that such a mega-dose could prove dangerous, even fatal, for someone unaccustomed to opioids.21
When the 160 mg OxyContin went on sale in July, Purdue launched an ad campaign in medical journals, trade shows, and online videos, promoting it for both cancer and noncancer patients to treat a wide variety of musculoskeletal and postsurgical pain.22 Purdue hoped that it might capture some of the market for pain relief from the 700,000 annual knee replacements, 650,000 tendon repairs, and 500,000 lower back surgeries. (A later study demonstrated that patients who used opioids after surgery were twice as likely as the general population to misuse them eventually.)23
While Purdue saturated its top prescribers with a sales pitch for Oxy’s 160 mg version, it dispatched spokesmen nationwide to reassure local politicians and police that “we strongly support… law enforcement efforts to combat the abuse and misuse of OxyContin and other pain medications.”24 It announced a program to help physicians better identify drug dependence. Television and print ads in some of the hardest-hit markets warned teenagers not to abuse prescription drugs. Purdue also rolled out an outreach program, “Painfully Obvious,” that provided educational materials to parents and teachers.25
The Sackler-family directors hoped the news of OxyContin abuse might stay limited to the dozen small regional newspapers and television stations that had covered it. Although Dr. Robert Kaiko, OxyContin’s co-inventor, had warned only a year after the drug went on sale that it was “highly likely that it will eventually be abused,” Richard Sackler wanted instead to focus on how to “substantially improve your sales.”26 The first notice the Sacklers got of how naive it was to think that news of OxyContin abuse might remain a regional Appalachian story came in November when Michael Friedman, Purdue’s COO, learned a New York Times correspondent was “sniffing about.”27
That the Times was interested made the Sacklers anxious. At their next board meeting they adopted a strategy to “deflect attention away from the company owners.”28 It was a theme, the author learned, inspired by Raymond Sackler. He had urged Richard to emulate the National Rifle Association motto: “Guns don’t kill people, people kill people.”29 J. David Haddox represented the company when reporters called. The board thought as medical director he should concentrate on the pain relief benefits of OxyContin while steering clear of talking about the pill’s incredible commercial success (prescriptions had increased twentyfold in just four years).30
The February 9, 2001, front-page story, titled “Cancer Painkillers Pose New Abuse Threat,” was the first New York Times article to mention OxyContin. The 1,200-word story by Francis X. Clines with Barry Meier included firsthand accounts from law enforcement officials and health care workers at the front lines in seven states. Oxy abuse had “been tracked over the past 18 months” and some of America’s poorest districts had become the equivalent of legally sanctioned dope exchanges. “Addicts have been paying about $1 a milligram for the drug,” reported the Times. The hardest-hit regions were those in which heroin was too expensive or in short supply. Oxy was soon dubbed “hillbilly heroin” in remote areas of Kentucky and West Virginia (in other states it became “OxyCotton” or “OC”).31 I 32
According to the Times, OxyContin had in just a few years come from nowhere to become the favorite drug for addicts who “have learned to circumvent its slow time-released protection and achieve a sudden, powerful morphine-like high.”33 In some cities, Oxy was muscling aside heroin and it was behind a sharp uptick in overdoses, car accidents, workplace injuries, and even suicides. 34
“I personally counted 59 deaths since January of last year that local police attributed to addicts using the drug,” Joseph Famularo, the U.S. attorney in Kentucky, told the Times. “And I suspect that’s pretty conservative.’’ The paper quoted Haddox disputing the number of overdose deaths and warning that “inflammatory statements like that” might cause doctors to withhold the drug from patients suffering from chronic pain.35 Richard Sackler’s reaction to the article was relief. “That is not too bad. It could have been far worse.”36
Still, the Sackler-family directors felt as if the paper had picked on OxyContin because of its great success. According to one assistant marketing manager, they believed the press coverage was “patently unfair.” Law enforcement vilified popular prescription drugs in order to get bigger enforcement budgets.37 Benzodiazepines and amphetamines in the 1970s had given way to Quaaludes, then Adderall. Americans consumed the most opioids by far on the planet (a 2009 study confirmed by how much the U.S. was in the lead: 81 percent of the world’s oxycodone and 99 percent of all hydrocodone).38
