by Olivia Hayward
I. The Epidemic
Dr. Wayne “Art” Van Zee, a physician who specializes in addiction medication in Lee County, Virginia, was among the first to recognize the ravages of OxyContin misuse in 2000. It was he who made federal agencies aware of the marketing misconduct by OxyContin manufacturer Purdue Pharma. Having treated many patients with narcotics, Dr. Art Van Zee witnessed first hand, the tragedies of OxyContin. His poem encapsulates the scope, scale, and carnage of the progressing opioid epidemic. What began in the 1990s as a sharp rise in prescription-drug overdoses has been replaced by a frightening surge in deaths caused primarily by illicit synthetic opioids and heroin. Today, the opioid crisis is embedded in the framework of American life. Barry Meier, Pulitzer Prize-winning New York Times reporter and author of Pain Killer, An Empire of Deceit and the Origins of America’s Opioid Epidemic, reflects on the current crisis, “In hospitals, newborns, separated from the narcotics coursing through the bloodstream of their addicted mothers, enter the world writhing in the pain of opioid withdrawal. On the streets, police officers carry a new piece of standard equipment, a nasal spray containing medicine that could save the life of a person in the midst of an overdose.”1 Newspapers, magazines, commercials, and broadcasting programs are suffused with reports of the devastation caused by opioid overdoses in large and small communities alike. One person every eleven minutes, 130 people a day, and over 47,000 people a year die from overdoses on opioids in the United States alone - making it the deadliest drug epidemic in American history.2 The Center for Disease Control estimates the total economic burden of prescription opioid misuse in the US resembles a $78.5 billion dollar figure.3 Following the lead of both President George Bush and President Obama, Donald Trump declared the opioid crisis a national Public Health Emergency and appointed a panel to propose research, treatment, and recovery solutions in October of 2017.4 Nonetheless, opioid overdose deaths continue to climb rapidly.
The question looms, who or what is responsible for this “napalm”? The answer, while nuanced, is that although the government does bear some responsibility, the actions of one company are primarily to blame. Introduced in 1995, OxyContin was America’s breakthrough prescription “wonder drug.” However, OxyContin was not an entirely new drug. In fact, OxyContin is Purdue Pharma’s brand name for the drug, oxycodone which was first developed in Germany in 1916. Essentially, Purdue introduced a time-release mechanism to this pre-existing drug to "lessen" the addictive nature.5 Purdue claimed the drug was safe and effective, despite having valid scientific evidence to support this claim. Yet, Purdue achieved both the approval from the FDA and the approval of thousands of physicians and patients alike. According to Barry Meier, a New York Times reporter, “The FDA allowed Purdue to make the claim that because it was a long-acting drug, it might — the stress being on the word “might” — be less prone to addiction and abuse than traditional drugs.”6 The FDA failed to thoroughly examine the risks and request scientific evidence regarding the plausibility of Purdue Pharma’s OxyContin claim before negligently approving the drug. Once approved, Purdue Pharma aggressively marketed the drug using long-established tactics that were first instituted by Arthur Sackler, an advertiser who purchased Purdue in 1952. As Purdue continued to assertively market OxyContin, prescriptions rose in number, and mortality rates accompanied this rise. Yet, as physicians began realizing the negative effects of OxyContin, fears of addiction skyrocketed and physician-mandated prescriptions began to decline as a result. However, mortality rates still continue to soar as thousands have turned to a cheaper and more accessible replacement: illicit synthetic opioids and heroin. Evidently, the FDA is partially to blame for igniting the epidemic. Likewise, the Sackler family and its drug manufacturing company, Purdue Pharma, are prime examples of the destructive power of “Big Pharma” and deceptive marketing; having also played a major role in unleashing and fostering the opioid epidemic in the United States.
