Download The Rise and Fall of OxyContin: A Critical Analysis of the Opioid Crisis and more Study Guides, Projects, Research Administrative Law in PDF only on Docsity!
Suslavich 06593360
OVERDOSE: THE PUBLIC HEALTH POLICIES THAT CREATED THE OPIOID CRISIS
CONTENTS
Introduction................................................................................................................................................. 1 Part I............................................................................................................................................................ 5 The Origins of the Pain Movement in the United States.......................................................................... 5 The History and Approval of MS Contin and OxyContin........................................................................ 8 The Approval of OxyContin—How the FDA Overlooked Problems.................................................... 15 Part II......................................................................................................................................................... 18 The Pain Rights Public Health Policy.................................................................................................... 18 American Pain Society.......................................................................................................................... 21 Joint Commission.................................................................................................................................. 24 State Pain Management Legislation and State Medical Boards............................................................. 28 Table 1: A list of examples of pain policies created by States........................................................... 31 CMC and HCAHPS............................................................................................................................... 36 Part III....................................................................................................................................................... 43 The Reversal of Pain Policy—When the cure is worse than the disease................................................ 43 Where do we go from here?................................................................................................................... 49 Conclusion............................................................................................................................................. 52 INTRODUCTION Addictive substances have played in an important role in shaping societies and economies throughout human history. The pharaohs of Ancient Egypt paid farm laborers in beer.^1 Falernian wine was a prized commodity in the ancient world, and thus many establishments in ancient Rome sold fraudulent Falernian wine to bolster sales.^2 The British notoriously were able to seize control of the 19th^ century Chinese economy by introducing cheap opium into the country.^3 The incredible influence that addictive substances have has not gone away. Addictive substances are to this day, shaping the history of both the United States and the world.
Suslavich 06593360 Opioid addiction is one of the most devastating health crises that the United States (U.S.) has ever faced. In 2020 alone, approximately 92,000 persons died in the U.S. as a result of a drug overdose.^4 The cost to the U.S. economy is estimated to be between $631 billion and $2. trillion.^5 This cost has been rapidly rising over the years.^6 In 2013 , approximately 1.9 million people reported a dependence or abuse of prescription opioids.^7 The cost of the opioid crisis comes not only from the cost of additional medical care, the cost of preventing illicit black- market synthetic opioids, and the fallout that addiction has on communities, but also comes from the loss of productive members of society.^8 Similar to the tobacco litigation of the 1990s, many localities have initiated lawsuits against manufacturers of opioids.^9 While the litigation has appeared to focus on Purdue Pharma, other manufacturers such as Johnson and Johnson, Janssen Pharmaceuticals Inc, , and Teva Pharmaceuticals have been defendants in these suits.^10 In addition, pain management groups and pain specialists have been named in complaints as well for promoting the aggressive prescription of opioids.^11 Furthermore, opioid distributors and pharmacy retailers such as AmerisourceBergin, Walgreens, and CVS^12 Some officials have capitalized on this extensive litigation to assign blame for the national crisis with New York Mayor Bill de Blasio stating that “It’s time [to] hold the companies accountable for what they [have] done to our City [.... ]”^13 While opioid litigation appears to parallel the tobacco litigation, the opioid cases have been consolidated into nationwide multidistrict litigation under 28 U.S.C. §1407, currently before Judge Dan Polster in the northern district of Ohio.^14 Judge Polster has taken a more holistic view of the responsibility for the opioid crisis, opining: [I]n my humble opinion, everyone shares some responsibility, and no one has done enough to abate it. That includes the manufacturers, the distributors, the
