Despite the fact that the United States has weathered several drug epidemics fueled by narcotics derived from the papaver somniferum (opium poppy), this country finds itself in the middle of (yet another) major opioids crisis. This one differs from previous episodes in that it is the largest one in history, but it is similar in that it can trace its roots to the same genesis as the others – iatrogenic addiction. Whether intended or not, the medical community is largely responsible for the current situation and can consider drug manufacturers, drug distributors and pharmacies among its many accomplices. All of these groups have acted (at best) irresponsibly and (at worst) criminally to create and perpetuate the cycle of addiction, and each must recognize its contributions, take responsibility, make sweeping changes and learn from history in order to prevent it from happening again. Thousands upon thousands of preventable deaths can be attributed to opioids every year. These tragic outcomes affect all ages, races and socio-economic groups. There will always be a new, stronger, faster-acting, addictive drug on the horizon, so unless a comprehensive strategy that clamps down on the way they are prescribed and used is put in place, they will continue to be subject to abuse. Reform, accountability and action are imperative, or countless lives will continue to be destroyed, resulting in unnecessary illness, misery and death. This week’s article will examine the role that the drug companies played in the current crisis and next week’s installment will delve further into the physicians’ culpability.
Prescribers are undoubtedly complicit in this national crisis, but the subversive (and well-documented) tactics used by drug companies and drug wholesalers are largely responsible for its onset. Emboldened by unsubstantiated and unscientific claims about opioids – published by the New England Journal of Medicine (Porter and Jick, 1980) and Pain (Portenoy and Foley, 1986) drug companies sprung into action.
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“Most of the questionable practices that propelled the pharmaceutical industry into the scourge it is today can be attributed to Arthur Sackler.”
Dr. Allen Frances, Former Chair of Psychiatry, Duke University School of Medicine
In 1952, brothers Mortimer and Raymond Sackler (both psychiatrists), purchased a drug company called Purdue Frederick, whose main product at the time was a “medicinal tonic” called Gray’s Glycerine (see earlier article in this series about patent medicines). Under the brothers’ ownership, the company branched out and began to sell products of a less dubious nature, including laxatives and antiseptics. The third Sackler brother, Arthur (also a psychiatrist), helped financially with the purchase of the drug company, but was primarily busy working at an advertising company. Arthur, who by all accounts, possessed a brilliant mind, honed his marketing and advertising skills while working on a campaign for a new drug called Valium. This was a considerable challenge because another drug called Librium dominated the sedative market at that time and Valium was very similar chemically. Arthur’s acumen for advertising materialized when Valium became the first drug to reach the one hundred million dollar sales mark. But Arthur Sackler was just getting started.
Arthur’s keen insight told him that pain medication was the future, so in 1984 Purdue Frederick reformulated an old cancer drug into a time-release version and brought MS Contin (morphine sulfate continuous) to market. Primarily used for cancer-related pain, sales skyrocketed to hundreds of millions of dollars in sales, solidifying the company’s success in the growing pharmaceutical industry. At the end of the ‘80s and with patents for MS Contin about to expire, Purdue went to work to develop the next generation of pain medicines.
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“(Pain is) whatever the experiencing person says it is, existing whenever and wherever the person says it does.”
Margo McCaffery, American Nurse, 1968
Despite this nation’s history with physician-facilitated addiction, this definition of pain became the standard by which the medical community would conceptualize and treat pain for several decades. While doubtlessly well-intentioned, and spoken by someone who is considered a pioneer in the field of pain management nursing, this definition set the tone for generations of clinicians, including those who had not been adequately trained in pain management. Unfortunately, this characterization was predominant during the era that ushered in the nation’s worst addiction epidemic.
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By the time OxyContin came to market in 1996, advertising genius and eldest Sackler brother, Arthur, had been dead for nearly a decade. The die, however, had been cast, and Purdue continued on its trajectory of success. With the development a new controlled-release formulation of the existing drug oxycodone, the company was poised to become a juggernaut in the quest to treat pain. Though originally intended for cancer patients (a relatively stable population), it was eventually determined that OxyContin should also be marketed and used to treat chronic non-malignant cancer pain. It should come as no surprise that the success of this strategy exactly coincides with the beginning of the current opioids crisis. The stars were aligning.
Several things occurred in the mid 1990s that would bolster Purdue’s efforts. For starters, patient groups, academic journals and the federal government asserted that doctors weren’t doing enough to alleviate pain. Around this time, pain scales were introduced – these are the ubiquitous smiley face charts rating pain on a 1-10 scale that still populate treatment rooms. Also, in his keynote address at the annual conference of the American Pain Society, Dr. James Campbell, a neurosurgeon at Johns Hopkins University (and Society president) called for the medical community to consider pain “the fifth vital sign” and treat it accordingly.
These developments resulted in a prevailing attitude that doctors should endeavor not only to reduce pain, but to eliminate it completely. The American Pain Society trademarked the slogan “Pain: The Fifth Vital Sign,” and received funding from Purdue during Campbell’s presidency. The demand to eradicate pain completely was further advanced in 1998 when a memo from the Veterans Health Administration suggested “a comprehensive pain assessment and prompt intervention” upon a patient’s indication of 4 (or greater) on the pain scale. That same year, The Federation of State Medical Boards released a policy reassuring doctors that they wouldn’t face regulatory action for prescribing even large amounts of narcotics – provided it was in the course of medical treatment. The Joint Commission (who is responsible for accreditation of health care organizations) supported much of this sentiment.
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“The distributors knew what was going on. They just didn’t care.”
