The Opioid Epidemic: How did we get here? - From pain management to a National epidemic, a look at the rise of opioid dependency in the US - Confidio
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The Opioid Epidemic:
How did we get here?
From pain management to a
National epidemic, a look at
the rise of opioid dependency
in the USA Confidio Whitepaper
The Opioid Epidemic: How did we get here? 2
It Started with Pain Management
NATIONAL SURVEYS HAVE FOUND THAT CHRONIC PAIN, DEFINED AS PAIN LASTING LONGER THAN 3-6
MONTHS, AFFECTS APPROXIMATELY 100 MILLION AMERICAN ADULTS and that the economic costs attributable
to such pain approach $600 billion annually.1 Pain has been described as a “uniquely individual and subjective
experience” and “among the most controversial and complex” medical conditions to manage.1,2 Opioids are drugs
derived from the opium poppy or man-made derivatives thereof. Because they resemble pain-relieving chemicals
naturally found in the human body (endorphins), they can have a profound effect on pain, so much so that opioids
have long been considered the gold standard in treatment of cancer pain. In fact, the beneficial effect of opioids on
pain has been recognized for centuries, at least since laudanum, a liquid version of opium, was used therapeutically in
the 17th century.
Fast forward to 2017, when 130 people died every day in the United The presence of
pain is one of the
States from opioid-related overdoses, up 11% over 2016. 6.1% of
individuals misusing opioids in 2017 were between the ages of 12 and
most common
17.6 The US makes up 5% of the world’s population and consumes
approximately 80% of the world’s prescription opioid drugs.3 The
National Safety Council revealed that Americans are more likely to die
of an opioid overdose than in a car crash. On October 26, 2017, the U.S. reasons people
Department of Health and Human Services (HHS) declared the opioid
epidemic a “public health emergency”.
seek health care.
How did we get here?
From Medication to Drug
There is no question that opioids are excellent pain-relievers. But physicians were aware of the dangers of opioids
long before the days of California’s 19th century opium dens—why the crisis now?
In the days of “sex, drugs and rock and roll”, heroin was almost as big a problem as it is now. The response by the
healthcare community at the time was to cut back on use of opioids—to the point that even people with severe,
relentless pain were not getting adequate pain relief.
This in turn triggered a public outcry that resulted in “Cancer Pain Initiatives” springing up across the country in
the 1990s. In addition, The Joint Commission (the primary accreditation body for hospitals and clinics in the US) in
2010 deemed pain the “fifth vital sign”—to be assessed (and treated if necessary) each time pulse, blood pressure,
temperature and respiration were measured. In short, opioids became popular again.
Enter Big Pharma.
The Big Business of Opioids
In 1996, Purdue Pharma released OxyContin to the market. With its new “Contin” slow release formulation, this
product was marketed as a safer alternative to traditional opioids. In addition, Purdue seized upon a letter to the
editor that was written in 1980 to the New England Journal of Medicine. The report stated that of 11,882 patients
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The Opioid Epidemic: How did we get here? 3
who had taken at least one opioid product, there were just four patients with “reasonably well documented
addiction”, only one of which was considered major, among patients with no history of addiction.5 Based on
this evidence, the authors concluded that “development of addiction is rare in medical patients with no history
of addiction”. Armed with this information and their new slow-release oxycodone product, Purdue created what
appeared to be a legitimate third-party group called the American Pain Society. This group travelled across the
country with “key opinion leaders” who touted OxyContin as being safe for long term use, and a good treatment for
pain. Citing the 1980 New England Journal letter to the editor, they also proclaimed that opioids are addictive less
than 1% of the time.
In 2001,
In addition to leveraging its “American Pain Society”, Purdue capitalized
on designation of pain as the fifth vital sign by creating a website
Purdue sales
called “Pain is the fifth vital sign”. They promoted this idea and
introduced patients to a new pain scale comprised of a series of faces
representatives progressing from a frowny face to a smiley face—in an attempt to adapt
the numeric tool to children. During this period, Purdue engaged in
received egregious marketing practices; such as a patient coupon program for
free 7- to 30-day supplies of Oxycontin; conferences where more than
$40 million in sales
5000 physicians, pharmacists, and nurses attended all-expenses-paid
symposia at resorts in “sunshine states” and were recruited and trained
incentive bonuses.
for Purdue’s speaker bureau; and $40 million in sales incentive bonuses
to its sales representatives in 2001.6
Unfortunately, much of the content of these marketing schemes was based on grains of truth that were taken out of
context or inappropriately interpreted.
