How Fear, Misinformation, Stigma Have Devastated US Pain Patients

    Tamera Lynn Stewart had been taking prescribed opioids for 12 years to treat her chronic pain, following some cancer-related surgeries. Then one day in April 2018, her doctor told her he could no longer maintain the treatment that had worked so well for all those years.

    I’m so sorry to tell you, but the state law is changing, and your dose was seven times higher than the dose Oklohoma law is going to [permit], Stewart recalled him saying. I have to have your doses reduced by November.

    Over the next five months, her dosage was dropped by hundreds of units, measured in morphine milligram equivalents (MME). The consequence: “My health deteriorated so bad,” she said. She developed chest pain “because my heart was not handling the extra pain,” and her blood pressure soared. To address the additional pain caused by the rapid reduction of the single opioid medication, she says she was prescribed five non-opioid drugs and had to see a gastroenterologist due to the cocktail’s damage to her digestive system.

    Additionally, her mental health declined. She was unable to provide for her family members the way she’d like. “I basically laid in bed and cried.”

    The new law’s language seems to have spooked her doctor.

    No state law required her doctor to forcibly taper her dosage. But then-Governor Mary Fallin had just signed into law Oklahoma Senate Bill 1446, which imposed new opioid prescribing regulations aimed at discouraging this form of treatment for pain.

    Fear, in Stewart’s opinion, drove her doctor’s decision. “It had enough big scary words that all the doctors thought that meant they had to reduce every dose under a certain point and try to get as many patients off of pain management as possible.”

    The bill made prescribing more than 100 MME legally risky for practitioners. Stewart had been on nearly seven times that. The statute only granted greater leniency for patients in “active treatment for cancer,” not former cancer patients like herself. Her pain treatment was working for her, but the new law’s language seems to have spooked her doctor.

    What happened to Stewart is an increasingly common experience among chronic pain patients across the United States.

    No formal legal structure incentivizes those registered with the Drug Enforcement Administration (DEA) to handle controlled substancesprescribers, pharmacists and suppliersto ensure that the people who need opioids can access them. Governments of all scales consider opioids more of a liability than an asset. And in a health care system where profit outweighs people, it’s no wonder that registrants have abandoned pain patients.

    Tamera Lynn Stewart

     

    Prescribing Plummeted After CDC Guideline

    Tamera Lynn Stewart, who quickly blossomed into a pain patient advocate, wanted to get to the bottom of her physician’s decision.

    After seeking explanations from regulators, law enforcement and lawmakers about why prescribers were working in fear, she was led to the Centers for Disease Control and Prevention. In March 2016, the federal health agency published a “voluntary” and “not prescriptive” Guideline for primary care physicians treating chronic pain patients (except those receiving active cancer treatment, palliative care and end-of-life care).

    The Guideline stated that clinicians “should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day.” Yet nowhere in the document are prescribers told to stop prescribing opioids. Quite the contrary: “Clinicians should consider the circumstances and unique needs of each patient when providing care.”

    Despite the Guideline’s language, opioid prescribing plummeted in its wake. It had already been declining since 2012, but that only accelerated in the months after publication, according to a 2018 study.

    “The messaging that has resulted … inappropriately suggests opioid prescriptions above certain day or dose limits are outside appropriate medical practice.”

    “Most states have enacted laws that put arbitrary limits on what a physician or other health care professional can prescribe to a patient in pain,” Dr. Patrice A. Harris, the American Medical Association’s immediate past president and chair of its Opioids Task Force, told Filter. “As a result, a physician who prescribes above those limits may believe that he or she is breaking the law. Related to that is the messaging that has resulted from the … guideline that inappropriately suggests opioid prescriptions above certain day or dose limits are outside appropriate medical practice.”

    Civil rights attorney Kate Nicholson, who recently founded the National Pain Advocacy Center, notes the way specific recommended numberslike “avoid increasing dosage to” more than 90 MME per daywere mistaken for commandments. “The problem that occurred was the provisions were fairly concrete. [They] had numbers in them that were then seized by the federal and state legislators, by the healthcare system,” Nicholson told Filter.

