The Opioid Addiction Epidemic:
How marketing and regulatory failure led to a
public health crisis
Andrew Kolodny, M.D.
Chief Medical Officer, Phoenix House Foundation Inc.
Executive Director, Physicians for Responsible Opioid Prescribing
Senior Scientist, Heller School for Social Policy and Management, Brandeis University
Research Professor, Global Institute of Public Health, New York University
The Opium Poppy
Papaver Somniferum
2
Opium
3
Opioids
• 
• 
• 
• 
• 
• 
• 
• 
Morphine
Naturally occurring opioidsCodeine
also called opiates
Thebaine
Diacetylmorphine (Heroin)
Hydrocodone (Vicodin)
Oxycodone (Oxycontin)
Oxymorphone (Opana)
Hydromorphone (Dilaudid)
Semi-synthetic
opioids
Unintentional Drug Overdose Deaths
United States, 1970–2007
10
Death rate per 100,000
9
43,982 drug overdose deaths in 2013
8
7
6
5
4
3
2
Cocaine
Heroin
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
Drug Overdose Deaths by Major Drug Type,
United States, 1999–2010
Opioids
Heroin
Cocaine
Benzodiazepines
18,000
16,000
Number of Deaths
14,000
12,000
10,000
8,000
6,000
4,000
2,000
0
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
Year
CDC, National Center for Health Statistics, National Vital Statistics System, CDC Wonder. Updated with 2010 mortality data.
2009
2010
Heroin admissions, by age group & race/ethnicity: 2001- 2011
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
Primary non-heroin opiates/synthetics admission rates, by State
(per 100,000 population aged 12 and over)
11
Primary non-heroin opiates/synthetics admission rates, by State
(per 100,000 population aged 12 and over)
12
Primary non-heroin opiates/synthetics admission rates, by State
(per 100,000 population aged 12 and over)
13
Non-heroin opioid admissions, by gender, age, race/ethnicity: 2011
14
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
8000
Number of
6000
Deaths
500
Opioid sales (mg/400
300
person)
4000
200
2000
100
0
0
'97
'98
'99
'00
'01
'02
'03
'04
'05
Source: National Vital Statistics System, multiple cause of death dataset, and DEA ARCOS
* 2007 opioid sales figure is preliminary.
'06
'07
Rates of Opioid Sales, OD Deaths, and Treatment, 1999–2010
8
Opioid Sales KG/10,000
Opioid Deaths/100,000
2000
2003
Opioid Treatment Admissions/10,000
7
6
Rate
5
4
3
2
1
0
1999
CDC. MMWR 2011
2001
2002
2004
2005
Year
2006
2007
2008
2009
2010
17
18
Dollars Spent Marketing OxyContin (1996-2001)
Source: United States General Accounting Office: Dec. 2003, “OxyContin Abuse and Diversion and
Efforts to Address the Problem.”
Industry-funded “education” 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.
20
Industry-funded organizations
campaigned for greater use of opioids
•  Pain Patient Groups
•  Professional Societies
•  The Joint Commission
•  The Federation of State Medical Boards
21
“The risk of addiction is much less than 1%”
Porter J, Jick H. Addiction rare in patients treated
with narcotics. N Engl J Med. 1980 Jan 10;302(2):
123
Cited 824 times (Google Scholar)
22
N Engl J Med. 1980 Jan 10;302(2):123.
23
By 2001, OxyContin Sales Exceeded $1 Billion
26
Controlling the epidemic:
A Three-pronged Approach
•  Prevent new cases of opioid addiction.
•  Treatment for people who are already
addicted
•  Supply control- Reduce over-prescribing
and black-market availability.
27
How the opioid lobby frames the problem:
Source: Slide presented by Lynn R. Webster MD at FDA meeting on
hydrocodone upscheduling, January 25th, 2013.
Non-medical Opioid Users
Opioid Overdose Decedents
Source: Kolodny et al. The Prescription Opioid and Heroin Crisis: A Public Health Approach to an Epidemic of Addiction. Annu
29
Rev Public Health. 2015: 36:559-574
This is a false dichotomy
Aberrant drug use behaviors are common in pain patients
63% admitted to using opioids for
purposes other than pain1
Pain Patients
“Drug Abusers”
35% met DSM V criteria for
addiction2
92% of opioid OD decedents
were prescribed opioids for
chronic pain.
1. Fleming MF, Balousek SL, Klessig CL, Mundt MP, Brown DD. Substance Use Disorders in a Primary Care Sample Receiving
Daily Opioid Therapy. J Pain 2007;8:573-582.
2. Boscarino JA, Rukstalis MR, Hoffman SN, et al. Prevalence of prescription opioid-use disorder among chronic pain patients:
comparison of the DSM-5 vs. DSM-4 diagnostic criteria. J Addict Dis. 2011;30:185-194.
3. Johnson EM, Lanier WA, Merrill RM, et al. Unintentional Prescription Opioid-Related Overdose Deaths: Description of
Decedents by Next of Kin or Best Contact, Utah, 2008-2009. J Gen Intern Med. 2012 Oct 16.
Summary
•  The U.S. is in the midst of a severe
epidemic of opioid addiction caused by
overprescribing
•  To bring the epidemic to an end:
–  We must prevent new cases of opioid
addiction
–  We must ensure access to treatment for
people already addicted