Just How Responsible is PROP?

“When I use a word,” Humpty Dumpty said in rather a scornful tone, “it means just what I choose it to mean -- neither more nor less.”(from Alice in Wonderland by Lewis Carroll)

Physicians for Responsible Opioid Prescribing (PROP) is an organization of medical doctors whose mission is to “reduce morbidity and mortality resulting from prescribing of opioids and to promote cautious, safe and responsible opioid prescribing practices.” At first blush, this is a worthy goal that few would challenge. A quick glance at the “Who We Are” section of the PROP website reveals several familiar names: Andrew Kolodny, MD (President); Michael Von Korff, ScD (Vice-President); Rosemary Orr, MD (Treasurer); Stephen Gelfand (Secretary); and several directing members, including Jane Ballentyne, MD, Irfan Dhalla, MD, Gary Franklin, MD. External reviewers for their Cautious, Evidence-based Opioid Prescribing guide include Roger Chou, MD; Mark Edlund, MD; Richard A. Deyo, MD; Thomas Kosten, MD; Mark Sullivan, MD; and Judith Turner, PhD.

In an opinion piece Kolodny published in The New York Times in February 2012, he wrote that “opioids are rarely the answer” for the management of chronic pain, and that “doctors have contributed to an epidemic of overdose deaths and addiction by overprescribing opioids” for chronic pain. While declaring that doctors did not do this out of malicious intent, Kolodny nevertheless claimed that “for most of us, it was a desire to treat pain more compassionately…” Kolodny’s thesis is that “overprescribing” physicians “need access to education and training programs that are free of industry bias” because he feels that “an industry-funded campaign” caused sales of opioids to increase exponentially, without mentioning the context in which this happened.

At the end of the 1990s, US physicians were chastised for the collective undertreatment of pain (which Kolodny admits is “a serious problem”). At a time when the Veterans Administration, Joint Commission, and others were describing pain as “the fifth vital sign,” the Medical Board of Oregon sanctioned a physician for undertreating pain, and two California-based physicians were sued in civil court for elder abuse because they failed to adequately relieve pain.

By 2001, the Joint Commission added assessment of pain, treatment of pain, and several corollaries to its accreditation standards for health care organizations. Buoyed by the success of treating cancer-related pain with opioids, many physicians rose to the challenge of doing more for their patients suffering with chronic pain. This led to an increase in the number of prescriptions for opioids, which had the unintended consequence of more opioids ending up in medicine cabinets in more homes, ultimately giving more people (not patients) access to these valuable medications for nonmedical purposes.

The ideas about the risks, benefits, and role of opioid medications put forth by PROP are among the many opinions about the role of opioids in the management of chronic noncancer pain that are being proposed at a time when Congress has already directed the Food and Drug Administration to do more about opioid use, abuse, misuse, diversion, overdose, and death as part of the Food and Drug Administration Amendment Act of 2007 (FDAAA 2007), which is the enabling legislation for the delivery of Risk Evaluation and Mitigation Strategies (REMS) for extended-release/long-acting opioids. Commencing in 2013, the REMS is intended to provide education and training by the end of 2016 to hundreds of thousands of US prescribers—the FDA estimates that “more than 320,000 prescribers registered with the Drug Enforcement Administration (DEA) wrote at least one prescription for these drugs in 2011.”

However, in their July 25, 2012 petition to the FDA, the members of PROP asked the FDA to “strike the term moderate from the indication for noncancer pain, add a maximum daily dose, equivalent to 100 mg of morphine for noncancer pain, and add a maximum duration of 90-days for continuous (daily) use for noncancer pain.” Among the “statements of scientific basis” underpinning its case against the use of opioids for chronic noncancer pain, the PROP petition cited a four-fold increase in opioid prescribing leading to a four-fold increase in opioid-related overdose deaths and a six-fold increase in individuals seeking treatment for opioid addiction, a lack of data on long-term safety and efficacy, surveys showing that many patients continue to report pain when receiving opioid therapy, comorbidity with mental health issues, and studies showing that high doses of opioids are associated with increased risk of emergency room visits and fractures in the elderly.

When I first read the PROP petition I immediately had to ask “Who died and left these people in charge?” Sarcasm aside, the radical nature of their proposal made me closely examine their claims and concerns. Could there be a basis for concern, I wondered, and do their opioid analgesic labeling demands have merit? I have been a pain practitioner since 1985. I practiced without opioids for the first 10 years of my career, taking nearly every patient with chronic noncancer pain off of opioid therapy. I recall the “bad old days” when I told patients that chronic opioid therapy for their pain condition was not recommended. I did occasionally identify specific patients for chronic opioid therapy who responded well clinically, played by the rules, and suffered no obvious harm. When the paradigm shifted toward the use of opioids for chronic pain in the mid-to-late 1990s, I adapted my prescribing behavior accordingly. Now, we face a national “crisis” situation, and we are moving back toward more judicious opioid use. I understand that “trends” come and go, and practitioners must stay current and evolve in response to new evidence.

However, I do not believe that PROP has made its case. For starters, consider the language we use to describe pain. Since we have no scientific basis for the precise measurement of pain, exactly how will the line between moderate and severe chronic noncancer pain be determined? If opioid analgesics are not anesthetics, why wouldn’t we expect patients to continue experiencing pain while taking opioids? If patients have chronic pain, and it is associated with depression about 50% of the time, why are we surprised that there are comorbid mental health issues? If an individual patient has no problems associated with the use of 120, 180, or 240 mg of morphine equivalent on a daily basis, why do we need to reduce that dose? If an individual patient is functioning well with opioid therapy after 90 days, and there is no better treatment available, why would we stop treatment and inflict worsening pain? Assuming we agree to restrict opioids to fewer patients, will we really see fewer deaths, or just fewer deaths directly due to overdose instead of suicide? How exactly do we respect the patient’s right of autonomy and then override the decisions they make in consultation with their providers? What will become of the patient-physician relationship when absolute “rules” are enacted, and no individual distinctions are permitted?

I fear that PROP and its Congressional supporters will attempt to maneuver the FDA to take drastic action denying patients with chronic noncancer pain the opportunity to use opioid therapy before we even implement REMS education in 2013. The REMS training will occur 2013-2016, so I believe we should not draw absolute lines in the sand until we evaluate these educational efforts. It has taken us more than 15 years to arrive at this current moment in time in the ongoing conversation about the role of opioids in managing chronic noncancer pain, so we need to incrementally adjust prescribing behavior before we throw out everything we have done.

Prescribers who treat people with chronic pain are on the frontline. Patients who are now receiving chronic opioid therapy have legitimate concerns. Each one of us will have to set personal practice limits and rules, but please do not forget the need to treat pain sufferers with compassion and be careful not to use a “broad brush” approach to deny all patients access to pain relief.

B. Eliot Cole, MD, MPA, FAPA, CPE, is a member of the Pain Management editorial advisory board. He has served in executive positions for several prominent pain management organizations and societies, including the American Society of Pain Educators and the American Academy of Pain Management. He has been a pain management fellow, clinician, educator, and advocate for nearly 30 years and has practiced in a variety of settings serving a wide range of patients.