    In response to the outpouring of testimony and data indicating patient abandonment informed by the CDC’s 2016 Guidelines, the CDC then denounced forced tapers, among other erroneous interpretations, in a 2019 New England Journal of Medicine article. It explicitly stated: “the guideline does not support stopping opioid use abruptly.”

    Yet even after that, advocates say things haven’t gotten better. “I’m surprised we haven’t had a trickle-down of the clarifications by CDC among policy makers and with pain patients. I haven’t seen any improvement for people on the ground,” said Nicholson. But for Stewart, it’s no surprise. “Everybody thought those 2019 clarifications were just virtue signalling. Nobody took them seriously,” she said.

     

    Law Enforcement’s Chilling Effect

    In the fall of 2018, Stewart walked into an Oklahoma State Board of Medical Licensure and Supervision meeting as part of her quest to get answers about her forced taper. The members, she recalled, “said they felt bad for me, and that it was basically the drug cops doing it, not them.” (The Medical Board did not respond to Filter’s request for comment.)

    It was Oklahoma’s attorney general who pioneered the use of lawsuits seeking billions of dollars from Pharma corporations for their  misleading marketing of opioids. More than 2,000 lawsuits by other prosecutors have also been pursued, yielding spectacular results—like Purdue Pharma pleading guilty to criminal charges in October 2020.

    The DEA has been increasingly conducting criminal and regulatory investigations and bringing lawsuits.

    The fear of law enforcement in chilling prescriptions cannot be overstated. For over a decade, the DEA and attorneys general have ramped up investigations of practitioners, pharmacists and distributors. It’s no wonder that those in the prescribed opioid supply chain have exercised an abundance of caution to the detriment of chronic pain patients.

    Since 2006, the DEA has been increasingly conducting criminal and regulatory investigations and bringing lawsuits against distributors and pharmacies. Practitioners working in the field of pain medicine are most commonly targeted for criminal sanction, according to a 2020 study.

    Advocates have warned of how law enforcement actions are affecting those working to care for chronic pain patients. “Even when medical providers understood that the Guideline was voluntary, they believed they risked punishment or unwanted attention from law enforcement agencies or state medical boards if they maintained patients at high doses,” Human Rights Watch found in a 2019 report.

    Asked to comment on the DEA’s role in obstructing chronic pain patients’ access to treatment, a spokesperson told Filter: “DEA exists to enforce the drug laws of the United States and does not interfere with the practice of medicine. As long as doctors are operating within the normal course of professional practice, can show legitimate medical need for the medications they prescribe, and are not otherwise in violation of the Controlled Substances Act, they would not be subject to law enforcement action.”

    But a federal government watchdog has confirmed how fear of legal scrutiny has driven health industry practices that make it harder for patients to access their medically-necessary opioids.

    The Government Accountability Office (GAO) found in a 2015 investigation that more than half of 62 distributors surveyed were placing stricter thresholds on opioid orders from practitioners and pharmacies, attributing these actions mostly to the DEA.  Fifty-two out of 84 individual pharmacies and 18 of 29 chain pharmacy corporate offices said that the stricter thresholds limited their ability to supply drugs to those with a legitimate need.

    One distributor, the GAO noted, “reported it refuses to distribute large volumes of controlled substances to prescribers or pharmacies that specialize in pain management, even if it has no evidence that the prescribers or pharmacies are engaged in diversion.” Because of the DEA’s threat to hold distributors responsible for “diversion” at the prescriber and pharmacist level, the distributor explained that “supplying a large volume of controlled substances to customers with a pain management practice creates too great a risk of being the target of a DEA enforcement action.”

    The DEA’s lack of clarity about the definition of a “suspicious order” meant that some “distributors elected to arbitrarily set thresholds for the amount of controlled substances pharmacies could order,” as the GAO summarized in its report.