Suslavich 06593360 these drugs is important because it shows who was funding (at least initially) the public health policies that catalyzed the opioid crisis. Part II of this study will explore the pain policy and how it was enforced on all levels of the government and medical organizations. Part II will look closely at the formal origin of the policy, and track the policy’s propagation from medical committees of “experts”, into hospital accreditation organizations, state legislatures, medical boards, and the federal government. Part II will also explore how these organizations and agencies strong-armed doctors to force them into compliance with the new national health initiative. In Part III, the study will look at how additional “backlash” policies and the retraction of pain management protocols exacerbated the opioid crisis, dramatically causing unprecedented numbers of deaths due to drug overdoses within the U.S. The purpose of this study is to better understand how well-intended public health policies lead to disastrous consequences, not only for individual patients but for entire countries. PART I The Origins of the Pain Movement in the United States In the 1960s and 1970s opioids were not often prescribed; many physicians considered them dangerous drugs. The United States was recovering from large amounts of heroin use during the 1970s, and opioids were seen as “gateways” for the illicit use of powerful narcotics.^16 However, the sentiment changed when Dr. Russell Portenoy published a series of medical papers in the late 80’s highlighting just how effective opioids were at managing pain. This series was inspired by a 1980 letter sent to the New England Journal of Medicine by Jane Portal and Dr. Hershel Jick.^17 The letter by Portal and Jick stated that despite widespread use of Meperidine, Percodan, and
Suslavich 06593360 hydromorphone in their clinic, neither physician foundthat a significant number of patients became addicted.^18 Thus, the letter concluded that the development of addictions using opioids is rare.^19 While it may appear to be innocuous, this letter created a shift in national policy that metastasized into a nation-wide medical disaster.^20 Over the years, the letter was cited numerous times as “a landmark study” proving that the “fear [of addiction] is basically unwarranted.”^21 The World Health Organization (WHO), declaring the letter as a cornerstone of the future of pain treatment, stated that the fear of addiction and subsequent diversion^22 of opioids into illicit channels is “ill-founded.”^23 In 1986, Dr. Portenoy co-authored a paper that studied the effects of opioids on 38 patients and reported that opioid therapy is a safe alternative to surgery in the treatment of non-malignant pain.^24 Dr. Portenoy believed that opioids should be used liberally to treat chronic pain and pointed to two factors that he believed were preventing medicine from embracing modern analgesic drugs: ignorance of the pharmacology of analgesic drugs and “inappropriate concerns about psychological dependence on opioids.”^25 In Dr. Portenoy’s opinion, both of these factors were “perpetuated and compounded by a striking lack of emphasis in medical education on pain and its management and the limited availability of opioid drugs [... ] within the United States.^26 For his support in encouraging the use of opioid analgesics, Perdue Pharma and other opioid makers selectively paid Portenoy for studies that supported the conclusion that furthered the agenda of the drug manufacturers.^27 The manufacturers, to promote opioid analgesics, would reference the positive statements made by Portenoy without providing any background or analysis of his literature.^28 The development of Portenoy’s studies is important to the history of the opioid crisis because research and ideas often build upon the results of prior studies. However, if the underlying
Suslavich 06593360 morphine or heroin by injection; thus, patients seeking pain management would need to be treated at the hospital.^38 In 1981, Napp Pharma released a groundbreaking medication designed to replace heroin—a time-release morphine pill that would eventually be called MS Continus (or MS Contin for short) which utilized Napp Pharma’s “Contin” system.^39 The Contin extended- release delivery system worked by first blending morphine sulphate with a hydrophilic cellulose.^40 This dry powder was then hydrated with a polar solvent such as water and an aliphatic alcohol, the ratio of which controlled the release of the drug.^41 MS Contin changed the game for pain treatment for Europe. Dr. Ian Clarke of the North West Pain Relief Centre at Hope Hospital stated in the London Times that MS Contin as “the most important advance in narcotics this century.”^42 Napp Pharma often quoted the Times article in its advertisement, and the Sackler’s were quite proud of their achievement.^43 Determined to expand the market for MS Contin into the United States before competitors, Perdue began distributing MS Contin in the United States. Unfortunately for Perdue, the FDA required all new drugs to go through the standard New Drug Application (“NDA”); however, at the time there was a rapidly closing loophole in the law.^44 Under the Food, Drug, and Cosmetics Act (“FDCA”) and implementing regulations, the FDA regulates prescription drugs and is tasked with ensuring that prescription drug marketing and promotion is truthfully and accurately communicated.^45 Enacted in 1938, the FDCA established a premarket review procedure for all new drugs by requiring manufacturers to obtain an effective NDA.^46 At that time however, certain drug products were exempted from the new FDCA requirements if they were marketed before the implementation of the FDCA. This was known as the 1938 “grandfather exemption.”^47 In 1962, the FDCA was amended to require the FDA to evaluate the effectiveness of prescription drug products which were marketed prior to 1962.^48 This review became known as the Drug