II. The Approval
While the Federal Drug Administration did not directly market the drug to physicians, it did play a significant role in releasing OxyContin for use and as a result, kindling the abuse crisis. The job of the FDA was, and still is, to ensure appropriate access to analgesics while also making sure to mitigate any risks associated with the abuse of such drugs. In the 1990s, Purdue Pharma worked tirelessly, running a multitude of clinical trials to gain FDA approval of OxyContin. In 1989, Purdue conducted its first clinical study, utilizing women recovering from abdominal and gynecological surgery at hospitals in Puerto Rico.7 In the study, designed, managed, and paid for by Purdue, 90 women received a single dose of OxyContin while other patients received generic, short-release painkillers. “Over a third of the women given OxyContin started complaining about pain in the first eight hours and about half required more medication before the 12-hour mark.”8 The study revealed that OxyContin provided relief and lasted longer than the short-release painkillers but did not last the full 12 hours. Shortly after this study, in the company’s 1992 Patent submission, Purdue claimed OxyContin to be, “a medical breakthrough that controlled pain for 12 hours “in approximately 90% of patients.”9
However, as further studies showed, several patients taking OxyContin every 12 hours asked for more before their next scheduled dose.10 For example, in a study based on cancer patients, “one third of those given OxyContin dropped out because they found the treatment “ineffective.”11 Researchers revised the study to permit patients to take extra painkillers known as “rescue medication,” in addition to the 12-hour doses of OxyContin.12 To secure FDA approval, Purdue had to prove the safety and effectiveness of the drug while also adhering to FDA permitted duration guidelines. These guidelines mandated that Purdue give viable evidence proving OxyContin lasted 12 hours for at least half of patients. Accordingly, Purdue submitted the 1989 Puerto Rico study and obtained FDA approval in 1995. Dr. Curtis Wright of the FDA led the medical review of OxyContin, and when pressed to provide information for an LA Times Magazine article, he “declined to comment.”13 This rejection was not surprising to the article’s authors as Dr. Wright left the FDA not long after the approval, “and, within two years, was working for Purdue in new product development.”14 Similarly, when The LA Times asked the FDA to comment on OxyContin’s failure to provide 12 hours of pain relief for several patients, “officials at the agency declined to be interviewed.”15 These responses demonstrate the extent to which the FDA was complacent in enabling the authorization of OxyContin as well as condoning Purdue’s 12-hour relief claim.
In 1995, OxyContin became the first opioid to be approved by the FDA, and the verdict was based on science that stated it was safe and effective solely for “short term” pain relief.16 Dr. David Kessler, the FDA commissioner during the approval process stated, “There was a belief, based on the data, that if you controlled the release, you would not get the highs and lows associated with addiction.” He also acknowledged, “There was a kernel of truth in that, but it ended up not being used in that way.”17 6 years after the first approval, “in 2001, pressured by big pharma and pain sufferers, the FDA made a fateful decision and with no new science to back it up, expanded the use of OxyContin to just about anyone with chronic ailments.”18 The FDA authorized this advancement and approved the label stating OxyContin as a “12 hour drug.” While many doctors had complaints regarding OxyContin’s inability to last, Purdue reps were trained to recommend increasing the strength of one dose rather than the frequency. Ed Thompson, the owner of PMRA, and Pennsylvania pharmaceutical company has recently filed a suit against the FDA, urging them to, “follow the science and limit the opioid label to short term use.”19 In an interview with the Clarion Ledger, Dr. Kessler of the FDA, declared in hindsight, “No doubt it was a mistake. It was certainly one of the worst medical mistakes, a major mistake.”20
III. The Man Who Shaped the Industry
Unfortunately, this major “medical mistake” initiated an aggressive marketing endeavor by Purdue Pharma. However, before delving deep into the marketing tactics used when promoting OxyContin, it is essential to address where the tactics originated. The tactics were first established by one man: Arthur Sackler. Arthur Sackler began his career as an advertiser for a small marketing firm known as William Douglas McAdams. In 1951, he landed a job with Charles Pfizer and company with the goal of marketing and selling the company’s new synthetic antibiotic: Terramycin. With the intention of turning Charles Pfizer and Company into a “house-hold name among doctors,” Sackler’s campaign focused on periodic contact with doctors involving individual sales visits, a radically new marketing endeavor. Sackler’s marketing tactics were labeled “radical” and rightly so, given he kept frequent tabs on physicians across the country to ensure that, “Doctors already known to prescribe a lot of drugs got extra mail.”21 Sackler’s innovative tactics brought him much success. Thus, anticipating the future of his career in ‘Big Pharma,’ Sackler decided to purchase the marketing firm he worked for, William Douglas McAdams, in addition to purchasing an “unknown” drug company: Purdue Frederick, along with his two brother Raymond and Mortimer in 1952. Before they purchased Purdue, the company was little-known for selling antiseptics, a laxative, and an earwax remover.22
