By Pat Anson, PNN Editor

The American Medical Association is once again calling on the CDC to scrap dosage limits and make other changes to its controversial 2016 opioid prescribing guideline.

In a letter sent Thursday to a top official at the CDC’s National Center for Injury Prevention and Control (NCIPC), the chair of the AMA’s board of trustees said pain sufferers “need to be treated as individuals” and should not be subject to dose limits. The CDC is currently preparing a revision and possible expansion of the guideline, a lengthy process that could take another year to complete.

“A revised CDC Guideline that continues to focus only on opioid prescribing will perpetuate the fallacy that, by restricting access to opioid analgesics, the nation’s overdose and death epidemic will end. We saw the consequences of this mindset in the aftermath of the 2016 Guideline. Physicians have reduced opioid prescribing by more than 44 percent since 2012, but the drug overdose epidemic has gotten worse,” wrote Bobby Mukkamala, MD, a Michigan surgeon and chair of the AMA board.

The CDC said last week that a record 93,331 Americans died of drug overdoses in 2020. Although the vast majority of those deaths involved illicit fentanyl, heroin and other street drugs, efforts at combating the overdose crisis continue to focus on patients, doctors and reduced opioid prescribing.

“Patients with pain continue to suffer from the undertreatment of pain and the stigma of having pain. This is a direct result of the arbitrary thresholds on dose and quantity contained in the 2016 CDC Guideline. More than 35 states and many health insurers, pharmacies, and pharmacy benefit managers made the CDC’s 2016 arbitrary dose and quantity thresholds hard law and inflexible policy,” said Mukkamala.

“CDC’s threshold recommendations continue to be used against patients with pain to deny care. We know that this has harmed patients with cancer, sickle cell disease, and those in hospice. The restrictive policies also fail patients who are stable on long-term opioid therapy.”

The AMA has been warning about the “inappropriate use” of the guideline since 2018, when its House of Delegates adopted resolutions calling for the elimination of dose thresholds based on morphine milligram equivalents (MME). The CDC guideline recommends that daily doses not exceed 90 MME, a dose that some patients consider inadequate for pain relief.  

Recommendations a ‘Rough Guide’

At a meeting last week of the CDC Board of Scientific Counselors, one of the authors of the 2016 guideline said the MME thresholds were only meant to be “a rough guide” for prescribers and shouldn’t been seen as “absolutes.”

“We heard the concerning reports about the misapplication of the 2016 guideline and we’ve learned from what happened. We know there is a very real possibility that, even with adjustments, the guideline update could be misused,” said Deborah Dowell, MD, Chief Medical Officer of NCIPC.

Critics might wonder if the agency has learned anything in the last five years. A preliminary draft of a revised guideline still contains dose thresholds, recommending that doctors “should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to >90 MME/day.”

An independent panel of outside advisors that reviewed the draft expressed concern about maintaining the dose thresholds, saying they would lead to more forced tapering of patients.

“Though workgroup members recognized the need to have thresholds as benchmarks, many felt that including these thresholds in the supporting text could serve to de-emphasize them as absolute thresholds, and thus recommended removing the specific MME range from the recommendation,” the Opioid Workgroup said in its final report to CDC.

The workgroup also warned that the current draft revision of the guideline was “not balanced” because it focuses heavily on the risks and potential harms of opioids, with less attention paid to their potential benefits. The AMA called on the CDC to adopt the workgroup’s recommendations.

“Patients with pain need the CDC to be their advocate and urge it to rescind the perceived limits on opioid therapy doses or days,” Mukkamala said in closing his letter.

Opioid Income Redistribution

That view is not shared by the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP), which sent out a news release this week claiming that prescription opioids are largely responsible for the overdose epidemic.

“Tragically, prescription opioids still account for about 28% of all opioid-related deaths.  Prescription opioids also contribute to synthetic opioid deaths because many heroin and illicit fentanyl users developed their addiction from taking prescription opioids,” PROP claimed. ”Overprescribing of opioids continues to fuel this epidemic. Reducing new opioid prescriptions remains vitally important.”

At least four PROP board members, including founder Andrew Kolodny, MD, have testified as paid witnesses for plaintiff law firms involved in opioid litigation, making as much as $725 an hour. Those law firms stand to make billions of dollars in contingency fees as those cases near an end, with one recent settlement expected to result in a $26 billion jackpot for states, cities and counties. As PNN has reported, many of the lawyers involved in the cases are major political donors.

“Businesses can’t print cash, so where do politicians think the money for these payoffs will come from? The answer is customers in higher prices and workers in lower wages,” The Wall Street Journal said in an editorial.

“The opioid settlement is another example in a growing list of lawsuits that redistribute income from the larger society to rich plaintiff attorneys, who then help politicians with their campaign contributions, who then rehire the lawyers to help with more mass tort claims. Alas, it’s the American way.”