HOW I FOUND MY RHYTHM WHEN THE MUSIC STOPPED

At a time in everyone’s life, we come to find ourselves in a situation where the music stops, and we must go on.  The unfortunate truth about life is that the unexpected will happen. Some of us learn from it, some of us change because of it and some of us find our life’s calling because of it. The latter was the case for me.  After our dad picked us up from middle school, we spent that afternoon like we had every afternoon that month. We went to the oncology unit at the hospital, where my brother was admitted.

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THE MAN IN A BLUE SARONG

I remember him. I remember the man in the dark blue sarong the same way I remember the lines on back of my own hand. He was hunched over next to a column on a dirty platform at a railway station in Calcutta, India in the middle of the harsh summer sun. His hands were withered, his fingers and toes looked like tiny nubs, and he was completely malnourished and alone. He had opaque blue eyes, as if fog had taken place of his irises and pupils.

….FULL ARTICLE

PATIENT “OWNERSHIP”

I studied insects in college; my favorite insects were the bees (I found them diligent and so helpful to humankind).  One of my favorite classes was about medical diseases caused by insects. My professors noticed my interest in the medical side of things and connected me with a professor who did clinical research. Our work focused on a clinical trial for children with intractable epilepsy and exposed me early on to patient care and patients.

….FULL ARTICLE

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long-term studies implicating chronic opioid use and addiction. (The fact was that there were no long-term studies regarding chronic opioid use whatsoever!) Despite the poor quality of the available studies, the 1986 Foley and Portenoy study was cited repeatedly to support aggressive opioid pain management.  Most concerning, the one paragraph letter to the NEJM was cited 608 times as a “study” supporting opioid safety. (3)


In 1997, the American Academy of Pain Medicine (AAPM) and American Pain Society (APS) published a consensus statement that there was lacking evidence implicating opioids to addiction. (6)  In 1998, the Veteran’s Health Administration incorporated pain as the “fifth vital sign” into their national strategy for the assessment and treatment of pain. (7)  Similarly, JCAHO ( Joint Commission on Accreditation of Healthcare Organizations) embraced the “Pain is the Fifth Vital Sign” and issued standards requiring the use of a pain scale and treatment of pain, especially with opioids. JCAHO also referred to pain management as a patient’s rights issue, inferring sanctions if the pain was not adequately controlled. (8-10) Also, in 1998, the Federation of State Medical Boards (FSMB) issued guidelines stating that “physicians should not fear disciplinary action” from FSMB if prescribing opioid analgesics for “legitimate medical purpose and in the usual course of professional practice.” (11)


The FDA (Food and Drug Administration) granted its approval of Oxycontin in December of 1995 without evidence of efficacy or safety from any clinical trials!  Purdue Pharmaceuticals, the manufacturer of Oxycontin, claimed that the long-acting formulation was “believed to reduce” its appeal to drug abusers compared to shorter-acting analgesics.  The FDA believed them! Pharmaceutical companies, particularly Purdue, aggressively marketed their analgesic products, citing “evidence” that opioid use was efficacious and safe, and contributed substantially to regulatory organizations and professional organizations.


Another factor contributing to this perfect storm was Press Ganey, a survey of patients which began in 1985 to identify opportunities to improve patients’ experiences. Collection of data was necessary for improvement; but, the distinction between patient satisfaction and quality of care became blurred. Press Ganey monetized their concept and promoted the notion that patient satisfaction was a proxy for quality of care. (There is still no definitive data to correlate patient satisfaction and quality of care.) The final ingredient was CMS (Centers for Medicare and Medicaid Services). CMS realized that the current pay for volume healthcare system was insolvent; thus, CMS developed the value-based purchasing program.  Scoring for hospitals depended upon performance on equally weighted metrics: 1) Processes of care, 2) Outcomes of care, 3) Efficiency, and 4) Patient experience.  The patient experience was collected via HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) surveys which included patient scoring of satisfaction with pain management.   “Did hospital staff do everything they could to help you with your pain?”


With the aforementioned factors in place, it is easier to understand the following contributors to the opioid epidemic because these factors are unintended responses/ reactions.  The predominant thought was that there were too many patients suffering unnecessarily because of inadequate pain management.  Physicians needed pain management guidelines, to include the use of opioid medications.  Physicians needed education to dispel the concern for addiction.  Additionally, insurances were not reimbursing for non-pharmacologic modalities for the treatment of chronic pain.  The landscape was perfect for the pharmaceutical companies to capitalize on the pain revolution.  Since regulatory organizations and professional medical societies were doing such a great job of promoting the pharmaceutical companies’ marketing strategies, financial contributions (or payments) were justified (from a pure business perspective).   Everyone was doing their part to expose the undertreatment of pain and promote the opioids are safe and efficacious propaganda.


Since reimbursement to hospitals were tied to patient satisfaction, hospital administrators were forced to implement initiatives to improve patient satisfaction scores and avoid a penalty.  CMS only required 300 surveys in a 12-month period.  And if only a small number of patients actually completed and returned patient satisfaction surveys (estimated to be around 25%), a single poor survey could significantly impact whether the hospital achieved the required 90% percentile goal.  Thus, hospitals coerced physicians (via withholding payment or bonuses) to ensure that every patient was satisfied, especially when completing the survey questions regarding adequate pain management.   When patients requested/demanded opioid pain medications, physicians were often compelled to satisfy the patients, despite their reservations about the need for opioids.(12-14)  


As the prescription opioid problem escalated, the spike in opioid related overdose deaths caught the public’s eyes.  This resulted in a cascade of reflexive responses which unintentionally facilitated the reintroduction of heroin and later fentanyl to Americans.  It was easy to see.  If the amount of prescription opioids were reduced, there would be less prescription opioids to abuse and that should result in decreases in opioid related overdoses and deaths.  Thus, the campaign to limit prescription opioids began.  Legislators demanded implementation of prescription drug monitoring programs (PDMPs) to mitigate doctor shopping.  It also allowed physicians to identify patients who were already receiving other opioid or scheduled medications.  Various medical societies, CDC, and governmental agencies all switched their stances on the treatment of pain, cautioning physicians regarding the danger of opioid addiction.  Law enforcement aggressively sought and closed the numerous “pill mills” throughout the country.  Naloxone kits were widely dispersed to treat overdoses.  The message was clear, physicians must stop overprescribing opioid medications.  But other than the American Society of Addiction Medicine (ASAM) or a handful of physicians who were treating addiction, there were no plans for the void which these interventions created.  That is, what was the plan for the patients who were already addicted to opioids?  With all of the prescription opioids gone, what were these addicted patients going to use?


Coincidentally, it was around this time that several states were decriminalizing marijuana.  More American marijuana customers were growing their own supply.  The wholesale price of marijuana dropped from $100 per kilogram to less than $25.  Farmers in Mexico, particularly the “Golden Triangle,” the region of Mexico’s Sinaloa state which produced the country’s most dangerous gangsters and largest marijuana producers, quickly changed their crop to opium poppies, heroin.  With a large, eager American demand from addicts who had their supply of prescription opioids quickly removed, the Mexican heroin suppliers had an immediate market.  Not only was there an abundant supply of opioids (heroin from Mexican suppliers), the cost of heroin was relatively cheaper.   The prices of prescription opioids or heroin depend upon location, availability on the streets, and the heroin’s “purity.”  The current market value of Oxycodone is about $1 per milligram and based upon patient testimonies during treatment, a typical addict will use 80-160 mg per dose up to 4-5 times per day (about $400/day).  Money was usually the limiting factor.  On the other hand, a gram of heroin has a street value of about $100 and a typical dose is 5-20 mg 4-5 times per day ($10/day).  (For in-depth details of how clever Mexican heroin entrepreneurs capitalized on the American demand for opioids, read DreamLand: The True Tale of America’s Opiate Epidemic.) (18)


