Naloxone -- The Debate Over Moral Hazard

“There are certain people who might overdose more frequently than others, so maybe on an individual level, we’ll see a little bit of that. But I think if we’re talking about the population as a whole, I would not really be willing to say that the use of naloxone is making things worse. We’re just trying to save a life.”

– Jody B. Glance, MD, medical director of addiction medicine services at the University of Pittsburgh Medical Center

According to the National Institute on Drug Abuse, every day, more than 130 people in the United States die after overdosing on opioids. The misuse of and addiction to opioids – including prescription pain relievers, heroin, and synthetic opioids such as fentanyl – is a serious national crisis that affects public health as well as social and economic welfare.

According to the US Centers for Disease Control and Prevention estimates for each fatal overdose, there are approximately 30 nonfatal overdoses – many of the cases appearing in emergency rooms across the country.

The Centers for Disease Control and Prevention estimates that the total "economic burden" of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.

A “Miracle Treatment”

Naloxone (also known as Narcan) is a medication that can reverse an overdose caused by an opioid drug (heroin or prescription pain medications). When administered during an overdose, naloxone blocks the effects of opioids on the brain and quickly restores breathing.

Naloxone has been used safely by emergency medical professionals for more than 40 years and has only this one critical function: to reverse the effects of opioids in order to prevent overdose death. Naloxone has no potential for abuse.

In 2014, only 12 states allowed basic EMS staff to administer naloxone for overdose. Today, laws in every state allow the drug to be administered by anyone, from a physician to a family member.

One survey of a small number of community organizations in Delaware Country Pennsylvania, that used the 4-mg nasal spray found that first responders were successful at reviving about 98% of cases who went on to survive. In addition, a review of emergency medical services data from Massachusetts found that when given naloxone, 93.5% of people survived their overdose. The research looked at more than 12,000 dosages administered between July 1, 2013 and December 31, 2015. A year after their overdose, 84.3% of those who had been given the reversal drug were still alive.

The Debate

There is no doubt that naloxone saves lives. However, the increased availability of naloxone has engendered an ethical debate. Does the prospect of not dying from opioids make people more likely to use opioids? And, what about those who are revived multiple times? How many “second chances” for life should be given and at what cost? Some have even suggested there should be limits on how many times naloxone should be administered to the same person.

Critics of the life-saving medication say that it gives drug users a safety net and allows them to take repeated risks as they continue to get high. Opponents also argue that naloxone prevents users from feeling the consequences of their actions and this attitude is evidenced by the fact so many addicts fail to turn their lives around after the drug has been administered. They say using the treatment merely feeds the cycle of addiction.

Indeed, many users overdose more than once – some O.D. multiple times before learning their lesson. Each time, naloxone brings them back from the brink of death. Unfortunately, some never do shake addiction and lose their lives to repeated overdosing.

Researchers like Jennifer Doleac of the University of Wisconsin looked at the time period before and after different naloxone-access laws were put into place, such as providing legal immunity to people who prescribed or administered the drug and allowing anyone to buy naloxone in a pharmacy without a prescription.

Doleac found arrests related to the possession and sale of opioids went up, as did opioid-related ER visits. Meanwhile – and most worryingly – Doleach found there was no overall impact on the death rate. In fact, in the Midwest, the implementation of naloxone laws led to a 14 percent increase in opioid-related mortality, she found.

To Doleac, the administration of naloxone presents a moral hazard. In other words, “anytime you make something less dangerous, people are going to do more of it,” she said.

Note – Here is an example of an economic moral hazard. If you rent a car and opt for the maximum insurance coverage possible, damaging the vehicle does not have significant negative consequences. The insurance company will pay for repairs—or a replacement car—if something happens. In exchange for that coverage, you pay a price that seems fair, and everybody is satisfied.

Doleac's views have been criticized. She is an economist, and economists are known often to make “causal inferences”: They study natural experiments like law changes, use statistical tools to rule out other explanations and draw conclusions about cause and effect. (Doleac, in turn, criticized the methods used in the studies that came to different conclusions than her own.)