    The vagueness has had a trickle-down effect. One pharmacy told the GAO that “DEA has clearly stated that it is not calling for distributor cutoffs (i.e., thresholds), but their distributors have communicated that these changes are made because of fear of DEA enforcement actions, which has led many pharmacies to refuse to fill legitimate prescriptions.”

    The GAO recommended that the DEA offer suppliers guidance on suspicious order monitoring and reporting—something the DEA has since failed to do. In November 2020, the agency published a proposed rule updating requirements, but it’s unclear how it will impact suppliers’ business practices.

    The DEA’s method for measuring “success” included simply tracking the number of investigations conducted and the number of sanctions imposed.

    Even with that potential clarification, the damage to how pharmacies operate has been done. In one of the highest-profile cases, Walmart, the fifth largest pharmacy chain in the country, installed in 2018 a block on “suspicious” prescribers and a seven-day, 50 MME-per-day limit on initial opioid prescriptions for acute issues. That came after the Department of Justice considered criminally indicting the world’s largest company for filling “suspicious” prescriptions.

    A 2019 letter to the DoJ from an attorney representing Walmart demonstrates that the company’s “aggressive policy,” supposedly modeled on the 2016 CDC guidelines, was made to reassure investigators that they were doing their part, even if it meant “significant blowback” from state Boards of Pharmacy. According to the letter, three states sent letters warning that the policies were impermissible. In December 2020, DoJ sued Walmart anyway.

    Despite the resources poured into these investigations, there’s no evidence supporting their effectiveness at stopping diversion—an activity criminalized on the premise that using unprescribed pharmaceuticals is undesirable, despite their being far safer than the unpredictable illicit opioid supply driving fatalities. In 2011, in response to the agency’s escalating enforcement actions, the GAO found the DEA did not have a system in place to accurately measure any impact on diversion. The DEA’s method for measuring “success” included simply tracking the number of investigations conducted and the number of sanctions imposed, among other things.

    In a letter responding to the watchdog’s findings, Joseph Rannazzisi, the head of DEA’s Diversion Control office, made two things clear: 1) the “vast majority of registrant inspections do not uncover serious violations of the [Controlled Substances Act]” and 2) “it is impossible” to measure whether anti-diversion efforts are actually working. Instead, he wrote, “the specter of increased scheduled regulatory investigations” has a “deterrent effect that cannot be measured by raw data.”

    In other words, the DEA had a hunch that scaring people with policing would make a difference.

    Years before the escalating prosecutions, Dr. Scott Fishman, now the director of Center for Advancing Pain Relief at University of California, Davis, outlined the impact of the kind of fear mongering that Rannazzisi later championed.

    “It seems that all you may need to change physician behavior is to simply advance intimidating policy statements or even initiate a few physician investigations that begin with a visit from DEA field agents dressed in flak jackets who carry weapons,” Dr. Fishman wrote in 2006. “Physician fear of regulatory scrutiny may not always be based on real threats, but they lead to real changes in prescribing behaviors that can substantially impair the treatment of patients in pain.”

     

    Prescription Drug Monitoring Programs

    When Stewart sought answers from the Oklahoma Medical Board, they clarified that “the law doesn’t say they have to take me off of it,” she recounted, and that she should therefore just “find a new doctor.”

    But it’s not that simple. Although Stewart says she eventually was able to get her dosage increased after her cardiologist and gastro-enterologist sent a letter to her pain management doctor urging the reversal, a wave of reports from chronic pain patients say that practitioners willing to prescribe the dosage they need are increasingly scarce.

    In large part, the stonewalling has been facilitated by prescription drug monitoring programs (PDMP)—state-run databases, the use of which is available to and, as of October 2021, required of practitioners and pharmacists to track controlled substance prescriptions. If Missouri approves a bill to start a PDMP, all 50 states will have one. PDMP data are monitored by law enforcement for investigations of both “pill mills” and “doctor shoppers.”

