If you follow healthcare news, you know that millions of US pain patients are experiencing a world of troubles. If their pain itself wasn’t enough, the US Centers for Disease Control and Prevention added to their agony in March 2016 by issuing a restrictive “Guideline” to primary care physicians on prescription of opioid medications to adults with long-lasting non-cancer pain.
The Guideline was phrased as advisory rather than mandatory. But that distinction quickly got lost as the US Drug Enforcement Administration ramped up disciplinary proceedings and prosecution of doctors for “over-prescribing” opioids like OxyContin and hydrocodone. Even before final publication, Congress made the Guideline mandatory for the Department of Veterans Affairs. More recently, the US Centers for Medicare and Medicaid Services are seeking to turn the Guideline into a mandatory restrictive practice standard for insurance reimbursement.
The new CMS standard will impose legal limits on the maximum amount of opioid pain relievers that a doctor may prescribe to a patient who isn’t actually dying of cancer. A maximum of 90 Morphine Milligram Equivalents per Day (MMED) will be imposed retroactively on patients who have done well on much higher doses for years, with no evidence of addiction or overdose risk. This despite the fact that the methodology of MMED is itself considered a meaningless medical mythology by many experts in the field.
Consequences of these changes are predictable. Even more physicians will leave pain management practice, throwing thousands of patients into the street without medical referral or support when they go into opioid withdrawal. Whole areas of US States are already no longer served by any pain management center. Potentially millions more patients will be forcibly tapered down or cut off cold-turkey, plunging them into agony and disability when they can no longer work or maintain family relationships due to under-treatment of their pain. More patients will be turned away by emergency rooms and family doctors. Suicide rates -- already on the increase -- will soar.
A deceptive bureaucratic maze adds deep insult and possibly criminal intent to this obvious injury.
Many of the core assumptions of the CDC guidelines are supported by only the weakest medical evidence – and others are clearly contradicted by the evidence. Medical professionals have published sharp criticisms of the CDC guideline and of the anti-opioid biases of consultants who wrote the document. A recent paper in Pain Medicine [ref: Pain Med (2016) 17 (11): 2036-2046] offers analysis that shows the writers of the Guideline deliberately distorted the evidence they gathered.
CDC consultants performed a literature review on the effectiveness and risks of three classes of treatments for severe chronic pain: opioids, non-opioid medicines like Tylenol, and behavioral therapies like rational cognitive therapy. Based on this review, they declared that there is very little evidence that opioids work for pain over long periods of time. But they neglected to inform readers that they had rejected any study of opioid medications that hadn’t lasted at least a year, then declaring that there was no proof that opioids are effective over the long term. But they did NOT reject studies of non-opioid medications or behavioral therapies that were similarly short.
As the Pain Medicine paper states, “To dismiss trials as “inadequate” if their observation period is a year or less is inconsistent with current regulatory standards… Considering only duration of active treatment in efficacy or effectiveness trials, published evidence is no stronger for any major drug category or behavioral therapy than for opioids.”
This didn’t keep the writers of the CDC Guideline from recommending that non-opioid treatments be favored over opioids, despite lack of evidence that they work. Nor did it keep the writers from exaggerating opioid risks – using the term “overdose” no less than 150 times in their biased and unscientific practice standard.
It is time for the CDC to withdraw its misdirected “opioid guideline” for a major rewrite. This time, the effort should be led by pain management specialists, not addiction psychiatrists. Pain patients or their advocates should be voting members of the writers group.
An expanded version of this article was published on March 15, 2017 after collaboration with Dr. Lawhern, under the byline of Frank Carroll in the Custer County Chronicle (SD), titled “Opioid Guideline Needs a Rewrite”.