First, the “fifth vital sign” designation, while well-intentioned, had some unforeseen fallout due to the fact that
pain simply cannot be measured objectively; and that pain scales need to be used in context with other patient
considerations when prescribing opioids. At that time, medical practitioners treated patients based on a pain scoring
system from 0 to 10. No matter what a patient’s objective clinical signs reflected, measurable pain was almost always
documented; based on the pain score, practitioners were expected to prescribe painkillers in order to improve the
patient’s pain score and thus patient satisfaction. In the words of Vijay Rajput at KevinMD.com, a popular physician
blog from MedPage Today, “We physicians were pressured to relieve all the pain as a result of the Fifth Vital Sign
program started around 2000.”4
Second, it is true that the American Pain Society’s platform was based on information published in a highly respected,
peer-reviewed journal; however, as with many letters to the editor, the specific claims made by the author were not
based on a controlled study, nor were they peer-reviewed.
In retrospect, we now recognize that Purdue misled doctors into thinking Oxycontin was not addictive. They
convinced doctors to write millions of prescriptions for something they knew was addictive for more than two
decades.
From Drug to Crisis
When used over a long period of time, opioids cause a condition called “dependence”: the user experiences
unpleasant side effects upon rapid discontinuation of the drugs. High doses of opioids can cause feelings of intense
happiness and/or well-being that are often referred to as euphoria. Both situations can lead to “drug seeking
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The Opioid Epidemic: How did we get here? 4
behavior”—compulsive, often irrational and reckless activities focused on obtaining and using the drugs that would
prevent withdrawal or make them feel good.
Prompted by drug-seeking behavior, fueled by drug company propaganda and encouraged by overzealous
accreditation standards, well-intentioned practitioners began to prescribe opioids in large doses and quantities to
ensure their patients remained pain-free.
It is easy to see how drug-seeking behavior, combined with a culture in which prescribers felt safe and even
encouraged to prescribe opioids freely, caused an upward spiral in opioid use and abuse.
The upshot of all this is that the US is now in the throes of an of opioid addiction epidemic. Addiction eventually
causes a deterioration in the quality of the user’s life, and can end in death. Since some of the strongest forms of
opioids are not legal in the US, users of these are at the mercy of unscrupulous dealers who often manipulate the
product to increase either its addictive properties or their own profits. The resulting variability in the purity of illegal
products has led to an unprecedented number of overdose deaths over the past few years. Action is clearly needed.
Recognizing Chemical Dependency
Early recognition of a patient struggling with chemical dependency is also a key component of combatting opioid
addiction. If a patient is requesting an opiate prescription for chronic low back pain, it’s the responsibility of the
primary care physician (PCP) to properly diagnose the back pain early on in treatment. They should make sure all
the other treatment protocols for low back pain – physical therapy, nonsteroidal anti-inflammatory drugs, etc. – have
been adequately tried before an opioid prescription is written. If there is no other course of treatment, it is now the
PCP’s responsibility to assess the patient’s use of the opioid. Sometimes, this means the PCP needs to spend more
time with the patient than usual. Unfortunately, in this healthcare day and age where PCPs are so tightly scheduled, it
can be difficult to incorporate this into the schedule.
Point of care drug testing could speed up the conversation process between the PCP and the patient. Most primary
care offices can now test blood sugar and perform a dip urine test to see if there is a urinary tract infection before
prescribing therapy; a point of care drug test could be used in the same way by opening the door to a conversation
about drug misuse, and possibly providing a strong argument for referral to an addiction specialist or treatment
center.
