The CDC's other major failure in recent years

From Painful Consequences of Federal Prescription Guidelines by Nita Ghei.  

Late in 2016, I went to what I expected to be a routine follow-up appointment with my neurologist for my intractable chronic migraine disease. Instead, I found that the neurologist I had been seeing for 15 years had abruptly left the practice and a new policy prohibiting any opioid prescriptions had been instituted, with no discussion of individualized care plans. I was no longer able to receive the only medication that, at the time, could help me through the most painful episodes of my disease.

I empathize though I have been more fortunate.  I have had severe rheumatoid arthritis for three decades and pain is an ever present and episodically severe attribute of the condition.  I am fortunate in that my father and grandfather had it before me and a) learned from them the importance of not letting pain be an inhibitor of a full life simply by muscling through it and b) I suspect that whether genetically or behaviorally I have inherited or developed a high level of pain tolerance.  

Yes I need the medications which control the underlying inflammation and yes, when necessary, I need recourse to pretty powerful pain suppressors.  I avert the pain suppressors as long as I can, both on principle and due to the fact that in contrast to most, they induce nausea, but when I need it, I need it.

I have also been fortunate in always having pragmatic doctors.  I am aware from them of the increasing regulation and control of pain killers (which I would have told you long preceded 2016) but have only been inconvenienced at the margin.  I have never not had access when I needed it.

But the CDC advice has always been suspect to me.  It looks like Kabuki Theater - a federal bureaucracy wanting to appear to be doing something and undertaking activities regardless of their relevance.  Ghei explains the origin of this theater of empty performance art.

Though opioid prescriptions have been declining since 2012, pain patients have seen an extraordinary acceleration of restrictions in their treatment plans and access to care, particularly in the past five years. Various factors might be cited to explain this trend, including state regulations, insurance requirements or the risk aversion of prescribing physicians. Whatever the justification, one document issued by the Centers for Disease Control and Prevention in March 2016 has been frequently cited: the “CDC Guideline for Prescribing Opioids for Chronic Pain.”

The CDC document was meant to be a prescribing guide for primary care physicians, in an effort to prevent “overprescribing” according to the conventional narrative of the opioid crisis. The Guideline was supposed to help prevent primary care physicians from writing too-generous opioid prescriptions and contributing to the substance use disorder crisis.

What actually unfolded was completely different—and entirely foreseeable.

In what probably became its most notorious metric, the CDC Guideline said clinicians “should avoid increasing dosage to =90 MME/day or carefully justify a decision to titrate dosage to =90 MME/day,” where MME stands for morphine milligram equivalents, a way to compare the potencies of opioid doses. Following that statement, 90 MME became the magic number. It gave lawmakers and law enforcement personnel a number to use. It gave increasingly risk-averse physicians a concrete goal as they sought to avoid legal scrutiny.

As the Drug Enforcement Administration stepped up raids based on the metrics suggested in the Guideline, the numbers of pain-management physicians shrank, particularly in rural areas. All too often, hundreds of medically fragile patients were left without care or health records overnight, as law enforcement swept up all documents in an ever-expanding search for “overprescribers.” Chronic pain patients saw access to opioid therapy rapidly shrink. Worse, they found that primary care was also harder to find: almost 80% of primary care physicians surveyed were reluctant to take them on as patients.

The physicians who still provided pain management and opioid prescriptions tried to protect themselves. For their patients—Americans with disabilities or with incurable or progressive diseases—this meant jumping through an increasing number of humiliating and demeaning hoops to secure the medication that was necessary for maintaining quality of life. The CDC Guideline suggested drug testing every two to four months. Many practices began to require monthly tests, which are often not covered by insurance. This expense alone can push care out of reach for many chronic pain patients.

Each new requirement increases the burden on chronic pain patients and might make it impossible for seriously sick people to get pain relief or even medical care. Many physicians require patients to sign “pain contracts” that can contain a variety of terms, including random pill counts, travel limitations, a promise to refuse opioid prescriptions from another physician even in a surgical emergency, and so forth. Often, these conditions are harsher than those imposed on a parolee.

