Author: W. Harry Fortuna
The incendiary response from the medical community to the working white paper written by two economists on the moral hazards of naloxone access resulted in a full-throated defense of the much heralded recovery drug. Although the white paper seems unlikely to affect policy, as the recent statement from Surgeon General Jerome M. Adams, MD, MPH, suggests, it did ignite a fierce conversation among health care providers around the country about the need for and value of naloxone.
In 2000, the United States had fewer than 10,000 deaths due to what the Kaiser Family Foundation classified as an opioid overdose. In 2016, that number had quadrupled to over 40,000. Last year, opioid-related deaths killed more Americans than guns (36,252) or car crashes (37,757).
But we can’t put a bullet back in a gun, we can’t stop a car with a needle, but an opioid overdose has a cure—and even a kid could use it. “The [Evzio, kaléo Pharma] device has an audio track,” said Jeremy A. Adler, MS, PA-C, the chief operating officer of Pacific Pain Medicine, in Encinitas and Oceanside, Calif., in an interview. “When you open it up, it tells you what to do. [kaléo] has shown in their data a 90% successful use from somebody that’s had no training.”
But the patient would live. So, why not put as much of that lifesaving capability in as many hands as possible? The states couldn’t think of a good reason; all of them have naloxone access laws on the books. The surgeon general couldn’t think of one either. Earlier this month, Dr. Adams fell a phrase or two short of calling on every American citizen with hands to carry naloxone. Popular public policy on the opioid issue has trended toward this motto: “Naloxone saves lives, and lives saved will turn the tide against this epidemic.”
Most of the experts interviewed agreed that naloxone does far more good than bad, and no one should ever need it and be left wanting. Where there’s nuance is how often, where and when that need actually exists.
Analyzing the Core Argument
Economists Jennifer L. Doleac, PhD, an associate professor of economics at the University of Virginia, in Charlottesville, and Anita Mukherjee, PhD, an associate professor of risk and insurance at the University of Wisconsin–Madison, distributed a white paper online in March 2018 that refutes that statement. Drs. Doleac and Mukherjee analyzed law enforcement and public health data from communities that had recently passed and implemented naloxone access laws. Their work meanders at times, and they approach some questions uniquely: To wit, while opioid abuse is a big problem in rural areas, the two authors focused on cities because, as they wrote, there is a “greater density of potential bystanders who could administer the drug, more efficient distribution by community groups, and shorter 911 response times.” In cities, they argue, it’s more likely that naloxone will get to the person who needs it when they need it.
The pioneering moral hazard argument asserted that seat belts increase unsafe driving (J Pol Econ 1975;83:677-725), but later studies found those effects were negligible compared with the gains in safety. However, later moral hazard explorations found that effective HIV treatments encourage riskier sex practices (Quart J Econ 2006;121:1063-1102). Drs. Doleac and Mukherjee used that framework of moral hazard to put forth the idea that naloxone saves an addicted person only for a moment. But before too long, the pull of their addiction and the realization of a lifeline fuels the feeling that they can take stronger drugs. Drs. Doleac and Mukherjee seem to echo the sentiment of Paul LePage, the governor of Maine, who wrote in his veto of a bill to allow pharmacists to dispense naloxone without a prescription, “Naloxone does not truly save lives; it merely extends them until the next overdose.”
What Doesn’t Kill Us
“It’s pretty well described in public health literature about unintended consequences of well-intended public health efforts,” said Lewis Nelson, MD, the chair of the Department of Emergency Medicine at Rutgers New Jersey Medical School, in Newark. Dr. Nelson said it’s conceivable that addicts would use naloxone as a backstop against their worst decisions. “That in order to get that same effect as when they started using drugs, knowing that if they’d push it a little too far, that they’d have someone there to rescue them, I think that makes total sense,” he said.
Dr. Nelson is in favor of naloxone distribution. He has full faith that increased naloxone access will almost certainly end up as a net positive. That said, he cautions against ignoring an important point: not all overdoses are created equal, and most of them won’t kill you. Therefore, many times naloxone is used when it isn’t necessary and it is not risk free.
“Even I would have a hard time identifying a patient with a life-threatening overdose if I just came up to this person on the street,” he said in an interview. An untrained professional would have almost no chance to distinguish between a patient with an imminent death and an intentional high. And even if for only the examples of, “well-intentioned public health benefits gone awry,” he thinks the naloxone issue is more complicated than it seems on the surface and is worth further study. In the interim, he believes it should be widely available.
