When Stephen Hill, a police sergeant in Louisville, Kentucky, arrived at a McDonald’s parking lot in response to a call about a suspected drug overdose, he found a young man, his lips purple, slumped in the front seat of a car, clearly in respiratory distress. The man’s frantic girlfriend had told the emergency dispatcher that her boyfriend had taken heroin. His breathing was shallow, and the clock was ticking.
Sergeant Hill reached for a product called Evzio, an opioid reverser that he carries with him and that was designed to be administered by people with little or no medical training—not just police officers and firefighters but friends, bartenders, and taxi drivers. Evzio, which gained approval by the Food and Drug Administration in 2014, is an “automatic injector” that guides its users through the steps of treating an overdose victim via voice instructions. It’s about the size of a deck of cards. The drug’s active ingredient, naloxone, blocks the effects of opiates, and provides a thirty-to-ninety-minute window to keep overdose patients alive.
In the early two-thousands, a dose of naloxone, which has been off patent for decades, went for about a dollar. When Evzio, which offered a simple-to-use injection system, first came on the market, it cost five hundred and seventy-five dollars. An Evzio auto-injector kit, which contains two doses of naloxone, now costs forty-five hundred dollars, a six-hundred-and-eighty-two-per-cent increase. The price hike by Evzio’s maker, Kaleo Pharmaceuticals, has drawn sharp criticism at a time when the abuse of opioids is becoming more prevalent and more dangerous. Opioid overdoses have quadrupled since 1999, accounting for thirty-three thousand and ninety-one deaths in 2015, according to the Centers for Disease Control and Prevention. Evzio is one of just two naloxone devices approved by the F.D.A.; the other, the nasal spray Narcan, costs a hundred and fifty dollars for two doses. (Last week, the agency rejected the application of a competing nasal spray.)
“It is the coolest and the sharpest device on the market for naloxone,” Arlene Rice, a founder of the Kentucky Harm Reduction Coalition and the mother of children with substance-abuse problems, said. Her organization received five hundred free doses of Evzio to hand out to drug users and their families. “They went like hotcakes,” she said. But for those not in on the free offer, the price “is astronomical and opportunistic,” she said. “Who can afford that?”
PHOTOGRAPH BY CLIFF OWEN / AP
In the McDonald’s parking lot, Sergeant Hill took his department-issued Evzio device out of its packaging and a recorded voice began to speak to him. “To inject, place black end against outer thigh,” it said. “Then press firmly and hold in place for five seconds.” This would allow the device’s retractable needle to descend and inject the overdose patient with two milligrams of naloxone. Hill did this, and heard a mechanical clicking that sounded like a staple gun. A five-second countdown began. “Injection complete,” the voice said. Hill waited, but the man in the car barely stirred. In recent months, much of the heroin in Louisville has been laced with fentanyl, a prescription painkiller that is so potent it can take up to twenty doses of naloxone to reverse the overdoses it induces (fentanyl is what the musician Prince overdosed on last April). The Evzio kit comes with two doses, so Hill administered the second one in short order. “It’s kind of dumb-proof,” he said, of using the device to treat an overdose. The man came to, gasping for air.
With a population of more than six hundred thousand, Louisville is the largest city in a state with one of America’s highest death rates from opioids. In the course of four days in February, Louisville Metro Emergency Services received a staggering hundred and fifty-one calls about overdoses, largely from heroin and synthetic opioids. Thanks to first responders carrying devices like Evzio and Narcan—and recent laws in forty-eight states, including Kentucky, that remove barriers to accessing naloxone—many of those overdoses in Louisville were not fatal.
Arlene Rice, whose adult son Gabriel died after an overdose, in 2013, said she keeps Evzio on her at all times. “I keep it with my lipstick,” she said. Sergeant Hill carries three doses with him every time he goes out on patrol. “I call it the Batman gear,” he said. In some overdose cases, it’s easier to administer than the cheaper Narcan nasal spray. “If you have the nasal device, and you can’t get to the nasal passages, then you are up a creek,” Rice said. “A lot of times O.D.s happen in bathrooms. Families break in the door, and the person is often lying against it,” said Sonia Rudolph, a nursing professor in Louisville whose twenty-two-year-old son has overdosed five times. It can be simpler to access a patient’s arm or leg than their face. “When you’re in a stressful situation, it takes out the critical thinking you’re going to have to do,” Rudolph said.
