The story of the EpiPen: from military technology to drug-industry cash cow
The nerve-gas backstory of the autoinjector
This week, the pharmaceutical company Mylan has been in the news following a price hike on the EpiPen, a medical device that administers a crucial allergy drug in case of emergency.
The drug itself, epinephrine, costs about a dollar. So it’s the autoinjector device on which the controversy is hinged. Mylan acquired a version of this technology, as well as the EpiPen brand, from Merck in 2007. Now that many of its potential competitors are either out of commission or are barred from entering the market by the FDA, Mylan has been granted a quasi-monopoly on the device. And how else to celebrate than by raising prices? About ten years ago, a pack of two EpiPens was priced around $100. After the latest price hike: $609.
That Mylan has restricted domain over the EpiPen is ironic since it owes its existence to public initiative. In 1973, as fears of chemical warfare mounted, the Pentagon asked scientists at Survival Technology, Inc. to develop a first-line of defense for soldiers exposed to nerve gas. Their concerns centered on the so-called G-series of nerve agents — including tabun, sarin, and soman gas — developed for the Nazis by the German chemical company IG Farben in the 1930s and 40s. Similar to EpiPens today, the Nerve Agent Antidote Kit was intended for use with little training, to keep the patient healthy in the critical moments prior the arrival of proper medical help.
The Iranian military widely carried atropine autoinjectors during the Iran-Iraq War, some of which were supplied by the Soviets, helping us estimate the scope of one of the deadliest episodes of chemical weapon-use in human history. In 2002, Iraq startled the U.S. intelligence community when it made a bulk purchase of atropine and autoinjectors, a move taken by some as an indicator for the country’s plan for a chemical offensive.
Today, a company named Meridian Medical Technologies controls the trademark for the AtroPen, an atropine autoinjector for immediate defense against nerve agents, but access to the device remains restricted. In the State of New York, for instance, only emergency medical services are permitted to purchase the product.
While the atropine autoinjector became the focus of international intrigue and speculation, its more benign sibling was being developed in tandem.
One of the leading engineers on the autoinjector project was Sheldon Kaplan, who is remembered in his 2009 obituary for having “invented the EpiPen.” His name appears alongside four other inventors on the 1977 patent for the hypodermic autoinjector. His team’s innovation included a non-reactive glass cartridge (previous models were stainless steel) to preserve the contents. Kaplan anticipated the device’s potential to hold epinephrine, which could be used quickly for the treatment of anaphylaxis — a possibly fatal stress response that can follow a severe allergic reaction.
Mylan estimates the market saturation of EpiPen comprises over 2 million people. But the company believes there are even more who are at risk of anaphylactic shock who they haven’t yet reached. Anaphylactic shock can manifest in a variety of symptoms, from vomiting to severe swelling, but by far the most dangerous is difficulty breathing, in which case emergency epinephrine is essential. The response itself can be triggered by many allergens, including food, medicine, bee stings, and in lesser cases, foreign substances like latex. Today, 200,000 people suffer anaphylaxis every year. About 200 of them die.
Kaplan continued to improve his design over the years, reconfiguring the autoinjector’s dosage, deployment sensitivity, and function. Patent 6767336, named Automatic Injector, was issued to Kaplan in 2004.
It’s hard to say if he anticipated just how much his life-saving device would be marshaled for profit. With over $1 billion in sales, the EpiPen makes up about 40% of Mylan’s profits. Though the corporation does have some patent-protection, their intellectual property does not extend far enough to give Mylan total proprietary control over the epinephrine autoinjector. For instance, Teva, a pharmaceutical company, was granted the legal ability to market a generic EpiPen, but their product was rejected by the FDA for deficiencies this year. But despite the availability of alternatives like Adrenaclick for consumers, the EpiPen reigns on.
Why? Mylan’s success is mostly due to expert marketing. The company recently acquired permission to advertise to wide audiences, and have made major gains for brand awareness, including celebrity endorsements and a 2013 federal bill encouraging schools to keep EpiPens on hand. For many patients and families who have to stay wary of allergic reactions, the EpiPen is the first thing that comes to many a physician’s mind.
So much so that EpiPens constitute about 85% of annual epinephrine prescriptions, and it will take more than public backlash to curtail its control of the market. We may not be talking about military-grade, chemical- weapon defense, but when it comes to the business of the autoinjector, business is good.
