America has a prescription pill problem. According to a CDC report released this month, doctors wrote 259 million opioid prescriptions in 2012—which means that in some states, there are more painkiller prescriptions than people. Both doctors and pharmaceutical companies profit from overprescribing the pills that have led to the rise in America's harrowing narcotic addiction, and now that opioid overdose is among the leading causes of death, they've also found a way to profit from the antidote, naloxone.
A new naloxone-injection device called Evzio was released on the market just this week, after receiving fast-tracked approved by the FDA in April. But it's doubtful that Evzio will actually improve access to naloxone, and more likely that it will become a golden goose for Kaléo, the pharma company that created it.
Naloxone is basically like a magic cure for opioid overdoses: inject a dose of it into someone who has just ODed, and it can literally wake them up. The drug blocks the body's opiate receptors, reversing the effects of whatever you overdosed on, whether it's heroin or Vicodin or OxyContin. Naloxone works extremely well, but only if it's administered within a certain time frame. To make this easier, Evzio claims to be the first user-friendly at-home naloxone injector, which doctors can prescribe at the same time that they prescribe opioids.
This isn't the first time that the pharmaceutical industry has made money from opioid overdoses. Naloxone, which is an off-patent drug, has been available since 1971 and costs about $3 per dose. But a pharma company called Hospira, which was the sole manufacturer of naloxone in the US until this year, increased the price of the drug tenfold in 2008—the same year that opioid overdose was declared an "epidemic" by the CDC. Prescription doses of naloxone now costs a little more than $30.
Evzio, by comparison, is estimated to cost is between $400 and $600.
Evzio's representatives dodged my questions about exact pricing, but they made sure to emphasize that it's different from the status quo because of its user-friendly design: Similar to an EpiPen, all you have to do is stab the device into the ODing person. In April, when the FDA approved the device, FDA Commissioner Margaret Hamburg told reporters that the "lack of a lay-friendly delivery system has made it difficult to make naloxone broadly available to the public and to foster its use in non-medical settings, where it is often most urgently needed."
The thing is, that's only half true. Naloxone is most essential in the non-medical setting, but administering naloxone isn't nearly as difficult as she—or the makers of Evzio—suggest. A recent study found that people without training were able to use the syringes in a naloxone rescue kit just as easily as people who had been trained. Tessie Castillo, who works for the North Carolina Harm Reduction Coalition, told me that at-home naloxone kits are so easy to use that "anyone with common sense could figure it out, even without training." The New York Times once compared the ease of the process to "basting a turkey."
The point here is that barriers to naloxone use aren't related to administration, but access. Naloxone is available via prescription in all states, but Castillo told me that "many people are afraid to ask their doctor for a prescription because it could potentially mean admitting to using illicit drugs or taking medications not as prescribed." Combine this with confusing naloxone laws and some doctors' reluctance to prescribe it, and you can understand why many users don't have it. And although naloxone can save your life from an overdose, it only works if you have it with you.
Castillo told me that her organization has distributed more than 2,600 naloxone kits throughout North Carolina in the past year, which are free of cost and do not require a prescription. There are around 200 other organizations like hers that distribute naloxone at a subsidized cost or for free—but many of these organizations are grossly underfunded, and they can't distribute enough naloxone kits to match the demand.
Evzio, which is both pricey and prescription-based, does nothing to improve these access barriers. In fact, it's literally the opposite of what naloxone advocates say they need.
When I asked her about Evzio, Castillo was unenthusiastic. "I wish that the FDA would have fast tracked over-the-counter naloxone instead of an expensive product for a private company," she said. "Intramuscular and intranasal naloxone are already available, easy to use, and much less expensive than Ezvio, so I don't see how the addition of a machine that talks will improve access for anyone."
At worst, Evzio's high out-of-pocket price could be a major access deterrent for the device; at best, it could create a two-tiered system of access, giving access to those who have good quality insurance and are legitimately prescribed opioids, while leaving out users who are uninsured, who get pills by illicit means, or who use heroin instead.
Tracey Helton, an outspoken naloxone advocate, told me she's optimistic that "there may come a day when [Evzio] is required to go in compliment with opiate based medication," meaning your doctor would write a prescription for Evzio alongside any opioid prescription, thereby mandating greater access to the antidote.
This is certainly what Evzio's makers, Kaléo pharmaceutical, have in mind. The company's Chief Medical Officer, Eric Edwards, stated that the company wants Evzio "in every medicine cabinet of every person who might be at risk." Most naloxone proponents would agree that this is admirable in terms of broadening access. But as Helton points out, while increasing access is the goal, this strategy also provides a lucrative opportunity for the pharmaceutical industry: If Kaléo convinces doctors to write a prescription for Evzio alongside every opioid prescription, the device "could become a cash cow."
Put plainly: pharmaceutical companies can now sell you the poison and sell you the antidote.
The problem is that this makes naloxone a part of the opioid economy—and that economy is booming. A study from last year confirmed that painkiller prescriptions doubled between 2000 and 2010—without any evidence of improved pain management or increased incidents of pain. In California, a lawsuit is underway alleging that pharmaceutical companies profit from doctors overprescribing opioids. Specifically, the suit alleges that in 2010, the sale of prescription opioids generated $8 billion in revenues for pharmaceutical companies. If Evzio (rather than generic naloxone) is sold in tangent with every opioid prescription, Kaléo's profits could well surpass that.
To be fair, Kaléo is in the process of developing a "patient assistance program" to subsidize the cost for eligible patients, and has agreed to donate devices to some harm reduction centers. But by so closely linking their product to prescribed pills, they have a stake in maintaining the gross over-prescription problem—arguably, the source of opioid addiction. In other words, Kaléo needs you to stay addicted to opioids so that they can turn a profit on your potential overdose.
Access to naloxone is invaluable, but it isn't priceless. If we want to prevent overdose related deaths, we need to provide low-cost, easy-access versions of naloxone rather than allowing pharmaceutical companies to cash in on opioid overdoses.
Follow Arielle Pardes on Twitter.
Topics: Evzio, pharmaceutical profit on drug abuse, opioid overdose, opioid abuse, kaleo pharmaceuticals, overdose, drug overdose, opiates, Heroin, Big Pharma, narcotic addiction, Naloxone, naloxone access, naloxone is too expensive, naloxone rescue kit, fda, opioid economy, overdoses are lucrative, naloxone price, prescription naloxone, North Carolina Harm Reduction Coalition, doctors profit from drug addiction, prescription pill addiction, prescription pill overdose