Not long after, in 1963, Sackler continued emphasizing physician contact to promote a new drug called Valium. He essentially manipulated the role stress plays in physical pain, and accused physicians of being negligent unless they treated stress symptoms with drugs such as Valium. Sackler promoted the idea that “a pill could solve any ailment.”23 Win Gerson, a long time partner of Sackler’s, remarked on the subject, “It kind of made junkies out of some people, but that drug worked.”24 In fact, it worked so well Sackler’s campaign for Valium made it the industry’s first $100 million dollar drug and "marked the emergence of modern pharmaceutical advertising, a field that up to then, in the words of one executive, "existed but it didn't."25 Acceding Sackler’s success, numerous other drug companies began marketing their drugs in a similar manner. Subsequently, after Arthur Sackler passed away in 1987, he was inducted into the Medical Advertising Hall of Fame, for having “helped shape the industry through creative and innovative accomplishments in every aspect of advertising.”26
Following Arthur Sackler’s death in 1987, Arthur’s brothers Mortimer and Raymond Sackler took control of the company and renamed it Purdue Pharma. Nearly four decades following Arthur’s groundbreaking promotion of Valium, Purdue Pharma began producing a new painkiller strikingly similar to Valium, and promoting it through Arthur’s ad firm, William Douglas McAdams.27 This new breakthrough painkiller was called OxyContin. The marketing techniques used by Raymond, Mortimer, and Arthur Sackler’s nephew, Richard Sackler, to promote OxyContin were identical to the ones Arthur implemented when advertising Terramycin and Valium.
IV. The Letters that Fueled Crisis
When OxyContin was first introduced in 1995, the drug was marketed as a "smooth and sustained" time-release pill with virtually no abuse potential. Purdue fabricated this claim through the meticulous manipulation of two sources. One being a single-paragraph letter from The New England Journal of Medicine in 1980, and the second being a study from the journal, Pain, published in 1986. Purdue morphed the data from both sources in order to fit the claim that “less than one percent of patients treated with opioids become addicted,” despite having grounded scientific evidence to validate that conclusion.
In 1980, a 100 word ‘letter to the editor’ by Dr. Hershel Jick and his co-author Jane Porter of the Boston Collaborative Drug Surveillance Program at Boston University medical Center, was published in the New England Journal of Medicine with the headline, “Addiction Rare in Patients Treated With Narcotics.” The letter outlined their findings regarding hospitalized patients treated with a minimum of one dose of a narcotic painkiller. Within the approximately 12,000 patients who received at least one narcotic preparation, they determined, “there were only four cases of reasonably well documented addiction in patients who had no history of addiction.” The final verdict: “addiction was considered major in only one instance [...] despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction."28
However, there was no data about how often, how long, or what dosage these patients were given; nor the ailments the opioids treated. Thus, “the paragraph simply cited the numbers and made no claim beyond that."29 It was Purdue Pharma that took the letter out of context and used it to shape a narrative that allayed prescribers' very real concerns about the risk of addiction affiliated with long-term opioid use. Purdue falsely used the findings to say that fewer than one percent of patients treated with opioids become addicted. This statement was routinely cited in multiple advertising pamphlets, sales pitches, and lectures. Jick recently told The Atlantic, “I’m essentially mortified that that letter to the editor was used as an excuse to do what these drug companies did.”30
The second piece of writing that was manipulated was a study published in 1986 in the journal Pain.31 The study deduced that, for non-cancer related pain, opioids “can be safely and effectively prescribed to selected patients with relatively little risk of producing the maladaptive behaviors which define opioid abuse.”32 However, this conclusion was made alongside the acknowledgement that opioids should be seen as an “alternative”33 method of relief, not a long term solution. It is important to note that both studies were short-term studies of patients on narcotics that yielded limited conclusions as a result. Nonetheless, the letter and the study laid the foundation for a broadened role for prescription opioids.
