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Nora Volkow on prescription opioids, chronic pain and ‘hype’
By ROGER PARLOFF|July 13, 2018
Nora Volkow, Director of the National Institute on Drug Abuse, as a TEDMED speaker in 2014.
TEDMED
Quick Takeaway
  • "About one third of those who misuse opioids got them directly from a physician’s prescription."
  • "It is incorrect to conclude that persistently high ... opioid overdose numbers in the face of [prescription] declines mean that prescription opioids play no role in the epidemic."
  • "We must recognize that opioid analgesics, even at high doses and for long-term treatment, may be the appropriate strategy to mitigate chronic pain in some patients."

Research psychiatrist Nora Volkow, MD—the director of the National Institute on Drug Abuse for the past 15 years—is one of the world’s foremost authorities on addiction. Her pioneering work with brain imaging has changed society’s understanding of the phenomenon. By showing how addictive drugs alter the brain’s chemistry, she helped prove that addiction was a chronic disease rather than a moral failing.

Volkow grew up in Mexico in the home where her great grandfather, Leon Trotsky, was murdered by an assassin sent by Joseph Stalin. She earned her medical degree from the National University of Mexico in Mexico City before doing her psychiatric residency at New York University. Before NIDA, she spent most of her professional career at the Department of Energy’s Brookhaven National Laboratory in Upton, NY. She has published more than 680 peer reviewed articles and more than 100 book chapters.

We asked Volkow if she would take time out from her demanding schedule to answer what we believe to be the most pressing and controversial questions the opioid epidemic is posing today for our society.

She agreed.

What follows is part 1 of a two-part interview, which was conducted by email. All links in her answers are to supporting references Volkow provided.

Opioid prescriptions have come down since their peak, yet opioid-related overdoses have continued to rise. Many people write me saying that this proves that prescription opioids play no role in the epidemic, that perhaps they never did, and that the focus on the dangers of prescriptions opioids is “media hype.” What is your view?

Prescription opioid volumes in the US peaked in 2011 and have indeed declined since then by about 29% (See here and here.) It seems reasonable to assume that this downward trend reflects an increased concerted effort (by policy and medical establishments) to address the nation’s opioid overdose epidemic.

Nora Volkow, MD, in June 2013. (Photo: Mary Noble Ours)

However, it is incorrect to conclude that persistently high OUD [opioid use disorder] and opioid overdose numbers in the face of such declines mean that prescription opioids play no role in the epidemic. Data from the Centers for Disease Control and Prevention clearly indicate that the prescribing of opioids by clinicians has increased threefold in the last 20 years, contributing to the problem of prescription opioid misuse. [Volkow’s citation: CDC. Underlying Cause of Death 2000-2010 on CDC WONDER Online Database. Extracted February 11, 2013. In: Centers for Disease Control and Prevention N. C. f. H. S., editor, Atlanta, GA; 2016.]

Thus, physicians have been partly responsible for the crisis, since about one third of those who misuse opioids got them directly from a physician’s prescription, while most others got them from a friend or relative who had been prescribed opioids. (See here.)

And, indeed, epidemiological data show that as widely prescribed opioids became less accessible due to supply side interventions, heroin use skyrocketed. There can be little doubt that the “flooding” of US communities with opioid prescriptions has facilitated diversion of these medications and caused serious public health consequences.

Nora Volkow on MAT, naloxone, new drugs, and why opioids are unique

Thus, there is a continuous need for physicians to reconsider the management of chronic non-cancer pain with opioids and to better understand the separate but related effects of opioids on analgesia, overdose, and addiction.

However, expecting that declines in rates of prescribed opioids could, by themselves, stem the tide of the opioid crisis is naïve and an oversimplification of the complex nature of the crisis. Legitimate questions have been raised about whether some pain patients might now be undertreated, and whether tightened prescribing practices over the last few years has contributed to the surge in overdose deaths from heroin and especially fentanyl.

“We must recognize that opioid analgesics, even at high doses and for long-term treatment, may be the appropriate strategy to mitigate chronic pain in some patients.”

But the fact is that this crisis has been brewing for many years, fueled by a wide range of interrelated factors that cannot be considered in isolation. The contributing factors (e.g., sheer numbers of painkillers in the market, inadequate health care, mismanagement of chronic pain conditions, social angst, and economic distress) are all intimately connected and working interdependently. These factors must be addressed in a comprehensive, integrated, and strategic fashion if we want to see results.

In recent months, several articles in the press have criticized the rest of the media for overstating the dangers of prescription opioids. Some of these resuscitate the notion that fewer than one percent of patients on chronic opioid therapy will develop addiction, especially if screened properly. (See, for instance, articles in Politico and Reason, each citing a review published by Cochrane in 2010.) What is your best estimate of the percentage of prescription opioid patients that will develop addiction? What are the societal implications of your estimate?  

First, it is very difficult to calculate a precise number, because there are many variables to consider, but the best and most recent estimate of the percentage of patients who will develop an addiction after being prescribed an opioid analgesic for long-term management of their chronic pain stands at around 8 percent. It is important to mention that the evidence supporting the conclusions of the 2010 review was admittedly “weak” and that the close to 5000 patients who were included in the 26 studies (all of which, except for one, were case series or uncontrolled long-term trial continuations), had no history of substance addiction or abuse. Thus, the conclusions of the Cochrane report don’t necessarily apply to a real-world situation where many patients were prescribed opioid analgesics without evaluating their past history with substances of abuse or addiction risk, and unsupervised misuse and diversion were rampant.

