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The Opioid Analgesic Epidemic: How it Happened

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Presentation was originally done at Group Health Cooperative’s National Summit on Opioid Safety: http://www.ghinnovates.org/?p=3502.
Presentation by Andrew Kolodny, M.D., chair, department of Psychiatry Maimonides Medical Center Brooklyn, New York

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The Opioid Analgesic Epidemic: How it Happened

  1. 1. The Opioid Analgesic Epidemic: How it Happened National Summit on Opioid Safety Group Health Cooperative Nov 1, 2012 Andrew Kolodny, M.D. Chair, Department of Psychiatry Maimonides Medical Center Brooklyn, New York
  2. 2. DisclosuresDr. Kolodny has disclosed no financial relationships that may pose aconflict of interest.There will be no unannounced disclosures of off-label use of drugs,biologics or medical devices
  3. 3. Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
  4. 4. Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
  5. 5. Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
  6. 6. Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
  7. 7. Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
  8. 8. Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)
  9. 9. Unintentional Drug Overdose Deaths United States, 1970–2007 10 36,450 drug overdose deaths in 2008 9 8 Death rate per 100,000 7 6 5 4 3 Cocaine Heroin 2 1 0 70 72 74 76 78 80 82 84 86 88 90 92 94 96 98 00 02 04 06 Year National Vital Statistics System, http://wonder.cdc.gov10
  10. 10. Unintentional overdose deaths involving opioid analgesics parallel per capita sales of opioid analgesics in morphine equivalents by year, U.S., 1997-2007 14000 800 * 12000 700 10000 600 500 8000 Number of Opioid sales 400 6000 Deaths (mg/person) 300 4000 200 2000 100 0 0 97 98 99 00 01 02 03 04 05 06 07Source: National Vital Statistics System, multiple cause of death dataset, and DEA ARCOS* 2007 opioid sales figure is preliminary.
  11. 11. Rates of prescription painkiller sales, deaths and substanceabuse treatment admissions (1999-2010) SOURCES: National Vital Statistics System, 1999-2008; Automation of Reports and Consolidated Orders System (ARCOS) of the Drug Enforcement Administration (DEA), 1999-2010; Treatment Episode Data Set, 1999-2009
  12. 12. Dollars Spent Marketing OxyContin (1996-2001)Source: United States General Accounting Office: Dec. 2003, “OxyContin Abuse and Diversion andEfforts to Address the Problem.”
  13. 13. Total Sales & Prescriptions for OxyContin (1996-2002)Source: United States General Accounting Office: Dec. 2003, “OxyContin Abuse and Diversion andEfforts to Address the Problem.”
  14. 14. Industry-influenced “Education” on Opioidsfor Chronic Non-Cancer Pain Emphasizes:• Opioid addiction is rare in pain patients.• Physicians are needlessly allowing patients to suffer because of “opiophobia.”• Opioids are safe and effective for chronic pain.• Opioid therapy can be easily discontinued.
  15. 15. “Only four cases of addiction among 11,882patients treated with opioids.”Porter J, Jick H. Addiction rare in patients treatedwith narcotics. N Engl J Med. 1980 Jan10;302(2):123Cited 693 times (Google Scholar)
  16. 16. N Engl J Med. 1980 Jan 10;302(2):123.
  17. 17. Weak evidence regarding COT efficacy and safety was widely cited 700Cumulative Number of Citations 600 500 400 Porter and Jick 1980 Portenoy and Foley 1986 300 200 100 0 81 84 87 90 93 96 99 02 05 08 11 Year
  18. 18. Photo taken at the The 7th International Conference on Pain and Chemical Dependency, June 2007