V. The Promotion of the “Wonder Drug”
Beginning in 1995 and continuing well into the 2000s, Purdue Pharma aggressively marketed and greatly profited from the false portrayal of OxyContin. From the onset, Purdue Pharma intentionally misinformed consumers of OxyContin’s addictive nature through pro-opioid research projects, direct-to-consumer advertising, and the manipulation of pain perception under the marketing strategy Arthur Sackler pioneered. At nearly the same time as both medical journals mentioned above were published, Purdue Pharma began to forcefully market OxyContin for long-term, non-cancer pain; a relatively new enterprise.34 Prior to the 1990’s, the U.S. consumption of opioids was slim to none. And if prescribed, opioids were used for the final stages of cancer pain. For a long time, doctors avoided treating pain with opioids due to fears of addiction. Ironically, Purdue’s marketing campaign focused on convincing doctors that the undertreatment of pain was a major public health concern. One of the main ways Purdue Pharma got this concern across and promoted OxyContin to doctors and patients was through “key opinion leaders,”35 marketing materials such as videos, pamphlet ads, and “educational” courses for physicians.
Early on, Purdue targeted and appointed well-known and respected physicians to be "key opinion leaders.” The appointed doctors already supported the idea that pain was undertreated and believed opioids should be more liberally prescribed. For example, Dr. J. David Haddox was a long time “key opinion leader” who helped create the term: "pseudoaddiction."36 According to Haddox, “Pseudoaddicts, were pain patients who displayed common drug-seeking behaviors [...] Pseudoaddiction looked a lot like addiction,” Haddox said, “but it wasn't addiction.” When some doctors expressed concerns about addiction, Purdue replied by saying their patients suffered from pseudoaddiction. Haddox claimed that the solution to “pseudoaddiction” is “more pills.” He made this counterintuitive claim based off of a study of a single cancer patient. Although the study was based solely off of one patient, Purdue immediately utilized the new word - pseudoaddiction - and “liberally sprinkled it throughout educational materials. The company also hired Haddox and made him a top executive."37
Additionally, Purdue sponsored videos of patient testimonials sent to doctors in the late 1990s revealed how marketing trumped science as more and more physicians began prescribing. Purdue’s internal budget documents from 1998 outlined a marketing objective to “achieve $220 million dollars in factory sales”38 and “to continue to expand OxyContin use by marketing it as the opioid to start with and stay with.”39 That document also revealed the company’s main selling points; one was that OxyContin was “easy to live with.”40 One specific campaign video created that year and titled “I Got my Life Back,” highlighted 6 opioid prescribed patients.41 This particular video was distributed to 15,000 doctors across the country.42 Two years later, Purdue released a follow-up to show that the patients remained stable and the pills, successful. The physician who prescribed the opioids, Alan Spanos, weighed in on the subject, stating how the patients showed that “when pain treatment is successful - it stays successful.”43 This was far from the truth. 15 years after this follow-up video, members of Advocates for the Reform of Prescription Opioids, Inc. reached out to the same 6 patients to see how they were doing. The advocates found that 3 out of the 6 patients suffered from addiction and 2 out of the three 3 who were addicted died as a result. The one victim who suffered through withdrawal and survived stated, “If I was still on OxyContin I’d probably be dead.”44 Sadly, since the making of the promotional video, more than 100,000 Americans have died from opioid overdoses.45 Dr. Michael Barnett, a physician and assistant professor at the Harvard T.H. Chan School of Public Health, said, “some of Purdue's early marketing claims may have seemed reasonable to many doctors 20 years ago.” However, he faulted the medical profession for, “not demanding scientific evidence that opioids were in fact safe and prudent for widespread use.”46
On a similar note, Purdue distributed countless brochures and instituted education programs targeting addiction worries. In 2000, Purdue faced many challenges regarding the abuse and diversion of OxyContin in the states of Maine, Ohio, Virginia, Louisiana, and Florida.47 Noticing that these challenges would continue to hinder success of OxyContin, Purdue increased educational and public relation efforts to address “patients in need of substance abuse counseling.”48 They also worked to abolish “myths and misconceptions about addiction and tolerance."49 One specific pamphlet, “Partners Against Pain,”50 declared, "Drug addiction means using a drug to get 'high' rather than to relieve pain. You are taking opioid pain medication for medical purposes. The medical purposes are clear and the effects are beneficial, not harmful. This fear (of addiction) should not stand in the way of relief from your pain." Purdue Partnered with the Veterans Administration and the American Pain Society in an effort to make Pain: “The 5th Vital Sign.”51 This initiative positioned Purdue as the “leader in pain management education."52 As a result, The American Pain Society published guidelines that advocated for doctors to expand their use of prescription narcotics to relieve pain. Deceiving physicians and patients through marketing materials, complimentary pain-management seminars, and frequent sales visits, Purdue’s sales soared, growing from $48 million in 1996 to approximately $1.1 billion in 2000.53
This success was also in part due to Purdue Pharma’s lucrative bonus system. In 2001, Purdue implemented an Incentive Bonus Program with two components: “representatives who attain quota qualify for a "base bonus" equal to 1.5% of quarterly net dollar sales and representatives who exceed quota by more than 1% qualify for a growth bonus based on the percentage of growth in net dollar sales over quota."54 That year, Purdue paid $40 million in sales incentive bonuses to its sales representatives.55 This system fostered a competitive sales environment and rapidly ramped up company profits.