“We shouldn’t be surprised if policies enacted in the heat of a devastating and protracted public health emergency fall victim to the ‘pendulum’ effect.”

This is why physician education and acceptance of a shift to alternative non-opioid and/or non-pharmacological treatments for chronic pain will be key to solving this problem. At the same time, we must recognize that opioid analgesics, even at high doses and for long-term treatment, may be the appropriate strategy to mitigate chronic pain in some patients.

Thus, advocating for the exploration of alternative pain management approaches must be accompanied by an equally potent advocacy for ensuring that opioids continue to be accessible, affordable, and covered by insurance for the patients for whom opioid medication might be the only available ones to control their pain.

There is a growing backlash among chronic pain patients and their advocates, who argue that public health reforms triggered by the opioid epidemic have now made it too hard for pain patients to get their medications. What is your view?

As always, science should be the driver of smart policies designed to reverse the course of this crisis. At the same time, we shouldn’t be surprised if policies enacted in the heat of a devastating and protracted public health emergency fall victim to the “pendulum” effect.

Indeed, the typical risk of going too far in our otherwise “well intentioned” responses is the main reason why our policies should always be based on the best available evidence and attentive to the patients who depend on legitimate medically prescribed opioid use for chronic pain management.

We also believe that chronic pain patients should receive the best evidence-based care possible with a minimum of risk, which is why the HEAL Initiative also supports novel, less-addictive or non-addictive treatments for pain. [HEAL, which stands for Helping to End Addiction Long-term, is a National Institutes of Health initiative to bolster research into ways to combat the opioid crisis.]  It may be possible to discover innovative approaches to treating chronic pain that are both more effective and less addictive than existing treatments, including non-opioid therapies and novel opioids that lack the rewarding and respiratory-depressing effects that make existing drugs so risky.

Human Rights Watch is reportedly doing a study on whether chronic pain patients’ human rights are now being violated because of the difficulty they encounter in obtaining opioid medications at the levels they used to. The group is reportedly focusing on the CDC Guidelines of 2016, and theorizes that insurers, state licensing authorities, and the DEA are interpreting the guidelines too rigidly, effectively barring prescriptions above 90 morphine milligram equivalents (MME) per day. Are you aware of excessively rigid interpretations in either the public or private sector? Would you like to see the CDC clarify its views? [Since some opioids are stronger than others, doctors convert them to MMEs to make cross-medication comparisons. For instance, 30 mg of tramadol = 3 MME, while 30 mg of oxycodone = 45 mg of MME.]   

HRW has the right to commission any study they deem appropriate. However, I certainly do not share their concerns about hidden agendas or the rigorous process that the CDC used for collecting, analyzing, and distilling the evidence that went into writing their latest guidance for the management of non-cancer chronic pain.

How should physicians treat patients currently taking very high doses of prescription opioids—say, levels of 200 to 600 MME, or even higher? If physicians think the patient should taper down for his or her own safety and better functioning, and the patient refuses, what should the physician do then?

Increased MMEs are associated with a significant increased risk of adverse effects including overdoses. For example, a good-quality population-based, nested case-control study found a dose-dependent association between increasing daily morphine milligram equivalent (MME) dose and risk for overdose death.

Nora Volkow, MD, in 2017. (Photo: National Institute on Drug Abuse)

This is one of the reasons why current guidelines (e.g., CDC, Mayo Clinic) define which patients receiving high doses of opioid analgesics for the management of chronic pain should consider, with the help of their physicians, a personalized and carefully designed tapering protocol.

The problem, though, is that opioid tapering can be very challenging for both doctors and patients . Existing opioid tapering models require interdisciplinary teams that are either very expensive or simply inaccessible to most patients (See here and here.) As this TED talk suggests, too many chronic pain patients may be falling through the cracks of a system ill-designed to deal with the adverse effects of current pain management practice. This is an important but larger health care policy issue that needs to be addressed as part of a comprehensive effort to combat the opioid crisis.

And before answering your last question, it is important to remember that, when treating patients on high doses of prescription opioids, a doctor must evaluate and support the patient’s mental health in the process. Results of a recent study of high-risk veterans on chronic high-dose opioid therapy found that moderate-speed tapering can be achieved with support from mental health services and adequate follow-up and monitoring.

Now, there is some evidence to suggest that at least some patients who refuse tapering protocols may display increased levels of psychological inflexibility, characterized by (a) a tendency to withdraw from valued activities and social participation in response to pain or its expectation and (b) difficulty of distancing themselves from thoughts about the pain and its possible causes. These and associated traits may be amenable to specific behavioral or psychological targeting, such as exposure therapy, cognitive behavioral therapy (see here and here), acceptance and commitment therapy, or mindfulness. Thus, a better understanding of a patient’s personality and how it might interact with their care could allow properly trained health care professionals to tailor not only the tapering protocol, but also their communication style in ways that make them more likely to be heard.

[Part 2 of the interview will appear next week. There Volkow will address questions about the most promising new research into addiction and chronic pain treatment; how well naloxone overdose-reversal products (like Narcan) work against fentanyl overdose; and how we can improve the availability and use of medication-assisted treatment for addiction.]