Acceptable Level of Risk
David Craig, PharmD, the palliative pain care lead at Moffitt Cancer Center, in Tampa, Fla., said, “I’m not opposed to people having Narcan [naloxone, Adapt Pharma]. Having it more available I think is wise, but it’s generally those people who need it most that are the hardest to reach.” Because of the depth of their addiction, illicit users are at the greatest risk and are the furthest from care.
Dr. Craig also agreed with the concern of Drs. Doleac and Mukherjee that these are the people who would push the envelope with their addictions, knowing naloxone was there to bail them out. As such, naloxone access should be limited to first responders, EMTs (emergency medical technicians), police, and those whose job it is to respond to an overdose.
He doesn’t agree with the idea that patients who are prescribed opioids under the care of medical professionals get those prescriptions with a side of naloxone. “I’m adamantly against that. I think that makes no sense at all. It sends the wrong message.” When a patient is prescribed something for the pain, “it’s either a safe drug or it’s not,” he said.
But neither the message sent nor risk accepted is important if someone who doesn’t understand gets a hold of something that wasn’t intended for them. “By having an opioid in the home, the risk of having an opioid overdose or accident is enhanced,” Mr. Adler said. He added that he provides those in his care with naloxone because “I think that earlier access could certainly result in saved lives in an accident situation.” And for him as for many of the experts we talked to, there is little to no downside in the administration of naloxone.
To the point that naloxone access will increase the willingness of people in pain to test the boundaries of their tolerance, Mr. Adler had this to say: “To put naloxone in a home, to me, is very similar to placing a fire extinguisher in one’s kitchen. You don’t put a fire extinguisher in your kitchen so you can be reckless and careless with your stove.”
“I really think this is reprehensible. You have to put some value on human life,” Michael Schatman, PhD, CPE, DASPE, the director of research at Boston Pain Care, said in an interview. “My sense is that those economists, and certainly the governor of Maine, are for lack of a better term, unbalanced on multiple levels.”
He doesn’t disagree that there is some room for misuse; “addiction is not simple, and its treatment is not simple.” But even if naloxone was creating a net negative situation, causing more harm than good, which he didn’t believe was even remotely the case, “I think we owe it to [sufferers], since we have something that will save lives to keep them alive long enough to get treatment.”
It’s the same dose for children as it is for adults, said Dr. Yealy, who found multiple problems with how the authors framed and presented their findings. “There is not the data to suggest that either the medical harm or the global societal harm is improved with withholding naloxone.”
Short- Versus Long-Term Gains
Drs. Doleac and Mukherjee argued that they weren’t advocating for any intentional withholding of helpful therapies for those suffering from addiction. But instead, as Dr. Doleac would later explain via Twitter, they wanted only to point out that naloxone should be viewed as a stopgap measure, not a national treatment plan. They asserted their paper intended to highlight the need for more exploration, such as that short-term gains of naloxone might not hold up in the face of the need for long-term solutions like well-staffed drug treatment facilities.
Jeremy Samuel Faust, MD, an emergency physician at Brigham and Women’s Hospital, in Boston, and the author of a scathing response to their white paper on Slate, took the authors to task on Twitter. In short, he wasn’t buying it.
“It’s how you frame the data,” he said. “If you start with quotations from officers who are saying they’ve had to Narcan the same guy 20 times, that’s not about a moral hazard in the economic sense. That’s about moral hand-wringing, like do these people deserve our attention? Do these people deserve to live?”
Regardless of whether they found the white paper by Drs. Doleac and Mukherjee appalling or intriguing, all experts interviewed agreed with the authors’ assertion that naloxone wasn’t going to end the opioid epidemic by itself.
For the supporters of free distribution, it’s a tool in an arsenal against a complex and formidable opponent. For the detractors, it’s the best of what’s available while we search for better, longer lasting alternatives, according to many of them.
As for whether or not naloxone incentivized people to fall further into a cycle of poor health, addiction and treatment—that it allowed for a pattern of behavior that could offset potential positives achieved from bringing people back from the brink of death—it’s not entirely clear.
Dr. Faust put it simply: “The idea that people living longer is not in itself a victory; it was shocking to me.” In the end, it came down to a simple point for most experts interviewed, that the best reason for naloxone to be freely available is because regardless of the harm, if any, caused it’s always impossible to save someone who’s already dead.