We Need New Laws To Protect People in Pain

https://reason.com/2023/02/14/we-need-new-laws-to-protect-people-in-pain/

The CDC’s revised prescribing guidelines retain an anti-opioid bias and do nothing to reverse the harmful policies inspired by the 2016 version.

“I hope I will remain alive for 2023 to see changes in pain control,” a woman I’ll call Nancy H. says in a recent email. “I have been treated with opioids for over 25 years at the pain management center of a world-renowned hospital in Boston. I now am suffering daily because I was force tapered down from 150 milligrams of oxycontin and 60 milligrams of oxycodone per day…to just 60 milligrams of oxycodone.”

As a health care writer and advocate for people living with chronic pain, I get a lot of messages like this one. They reflect the experiences of patients suffering the consequences of opioid prescribing guidelines that the Centers for Disease Control and Prevention (CDC) published in 2016. Those consequences include sharp reductions in medication, undertreatment of pain, reduced access to care, and outright abandonment of patients, resulting in needless suffering and sometimes suicide.

The horrifying fallout from the CDC’s 2016 recommendations, which inspired laws, regulations, policies, and practices aimed at reducing the medical use of opioids, was obvious to patients, pain experts, and the American Medical Association. It attracted attention from the Food and Drug Administration and ultimately prompted the CDC to issue new, supposedly improved guidelines in 2022.

The revised version implicitly acknowledges the damage done by what the CDC describes as “misapplication” of its advice. But the agency’s updated recommendations retain a bias against treating pain with opioids and a preoccupation with arbitrary dose limits. They do little to address doctors’ fears of regulatory or criminal sanctions, and they do nothing to reverse the misguided rules that legislators, regulators, insurers, pharmacists, and health care organizations adopted in response to the 2016 guidelines. A real course correction will require new legislation, which starts with recognizing how those rules have harmed patients like Nancy H.

“Utter Madness”

“The pain and other withdrawal symptoms from this forced taper are horrifying, and the pain I suffer is unrelenting,” Nancy H. writes. “My pain management physician did NOT want to taper me and other patients off of the amounts we were being prescribed. The hospital board mandated that all patients being treated for noncancer pain were to be tapered down to 60 milligrams. My physician and other physicians at the pain clinic were told that they would be fired if they did not taper every patient to 60 milligrams.”

According to the scientifically dubious conversion system used by the CDC, that daily dose of oxycodone corresponds to 90 “morphine milligram equivalents” (MME), a threshold that the 2016 guidelines warned doctors against crossing. The 2022 guidelines omit that recommendation but include a warning that is potentially even more damaging.

“Before increasing total opioid dosage to ≥50 MME/day,” the CDC says, “clinicians should pause, considering that dosage increases to >50 MME/day are unlikely to provide substantially improved pain control for most patients while overdose risk increases with dosage, and carefully reassess evidence of benefits and risks.” Although this daunting advice implies that daily doses exceeding 50 MME are rarely appropriate, millions of patients have been well served by opioid therapy at much higher doses, often for years without negative outcomes.

The 2016 guidelines did not say patients who already exceeded the 90-MME threshold should be forced to get by with less. But that is how the guidelines have been widely interpreted, as illustrated by Nancy H.’s account, which is similar to numerous reports on social media. “Along with so many chronic pain patients,” she says, “I have given up any hope that I will ever receive the pain management treatment that is necessary to have some quality of life.”

The 2016 guidelines, like the revised version published last year, were not supposed to affect cancer patients or end-of-life care. But they contributed to an anti-opioid culture that resulted in shocking maltreatment of patients on their deathbeds.

“My husband, who just died of brain cancer, spent many of his last days in agony,” Rhonda F. reports in a January 2023 email. “I had to fight for him to receive any pain relief. Yes, a wonderful man with terminal brain cancer was forced to suffer. I asked the doctor why nobody was giving Larry pain relief, and he replied, ‘They are all afraid for their licenses.’ My poor, dying husband would moan, lifting his hand to his head, and cry. This is complete and utter madness.”

One Size Does Not Fit All

The madness began with the conviction that pain relievers prescribed by doctors—even for bona fide patients—caused and sustained the “opioid crisis.” But the correlation between opioid prescribing and drug-related deaths that the CDC cited in its 2016 guidelines was no longer apparent after 2010. The 2022 revisions nevertheless falsely assert the same connection, relying on outdated numbers to support the belief that curtailing prescriptions will somehow reduce opioid-related deaths, which nowadays overwhelmingly involve illicit fentanyl.