Strategies to Combat the Opioid Epidemic

To effectively implement strategies to combat the current U.S. opioid epidemic, there are certain myths regarding addiction which require dispelling.  The most significant misconception is that addiction is related to poor individual choices, moral failures, and/or weak willpower.  Compulsion to use drugs is a voluntary choice.  MAT, also previously known as opioid replacement therapy, is substituting one addiction with another.  The best way to combat opioid addiction is without medication.  These attributes (stereotypes) contribute to the stigma which often shame people who have addiction, their family members and associates.  These fallacies will harm those who are at most risk!  Similar to other medical conditions (emphysema, heart disease, hypertension, diabetes), voluntary unhealthy behaviors (or choices) do contribute to the disease.  We promote proper dietary changes to the diabetic who consumes excessive sweets.  We discourage patients who smoke.  We encourage our patients to exercise.  But we do not withhold evidence- based treatment from patients who do not comply with our recommendations!  Chronic opioid use causes changes in the brain reward system which depresses the addicted person’s valuation of normal motivational stimuli (food, social interactions, sex) and shifts it toward more potent reward stimuli such as opioids.  As discussed, there are also simultaneous changes causing dysphoria and discomfort which drives an addict to use opioids to mitigate the aftereffects of opioid use.  We should constantly discourage patients from further use of opioids; but, we should also continue to offer them evidence-based treatment.


Abstinence, the complete cessation of drug use, has been the gold standard for addiction treatment in the U.S. for many years.  Originally created for alcoholism, the model is currently used to treat all addictions.  After the creation of AA (Alcoholics Anonymous) in 1935 and the publication of “The Big Book,” written by William Wilson to describe how to recover from alcoholism, the model (also referred to as the Minnesota Model) was spread to not-for-profit organizations such as the Hazelden Betty Ford Foundation, the premier residential and outpatient facility for addiction, the nation’s largest addiction and recovery publishing house, a fully accredited graduate school of addiction studies, and an addiction research center.  Although the model is based primarily on AA principles, it added medical and psychological components.  In 2006, a Scottish study followed 695 recovering alcoholics for 33 months following treatment using this model and reported only 5.9% of females and 9% of males had remained abstinent for at least 90 days. (19)  In regards to efficacy for opioid addiction, there are no reliable or accurate studies to support the use of abstinence.  In 2012, the Hazelden Betty Ford Foundation announced that it has incorporated MAT into its treatment plan for opioid addiction.


Multidisciplinary approaches to limit the supply of prescription opioids have been successful.  Dr. Patrice Harris, Chair of the AMA Opioid Task Force, announced Apr 19, 2018 that between 2013 and 2017, there was a 22% decrease (55 million less) in opioid prescriptions. (20)  Physicians and patients are aware of the dangers of opioid addiction.  Many professional organizations have created pain management guidelines for physicians.  Regulatory and legislative organizations have tightened restrictions for the prescribing and monitoring of opioid pain medications.  Naloxone kits are readily available to mitigate overdose deaths.  Law enforcement has diligently worked to disrupt the heroin traffic.  And most important, there has been tremendous promotion of treatment for people already addicted to opioids.  This intervention was lacking during the initial response to the prescription opioid crisis.  Successful interventions to limit the supply of prescription opioid drugs created an imbalance of supply versus demand and drug dealers exploited the opportunity with heroin to satisfy the unmet demand for opioids.  Learning from the 2010 experience, future strategies to combat the opioid epidemic must include interventions to limit both supply and demand.  If treatment for opioid dependence becomes easier to attain than other opioids to relieve withdrawal symptoms, the demand for opioids will decrease. As the demand decreases, the supply will initially rise which will devalue the illicit opioids (heroin, fentanyl), and eventually cause supply to decrease.  For example, New York City recently used this approach to tackle the tobacco problem.  The city banned smoking in public spaces and significantly raised the taxes on cigarettes.  Simultaneously, the city promoted and facilitated the public’s access to free nicotine patches or free nicotine gum. The intervention was successful!


