Toxicology and Forensic Medicine

Open journal

ISSN 2474-8978

The Role of Industry in the Modern Opioid Crisis

Ravi Katari*

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

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 longawaited 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.

In 2008, prescription painkillers were estimated to have been responsible for approximately 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 disorder treatment.8 From 1999 to 2008, the overdose death rate grew by 400%, sales of prescription 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 marketing 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 withheld 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 under 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 enact change by enacting legislation to expand grants for prescription 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

The evidence outlined above suggests a role for industry brokers that extend beyond garden variety market participants. It is easy to carry on, in fact, as misbehavior in the pharmaceutical industry makes a regular appearance in the major headlines around the world: one only need to pay attention. Primary 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 potentially 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 administration, and pharmaceutical abuse.19 However, the downstream effects which devastate contemporary society are only recently being 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 responsibility 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 epidemic notwithstanding.

1. Centers for Disease Prevention and Control (CDC). CDC guideline for prescribing opioids for chronic pain – United States, 2016. JAMA. 2016; 315(15): 1624-1645. doi: 10.1001/ jama.2016.1464

2. Perrone M. Drug makers score a win in painkiller battle with CDC. Los Angeles Daily News. Website. http://www.dailynews. com/government-and-politics/20151218/drug-makers-score-awin-in-painkiller-battle-with-cdc. Accessed August 21, 2016

3. CDC. Vital Signs: Overdoses of Prescription Opioid Pain Relievers — United States, 1999–2008. Morbidity and Mortality Weekly Report (MMWR). 2011; 60(43): 1487-1492. http://www. cdc.gov/mmwr/preview/mmwrhtml/mm6043a4.htm. Accessed August 21, 2016

4. CDC. Increases in drug and opioid deaths-United States 2000- 2014. Website. http://www.cdc.gov/mmwr/preview/mmwrhtml/ mm6450a3.htm. Accessed August 21, 2016

5. Hedegaard H, Chen LH, Warner M. Drug-poisoning deaths involving heroin: United States, 2000-2013. NCHS Data Brief. 2015: 190: 1-8. Website. https://radarcart.boisestate.edu/radar/ pdfs/NCHSdb190_March%202015.pdf. Accessed August 21, 2016

6. European Monitoring Centre for Drugs and Drug Addiction. Preventing overdose deaths in Europe. Website. http://www. emcdda.europa.eu/topics/pods/preventing-overdose-deaths. Accessed August 21, 2016

7. Park H, Bloch M. How the Epidemic of Drug Overdose Deaths Ripples Across America. The New York Times. Website. http:// www.nytimes.com/interactive/2016/01/07/us/drug-overdosedeaths-in-the-us.html. Accessed August 21, 2016

8. American Society of Addiction Medicine (ASAM). Opioid Addiction 2016 Facts & Figures. Website. http://www.asam. org/docs/default-source/advocacy/opioid-addiction-diseasefacts-figures.pdf. Accessed August 21, 2016

9. Katari R, Baker D. Center for Economic and Policy Research. Patent monopolies and the costs of mismarketing drugs. 2015. Website. http://cepr.net/publications/reports/patent-monopolies-and-the-costs-of-mismarketing-drugshttp://cepr.net/publications/reports/patent-monopolies-and-the-costs-of-mismarketing-drugs. Accessed August 21, 2016

10. Meier B. In Guilty Plea, OxyContin Maker to Pay $600 Million. The New York Times. Website. http://www.nytimes. com/2007/05/10/business/11drug-web.html. Accessed August 21, 2016

11. Center for Responsive Politics. Judy Chu. Web site. https://www.opensecrets.org/politicians/summary.php?cid= N00030600. Accessed August 21, 2016

12. McKay B. Senate Passes Bill to Fight U.S. Opioid Epidemic. The Wall Street Journal. Website. http://www.wsj.com/articles/ senate-passes-bill-to-fight-u-s-opioid-epidemic-1457633374. Accessed August 21, 2016

13. Gillette F. American Pain: The Largest U.S. Pill Mill’s Rise and Fall. Bloomberg. The Wall Street Journal.

14. Washington Legal Foundation. Re: Guideline for Prescribing Opioids for Chronic Pain. November 2015. Website. http:// www.wlf.org/upload/litigation/misc/CDCComments-Opioids. pdf. Accessed August 21, 2016

15. Anson P. CDC Accused of ‘Blatant Violations’ of Federal Law. Pain News Network. November 2015. Website. http:// www.painnewsnetwork.org/stories/2015/11/18/legal-foundation-accuses-cdc-of-blatant-violations-of-federal-law. Accessed August 21, 2016

16. Harris G, Huetteman E. Actions by Congress on Opioids Haven’t Included Limiting Them. The New York Times. May 2016. Website. http://www.nytimes.com/2016/05/19/us/politics/opioid-dea-addiction.html. Accessed August 21, 2016

17. Ryan H, Christensen K. Amid opioid epidemic, rules for drug companies are loosened. The Los Angeles Times. July 2016. Website. http://www.latimes.com/local/california/la-mepharma-bill-20160728-snap-story.html. Accessed August 21, 2016

18. National Public Radio (NPR). CDC Has Advice For Primary Care Doctors About Opioids. March 2016. Website. http://www.npr.org/sections/health-shots/2016/03/15/470559682/cdchas-advice-about-opioids-for-primary-care-doctors. Accessed August 21, 2016

19. Boyer EW. Management of opioid analgesic overdose. N Engl J Med. 2012; 367(2): 146-155. doi: 10.1056/NEJMra1202561

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