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13 Articles in Volume 12, Issue #9
PROMPT Challenges PROP’s Petition
PROP Answers Questions Raised About Opioid Label Changes
PROP vs PROMPT: Who Speaks for the Pain Doctor?
PROP’s Petition: PPM’s Editorial Board Weighs in
Assessment of Long-term Outcomes Of Opioid Treatment: How to Set Goals and Objectives
Extracorporeal Shock Wave Therapy: Applications in Pain Medicine—Part One
Neck Pain: Diagnosis And Management
Part Two: Trigeminal Neuralgia: A Closer Look at This Enigmatic and Debilitating Disease
Reducing Musculoskeletal Disorders Through Ergonomics
Risk Evaluation and Mitigation Strategy Compliance
Treating the Opioid-addicted Chronic Pain Patient: The Role of Suboxone
Electromagnetic Devices: A New Partner in Pain Management
Methadone Management in a Patient With Pain and History Of Addiction

PROP’s Petition: PPM’s Editorial Board Weighs in

More about PROP and PROMPT

The October 2012 issue of Practical Pain Management included an Exclusive Report on PROP vs PROMPT.  This featured several articles, in addition to this one with feedback from our Editorial Board:


Restricting Access Does Not Improve Pain Treatment

Michael J. Brennan, MD
Fairfield, Connecticut

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.

An article by Shurman J, Koob GF, and Gutstein HB, “Opioids, Pain, the Brain, and Hyperkatifeia: A Framework for the Rational Use of Opioids for Pain,” discusses if opioids are titrated slowly and not in excess, nor too rapidly, with appropriate relief of pain, opponent processes are not engaged (hyperalgesia, hyperkatifeia).3 The abstract of the article appears below.

Don’t Forget Pain Is Biopsychosocial Problem

Raleigh-Durham, North Carolina

A major issue with the PROP request is that it appears to forget that pain is a biopsychosocial problem. Taking patients with chronic pain that is “moderate” in nature off opioids will increase detremental psychological and sociological aspects in their lives. You can anticipate increasing depression and anxiety, along with decreasing their ability to work. This then raises the question of whether their insurance company will pay for treating the secondary depression/anxiety. Also, once the “word” is out, all pain will become “severe,” which will create significant issues with physician determination of exactly what is occurring.

Second, the severe chronic non-cancer pain patients would only be able to obtain opioids for 3 months at a relatively low dosage (not really enough to cover severe pain for most chronic, severe non-cancer pain patients). In the face of chronic pain, which by definition lasts longer than
3 months, you create a situation where more patients may be looking to non-appropriate sources for their opioids. Dealing with diversion through labeling changes may create “unintended consequences” and this would be absolutely abhorrent and illogical.

Patients who experience chronic pain secondary to arthritis, failed back surgery, complex regional pain syndrome, for instance, who are unable to work without opioids, will cause significant problems by increasing patient pain issues. This will cause a reduction in their ability to have appropriate functional restoration/ability to work. There may be a thought that we can use antidepressant and anticonvulsant medications in lieu of opioids—but in reality opioids are often used with these medications for a number of pain problems (ie, neuropathy) and such polypharmacy is necessary and typical.

Finally, what is the pain specialist going to do to help their patients? Particularly as most medical insurance does not pay well (if at all) for alternative pain treatments such as physical therapy, psychotherapy, etc.

As physicians, we should do no harm. But as physicians we should do something to help our patients.

While the PROP group has no problem taking opioid pain medication away from pain patients, they have no idea as to how to help them if they can’t use opioids. Their “one size fits all” treatment is absurd on its face. Over the 25 years I ran a tertiary care interdisciplinary chronic pain center, I treated a number of patients who had both moderately severe and severe pain with opioids for more than 3 months. This kept many of them working and I never had an opioid-related adverse event or serious adverse event. And in this population, I would have known if one had occurred.

Therefore, it is not worth it for the patients or the physicians to do without opioids if there are no easily obtainable treatments that can adequately replace them. The Drug Enforcement Administration won’t like it either as they will see more illegal use of opioids. The unintended consequences will be tremendous. And what’s worse, we know enough to anticipate what a number of these consequences would be now. Are we that stupid and intolerant? No.

Opioids, Pain, the Brain, and Hyperkatifeia: A Framework for The Rational Use of Opioids

Joseph Shurman, MD, George F. Koob, PhD, and Howard B. Gutstein, MD

Opioids have relieved more human suffering than any other medication, but their use is still fraught with significant concerns of misuse, abuse, and addiction. This theoretical article explores the hypothesis that opioid misuse in the context of pain management produces a hypersensitivity to emotional distress, termed hyperkatifeia.

In the misuse of opioids, neural substrates that mediate positive emotional states (brain reward systems) are compromised, and substrates mediating negative emotional states (brain stress systems) are enhanced. A reflection and early marker of such a nonhomeostatic state may be the development of opioid-induced hyperkatifeia, defined as the increased intensity of the constellation of negative emotional/motivational symptoms and signs observed during withdrawal from drugs of abuse (derived from the Greek “katifeia” for dejection or negative emotional state) and is most likely to occur in subjects in whom the opioid produces a break with homeostasis and less likely to occur when the opioid is restoring homeostasis, such as in effective pain treatment. When the opioid appropriately relieves pain, opponent processes are not engaged. However, if the opioid is administered in excess of need because of overdose, pharmacokinetic variables, or treating an individual without pain, then the body will react to that perturbation by engaging opponent processes in the domains of both pain (hyperalgesia) and negative emotional states (hyperkatifeia).

Repeated engagement of opponent processes without time for the brain’s emotional systems to re-establish homeostasis will further drive changes in emotional processes that may produce opioid abuse or addiction, particularly in individuals with genetic or environmental vulnerability.

Last updated on: December 22, 2014
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