Suslavich 06593360 Efficacy Study Implementation (“DESI”) project.^49 However, the FDA policy was to continue allow manufacturers to market new unapproved products or to change existing unapproved products after 1962 as long as the new or changed product was “identical, similar, or related to a pre-1962 drug product of unresolved regulatory statutes.”^50 In essence, the “grandfather exemption” loophole was available even after the DESI project was initiated—provided a drug was identical, similar, or related to the original product. This all changed in 1984 when the FDA revised its compliance policy to fully remove the “grandfather exemption” loophole—a drug would no longer be similar or related to a pre- drug if either the formulation, dosage, strength, dosage form, route of administration, indication for use, or intended patient population changed from the original drug.^51 Under the old standard, Purdue probably could have released MS Contin into the United States since morphine sulfate was one of the oldest analgesics still used in medicine at the time.^52 However, since MS Contin used a different dose of morphine sulfate as well as an entirely new delivery mechanism, a NDA would be required under the new FDA policy of 1984.^53 When Perdue heard that the expungement of the “grandfathered” drug exception was imminent, it put MS Contin on the market in October of 1984^54 without notifying the FDA.^55 Eventually, the FDA discovered that Perdue had circumvented the NDA process, and the agency sought to recall MS Contin from the market.^56 Ordinarily, Perdue’s noncompliance would instigate recall and the filing of an NDA to start the lengthy FDA approval.^57 However, between the time Perdue released MS Contin and the time the FDA discovered the noncompliance, many cancer patients had become dependent on MS Contin to treat their pain; thus, abruptly removing MS Contin from the market would be devastating.^58 As a result, the FDA chose to let Perdue continue selling MS Contin without traditional approval.^59 In only a few years, MS Contin
Suslavich 06593360 were advocating more aggressive pain treatment and management, and Perdue capitalized on Dr. Portenoy and Foley’s recommendations by marketing their new Oxycodone based drug OxyContin as an analgesic for all pain.^71 However, since controlled-release oxycodone is 1. times more powerful than controlled-release morphine, Purdue’s ambitious goal of obtaining FDA approval not only for cancer pain, but also for general pain relief for moderate to severe pain would be a challenge.^72 The concept behind the design and marketing of OxyContin appeared to be selling the drug as an extended-release Percocet (acetaminophen and oxycodone).^73 Provided that OxyContin could be approved to treat general chronic pain as opposed to only cancer pain, OxyContin would be able to lead the market of general-use narcotic analgesics. The Approval of OxyContin—How the FDA Overlooked Problems In 1995, the FDA approved Perdue’s OxyContin as an analgesic. OxyContin was an effective tool in the management of pain with controllable analgesic behavior and no ceiling effects.^74 The 1995 label warned that OxyContin could be habit-forming and that, like all opioids, individuals could form a tolerance or experience feelings of relaxation and euphoria.^75 Purdue argued that OxyContin was less addictive than similar opioids because of its extended-release formula.^76 However, in reality, OxyContin offered no advantage over appropriate doses of other opioids for patients.^77 OxyContin’s marketing campaign consistently emphasized that the drug minimized the risk of iatrogenic addiction. An estimated 3-16% of the general population is predisposed to naturally form an addiction to opioids such as oxycodone;^78 however, Purdue continued to market OxyContin as having less than a “one percent” risk of addiction.^79 The marketing clearly worked because by 2002, Perdue’s OxyContin accounted for 68% of national oxycodone sales.^80 The
Suslavich 06593360 FDA, grossly under resourced at the time, never properly addressed or even questioned Purdue’s dangerous dissemination of information. Notably, in 2002, the FDA had only 39 staff members responsible for reviewing the entirety of promotional materials, including consumer advertisements and promotions to physicians.^81 However, the lack of FDA oversight on the promotional materials for drugs was moot since the FDA accepted Purdue’s claims (by way of approving labeling) that stated that iatrogenic addiction was “very rare” because of the delayed-release mechanism of OxyContin.^82 There were no studies at the time showing that OxyContin’s delayed-release mechanism produced less risk of addiction; moreover, there is no evidence that the FDA ever pressured Purdue to show proof of its claims. In fact, the FDA might have very well known that Purdue’s claims about the abuse of OxyContin were false by 2002. On April 12, 2002, a meeting occurred between the FDA, the Drug Enforcement Agency (DEA), and Purdue at the DEA’s Washington headquarters.^83 Present at that meeting were Dr. Debra Leiderman, then director for controlled substances in the Center for Drug Evaluation and Research at the FDA, and Purdue’s own COO, Michael Friedman, Chief Counsel, Howard Udell, and Purdue’s medical director, Paul Goldenheim.^84 Presumably, at this meeting, an unauthenticated PowerPoint containing two years of data that the DEA had compiled from the National Association of Medical Examiners was discussed.^85 The data showed that OxyContin had become favored by those addicted to opioids and was responsible for an increasing number of overdose fatalities.^86 Drug abusers had discovered that by crushing or chewing OxyContin, all of the oxycontin would be released at once, causing a quick heroin-like high.^87 Interestingly, as if almost providing instructions to potential abusers, the FDA subsequently issued a black box warning on the OxyContin package inserts recommending