    “That data is context-free … You can’t assume or conclude anything about it.”

    The information provided by PDMPs is limited: drug, dose days and units, prescriber and pharmacist, usually. It does not account for why a patient may be prescribed multiple or high-dosage opioid prescriptions from one or more practitioners. “That data is context-free,” said Dr. Terri Lewis, a clinical educator who researches PDMPs. “It doesn’t really lend itself to analytics: You can’t assume or conclude anything about it,” such as whether the personal is “doctor-shopping,” “because that’s not what you’re collecting.”

    Amid a climate of fear cultivated by law enforcement, practitioners have denied care to patients simply on the results of a PDMP search, which offer no resources or referrals to those suspected of having an opioid use disorder.

    “PDMP surveillance provokes prescribers to cut loose chronic pain and other complex patients for whom opioids and other suspect controlled substances are indicated,” Jennifer Oliva, a law professor and director of the Center for Health & Pharmaceutical Law at Seton Hall University, told Filter. “Prescribers engage in such behavior to avoid DEA investigation and professional licensing board scrutiny. Research further teaches that prescription surveillance puts patient lives at risk by incentivizing opioid patients to opt out of the health-care delivery system to avoid law enforcement surveillance and possible prosecution.”

    This abandonment of care for chronic pain patients has led to devastating outcomes: an alarming number of suicides and fatal overdoses, according to a 2020 study. Numerous anecdotal reports of patients taking their own lives have proliferated online—a major reason for the CDC’s 2019 clarification. For those seeking to treat their pain when medical professionals won’t, the more-accessible criminalized market exposes them to an unpredictable supply, often cut with highly potent opioids like fentanyl, and with other depressants that drive up overdose risk.

    Practitioners’ problematic conceptions or perceptions can play a role in whether they abandon a chronic pain patient after querying a PDMP. One faulty assumption promoted by regulators is that a higher dosage means greater risk of an overdose. Although there is a risk relationship between dosage and overdose, the assumption that dosage predicts overdose misunderstands when overdoses actually occur among prescribed patients—as three physician-advocates explained in a 2018 letter to the Center for Medicaid and Medicare after the agency proposed negatively rating the performance of physicians by the number of high-dosage prescriptions written. As they found through examining a number of studies, it’s patients on lower doses (under 90 MME) who most frequently end up fatally overdosing, not those on the higher doses targeted by laws and regulations.

    Stigma against and misconceptions about people living with substance use disorders (SUD) also influence practitioner decision-making. “I don’t want heroin addicts in my waiting room,” Dr. Eric Schnakenberg, a New York family medicine doctor, previously told Filter in explaining why he uses PDMPs. Physical dependence (experiencing withdrawal when a substance is removed) is not the same as SUD, defined as continuing to consume drugs despite negative consequences. Yet that distinction can be lost on practitioners making clinical determinations merely off of PDMP-reported dose days and units.

     

    Racism and Bias

    Other subjective factors have been shown to play a role in PDMP-influenced decision-making. A 2016 study found that a patient’s perceived honesty and intent played a role in discharging them from care. The researchers flagged for further study the need “to examine clinician interpretation of apparent patient dishonesty and to determine the appropriate level of influence of this factor in formulating prescribing decisions.”

    Whose pain can be trusted is shaped by racist stereotypes. “Black Americans are seen as drug seekers and not as a patient who wants to remedy their pain,” said Dr. Tamara Baker, a psychiatry professor and an expert on racial disparities in pain management, referencing the broad literature demonstrating that Black pain is taken less seriously than others’.

    The racist idea that Black people experience less pain dates back to chattel slavery, and appears to be alive and well. In a systematic review of 20 years of data, researchers found that Black patients were 29 percent less likely than whites to receive treatment with opioids for similar painful conditions. Another racist idea, that Black people are seeking drugs unnecessarily, also seems to be illustrated by the numbers. Black patients seeking emergency medical attention for issues not readily verifiable, like abdominal or back pain, were far less likely to be administered or prescribed opioids compared to their white counterparts, a 2016 study found.

