By: Remy Bell*

“Ms. Steinberg, I hate to make you get up off your cot,” Senator Johnny Isakson said sympathetically.[1]

Ms. Steinberg—adding some levity to the severity of her condition, which required her to lay down until it was her turn to testify—chuckled and replied, “That’s okay: I’m used to going back and forth.”[2]

During the 2019 hearing held by the Senate Health, Labor and Pensions Committee to discuss pain management alternatives, Cindy Steinberg, the National Director of Policy and Advocacy for the U.S. Pain Foundation, described chronic pain as feeling like “a prisoner in your own body, only you are a prisoner being tortured 24/7, and there is no escape.”[3] Advocating for improvement to pain management, Ms. Steinberg shared the story of the day over 20 years ago that changed her life forever:[4] the simple, everyday act of opening a filing cabinet at her workplace left her trapped underneath stacked cubicle walls, resulting in “severe back pain that has never gone away.”[5]

Ms. Steinberg is not alone. Over 50 million Americans are currently living with chronic pain, which is pain that occurs almost every day for more than 3 to 6 months.[6] 20 million Americans suffer from “high-impact” chronic pain, which negatively affects an individual’s ability to physically care for themselves or others, and often makes it difficult or impossible to work, attend school, or socialize.[7]

In the United States, the primary reason for long-term disability is pain.[8] Chronic pain “is relentless and never end[ing][.]”[9] It isolates, debilitates, and strips individuals of “their sense of self.”[10] A chronic pain sufferer’s quality of life is entirely dependent on their ability to find relief.[11]

Prescription opioids are “one of the most effective pain relief tools” available.[12] While not always the best choice for treating patients with acute pain, prescription opioids can be very successful at providing relief for chronic pain patients. [13]

For millions of Americans currently living with chronic pain, restricted access to prescription opioids has caused life-altering consequences. Chronic pain sufferers “fear a future of constant pain[,]”[14] and when dosages are tapered, or prescriptions are cut off completely, they find themselves left with “really bad choices,”[15] including turning to illicit drugs for relief or “contemplat[ing] or attempt[ing] suicide.”[16]

Changes in Opioid Prescribing

Rising prescription rates and overdose deaths have sparked demand for changed policy, legislation, and guidelines. Enormous pressure has been placed on physicians and pharmacists, who hold power over prescribing and supplying medication, to drastically cut back on prescriptions for opioids.[17]

In 2016, the Center for Disease Control and Prevention (“CDC”) released a “Guideline for Prescribing Opioids for Chronic Pain” (“Guideline”)[18] aimed at “reduc[ing] excessive and unnecessary opioid prescribing,” and ultimately, reducing overdose and death rates.[19] The Guideline, created without the expertise of pain specialists, placed a dosage and duration ceiling on opioid prescriptions.[20]

The Guideline was and continues to be grossly misinterpreted:[21] while it only provided recommendations, the messaging and influence of the CDC caused many doctors, pharmacists, and insurance companies to treat the Guideline as if it was mandatory.[22] It has been followed so strictly that some states have gone as far as implementing its recommendations into their laws and policies.[23]

The Guideline advised against using opioids as first-line medications for chronic pain treatment, but many interpreted this to mean that opioids should never be prescribed.[24] Doctors, afraid of the potential legal, criminal, and ethical consequences of suspected overprescribing, have rapidly decreased prescription opioid dosages or cut patients off of their medication immediately, despite patients responding well to their treatment.[25] Dosage ceilings have been treated as “hard limits” and have created a perverse incentive to avoid “caring for patients [that] require above average amounts of opioid mediation[.]”[26]

In 2019, the CDC issued a statement attempting to clarify and repair the misunderstandings and subsequent consequences of its 2016 Guideline.[27] The statement highlighted the risks of misapplying its recommendations and advocated against the rapid tapering or immediate cutting off of opioid prescriptions, explaining the result could lead to “severe opioid withdrawal symptoms” and cause patients to “seek other sources of opioids.”[28]

In 2022, the CDC released an updated version of its 2016 Guideline.[29] Apart from small improvements such as acknowledging the importance of patient-physician communication prior to the tapering or removal of a patient’s opioid prescription, chronic pain advocates believe the 2022 Guideline fell short of repairing the damage caused by the original Guideline.[30]

The Impact on Individuals with Chronic Pain

Prescription opioids, while not a cure for chronic pain, can provide patients with “some quality of life and lessen their relentless pain.”[31] An estimated 5 to 8 million chronic pain patients depend on prescription opioids for pain relief,[32] and many have already exhausted every other available pain treatment option.[33]

