The Drug That Saves Addicts: FDA Will Discuss Making Naloxone Over-the-Counter

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When I was injecting drugs back in the mid-1980s, several sneaky killers were haunting addicts. We didn’t know it at the time, but half of all New Yorkers who shot drugs were already infected with HIV and many more were carrying the hepatitis C virus. There was no effective treatment for either disease. Thousands died. And unfortunately, many in the recovery community stayed silent. 

The risk we knew about—overdose—seemed just as implacable. You could reduce the danger by limiting your doses and not mixing similar drugs, such as heroin, Valium and alcohol, say, or cocaine and amphetamines, and that remains good advice. Back then, we fatalistically assumed that this menace pretty much came with the territory.

In 2012, however, both HIV and hepatitis C are not only treatable but amenable to prevention campaigns. New HIV infections among drug users have been cut in half in the last decade, largely by clean-needle programs, which can also fight hepatitis C (though not as effectively).

But some 15,000 people still die annually from opioid overdoses—even though there’s a cheap, effective and safe remedy that could save most of these lives if it were more widely available. With prescription opioid misuse now the main cause of rising overdose fatalities and with the overwhelming failure of ongoing efforts to cut supply, it’s long past time to focus on the most direct way to prevent death by OD.

Since 1996, when Dan Bigg, of the Chicago Recovery Alliance, first began promoting the idea of distributing the opioid overdose antidote, naloxone, to drug users, overdose has been known to be a risk that can be dramatically reduced. As with needle exchange, however, drug-war politics has meant delays—and many needless deaths. The advocacy of the recovery community needs to be louder this time.

And more ambitious. We need not only to educate people about how to save lives with naloxone but to make it available over-the-counter and start a public-education campaign about why it’s essential for every first-aid kit.

Last month, the CDC reported that since Bigg started, more than 10,000 successful overdose reversals have been reported by the 188 programs in 15 states that currently provide naloxone and train users to administer it. Over 50,000 doses of the drug have been distributed.

Although some of the treated overdoses might not have been fatal without naloxone, the vast majority likely would have been because the drug is only used if the victim has stopped breathing.

Here are the facts about naloxone (brand name Narcan). It immediately reverses overdoses that involve an opioid, even if alcohol and benzodiazepines like Xanax are also involved, as is true in the vast majority of cases. It’s nonaddictive: in fact, about the only imaginable way to misuse it would be to torture people who are opioid addicted by using high doses to put them into withdrawal.

This property also means that addicted people won’t take extra opioids because they know a rescue drug is on hand: coming around from an overdose via naloxone is stressful, and anyway addicts tend to take the highest dose they have.

The story of Mark Kinzly, a recovering addict who now runs a harm-reduction program that distributes naloxone but who was himself saved by the drug during a relapse, illustrates why:

Kinzly was watching a Red Sox victory with a friend when he overdosed. “I am a Red Sox fan, but that's not what put me into an OD,” he jokes. He had injected two or three bags of heroin—a dose that he thought he could handle. Dangerously, he had misjudged his tolerance after years without heroin…

Fortunately, in Kinzly’s case, his friend had naloxone and knew how to help. “He said that he looked over and noticed I was turning gray and my lips were bluish. I had what he called a death gurgle. He loaded the Narcan into a syringe and injected it into my upper arm.”

Kinzly woke up, filled with shame over his relapse when he realized what had happened. Because naloxone reverses the effects of narcotics, it can cause withdrawal symptoms in addicted people. The symptoms are unpleasant but not dangerous.

“I certainly didn’t feel great, but I sure was grateful,” he says. “I was very embarrassed [but] I was incredibly grateful that I was going to have another opportunity to get clean again and watch my son grow up.”

Before his own overdose, he’d saved four people with naloxone and has since saved 10 others.