Although OxyContin was Purdue’s top seller, it was then less than 10 percent of the opioid market. Johnson & Johnson, Janssen, Cephalon, and Endo Pharmaceuticals had their own narcotic pain relievers and their ads were as “aggressive” as any from Purdue. Their sales teams also pitched them for neck and back pain, and the companies subsidized many of the same nonprofits and patient advocacy groups as did Purdue. Janssen had even managed to get FDA approval in 1990 for the first ever fentanyl patch to treat severe pain. Fentanyl was then the most potent synthetic opioid, one hundred times stronger than morphine and 1.5 times more powerful than oxycodone.39 Two years after the FDA had given a green light to OxyContin, it approved Cephalon’s Actiq, a fentanyl “lollipop,” for cancer patients whose intense pain did not respond to other narcotics.40 Fentanyl patches and Actiq pops had been diverted illicitly for big profits and sometimes had deadly side effects. There were widespread rumors inside the industry that Cephalon’s detail team was pushing its lollipops off-label as “ER on a stick” for generalized chronic pain. It is understandable that the Sacklers wondered why the media was not writing about their rivals.II41
Inside Purdue there was a widespread belief that if OxyContin became the target of a “media frenzy,” sensational coverage itself might become a self-fulfilling prophecy. A media blitz that damned the relatively unknown drug as a modern-day scourge was much more likely to attract the attention of addicts and even casual drug users who wanted to see if it lived up to its notoriety.42
Only a month before the Times story, the Justice Department’s National Drug Intelligence Center had issued its first systemwide Information Bulletin concluding that “diversion and abuse of the prescription pain reliever OxyContin is a major problem, particularly in the eastern United States.” The bulletin warned that addicts were frequently substituting it for heroin and that the problem would worsen.43
In an internal Purdue email distributed the same month as the Times story, Richard Sackler said: “We have to hammer on the abusers in every way possible. They are the culprits and the problem. They are reckless criminals.”44 Sales representatives were instructed again that “patients were to blame for abuse and addiction, not the drug.”45 It was a more aggressive version of a defense that had been used by drug companies since Miltown came under scrutiny in the 1950s.46III
Hope of a respite from mainstream press coverage about OxyContin, however, was dashed a month later. Another front-page Times story, “Sales of Painkiller Grew Rapidly, But Success Brought a High Cost,” marveled at Oxy’s commercial success while extensively reporting more about its emerging dark side.47 “In a little over four years, OxyContin’s sales have hit $1 billion, more than even Viagra’s. Although the drug has helped thousands of people in pain, its success has come at a considerable cost.” A DEA official blamed the drug “in the deaths of at least 120 people, and medical examiners are still counting.”48
The tone of the Times coverage had changed in the month between the two stories. The first quoted police and doctors about OxyContin’s excesses and abuses. The second put the spotlight on Purdue by questioning if its aggressive marketing was partially responsible for the growing problem. A Maine pain treatment physician who threw a Purdue salesman out of his practice told the reporters, “They were pushing it for everything.” A pain specialist at New York’s Mount Sinai Hospital noted that while “all companies market… these people were in your face all the time.” A West Virginia pharmacist said, “The problem with this drug is the company.”49
The Times revealed that Purdue had paid for all-expenses-paid junkets for two to three thousand physicians to Florida, California, and Arizona. Hundreds of others were paid hefty speaker’s fees at some seven thousand Purdue-sponsored “pain management seminars.”50 The article also had the first brief background about the Sacklers, from the founding of Purdue Frederick by Arthur, Mortimer, and Raymond to the family’s “illustrious ties to the arts and sciences.”
The family directors refused interview requests. Haddox stuck to talking points emphasizing that Purdue was “as surprised as anyone” at OxyContin’s abuse. He disclosed that the company was researching how “to reformulate OxyContin” so it was more difficult for patients to abuse. That was true. Purdue was spending a lot of money to develop a way to foil, or at least make it tougher, to tamper with the pill’s time release technology. It tried adding a small amount of a narcotic blocker, naloxone, to counter the effects of the oxycodone. That might turn off users looking for a euphoric rush. The obstacle the researchers ran into was that no matter how they adjusted the dose and release time of the naloxone, it blocked too much of OxyContin’s pain relief.51 Purdue experimented next with converting Oxy from a tablet to a capsule and inserting microscopic beads of a different narcotic blocker, naltrexone. By the time Haddox had his second interview with the Times, that combination showed some promise, but it was in very early research.52
What caused the most anxiety inside Purdue from the March 5 Times story were a few sentences indicating that Oxy had attracted unwanted attention from several critical federal agencies. An unnamed DEA official told the paper that “no other prescription drug in the last 20 years had been illegally abused by so many people so soon after it appeared.” Dr. Cynthia McCormick, director of the FDA’s Anesthetics, Critical Care, and Addiction Drug Products, admitted the FDA had not adequately considered the many ways patients bypassed Oxy’s protective coating. “We’ve learned something from this,” she admitted. And finally, the Times reported, “Last Thursday, officials of five states met in Richmond, Va., to discuss ways to halt illegal traffic in OxyContin.”
