In this Wednesday, Sept. 21, 2016, file photo, Mylan CEO Heather Bresch holds up EpiPens while testifying on Capitol Hill in Washington, before the House Oversight Committee hearing on EpiPen price increases. On Friday, Oct. 7, 2016, Mylan agreed to pay $465 million to settle Justice Department allegations that it overbilled Medicaid for its life-saving EpiPen allergy injection.
The EpiPen is a device for administering epinephrine, which can be life-saving for someone going into anaphylactic shock from a severe allergic reaction. Recently, this device made headlines when its manufacturer, Mylan Pharmaceuticals, raised its price to $600 from $100.
Besides being overpriced, EpiPens are overprescribed and overused. An old and effective drug, epinephrine is vitally important for people with life-threatening allergies because it buys time before additional medical care is needed. However, most of the people carrying EpiPens have food allergies. In contrast to, say, penicillin allergy, food allergies are rarely life-threatening. Most allergic reactions to food involve rashes, or an itchy mouth, or nausea — symptoms best treated with an antihistamine, not epinephrine.
This information isn’t widely known because industry-funded patient advocacy groups encourage overreaction and overtreatment. For example, Food Allergy Research and Education (FARE), an industry-funded group, calls food allergy a “potentially deadly disease” that “affects 1 in every 13 children… roughly two in every classroom.” In fact, food is the least common cause of death by allergy.
Drugs, including antibiotics and cancer drugs, and drugs used to enhance contrast for CT scans, are the most common cause of fatal allergic reactions. Among allergic children and adults, severe anaphylaxis is unusual; the risk of dying from an allergy — two per million per year — is about 20 times lower than the risk of dying from an accident.
The treatment action plan on FARE’s website provides dangerous misinformation, advising an epinephrine injection for a combination of a runny nose and itching, or for “feeling something bad is about to happen, anxiety, confusion”.
Astoundingly, for highly allergic people, FARE’s treatment plan includes an option to administer epinephrine to someone who is having no symptoms and who is unsure whether or not they actually ate something they were allergic to. Antihistamines, on the other hand, are presented unenthusiastically, and only “if ordered by a healthcare provider.”
The Asthma and Allergy Network, another industry-funded group, also warn against antihistamines 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.”
It’s probably not a coincidence that both of these groups have received substantial financial support from Mylan, EpiPen’s manufacturer. Since 2011, Mylan has provided more than $10 million to fund various “educational efforts”. Money buys silence: FARE was markedly quiet about the EpiPen pricing debate until about a month ago, when it announced that the organization would stop taking money from epinephrine manufacturers until there is “meaningful competition” in the market.
That means exactly nothing. An EpiPen is just a century-old, generic, inexpensive drug in a patented syringe. Epinephrine is adrenaline, the hormone your body produces in a fight-or-flight response. Epipens are unnecessary — and FARE’s promises ring hollow — because much less expensive alternatives already exist.
Adrenaclick, another epinephrine autoinjector, is less expensive, but don’t buy that either. Why? Because a generic version is available for as little as $146 for a pair of autoinjectors — about half of what a yet-to-be-released generic EpiPen will cost.
The cheapest epinephrine self-injector is still ten times too expensive. Two vials of epinephrine, packaged with a syringe, costs less than a movie ticket. It’s easy enough 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.
Epinephrine is an effective, potentially lifesaving drug — but it can also kill you. Epinephrine increases blood pressure and can trigger heart arrhythmias, strokes, and heart attacks. One woman committed suicide with epinephrine injectors. Accidental injection into the bone has happened, especially in children, and accidental injection into hands can temporarily cut off circulation to a finger, causing numbness.
It’s too bad that industry funded, so-called consumer advocacy groups have abdicated their responsibilities to patients in order to help EpiPens corner the market on epinephrine and fear-mongering.
Adriane Fugh-Berman is the director of Pharmed Out, a Georgetown University Medical Center project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices.