Origins of the Heroin Crisis

Presenters:

• Phillip Walls, RPh, Chief Clinical Officer, myMatrixx

• Andrew Kolodny, MD, Chief Medical Officer, Phoenix House Foundation, Inc., and Executive Director, Physicians for Responsible Opioid Prescribing

Moderator: Jackie L. Steele, Jr., JD, CommonwealthAttorney, Kentucky 27th Judicial Circuit, and ViceChairman, Operation UNITE Board of Directors

Heroin Track

Disclosures

• Andrew Kolodny, MD, and Jackie L. Steele, Jr., JD, have disclosed no relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.

• Phil Walls, RPh - Employment and ownership interest: Matrix HCS, Inc.

Disclosures

• All planners/managers hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.

• The following planners/managers have the following to disclose:– John J. Dreyzehner, MD, MPH, FACOEM – Ownership interest:

Starfish Health (spouse)– Robert DuPont – Employment: Bensinger, DuPont &

Associates-Prescription Drug Research Center

Learning Objectives• Describe the history of heroin use in America, with

emphasis on its relationship to the Rx drug abuse epidemic.• Identify key roles for pharmacists and other health

professionals in identifying patients at-risk of heroin abuse.• Explain the relationship between the rising rates of opioid

addiction, heroin use and overdose deaths.• Specify health interventions and policy responses to the

heroin crisis.• Provide accurate and appropriate counsel as part of the

treatment team.

Heroin Track:

Origins of the Heroin Crisis

Why Focus on Heroin?

• $177 billion – annual cost of prescription drug abuse to the US healthcare system

• The Drug Enforcement Administration (DEA) estimates that diversion is a $25 billion-a-year industry

• $8.5 billion – annual cost of hospital admissions for people who do not take their medications as prescribed

How did this happen?

Prescription Drug Abuse, Misuse and Diversion

Timeline to Discovery of Heroin• 1806 – morphine isolated from opium poppy – named after Morpheus, the

Greek god of dreams– Heinrick Emanuel Merck – converted pharmacy into a full-time producer of

morphine – Engel-Apotheke or The Angel Pharmacy– Today known as Merck and Company

• 1853 – invention of the hypodermic syringe and first injection of morphine

– Co-invented by Alexander Wood and Charles Pravaz– Woods’ wife was the first fatality of an injected overdose of

morphine

Alexander Wood (1817 – 1884)

Timeline to Discovery of Heroin• Dr. Woods’ discovery preceded the American Civil War by almost a

decade– Approximately 400,000 soldiers became addicted to morphine– Characterized as “old soldiers’ disease”

• One of these veteran’s was Colonel John Pemberton– A pharmacist by training– Mixed cocaine and the kola nut in an elixir to treat morphine withdrawal– Branded as Coca Cola in 1886– Original formula with cocaine available until 1905

• 1874 - Diacetylmorphine is first synthesized

Timeline to Discovery of Heroin

Between 1878 and 1885 however opium addiction became much more widespread among middle- to upper-class white women

Timeline to Discovery of Heroin

• Diacetylmorphine is “re-discovered” by chemists working for Friedrich Bayer in the mid-1880’s through a process known as acetylation– Morphine → diacetylmorphine– Acetylsalicylic acid → aspirin

• Bayer named this drug heroin after the German word heros meaning hero.

Morphine Heroin

The two drugs differ by the addition of two acetyl groups

Metabolism of Opioids

*Not comprehensive pathways, but may explain the presence of apparently unprescribed drugs

†6-MAM=6-monoacetylmorphine, an intermediate metabolite

Gourlay DL, et al. Urine Drug Testing in Clinical Practice: Dispelling the Myths & Designing Strategies [monograph]. 2004

hydrocodone

heroin6-MAM†morphinecodeine

hydromorphone

oxycodone oxymorphone

Timeline to Discovery of Heroin

• Aspirin was first synthesized a year later – ironically aspiring required a prescription whereas heroin did not

• Bayer and Merck had launched the start of the modern day pharmaceutical industry with the development of three of the world’s most popular analgesics: morphine, heroin and aspirin

Trial Treatment – Free of Charge!

The Solution for Coughs

Early Attempts at Regulation

• 1906 – Pure Food and Drug Act – Coca Cola was one of few products that survived this legislation

• 1914 – Harrison Narcotic Act• 1919 – ruling by the Supreme Court that it was

unconstitutional to stop physicians from prescribing narcotics for addicts, but then the court later reversed that decision

• The case of Alexander Ameris – characterized as a “dope fiend”

Prevailing attitude early to mid-century

1900• “…save our people from the clutches of this hydra-headed

monster which stalks the civilized world, wrecking lives and happy homes, filling our jails and lunatic asylums…”

Witherspoon JA. A protest against some of the evils in the profession of medicine. JAMA. 1900;34 :1589– 1592

1941• “The use of narcotics in the terminal cancer patient is to be

condemned … due to undesirable side effects … dominant in the list of these … is addiction” Lee LE Jr. Medication in the control of pain in terminal cancer. JAMA 1941;116:216-219

The Vietnam War Era• Represented a turbulent time in American history• Janis Joplin dies of a heroin overdose on October 4, 1970• The following May, Congressmen Steele and Murphy conducted an

official visit to Vietnam• Their message upon returning: 15% of US servicemen in Vietnam

were addicted to heroin• The timing coincided with the implementation of the

Comprehensive Drug Abuse Prevention and Control Act of 1970• On June 17th of 1971, President Richard Nixon characterized drug

abuse as “a national emergency” - He asked Congress to amend the Narcotic Addict Rehabilitation Act of 1966 to increase access to methadone maintenance programs

