The state of Kentucky may finally get its deliverance. After more than seven years of battling the evasive legal tactics of Purdue Pharma, 2015 may be the year that Kentucky and its attorney general, Jack Conway, are able to move forward with a civil lawsuit alleging that the drugmaker misled doctors and patients about their blockbuster pain pill OxyContin, leading to a vicious addiction epidemic across large swaths of the state.
A pernicious distinction of the first decade of the 21st century was the rise in painkiller abuse, which ultimately led to a catastrophic increase in addicts, fatal overdoses, and blighted communities. But the story of the painkiller epidemic can really be reduced to the story of one powerful, highly addictive drug and its small but ruthlessly enterprising manufacturer.
On December 12, 1995, the Food and Drug Administration approved the opioid analgesic OxyContin. It hit the market in 1996. In its first year, OxyContin accounted for $45 million in sales for its manufacturer, Stamford, Connecticut-based pharmaceutical company Purdue Pharma. By 2000 that number would balloon to $1.1 billion, an increase of well over 2,000 percent in a span of just four years. Ten years later, the profits would inflate still further, to $3.1 billion. By then the potent opioid accounted for about 30 percent of the painkiller market. What's more, Purdue Pharma's patent for the original OxyContin formula didn't expire until 2013. This meant that a single private, family-owned pharmaceutical company with non-descript headquarters in the Northeast controlled nearly a third of the entire United States market for pain pills.
OxyContin's ball-of-lightning emergence in the health care marketplace was close to unprecedented for a new painkiller in an age where synthetic opiates like Vicodin, Percocet, and Fentanyl had already been competing for decades in doctors' offices and pharmacies for their piece of the market share of pain-relieving drugs. In retrospect, it almost didn't make sense. Why was OxyContin so much more popular? Had it been approved for a wider range of ailments than its opioid cousins? Did doctors prefer prescribing it to their patients?
Because there was simply so much OxyContin available for over a decade, it trickled down from pharmacies and hospitals and became a street drug, coveted by teens and fiends and sold by dealers at a premium
During its rise in popularity, there was a suspicious undercurrent to the drug's spectrum of approved uses and Purdue Pharma's relationship to the physicians that were suddenly privileging OxyContin over other meds to combat everything from back pain to arthritis to post-operative discomfort. It would take years to discover that there was much more to the story than the benign introduction of a new, highly effective painkiller.
In 1952, brothers Arthur, Raymond, and Mortimer Sackler purchased Purdue Pharma, then called Purdue Frederick Co. All three men were psychiatrists by trade, working at a mental facility in Queens in the 1940s.
The eldest brother, Arthur, was a brilliant polymath, contributing not only to psychiatric research but also thriving in the fledgling field of pharmaceutical advertising. It was here that he would leave his greatest mark. As a member of William Douglas McAdams, a small New York-based advertising firm, Sackler expanded the possibilities of medical advertising by promoting products in medical journals and experimenting with television and radio marketing. Perhaps his greatest achievement, detailed in his biography in the Medical Advertising Hall of Fame, was finding enough different uses for Valium to turn it into the first drug to hit $100 million in revenue.
The Medical Advertising Hall of Fame website's euphemistic argot for this accomplishment states that Sackler's experience in the fields of psychiatry and experimental medicine "enabled him to position different indications for Roche's Librium and Valium."
Sackler was also among the first medical advertisers to foster relationships with doctors in the hopes of earning extra points for his company's drugs, according to a 2011 exposé in Fortune. Such backscratching in the hopes of reciprocity is now the model for the whole drug marketing industry. Arthur Sackler's pioneering methods would be cultivated by his younger brothers Raymond and Mortimer in the decades to come, as they grew their small pharmaceutical firm.