It did not matter that the Guideline was not an official regulation and therefore had no force of law. Nor did it matter that the Guideline was never intended for specialist practices like the neurology practice I went to, or that doses higher than 90 MME were not banned but merely flagged for extra thought. Repeated statements by the CDC about misapplication of the Guideline have been ignored.

In an increasingly uncertain environment, with an inchoate threat of criminal prosecution and asset forfeiture looming, many medical practices, including my neurologist’s, decided that the safest number of opioid prescriptions was zero. From a risk-management perspective, it may have been. In terms of patient outcomes, however, it was not. 

Those are the mechanics of the problem.  But why was everyone so hepped up in the first place?

The Guideline was based on the factional narrative around the so-called opioid crisis and “deaths of despair.” This narrative is one of doctors overprescribing narcotics, of widespread distribution of large prescriptions of opioids for minor aches, and of addiction following even a short-term use of prescribed pain relievers as directed. Sometimes this narrative includes an additional flourish: its proponents claim that there is no evidence that opioids help with chronic pain, and that there are “more effective” treatments available.

This narrative is plausible. It is superficially convincing. It offers a simple solution: restrict access to prescription opioids, and the crisis will be resolved! Unfortunately, it is also almost entirely wrong. 

As H.L. Mencken observed in 1920 in Prejudices: Second Series.  Since the lesson has not gotten through, perhaps a placard should be posted in every Federal and State office and agency as a reminder.   

There is always a well-known solution to every human problem—neat, plausible, and wrong.  

 Back to Ghei.

Nonmedical opioid users are mostly distinct from medical users, and medical users very rarely end up with substance use disorder. In a study of fatal overdoses in Massachusetts, only about 1% of those who died had a valid prescription. Additionally, for millions of chronic pain patients, there are no other treatments available that are as effective. Typically, we have tried everything else.

Nonetheless, this tidy narrative, focused entirely on the damage from addiction, drives policy. It conflates all opioids and all users, ignoring the enormous benefit opioids have provided to millions of sick and disabled Americans. The entire policy conversation on the opioid crisis is rife with conflation on multiple levels that muddies the analysis: medical and nonmedical users, prescription and street drugs.

This conflation allows for an easy and visible policy fix: impose constraints on prescribing opioids. And we end up with policies that focus on restricting access to prescription opioids for both people and pets. In fact, however, illicit fentanyl analogs are the leading cause of overdose deaths, and 85% of overdose deaths in 2019 were linked to street drugs. Opioid prescription numbers peaked in 2012 and have fallen sharply ever since, but overdose deaths have continued to grow. There is little reason to believe that diversion of prescription opioids is taking place at the patient level; chronic pain patients, anecdotally, are undertreated. To the extent that there is diversion, it seems to happen before the medication gets to the patient. 

And this is what has driven me crazy over the past decade.  I think we are up to perhaps 80,000 drug overdose deaths a year and hardly anyone is talking about how to deal with it other than these fatuous gestures as Ghei describes.  We are not following empirical evidence and making hard choices.  We are going through the motions of pretending to care and pretending to address the problem.  Without doing anything beneficial and making things worse for law-abiding citizens.

Street drugs, especially illicit fentanyl analogs, are driving the overdose crisis. The CDC Guideline, and its entirely foreseeable misapplication by policymakers and medical providers, focuses on the wrong target. In doing so, the Guideline actively harms a vulnerable population: Americans with disabilities and with painful, incurable, progressive diseases. And it fails to help address the ostensible problem of overdose deaths.

It is a crying shame.  The CDC needs a thorough managerial shake-up from top to bottom.  They specialize in theatrics and don't deliver on their core mission, be it Covid-19 or drug overdoses.  And they have been getting away with it for too long.