Sam Suppa, retired pharmacist from Charleston, West Virginia
All of these developments dovetailed nicely with Purdue’s desire to increase sales. Unfortunately, their zeal to flood the market with OxyContin outweighed any concern voiced by the medical community, the results of their own clinical trials and, perhaps most disturbingly, the wellbeing of the unsuspecting general public. Even before its release Purdue and its marketing company, Abbot Laboratories ignored scientific evidence, which proved its highly addictive nature as well as studies, which stated that the drug often fell far short of providing the twelve hours of relief that it promised.
Despite their awareness of the drug’s pitfalls and shortcomings, Purdue and Abbot went full steam ahead with an unparalleled marketing campaign. Fearing they would face resistance from doctors, they marketed OxyContin as having “a reduced risk for addiction.” Citing the scant and highly questionable “evidence” provided by Portenoy & Foley and Porter & Jick, Purdue undertook a systematic effort to downplay the drug’s addictiveness and endeavored to win over members of the medical community. Between 1996 (the year it was released) and 2001 thousands of doctors, pharmacists and nurses were treated to all-expense paid symposiums in California, Arizona and Florida. The purpose of these retreats was to recruit and train attendees to become part of Purdue’s National Speakers Bureau. Armed with incentives that ranged from plush toys to free-trial coupons for patients, Purdue aggressively sought to tighten their grip on the population that suffered with chronic pain.
It worked.
OxyContin reached forty-million dollars in sales in 1996, but hit over one billion by 2000. The sales force grew and so did the list of potential targets. General practitioners, dentists and OB-Gyns were soon fielding visits from Abbott sales reps, who likened their efforts to a “crusade,” and were supervised by a group of executives that was known within the company as, “The Royal Court of OxyContin.” Pedaling information that lacked scientific support, sales reps, aka “royal crusaders,” cajoled doctors into prescribing OxyContin by treating them to lunches and other incentives. Though doctors deny that these ploys don’t affect their prescribing practices, studies prove otherwise. Sales reps who were successful were the beneficiaries of large cash bonuses and sometimes even a royal title. Sales were further increased by the use of sophisticated marketing data that identified the highest and lowest prescribers in a given area. These prescribers could then be targeted accordingly.
This relentless pursuit resulted in billions of dollars worth of sales and an ever-growing population of people who were hopelessly addicted to a drug that had been legally prescribed to them. The addictive properties of the OxyContin were continually minimized and doctors were told to increase dosage amounts when the effects wore off prior to twelve hours. Pill mills (clinics that hand out prescriptions, no questions asked) sprung up as unethical doctors “titrated to effect” (prescribed any amount necessary to alleviate pain), and mom and pop pharmacies were suddenly dispensing staggering amounts of narcotics unchecked. Steven Passik a psychologist (and disciple of Dr. Portenoy), characterized the period: “It had all the makings of a religious movement at the time. It had that kind of spirit to it.” Purdue Pharmaceuticals made three billion dollars during the first five years that OxyContin was on the market.
Even as the epidemic worsened, the Joint Commission published a guide in 2003 that was sponsored by Purdue. It stated that, “Some clinicians have inaccurate and exaggerated concerns about addiction tolerance and risk of death.” And astonishingly, “This attitude prevails despite the fact that there is no evidence that addiction is a significant issue when persons are given opioids for pain control.”
Predictably, the parties involved in creating this catastrophe all blamed each other for the growing number of addicts. Systems that were in place to check suspicious drug orders were routinely ignored as patients continued to believe that OxyContin was safe because a doctor had prescribed it. Drug abusers found ways around safeguards designed to prevent diversion (using the drug in unintended ways) and a black market sprung up in response to high prices. People sold their prescription pills on the street at inflated prices and then purchased less expensive heroin to support their habits. By 2004 OxyContin was the leading drug of abuse in the United States.
2007 was the first time that Purdue was forced to take some responsibility for the opioids crisis. The company and three of its executives pleaded guilty to criminal charges of misleading doctors and patients about the addictive properties of the drugs and for misbranding it as “abuse resistant.” They were fined six hundred and thirty-five million dollars.
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The three Sackler brothers have all died, but their legacy endures not only because of their association with Perdue Pharma and OxyContin, but also for their philanthropic efforts. Starting in the 1970s, they began to donate what has become millions of dollars to museums and cultural institutions. One of their most significant gifts was a three and a half million-dollar donation to the Metropolitan Museum of Art in 1974. The endowment was used to construct the Sackler Wing, which was built to house The Temple of Dendur. The Temple was given to the United States by Egypt in 1965 and (according to the Met) “was a dwelling in which rituals were enacted to nurture deities who would ensure the prosperity of the community.”
Surrounded by a dramatic sloping wall of windows and a massive reflecting pool, The Temple of Dendur was recently the site of an anti-opioids protest led by famed photographer (and former opioids addict) Nan Goldin. She, along with several dozen protesters, gathered in the Sackler Wing to call for cultural institutions to reject money from the Sackler family on the grounds of their connection with the addictive drugs. The group threw prescription bottles into the reflecting pool and about fifty of the protesters laid down on the floor in a symbolic “die-in.” Afterwards they walked through the museum chanting, “Sacklers lie! People die!” Brilliant Arthur Sackler, who was inducted into the Medical Advertising Hall of Fame in 1997, would not have missed the irony of The Temple (whose very existence was meant “ensure the prosperity of the community) being used as a locale to protest the dangerous consequences of opioid abuse.
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Admirably, Dr. Russell Portenoy, the early opioids champion, has amended his opinion considerably. In 2012 he said, “I gave innumerable lectures in the late 1980s and ‘90s about addiction that weren’t true.” And: “Clearly if I had an inkling of what I know now then, I wouldn’t have spoken the way that I spoke. It was clearly the wrong thing to do.”
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