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.

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  1. A few years ago, I was trying to figure out if I had some allergies to certain foods, such as dairy, etc. I was part of the growing number of people questioning their food choices. I should say that I had never had any dramatic reaction to food, perhaps being stuffed up but that was about it. While exploring the issue of food intolerance, I contacted food allergists who recommended various techniques but at one point one of them prescribed an EpiPen for me. Needless to say that I never got one and I felt and still feel that in my case prescribing an EpiPen was not a good idea. I had not had any serious issues with food. I do not deny that some people may need an EpiPen but in my case it was misplaced.

    1. Do either of you authors have any experience as the parent of a child with food allergies? I don’t like Mylan’s shady practices at all but an auto injector is a necessity for those who have tested positive for the food proteins that cause anaphylaxis. I have experience with insulin as you suggested and there’s no way I would be able to fill a syringe with the proper amount of a drug while my child is vomiting, crying, gasping, turning blue, going into cardiac arrest and dying in front of me. Epinephrine auto injectors were developed for the military to allow for portable and rapid injection.

      It doesn’t matter if only 20 people or 200 people die from allergic reactions each year. Epinephrine needs to be carried by every one of the people who have the potential to die. There is no way to know whether a reaction will result in just hives or if it will immediately progress to unseen internal symptoms as the body begins to shut down without any external warning. Are you psychic doctors? Do you have magical x-ray vision?

      It is irresponsible for a physician to dissuade people from carrying a drug that is the ONLY chance they have to stop anaphylaxis. Like any drug, if it is misused, it can be deadly. Giving yourself an overdose of epinephrine to commit suicide is no different than downing a bottle of aspirin or any other drug. Insulin kills if used improperly. Chemotherapy drugs can kill if administered improperly. Should we stop using those drugs? Over-prescription of pain meds has caused an epidemic of addiction. What has epinephrine prescription caused?

      Yes, big pharma is gouging people right and left but THEY are the problem –Not the drug itself or those who carry it or the doctors who prescribe it. Epipens cost less than $100 in Canada and other countries. A reduction in the cost is what is needed.

      Be responsible! Do your research! Uphold the Hippocratic Oath! Learn from the stories of those who have died.
      Start with Natalie Georgi from 2013 or the most recent death from last week – Oakley Debbs.

      1. Thank you for your response. We do not fault parents for doing what they believe is best for their children, but the public needs balanced information. Our blog argued that organizations like the Food Allergy Research and Education (FARE) that have received financial support from Mylan are a questionable resource for patients and parents of children with allergies.
        We agree completely that epinephrine can save lives, that autoinjectors are useful, and that anyone with a severe allergy that predisposes them to anaphylaxis should have easy access to epinephrine. However, epinephrine should be available to everyone with severe allergies, not just those who can afford EpiPens. It is not acceptable for Mylan to package two dollars worth of medication into an inexpensive device, and then price the product at $600.
        Many drugs, including epinephrine, pose risks even if used properly. We advocate rational drug use, which minimizes harms from the drugs themselves as well as from the conditions they treat. Many chemotherapy drugs can and do kill patients when used as indicated. Should we still use them? Yes. Should we use them more judiciously than we do? Yes. (Read surgeon Atul Gawande’s heartwrenching essay, Letting Go, on the suffering cancer patients can undergo when well-meaning physicians prescribe chemotherapy drugs despite miniscule odds of benefit.
        We criticized FARE’s emergency plan, which states that “for mild symptoms from more than one system area, give epinephrine,” and contains a checkbox option for administering epinephrine when someone has no symptoms. We argued against frightening people with mild food allergies to use this powerful drug, even in the absence of symptoms and we are not alone in doing so. In a recent article published in the Journal of Allergy and Clinical Immunology: In Practice, Dr. Paul Turner of the Imperial College of London and his colleagues argue that early use of epinephrine may increase adverse effects. They conclude that “…a care plan that recommends the use of epinephrine autoinjectors, in the absence of any symptoms of an allergic reaction, is ill-advised and not based on any supporting evidence.”
        Patients and the public look to advocacy groups that act in their name to provide accurate, balanced information on drug use and to challenge overpricing. Our blog argues that groups like FARE and AAN, which have accepted grants from Mylan, tend to provide industry-friendly advice and are unlikely to publicly criticize donor companies, even when doing so is in the interest of patients.

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  3. I am an allergist who treats a lot of food allergy. I do not prescribe epinephrine injectors to all of these patients. I agree that many Epipens are prescribed unnecessarily, but they are also under prescribed. Many patients who are at risk of life threatening reactions do not have access to Epi. It is not whether they are over or under prescribed, but whether they are prescribed appropriately. For the patients who do need them, personalized discussions on when to use them is an essential part of the process.

  4. This article is so ridiculous that I had to check to see if it was from The Onion. As a mother of a child with multiple life-threatening food allergies, I have used an Epi-pen5 times and each time there was no doubt my child was dying before my eyes. The 6th time? It was administered by an RN at a church camp where she told me she got the sickest feeling that my child was dying before her eyes. I have also helped another family administer an Epi-pen the first time their child had a life-threatening reaction where he turned blue and collapsed. I fully realize how cheap epinephrine is and how overpriced Epi-pens are. But the idea that you can just carry around a syringe and a vial of epinephrine shows how ignorant you are on the severity of food allergies. My daughter is 17 and her throat almost immediately closes off when she encounters even a trace of a food she is allergic to. That means she is losing oxygen and starting to panic as she realizes she could die, but she should calmly measure out the right dosage of medication in a syringe. Doctors made mistakes in administering epinephrine all the time and they are supposed professionals. I am not willing to risk her life to save a few bucks. This kind of opinion you are spreading is dangerous and could cause the death of children. The most common reason children die from anaphylaxis? Because Benadryl is given and administration of epinephrine is delayed. The Adrenaclick is still expensive, has no trainer pen, and only comes with one pen per pack. Epineprhine is safe and your message that is is not is dangerous and spreads false information.

    1. Clearly your daughter needs epinephrine. We did not suggest individuals with severe allergies use diphenhydramine (Benadryl®) in response to anaphylaxis. Benadryl is not indicated for anaphylaxis- and epinephrine is not indicated for a mild allergic reaction. That’s not just our opinion; it’s backed by the NIAID Guidelines for the Diagnosis and Management of Food Allergy in the United States. Please read our response to Ellen Izenson for an expansion of our views on epinephrine overuse.

      We take issue with your statement that epinephrine is safe. According to the product label epinephrine can cause, among other things, fatal arrhythmias, hypertension, stroke, and respiratory difficulties.

      We did not mean to imply that a syringe is preferable to an autoinjector or that a parent should risk a child’s life “to save a few bucks.” Six hundred dollars is not a few bucks for many parents. Pre-filled syringes are an option for people with severe allergies who cannot afford, or prefer not to buy, overpriced EpiPens.

      The United States has the highest drug prices in the world. One reason for this is that all high-income countries except the United States have a system of price controls on essential medications. If people with allergies and the advocacy groups that claim to represent their interest stood together in support of affordable drugs, this might change. Unfortunately, we think it unlikely that organizations with funding from a pharmaceutical company will advocate for legislation to keep prices down when the industry strongly opposes price controls.

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