Treatment For Addiction
Nearly 70%
Unlike other patients, people with the medical condition of opioid
addiction are often blamed when they cannot achieve remission—the of residential
rationale being that “they didn’t want it bad enough”. In many disease
states, other treatment options are explored when the first treatment
treatment facilities
fails. From this perspective, opioid dependency and addiction should
be managed in the same way: there should be an outcomes-based
in the US do not
treatment model derived from clinical studies. offer medication
Opioid addiction treatment is not a one-size-fits-all proposition. Instead assisted treatment.
there should be individualized care through a wide range of treatment.
One example of outdated treatment methods is the fact that today, nearly 70% of residential treatment facilities in
the United States do not offer medication-assisted treatment even though the data support this type of treatment.7
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The Opioid Epidemic: How did we get here? 5
Medical professionals are too often treating chemical dependency based on opinion and not data.
The stigma surrounding addiction and misinformation about its treatment need to be addressed: addiction is a
chronic disease and needs to be viewed as such.
As a recognized center of excellence in treatment of substance abuse and addiction, Hazelden Betty Ford treatment
facilities provide examples of best practices in all aspects of this field. One such practice relates to positioning
addiction in the patient’s mind. After a patient’s initial history and physical assessment are completed, they are told
they have been diagnosed with a chronic disease, the disease of addiction. It’s then explained that they are going
to be required to think about their disease and treat it every single day. Just like a diabetic patient may need their
insulin every day, the chemically dependent patient is going to need some level of treatment every day-- whether it’s
getting up and going to their meeting, working with their support network, taking their Suboxone, or taking their
naltrexone. They are required to be involved in some level of treatment every day for the rest of their life because
they have an incurable medical condition.
Reeducating the Medical Community
Prescribing opioids appropriately isn’t easy. Nor is treatment of opioid addiction. As guidelines and treatments
evolve, it is critical that we continually reeducate medical practitioners.
One example of effective reeducation is the summer course at Betty Ford where medical students participate in
an immersion program. The students are assigned a patient and follow them through the entire treatment process,
working with the medical team and hopefully learning early in their medical career about the possible consequences
of every opioid prescription they write. They leave the program with a better understanding of how their
prescriptions can dramatically affect a patient’s life.
Betty Ford also offers a program for children of their patients. These children can come and learn about the disease
of addiction, and how to support their family member. Starting early in a physician’s education so they can learn
about opiates is paramount in battling this disease.
What of Purdue Pharma?
In 2007, US Attorney General announced that Purdue was being fined $634.5 million8 for misleading regulators and
others about the addictive potential of Oxycontin, but at this point they were a $3 billion-dollar company that had
changed the pain management landscape drastically. They had already drafted the language on pain management
that was being taught in medical schools across the country —language implying that opioids are safe and effective
for the long-term treatment of any type of pain, and that they uniformly improve the quality of patients’ lives.
In 2009, an article published in the American Journal of Public Health provided numerous examples of marketing
practices that drove OxyContin to be the leading drug of abuse in the US by 2004—despite lack-luster comparisons
to other pain-killers and weak support for claims of low addiction potential6. Later, after a reformulation of OxyContin
improved its abuse-deterrent properties, use dropped somewhat (although 24% of users found ways to thwart even
this new formulation). This success, unfortunately, led 66% of OxyContin users to simply switch to another opioid—
the most commonly reported of which was heroin9.
The 2009 article stimulated a wave of lawsuits against makers of opioid medications, particularly Purdue Pharma.
Subsequently, in September 2019, a tentative settlement was reached between Purdue Pharma’s owners and more
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The Opioid Epidemic: How did we get here? 6
than 2300 government entities that filed lawsuits against the company. Although a judge halted this litigation in early
October, due to escalating costs that he felt could be better used elsewhere, some key components of the proposed
settlement included:
Purdue Pharma filing for Chapter 11 bankruptcy and being dissolved as a company
A new company being created to continue selling OxyContin and other drug products, the profit from
which will be used to pay plaintiffs in the nearly 2300 suits filed against Purdue
A $3 billion cash payment
Donation of drugs for treatment of opioid overuse disorder and opioid overdose by Purdue
No admission of wrongdoing on the part of Purdue
Relevance for Payers
One might say that the battle against Purdue Pharma is all but won, but the war on opioid abuse is far from over.