The news might have been worse if reporters had followed the Sacklers’ pharmaceutical ownership to the U.K. There, MST Continus, OxyContin’s predecessor, had been on sale since 1980. The British government had charged Napp Pharmaceuticals with exercising monopoly powers in the U.K.’s narcotic painkiller market. Thousands of pages of filings spelled out the details of how Napp executives conspired to use discounts to 90 percent of British hospitals so that the low prices did not attract competitors. Then Napp charged up to ten times the list price when selling to the country’s National Health Service for individual patients. Mortimer Sackler oversaw Napp’s operation. The prosecutor’s case, which resulted in a $7.5 million fine and a strict consent agreement, provided a roadmap for how Napp had cut corners and skirted the law in pursuit of ever-bigger profits.53
The Sacklers soon had their hands full in the U.S. Purdue and its marketing of OxyContin were the subject of two preliminary investigations, one at the DEA and one by the U.S attorney in Virginia. Both would have wide-ranging consequences.
Laura Nagel, a twenty-two-year veteran of the DEA, had been promoted the previous year from the Criminal Division to become the deputy assistant administrator of the Office of Diversion Control. That was government-speak for the agent in charge of investigating the enormous illicit trade in prescription meds. Drugs subject to abuse came in and out of fashion. The DEA intervened when they began showing up in large quantities on the black market. Nagel knew there were plenty of ways that legal drugs got diverted. Doctors sometimes got greedy and operated pill mills; users forged or altered physician prescription pads or robbed drug company warehouses and pharmacies; free samples at doctor’s offices were sold to crooked pharmacists; health care workers stole from supplies at hospitals or nursing homes; and sometimes there was theft at the source, the pharmaceutical company’s manufacturing and distribution centers.
As Nagel settled into the new role, OxyContin was at the top of her list.54 The veteran agents in Diversion Control told Nagel that they believed Purdue was not doing anything to warn physicians and patients that their best-selling drug was far more addictive than what it claimed in its promotion.55
The DEA was aware Purdue had a problem at PF Laboratories, its Totowa, New Jersey, manufacturing plant. Nagel had reports the company could not account for small batches of pills at the end of some manufacturing runs. Were there compliance problems at PF Laboratories? She knew that a chemical explosion at New Jersey–based Napp Technologies in 1995 had killed five and injured forty-eight. Napp made MS Contin there. The Occupational Safety and Health Administration had considered filing criminal charges against the company for willful safety violations but ultimately brought only an administrative proceeding and settled for a $127,000 penalty.56 Except for local papers, the story had gotten lost under saturation coverage of the terror bombing at the Murrah Federal Building in Oklahoma City two days earlier. The Sacklers had authorized general counsel Howard Udell to settle all civil claims from the Napp explosion. OxyContin approval was then pending before the FDA and the family wanted no bad press that might in any way delay its release.57
Nagel had reviewed the OSHA report on the Napp explosion. The company’s fire brigade never had proper emergency training. The guidelines for mixing the volatile chemicals were ignored.58 Nagel wondered if there were similar shortcomings at PF Labs. There were strict protocols under federal law for manufacturing controlled substances.
In April, Nagel and some of her Diversion Control team met with Purdue COO Michael Friedman, the new medical director, Paul Goldenheim, and Howard Udell. Richard Sackler attended for the first half of a two-hour discussion. When Nagel asked about PF Laboratories, Udell said he did not know of any problem. That was a lie, the author learned. The reports of diversion had reached him at the Stamford headquarters.59 Purdue had hoped to keep the diversion at their New Jersey plant an internal matter, since the company was preparing to open a second manufacturing plant in North Carolina to meet the booming Oxy demand.
The DEA next presented evidence that abuse and deaths were up significantly since OxyContin went on sale in 1996. The troubling numbers tracked Oxy’s success from 300,000 prescriptions in its first year to nearly 6,000,000 by 2001.