    “We’re not believed when we say we are in pain, generally thought to be lying or overestimating our pain and written off as disingenuous.”

    Advocates for patients living with sickle cell disease—an inherited disorder most common among Black people and which can involve recurring episodes of acute pain as well as chronic pain—say that the confluence of racism and opioid prescribing crackdown has harmed their health.

    SCD patients are often undertreated, treated as drug seekers and many times ignored when they say they’re in pain,” said Jemela Williams, an SCD advocate and a Black woman herself living with the condition. Doctors and nurses often believe SCD patients are more likely to become “addicted” than other patient populations, resulting in reported reluctance to administer high dosages. Black SCD patients have reported that they had more difficulty accessing their needed dosage due to prescribing restrictions, stigma and racist bias after the 2016 CDC guidelines.

    “A lot of the reasons we face these barriers has a lot to do with race,” Williams told Filter. “We’re not believed when we say we are in pain, generally thought to be lying or overestimating our pain and written off as disingenuous if we’re not acting the way that that medical professional thinks we should be if we are hurting.”

    At first glance an increasingly-utilized artificial intelligence program—NarxCheck, a proprietary algorithm that produces a risk score (NarxScore) based on PDMP data—bears the promise of avoiding messy human bias. But Lewis and her colleagues are concerned its use will further disrupt chronic pain patients’ access. Forty-three jurisdictions  and companies, like Walmart, have adopted NarxCheck, even though the Food and Drug Administration has not evaluated it and nor has it been subjected to peer review.

    Originally patented in 2011, the algorithm is largely based on the decontextualized data points visible to PDMP users and already vulnerable to erroneous human assumptions–––MME, number of providers and pharmacies, potentiating drugs, and number of overlapping prescription days, according to a paper by Appriss, the company bearing the rights to NarxCheck. It also includes data points that Oliva, who studies PDMPs’ discriminatory consequences, warns could exacerbate racial and gender disparities in pain treatment.

    “NarxCare has begun to incorporate information from non-prescribing data setssuch as criminal and sexual trauma historyinto its risk generating algorithms that are sure to disparately impact particular patient populations who have a long history of discriminatory treatment in the pain management setting,” she said.

    The validity of NarxCheck is questionable, for Lewis, because of the data from which it was built.

    NarxCheck stakes the threshold of risk at 90 MME per day, meaning those exceeding it will be predicted to be more likely to overdose. And it produces a numerical score, from 000 to 999, that Lewis says could inappropriately replace clinical judgement, as PDMPs have in some cases.

    Additionally, the validity of NarxCheck is questionable, for Lewis, because of the data from which it was built: a sample of opioid-prescribed patients from Ohio’s PDMP who fatally overdosed and were suspected of “opioid misuse.” This begs the question of whether it is generalizable to people who do not have a problematic relationship with opioids, such as many chronic pain patients.

    Here’s the problem: If you’re sick and have been using your medicine for a while, you’re going to be flagged,” Lewis said. And there’s emerging evidence to back that up. Northeastern University researchers developed a machine learning model using data similar to NarxCheck to predict opioid use disorder among patients prescribed opioids. Their model targeted patients living with “complex chronic pain conditions and other burdensome comorbidities,” despite such patients not being likely to enjoy benefits from reduced prescribing, consequentially suggesting that the ways in which comparable risk-scoring algorithms have been constructed may be biased.

    Through her advocacy work, Nicholson has heard anecdotes about NarxCheck’s misidentification of chronic pain patients. “We’ve seen a patient with a bad NarxScore because they have multiple doctors. They take that as doctor shopping, but there are lots of innocent reasons, and the problem is they overreach,” said Nicholson. “These algorithms assign them scores that can lead to turning them away.”

    Appriss did not respond to Filter’s request for comment.