Meanwhile, at least 40 percent of all U.S. community clinics are refusing to accept new patients for pain management. Many pain patients dropped by their doctors cannot find anyone to continue their care.

The 2022 guidelines say nonopioid therapies are “preferable” for most patients. But medical literature does not support that recommendation, especially for severe pain. No published trials directly compare opioid therapy with nonpharmacological treatments on an either-or basis. When used to supplement pain relievers, alternative treatments such as acupuncture, physical therapy, and counseling offer only marginal and temporary improvements in pain or quality of life. While prescription opioid therapy is not a default first option for all patients, it is indispensable for both acute and chronic severe pain when the alternatives are less effective.  

Like the 2016 guidelines, the new version completely ignores genetic variations in drug sensitivity between individuals. Because of those differences, which have been recognized for at least 20 years, the minimum effective dose is estimated to be as much as 15 times higher for some patients than for others with similar conditions. But published medical trials do not address this wide variability, and neither do the CDC’s one-size-fits-all practice standards. 

The CDC says its guidelines “should not be applied as inflexible standards of care across patient populations.” But the CDC’s bias against opioid therapy in general and against high-dose therapy in particular, which is based on an exaggerated depiction of the risks it entails, belies that stance.

It seems clear that we cannot rely on the CDC to correct its errors. But state and federal policy makers can take steps to ameliorate the harm caused by ham-handed 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 they need to be confident that following that standard will protect them from criminal prosecution, regulatory sanctions, and institutional penalties. Such guidance would necessarily replace the CDC’s recommendations, and federal legislation may be necessary to stop the agency from presuming to tell doctors how to practice medicine.

Six U.S. medical organizations have urged an end to “political interference in the delivery of evidence based medicine.” These organizations represent more than 500,000 frontline clinicians and medical students spanning family practice, internal medicine, obstetrics/gynecology, osteopathic medicine, pediatrics, and psychiatry. Additional specialties are represented in the American Medical Association’s Substance Use and Pain Care Task Force, which aims to “promote evidence-based policy to end the epidemic of deaths related to drug overdose.”   

A truly balanced practice guideline could be developed by a committee of clinicians who actually practice pain management in communities or hospitals, with representation from clinical specialty academies and organizations. Like the Inter-Agency Task Force on Best Practices in Pain Management that the U.S. Department of Health and Human Services established in 2019, such a committee should also include chronic pain patients and their advocates as voting members. 

The committee’s work should start with a few basic principles. Treatment begins with a cooperative, face-to-face relationship between patient and physician. It includes documenting therapy plans, monitoring progress, tailoring treatment to the individual, and educating patients and family caregivers. Doctors and patients should understand the difference between addiction—a compulsive attachment that persists despite identifiable harms—and physical dependence, which involves withdrawal symptoms following abrupt cessation. Clinicians also must recognize that forced tapering of stable patients is never ethically appropriate and may risk patients’ lives. 

Pending completion of that project, Congress should require the CDC to withdraw its pain treatment recommendations and notify state medical boards that they should not rely on those guidelines in regulations or practice standards. Congress also should repeal Sections 131 and 133 of the 2018 Veterans Affairs Mission Act, which aim to reduce opioid prescribing throughout the V.A. system, based on the same mistaken premises as the 2016 CDC guidelines.  It should direct the V.A. to withdraw its Opioid Safety Initiative and the clinical practice guidelines associated with it, which have been used to justify blanket denial of opioid therapy to veterans. 

The Controlled Substances Act, which the Drug Enforcement Administration (DEA) has long deployed against physicians whose prescriptions it deemed medically inappropriate, is another barrier to pain treatment. Last year in Ruan v. United States, the Supreme Court may have reduced that threat by ruling that doctors can be convicted of drug trafficking only if they “knowingly or intentionally” violate accepted standards for medical use of controlled substances.

Amending the Controlled Substances Act could provide further protection for physicians who worry that their good-faith prescribing decisions might jeopardize their liberty, licenses, and livelihoods. Clinical staffs should no longer be subject to coercion by DEA agents who threaten prosecution to obtain testimony against clinicians. Congress should also curtail pretrial asset forfeiture, which often denies clinicians the resources they need to defend themselves effectively in court. 

Several states, including New Hampshire, Rhode Island, Oklahoma, Arizona, and Minnesota, have already enacted reforms aimed at protecting clinicians from inappropriate sanctions. These laws are designed to prevent medical boards and law enforcement agencies from penalizing or prosecuting clinicians for “appropriately” prescribing opioids within a “current standard of care.” No one should look to the CDC for that standard.

Filed under: General Problems