The strange history of the EpiPen, the device developed by the military that turned into a billion-dollar business
Jul 26, 2021, 12:47 IST
Epinephrine, another name for the hormone adrenaline, is something our bodies produce naturally. It increases blood flow to the muscles during "fight or flight responses."
Japanese chemist Jokichi Takamine is credited as one of the first people to discover and isolate adrenaline as its own chemical. Not long after its discovery, scientists figured out how to produce it in large enough quantities to see how it could be used in different medical settings.
Doctors continued to investigate how adrenaline works during the early part of the 20th century. In the past 100 years, it's been extensively studied, with more than 12,000 studies referencing it.
The study of epinephrine jump-started other areas of emergency medication for heart and lung problems. The hormone is now used in hospitals around the world, and is included on the WHO's list of essential medicine. It only costs a few dollars for a vial.
In the 1970s, Sheldon Kaplan, a biomechanical engineer, unknowingly invented the ultimate way to self-inject epinephrine. At first, his device, called the ComboPen, was used by the military to protect soldiers in the event of chemical warfare. The military needed a device that wouldn't react with the drug inside, and that could be easy to use in emergency situations.
Shortly after, Kaplan and others noticed that this same device could be used to deliver emergency epinephrine to treat allergic reactions. The drug and device combo we now know as an EpiPen was first approved by the FDA in 1987. By then, it was owned by a company called Meridian Medical Technologies.
Meridian Medical is now a subsidiary of Pfizer, where it still makes a host of other auto-injector devices — including an anti-nerve-gas pen still in use by the military.
The EpiPen passed hands a few times on the commercial side of things before ending up with Merck KGaA, a German company who sold their generics business to Mylan Pharmaceuticals in 2007. (Meridian is still the contract manufacturer of the EpiPen, though it is sold and marketed by Mylan.)
When Mylan acquired the EpiPen, the drug was making about $200 million a year. Now, it makes more than $1.1 billion a year. Mylan has about 90% of the market share for epinephrine devices.
Other devices do exist, but none has been able to grab much of the market from the EpiPen. Among them was a device called Twinject that was first approved in 2003 and then was later updated to become Adrenaclick. Another device, the Auvi-Q, was first approved in 2012.
Auvi-Q has been recalled since last October, and the company that was marketing the product has since returned the rights. The device doesn't seem to have a timeline specifying when it will be back in the US, if ever.
In an interview with Fortune magazine in 2015, Mylan CEO Heather Bresch called the EpiPen her "baby." As the price began to rise, so did Mylan's education efforts and marketing strategies.
Among those steps to making the EpiPen a billion-dollar drug, President Barack Obama signed legislation in 2013 that helped public schools build up emergency supplies of EpiPens.
There was very, very little awareness," Bresch said Thursday in an interview with CNBC. "We took on — we have doubled the lives of patients that are carrying an EpiPen. We have passed legislation in 48 states to allow undesignated EpiPens to be in schools.
Mylan has also pushed out marketing to promote awareness for anaphylaxis, a severe allergic reaction that can make people go into shock, struggle to breathe, or get a skin rash. Most recently, they've run a "Face Your Risk" campaign, including an ultra-realistic commercial about someone having an extreme allergic reaction to peanut butter brownies.
In August, members of Congress, along with Democratic presidential nominee Hillary Clinton called out Mylan for the EpiPen's high price.
In response, Mylan announced a change in the company's copay coupon system, more than doubling the available discount for a two-pack to $300. But that did little to quell the tempers of those in Congress, who still wanted to see a cut to the company's list price.
Mylan isn't out of the woods yet, and neither is the pharmaceutical industry overall. Still, newer versions of emergency epinephrine, including a pre-filled syringe that hopes to be a low-cost alternative, could be approved as soon as 2017. In the meantime, the issue of pharmaceutical prices, which routinely go up across the board, will continue to come under scrutiny.