By David Nagel, MD.
There are three kinds of lies: lies, damned lies, and statistics.
– Benjamin Disraeli
A few days ago I met with my doctor for my annual physical. Despite 57 years of use and abuse, my body is in pretty good shape, and our discussion was directed more at prevention than treatment. We talked a great deal about the utility of the prostate specific antigen (PSA) test which has been used for a few decades to predict and, hopefully, prevent prostate cancer. It came as a bit of a surprise to me that this widely touted test was no longer recommended. Without explaining why, he told me that it was up to me if I wanted to have the yearly test done. I needed more information, so I pressed him. He told me that the evidence for the test was level 3 or level 4, which is not particularly good. I thought that one might want to have the test done to err on the side of caution. He quickly responded that the test has a high false positive rate which led to unnecessary biopsy and therapy, too often harming the patient. In saying that, he was speaking to the choir. My father, based on a false positive PSA, submitted to an unnecessary radical prostatectomy which left him incontinent and impotent the last 23 years of his life. Case made. Still, I know many who had early detection of their prostate cancer by PSA. So, what is one to do?
* * *
In 2016, the Centers for Disease Control (CDC), faced with what has been described as an opioid epidemic, felt it was within their purview to assess the cause(s) of this epidemic and create guidelines to control it. Their report, published in the Morbidity and Mortality Weekly Report (MMWR) on March 18, 2016, outlined twelve guidelines to assist primary care physicians safely prescribe opioids for adults. The authors opened the report with a preface which re-stated what had been said by the Institute of Medicine (“Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research,” June, 2011),
the Federation of State Medical Boards (“Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain,” July, 2013), and the National Pain Strategy (released by the US Department of Health and Human Services in March, 2016), that we are faced with two parallel public crises, one of poorly managed pain and one of addiction, each of which harms too many, the former greatly out-numbering the latter, and the solutions for each often conflicting. In constructing public policy, the needs of each must be acknowledged and balanced. The authors took great lengths to explain the strength of the evidence on which the guidelines were based, in effect their limitations. In sum, it was poor. The evidence for eleven of the twelve guidelines was graded as level 3 or 4, with only medication assisted treatment for opioid addiction receiving level 2 evidence.
Sound like PSA? The story gets much worse.
In acknowledging the weakness of the evidence, the authors emphasized that the recommendations should be viewed as guidelines. Failing to heed the law of un-intended consequences, public policy makers in many states, armed with a passionate, perhaps, mis-guided need to do something, turned the guidelines into rules, ones which must be obeyed by physicians at the risk of loss of licensure or arrest. In many states, such as my state of New Hampshire, the rules enacted went beyond the CDC guidelines, making them more onerous. In effect, they were deferring the needs of the many, those who suffer from pain, for the needs of the few, those who abuse or mis-use opioids, failing to understand that poorly managed pain also has the potential to kill. The rules and the record keeping entailed stressed the limits physicians already face from other governmental interventions in the health care sector. In response, too many physicians decided to respond in one of two ways. Some chose to stop writing opioid prescriptions. Others chose to not treat pain patients at all, deferring that to the 5000 pain physicians in the US. One of my patients who had been receiving a relatively small and effective opioid prescription for over 20 years from the same physician was informed by that doctor he could no longer do so, citing our governor’s rules as the reason. I hear similar stories almost every day.
I do not wish to trivialize the effects of the opioid crisis on those addicted or the role poor prescribing practices have played in creating it. However, the net effect of these rules was the creation of a third public health crisis, now referred to as “pain and/or opioid refugees,” meaning patients who have not been abusing their medications or their treatment who no longer can find someone to care for them. The irony is that two reports, one form the University of Alabama (Stefan G. Kertesz, MD, Substance Abuse Vol. 38 , Iss. 1, 2017) and one from the Massachusetts Department of Public Health (http://www.mass.gov/eohhs/docs/dph/stop-addiction/dph-legislative-report-chapter-55-opioid-overdose-study-9-15-2016.pdf), both conclude that prescription opioid abuse is now an infrequent cause of opioid related death (<10%), that the bulk of deaths are due to an illegally acquired cocktail of opioids and other drugs increasingly including heroin and fentanyl, and the reasons for the epidemic of opioid related death is much more complicated than an increase in physician prescribing.
* * *
In medical discussions everywhere, it has become chic, almost biblical, to refer to evidence based medicine (EBM). It is striking to note that many do not even understand what EBM is. In my book, Needless Suffering, How Society Fails Those Who Suffer from Chronic Pain, I discuss the pitfalls of EBM, which is defined as: “
…the conscientious, explicit and judicious use of CURRENT BEST EVIDENCE in making decisions about the care of INDVIDUAL PATIENTS. (Sacket, DL et al. “Evidenced based medicine: what it is and what it isn’t.” British Medical Journal, 312: 71-2, 1996)
There are four elements to EBM:
- The personal, clinical, objective experience of the doctor.
- Lessons learned from mentors.
- The body of medical literature
- The practical application of the above three to the unique circumstances of the individual patient.
Too often, EBM is falsely assumed to be synonymous with number 3, and number 4 doesn’t matter. However, that assumption implies there is sufficient evidence to make therapeutic recommendations for most medical conditions. That is not even close to being true. In fact, only a small number of conditions have such evidence (El Dib, RP, Atallah, AN, Andriolo, RB, “Mapping the Cochrane evidence for decision making in health care,” J Eval Clin Pract, 13(4): 689-692, 2007). Many questions have never even been addressed, especially those pertaining to complex biopsychosocial, multi-variate problems such as chronic pain and addiction.
To complicate matters, it is incorrect to assume that presence of even good medical evidence means the evidence base is accurate. For example, early in my career in the late 1980’s, I came to see post-concussive syndrome (PCS) as something real, and began to treat it as such. What I discerned from personal experience and common sense put me at odds with the published medical evidence base which referred to PCS with de-meaning terms such as “litigation neurosis.” It is anti-intellectual to assume that problems we don’t understand to be merely psychological tricks of the mind, but too often that is what we do, and when the evidence base supports that false premise, too many suffer needlessly.
Therein lays the problem with turning EBM from guidelines to rules. The reality is that lack of evidence does not mean lack of efficacy, and presence of evidence does not mean efficacy for all patients. While the CDC guidelines have value, they have limits. As the definition of EBM above states, evidence needs to be interpreted within the context the individual patient presents when making clinical decisions. Failure to acknowledge this individuality has the potential to harm too many, and that is what is happening as a result of poorly thought out public policy.
Primum non nocere…First, do no harm…
That ethos of Hippocrates applies to physicians. Does it not apply to public policy makers as well? In their act of desperation, they have harmed millions. In pointing out their error, the cries of my colleagues and my patients too often fall on deaf ears.
* * *
There is hope. The National Pain Strategy is the first attempt to comprehensively address the problems created by chronic pain and addiction, and to find a balanced solution that will meet the needs of each. The problem is that too few know it exists. Hopefully that will change. While there are many steps to this process, one of the first is a willingness to acknowledge what we don’t understand, and, related, accept EBM for what it is, a potentially beneficial tool which only has value when one understands what it is, what it may be used for, and, more importantly, what its limits are.
David Nagel is an MD, author and frequent contributor to National Pain Report.