Evidently, advertising techniques were incredibly misleading as they utilized real people presenting incorrect information. This led doctors and patients suffering from pain to believe opioids were virtually non-addictive and effective for long term use. What prescribers pharmacists, and patients didn’t know was that this was a far cry from the truth. Prescription opioids are dangerously similar to heroin, and the risks of addiction increase with each additional day.
VI. The Rise in Prescriptions, Addiction, and Death
As drug manufacturers assured health care officials that OxyContin was safe and abuse-resistant, physicians and other health care providers began prescribing opioids at increased rates. Before releasing OxyContin, Richard Sackler declared, “The launch of OxyContin will be followed by a blizzard of prescriptions that will bury the competition. The prescription blizzard will be so deep, dense, and white.”56 This rise in opioid proliferation contributed not only to an increase in abuse and death rates, but also to the diversion of painkillers onto the black market - bolstering illegal consumption. In Florida, one of the state’s most effected, “prescription drug overdoses increased by 84 percent from 2003 to 2009. During this period, the greatest increase in death rate was observed for oxycodone.57 Rates of addiction and death skyrocketed. Subsequently, Purdue sent representatives across the country to defend OxyContin. They blamed the heightened mortality rates on patient misuse and insisted their pill was safe and effective if taken as directed.58 In an attempt to shift the blame, Sackler stated in an internal memo from 2001, “We have to hammer on abusers in every way possible. They are the culprits and the problem. They are reckless criminals.”59 Dr. Art Van Zee of Virginia mentioned on the subject, "some people who became addicted were drug abusers but there clearly are people that I've taken care of who took it as directed orally and became opioid addicted."60
VII. Purdue in Court
Many physicians like Dr. Art Van Zee began began doubting Purdue Pharma’s claims and in 2007, Purdue Pharma faced their first lawsuit. They pleaded guilty to defrauding doctors and consumers. In the end, they wound up paying $634.5 million in civil and criminal fines. In a statement, the company said: “Nearly six years and longer ago, some employees made, or told other employees to make, certain statements about OxyContin to some health care professionals that were inconsistent with the F.D.A.-approved prescribing information for OxyContin and the express warnings it contained about risks associated with the medicine.”61 The statement then went on to read, “We accept responsibility for those past misstatements and regret that they were made.”62 In the end, individuals and the company as a whole faced major fines. The three top former and current Purdue Pharma executives, as well as Michael Friedman, the company’s president, had to pay $19 million in fines. Furthermore, Howard R. Udell, Purdue’s top lawyer, payed $8 million, and Dr. Paul D.
Goldenheim, Purdue’s former medical director, payed $7.5 million.63 In addition, Purdue also consented to independent monitoring of its practices. While Purdue and the company’s top executives did face incredibly high fines, money will never account for the number of lives destroyed. Purdue was placed on probation for three years but the company returned yet again with an aggressive sales push. The deceptive sales did not end after this lawsuit, as the term ‘pseudoaddiction’ still surfaced when employees sold the drug.