Suslavich 06593360 Figure 1 : The number of prescriptions dispensed for Opioid Analgesics vs. the number of prescriptions for oxycodone extended release from U.S. outpatient pharmacies.^91 In the 1990s, the United States was in the clutch of a nationwide public health movement to put patient pain at the forefront of overall medical care. Although it is difficult to state exactly where the movement began, it appears the movement originated from several young doctors who began to question the general consensus of medicine: that high strength analgesics should be reserved for the terminally ill, or those in extraordinarily high pain. Instead, these doctors suggested that narcotic analgesics should be more accepted for more routine pain management. This movement was likely a spin-off of a similar movement that occurred in the United Kingdom a decade prior which advocated for the more liberal use of opioids for hospice care.^92 Initially, the intentions of the patient pain movement likely originated from a place of compassion for the sick and dying—especially in cancer patients. Looking at the initial sale of MS-Contin in the US, opioids taken orally in pill form allow those with debilitating chronic pain to regain their lives.^93 Unfortunately, the pursuit of perfection is often the enemy of good. Somewhere in between the initial pain movement and the mid-1990s, the movement changed. At best, someone saw the success of the pain movement for cancer and end of life care and
Suslavich 06593360 concluded that if opioid analgesics could help those patients, the same drugs could be used to help all patients who suffered from pain.^94 At worst, those who had a financial stake in the U.S. analgesic market realized the tremendous opportunity if only doctors would change their prescribing habits. Regardless of the motivations behind the movement, the message that constituent patients are in pain and doctors are being needlessly cautious with their prescription pads was an easy sell to policymakers.^95 Within a couple of years of the new pain movement being introduced, nearly every level of government which deals with healthcare law adopted the new public health policy.^96 The problem with this rapid uniform adoption is that no one hesitated, much less questioned the validity of this policy until almost a decade after its adoption. To make matters worse, the validity of the policies was often presented by “specialists” as being medically sound and their accuracy was beyond reproach since the views were based on the newest breakthroughs in medical thought. The issue was that almost all the “specialists” were wrong. This article will thus look at the implementation of pain management policies within the United States and show how they caused the US opioid crisis. American Pain Society In the early to mid-1990’s, the American Pain Society (APS), introduced a campaign to promote the concept of pain management in hospitals across the United States. In his 1996 Presidential Address, Dr. James Campbell of the APS began to compare modern analgesics to the discovery of drugs such as penicillin and that pain should be considered the “fifth vital sign.”^97 Dr. Campbell and the APS’s position was that medicine needed to “train doctors and nurses to treat pain as a vital sign [and that] [q]uality care means that pain is [... ] treated.”^98 In addition, Dr. Campbell and the APSs went on to proffer that ‘chronic pain’ comes in many forms aside from
Suslavich 06593360 Figure 2 : Email from Dr. Richard Sackler illustrating the intention of Purdue Pharma to influence the APS to support the "pain movement."^106 It appears that the mentality of Purdue Pharma was to increase the sales of OxyContin by increasing the overall market for analgesics. In other words, instead of increasing the slice of the pie, the goal was to make the pie much larger; however, small professional societies only influenced the market to the extent that physicians took their recommendation. Doctors, on the other hand, have the discretion on what they will prescribe to patients.^107 Thus, in order to truly expand the market, Purdue would need to force the hand of doctors. Joint Commission The Joint Commission on Accreditation of Healthcare Organizations (Joint Commission) is a health-care program assessor that accredits more than 20,000 health care programs across the country.^108 Hospitals have essentially two options to operate: hospitals can be licensed by the State and submit to State inspections to verify compliance, or hospitals can be accredited by the Joint Commission.^109 The Joint Commission can promulgate and enforce rules on hospitals and, if non-compliance is found, can revoke accreditation.^110 In addition, since the Joint Commission is a private organization, it is not subject to notice and study requirements that a government