    Taking together all the factors chilling opioid prescribing, Lewis believes we’re missing the point: empowering people to keep themselves safe, instead of making paternalistic judgements.

    We know a lot of people use street drugs properly, and they manage their risk very well,” she pointed out. “But patients’ individual risk management strategies, like taking their medicine with others if opioid naive [or] having naloxone on hand, won’t show up [in PDMPs or NarxScores] because it’s not counted!”

     

    “Death by a Thousand Paper Cuts”

    Once the horse is out of the barn, you can’t put it back.

    That’s what sitting Oklahoma State Senator Rob Standridge allegedly told Tamera Lynn Stewart when she asked why he kept pursuing stricter opioid prescribing laws even as chronic pain patients suffered as a result. She had come to give him an obituary of a patient who had taken their own life. Senator Standridge did not respond to Filter’s request for comment.

    It’s been two years since the CDC denounced misapplications of its Guideline—yet legislators continue to take the agency’s 2016 recommendations as orders to be codified.

    There surely are numerous reasons why politicians continue passing laws at odds with a growing public health consensus. For one, the flawed narrative of overprescribing as a driver of the overdose crisis has “been on non-stop” in our media and culture, said Kate Nicholson. She also thinks “It’s a good narrative for politicians,” namely that they’re protecting vulnerable patients from predatory corporations.

    And then, of course, there are the lobbyists. One such anti-opioid group is Physicians for Responsible Opioid Prescribing (PROP), whose VP for federal affairs, Dr. Andrew Kolodny, was a star witness in the Oklahoma lawsuit against Johnson & Johnson and has testified before Congress on the so-called “opioid crisis.” Publicly, PROP has remained steadfast in supporting the CDC’s 2016 Guideline. Most recently, the group confronted the head of the American Medical Association for urging “governors and state legislators to take action [to] remove …. arbitrary dose, quantity and refill restrictions on controlled substances.” In a February 2021 letter, PROP alleged that AMA’s recommendation is “simply a repeat of the pharmaceutical industry’s playbook that led to an epidemic of opioid use disorder,” instead of one informed by chronic pain patients’ lived experiences and empirical evidence.

    With waves of new anti-opioid bills being drafted, Stewart and her advocate colleagues have their work cut out.

    Despite the misinformation that remains on Capitol Hill and at state capitols across the country, some progress is being made. For example, Kate Nicholson and a slew of other advocates successfully had removed from CARA 3.0, prior to its introduction in March 2021, a section that would have installed a three-day limit on initial opioid prescriptions for acute pain across the country.

    Back in Oklahoma, Stewart helped get Senate Bill 57 passed through both houses of the state legislature, though final approval of amendments and the governor’s signature are still pending. Nevertheless, when Filter spoke with her, she was excited: Patients receiving aftercare for cancer would be eligible for exemption from the 2018 law that sparked her forced taper. The bill also prohibits the misinterpretation of the law establishing the state’s PDMP to mean that it “require[s] a practitioner to limit or forcibly taper a patient on opioid therapy.”

    With waves of new anti-opioid bills and the new CDC guidelines currently being drafted, Stewart and her advocate colleagues have their work cut out for them.

    Stewart has a phrase for both how chronic pain patients have been harmed by the opioid prescribing crackdown, and the amount of work needed to undo that harm: “death by a thousand paper cuts.’’ 

     


     

    Top photograph by Preslava Glushkova on Unsplash. Other photograph courtesy of Tamera Lynn Stewart.

    R Street Institute supported the production of this article through a restricted grant to The Influence Foundation, which operates Filter.

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      Sessi is a writer and organizer interested in cultural criticism, transnational politics and the ways that controlled substances are traded, policed and consumed. Having graduated from Vassar College with a degree in philosophy and women’s studies, she kick-started her writing career with work appearing in publications like Broadlyi-DPitchfork and them., among others. Sessi was previously a staff writer at Filter.

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