The American Medical Association Takes on the CDC Opioid Guidelines
This is an article by Richard A. Lawhern, Ph.D. I offer it with the author’s permission for informational purposes. The author and I have no financial involvement.
THE VIEWS EXPRESSED BY THE AUTHOR ARE HIS OWN AND DO NOT REPRESENT MY VIEW OR MEDICAL ADVICE.
–Lynn Webster, MD
A “War on Pain Patients”
In March 2016, the US Centers for Disease Control and Prevention (CDC) published a guideline on opioid analgesics prescriptions for adults with chronic non-cancer pain. This guideline and related policies of the US Veterans Health Administration immediately became controversial. Some medical professionals have characterized the CDC Guideline as “neat, plausible, and generally wrong.” Thousands of patients describe the guidelines as a “war on pain patients” and their doctors.
Following a public call for correction of errors made by over 300 practicing physicians, the CDC issued a partial disclaimer in March 2019 for some of the worst consequences of their guideline. The guideline had never been intended, they said, to be a de facto mandatory standard of care — or to force the tapering of legacy patients who were otherwise managed successfully on opioid analgesics.4 Not addressed in this disclaimer, however, were desertions of tens of thousands of patients by doctors increasingly afraid of being sanctioned or prosecuted for prescribing any opioid to any patient.
In December 2019, the CDC announced the formation of an Opioid Workgroup to be overseen by the Board of Scientific Counselors of the National Center for Injury Prevention and Control (NCIPC-BSC). The Workgroup is charged with overseeing the work of unnamed researchers who are to revise, and possibly expand, the 2016 guidelines to address management of acute as well as chronic pain. Publication of revised guidelines is projected for late 2021.
Call for Stakeholder Comments
As part of the guideline revision process, the CDC issued in the April 2020 Federal Register a “call for stakeholder comments” on treatment of acute and chronic pain. Over 5,300 comments were received from a mixture of medical professional associations and patients. Among patients, responses were overwhelmingly critical of the CDC on multiple grounds — including that the 2016 guideline was not only misapplied but, more fundamentally, wrong on science and medical ethics.
What Did the AMA Have to Say?
Among the stakeholder comments is a 17-page paper submitted by the American Medical Association. Proposed changes and amplifications were offered for each of the 12 original recommendations in the 2016 CDC document. A 13th recommendation was also proposed. While the AMA text is often conciliatory in tone, the central messages are unmistakably as critical as those rendered by patients. Among quotations that stand out are these:
- “We can no longer afford to view increasing drug-related mortality through a prescription opioid-myopic lens.”
- “…some patients with acute or chronic pain can benefit from taking prescription opioid analgesics at doses that may be greater than guidelines or thresholds put forward by federal agencies.”
- “A CDC Guideline only focused on ‘opioid prescribing’ will perpetuate the fallacy that by restricting access to opioid analgesics, the nation’s overdose and death epidemic will end.”
- “The CDC Guideline has been misapplied as a hard policy threshold by states, health plans, pharmacy chains, and PBMs [pharmacy benefit managers].”
- “It is clear that the [2016] CDC Guideline has harmed many patients — so much so that in 2019, the CDC authors and HHS issued long-overdue … clarifications that states should not use the CDC Guideline to implement an arbitrary threshold.” [emphasis added]
Central to AMA recommended changes is an extraordinary redirection of basic assumptions asserted by the CDC. The AMA says:
“Physicians should initiate opioid therapy with the lowest effective dose. Continued opioid therapy and/or dose escalation should occur only if there is clinically meaningful improvement or maintenance in treatment goals for pain and function that outweighs risks to patient safety. Hard thresholds should never be used.”
“…MME thresholds remain as hard policy by many health insurers, pharmacy chains, and PBMs. The AMA strongly urges CDC to add language to the revised CDC Guideline urging those entities to rescind these policies given the absence of data to suggest a relationship between the arbitrary thresholds and improved patient outcomes — as well as the harms done to patients as a result of inappropriate tapering or denials of care. As such, the AMA recommends recasting this recommendation in its entirety…”
These central themes seemingly contradict the assumptions that prompted the 2016 guidelines in the first place. The AMA reinforces these themes with comments cautioning that results of urine tests or indications from Prescription Drug Monitoring Programs (PDMPs) should never be used alone or as an excuse for unilaterally discharging patients. This was previously stated in a consensus statement by experts in pain medicine.
The new recommendation offered by the AMA holds to a long-held belief by many physicians with expertise in pain and addiction medicine that patients with a current, or a history of an, opioid use disorder should receive effective pain care, including opioid therapy, when clinically indicated and in consideration of known risks and benefits.
In support of this recommendation, the AMA observes:
- “By placing so much emphasis on reducing opioid prescribing, the CDC has caused considerable fear in the patient and medical community that opioid therapy for pain will automatically cause opioid use disorder, overdose, and death.
- “This has led to patients sometimes being denied effective pain care in the emergency department, after surgery, and in primary care settings.”
Room for Improvement
If they are accepted and acted upon, the AMA recommendations should significantly redirect the logic and assumptions of all US policies concerning opioid analgesic therapy in chronic pain. That being said, remaining loose ends need to be addressed. Specifically, the AMA states that “Non-opioid and non-pharmacological therapy are preferred for patients with chronic pain.”
This statement needs further qualification. While non-pharmacological therapies should be used preferentially when they are effective; they often fail to deliver the type of relief many patients need. Even multidisciplinary management which is believed to be the best approach to treating chronic non cancer pain has only modest beneficial effect.