Suslavich 06593360 agency would be.^111 However, the Joint Commission has a close working relationship with the government since accredited hospitals are considered to meet both state licensure requirements as well as the Medicare health and safety standards.^112 The Joint Commission is not only affected by government but also has a profound effect on government itself. In the late 1980s, 39 states and the District of Columbia had incorporated the Joint Commission’s hospital accreditation requirements, in whole or part, into their own state or district’s hospital licensure system.^113 This influence would eventually contribute to the spread of bad medical policy into government. 114 In 2001, the Joint Commission implemented patient pain assessment and management standards to all accredited healthcare providers.^115 The goal of the Joint Commission’s new policy was to increase the likelihood that patients would have pain both recognized and treated by health care providers faster.^116 The Joint Commission readily adopted the language of the APS and regarded pain as the “fifth vital sign” for a hospital’s care of patients.^117 To ensure consistency across departments and institutions, the 0-10 scale and the Wong Baker FACES Pain Rating Scale (smile-frown) was to be used.^118 It should be noted that the Joint Commission was not the only medical organization to adopt these standards. For instance, the Veterans Health Administration incorporated routine assessment of pain as the “fifth vital sign” in 2000.^119 It was found that these pain ratings were wholly ineffective at monitoring patient pain and the overall quality of medical treatment received.^120 However, what is perhaps the most troubling aspect of the Joint Commission is how the organization was influenced pressured by Purdue and others in the analgesics market to create the new pain policy.^121 To be fair, lobbyist can influence government in detrimental directions as well, but the difference is that the government is at least
Suslavich 06593360 the Joint Commission’s pain standard, Purdue funded programs throughout the country to help educate physicians and staff on how to stay in compliance.^128 However, given the extremely aggressive approach the Joint Commission took towards treating pain management, as opposed to fixing the underlying cause of the pain, compliance could realistically only be achieved through aggressive prescribing.^129 After all, the treatment of pain was now a matter of a patient’s rights and any dissent against the mandate of the Joint Commission may lead to the organization taking action against the hospital.^130 While the standard never explicitly commanded that doctors prescribe opioids, the command was nevertheless unambiguous—doctors should be treating patient’s pain with more opioids.^131 The trouble that doctors, who would otherwise be hesitant to prescribe opioids, encountered with the new standard was that non-narcotic analgesics such as ibuprofen and acetaminophen are not as effective at treating severe pain because they have a ceiling effect.^132 The ceiling effect means that an increase in dosage does not increase analgesia but does increase side effects.^133 While non-narcotic analgesics are not addictive, there is no assurance that they will actually stop all of the pain because of the ceiling effect.^134 If the goal is to eliminate pain, then giving non-narcotic analgesics to a patient is a gamble for physicians whereas giving narcotic analgesics like opioids is a sure bet that the physician will be in compliance with the standard. Thus, when standards use words such as ‘prioritizing pain management,’ ‘effective pain management,’ or ‘patient’s pain rights,’ that translates into the requirement for doctors to prescribe opioids. State Pain Management Legislation and State Medical Boards While the implementation of the Joint Commission’s pain policy was assisted by the support of pharmaceutical manufacturers such as Purdue and societies such as the APS, the same cannot be said for many State Legislatures. The first opioid related pain management policy to surface
Suslavich 06593360 came out almost a half-decade before Oxycontin would be released into the market. Almost every state contributed to this. In May of 1998, through the adoption of model guidelines, the Federation of State Medical Boards (“FSMB”) determined that, as a matter of policy, it was imperative that state medical licensing boards transition to fully eliminate untreated pain.^135 The FSMB adopted guidelines such as forming a treatment plan for pain relief, and after diagnostic evaluations, the physician should start drug therapy adjusted to the individual medical needs of the patient.^136 The FSMB encouraged “physicians to view effective pain management as part of quality medical practice,” and that “[a]ll physicians should become knowledgeable about effective methods of pain treatment as well as statutory requirements for prescribing controlled substances.”^137 The FSMB went on to state in their preamble to the model guidance that “[i]nadequate pain control may result from physicians’ lack of knowledge about pain management or an inadequate understanding of addiction.”^138 The FSMB Model Guidelines are unique because, unlike many medical board standards, the FSMB mentions opioids by name. The FSMB states that “[p]ain should be assessed and treated promptly” and that “[p]hysicians should recognize that tolerance and physical dependence are normal consequences of sustained use of opioid analgesics and are not synonymous with addiction.”^139 What the FSMB likely wished to accomplish with their updated guidelines was to expand the use of opioids. This article will now go through each of the states and look at the policies which were enacted as a result of these model guidelines. Furthermore, as further explained in Part III of this Article, many states had a complete reversal of policy around 2008-2012 that attempted to disincentivize prescribing narcotic analgesics to outpatients. The reversal of policy described in
