A Need for Personalized Chronic Opioid Therapy

Charles E. Argoff, MD


December 07, 2015

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This is Dr Charles Argoff, professor of neurology at Albany Medical College and director of the Comprehensive Pain Management Center at Albany Medical Center in Albany, New York. I'd like to title this blog, "Considering Patient-Centered Evidence for Chronic Opioid Therapy for Chronic Noncancer Pain."

Consider the following situation. Let's use the initials DR. DR has been under the care of a primary care physician for many years. We recently received a referral at Albany Medical Center to consider taking over the care of DR.

This is literally what the referral said: "DR has been under my care for many years and has been on many regimens for the management of her chronic post-cervical fusion pain. These have included opioids as well as adjuncts." The referring physician then stated, "Currently, my colleagues and I are in the process of discontinuing prescribing opioids to patients under 65 years of age. The lack of consensus in the profession about the efficacy of opioids in chronic noncancer pain makes it difficult to justify the use of opioids in primary care practice."

Now, let's pause and just think about what he said next: "Having said that, I think that DR has done better on opioids than without them." This is a person who has been treating DR for years for chronic noncancer pain with chronic opioid therapy. He is now potentially going to take her off of these medications and is seeking help.

Confusion in the Literature

Let's review this a little bit more. There has been some confusion in the literature. Let's take a look at the journal Neurology.

In 2014, a single author— and I say that again, a single author, Gary Franklin—published a position paper[1] of the American Academy of Neurology regarding the use of chronic opioid therapy in chronic noncancer pain. This year, in 2015, Dr Stephen Nadeau published a response[2] in the Views and Reviews section with a very different view. I also had the opportunity to debate with Dr Gary Franklin at the annual meeting of the American Academy of Neurology about this topic.

The American Academy of Neurology position paper that Gary Franklin wrote stated that the benefits of opioid treatment are very likely to be substantially outweighed by its risks. Dr Franklin recommended avoidance of doses above 80-120 mg/day of morphine equivalence. He also stated in the position paper that there is no substantial evidence for the maintenance of pain relief over longer periods of time, and in this regard, he was referring to the chronic use of opioids.

Dr Stephen Nadeau, in his Views and Reviews publication in Neurology, wrote, "Opioids for Chronic Noncancer Pain: To Prescribe or Not to Prescribe—What Is the Question?" He stated that a thorough, clear, and close reading of the primary literature supports a very different conclusion than what Dr Franklin had concluded. In fact, he stated that opioids have been shown in randomized controlled studies to be associated with highly effective outcomes for the treatment of chronic noncancer pain and that long-term follow-up studies have shown that their effectiveness can be maintained. Their effectiveness has been limited in clinical trials by the failure to take into account high variability in dose requirements, failures to adequately treat depression, and the use of suboptimal outcome measures.

In addition, Nadeau noted that the frequency of side effects in many randomized controlled studies has been inflated by overly rapid dose titration and failure to appreciate the high interindividual variability and side-effect profile.

Both authors noted that the recent increase in the incidence of opioid overdose is of great concern. Certainly, we would all echo that. Nadeau pointed to potential causes of overdose, including depression, inadequately treated pain, hopelessness as a consequence of inadequately treated pain, inadvertent overdose, concurrent alcohol use, and insufficient practitioner expertise. He also noted that effective treatment of pain can enable large numbers of patients to lead productive lives and improve their quality of life. Nadeau reported that the alleviation of suffering associated with pain falls squarely within the physician's professional obligation to the person that he or she is treating.

Just so that you're aware as we consider these particular views, the Centers for Disease Control and Prevention is actually considering new recommendations that may be much more stringent than prior recommendations for using opioid therapy.

Applying Evidence-Based Medicine to Individual Patients

Now let's apply evidence-based medicine principles to this. What I'd like to focus on is using evidence-based medical principles and applying them to individuals. I'm sure that many of you, though not all of you, believe in evidence-based medicine. So, what exactly is it, and what is it not?

In 1996, the British Medical Journal, with author David Sackett and several other international colleagues, wrote an editorial[3] outlining what evidence-based medicine is and what it's not. In defining evidence-based medicine, they stated:

It's about integrating individual clinical expertise and the best external evidence. It is described as a conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best external clinical evidence from systematic research. By individual clinical expertise, we mean the proficiency and the judgment that individual clinicians acquire through clinical experience and clinical practice.

That is certainly not the way in which so-called evidence-based medicine or evidence-based medicine guidelines are used. Many guidelines that are used in clinical care, for example, are themselves not derived from patient care experiences in any way, but solely from literature review that is analyzed with levels of evidence and recommendations made from such. This is basically the Franklin position paper.

Such reviews, and therefore the guidance that would come from such reviews, leave out most of the patients that we all take care of. Perhaps yours. I'm just assuming it's your patients, too, because many of the people whom we take care of would be excluded from the very studies that are used to make guidelines in so-called evidence-based medicine because those patients are too complicated. Am I the only one who doesn't see the logic here?

In addition, published guidelines sometimes conveniently don't tell the truth or leave out data. That is something to consider.

In summary, I really think that we need to recognize the need to personalize treatments to optimize the use of medical evidence for patient care. When it comes to the use of chronic opioid therapy for chronic noncancer pain—a topic that is in the news practically every single day—I think that we need to keep in mind what Stephen Nadeau wrote about: the significant experience of having great success using chronic opioid therapy for chronic noncancer pain. We need to realize that we are managing real people and recognize that they are all unique. We know that this is an era of personalized medicine, and we cannot use population-based statistical approaches alone to treat fellow human beings.

I'm Dr Charles Argoff. Thank you very much for viewing this blog.