“I hope to be alive in 2023 to see changes in pain management,” says a woman I’ll call Nancy H. in a recent email. “I was treated with opioids for over 25 years at the pain management center of a world famous hospital in Boston. Now I suffer daily because they forced me down from 150 milligrams of oxycontin and 60 milligrams of oxycodone a day…to only 60 milligrams of oxycodone.”
As a health writer and advocate for people living with chronic pain, I get a lot of messages like this. They reflect the experiences of patients who suffer the consequences opioid prescribing guidelines which the Centers for Disease Control and Prevention (CDC) published in 2016. These consequences include sharp reductions in medicines, insufficient treatment from pain reduced access to careand complete abandonment of patients, which results needless suffering and sometimes suicide.
The dire consequences of the CDC’s 2016 recommendations, which inspired laws, regulations, policies, and practices aimed at reducing the medical use of opioids, were evident to patients, pain specialistsand American Medical Association. He attracted attention Food and Drug Administration and eventually prompted the CDC to an issue new, supposedly improved guidelines in 2022.
The revised version it implicitly acknowledges the harm caused by what the CDC describes as “misapplication” of its advice. But the agency’s updated recommendations retain a bias against opioid pain treatment and a preoccupation with arbitrary dose limits. They do little to address physicians’ fears of regulatory or criminal sanctions, and do nothing to reverse the flawed rules that legislators, regulators, insurers, pharmacists and healthcare organizations adopted in response to the 2016 guidelines. A true course correction will require new laws, which begin by acknowledging how these rules have harmed patients like Nancy H.
“Total Madness”
“The pain and other withdrawal symptoms from this forced taper are excruciating and the pain I’m in is excruciating,” writes Nancy H. “My pain doctor did NOT want to reduce the doses we were prescribed for me and other patients. The hospital board ordered that all patients being treated for non-cancer pain should be reduced to 60 milligrams. My doctor and other doctors at the Pain Clinic were told they would be fired if they did not reduce every patient’s dose to 60 milligrams.”
According to scientifically doubtful conversion system used by the CDC, that daily dose of oxycodone corresponds to 90 “morphine milligram equivalents” (MME), a threshold that 2016 guidelines warned doctors not to exceed. The 2022 guidelines omit that recommendation, but include a warning that is potentially even more damaging.
“Before increasing the total opioid dose to ≥50 MME/day,” says the CDC, “clinicians should pause, considering that increasing the dose to >50 MME/day is unlikely to provide significantly improved pain control for most patients, while the risk of overdose increases with dose, and carefully reassess the evidence for benefits and risks.” Although this dire advice implies that daily doses exceeding 50 MME are rarely appropriate, mthere were millions of patients serves well with opioid therapy in much higher doses, often for years without negative outcomes.
The 2016 guidelines do not say that patients who have already exceeded the 90-MME threshold should be forced to do less. But that’s how the guidelines have been widely interpreted, as Nancy H.’s account, which is similar to many, illustrates reports on social networks. “Along with so many chronic pain patients,” she says, “I had given up all hope of ever getting the pain relief treatment necessary to live a quality life.”
The 2016 guidelines, like the revised version released last year, were not intended to affect cancer patients or end-of-life care. But they contributed to an anti-opioid culture that resulted in shocking abuse of patients on their deathbeds.
“My husband, who just died of brain cancer, spent many of his last days in agony,” reports Rhonda F. in a January 2023 email. “I had to fight for him to get any pain relief. Yes, a wonderful man with terminal brain cancer was forced to suffer. I asked the doctor why no one was giving Larry pain medication and he replied, ‘Everyone is afraid for their licenses.’ My poor, dying husband would moan, raise his hand to his head and weep. This is complete and utter madness.”
One size does not fit all
The frenzy began with the belief that prescription painkillers—even for bona fide patients—caused and perpetuated the “opioid crisis.” But the correlation between opioid prescriptions and drug-related deaths reported by the CDC in its 2016 guidelines was is no longer visible after 2010. The 2022 revisions nevertheless falsely claim the same link, relying on outdated numbers support the belief that limiting prescriptions will somehow reduce opioid-related deaths, which today overwhelmingly include illicit fentanyl.
Meanwhile, at least 40 percent of all US public clinics are refusing to accept of new patients for pain management. Many patients suffering from pain visited their doctors can’t find anyone continue to care for them.