At one stage, Nagel told Richard Sackler that “People are dying. Do you understand that?”60 All the Purdue executives disagreed that OxyContin was behind the spike in overdose deaths. The meeting ended in a stalemate, neither side able to agree on what measures Purdue should undertake. Nagel offered a final suggestion: Purdue should voluntarily limit Oxy sales to select pharmacies and restrict the detail team to oncologists and certified pain management specialists. The three Purdue executives stared at her blankly. Udell finally gave the noncommittal “We’ll take it under advisement.”61
Purdue knew the only federal agency with the power to regulate how it sold Oxy was the FDA. Still, as a sign of good faith to the DEA, a few weeks after that meeting, Purdue announced its “temporary suspension” of its mega-dose 160 mg pill. A press release said it was because the company was “concerned about the possibility of illicit use of tablets of such high strength.” Much of the evidence the DEA had provided about diversion and abuse involved that dosage. It had gotten the nickname “Oxy-Coffin.”62 Its potency meant it was much sought after by addicts, and drug dealers priced it at a huge premium compared to lower-strength Oxy street pills.63
Nagel wondered whether Purdue’s withdrawal of it was a temporary public relations play and it would reintroduce it when there was not as much scrutiny. To keep up the pressure, Nagel began drafting a “national strategy” to fight OxyContin abuse. She wanted to document the crisis with evidence that Purdue could not ignore or brush aside as “mere anecdotal stories.” She huddled with Frank Sapienza, chief of the Drug & Chemical Evaluation Section, Christine Sannerud, senior scientific advisor in the Diversion Control Division, and David Gauvin, a pharmacologist who was a senior drug science officer. They asked the National Association of Medical Examiners to collect and send to the DEA up to two years of autopsies in which there had been “oxycodone positive toxicologies.”64
While the science team analyzed those autopsies, Nagel kept the pressure on Purdue. In May, she publicly released her proposal asking the company to voluntarily limit its dispensing of Oxy.65 That caused an unexpected, sharp pushback from doctors who thought the idea draconian. There were so few licensed pain management specialists it almost certainly would force patients with chronic pain to go untreated.
The first private lawsuits charging that OxyContin had been overprescribed as a result of Purdue’s deceptive marketing were filed in Ohio, Kentucky, Virginia, and West Virginia. Most of the plaintiffs were outraged families who had relatives die while prescribed OxyContin.66 In early July, two employees at the Sackler-owned PF Laboratories were arrested and charged with theft of two thousand pills, worth an estimated street value of $160,000.67 That came shortly after fourteen arrests in a syndicate that forged prescriptions and got eight thousand pills covered by insurance.68 IV 69
By the time of the July arrests, the Sackler-family directors and top executives were not paying much attention to anything but their negotiations under way at the FDA. Curtis Wright, who had left the agency to work at Purdue as its medical officer for risk assessment, had stayed in touch with his former colleagues and had reported that the FDA was reviewing the OxyContin label it had approved in 1995. Some state prosecutors and victims’ families had petitioned the FDA to reevaluate the wording in light of emerging evidence of abuse and diversion. Purdue grudgingly cooperated in the hope it might influence any revisions to its label.70 There are no records of the private meetings between Purdue executives and FDA regulators. All that is available is the result of those talks. In July the FDA acted.71 It seemed as if the FDA had cracked down on Purdue’s hit drug, because it ordered the addition of a so-called black box warning. The bold font warning was a reminder to doctors that OxyContin was “a Schedule II controlled substance with an abuse liability similar to morphine.” No drug company liked having a black box warning added to its label, but as the author learned, Purdue was not that distressed since it considered the language a good compromise. One marketing executive remarked later, “It is black box lite.”72 It merely reiterated what most physicians knew already about OxyContin.