While doctors initially feared that naloxone carried the risk of causing seizures, this hasn’t been seen in the field. Naloxone distribution programs use lower doses than ER docs and EMTs typically do, finding that this saves lives without producing the intense withdrawal symptoms that might prompt users to seek and take more drugs. The drug is harmless if given in error for the wrong type of overdose. And because it's an opiate-receptor antagonist, or blocker (not to be confused with methadone and other opiate agonists, or substitutes), overdosing on naloxone itself is almost impossible.

Another fear has been that since naloxone is short-acting and some opioids have longer-lasting effects, people would be revived only temporarily and would need hospitalization for monitoring. While users are always advised to call 911 immediately—and many states are making “Good Samaritan” laws to exempt them from prosecution for drug possession if they call for help—at least one study found that refusing further medical care doesn’t increase the risk of death.

So what’s the catch? As with needle exchange, there’s moral discomfort among drug warriors who apparently feel that the wages of drug use should be death. Bertha Madras, the deputy drug czar under President George W. Bush, told NPR in 2008 that providing naloxone might sap users' motivation to get treatment because "sometimes having an overdose, being in an emergency room, having that contact with a healthcare professional, is enough to make a person snap into the reality of the situation and snap into having someone give them services."

Anything that reduces the risks of drugs, from this overdose-as-teachable-moment perspective, will keep addicts using longer and—why not?—even encourage children to start using. Yet in reality, of course, there’s no evidence that saving addicts’ lives prompts teens to take up drugs—and none that providing clean needles or naloxone deters recovery.

Indeed, Kinzly’s reaction to being revived—a recommitment to recovery—is common. And he might not have lived long enough to have it if he'd had to wait for an ambulance. Many people immediately seek treatment after surviving overdose. Also frequently reported by naloxone programs are people who kick addictions because the person who saved them was a sober example, showing them it was possible. In addition, the empowerment and self-esteem that comes from learning to help others and actually saving lives with naloxone can spur positive change.

So that’s why, just as I once called for recovery activism in support of needle exchange, I now believe we need it to push naloxone. People in recovery—simply by existing—show that addiction isn’t necessarily forever and that valuable, productive people can suffer from and beat back addiction. We need to stand with those who are not yet ready so they can survive long enough to hear that message of hope.

While more naloxone distribution programs at needle exchanges and other places frequented by active addicts are important, equally important is making naloxone available cheaply over-the-counter and educating the public that it’s a household essential. Here’s why. The riskiest periods of addiction are times when people have either just started using or recently quit, either in treatment or in prison. At those times, they are simply not likely to attend a needle-exchange program or to believe they have any need for naloxone.

Moreover, what parent—whether they find a teen blue on the couch or find a toddler (or even a pet) gobbling Grandma’s codeine—would not want to have the antidote on hand? Since parents typically believe, “Not my kid,” most would never visit a needle exchange or even think about overdose antidotes. Pain patients prescribed large doses of opioids are also at risk, not to mention addicted people who “doctor shop” and don’t associate with street drug users.

But if the Red Cross and similar organizations promoted naloxone as a first-aid measure that everyone should keep at home, this denial wouldn’t matter. There’d be no stigma to having it; it would just be something everyone stores in the bathroom or kitchen, like ace bandages or disinfectant. As pilots say about safety equipment, it’s better to have it and not need it than to need it and not have it.

At least half of all overdoses are witnessed, but if people don’t know the signs to look for or have the means to help, these lives can’t be saved. Key is recognizing erratic breathing, blue skin tone and strange snoring—and not letting someone “sleep it off,” which can be fatal.  

Because people who have “been there” know what addiction is like and how helping others helps our own recovery, our voices are essential. Some of the key leaders in the fight for needle exchange, in fact, are or were recovering ex-addicts, and this is true for naloxone as well. But many, many more voices are needed—the fact that we’re still fighting with Congress over syringe exchange funding is only one illustration of why.

The FDA will hold a meeting April 12 to discuss making naloxone over-the-counter. Wouldn’t it be great if thousands of recovering people showed up or at least contacted the agency (where? click here) to make it know that our lives matter and we support OTC naloxone?  

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