Starting in 1996, Purdue Pharma expanded its sales department to coincide with the debut of its new drug. According to an article published in The American Journal of Public Health, “The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy,” Purdue increased its number of sales representatives from 318 in 1996 to 671 in 2000. By 2001, when OxyContin was hitting its stride, these sales reps received annual bonuses averaging over $70,000, with some bonuses nearing a quarter of a million dollars. In that year Purdue Pharma spent $200 million marketing its golden goose. Pouring money into marketing is not uncommon for Big Pharma, but proportionate to the size of the company, Purdue’s OxyContin push was substantial.
Boots on the ground was not the only stratagem employed by Purdue to increase sales for OxyContin. Long before the rise of big data, Purdue was compiling profiles of doctors and their prescribing habits into databases. These databases then organized the information based on location to indicate the spectrum of prescribing patterns in a given state or county. The idea was to pinpoint the doctors prescribing the most pain medication and target them for the company's marketing onslaught.
That the databases couldn't distinguish between doctors who were prescribing more pain meds because they were seeing more patients with chronic pain or were simply looser with their signatures didn't matter to Purdue. The Los Angeles Times reported that by 2002 Purdue Pharma had identified hundreds of doctors who were prescribing OxyContin recklessly, yet they did little about it. The same article notes that it wasn’t until June of 2013, at a drug dependency conference in San Diego, that the database was ever even discussed in public.
Combining the physician database with its expanded marketing, it would become one of Purdue's preeminent missions to make primary care doctors less judicious when it came to handing out OxyContin prescriptions.
Beginning around 1980, one of the more significant trends in pain pharmacology was the increased use of opioids for chronic non-cancer pain. Like other pharmaceutical companies, Purdue likely sought to capitalize on the abundant financial opportunities of this trend. The logic was simple: While the number of cancer patients was not likely to increase drastically from one year to the next, if a company could expand the indications for use of a particular drug, then it could boost sales exponentially without any real change in the country's health demography.
This was indeed one of OxyContin’s greatest tactical successes. According to "The Promotion and Marketing of OxyContin," from 1997 to 2002 prescriptions of OxyContin for non-cancer pain increased almost tenfold. Meanwhile, in 1996 the FDA approved an 80mg version of the pill; four years later it approved a 160mg tablet. According to the FDA’s “History of OxyContin: Labeling and Risk Management Program,” higher dosages were approved specifically for opioid-tolerant patients.
These high-milligram pills were probably one of biggest reasons that OxyContin became such a popular street drug. Recreational users and addicts could crush, sniff, and inject the pill for a powerful high that, as promised, lasted over eight hours. The euphoric effects and potential for abuse were comparable to heroin. But clearly doctors and pharmacies never drew the ghastly parallel. Why?
The state of Kentucky's lawsuit against Purdue Pharma is not the first legal trouble the company has run into. In 2007, in United States of America v. The Purdue Frederick Company, Inc., Purdue and its top executives pleaded guilty to charges that it misled doctors and patients about the addictive properties of OxyContin and misbranded the product as "abuse resistant." Prosecutors found a "corporate culture that allowed this product to be misbranded with the intent to defraud and mislead." Purdue Pharma paid $600 million in fines, among the largest settlements in U.S. history for a pharmaceutical company.
From 1999 to 2010, the sale of prescription painkillers to pharmacies and doctors' offices quadrupled. In the exact same time span, the number of overdose deaths from prescription painkillers also quadrupled, rising to almost 17,000.
Perhaps knowing that doctors would be vigilant against prescribing drugs with the potential for abuse, Purdue set out to distinguish OxyContin from rivals as soon as it dropped. The cornerstone of its marketing campaign was the drug's incredibly low risk of addiction, an enviable characteristic made possible by its patented time-release formula. Through an array of promotional materials, including literature, brochures, videotapes, and Web content, Purdue proudly asserted that the potential for addiction was very small, at one point stating it to be "less than 1%."