Earlier this month, thirty-one U.S. senators sent a letter to Kaleo Pharmaceuticals, asking the company to explain its “startling price hike.” The company released a statement to media saying that the cost was necessary to subsidize the philanthropic program to distribute Evzio free of charge. Indeed, Evzio, which costs thirty times more than its only other F.D.A.-approved competitor, is available through a donation program to first responders, health departments, and nonprofit organizations. Kaleo said in a statement that it has donated two hundred thousand auto-injectors to date, and plans to donate a hundred thousand more in 2017—and the company has an “access program” that allows commercially insured patients to call a hotline to eliminate their co-payments. “Kaleo felt compelled to increase the list price of Evzio in February, 2016, more than a year ago, because too many patients were not able to obtain Evzio even when their doctor prescribed it to them,” Spencer Williamson, Kaleo’s C.E.O., said through a public-relations firm.
Patient-assistance programs like Kaleo’s have historically been used to justify exorbitant price hikes, while undercutting the political case for pricing regulation. “That has been an effective P.R. tactic that has helped to forestall regulation for half a century,” said Jeremy Greene, a medical historian and the author of the book, “Generic: The Unbranding of Modern Medicine.” Philanthropy programs, in other words, are used to inoculate the company against complaints that the full prices of their drugs are too high. “The patient-assistance programs are ways to charge much higher prices to people in insured populations,” Geoffrey Joyce, a health economist at the University of Southern California, said. “But that money gets paid by someone, generally by ending up in premiums or by being born by taxpayers.”
Drug companies would like Americans to believe that high list prices for drugs are irrelevant—that they are merely opening bids sent out to insurance companies and large group providers, like the Department of Veterans Affairs, that will be negotiated down. But list prices do matter. When insured drugs jump in price, those costs will be embedded in higher health-care premiums, taxes, or co-payments later on. “Everybody pays for those costs; you just don’t pay at the pharmacies,” Michelle Mello, a health-law scholar at Stanford, said.
In September, consumers grew incensed when the drug company Mylan raised the price of its EpiPen auto-injectors for allergic reactions by five hundred per cent, from a hundred dollars to six hundred. And, of course, there was the story of Martin Shkreli, of Turing Pharmaceuticals, who raised the price of the drug Daraprim, which is used to treat the effects of H.I.V., from thirteen dollars and fifty cents to seven hundred and fifty dollars per pill. Shkreli’s sneering, superior public attitude made him the perfect villain in the age of memes and Twitter.
Public shaming is the only weapon against these price hikes, which are permitted under the law, Greene told me. “There’s nothing stopping Shkreli and people like him from hiding behind the F.D.A. approval process to effectively price gouge, simply because they can.” The senators’ letter to Kaleo was another effort at shaming, backed without much legislative force. (There is one bill, being considered by the state legislature in Maryland, which would give the state attorney general the power to prosecute drug companies for price gouging in the sales of “essential” generic drugs.) Executive action appears even less likely. President Donald Trump has announced his intention to deregulate the health-care sector, and there are reports that he is considering as his F.D.A. chief the libertarian Jim O’Neill, who has stated he does not believe that drugs even need to be proven effective before going to market.
Arlene Rice’s daughter Lindsay, a bartender in Louisville, was twenty-five years old in 2010, when she nearly died from a heroin overdose. The paramedic gave her a dose of Narcan, and she woke up in the back of an ambulance. “I wasn’t able to breathe and was gasping for air,” she said. “I heard them say they were losing me again. I remember vividly thinking, This is what it’s like to die, and wondering how I can go to heaven.”
Sometimes Lindsay reads the comments under news stories and gets frustrated when she sees the things that people say about drug users—that junkies don’t deserve to be saved, and that they are choosing to become addicts. “It took my brother dying for me to get some help,” she said. “I thought, Either I can die too, or I can live for us both and not let his death be in vain.” Naloxone—which was not available to her brother in 2013—gave her another chance to get treatment. She has now been sober for more than three years.