Facilitation of access to opioid treatment is beneficial; but, there are potential pitfalls.  Buprenorphine is an opioid agonist and will induce mu opioid effects to include euphoria, particularly opioid naïve individuals, and respiratory depression.  Because buprenorphine is an opioid partial agonist, the ceiling effect will limit the potency of the euphoria and similarly the respiratory depression risk. Fatal overdoses solely due to buprenorphine are rare. (21) Most overdoses involving buprenorphine occur when other drugs are taken concomitantly, (22.23) usually benzodiazepines and/or alcohol.  (Buprenorphine has the ceiling effect to mitigate respiratory depression; but, benzodiazepines and alcohol do not.)  Despite buprenorphine’s safety profile, ceiling effect, and lower abuse potential, once buprenorphine becomes “more available,” and/or cheaper, it will become the next abused and diverted drug problem.  Yokell et al. conducted an international review of buprenorphine diversion, misuse, and illicit use. (24) The authors reported that since France’s adoption of buprenorphine for OUD in 1995, about 20% of buprenorphine patients were misusing the drug intravenously (snorting is also a common delivery mechanism).  In Finland where buprenorphine has been used for pain management since 1997 and OUD since 2002, buprenorphine has become the most commonly abused drug. The authors noted that the rise in buprenorphine use in Finland coincided with a decrease in availability of heroin in 2001. Despite reported diversion and misuse, buprenorphine was ranked as the least-abused or misused opioid in America.  Motivating factors for diversion and/or misuse included: price, euphoria, availability, and self-treatment for opioid addiction (non-medically supervised buprenorphine use).


While it is desirable to promote MAT for treatment of opioid addiction, it may be more prudent to encourage treatment which includes MAT, counseling/behavioral therapies, and case management. We want to encourage the use of buprenorphine as treatment, not simply the use of buprenorphine. Promoting many prescribers to simply write for buprenorphine without supporting psychotherapy and case management may create a future state where buprenorphine becomes the next drug crisis. National Institute on Drug Abuse’s principles of effective treatment for drug addiction includes counseling and other behavioral therapies and addressing all of the patient’s needs, not just his or her drug use. Patients with opioid addiction have many complex socioeconomic and legal issues. Combine this with poor coping and inadequate social skills (neglected during long-time drug use), these vulnerable patients face significant challenges. For effective treatment of opioid addiction, management of the basic needs of the patients such as employment, housing, food, finances, and social complications (loss of child’s guardianship, criminality) is extremely critical to successful treatment.  Without resolution of these issues, they become constant sources of stress and triggers for drug use. Additionally, patients with opioid addiction require intense counseling and behavioral therapies.  With the assistance of MAT, patients’ withdrawal/ dysphoric symptoms are mitigated and they will be much more receptive/capable of participation with psychotherapeutic intervention.


The third crucial element necessary for successful strategies to combat the opioid epidemic is improving the current management of chronic pain.  In 2011, the Institute of Medicine (IOM) published “Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education and Research,” the most comprehensive report on pain in America. (25)  IOM reported that 116 million Americans suffer from chronic pain (1 in 3 adults) and estimated $560 billion in healthcare and lost productivity costs.  “Human suffering is often unnecessary – millions of people get inadequate pain relief for conditions that could be treated or managed.” This is one tough quandary! There is an opioid epidemic and everyone is doing their part to reduce the use of opioids. But what about the patients who have legitimate chronic pain? Not all of these patients require opioid pain medications; but, what are their options? There are not enough pain specialists to properly diagnose or perform injections/procedures. Despite general support for non-pharmacologic modalities such as yoga, physical therapy, massage, acupuncture, and Cognitive Behavioral Therapy (CBT), these services are often not covered by insurances or not available in many rural areas.