The time-release conceit even worked on the FDA, which stated that "Delayed absorption, as provided by OxyContin tablets is believed to reduce the abuse liability of a drug." Armed with the time-release formula and misleading statistics about the risk of addiction, Purdue positioned the drug as a relatively safe choice for CNCP patients. Sales representatives told some doctors that the drug didn't even produce a buzz, according to USA Today. (This for a pill that has since drawn frequent comparisons to heroin in terms of analgesia, euphoria, and the propensity for addiction.)
Between physician databases, incentive-happy sales reps, and an aggressive blitz package of promotional ephemera, Purdue's multifaceted marketing campaign pushed OxyContin out of the niche offices of oncologists and pain specialists and into the primary care bazaar, where prescriptions for the drug could be handed out to millions upon millions of Americans. The most scathing irony is that what allowed OxyContin to reach so many households and communities was the claim that it wasn't dangerous.
Kentucky originally filed its civil suit, Commonwealth of Kentucky v. Purdue Pharma, over seven years ago, back in 2007. After years of Purdue Pharma fighting to keep the trial out of Pike County, and Kentuckians watching as the suit pinballed from appeals court to appeals court, at one point even being transferred to New York, Purdue has finally exhausted its adjournment artistry. Unless the pharmaceutical company wins its latest appeal in the state Supreme Court, trial will most likely begin this year.
Kentucky is filing a total of 12 claims against the company, including false advertising, Medicaid fraud, unjust enrichment, and punitive damages. In total the suit could cost Purdue Pharma $1 billion (which is just one-third of its annual revenues from OxyContin).
No state has been more devastated by the nationwide opiate problem than Kentucky. Much of the eastern part of the state and the Appalachians has watched as men, women, and teenagers fell victim to the potent pain pills. There were several different gateways—back injuries, operations, parents' medicine cabinets—but all of them led to an implacable addiction that rivals that of the hardest street drugs. And that’s the rub. Because there was simply so much OxyContin available for over a decade, it trickled down from pharmacies and hospitals and became a street drug, coveted by teens and fiends and sold by dealers at a premium (prices often shot up well over $1 a milligram, pricing the popular 80mg tablets at over $100 for a single pill).
Whatever the gray areas on OxyContin's many paths to perdition, the statistics on the first decade of this century bear out a staggering epidemic. From 1999 to 2010, the sale of prescription painkillers to pharmacies and doctors' offices quadrupled. In the exact same time span, the number of overdose deaths from prescription painkillers also quadrupled, rising to almost 17,000.
To call this a coincidence would be analogous to declaring no connection between loosening enforcement on drunk driving laws and observing a sudden increase in deaths caused by drunk driving. It goes almost without saying that these figures dovetail seamlessly with the release of OxyContin and Purdue's marketing timeline, which hit hardest in the early 2000s.
The figures on fatal overdoses, which in recent years have eclipsed the number of deaths caused by cocaine and heroin combined, speak nothing of the skyrocketing rates of addiction throughout the country. Funerals from overdoses are anguishing enough, but as places like Pike County know too well, fatalities are only one dimension of a problem whose insidious sprawl affects local economies and health care costs, incites crime, and ruptures families through the vagaries of addiction, rehab stints, and prison sentences.
The degree to which Purdue Pharma is responsible to Kentucky for a decade rotted and warped by its popular drug is still pending in the eyes of the justice system. Now that federal regulations have finally caught up to the pharmaceutical drug problem in this country and doctors have wised up to the sinister realities of the drug nicknamed "Hillbilly Heroin," the hard and fast days of OxyContin are over.
Many are now arguing that the epidemic hasn't gone away so much as it has evolved: Heroin use is again on the upswing. Like a shrewd virus that mutates once it confronts a vaccine, Americans' addiction to opioids has survived the government crackdown on OxyContin and fled to the seedy asylum of heroin. It's a kind of evolution in retrograde, with pill users turning to an old 20th-century scourge that once flourished in urban decay and is uglier, more stigmatized, and more lethal than its pharmaceutical counterpart. But for OxyContin, a drug that, despite its manufacturer’s many clever disguises, was always frighteningly close to heroin, there's a morbid sort of symmetry.