Bioethics Forum Essay
EpiPens and the Sale of Fear
On September 21, Heather Bresch, CEO of Mylan, took heat at a Congressional hearing about high EpiPen prices. EpiPens are definitely overpriced – but they are also overprescribed.
An EpiPen is just adrenaline (also called epinephrine) – the “fight or flight” hormone – in a patented syringe. Epinephrine can be lifesaving in someone who has trouble breathing from anaphylaxis (a severe allergic reaction). Anaphylaxis, however, is rare. Most fatal allergic reactions are caused by drugs (including antibiotics and cancer drugs), followed by stings from wasps and other venomous insects. Most of the people carrying EpiPens are allergic to food, and food is the least common cause of death by allergy.
Most allergic reactions to food are mild, involving rashes, nausea, or an itchy mouth – symptoms that can be treated with diphenhydramine (Benadryl), an inexpensive, over-the-counter antihistamine. Epinephrine should be reserved for serious reactions.
It’s understandable that people don’t know this. A company like Mylan isn’t going to tell you, because it’s in the business of selling EpiPens. One might expect patient advocacy groups, which claim to represent the interests of patients with a particular condition – in this case, allergies – to cut through the myths that corporate marketing creates, and explain to the allergy-afflicted which remedies are most effective, safest, or least expensive. Curiously, though, allergy and asthma advocacy groups, like the drug company itself, encourage overreaction and overtreatment. Most patient advocacy groups that speak on behalf of people with allergies are funded by Mylan, which means they not only won’t critique the company’s outrageous price hikes for fear of losing funding, but they also won’t critique the over-use of EpiPens.
For example, the industry-funded Food Allergy Research and Education (FARE) calls food allergy a “potentially deadly disease” that “affects 1 in every 13 children . . . roughly two in every classroom.” Sure, many children have food allergies, but only a tiny minority of those with food allergies die from anaphylaxis – about two per million per year. That’s far less than anyone’s risk of dying from accidents, which is 42.7 per million.
The treatment action plan on FARE’s website provides misinformation that encourages over-use of epinephrine. A document that appears to be a patient handout, advises giving epinephrine for a combination of a runny nose and itching, or for “Feeling something bad is about to happen, anxiety, confusion.” Astoundingly, FARE’s treatment plan includes an option to administer epinephrine to a highly food-allergic person who is having no symptoms and who is unsure whether or not they ate something they were allergic to. At the same time, the treatment plan presents antihistamines like Benadryl unenthusiastically, and only “if ordered by a healthcare provider.” Encouraging people to inject an expensive, potent prescription drug if they so much as suspect that they ate a peanut is both irrational and unethical.
The Asthma and Allergy Network, another industry-funded group, also opposes Benadryl, instead urging use of an epinephrine auto-injector “as the first treatment for any sign of an allergic reaction. A dose of epinephrine for a relatively mild reaction does not harm a patient in any way.”
Really? Epinephrine can kill you. One woman committed suicide with epinephrine injectors. Epinephrine increases blood pressure and can trigger heart arrhythmias, strokes, and heart attacks. Accidental injection into the bone has happened, especially in children, and accidental injection into fingers can cut off local circulation, causing numbness.
Industry driven “consumer advocacy groups” have not only avoided demanding that Mylan reduce prices, but in some cases have defended Mylan. Tonya Winders, the chief executive of the Allergy and Asthma Network, wrote to key Congressional legislators to request that EpiPens be added to a federal list of preventive medical services, a move that would eliminate copay costs to consumers while passing the costs on to payers and employers. Winders organized a nonprofit coalition funded by Mylan to pressure lawmakers to make the change, which would take pressure off of Mylan to reduce costs. “Mylan can’t just cut the price to relieve patients of the high out-of-pocket cost “ Winders wrote in an article on Allergy and Asthma Network called “EpiPen Pricing – More Must be Done. “The article goes on to tell patients they should “work with manufacturers” and try to get politicians to “encourage insurers to add epinephrine to the preventive drug lists”
It’s no surprise that industry-funded “consumer advocacy” groups are uncritical of Mylan’s strategies for expanding their consumer base. Drug companies invest millions of dollars in health advocacy groups for a reason: a group that claims to speak by and for patients can be very effective in spreading industry messages that appear free from the taint of industry bias. This is why credible consumer advocacy groups (such as the National Women’s Health Network, the Center for Science in the Public Interest, the National Center for Health Research, and Public Citizen’s Health Research Group) don’t take industry funds; they recognize they can only defend patient safety if they are free to critically analyze misleading corporate claims.
Epinephrine is vitally important for people with a life-threatening allergy because it buys time before additional medical care is needed. But it shouldn’t be used for anything short of a severe anaphylactic reaction. People who have a mild allergic reaction to food would be better off taking Benadryl, not epinephrine. And even those who do have severe allergies don’t need to buy overpriced EpiPens. A generic version of Adrenaclick, another epinephrine autoinjector, is available for less than $146 a pair, about half what a promised — but not yet released — generic EpiPen will cost.
Even the cheapest epinephrine self-injector is still 10 times too expensive. Two vials of epinephrine, packaged with a syringe, costs less than a movie ticket. It’s easy to teach someone to draw up a drug with a syringe; children with diabetes do it all the time. Or a prefilled syringe lasts three months – no refrigeration needed. Autoinjectors aren’t rocket science. There are even directions available on the internet for making a homemade autoinjector for under $30.
Epinephrine is useful, but Mylan has done what drug manufacturers often do – established a legitimate market for an effective product, and then played on the fears of anxious patients (and parents) to expand that market far beyond the bounds of responsible medicine. What EpiPens deliver most efficiently are paranoia and profits.
Adriane Fugh-Berman, MD, is associate professor of pharmacology and physiology at Georgetown University Medical Center and director of Pharmed Out, a Georgetown project that advances evidence-based prescribing and educates health care professionals about pharmaceutical marketing practices. Sharon Batt, PhD, a social science researcher in pharmaceutical policy, is an adjunct professor in bioethics and a team member with the Technoscience and Regulation Research Unit at Dalhousie University in Canada. Her book on patient group activism will be published in early 2017.