EpiPen Nation

What it means to live with a fatal food allergy

Photograph by AmyKerk

In 2013, I was visiting friends in Boston. We had gone to a late-night happy hour. I ordered “Bone Marrow—$5” off the menu. The dish (an appetizer I have ordered a dozen times) normally consists of halved, roasted beef bones, the cooked marrow inside, and maybe toast. However, after one bite, I knew I had eaten a tree nut. My allergic reaction to tree nuts is anaphylaxis—in other words, life-threatening.

When I asked the waiter if there were nuts in the marrow, he responded with an exhausted “Duh, it comes covered in a hazelnut remoulade.” I told him I was allergic and he said, “Well, you didn’t ask if there were nuts.” That kind of attitude is far more pervasive than it should be. Those of us with allergies are put into the same hysterical corner as people who refuse to eat gluten simply because they believe it’s healthier. We’re the fodder for South Park episodes and Louis CK bits (“If touching a nut kills you, you’re supposed to die.”). Yes, I should have asked. Yes, I almost always do. But the menu should have also reflected all the ingredients, especially known allergens.

I had two EpiPens with me. Both were expired by several months because I couldn’t afford a new prescription. By the time we returned to my friends’ apartment, I was breaking into hives and having trouble breathing. So I gave myself a shot. Epinephrine’s effect on the body is like pressing the reset button on a gaming system that’s gone haywire—it basically tells the immune system to cool out. What it actually does is constrict your blood vessels to decrease swelling, increase your heart rate to prevent cardiovascular collapse, and relax the muscles in your lungs to keep airways open—all symptoms of anaphylactic shock. My symptoms didn’t subside after I used the Epipen, they didn’t worsen either. I figured it couldn’t hurt to use the second expired EpiPen; it might do the trick by doubling up on the previous shot’s dose. So I hit the reset button again. We waited. I felt a little better. By two in the morning, I fell asleep on the couch while watching, of all movies, Se7en.

Not an hour later, I woke up my friends because of how loudly I was coughing. I went into the bathroom and found my whole body covered in hives, my face flushed bright red, my breaths in choked wheezes. My friends rushed me to the ER. After I relayed to several on-duty techs that I’d already used two expired EpiPens, I immediately felt judged. Their eyes said, “Why do you only have expired EpiPens?” My best response would have been: “Because new ones cost almost as much as my rent.”

The more pressing question to me, however: if I couldn’t pay for an EpiPen, how would I now pay for a visit to the emergency room?

Right now, Mylan N.V., the company that owns the EpiPen, charges $609 (all figures USD) for a two-pack of EpiPens. Back in 2009, Mylan began to raise the price of a two-pack: in 2009, the wholesale price of two EpiPens was about $100; in July 2013, $265; in May 2015, $461; and in May 2016, the price rose to $609. That means there was a 500 percent jump from the 2009 price tag.

Canadians don’t have to worry. For the roughly 2,600,000 million Canadian adults and children whose food allergies put them at risk of a health emergency, the cost of a single EpiPen remains about $100. It will likely stay that way thanks to provincial constraints that severely limit pricing spikes. (Pfizer distributes the EpiPen in Canada under a licensing agreement with Mylan.)

But for Americans, the situation is absurd. Thanks to Mylan’s most recent price increase, those of us with life-threatening allergies and no commercial insurance feel disenfranchised, if not completely left out in the cold. These circumstances beg the question: what happens when I have a reaction, but no EpiPen? Yes, the obvious answer is head straight for the ER. But what if that option isn’t available? This is not a situation anyone with fatal allergies should ever have to entertain. (Unsurprisingly, dozens of Canadian mail-order phramacies report seeing a boost in EpiPens sold to US customers.)

It’s important to understand how and why the EpiPen situation has gotten so out of hand. The first modern epinephrine autoinjector was approved by the FDA in 1987. Over the next twenty years, the approved EpiPen changed several hands. In 1997, Dey, a subsidiary of Merck KGaA, acquired exclusive rights to market and distribute EpiPens. In 2001, Dey (in conjunction with Meridian Medical Technologies Inc) introduced a two-pack version of the EpiPen. In 2002, King Pharmaceuticals acquired Meridian, and King was later acquired by Pfizer. Then in 2007, Mylan acquired the right to market and distribute EpiPens from Merck KGaA. The paper trail is confusing, but the important thing to keep in mind is that EpiPens remain the only autoinjector consistently on the market.