The Cost

According to www.statnews.com, a decade ago, a lifesaving dose of naloxone cost $1. Today, that same dose costs $150 for the nasal spray, a 150-fold increase. A naloxone auto-injector, approved in 2016, costs $4,500. Pharmaceutical innovation hasn’t driven up these prices. Opportunity has.

Bjanttac National Training and Technical Assistance Center Office of Justice Programs, U.S. Department of Justice, says naloxone, depending on the specific form of naloxone used by the department, runs from a single naloxone rescue kit approximately $22-$60 for intranasal kits.

As a general rule, law enforcement training for overdose reversal programs is provided at no cost by a sister or a community agency. In some instances, costs for transportation and related training expenses may be covered by state grants.

As far as personnel costs, the time required for personnel to undergo training as part of law enforcement overdose reversal and prevention varies on case-by-case basis. Labor unions may consider opioid overdose reversal training as a change in work conditions.

The Surgeon General’s advisory explicitly addresses the importance of low out-of-pocket costs for naloxone. The reduction or elimination of consumer cost sharing to optimize naloxone distribution will require participation from health sciences companies, pharmaceutical benefit managers, and health plans.

Whose Morality?

To others like Lisa Campo-Engelstein, PhD, associate professor in the Alden March Bioethics Institute in department of obstetrics & gynecology at Albany Medical College, the moral hazard associated with naloxone is acceptable.

Campo-Engelstein concludes ... 

“The moral component here is that a lot of people think drug use is ‘bad’ and that people who use drugs are moral failures. Obviously, we want people to take responsibility for their actions, but we don’t deny people health care because they make ‘bad decisions.’”

Campo-Engelstein continued … ““We see this type of argument for a lot of public health problems. We see it with health education, with the HPV vaccine, and for any health issues that have a moral component.”

Lawrence H. Greenblatt, MD, Professor of Medicine and Community and Family Medicine at Duke Health, refutes those who believe naloxone presents a moral hazard. He says …

“They (the opposition) literally make the argument that by saving the lives of people who use injectable illicit drugs, you’re increasing the problem because there are more users. That’s a pretty unethical argument. It’s suggesting that if these drug users just got out of the way by dying of an overdose, we’d have less of a problem. It’s really ugly. It’s certainly hard to get behind that.”

Greenblatt adds that some of the data does not seem to be particularly strong or even applicable to the questions critics seek to answer. He says ...

“For example, they report a 1.4% drop in Google searches for the term ‘drug rehab’ after naloxone became available in a community. First of all, that’s a tiny reduction. Second of all, is tracking Google searches even a legitimate means of assessing peoples’ attitudes toward coming off opioids?”

Greenblatt also took issue with the fact that some studies have compared places where naloxone is widely available to places where it is not yet widely available. Naloxone’s effects likely depend on the availability of local drug treatment: when treatment is available to people who need help overcoming their addiction, broad naloxone access results in more beneficial effects.

Some clinicians maintain that rather than perpetuate risky behavior, naloxone can be used as an opportunity to disrupt this vicious cycle. When accompanied by resources and advice on rehabilitation, naloxone can be a valuable intervention point.

David A. Thomas, PhD, of the National Institute of Drug Abuse told Healio Family Medicine, concludes …

“When a patient goes to the ED, treatment should not just end with recovery from the overdose – there should be what we call a ‘warm handoff’ into the health care system, where they can get into treatment,” There are treatments out there that work. After a near-death experience, a patient might be particularly open to a teaching moment that could potentially change that behavior.”

Naloxone Understandings

Naloxone does not treat addiction, per se. However, naloxone is the only reversal agent for opioid overdose death in the community and in other situations where ventilatory support is not available. The alternative to the unresponsive, apneic opioid overdose patient is death.