In January of 2018, however, Purdue Pharma claimed that it “cut its sales force in half and will stop promoting opioids to physicians, following widespread criticism of the ways drumakers market addictive painkillers.”64 Amid the opioid epidemic, 24 states and more than 400 cities and countries are suing Purdue Pharma, accusing the company of fueling the crisis through deceptive marketing.65 The lawsuits have blamed Purdue of intentionally down-playing OxyContin’s risk of addiction and abuse. Nonetheless, Purdue has denied numerous allegations, affirming that OxyContin and it’s label were approved by the FDA.
VIII. The Shift to Heroin and Fentanyl
As lawsuits surfaced, and OxyContin became harder and more expensive to get, prescription opioid use decreased as those addicted to painkillers turned to illicitly manufactured opioids. Data from the Substance Abuse and Mental Health Services Administration (SAMHSA) reflects, “heroin use rose sharply for people ages 12 to 49 between 2007 and 2011.”66 This was the result of many factors, the main one being the nationwide crackdown on prescription drug abuse. As federal and state authorities focused efforts on eliminating “doctor shopping,” the process by which a patient requests opioids from multiple doctors, and “pill mills,” the distribution of opioids without medical reason, OxyContin became much more difficult to obtain. In addition to state crackdowns, the FDA took steps to limit the number of pills doctors could prescribe at one time. As a result, the price of OxyContin rose greatly. Consequently, many opioid-dependent patients turned to heroin, a much cheaper alternative, thus contributing to the ongoing drug epidemic.67 The National Institute of Drug Abuse reports, “nearly 80% of heroin users started with prescription opioids.”68 Moreover, “during the 1999-2016 time frame, overdose deaths from heroin increased 7x.
And deaths from synthetic opioids like fentanyl increased almost 21x.”69 Illicitly-made fentanyl is sold illegally for its heroin-like effect, “often mixed with cocaine as a combination drug—with or without the user’s knowledge—to increase its effects.”70 These illicitly-made drugs such as heroin and fentanyl are cheaper but dangerously more harmful than prescribed opioids, having no FDA standards for safety or quality control. As addiction continued to sweep the nation, Donald Trump declared the opioid crisis a public health emergency in October of 2017. And while there have been efforts to address addiction treatment and combat the selling of illicitly manufactured opioids, the three decade long fight continues.
IX. Massachusetts’s Fight
The fight against the opioid crisis, deceptive marketing, and most notably Purdue Pharma persists with the most recent lawsuit filed by the state of Massachusetts. Maura Healey, the Massachusetts Attorney general who filed the suit, tweeted, “The opioid epidemic is killing 5 people every day in Massachusetts. We will hold Purdue Pharma and its executives accountable for the death and devastation they caused.”71 Shown above the tweet was a disconcerting statistic: “11,169 lost to opioid-related overdose in Massachusetts, 2008-2017.”72 The 274 page complaint filed by Healey underscores Purdue Pharma’s negligence mentioning how, early on, Purdue Pharma was aware of OxyContin abuse, including "reports that the pills were being crushed and snorted; stolen from pharmacies; and that some doctors were being charged with selling prescriptions,” but still marketed the drug as less addictive.73 The lawsuit reveals Purdue Pharma’s deep-seeded marketing ploy and the intense measures that were taken to advertise the drug. In retaliation, Purdue called the complaint inaccurate and ironically, “misleading.” However, the thorough complaint proves in reality, Purdue was doing the “misleading.” In fact, Purdue targeted physicians in virtually every part of the Commonwealth, allocating sales representatives to fixed territories in Massachusetts.74 The complaint notes, “Since the 2007 Judgment, Purdue sales reps visited Massachusetts prescribers and pharmacists more than 150,000 times.”75 (See appendix 1)
X. Conclusion
In conclusion, while the FDA may be partially to blame for approving the highly addictive drug OxyContin, the deceptive marketing of one company, Purdue Pharma, triggered and bolstered the opioid epidemic in the United States. While it took several years to fully uncover the company’s misconduct, today, multiple newspaper articles, documentaries, podcasts and comprehensive reports filed by state generals urgently call for justice. Barry Meier, the first journalist to elucidate the abuse of OxyContin, declared in his book, Pain Killer, “OxyContin was not a “wonder” drug. It was the gateway drug to the most devastating public-health disaster of the twenty-first century.”