The public perception of pain and opioids combines individuals with chronic pain who depend on prescription opioids for relief and individuals with opioid use disorder into one category.[34] However, most patients with a legitimate opioid prescription do not become addicted to their medication:[35] studies have found that the likelihood of addiction in these cases falls between below 1% and 8%, decreasing to as low as .19% for patients without a “history of abuse [or] addiction[.]”[36] It is only when opioid prescriptions are diverted—that is, taken by an individual that was not prescribed the medication—that the risk of addiction increases to above 8%.[37]

Both the pressure of dosage ceilings and the stigma surrounding prescription opioids have caused doctors to abruptly lower dosages, cut patients off cold-turkey, or drop patients altogether.[38] Maria Higginbotham, a chronic pain patient previously able to clean her house, cook dinners, and care for her family because of her opioid medications, is now unable to stand for more than a couple of minutes at a time, requiring her family’s assistance to leave her bed or use the restroom.[39] Her doctor “believed [she] had done well on the medication,” but chose to lower her opioid dosage by 75% to meet the CDC’s recommended ceiling because “he feared liability for prescribing high doses.”[40]

“Patients have become ‘opioid refugees,’ traveling long distances to find anyone willing to write a script[,]”[41] and the search is often unsuccessful: 81% of physicians are reluctant to take on chronic pain patients who rely on prescription opioids for treatment.[42] Ms. Steinberg searched for five years before she was able to find a doctor that was willing to prescribe her opioids.[43]

Despite the drastic decline in opioid prescriptions from a high of 255 million in 2012 to just under 143 million in 2020—the lowest reported number in fifteen years[44]—overdose deaths continue to rise,[45] largely due to the fact that a majority of fatal overdoses are caused not by prescription medications like opioids, but by illicit drugs, specifically fentanyl and other synthetic opioids.[46]

Studies involving chronic pain patients who were abruptly taken off of their opioid medication have revealed a 3.5 to 4 times higher chance of suicide[47] in addition to an increased risk of fatal overdose.[48] Chronic pain accounts for at least 10% of suicides in the United States.[49] Many chronic pain patients, desperate to find relief after losing access to their medication, have tried to self-medicate with illicit drugs like fentanyl or heroin or have taken their own lives.[50]

Danny Elliot suffered a nearly life-ending electrocution that left his brain feeling like it was “loose inside [his] skull[.]”[51] Prescription fentanyl brought his pain down from a 10 to a 5, which he considered to be “almost pain free[,]” but he lost access to his medication when his doctor became the target of a DEA investigation—a situation that had happened to 2 of Danny’s doctors in the past.[52] After contacting 17 doctors for help to no avail, Danny and his wife committed suicide.[53] In an email to his brother shortly before his death, Danny wrote, “I just can’t live with this severe pain anymore, and I don’t have any options left[.]”[54]

Millions of chronic pain patients, left without access to prescription opioids, have become collateral damage of failed efforts to combat the opioid crisis.[55] The societal and political pressure to “hold someone liable for this deadly epidemic” has increased the risk of potential liability for opioid prescribers, causing a major shift in the way doctors and pharmacists practice medicine.[56] Ultimately, chronic pain patients have been deprived access to medication that often serves as their only hope for pain relief, resulting in tragic, and sometimes fatal, consequences.

 

*Remy Bell is a Note and Comment Editor for JLI Vol. 42.

[1] Testimony by National Director of Policy and Advocacy for U.S. Pain Foundation and chronic pain suffer, Cindy Steinberg, before the U.S. Senate Health, Education, Labor and Pensions Committee, offering her expertise on pain management during the opioid crisis. https://www.c-span.org/video/?457829-1/pain-management-alternatives [hereinafter Steinberg testimony].

[2] Id.

[3] Id.

[4] Id.

[5] Id.

[6] James Dahlhamer, PhD, Jacqueline Lucas, MPH, & Jacqueline Lucas, MPH, et al., Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults — United States, 2016, Morbidity & Mortality Wkly. Rep.  1001–06 (2018), https://www.cdc.gov/mmwr/volumes/67/wr/mm6736a2.htm.

[7] Id.; see also National Center for Complementary and Integrative Health, Prevalence and Profile of High Impact Chronic Pain, (Aug. 8, 2018), https://www.nccih.nih.gov/research/research-results/prevalence-and-profile-of-high-impact-chronic-pain.

[8] Chandrashekar Janakiram, MDS, PhD, Paul Fontelo, MD, MPH & Vojtech Huser, MD, PhD, et. al., Opioid Prescriptions for Acute and Chronic Pain Management Among Medicaid Beneficiaries, Am. J. Prev. Med. 57(3) 365, 368 (Aug. 2019).