One cannot assume drug users respond to incentives in any rational way. Addiction surely clouds judgment and makes policy in this area difficult. “Addiction is compulsive use despite the risk of harm,” says David A. Thomas, PhD, of the National Institute of Drug Abuse told Healio Family Medicine. Thomas continues …

“People who have opioid use disorder, or have a problem with any drugs of abuse, tend not to have enough executive function to have self-control and make good decisions about drugs. It’s really not a highly logical process - risk is just part of taking drugs.”

Jody B. Glance, MD, medical director of addiction medicine services at the University of Pittsburgh Medical Center, agrees with Thomas. She says, “When people are addicted, they’re going to use regardless of whether or not there is an antidote or a reversal agent, because their brains have really been hijacked and the addiction has taken over.”

Glance says ultimately naloxone’s ability to save lives is more important than any secondary moral concerns. She states ...

“Nobody wants to be an addict. Naloxone is going to save a life in the here-and-now and give that person another chance to enter a life of recovery, a life that they want to be living.”

Another rumor should be addressed – that of the drug being used as a “fix.” Naloxone is not sought out by patients for a "higher high." Naloxone availability laws haven't led to increase distribution or utilization. Stigmatizing addiction in this manner merely exacerbates the epidemic.

Critics of naloxone must understand that different policies concerning its use range in possible impact from trivial to significant. They also must not presume that a naloxone law’s passage has immediate effects. In practice, there is generally a significant lag between when laws are enacted and when they have their most powerful on-the-ground effects.

Any study of the use of naloxone must examine other key policies such as Medicaid expansion, targeted federal grants for the purchase of naloxone, and the implementation of parity regulations that require equal insurance coverage of services used to treat mental illnesses and substance use disorders. Richard G. Frank explains …

“Medicaid spending on outpatient naloxone prescriptions reached just under $20 million in 2016. Federal grants for naloxone purchases exceeded $20 million in 2015. In that same year, $100 million in federal grants were directed at high need community health centers.”

Remember the key phrase by Jody B. Glance: “We're just trying to save a life.” Harm reduction is based on the idea that the best way to help people suffering from drug addiction is to keep them as healthy as possible. One life saved is one more person who might just eventually find help and a way out. Others have. And many of them are now leading productive lives, yet were once thought to be hopeless and too addicted to recover.

We are presently taking baby steps to exit a major opioid health crisis. These advances are too recent to determine their long-term impact. I am in favor of giving every addict a chance (chances) at life until we do. Substance users deserve to live. We have at our disposal an overdose reversal medication that enables survival. It is immoral not to provide and use it. Any argument about a moral hazard fails when the victim of an opioid overdose is a loved one. 

References:

Jennifer Byrne “Increased Narcan availability evokes ethical debate.” Healio. April 2, 2018.

Tessie Castillo. “Should We Limit How Many Times Someone Is Saved with Naloxone?” The Fix. November 15, 2016.

Richard G. Frank, Keith Humphreys and Harold A. Pollack. “Does Naloxone Availability Increase Opioid Abuse? The Case For Skepticism.” Health Affairs. March 19, 2018.

Michael Hufford and Donald S. Burke. “The costs of heroin and naloxone: a tragic snapshot of the opioid crisis.” www.statnews.com. November 8, 2018.

Olga Khazan. “Why a Study on Opioids Ignited a Twitter Firestorm.” The Atlantic. March 14, 2018.

 Nadia Kounang. “Naloxone reverses 93% of overdoses, but many recipients don't survive a year.” CNN. October 30, 2017.

Ryan Marino, Brian Fullgraf and Jeremiah Escajeda. “Research Analysis: Conclusions about 'moral hazard' of naloxone not supported by methodology. Www.ems1.com. March 21, 2018.

National Institute on Drug Abuse. “Naloxone for Opioid Overdose: Life-Saving Science.” https://www.drugabuse.gov/publications/naloxone-opioid-overdose-life-saving-science/naloxone-opioid-overdose-life-saving-science.

Social Sciences Research Network “The Moral Hazard of Lifesaving Innovations: Naloxone Access, Opioid Abuse, and Crime.” https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3135264.

“What are the typical costs of a law enforcement overdose response program?” Bjanttac.