This drug manufacturer’s news release touts Ezvio, which delivers the drug naloxone in an auto-injector device, to treat narcotic overdoses in an emergency situation. Naloxone has garnered much attention in recent years as a way to prevent death in opioid addicts. It has reportedly saved lives and, as the release suggests, has the potential to save more if it were more widely available. The release uses testimonial quotes from an impressive array of public health and safety officials. Unfortunately, it provides no hard data backing up its benefits. Not even its attention-grabbing headline — “More than 1000 Lives Reported Saved with Help of EZVIO” — is backed up with a source. The release also neglected to include costs and only briefly mentions the product was tested in two clinical trials but provides no leads as to where the trials were published.
This matters because an estimated 15 million people are addicted to opioids and about 69,000 people in the world die from opioid overdose each year, according to the World Health Organization. It’s long been understood that addiction and death from opioid drugs are at epidemic levels in the United States. Strategies to combat drug overdose fatalities — especially in light of the spike in prescription opioids and heroin overdoses — are newsworthy and of keen interest to public health officials. In recent years many local governments have grappled with ways to find money to make naloxone available to more first responders.
The news release makes no mention of cost. That’s an important omission since the cost of even generic naloxone is undergoing steep price increases. According to a report from the American Society of Health-System Pharmacists last year, “When Kaleo Inc. launched its Evzio 1-mg/mL naloxone hydrochloride autoinjector in July 2014, the company priced each carton at about four times the invoice price of a box of same-strength 2-mL naloxone syringes, said Matthew Rosenberg, an analyst at FDA.”
An online search revealed that Evzio’s retail price was about $700 per kit, according to a MedPage Today article. Prices for standard naloxone kits ranged from around $40 to $60 per kit, with on-going price hikes.
There’s a very limited supply of money for drug abuse treatment and a naloxone injection is only the start. Is having an extremely expensive one the best use of funds? The release needed to address the cost disparity between this device and less expensive ones on the market.
The news release asserts that Evzio is reported to be saving lives. It then offers testimonials, but no data. For example, the president and CEO of the company says that, since October 2014, “we have received reports that EVZIO Auto-injectors have helped save an average of 14 lives per week.”
That’s it. No mention of where the reports came from, how they were compiled, what happened in October 2014 to start those reports being filed. It turns out the drug/delivery combo was approved by the Food and Drug Administration in April 2014.
Then, Laurie Fugitt, RN, BSN, co-founder of Georgia Overdose Prevention, says this: “It has already helped save many, many lives in Georgia.” How does she know? How many are “many, many?” When she says “helped save,” does she mean that something else was needed to complete the save? If so, what was it?
Then, we get another anecdote, this one from Dr. Michael Kilkenny of the Cabell-Huntington Health Department in West Virginia: “Following initial deployment of EVZIO on February 3, we had a confirmed life saved on February 12th.”
Who made the confirmation? How? What happened?
The news release lists a number of adverse reactions that have been identified during use of naloxone hydrochloride in postoperative patients, including hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest.
While we give the release credit for providing an extensive list of potential list of side effects, we question whether including a long laundry list of warnings under “important safety information” is sufficient to prevent accidents when untrained individuals are treating people who are suspected of opioid overdose. And yet this product is marketed for individuals without medical experience. In mentioning usability trials involving the product the release states that, on average, “more than 94% of users can correctly administer EVZIO without training, and 100% with training.” We’d like to know how many volunteers were involved and what is the effect of incorrectly administered Evzio.
The release only briefly mentions that two clinical trials involved Evzio but doesn’t give us any information on how to access the studies for independent review. Anecdotes are meaningful only if they are backed up by data. The news release doesn’t even describe how it came up with the more than 1,000 lives saved claim. We would like to have seen evidence comparing the device versus generic naloxone injections, if they exist.
The news release quotes an official in Baltimore stating,”we believe that naloxone should be a part of everyone’s medicine cabinet and everyone’s first aid kit.” While this initially seemed like a stretch to us, the breadth of the opioid overdose crisis in some regions of the country makes it a reasonable proposal.
If a news release is going to quote the president and CEO of the company that makes the drug, readers can assume he has a financial interest in his statements.
But they are left to wonder about the quotes from health professionals. It might have been a good idea to point out whether they, too, have a financial stake in their statements. If they do not, letting the reader know that might have made their statements appear more persuasive.
But since we don’t have specific evidence of a conflict of interest among any of the quoted sources, we’ll rate this Satisfactory.
No alternatives were offered. Besides the injectable forms of naloxone, a Narcan nasal spray is also on the market.
The National Institute of Allergy and Infectious Disease provides a listing of diffferent forms of naloxone.
The release states that the product is FDA approved and quotes numerous public officials discussing its use in their communities, so one can infer that it is on the market. However, since the release suggests that everyone should have the product in their medicine cabinets, it’s really important to know whether and how members of the general public could purchase this product. It’s not made clear that naloxone is something that must be prescribed. So we’re rating this Not Satisfactory on that basis.
The release states that the device is the first naloxone product approved for use by individuals without medical training. Further, the device employs “intelligent” voice and visual guidance for use. To our knowledge it is the only product to do so.
The release avoids the use of unjustifiable terms like “breakthrough” and “game-changing” so we rate this criteria as satisfactory, despite its heavy reliance on anecdotes.