America’s War on Drugs• President Nixon’s legacy includes creation of the Drug

Enforcement Administration in 1973• 1975: the Ford administration names marijuana a low-priority

drug• 1976: Carter campaigns for de-criminalization of marijuana• 1978: the Comprehensive Drug Abuse Prevention and Control

Act is amended to allow law enforcement to seize “all things of value” involved in and exchange for controlled substances

• 1981 – 1982: rise of the Medellin Cartel in Columbia and creation of a bilateral extradition treaty between the governments of Colombia and the United States

America’s War on Drugs

• 1984: Nancy Reagan launches her “Just Say No” campaign, which becomes a focal point of President Reagan’s anti-drug campaign

• 1989: President Bush creates the Office of National Drug Control Policy (ONDCP) and campaigns to “make drug abuse socially unacceptable”. Spending for treatment and law enforcement increase under the ONDCP, but the budget for treatment is less than one-third that of law enforcement.

• 1993: President Clinton signs the North American Free Trade Agreement (NAFTA). This agreement results in a significant increase in legitimate trade shipments across the Mexican-US border, but has the unintended consequence of making it difficult for US Customs agents to find contraband narcotics in these shipments.

• 2000: President Clinton commits $1.3 billion in aid to Colombia to fight drug trafficking.

America’s War on DrugsIt is important to note in the War on Drugs that the DEA announced just this past May the most successful enforcement action in its history: known as Operation Pilluted, this operation resulted in 280 arrests including 22 doctors and pharmacists; resulted in the seizure of $11,651,565 US currency and $6,745,800 in real property.

The Prescription Opioid & Heroin Crisis:Responding to an Epidemic of Addiction

Andrew Kolodny, M.D.Chief Medical Officer, Phoenix House Foundation Inc.Executive Director, Physicians for Responsible Opioid PrescribingSenior Scientist, Heller School for Social Policy and Management, Brandeis University

Opium

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

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

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

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

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

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

Non-heroin opioid treatment admissions: 2013

SOURCE: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration, Treatment Episode Data Set (TEDS). Data received through 01.23.15.

Unintentional overdose deaths involving opioid analgesics parallel per capita sales of opioid analgesics in morphine

equivalents by year, U.S., 1997-2007

0

100

200

300

400

500

600

700

800

0

2000

4000

6000

8000

10000

12000

14000

'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.

Number of

DeathsOpioid sales (mg/person)

*

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 20100

1

2

3

4

5

6

7

8

Opioid Sales KG/10,000 Opioid Deaths/100,000 Opioid Treatment Admissions/10,000

Year

Rate

Rates of Opioid Sales, OD Deaths, and Treatment, 1999–2010

CDC. MMWR 2011

Source: United States General Accounting Office: Dec. 2003, “OxyContin Abuse and Diversion and Efforts to Address the Problem.”

Dollars Spent Marketing OxyContin (1996-2001)

Industry-funded “educational” messages

• Physicians are needlessly allowing patients to suffer because of “opiophobia.”

• Opioid addiction is rare in pain patients.

• Opioids can be easily discontinued.

• Opioids are safe and effective for chronic pain.

Industry-funded organizations campaigned for greater use of opioids

• Pain Patient Groups

• Professional Societies

• The Joint Commission

• The Federation of State Medical Boards

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)

“The risk of addiction is much less than 1%”

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

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 20140

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

20,000

22,000

24,000

26,000

Painkillers Heroin Total Opioid

Year

Opioid Related Overdose Deaths: 1999-2013

Heroin treatment admissions : 2003-2013

SOURCE: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration, Treatment Episode Data Set (TEDS). Data received through 01.23.15.

Death rates from overdoses of heroin or prescription opioid pain relievers (OPRs), by age group

SOURCE: CDC. Increases in Heroin Overdose Deaths — 28 States, 2010 to 2012 MMWR. 2014, 63:849-854

Heroin admissions, by gender, age, and race/ethnicity: 2013

SOURCE: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration, Treatment Episode Data Set (TEDS). Data received through 01.23.15.

Deaths involving heroin, by age and race/ethnicity 2000 and 2013

Controlling the epidemic:A Three-pronged Approach

• Prevent new cases of opioid addiction.

• Treatment for people who are already addicted

• Reduce supply from pill mills and the black-market.

How the opioid lobby frames the problem:

Source: Slide presented by Lynn R. Webster MD at FDA meeting on hydrocodone upscheduling, January 25th, 2013.

Pain Patients “Drug Abusers”

35% met DSM V criteria for an opioid use disorder1

1. 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.

This is a false dichotomy Opioid harms are not limited to so-called “drug abusers”

92% of opioid OD decedents were prescribed opioids for chronic pain.2

2. 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.

Heroin treatment admissions with planned medication-assisted opioid therapy 2003-2013

SOURCE: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration, Treatment Episode Data Set (TEDS). Data received through 01.23.15.

Summary

• The U.S. is in the midst of a severe epidemic of opioid addiction

• 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

Origins of the Heroin Crisis

Presenters:• Andrew Kolodny, MD, Chief Medical Officer, Phoenix House

Foundation, Inc., and Executive Director, Physicians for Responsible Opioid Prescribing

• Phillip Walls, RPh, Chief Clinical Officer, myMatrixx

Moderator: Jackie L. Steele, Jr., JD, CommonwealthAttorney, Kentucky 27th Judicial Circuit, and Vice Chairman, Operation UNITE Board of Directors

Heroin Track