Many victims groups and prosecutors thought the original 1995 label had helped fuel OxyContin’s big sales. Although Purdue had not conducted any clinical trials to see whether OxyContin was less likely to be addictive or abused than other opioid painkillers, the FDA had approved the wording, “Delayed absorption as provided by OxyContin tablets, is believed to reduce the abuse liability of a drug.”73 The detail team highlighted that extraordinary sentence to persuade doctors it was a safer narcotic than its rivals. The FDA finally deleted that sentence on its 2001 label.74
The 1995 label declared that “iatrogenic addiction [one that resulted from treatment by a physician] is rare.” Purdue had also relied extensively on that in its promotion. The FDA’s 2001 revision was that addiction in “managed patients with pain has been reported to be rare.”75 That was a great disappointment to those who had expected the FDA to rely on recent studies that demonstrated the risk of addiction was “moderate to high.” Finally, on the 1995 label, the FDA had given Purdue a significant victory with the language that OxyContin was for “constant, moderate-to-severe pain that is expected to last a long time.” That was despite the existing science having only studied its active ingredient, oxycodone, for short-term safety and efficacy. Purdue cited that language to encourage doctors to prescribe Oxy for chronic ailments like back pain or arthritis.76 In the FDA’s 2001 revision, the label stated: OxyContin was “for the management of moderate to severe pain when a continuous, around the clock analgesic is needed for an extended period of time.”77
That provoked a furious reaction from victims’ families and patient advocacy groups.
“The label change was a blank check,” according to former FDA commissioner David Kessler, “one the drug industry cashed in for billions and billions of dollars. Now, Big Pharma had a green light to push opioids to tens of millions of new pain patients nationwide.”78
“If you’re taking them around the clock every day,” says Andrew Kolodny, co-director of the Opioid Policy Research Directive at Brandeis University, “you quickly become tolerant to the pain-relieving effect. In order to continue getting pain relief, you’ll need higher and higher doses.”79 That fit with Purdue’s marketing strategy of maximizing profits by getting physicians to dispense OxyContin for longer periods at ever-higher doses.
Ed Thompson, a drug manufacturer who made opioid products for several pharmaceutical companies for over a quarter century, told 60 Minutes in 2019 that changes such as the ones the FDA made on the 2001 OxyContin label “determine whether [a drug] can make $10 million or a billion dollars.… It opened the floodgates. It was the decision of no return for the FDA.”80
Inside Purdue the Sackler-family directors and marketing and sales departments were ecstatic. “The action by the FDA… has created enormous opportunities” was the conclusion of a widely distributed internal memo. Purdue’s advertisements to doctors soon reflected the emphasis on long-term dispensing. Sales tripled over the next two years.81
A month after their victory on the revised OxyContin label, the Sacklers sent COO Michael Friedman, general counsel Howard Udell, and senior physician Paul Goldenheim to testify before the House Subcommittee on Oversight and Investigations. Law enforcement officials told the committee that OxyContin was surpassing heroin and cocaine to become the top choice among addicts.82
The Purdue trio stuck to a prepared script, with more than half their time packaged as a veritable infomercial for OxyContin, replete with a tutorial about how pain had been historically undertreated and how Oxy had improved the lives of millions. The executives claimed they had no reason to expect there would be any abuse or diversion because there had been none with Purdue’s predecessor, MS Contin: “We had no reason to expect otherwise with OxyContin.” Friedman, Goldenheim, and Udell were smooth and no matter how hard the subcommittee pressed, they fell back on the theme that Purdue was doing everything possible to fight any abuse, which was, they insisted, exaggerated. They reminded the panel that “While all of the voices in this debate are important, we must be especially careful to listen to the voices of patients who, without drugs like OxyContin, would be left suffering from their untreated or inadequately treated pain.”V
The trio had honed their defense of OxyContin in more than one hundred presentations around the country. The only difference this time was that they were in front of a congressional committee. When they returned to Purdue headquarters, they received a standing ovation for their Capitol Hill performance.
The 9/11 terror attack on the World Trade Center and Pentagon took the focus far off Purdue for several months. By December, however, OxyContin was again in the news, and none of it was good. An $800,000 shipment of Oxy from the factory was stolen while in transport to Cardinal Health.83 An Indiana doctor who was in demand as a member of Purdue’s speakers bureau was arrested for illegally dispensing more than a million dollars in OxyContin to a drug ring and the state’s Medicaid program.84 CBS’s prime-time 48 Hours got its highest ratings for the year with an investigation into “OxyContin, a prescription painkiller that contains a synthetic opium and has become a lethal street drug.” MTV did the same with its True Life reality series and “I’m Hooked on OxyContin.”85 There were calls from state medical association directors in New York, Florida, Nevada, and Kentucky to develop prescription-monitoring programs that could more quickly identify overprescribing physicians and problem patients.86 The president of Odyssey House, a leading drug rehab center in New York City, warned that while it treated more crack cocaine and heroin addicts, “if this drug is not sufficiently controlled, that could change fast.”87
The low point came on December 12 before another congressional subcommittee. Asa Hutchinson, the chief of the DEA, blamed Purdue’s aggressive marketing for making OxyContin a drug of “disproportionate abuse.”88 Two hundred and eighty-two people had died from OxyContin overdoses in a nineteen-month period, charged Hutchinson. Purdue had dispatched the same executives who had testified before the House in August. Paul Goldenheim “vehemently disputed any suggestion that the company had inappropriately marketed” OxyContin.89
Harold Rogers, a congressman from a Kentucky district that was hit hard by OxyContin, pressed Goldenheim about instances in which physicians had greatly overprescribed. Why did Purdue not cut them off from getting the drug? “We don’t control what they prescribe,” said Goldenheim. “We can’t stop them from prescribing our product.”