All therapies should be assessed for their potential benefit to potential risks. This cannot be done without considering the needs of the patient. Each patient is different and, thus, will require a risk/benefit analysis unique to the individual.
Assessing for risk is important, yet there is little consensus on how to measure risks. The US Agency for Healthcare Research and Quality (AHRQ) has recently stated that no currently available patient profiling instrument has useful accuracy for predicting opioid tolerance, dependence, addiction, or mortality in individuals. However, there are tools available to help guide physicians in assessing potential risks of opioids, including the risks of abuse, addiction, and overdoses. It is hard to understand why the AHRQ ignored these important validated tools.
Conclusion
There has been a roaring insurrection by patients, and some physicians, about how the CDC opioid prescribing guideline has been misapplied, resulting in harm to millions of Americans experiencing chronic pain. The few willing providers who have gallantly withstood the pressure to withhold treating people in pain with opioids when no other therapies were available or affordable have now become the target of investigations and prosecutions. Sadly, those with the power have caused great harm to providers and patients in this battle. But, fortunately, the American Medical Association has challenged the way the 2016 CDC guidelines on prescription of opioids in chronic non-cancer pain have been interpreted and applied.
The AMA code of conduct states, “The relationship between a patient and a physician is based on trust, which gives rise to physicians’ ethical responsibility to place patients’ welfare above the physician’s own self-interest or obligations to others, to use sound medical judgment on patients’ behalf, and to advocate for their patients’ welfare.” Here, the AMA has shown that “we must let compassion lead us forward but allow science to light the way.™”
Richard A. Lawhern, PhD [@lawhern1 on Twitter] is a technically trained non-physician advocate and online forum moderator with over 22 years experience, communicating with tens of thousands of patients and caregivers. He has published over 100 papers and articles in both popular media and professional medical journals.
Very well written Red! Thanks again for all you do… I say that from the bottom of my heart ♥
The “war on patients” goes way beyond the myopic CDC guidelines, because, folks, to my great shock and horror, I learned, through a circuitous and tortuous route, that, on Sept 8, 2020, CVS Pharmacy’s Corporate Office took the unjustified, unreasonable, inequitable, unconscionable, despicable action to install a permanent block on all of my board-certified physician’s prescriptions, implying that my doctor had done something wrong or illegal, despite the fact that, for months now, the dose and quantity remain unchanged and despite the fact that all prior authorizations were on file, along with copies of my palliative care certificate and palliative care summary signed by the doctor. In fact, since Day One, my doctor has been extremely conscientious in his prescribing; he is what I would call an exceedingly careful prescriber, who only prescribes a medication if he believes it’s going to help the patient live a normal life without extreme physical pain and not cause adverse side effects. Nevertheless, CVS Pharmacy’s abrupt and totally arbitrary action of blacklisting my doctor on Sept 8, 2020 forced me to have all of my prescription medications transferred to another retail chain pharmacy. CVS Pharmacy had no right to interfere with my board-certified doctor’s clinical decision to prescribe medically necessary medications. It had no right to overrule my doctor’s clinical judgments or to block my long-term opioid treatment plan. But it did so anyway, without merit. In short CVS Pharmacy crossed the line, because, not only am I a palliative care patient, but I have a debilitating, incapacitating chronic disease that requires long-term opioid therapy for intractable pain. My doctor prescribed medications for a reason: he wanted to avoid putting up any barriers for effective pain care. When I abruptly come down with an intractable head pain flare, I must take medication to stop my pain quickly in order to prevent writhing in nonstop intense pain for hours and hours on end and to prevent emesis all day long. But CVS Pharmacy refused to dispense my medication when it arbitrarily placed a block on my doctor’s prescriptions, putting my life, health and well-being in danger and setting a dangerous precedent that it’s okay for a pharmacy to overrule a board-certified doctor. Perhaps just as egregious as blocking is the unjustified partial-fill bill that Senators Feinstein and Warren and other legislators are trying to push through Congress that would make it lawful for a pharmacist to only partially fill a patient’s prescription, forcing the patient to come back twice to the pharmacy to get the rest of their medication. Do these legislators think we’re children? No, we’re responsible adults who take our medications exactly as prescribed. It’s not prescription medications that are killing people. Rather, it’s illicit substances, including heroin, fentanyl, carfentanil, cocaine, alcohol and amphetamines that are causing all the street overdose deaths in the United States. This foolish bill will accomplish absolutely nothing to reduce the number of street overdose deaths in this country; it’s only going to make it more cumbersome, more burdensome, for chronic pain patients to get their much-needed medications. Has this country gone mad? Has this country lost its head? What the hell is going on? Leslie Bythewood (10-18-2020)
a out going surgen general sends a letter to every dr inamerica.not threat but never been done before. no real drs consulted,out going CDC director steps down because her financial manegers had her in tobbacco stocks.heavely invest in united healthcare. rehabes the new healthcare giants. no thought to healthcare fall out.only bigger medical problems to come to be paid for strokes heart attacks. BULL SHIT BIGGER BUISNEESS WINS BIG TIME ! it was donr deliberatly.
Continued enormous gratitude, Dr. Lawhern, for your many years of ever-ongoing, dedicated compassionate support for and service on behalf of thousands upon thousands of intractable/chronic pain patients, such as myself, and our caregivers. Bless you!!!