Naloxone Debate: FDA Hears Testimony About Making an Overdose Antidote Nonprescription

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(Updated) “Why didn’t I know about this when my child was alive?” That was the question raised over and over at a U.S. Food and Drug Administration (FDA) hearing on Thursday by parents whose families make up the terrible statistics on opioid overdose, which now kills some 15,000 Americans each year.

Parents testified at an open meeting called by the FDA to consider whether the lifesaving antidote to opioid overdose — a non-addictive, non-toxic drug called naloxone (Narcan) — should be made available over-the-counter, so that everyone can keep it in their first aid kit, just in case.

The meeting was sponsored by the FDA, the Centers for Disease Control and Prevention (CDC) and the National Institute on Drug Abuse, whose director, Dr. Nora Volkow, has said that she supports making the drug available without a prescription.

(MORE: A Lifesaving Overdose Antidote Should Be Made More Widely Available)

The hearing was emotional and, at times, heated. Dozens of people talked about losing family members and friends, and testified to the power of naloxone to save lives. Joanne Peterson, who runs Learn to Cope, a program for family members of drug-addicted people, testified that within two weeks of starting naloxone distribution: “We had a mom save a daughter and a father save a son.”

But what was most surprising about the meeting was the underlying sense of consensus. Whether or not the FDA changes the labeling on naloxone, which currently can be acquired only with a doctor’s prescription, the majority of people who attended the hearing appeared to be in favor of wider access; some explicitly said that access needs to be expanded, or presented data that supports broader availability.

Naloxone is an opioid antagonist, which means that it attaches to and blocks receptors for opioid drugs like Vicodin and heroin in the brain and body. Because naloxone is more strongly attracted to the receptors than the opioids are, when it is given after an overdose, it displaces these drugs and reverses their effects.

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Opioid overdose kills by slowly stopping a person’s breathing, so typically there is time to intervene — and often there are other people around when a drug user overdoses. Even though most opioid overdoses involve mixtures of drugs, not just opioids, naloxone is effective even in these cases, and it is not harmful if given in error. Even if used at doses 700 times higher than what is recommended, “you will not see any adverse effects in opioid-naïve patients who are not in pain,” testified anesthesiologist Greg Terman on Thursday.

Those who are in pain or who are dependent on opioids will suffer withdrawal symptoms, however. Pain will also return because naloxone blocks the pain-relieving effects of opioid drugs, but these symptoms are not life threatening. Terman noted that when you look in pharmacology textbooks, you’ll see that naloxone has a very short list of side effects, “in contrast to a dangerous drug like ibuprofen” (Advil).

Among the more than two dozen members of the public who testified, only one — a representative from the American Society of Anesthesiologists — argued against making naloxone available without a prescription. He argued that a physician’s direction is needed when using the drug.

(MORE: Should an Overdose Antidote Be Made More Accessible?)

Despite the widespread support for naloxone, however, there are significant barriers to change. For one thing, a drug company would need to submit an application to the FDA to change the status of the drug, which would require presenting a great deal of data. Alternatively, a citizen could petition the agency to make the drug available over-the-counter, but that procedure would take years longer than it would with a drug company involved, an FDA official said.

Since naloxone is off-patent, any company seeking over-the-counter approval would be able to market it exclusively for only three years; if it wanted to seek a longer period of exclusivity by patenting a new method of delivering the drug, that would require more data and more expense. The CEO of a start-up pharmaceutical company called Anti-Op, which would like to sell naloxone over-the-counter, estimated that the approval process would cost $10 to $20 million, an amount that could exceed the current market for the drug. With insurers and Medicaid unwilling to cover over-the-counter medications, and funding for naloxone programs currently extremely limited, how the drug would be paid for is also unclear.

Right now, only one manufacturer produces naloxone in the U.S. Not only is there currently a national shortage of the drug, its price has also risen dramatically.

(MORE: On Overdose Awareness Day, a Mother’s Plea for Compassion)

The last panel of the daylong meeting was officially charged with debating the question of over-the-counter availability. Of its five members, only one opposed wider availability of naloxone. Dr. Edward Boyer, a professor of emergency medicine at the University of Massachusetts Medical School, argued that making naloxone available without a prescription would actually “increase mortality.” He said that while the data supports its use to reverse heroin overdoses, overdoses of some long-acting prescription painkillers require medical attention because naloxone doesn’t last as long as those drugs do and so people who are revived might just die later if they aren’t taken to the hospital.

Earlier in the day, however, Dr. Alex Walley, assistant professor of medicine at Boston University, presented data that contradicted this argument. Walley said that a study of a Massachusetts naloxone-distribution program compared outcomes in 19 cities and towns that had all experienced at least five or more overdose deaths per year, some of which had naloxone-distribution programs. Communities with more than 150 people per 100,000 members of their population enrolled in the naloxone program saw a 50% reduction in overdose death rates compared with cities without such programs, while those with fewer than 150 per 100,000 participating saw a 27% reduction. Walley and Boyer had a charged exchange over the findings.

Moreover, a recent study published in the CDC’s Morbidity and Mortality Weekly Report surveyed 188 naloxone-distribution programs in 15 states, which train drug users and their families and friends how to use the drug and call immediately for medical help. It found that 10,000 overdose reversals have been reported.

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Since 1996, when Dan Bigg of the Chicago Recovery Alliance started the first naloxone-distribution program in the nation, the drug has been given to more than 50,000 people. Few side effects have been reported and the rare cases in which the drug did not work occurred either in overdoses of other drugs or when the drug was given after the victim was already dead. Boyer criticized this research, however, because he said it doesn’t provide information on whether people who are saved are more likely to overdose again and die later.

In a surprising vote of support, another panel member, Bertha Madras, a former deputy drug czar under President George W. Bush and a professor of psychology at Harvard, said she believed naloxone should be made more widely available, but that she wasn’t currently convinced that expanded access should go as far as making the drug nonprescription. Though Madras has previously been quoted as opposing wider distribution, she said that she her comments had been misconstrued. “Life comes first,” she testified, arguing that naloxone should be widely distributed but should be integrated into programs to get revived drug users into treatment.

Summing up, Sarah Wattenberg, senior adviser for substance abuse policy in the office of the assistant secretary for health said, “You have our attention. We understand that you want us to do more.”

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As a grieving mother, Susan Gregory, who lost her son, Denny, at age 20 to overdose, put it: “Any risk of naloxone is very minimal compared to death. … Drug users deserve to live. If it was your child, mother, brother, sister, would you want naloxone in the house?” I can’t imagine any parent answering no.

Correction [April 23, 2012]: The original version of this story misstated that communities with more than 150 people enrolled in the Massachusetts naloxone program saw a 50% reduction in overdose death rates compared with cities without such programs, while those with fewer than 150 people participating saw a 27% reduction. The correct population measure is 150 people per 100,000 people in the population. The story has been updated to reflect the correction.

Maia Szalavitz is a health writer at TIME.com. Find her on Twitter at @maiasz. You can also continue the discussion on TIME Healthland’s Facebook page and on Twitter at @TIMEHealthland.

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