The war on opioids is in full force, and we are losing. More than 64,000 Americans will die overdose deaths this year. Tighter regulations on prescription narcotics may just be shifting those with opioid addictions back to heroin cartels. During his last term, President Obama signed a bill funding $1 billion into programs combating opioid addiction, including programs that increased access to naloxone, the antidote for opioid overdoses. The current administration announced this year its plan to grant $485 million from the Department of Health and Human Services (HHS) to states to fight opioid addiction. At the same time, synthetic opioids like carfentanil are proving highly resistant to common doses of naloxone, sometimes requiring 10 or more doses of naloxone to reverse an overdose.
The opioid crisis quickly became a state of emergency. More than 40 states responded by making naloxone available without a prescription for the express purpose of enabling family members to revive their loved ones in case of overdose. Other local initiatives have involved the push to make naloxone available to all first responders, including the police and even their K9s who may be exposed to lethal levels of opioids at crime scenes.
While these initial strides have helped to combat deaths from opioid overdose, the financial burden is becoming exhausting. Naloxone has been on the market since 1971 and became generic in 1985. The drug itself is cheap, with current wholesale price cited as $0.33 for a 2ml vial or $11.70 for 10 2ml vials by the International Medical Product Guide. Comparatively, in the US, a simple vial of naloxone is 40 times that price. Price-gauging poster child Mylan of the now infamous EpiPen scandal sells naloxone at $23.72/ml, Hospira sells it at $14.25/ml, Amphastar at $19.8/ml and West-Ward at $20.40/ml.
These prices are for the drug naloxone only, and do not include any of the delivery devices like auto-injectors or nasal injectors. As a result, they are only helpful to medically-trained persons like paramedics, often funded by state and local taxpayer dollars. Citing cost concerns, communities have begun to propose "one and done" or "three strikes" rules where people are limited on the number of overdose responses they get from city ambulance services -- so the next time they call, the city will just let them die. Middletown, Ohio, was one of those cities -- a town that is on track to spend over $2 million this year responding to opioid addiction problems, with $100,000 on Narcan alone.
With government capabilities already limited by cost, the burden of life-saving shifts to private (usually lay, non-medically trained) consumers of naloxone, almost always family members of an opiate user. These loved ones need a naloxone option that is easy to deliver in a crisis, without the training required for syringes and measurements needed to use simple vials of naloxone. This is where the price gouging becomes more appalling. For a drug that costs as low as $0.16/ml, current naloxone options for the lay consumer are exorbitantly cost prohibitive. The naloxone auto-injector by Kaleo Pharma costs $4,500, and the naloxone nasal spray by Adapt Pharma, a simple plastic nasal sprayer that could be manufactured for pennies, now costs $110. This is the price to save a life now, with a generic drug that has been on the market for nearly 50 years.
This is concerning, especially for people living in poverty who are disproportionately affected by addiction. Concerned by the public health ramifications of this, earlier this year, 31 US Senators sent a letter to Kaleo, maker of Evzio, demanding an explanation for not only the cost of the drug, but also the 600 percent price hike in the drug. Like Mylan during the EpiPen scandal, Kaleo responded by citing donations of its product to various agencies, as well as a complicated web of rebates and discounts. These do make the drug more affordable for some patients, usually those with insurance, but more often than not, this results in increased market share as consumers are swayed to use the product and not enough impact from a population health perspective. Already, Kaleo has maxed its donations of product, but many that received those devices now rely on it. Meanwhile, Kaleo is enjoying a 20 percent overall market share on the retail naloxone dispensed. For the 40-64-year-olds that most often need naloxone, Kaleo holds an even more solid 50 percent of the market share.
Pharmaceutical price gouging has created a situation where access to life-saving medicines is limited by profit margins. As government agencies are already struggling with costs, the burden gets shifted to the private consumer. In that market, the message is clear: If you can't afford $4,500 for a dose of medicine, you don't get to live. In a way, haven't these pharmaceutical companies now become the "death panels" in the "rationing of health care" that we once so feared during the initial Affordable Care Act debates?
Naloxone is a life-saving drug, one that serves the public in an increasingly important way as we continue to search for other ways to limit the devastation caused by the ongoing opioid crisis.
As one example, Harm Reduction Therapeutics is a nonprofit pharmaceutical company that is working to maximize naloxone's over-the-counter availability while minimizing the price and financial burdens to consumers, first responders, and state and local governments. Co-founder and CEO Michael Hufford noted that "philanthropic foundations backing this new nonprofit pharmaceutical model will help with an urgently needed response to the opioid crisis, while realizing a tremendous return on their investment, measured not in dollars, but in lives saved."
With such public impact, it is time to stop relying on "pharma bros" and start creating and incentivizing nonprofit or government and academic-sponsored institutions for an alternative. Store shelves need to be flooded with easy-to-use naloxone devices that are sold for what they cost to make and distribute. Only then will the supply of this life-saving generic drug begin to meet the tragic demand for it.
In the words of Hufford, "As lives are lost every day from opioid overdoses, and debate continues as to whether it formally constitutes a crisis, we face a choice -- watch as price-gouging constricts access to naloxone or do something about it. We have chosen to do something about it."
Correction: This article incorrectly stated the amount of funding for fighting opioid addiction provided by legislation signed by President Obama. The 21st Century Cures Act, a bill signed into law by Obama last year, provides $1 billion in opioid funding.