  19. 19. Federation of State Medical BoardsModel Policy for the Use of Controlled Substances for the Treatment of Pain Distributed by 21 state medical boards to over 150,000 clinicians. The book’s sponsors include: Abbott Laboratories Alpharma Pharmaceuticals LLC Cephalon, Inc. Endo Pharmaceuticals King Pharmaceuticals Purdue Pharma L.P. Federation of State Medical Boards House of Delegates, May 2004. http://fsmb.org. Accessed March 2010.
  20. 20. In 2011, Journalists begin reporting on relationships between opioid manufacturers and opioid advocacy organizations
  21. 21. “I think that after 20 years of a failedexperiment that there are not many peoplesupporting this except for the die-hards andthe pharmaceutical industry.”Jane C. Ballantyne, MD FRCAProfessor, Univ. of Washington Source: New York Times, April 9, 2012. “Tightening the Lid on Pain Prescriptions”.
  22. 22. The Emperor’s New Paradigm:Patient Selection, Risk Stratification & Monitoring
  23. 23. Clozapine vs Opioids Comparison of methods for preventing serious adverse events Clozapine for Opioids for Schizophrenia Chronic PainEvidence-Based Treatment Yes NoAdverse Event (AE) Agranulocytosis AddictionRisk(%) 1% 25%Routine lab monitoring Weekly WBCs Urine ToxicologyMonitoring can prevent AE Yes NoPatient Registry Yes No
  24. 24. Urine Tox Results in Chronic Pain Patients on Opioid Therapy Source: Couto JE, Goldfarb NI, Leider HL, Romney MC, Sharma S. High rates of inappropriate drug use in the chronic pain population. Popul Health Manag. 2009;12(4):185–190.
  25. 25. Controlling the epidemic: A Three-pronged Approach• Primary Prevention- prevent new cases of opioid addiction.• Secondary Prevention- provide people who are addicted with effective treatment.• Supply control- Efforts by medical boards and law enforcement agencies to reduce over- prescribing and black-market availability.
  26. 26. Develop and Implement a Standard of Care Opioid Prescribing in 2012-The Wild West
  27. 27. FDA permits drug manufacturers to advertise opioidsas safe and effective for chronic pain.
  28. 28. FDA permits drug manufacturers to advertise opioids assafe and effective for chronic pain.
  29. 29. Signers of PROP’s citizen petition calling for opioid label changes filed with FDA on July 25, 2012• Jane C. Ballantyne, MD, FRCA • Kurt Kroenke, MD• Miles Belgrade, MD • Eric Larson, MD, MPH• Russ Carlisle, MD • Petros Levounis, MD, MA• Roger Chou, MD, FACP • Elinore F. McCance-Katz, MD, PhD• Edward C. Covington, MD • Lewis Nelson, MD, FACEP, FACMT• Robert W. Day, MD, PhD • Rosemary Orr, MD• Richard A. Deyo, MD, MPH • William Phillips, MD, MPH, FAAP• Irfan Dhalla, MD, MSc • Charles Reznikoff, MD• Thomas A. Farley, MD, MPH • Roger Rosenblatt, MD, MPH, MFR• Gary Franklin, MD, MPH • Nirav R. Shah, MD, MPH• Stephen G. Gelfand, MD, FACP • Harris Silver, MD• Stuart Gitlow, MD, MBA, MPH, FAPA • Kurt C. Stange, MD, PhD• Roland Gray, MD, FASAM • Jon Streltzer, MD• Erik Gunderson, MD, FASAM • Mark Sullivan, MD, PhD• W. Michael Hooten, MD • Barbara Turner, MD, MSED, MA• David Juurlink, MD, PhD • Judith Turner, PhD• Andrew Kolodny, MD • Michael Von Korff, ScD• Thomas R. Kosten, MD • Sidney W. Wolfe, MD • Art Van Zee, MD
  30. 30. PROP’s CP calls for the following changes on opioid labels• Strike the term “moderate” from the indication for non-cancer pain.• Add a max suggested daily dose, equivalent to 100 milligrams of morphine for non-cancer pain.• Add a suggested duration of 90-days for continuous (daily) use for non-cancer pain.
  31. 31. Please visit:www.supportPROP.org

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