In 2009, Israel-owned Teva Pharmaceuticals (the world’s largest generic drug maker) planned to market a generic EpiPen; yet, Pfizer and King sued them for infringing their US Patent, which is due to expire in 2025. Pfizer, Mylan, and Teva settled in April 2012 in a deal that allowed Teva to start selling the generic device in mid-2015, pending FDA approval. However, in March 2016, Teva’s application for a generic EpiPen was rejected. Meanwhile, Mylan began its price hikes.

If that weren’t already enough to draw the ire of consumers, then came the news that from 2007 to 2015, Mylan CEO Heather Bresch’s total compensation went from $2,453,456 to $18,931,068. That’s a 671 percent increase over eight years. Moreover, in 2008, Mylan reported spending $1.2 million dollars on lobbying (up from $270,000): according to NBC, “Legislation that enhanced [Mylan’s] bottom line followed, with the FDA changing its recommendations in 2010 that two EpiPens be sold in a package instead of one and that they be prescribed for at-risk patients, not just those with confirmed allergies.” To fund that salary-increase and lobbying, according to The Nation, “Mylan now collects more than $1 billion a year from EpiPen sales—a windfall made possible by US patent law and American taxpayers.” And most galling of all, it’s “shielded from US taxes because the Pennsylvania-based company reincorporated itself in the Netherlands in 2014.”

To wit, there’s a great deal of money wrapped up in Mylan’s monopoly of the EpiPen. And Mylan is fully aware of the fortune it will reap in the US because allergies are not a medical problem that will simply go away with time and research. Consumers who can afford EpiPens will continue to fork out the cash because their only other obvious option is to not buy one.

Is there a legitimate reason for this price hike? After all, medicine can be expensive to buy because it is expensive to manufacture (studies, patents, production, lobbying). But here is the staggering truth about the EpiPen: the device delivers $1 worth of epinephrine, it costs about $30 to make, and it usually expires after one year. So what accounts for Mylan’s ability to monopolize the EpiPen—up to 94 percent of the market? It’s not that Mylan has patented the actual use of epinephrine; rather, they have patented the injection device itself.

The side of every Mylan EpiPen reads “EpiPen Auto-Injector utilizes Truject technology. US Patent 7,449,012.” This “Truject” technology is Mylan’s cash cow. And because an EpiPen consists of twenty-six interworking parts, all of which must function together to deliver in seconds a dose of 0.3 miligrams of epinephrine with a sterile needle, there’s little room for error in inventing a new autoinjector.

So for such a cheaply produced mechanism, why is a generic version still unavailable? One recent reason is that Mylan filed a citizens’ petition in 2015 in order to persuade the FDA to not approve a rival to the EpiPen, and such petitions can “play a crucial role in delaying” generic drugs from becoming available. Meanwhile, doctors wrote 3.6 million prescriptions for EpiPens in 2015 alone, which is a 7 percent increase from the previous year. There is some good news: several weeks ago, the FDA has expressed interest in speeding another review of Teva’s application for a generic version of the EpiPen, with a possible approval by late 2017. The generic version would hit the market sometime in 2018. But even with this potential success, by that point in time, every single EpiPen currently in an allergy sufferer’s possession will have long expired.

I sometimes forget that other people don’t have allergies. That other people don’t look at a restaurant meal and wonder if it will send them into anaphylactic shock. That I might be the only one in the room with an EpiPen while my tablemates don’t realize that if a sliver of their pecan-encrusted salmon touches my non-encrusted salmon, my throat can close up in minutes.

During the summer of 2015, I sailed for three weeks on a ship in the Norwegian Arctic Circle. I had four unexpired EpiPens (thanks to employer-provided insurance at the time) stashed all over the ship. On the last day of the trip, I profusely thanked the chef, a quiet German named Sasha, for “keeping me alive.” From the way he wiped his brow and then looked to the heavens, it became clear Sasha had been just as nervous as me about my allergy. Even with EpiPens on board, if I had eaten a tree nut, I likely would have required an airlift out. Because I was at sea, with the closest hospital facilities several days’ away by boat, a rescue helicopter (the kind usually reserved for avalanche searches and victims of polar bear attacks) would have had to fly me back to Longyearbyen’s emergency department. I don’t even want to think about how long I would have had to wait for medical attention if no EpiPen had been available on the ship.

