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

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. Disclosures
Dr. Kolodny has disclosed no financial relationships that may pose a
conflict of interest.
There will be no unannounced disclosures of off-label use of drugs,
biologics or medical devices

4. Primary non-heroin opiates/synthetics admission rates, by State
(per 100,000 population aged 12 and over)

5. Primary non-heroin opiates/synthetics admission rates, by State
(per 100,000 population aged 12 and over)

6. Primary non-heroin opiates/synthetics admission rates, by State
(per 100,000 population aged 12 and over)

7. Primary non-heroin opiates/synthetics admission rates, by State
(per 100,000 population aged 12 and over)

8. Primary non-heroin opiates/synthetics admission rates, by State
(per 100,000 population aged 12 and over)

9. Primary non-heroin opiates/synthetics admission rates, by State
(per 100,000 population aged 12 and over)

10. 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.gov
10

11. 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 '07
Source: National Vital Statistics System, multiple cause of death dataset, and DEA ARCOS
* 2007 opioid sales figure is preliminary.

12. Rates of prescription painkiller sales, deaths and substance
abuse 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

15. Dollars Spent Marketing OxyContin (1996-2001)
Source: United States General Accounting Office: Dec. 2003, “OxyContin Abuse and Diversion and
Efforts to Address the Problem.”

16. Total Sales & Prescriptions for OxyContin (1996-2002)
Source: United States General Accounting Office: Dec. 2003, “OxyContin Abuse and Diversion and
Efforts to Address the Problem.”

17. Industry-influenced “Education” on Opioids
for 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.

18. “Only four cases of addiction among 11,882
patients treated with opioids.”
Porter J, Jick H. Addiction rare in patients treated
with narcotics. N Engl J Med. 1980 Jan
10;302(2):123
Cited 693 times (Google Scholar)

19. N Engl J Med. 1980 Jan 10;302(2):123.

21. Weak evidence regarding COT efficacy
and safety was widely cited
700
Cumulative 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

22. Photo taken at the The 7th International Conference
on Pain and Chemical Dependency, June 2007

23. Federation of State Medical Boards
Model 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.

24. In 2011, Journalists begin reporting on relationships between
opioid manufacturers and opioid advocacy organizations

25. “I think that after 20 years of a failed
experiment that there are not many people
supporting this except for the die-hards and
the pharmaceutical industry.”
Jane C. Ballantyne, MD FRCA
Professor, Univ. of Washington
Source: New York Times, April 9, 2012. “Tightening the Lid on Pain
Prescriptions”.

26. The Emperor’s New Paradigm:
Patient Selection, Risk Stratification & Monitoring

27. Clozapine vs Opioids
Comparison of methods for preventing serious adverse events
Clozapine for Opioids for
Schizophrenia Chronic Pain
Evidence-Based Treatment Yes No
Adverse Event (AE) Agranulocytosis Addiction
Risk(%) 1% 25%
Routine lab monitoring Weekly WBCs Urine Toxicology
Monitoring can prevent AE Yes No
Patient Registry Yes No

28. 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.

29. 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.

30. Develop and Implement a Standard of Care
Opioid Prescribing in 2012-The Wild West

31. FDA permits drug manufacturers to advertise opioids
as safe and effective for chronic pain.

32. FDA permits drug manufacturers to advertise opioids as
safe and effective for chronic pain.

33. 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

34. 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.

35. Please visit:
www.supportPROP.org