Also available as PDF (figures and tables appear in the PDF).
In March 2016, the Centers for Disease Control and Prevention (CDC) issued newly updated guidelines to address the growing opiate epidemic in the United States.1 The long awaited issuance from the CDC has not been without detractors, however, with many criticizing its scope as short-sighted and advantageous to corporate interests.2 The backlash is not unexpected, particularly when contextualized alongside the alarming growth in the rate of addiction and mortality associated with opioid and opiate-derivative prescription in contemporary society.
Keywords: Industry; Modern Opioid Crisis
Ravi Katari, MD* Department of Emergency Medicine, The Mount Sinai Hospital, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA *Corresponding author Ravi Katari, MD Resident Physician Department of Emergency Medicine The Mount Sinai Hospital Icahn School of Medicine at Mount Sinai 1 Gustave L. Levy Place New York, NY 10029, USA E-mail: ravi.katari@mountsinai.org Article History Received: August 22nd, 2016 Accepted: August 31st, 2016 Published: September 1st, 2016 Citation Katari R. The role of industry in the modern opioid crisis. Toxicol Foren- sic Med Open J. 2016; 1(1): 21-23.
doi: 10.17140/TFMOJ-1-104 Copyright ©2016 Katari R. This is an open access article distributed under the Creative Commons Attribution 4.0 International License (CC BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Volume 1 : Issue 1 Article Ref. #: 1000TFMOJ1104 The Role of Industry in the Modern Opioid Crisis Page 21 Opinion In March 2016, the Centers for Disease Control and Prevention (CDC) issued newly updated guidelines to address the growing opiate epidemic in the United States. 1 The long- awaited issuance from the CDC has not been without detractors, however, with many criticiz - ing its scope as short-sighted and advantageous to corporate interests. 2 The backlash is not unexpected, particularly when contextualized alongside the alarming growth in the rate of ad- diction and mortality associated with opioid and opiate-derivative prescription in contemporary society.
In 2008, prescription painkillers were estimated to have been responsible for approxi- mately 14,800 overdose deaths: a figure which rose above deaths attributed to cocaine and heroin combined. 3 In 2014, the number reached 28,657 in the United States. 4 This number includes overdoses due to heroin, a type of opiate. However, heroin is not without significance in this topic given that four out of five individuals addicted to heroin began with prescription opioid painkillers.5 Europe is an interesting comparison, demonstrating a decline in overdose deaths: 7,100 to 6,100 in 2009 and 2013 respectively. 6 According Robert Anderson, the Chief of Mortality Statistics at the CDC, the situation has grown comparable to the HIV epidemic in the late 1980̕ s and 1990's. 7 Opioids contributed to more than 61% of overdose-related deaths in 2014 (increases in drug and opioid deaths).
Drug overdose, the leading cause of accidental death in the United States, has grown concomitantly with prescription pain reliever sales and admissions related to substance use dis- order treatment.8 From 1999 to 2008, the overdose death rate grew by 400%, sales of prescrip- tion painkillers grew by 400% from 1999 to 2010, and admissions for substance use disorder grew by 600% from 1999 to 2009.3 Correspondingly, deaths due to heroin overdose quadrupled from 2000 to 2013.5 The growth in sales of prescription painkillers is partially explained by sordid market- ing tactics commonly practiced by pharmaceutical manufacturers. 9 In 2007, Purdue Pharma, the manufacturer of narcotic painkiller Oxycontin, pleaded guilty to illegally promoting the drug as less subject to abuse and addiction than alternatives on the market. 10 The company admitted to instructing subordinates to describe the drug as safe to health care professionals and to promote the drug for indications not approved by the U.S Food and Drug Administration (FDA). It was fined $600 million by the Department of Justice: more a cost of doing business than a punitive deterrent considering the $31 billion in revenue generated by Oxycontin. An investigation by the Los Angeles Times revealed that Purdue possessed but with- held from law-enforcement information suggesting that its drug was being trafficked illegally. Indeed, the company was monitoring an illegal distribution operation in a California district un- der the auspices of Representative Judy Chu (D-Monterey Park). Illegal distribution took place for years unchecked while Chu received over $31,000 in contributions from the pharmaceutical industry, according to the Center for Responsive Politics.11 In addition to the CDC draft guidelines, high level officials, including members of Congress and The White House, have responded to increasing pressure in recent years to en- Page 22 act change by enacting legislation to expand grants for prescrip- tion drug abuse and treatment. 12 The President asked congress for $1.1 billion in fiscal 2017 to fight prescription opioid and heroin abuse. The Comprehensive Addiction and Recovery Act (CARA) was recently passed in the Senate to combat drug abuse.
Not unsurprisingly, the pharmaceutical industry has mounted its own opposition against perceived threats to the $9 billion opioid market.13 To take one example, The Washington Legal Founda- tion (WLF), an industry-supported non-profit organization, criti- cized the new guidelines through a series of tortured legalisms.
They argued that the CDC, a public institution, should have been more inclusive of external parties during the drafting process.
The WLF describes itself as a “public-interest law firm and poli- cy center” which devotes a substantial portion of its resources to defending free-enterprise principles.14 Their clients have includ- ed Johnson & Johnson and Purdue Pharma, the manufacturer of Oxycontin. The group has accepted over $1 million in donations from Charles and David Koch, the billionaire financiers known for supporting ultra-conservative causes politically and finan- cially.15 One can only surmise which external parties the group had in mind.
Although political support for the treatment of addic- tion has been generally positive, it has not gone unnoticed that serious efforts to curtail access to these drugs, i.e the source of the problem, have not taken place in legislative chambers: an obvious victory for industry groups. 16 Indeed, at the very same time that lawmakers were proposing measures to treat addiction and drug abuse, Congress and the Executive Branch signed mea- sures to curtail the Drug Enforcement Agency’s (DEA) abilities to take action against manufacturers, pharmacies, and wholesal- ers suspected of distributing narcotics inappropriately. 17 While evidently another boon for the pharmaceutical sector, support- ers claim that the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 will facilitate cooperation between industry and law-enforcement. Not unsurprisingly, the top DEA official for the regulation of drug manufacturers resigned in pro- test.
The evidence outlined above suggests a role for indus- try brokers that extend beyond garden variety market partici - pants. It is easy to carry on, in fact, as misbehavior in the phar - maceutical industry makes a regular appearance in the major headlines around the world: one only need to pay attention. Pri- mary care physicians, including emergency medicine providers, ought to remain especially vigilant, as we provide nearly half of the opioid painkillers consumed in the United States.18 It is widely recognized among medical professionals and laypersons alike that opioid analgesic overdose is a poten- tially lethal, but wholly preventable, condition that results from prescribing practices, inadequate understanding on the patient’s part of the risks of medication misuse, errors in drug administra- tion, and pharmaceutical abuse.19 However, the downstream ef- fects which devastate contemporary society are only recently be- ing elucidated and examined by mainstream scholars featured in the toxicology and forensic medicine literature. It goes without saying that we have a moral and professional duty to treat pain when we see our patients suffering. Nevertheless, if we want to get serious about preventing opioid toxicity for the benefit of society, we must recognize our moral and professional responsi- bility as academics and privileged intellectuals to investigate the power dynamics which govern in the background of our clinical practice. It is the author’s opinion that this interpretation of the physician’s duty generalizes to all of medicine, the opioid epi- demic notwithstanding.