The 2022 guidelines say non-opioid therapies are “preferred” for most patients. But the medical literature does not support that recommendation, especially for severe pain. There are no published trials directly compare opioid therapy with non-pharmacological treatments on an either-or basis. When used as an adjunct to pain medications, alternative treatments such as acupuncture, physical therapy, and counseling they offer only marginal and temporary improvements in pain or quality of life. Although prescription opioid therapy is not the default first option for all patients, it is necessary for both acute and chronic severe pain when alternatives are less effective.
Like the 2016 guidelines, the new version completely ignores genetic variation in drug sensitivity among individuals. Because of these differences, which have been recognized for at least 20 years, the minimum effective dose is estimated to be as much as 15 times bigger for some patients than for others with similar conditions. But published medical trials do not address this wide variability, nor do the CDC’s one-size-fits-all standards of practice.
CDC he says its guidelines “should not be applied as inflexible standards of care for patient populations.” But the CDC’s bias against opioid therapy in general, and high-dose therapy in particular, based on exaggerated representation of the risks it implies, refutes that point of view.
It seems clear that we cannot rely on the CDC to correct its mistakes. But state and federal policymakers can take steps to mitigate the damage caused by relentless efforts to reduce the medical use of opioids.
What legislators can do
Clinicians need an evidence-based standard of practice for prescribing opioid analgesics and must be confident that adherence to that standard will protect them from prosecution, regulatory sanctions, and institutional punishment. Such leadership would be necessary to replace CDC recommendations and federal laws may be needed to prevent the agency from being presumed to tell doctors how to practice medicine.
Six American medical organizations have pushed an end to “political interference in the provision of evidence-based medicine”. These organizations represent more than 500,000 frontline clinicians and medical students in the fields of family practice, internal medicine, obstetrics/gynecology, osteopathic medicine, pediatrics, and psychiatry. Additional specialties are represented in the American Medical Association Task Force on Substance Use and Pain Managementwhich aims to “advance evidence-based policy to end the epidemic of drug overdose deaths.”
A truly balanced practice guideline can be developed by a committee of clinicians who actually practice pain management in the community or hospital, with representatives from clinical specialty academies and organizations. Like Interagency Working Group on Best Practices in Pain Management established by the US Department of Health and Human Services in 2019, such a committee should also include chronic pain patients and their advocates as voting members.
The work of the committee should start with a few Basic, fundamental principles. Treatment begins with cooperation, a face-to-face relationship between the patient and the doctor. This includes documenting treatment plans, monitoring progress, tailoring treatment to the individual, and educating patients and family caregivers. Physicians and patients should understand the difference between addiction—a compulsive attachment that persists despite identifiable harms—and physical dependence, which involves withdrawal symptoms after sudden cessation. Clinicians must also realize that forced downsizing of stable patients is never ethically appropriate and can endanger patients’ lives.
Until that project is complete, Congress should require the CDC to withdraw its pain management recommendations and notify state medical boards that they should not rely on these guidelines in regulations or standards of practice. Congress should also repeal sections 131 and 133 of 2018 Law on the mission of veteranswhich aim reduce opioid prescribing throughout the VA system, based on the same flawed premises as the CDC’s 2016 guidance. It should direct the VA to withdraw its Opioid Safety Initiative and Clinical Practice Guidelines associated with him, which were used for justification general denial opioid therapies for veterans.
The Controlled Substances Actwhich the Drug Enforcement Administration (DEA) has long had distributed against doctors whose prescriptions he considered medically inappropriate, is another obstacle to pain management. Last year in Ruan v. United StatesThe Supreme Court may have reduced that threat by ruling that doctors can only be convicted of drug trafficking if they “knowingly or intentionally” violate accepted standards for the medical use of controlled substances.
Amendments to the Controlled Substances Act could provide additional protections to doctors who worry that their good faith prescribing decisions could threaten their freedom, licenses and livelihoods. Clinical staff should no longer be subjected to coercion by DEA agents who threaten criminal prosecution to obtain testimony against clinicians. Congress should also reduce bias confiscation of propertywhich often deprives clinicians of the resources needed to effectively defend themselves in court.
Several states, including New Hampshire, Rhode Island, Oklahoma, Arizonaand Minnesota, have already passed reforms aimed at protecting clinicians from inappropriate sanctions. These laws are designed to prevent medical boards and law enforcement agencies from fining or prosecuting clinicians for “appropriately” prescribing opioids within the “current standard of care.” No one should look to the CDC for that standard.
Emails listed in this article have been edited with the author’s permission.