Conclusion

The opioid epidemic began with a well-intentioned request, “Can we manage patients’ pain better?” As more well- intentioned individuals contributed to the discussion, the question evolved into “Why are patients suffering unnecessarily from undertreatment of pain?” Once regulatory organizations joined, the question converted to mandates, “Pain must be assessed and pain must be treated.” In response to the opioid epidemic, the pendulum has swung completely to the other extreme. “Do not prescribe opioids or you will cause addiction.” Is it acceptable to allow patients to suffer now? Did we go full circle back to the pre-opioid crisis? And the question, “Can we manage patients’ pain better?” still needs answering.


References


  1. Hentoff N. The treatment of patients – I. The New Yorker 1965; June 26:32- 77.
  2. Courtwright D. A century of American narcotic policy. In: Institute of Medicine. Treating Drug Problems: Volume 2. Washington, DC: IOM, 1992, pp. 1-62. Available online  [Accessed August 19, 2018.]
  3. N Engl J Med 2017; 376:2194-2195.  June 1, 2017
  4. Portenoy RK, Foley KM. Chronic use of opioid analgesics in non-malignant pain: Report of 38 cases. Pain. 1986 May;25(2):171-86.
  5. Breivik Harald, Borchgrevink P C, Allen S M, Rosseland Leiv Arne, Romundstad Luis. Assessment of Pain – American Pain Society. BJA: British Journal of Anaesthesia. 2008.
  6. Haddox JD, et al., The American Academy of Pain Medicine and the American Pain Society.  The use of opioids for the treatment of chronic pain.  A consensus statement from the American Academy of Pain Medicine and the American Pain Society.  1977.  Clin J Pain 1997;13(1):6-8.
  7. United States Department of Veteran’s Affairs.  Pain as a fifth vital sign toolkit.  1999, revised 2000.  Available at: http://www.va.gov/.  Accessed August 23, 2018.
  8. Dowell D, Kunins HV, Farley TA. Opioid analgesics – Risky drugs, Not risky patients. JAMA 2013:309(21):2219-20.
  9. Pizzo PA, Clark NM. Alleviating suffering 101 – pain relief in the United States. N Engl J Med. 2012;366:197- 199.
  10. Lanser P, Gesell S. Pain management: the fifth vital sign. Health Benchmarks. 2001;8;62, 68-70.
  11. Federation of State Medical Boards of the United States, Inc. Model Policy For the Use of Controlled Substances for the Treatment of Pain. 1997. Available at: http://www.painpolicy.wisc.edu/.  Accessed August 23, 2018.
  12. Olds, D. How Patient Satisfaction Surveys Contribute to the Opioid Crisis. The Fix. 2017. Available at: https://www.thefix.com/. Accessed Aug 30, 2018.
  13. AMA Wire. Patient satisfaction surveys need to better address pain management: Fighting opioid epidemic. AMA Wire. 2016. Available at: https://wire.ama-assn.org. Accessed Aug 30, 2018.
  14. Falkenberg, K. Why Rating Your Doctor is Bad For Your Health. Forbes. 2013. Available at: https://www.forbes.com/sites. Accessed Aug 30, 2018.
  15. Quinones, S. Dreamland: The true tale of America’s opiate epidemic. New York: Bloomsbury Press, 2016.
  16. Wide-ranging online data for epidemiologic research (WONDER).  Atlanta, GA: CDC, National Center for Health Statistics; 2017.  Available at http://wonder.cdc.gov.  Accessed August 23, 2018.
  17. Johnston, L.D.; O’Malley, P.M.; Bachman, J.G.; and Schulenberg, J.E. Monitoring the Future National Results on Adolescent Drug Use: Overview of Key Findings, 2013. Bethesda, MD: National Institute on Drug Abuse, 2013. Available at www.monitoringthefuture.org
  18. International Narcotics Control Board Report 2008.External link, please review our disclaimer.. United Nations Pubns. 2009. p. 20
  19. McKeganey N, et al. Abstinence and drug abuse treatment: Results from the Drug Outcome Research in Scotland study. 2006.  Available at: http://www.tandfonline.com/. Accessed August 27, 2018.
  20. AMA. AMA Sees Progress in Declining Opioid Prescriptions. 2018. Available at: https://www.ama-assn.org/. Accessed August 27, 2018.
  21. Kintz P. Deaths involving buprenorphine: a compendium of French cases. Forensic Sci Int 2001;121(1-2):65-9.
  22. Amass L, Ling W, Freese TE, et al. Bringing buprenorphine-naloxone detoxification to community treatment providers: the NIDA Clinical Trials Network field experience. Am J Addict 2004;13(Suppl 1):S42-66.
  23. Auriacombe M, Fatseas M, Dubernet J, Daulouede JP, Tignol J. French field experience with buprenorphine. Am J Addict 2004;13(Suppl 1):S17-28.
  24. Comer SD, Collins ED. Self- administration of intravenous buprenorphine and the buprenorphine/ naloxone combination by recently detoxified heroin abusers. J Pharmacol Exp Ther 2002;303(2):695- 703.
  25. Comer SD, Sullivan M, Whittington RA, Vosberg S, Kowalczyk WJ. Abuse liability of prescription opioids compared to heroin in morphine-maintained heroin abusers. Neuropsychopharmacology 2008;33(5):1179-91.