While government and healthcare agencies continue to advocate for better control of access to opioids payors must
take an active role in the discussion and deploy hands one management within their benefit plans. As it relates
to payors, managing opioids may not be as simple as implementing a PBMs standard program. A robust opioid
management solution should also promote use of alternative analgesics, incorporate an analysis of potentiator
medications and integrate medical/Rx data to have a holistic picture of the patient which will serve as a solid
foundation for clinical and coverage decision-making.
The most effective pharmacy solutions are not one-size-fits all. Instead, it’s imperative to develop a customized
strategy that can address a plan’s current and future state needs. At Confidio, we keep a careful watch over the
ever-changing market dynamics looking beneath the surface of claims transactions with the ultimate goal of making
drug therapies more effective, less costly and more efficient which produces better health outcomes for your
enterprise.
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The Opioid Epidemic: How did we get here? 7
REFERENCES
1. IOM (Institute of Medicine, now National Academy of Medicine). Relieving Pain in America: A Blueprint for Trans-
forming Prevention, Care, Education, and Research. Washington, DC: The National Academies Press; 2011. https://
www.nap.edu/read/13172/chapter/2. Accessed March 28, 2018.
2. McLellan, Ph.D, D. & Volkow, M.D., N. (2016, March 31). Opioid Abuse in Chronic Pain — Misconceptions and
Mitigation Strategies. Retrieved from The New England Journal of Medicine: https://www.nejm.org/doi/full/10.1056/
NEJMra1507771. Accessed November 25, 2019.
3. Gusovsky, D. (2016, April 27). Americans consume vast majority of the world’s opioids. Retrieved from nbr.com:
http://nbr.com/2016/04/27/americans-consume-vast-majority-of-the-worlds-opioids/
4. Rajput, V. (2018, March 19). The pain scale shares the blame for the opioid crisis in America. Retrieved from Kevin-
MD.com: https://www.kevinmd.com/blog/2018/03/pain-scale-shares-blame-opioid-crisis-america.html
5. Porter J, Jicks H (1980). Addiction Rare in Patients Treated with Narcotics (letter). N Engl J Med, 123.
6. Van Zee A. The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy. Am J Public
Health. 2009 February; 99(2): 221-227
7. National Academies of Sciences, Engineering, and Medicine. (2019). Medications for opioid use disorder save
lives. Washington, DC: The National Academies Press.
8. Associated Press. (2007, May 10). Purdue Pharma, Execs to Pay $634.5 Million Fine in OxyContin Case. Retrieved
from CNBC.com: https://www.cnbc.com/id/18591525/
9. Cicero, Theodore J., Matthew S. Ellis, and Hilary L Surratt, ‘‘Effect of Abuse-Deterrent Formulation of OxyContin,’’
New England Journal of Medicine 367 (2012), 187–189.
10. Food and Drug Administration (FDA). “Timeline of Selected FDA Activities and Significant Events Addressing
Opioid Misuse and Abuse”. 2018. p. 34. Accessed 16 Sept 2019. https://www.fda.gov/drugs/information-drug-class/
timeline-selected-fda-activities-and-significant-events-addressing-opioid-misuse-and-abuse
11. Lindsey S. OxyContin maker, execs guilty of deceit. Associated Press, 5/10/2007
12. Centers for Disease Control and Prevention (CDC). Opioid Basics – Understanding the Epidemic. https://www.
cdc.gov/drugoverdose/epidemic/index.html Accessed October 24, 2019. Van Zee A. The Promotion and Marketing
of OxyContin: Commercial Triumph, Public Health Tragedy Am J Public Health. 2009 February; 99(2): 221–227
AUTHORS | Adapted from a transcript of Prescription Opioid Vigilance presented at PBMI March 2019 in
Palm Springs, CA presented by:
Sonja Quale, Pharm. D, Chief Clincial Officer and Vice President of Informatics| Confidio
Robert Riley II, Co-Founder | The Missouri Network for Opiate Reform and Recovery, Rebel
Recovery Florida and The Missouri SAFE Project
Jonathan P. Novak, Esq. | Former Attorney for the US Department of Justice DEA
Christine Hopkins, MSN, FNP-BC, APN | Nurse Practitioner at Betty Ford Center
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