[9] Steinberg testimony, supra note 1.

[10] Id.

[11] Id.

[12] Id.; Opioid Prescribing Estimates Workgroup. Observations presented to the National Center for Injury Prevention and Control’s Board of Scientific Counselors. Atlanta, Center for Disease Control and Prevention, (December 12, 2018), https://www.cdc.gov/injury/pdfs/bsc/NCIPC_BSC_OpioidPrescribingEstimatesWorkgroupReport_ December-12_2018-508.pdf.

[13] Steinberg testimony, supra note 1.

[14] Sam Whitehead & Andy Miller, CDC’s new opioid guidelines are too little, too late for chronic pain patients, experts say, NBC News, (Mar. 13, 2023), https://www.nbcnews.com/health/health-news/cdcs-new-opioid-guidelines-little-late-chronic-pain-patients-rcna74248.

[15] Joel Achenbach & Lenny Bernstein, Opioid crackdown forces pain patients to taper off drugs they say they need, The Wash. Post, (Sept. 10, 2019 at 10:54 AM), https://www.washingtonpost.com/health/opioid-crackdown-forces-pain-patients-to-taper-off-drugs-they-say-they-need/2019/09/10/3920f220-c8da-11e9-a4f3-c081a126de70_story.html

[16] Steinberg testimony, supra note 1.

[17] Emily J. Yang, The Opioid Crisis and the Wrongful Conduct Rule: Does It Matter Who’s to Blame?, Food and Drug J. 75(4) 574, 575 (2021).

[18] Deborah Dowell, Tamara M. Haegerich & Roger Chou, CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016, 65 Morbidity & Mortality Wkly. Rep. 1 (Mar. 18, 2016), https://www.cdc.gov/mmwr/volumes/65/rr/pdfs/rr6501e1.pdf [https://perma.cc/QF2R-T4WS].

[19] Alvin Powell, New CDC guidelines a ‘corrective’ for opioid prescriptions, specialist says, The Harv. Gazette (Nov. 21, 2022), https://news.harvard.edu/gazette/story/2022/11/new-cdc-guidelines-a-corrective-for-opioid-prescriptions-specialist-says/.

[20] Steinberg testimony, supra note 1.

[21] Madeline Orlando, The Doctor Will See You Now: How the Opioid Crisis Changed the Standard of Care for Physicians in Medical Malpractice Suits, 52 U. Pac. L. Rev. 231, 254 (2020).

[22] Kate M. Nicholson & Deborah Hellman, Opioid Prescribing and the Ethical Duty to Do No Harm, Am. J. Law Med. 46(2-3) 297, 307.

[23] Id.

[24] Keith A. Reynolds, Opioid Crisis Fallout: Physicians Increasingly Avoid Treating Chronic Pain Patients, Survey Finds, Med. Econ. (Nov. 6, 2019), https://www.medicaleconomics.com/news/opioid-crisis- fallout-physicians-increasingly-avoid-treating-chronic-pain-patients-survey-finds.

[25] Powell, supra note 18; Stefan Kertesz, An opioid quality metric based on dose alone? 80 professionals respond to NCQA, Medium (Nov. 6, 2019), https://stefankertesz.medium.com/an-opioid-quality-metric-based-on-dose-alone-80-professionals-respond-to-ncqa-6f9fbaa2338.

[26] Kurt Kroenke, MD, Daniel P. Alford, MD, MPH, & Charles Argoff, MD et. al., Challenges with Implementing the Centers for Disease Control and Prevention Opioid Guideline: A Consensus Panel Report, Pain Med. 20(4) 724, 726–29 (2019); Stefan G Kertesz, Outcomes after opioid dose reductions and stoppage: It’s time to start counting, J. of Substance Abuse Treat 103, 64, 65 (May 14, 2019).

[27]CDC Advises Against Misapplication of the Guideline for Prescribing Opioids for Chronic Pain, Center for Disease Control and Prevention, (Apr. 24, 2019, 5:00 PM), https://www.cdc.gov/media/releases/2019/s0424-advises-misapplication-guideline-prescribing-opioids.html.

[28] Id.; Orlando, supra note 21.

[29] Deborah Dowell, MD, Kathleen R. Ragan, MSPH & Christopher M. Jones, PharmD, DrPH, et. al., CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022, Morbidity & Mortality Wkly. (Nov. 2022), https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm.

