PROP’s Petition: PPM’s Editorial Board Weighs in
Restricting Access Does Not Improve Pain Treatment
Michael J. Brennan, MD
I have been in practice for more than 20 years across a number of clinical settings. The common thread has been the treatment of pain and pain-related disability affecting both cancer and non-cancer pain states.
The first impression of the PROP petition to the FDA is that this well meaning group is sending an incorrect message by conflating two separate facts—increase in prescription opioid prescribing for legitimate pain coupled with increasing morbidity of prescription opioids. The one fact does not necessarily beget the other.
Here are some facts: 1) pain remains the most common reason individuals seek medical care; 2) every published survey of pain reports that it remains undertreated in all venues including the elderly and cancer patients; 3) criminality has played a major role in prescription drug distribution.
The admirable goal of PROP—to reduce morbidity and mortality of prescription opioids—is lost by the petition’s approach: artificial doses and incoherent time lines serve no purpose. Rather, arguing for better research, better education, and better options and access to care is the only petition I would ever endorse.
Blanket Regulation Takes Patient Management Away From Physicians
Edwin D. Dunteman, MD, MS
St. Louis, Missouri
I have major concerns regarding further regulation of how we treat chronic pain patients. Granted, for many patients, long-term opioid use is not the ideal answer. However, there is a population of patients who are on stable and reasonable doses of opioids chronically with documented benefit and a history of no complications. A blanket regulation that would limit the dosage and duration of an opioid takes the management of the patient away from the physician and onto, essentially, bureaucrats. The limits proposed would definitely impact a large number of patients who have benefited from chronic opioid use for non-cancer pain. The impact on pain management patient care will be severe. Pain physicians should be playing a crucial role in deciding further governmental regulation and management of pain patients. Who else has a management understanding of some very complex pain problems?
Lack of Research Makes Judgment Difficult
Rae Marie Gleason
Nine Mile Falls, Washington
From a fibromyalgia (FM) point of view, it is very difficult to get doctors to be in favor of opioid treatments because they have not been shown to be effective in FM pain treatment; however, there really are no good studies on this issue, either. I think this points to the lack of research concerning the benefits of opioid treatment for chronic pain; there really isn’t enough known to make a judgment one way or the other. On the other hand, through my 20 years of helping patients with FM, many who have been completely homebound have been able to go back to work and take part in family activities, precisely because they are on some type of opioid treatment. On the scientific side of things, researchers point to N-methyl-D-aspartate (NMDA) receptor medications instead of opioid receptor medications in the treatment of FM, which might be a better alternative since the opioid pathways in FM do not seem to function well. Ketamine and other NMDA drugs seem to be a better match for FM pain.
More Long-term Studies Needed Reflecting Current Clinical Knowledge
Joseph Shurman, MD
La Jolla, California
Whoa! The pendulum swings from one extreme to another! First, there were the early no-ceiling days of a decade ago (massive doses of opioids were prescribed for non-malignant pain). Then came the introduction of the concept of opioid hyperalgesia (most still think it is rare or never have seen it; a few think it is common). After that came the investigations of pain doctors around the country (Drug Enforcement Administration, medical boards, malpractice, prosecution for murder [ie, US Government v. Hurwitz], etc). Models were developed in response, such as the Share the Risk Model (originating in San Diego), which was a catalyst for the national model Emerging Solutions in Pain.
Although the number of opioid prescriptions have risen consistently over the past 20 years, in my travels and in my own clinical experience, the total daily opioid doses have dropped significantly in the last 5 years. Lacking are evidence-based long-term studies (over 6 months) that demonstrate the benefit of opioids, such as improvement in function, quality of life, and even pain relief. However, such outcomes were documented in the Portenoy 3-year study1 (of which many academics are critical) and the Tennant survey2 (which myself and other doctors participated in and which involved patients on opioids for non-malignant pain for more than 10 years).
Regarding the PROP recommendations, I am okay with dropping the term “moderate pain,” as all of my patients have severe pain (constant or intermittent). The recommendation of a maximum of 100 mg of morphine (or its equivalent as a daily dose) and a maximum duration of 90 days, however, will bring the pendulum to the other extreme—the under-treatment of pain in many situations. And what happens after 90 days? Why did the majority of in-hospital pain centers close around the country? The theme of these centers was a multidisciplinary approach and in many cases the patients were detoxed, did relatively well in the pain centers, and were then sent back to the real world where they were in intractable pain and eventually back on their pain medications.
The pain management specialty is less than a generation old and is evolving. With the aging of the baby boomers, pain in this country has become epidemic in numbers. I respect many of the members of the PROP group, but in my opinion they have just gone too far. We desperately need better long-term studies showing what we know clinically—that many of our patients with nonmalignant pain who were desperate, disabled with intractable pain, and as a last resort are placed on long-term opioids—are back working with better quality of life and dramatic improvement in function and family relationships. In the Portenoy study and the Tennant survey, patients titrate up to doses with effective pain relief, and both studies showed that escalation and addiction were much less than one expected.