How the CDC’s opioid rules created a crisis for chronic pain patients

Adapted from Greed to Do Good: The Untold Story of CDC’s Disastrous War on Opioids.

The 2016 CDC opioid guideline seemed to make obvious sense: Americans were consuming far too many prescribed opioids. Many users of illicit opioids reported that prescribed opioids had been their gateway to illicit usage, even addiction. And users of illegal opioids, whether addicts or not, were dying of overdoses—more and more each year. The prescription gateway to addiction and overdose death was wide open. Not a big leap to arrive at a solution. Slam that prescription opioid gateway shut. Interrupt opioid transmission at its primary and most accessible point. Specifically: (1) have as few people prescribed opioids as possible, (2) keep the dose as low as possible, and (3) keep the duration as short as possible.

Sounds nice, sounds clean, but were opioid prescription limitations actually going to have any impact on addiction and overdose rates? The couple line-level CDC authors assigned the task of drafting the opioid guideline were heroically frank: The quality of evidence for an impact on addiction or overdoses was categorized in formal terms as “low.” That meant “the body of evidence has major or numerous deficiencies (or both).”

The CDC director published his own article a few weeks later in The New England Journal of Medicine, stating that “the guideline uses the best available scientific data.” Not exactly an untruth, if you give the director the courtesy of italicizing the word “available.” Unmentioned by the director was a practical advantage to the weakness of evidence. It freed the hands of CDC to designate the prescribing rules it preferred: Absent good evidence, it’s a judgment call.

So CDC leveraged weak data to tell clinicians exactly what they should do. For acute pain, opioids should be prescribed for only 3 days. Or 7 days max under unusual circumstances. For chronic pain (defined as longer than 3 months), the dosage should not exceed the equivalent of 50 milligrams of morphine, and clinicians should “carefully justify” going to 90 milligrams, above which no recommendation exists and hence should not be exceeded. Almost all these dosage limitations were designated Category A, or “applies to all persons.” Only a few were designated Category B, or “individual decision making needed.” Ingenious: The weaker the evidence, the stronger and broader the recommendation.

By October 2018, 33 states had passed laws requiring that medical providers conform to some aspect of the CDC opioid guideline, with most limiting initial opioid prescriptions to no more than 7 days. At least one state made it illegal to prescribe opioids stronger than the 90 morphine milligram equivalents specified in the guideline. The Departments of Defense and Veterans Affairs jointly published a set of policies almost identical to the CDC guideline. In November 2018, Medicare announced reimbursement rules conforming to the CDC guideline. Similarly, multiple health insurance companies (e.g., Blue Cross, Cigna, United Health Care) created payment limitations on opioids, often even more restrictive than the CDC guideline. Not to be outdone, pharmacy chains (e.g., Express Scripts, CVS, Walmart) began implementing their own restrictions consistent with, or even more restrictive than, the CDC opioid guideline. By August 2019, 35 out of 50 state Medicaid programs had implemented reimbursement rule changes that reflected dosage recommendations of the guideline. The Oregon Medicaid program even proposed that all patients with chronic pain have their opioid dosages tapered to zero.

Within two years, opioid prescribing rates had dropped dramatically within key provider groups: Primary care clinicians down 40 percent, cancer specialists down 60 percent, ER docs down 71 percent. Merely by our arts of persuasion, the whole country had raced to embrace the simple, rational, plausible, cost-free intervention of opioid prescription limitations—in much the same way that it had previously embraced the simple, rational, plausible intervention of mandatory minimum sentences for drug offenses.

Then prominent journals began publishing anecdotes and studies about patients who had attempted suicide and even succeeded because they couldn’t handle the pain levels that came with reduced dosages. Among veterans, those discontinued from long-term opioid treatment had doubled overall mortality and a sixfold increase in deaths from suicide or overdose, primarily in the months following discontinuance. A subsequent study of billing records for a broad sample of the U.S. population found a similar pattern. Among persons on Medicaid whose opioid dose was abruptly reduced, a study in one state found a threefold increased risk of suicide.

Then horror stories emerged of Medicaid or insurance companies applying the guideline dosage limitations to patients dying of cancer. A 2018 survey by the American Cancer Society found that 48 percent of cancer patients said their physicians had told them that treatment options for pain were now limited by laws, guidelines, or insurance coverage. The number of cancer patients and survivors with opioid prescriptions had decreased by more than half in just two years after the issuance of the CDC guideline. As many as 50 percent of cancer patients now were said to have undertreated pain.

Nor was the problem limited to cancer patients. A 2017 online survey of 3,000 chronic pain patients reported that 95 percent thought that the CDC opioid guideline had been harmful, and 84 percent said they now had more pain and a worse quality of life. A subsequent 2019 survey of pain medicine specialists found that 72 percent had been required to reduce the quantity or dose of medication they prescribed after issuance of the CDC guideline. The number of potentially affected persons was not trivial—by one CDC estimate, more than 50 million American adults experience chronic pain and, of these, more than 17 million have “high-impact” chronic pain that limits work and daily life activities.

An academic pain clinician, in an interview with Clinical Pain Advisor, asserted that his chronic pain patients were “being presented with three impossible choices: One, you can be totally non-functional. Two, you can go out and try to substitute some other form of opioid that would help you function, possibly heroin. Or, you can commit suicide.” He described this dilemma as an “abomination.” A past president of the American Academy of Pain Medicine described the guideline as “ill-conceived and frankly very harmful.” She went on to say that “too many people have already been a victim of CDC’s misguided attempt to address the opioid problem.” A commentary in the Journal of Pain Research by two academic pain specialists attributed the problems with the guideline to the closed manner in which it had been drafted: “CDC’s invitation for meaningful comment can best be described as somewhere between a charade and a comedy of errors … Remarkably, the actions of the CDC in the creation and publication of the prescribing guideline appear to violate every single standard that the Institute of Medicine recommended whenever clinical practice guidelines are created.”

Perhaps the most powerful argument against the CDC opioid guideline did not come from patient advocates, pain specialists, professional organizations, data reviews, surveys, or modeling studies. In December 2018, Human Rights Watch, an international organization with staff in 40 countries, best known for exposing torture by totalitarian regimes, published a hundred-page investigative report of the effects of the CDC opioid guideline. The report detailed a harrowing series of accounts of persons with undoubted severe chronic pain whose lives had been turned into hell by involuntary opioid dosage reductions or discontinuances prompted by the CDC opioid guideline. One provider, who insisted on anonymity, summarized: “It promotes an absolute culture of fear.”

Human Rights Watch wrote to CDC asking, “Is the CDC aware that in multiple states, its recommendations have been written into law and/or used by insurers, state medical boards, or other enforcement bodies as a mandate for physicians? Does the CDC believe that this is appropriate?” CDC gave no answer to these questions, merely reiterating in an anonymous response that “the recommendations in the guideline are voluntary.” Voluntary was an unusual choice of adjective, since the guideline specified that most of its recommendations applied “to all persons” with no “individual decision making needed.” Human Rights Watch concluded that the situation could be considered a violation of basic human rights since the United Nations Special Rapporteur on health and torture had specified that “the de facto denial of access to pain relief, if it causes severe pain and suffering, constitutes cruel, inhuman or degrading treatment or punishment.”