[30] An interview with Cindy Steinberg: CDC’s final issued Guideline for Prescribing Opioids for Chronic Pain, U.S. Pain Foundation, (Nov. 8, 2022) https://uspainfoundation.org/news/steinberg-discusses-cdc-final-guideline-for-prescribing-opioids/ (explaining that the updated Guideline continues to communicate a disapproval of opioid therapy by neglecting to mention the risks of undertreated pain and the benefits of properly administered opioids); see generally Dowell, et. al., supra note 29.

[31] Steinberg testimony, supra note 1.

[32] Kroenke, supra note 26 at 725.

[33] Not Allowed to Be Compassionate, Human Rights Watch, i, ii–iii (Dec. 2018), https://www.hrw.org/sites/default/files/report_pdf/hhr1218_web.pdf.

[34] Steinberg testimony, supra note 1; Elizabeth Llorente, As doctors taper or end opioid prescriptions, many patients driven to despair, suicide, Fox News (Dec. 10, 2018 at 11:29 AM), https://www.foxnews.com/health/as-opioids-become-taboo-doctors-taper-down-or-abandon-pain-patients-driving-many-to-suicide.

[35] Anuj Shah, Corey J. Hayes, PharmD & Bradley C. Martin, PharmD, PhD, Characteristics of Initial Prescription Episodes and Likelihood of Long-Term Opioid Use — United States, 2006–2015, Morbidity & Mortality Wkly. 265, 267, (2017), https://www.cdc.gov/mmwr/volumes/66/wr/mm6610a1.htm.

[36] David A. Fishbain, Brandly Cole & John Lewis, et. al., What percentage of chronic nonmalignant pain patients exposed to chronic opioid analgesic therapy develop abuse/addiction and/or aberrant drug-related behaviors? A structured evidence-based review, Pain Med. 9(4) 444, 447, (May 2008); Human Rights Watch, supra note 33.

[37] Opioid Overdose Crisis, National Institute on Drug Abuse, (Feb. 2020),

https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis [https://perma.cc/V294-2YZX].

[38] Nicholson & Hellman, supra note 22 at 303–07.

[39] Human Rights Watch, supra note 33 at iii.

[40] Id.

[41] Achenbach & Bernstein, supra note 15.

[42] Physician Perspectives and Diagnostic Insights on the Evolving Drug Crisis, Quest Diagnostics, 1, 6, (Oct. 2019), https://mma.prnewswire.com/media/1011170/Quest_Diagnostics___Health_Trends_Report.pdf?p=original.

[43] Steinberg testimony, supra note 1.

[44] U.S. Opioid Dispensing Rate Maps, Center for Disease Control and Prevention, (Nov. 10, 2021), https://www.cdc.gov/drugoverdose/rxrate-maps/index.html.

[45] Will Stone, Patients with Chronic Pain Feel Caught in an Opioid Prescribing Debate, NPR, (Jul. 8, 2018 at 6:10 PM), https://www.npr.org/sections/health-shots/2018/07/08/622729300/patients-with-chronic-pain-feel-caught-in-an-opioid-prescribing-debate.

[46] Maia Szalavitz, ‘Entire Body Is Shaking’: Why Americans With Chronic Pain Are Dying, N.Y. Times,  (Jan. 1, 2023), https://www.nytimes.com/2023/01/03/opinion/chronic-pain-suicides.html.

[47] Maia Szalavitz, What the Opioid Crisis Took From People in Pain, N.Y. Times, (Mar. 7, 2022), https://www.nytimes.com/2022/03/07/opinion/opioid-crisis-pain-victims.html.

[48] Jocelyn R. James et al., Mortality after Discontinuation of Primary Care–Based Chronic Opioid Therapy for Pain: A Retrospective Cohort Study, 34 J. Gen. Internal Med. 2749, 2755 (2019).

[49] Id.; Emiko Petrosky, MD, MPH, Rafael Harpaz, MD, MPH & Katherine A. Fowler, PhD, Chronic Pain Among Suicide Decedents, 2003 to 2014: Findings From the National Violent Death Reporting System, ACP J. (Oct. 2, 2018).

[50] Szalavitz, supra note 38.

[51] Keegan Hamilton, This Couple Died by Suicide After the DEA Shut Down Their Pain Doctor, Vice News, (Nov. 30, 2022 at 4:30 AM), https://www.vice.com/en/article/wxnyb9/dea-fentanyl-doctor-patient-suicide.

[52] Id.

[53] Id.

[54] Id.

[55] Will Stone, Patients with Chronic Pain Feel Caught in an Opioid Prescribing Debate, NPR, (Jul. 8, 2018 at 6:10 PM), https://www.npr.org/sections/health-shots/2018/07/08/622729300/patients-with-chronic-pain-feel-caught-in-an-opioid-prescribing-debate.

[56] Yang, supra note 17 at 574–75.