“We can,” said Rogers.
The Sacklers did not take the threat of government restrictions lightly. They knew that Rogers had taken a hard-line stance since his district had so many OxyContin-related problems. Still, there was the chance that such sentiment could build. That was why Purdue wanted to always give the impression that it was leading the fight against abuse and diversion.90
Although 2001 was a troubled year for Purdue, there was one area that was stellar. OxyContin sales and profits hit a new record. Sales were up 41 percent year over year, bringing in $1.45 billion in revenue. It would break its own record again for the coming year (2002), with $1.59 billion in sales and accounting for 80 percent of Purdue’s business. Although OxyContin was under attack from government agencies and angry patients, it had become the top selling brand-name, controlled substance drug ever (a title it holds still as of 2019).91
The entire pharmaceutical industry was booming that year. It seemed in some ways as if OxyContin was just one of many drugs surging in sales. The top ten drug companies in the Fortune 500 had more combined profits than the other 490 companies.92
The DEA was using every tool not only to track the amount of OxyContin sales, but to know from which doctors and pharmacies it was prescribed and for which ailments. It was, Drug Enforcement claimed, a better indicator of the drug’s effect across the country. Were the number of prescriptions rising in tandem with the jump in revenue or was Purdue just charging more since it had a patent monopoly? In the case of OxyContin, it was both. Not only had the revenues soared, but so had the numbers of prescriptions. In its first full year (1997), doctors had written 920,000 scrips. In 2002 it ballooned to 7.2 million.93 What most alarmed those who believed that OxyContin was prescribed far too easily: only one million were for cancer-related pain. Nearly half the drug’s prescribers were primary care doctors. OxyContin had gone mainstream.94
I. Patients covered under Medicaid and retirees with Medicare soon discovered that the government listed OxyContin as a covered drug. So did private medical insurance for the large number of the miners and construction workers in those early-hit states. In June, Britain’s Guardian reported a Medicaid patient who paid $3 for a prescription of one hundred 80 mg pills could earn $8,000. That was a third of what the average person earned annually in those West Virginia and Kentucky counties.
II. By 2005, oncologists wrote only 1 percent of Actiq’s 187,076 retail pharmacy prescriptions. Eighty percent of the patients given the drug did not have cancer. One of Cephalon’s sales representatives was so concerned about the detail team’s off-label marketing that he contacted the FDA and later wore a surveillance wire to a sales conference to help the U.S. attorney gather evidence. In 2008, Cephalon paid $375 million to settle civil charges of Medicare and Medicaid fraud and a separate $50 million for a single criminal count of illegal off-label marketing. The court awarded Bruce Boise, the detail rep turned whistleblower, $17 million.
III. The blunt language in many of Richard Sackler’s emails and memos became a weak spot for the company as it defended itself in hundreds of lawsuits. Richard’s son, David, himself a Purdue director from 2012 to 2018, tried defending his father in a 2019 Vanity Fair interview: “He just cannot understand how his words are going to land on somebody.… For a person like that, email is about the worst medium possible to communicate in, because there is no other cue. And so he’s saying things that sound incredibly strident and sound incredibly unsympathetic, and that’s not the person that he is.”
IV. Two ex-employees sued Purdue, charging that the manufacturing plant’s supervisors had forced them sometimes to bypass security protocols that required all batches of the drug always be kept on the assembly line, and even had them fake counts of vials and caps to cover up pills missing in the final inventory.
V. Friedman also disclosed that Purdue had discussions with the FDA about developing a version of OxyContin that included an opioid antagonist: “We have developed several technologies that should enable us to achieve the goal of having an opioid medicine that is resistant to abuse by the oral route as well as by injection.”