Taken from the May/June 2017 issue of the Women’s Health Activist Newsletter.
The EpiPen is an automatic injection device (an “autoinjector”) for administering epinephrine, which can be life-saving for someone who is going into anaphylactic shock as a result of a severe allergic reaction. EpiPens have been available since 1980, but after Mylan Pharmaceuticals acquired the EpiPen from Merck, in 2007, it increased the price of two EpiPens from $113.27 to $730.33.1; A competing device, Adrenaclick, was recently discontinued, but a generic version remains available. It’s still expensive, though, at $494.01 for two devices. Another version, Auvi-Q, was withdrawn from the market but will be reintroduced later this year. And, the Food and Drug Administration (FDA) is currently considering a new commercial version of an Epinephrine Prefilled Syringe.
EpiPens and other autoinjectors are popular because, while people can be trained to draw epinephrine into a syringe, it’s hard to do that accurately during an emergency. But, autoinjectors and the commercial version of a prefilled syringe aren’t absolutely necessary. