A health crisis in need of rehabilitation
Part II: Twenty Year Anniversary of OxyContin
A unique distinction of the last decade was the rise in prescription opioid abuse. By 2001, the Center for Disease Control and Prevention (CDC) identified the crisis as an epidemic. But the story of the prescription opioid epidemic – in light of its total impact – can be simplified to one readily accessible pain medication and the brutishly enterprising company that supplied it.
Once a fact of life, many everyday discomforts have become problems to be solved by medication. However, this culture wasn’t created overnight. In fact, we have been progressing in this direction for quite a while. Since the introduction of direct-to-consumer advertising to the U.S. pharmaceutical industry, prescribing patterns have drastically changed. Hoffman & Roche were early beneficiaries when they brought Valium to the market in the 1970s. Having properties similar to alcohol but without the social stigma of daily use, it quickly became wildly popular with homemakers and business people coast to coast, earning it the nickname “mother’s little helper.” Valium helped re-categorize what discomforts were considered ‘normal.’ As the drug’s power was slowly brought into public awareness, the consumer demanded an alternative with a lower abuse potential. Eli Lilly & Company met this demand in 1988 when they introduced Prozac, and a new class of medication that would become exceedingly popular.
So in 1995, when the medical community was told of a way to revolutionize how we treated pain with a non-addictive, around-the-clock pill, the “trojan horse” with hardly a whisper from the once-cautious American consumer – forcing a new generation to experience an ominous warning from generations past… buyer beware.
In 1952 three brothers, psychiatrists by trade, bought Purdue Frederick Co., today known as Purdue Pharma. The oldest brother, Arthur Sackler, made great contributions to the study of both psychiatry and pharmaceutical advertising. He was among the trailblazers who highlighted the enormous possibilities of medical advertising in journals and TV. He developed what today is a highly criticized yet commonly employed tactic unique to United States healthcare: direct-to-consumer advertising. Using the momentum from a surging advertising industry in the mid-20th century, Sackler paired this to a culture that was ready to accept nearly any product seductively advertised with a promise to make people “feel better.”
Although very influential and well-accomplished in his career, his family business remained small and modestly profitable when poor health marked the end of his career. Controlling interest of the company was then assumed by brothers, Raymond and Mortimer, who took their older brother’s advertising methods and looked towards the pain industry.
Purdue Pharma began marketing OxyContin in 1996. Over the next few years, it would become the most costly and highly sought after drug in the world. Shortly after its release, allaying concerns of the drug’s highly concentrated narcotic ingredient and its potential dependence profile, the Food and Drug Administration (FDA) released the following statement:
Delayed absorption, as provided by OxyContin tablets, is believed to reduce the abuse liability of the drug.
It was a statement originating from the the manufacturer and readily accepted by the federal agency responsible for protecting and promoting public health and safety.
The American Journal of Health article, The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy, claims that leading up to its big release, the company increased their sales team from 318 to 671 employees; nearly all of these were trained and assigned to OxyContin. The theory was that since the number of cancer patients was not likely to significantly change, they would focus on non-cancer pain to broaden the indications for the drug’s use. To accomplish this it was necessary to produce evidence-based research to support the claims. Since none existed, the studies were fabricated. Company employees falsified study after study to the prescribing community, all expertly written and professionally presented. At the time of its release, the prescribers were ready to write for it, and the pharmacies had it in stock.
It was a so called perfect storm – a confluence of unbelievably aggressive marketing by the company, the inadequacy of education to medical students, and the utter failure by the regulatory bodies to regulate and reign in their membership to provide proper oversight for how their members were prescribing medications. All three permitted the explosion of OxyContin.
Sales reps first targeted a region known as Appalachia, an aging population beset by aches and pains from hard work and hard living. Many of the people had union benefits or social assistance that provided prescription medications for free; it was a drug company’s dream. Prescribers were courted across the country, told of the new product’s improved dependence profile compared with shorter acting alternatives. In turn, these doctors were then paid by the company to share the message. Having effectively reached the prescribers, all that was left were the students to guarantee the message would live on. In 2002, Purdue Pharma paid for and published Managing Pain: The Canadian Healthcare Professional’s Reference. It would become the gold standard for doctors treating patients for their pain. The manual also became part of the curriculum for major medical programs.
OxyContin represented a caliber of drug that mirrored heroin in nearly every way. It was a type that under other circumstances would be controlled by underground drug cartels – subject to indiscriminate pricing and unpredictable quality control. What was initially free from the social taboo or police attention of common street drugs was also paid for by most insurance plans. Best of all, each tablet came stamped with an FDA product quality guarantee.
The new pharmaceutical swept across a countryside. A product once toted as a “miracle” was being exposed as merely a wolf in sheep’s clothing. As the decade progressed, hospitalization costs and drug overdoses grew; while the human toll climbed, so did the economic one.
The Coalition Against Insurance Fraud estimated the cost from prescription painkiller abuse to total roughly $75 billion in 2010. Nearly half of that is from lost wages alone. The criminal justice bill is $8+ billion. The number of people seeking daily maintenance treatment at government-funded methadone clinics increased 600% since 1997 – a cost to tax payers well over $1 billion. It all adds up.
Medicare and private insurers paid for the drugs themselves, which many would obtain by visiting unscrupulous distributors known as “pill mills.” Pain clinics which were once difficult to find began popping up in every town. Considerable efforts have been made to regulate their operations. However, the pain clinics themselves did not create a nation in desperate search of pain relief – merely they met a demand.
By the turn of the century, the abuse data was undeniable. Purdue Pharma came under intense public scrutiny as allegations arose that the company knowingly withheld information about the product’s dependence potential. Corporate executives denied any wrong-doing or validity of the accusations. In 2007 they were brought to trial in a small Virginia town. The company and three top executives were indicted on felony charges of misleading the public, misbranding, public endangerment, and obstructing justice. They plead guilty to every charge. Their legal team negotiated a plea deal that removed all mandatory incarceration elements in favor of a monetary penalty that cost the company $700 million; the fine represents 3% of the drugs total revenue. The criminal charges were a moral victory for the activists who had seen the impacts from the drug; they were merely a setback for the company.
OxyContin earned the company $3 billion in annual sales, the largest profit ever generated from a drug product. The brothers who planned and plotted the illegal fabrication of clinical research and the exploitation of healthcare professionals have evaded criminal charges over the past twenty years. Recently the money has been used for Philanthropic efforts across the globe. Texas attorney and anti-drug activist, Kay Van Wey, had this to say about the drug-moguls in her article, Of Money and Mummies:
May the Sacklers know as they attend ribbon cuttings and fund art museums and exhibits all over the world that they are responsible for a modern day Holocaust of death and addiction throughout the U.S. and Canada by their part in the criminal marketing of OxyContin. Gives new meaning to the words ‘never again’.
In 2010, as the drug’s patent life neared expiration, the pharmaceutical was reformulated with an abuse-deterring gel filling, rendering it much less desirable to abusers. There was only one problem. We were left with a nation of opioid-dependents whose well had suddenly run dry. While media outlets boasted the success of anti-drug policies, the stratospheric ascent of heroin abuse quietly began. Prior to 1995, exposure was low. Social taboo and avoidance were enough for most to stay away, but in 2010 we weren’t dealing with an opiate-naive population. This was a group exposed to a powerful narcotic without a ceiling effect; many consumed large amounts over long periods of time. National averages that had not budged in forty years have increased exponentially. Scores of citizens have come to experience the unbridled force of opioid dependence. The cost has been uncontrollable; countless lives have been affected.
In less than twenty years, one blockbuster pain medication has put the Sackler family ahead of the Mellons and the Rockefellers in total wealth. According to Forbes, their fortune ranks sixteenth largest in the country. After reformulation in 2010, drug sales have dropped by nearly 90%. To off-set the losses, Purdue Pharma petitioned the FDA for pediatric market share. On August 14, 2015, OxyContin was approved for use in children ages 11 to 16. The CDC’s Morbidity and Mortality Weekly Report shows that heroin abuse has quadrupled over the past five years. With this have come all of the costs and hardships typically associated with the illicit drug. As the wave of OxyContin abuse washes out to sea, the specter of what had been lingers in its wake – leaving a generation of people on shore left to solve the problem.