It’s necessary to remember that epinephrine shots save people’s lives. A Centers for Disease Control and Prevention 2013 study found that food allergies among children increased approximately 50 percent between 1997 and 2011. This means that, according to Food Allergy Research & Education, as many as 15 million adults and children in the US have food allergies; furthermore, every three minutes, a food allergy reaction sends someone to the emergency room, and every six minutes, the reaction is one of anaphylactic shock. That means people visit the emergency room about 200,000 times each year because of food allergies. FARE also reports that “Eight foods account for 90 percent of all reactions: milk, eggs, peanuts, tree nuts, soy, wheat, fish and shellfish.”

These collective numbers do not present a future in which a $609 EpiPen two-pack is a reasonably-priced product, especially given the fact that there are currently no generic alternatives except for Adrenaclick, which uses a different delivery system that could confuse consumers, or DIY methods of buying syringes and vials of epinephrine. And out of those 200,000 visits to the ER for food allergies, The Journal of Allergy & Clinical Immunology article found that roughly 200 of them die. 200. All due to allergies. Between the rampant increase in food allergies and the fact that EpiPens now cost so much, this number is more than likely to increase.

I have nearly been one of those 200 people. More times than I would like to admit to my own parents. But here I go: to date, I’ve had to use an EpiPen at least twelve times. There was the pastry in Prague, there was the chocolate in Carbondale. And who knows how many close calls I’ve had. The pistachios in Austin, the pesto in Galway, the pecan salad in Lakewood. Imagine: twelve separate circumstances (given a financial situation that prevented me from purchasing an EpiPen) in which I could have died after ingesting even a trace amount of a tree nut.

When I was a child—before my parents ever considered allergies as a possible culprit for my behavioral problems and near-constant illnesses—I remember eating Sunday School snacks. I can still picture them: those yellow-flecked butter pecan cookies. More Sundays than not, I would eat the cookies. Consequently, my lips would swell up. My eyes would itch. And then, on the drive home, I’d throw up in the back of the minivan.

It took a particularly bad reaction—I was seven years old when I ate a cappuccino ice cream truffle made with hazelnut butter—for my parents to realize there was more to the problem. So I went to an allergist. There, I learned that my allergies went beyond pecans and hazelnuts—far beyond tree nuts even—to nearly every possible food (as well as a slew of environmental allergies). I remember telling people that the only things I wasn’t allergic to were shrimp, chocolate, and strawberries. After my first visit to the allergist, he told me that I was “the most food-sensitive person he’d ever met.” To hear that as a kid? He might as well have said, “You are not long for this world.” Which was exactly how I felt then. And it’s exactly how I feel to this very day.

Amidst all the backlash for its price hike, Mylan has promised to produce (within a few weeks) a new, identical, generic version of the EpiPen. It will cost $300 per two-pack. As TIME reports, “Patients with commercial insurance will need to apply for a $300 savings card to access the generic EpiPen. The ‘My EpiPen Savings Card®,’ as its [sic] called on the company’s website, will then ‘act as cash’ at the pharmacy, bringing down the cost of a patient’s co-pay for a two-pack of EpiPens to no more than $300.”

However, only commercially insured patients paying full price will receive this discount; Medicaid insurance does not qualify for the discount. That means that the discount is not available to the people who most need it. For those of us without insurance (or without consistent employer insurance), these “solutions” are little more than lip service and promotion schemes. Mylan’s operating principles and methods should be held in congressional check while a cheaper, generic, non-Mylan EpiPen is created for the non-commercially-insured public of anaphylaxis allergy sufferers like myself.

Price hikes, salary increases, reincorporation overseas, petitions against competitors’ generics, marketing ploys to acquire even more consumers—Mylan is the embodiment of that particularly nasty deadly sin: Greed. And if I may quote from the film I fell asleep to while nearly dying of anaphylaxis in that Boston apartment three years ago, in Se7en, Kevin Spacey’s character John Doe says, “Wanting people to listen, you can’t just tap them on the shoulder anymore. You have to hit them with a sledgehammer, and then you’ll notice you’ve got their strict attention.”

We’ve now been hit with that hammer.

Alexander Lumans
Alexander Lumans has published in the Los Angeles Review of Books and American Short Fiction.