President Obama began his 2016 State of the Union address by referencing an American epidemic of opioid overdoses. He was right to do so. The Centers for Disease Control report that 2014 saw a record of 18,893 deaths related to opioid overdose, including both medications and heroin. Given a rising tide of deaths, it is only sensible to look at how opioids come into distribution. Doctors write prescriptions, and the pills may be consumed properly or improperly. Or they can be sold, given to friends (or family), or stolen. Heroin is incredibly cheap and potent these days. It's often laced with other drugs, causing overdose in ways that users can't predict.
A major portion of the public health response has focused on doctors and their prescriptions (disclosure: I'm a primary care doctor trained in internal medicine and addictions). Many authorities and researchers believe the rising tide of overdoses has something to do with the opioid prescriptions we write. Our tendency to write prescriptions for pills like hydrocodone or morphine rose precipitously from 2000 to 2011. Barring a few so-called pill mills (which alone cannot account for the rise in prescriptions), most doctors writing prescriptions for opioid pills do so in response to a patient with severe chronic pain. There are an estimated 100 million Americans with chronic pain, and between 5 and 8 million take opioids for that pain.
It stands to reason that among the patients who have received opioid prescriptions, surely some (or many) should not have received them. Many doctors are prescribing less, starting in 2012, data show. Thus, great hopes are pinned on getting doctors to prescribe differently (and less) for their patients with pain.
Last year the Centers for Disease Control prepared a draft guideline for doctors on prescribing opioids to effect such change. In December they placed notice in the Federal Register seeking public commentary. By deadline on Jan. 13, over 4,300 comments were received.
There is a reason this document excites so much passion. Already in December, Congress made the future guideline's recommendations mandatory for over 14,000 doctors who care for our nation's veterans. Organizations such as the American Cancer Society's Action Network project this guideline will not be voluntary, but will carry force of law.
The hope is to prevent development of addiction and overdose that devastates countless families. Yet, there are those 5 to 8 million patients who receive opioids, some of whom are at risk of losing access to a crucial medication that is helping manage their pain, improve their quality of life and overall function. As medical boards, insurers and government agencies enforce this guideline, prescribing differently from the top line recommendations is likely to become onerous, leaving many patients in the lurch.
The CDC pulled together experts and advocates to draft its guideline, including several I know and respect. They take a strong stand. They propose that the literature shows no evidence of enduring benefit from opioids, and that measurable harms are tied closely to higher dose. They urge aggressive use of urine drug testing to identify patients who take opioid medication differently from intended or use illicit drugs. In 56 pages, they say a lot more. My practice lines up closely with what this guideline recommends. And despite that, I feel the guideline is not yet ready, not given the regulatory power it will have.
I believe it reaches beyond the available science in places, neglects it in others, and misconstrues how best to translate it in the care of patients. Friends, some of them national leaders in primary care, addiction and pain medicine, have urged me to publish this concern broadly. I want to show that one can take a different stand without rejecting the science or the underlying public health commitment that I share with the drafters of the CDC's guideline.
A fuller account of these shortfalls is available at Medium.com. I encourage you to take a look. A few illustrations may help to introduce reservations many doctors feel.
Central to the guideline is a preference statement. It says that any and all treatments for pain that do not include opioids are "preferred" to any that do include opioids. That statement is so broad as to be untestable. Other national evidence based guidelines do not include such broad, unscientific propositions.
Behind that statement is an evidence review that oddly tilts the scales. When looking at opioids, the guideline asserts that only studies documenting benefit for over a year were worthy of inclusion. Studies of that length have generally not been conducted. Shorter opioid-focused studies, some reporting benefit, were excluded. For non-opioid alternatives, short-term studies were included. That seems unbalanced when human suffering hangs in the balance.
The draft guideline takes a strong stand on opioid doses. Higher doses are associated with more overdose risk, which is compelling enough that I keep doses low for most patients. But in most guidelines, such as the one for cholesterol, decisions are never based on relative risk, because 20 years of scholarship have shown that they are misleading. One has to consider absolute risk, and consider all other protective and exacerbating risk factors that apply to a patient. In one study, being over 60 years old (versus 18-29) reduced overdose risk by 82 percent, arguably wiping out any risk increase associated with a higher dose. The guideline's top line recommendation focuses on dose in a way that pressures doctors to ignore this part of the science, and what they know about their patients.
What caregivers know about the lives of their patients is central to good health care decisions, as described a series of federally-sponsored studies, summarized in the recent book Listening for What Matters. Patients are not dough, waiting to be stamped into conformity with whatever the cookie cutter requires. The guideline's top line recommendations do not recognize the central importance of personalized decisions. It opens the door to harsh and restrictive misinterpretation, even if the authors themselves had no such intention.
The public health concern behind this guideline has my full endorsement. And yet, given the regulatory impact this document will have, many doctors wish to see its science and its recommendations improved. For people who agree, or who see me as mistaken, I welcome your comments.
Readers interested in a fuller review of the guideline should see my post at Medium.com. Follow me @StefanKertesz.
Opinions expressed are solely my own and do not represent positions of any agency of the U.S. Government or the State of Alabama.