America’s first epidemic of opioid addiction occurred in the 1840s. Mothers dosed themselves and their children with opium tinctures and opioid containing medicines. Soldiers in the U.S. Civil War treated their injuries and diarrhea with morphine (“the Army disease”).(1) Drinkers treated their hangovers with opioids. However, the main source of the epidemic was iatrogenic morphine, which coincided with the invention of the hypodermic needles in the 1870s.  It has been estimated that consumption of opioids soared 538% from 1840 to 1890.  The Institute of Medicine estimated that by 1900, about 300,000 Americans were addicted to opiates. (2)


There were few alternatives to symptomatic treatment during the nineteenth century. The pathology of diseases, particularly chronic pain, was poorly understood. An injection of morphine magically alleviated most symptoms, particularly pain. Patients appreciated the relief and doctors felt empowered. Fast forward to present day. Despite our tremendous advancements in medicine, there are many diseases including chronic pain that continue to elude our understanding. Physicians overprescribe opioids.  Physicians also overprescribe diagnostic evaluations, labs, imaging and antibiotics.  But, these are all well-intentioned. Physicians do not want to miss a diagnosis which could harm their patients. And they definitely do not want their patients to experience pain. But instead of the 10-20 tablets (3-4 days of analgesics), physicians will often prescribe more than the necessary amount. And it is the leftover pills that cause problems. These pills sit forgotten in the medicine cabinets until a family member, neighbor,

BY TUYEN T. TRAN, MD

or visitor inappropriately abuses them. But the physicians’ contribution to the opioid epidemic also has a sinister side. There are, unfortunately, colleagues who have participated in “pill mill” operations, accepting cash payments in exchange for opioid prescriptions regardless of ailment. (Between 1992-2001, Dr. David Proctor, the “Godfather of Pill Mills,” operated America’s first “pill mill” in South Shore, KY until his arrest.) These doctors damage the reputation of every other physician who is working very hard to help patients.


In 1980, NEJM published a one paragraph letter from Jane Porter and Hershel Jick, MD, reporting that during their retrospective review of 11,882 hospitalized patients who received narcotics, only four (4) patients were found to have “well documented addiction.” (3)  In 1986, doctors Kathleen Foley and Russel Portenoy published in Pain that iatrogenic addiction risk was low in 38 chronic non-cancer pain patients treated with opioids. (4)  In 1995, James Campbell, MD, president of the American Pain Society, promoted, “Pain is the Fifth Vital Sign.” He encouraged physicians to assess pain with as much “zeal as other vital signs” if we were going to adequately treat pain. (5) Many of the pain specialists at the time felt that physicians were undertreating pain because of a misconception among physicians regarding opioid use and addiction. They reported that there were no

TUYEN T. TRAN, MD

Tuyen Tran, MD emigrated from South Vietnam after the war. He completed his undergraduate in biology/chemistry and medical school at the University of Missouri – Kansas City in a six year program. His is currently boarded in internal medicine and addiction medicine.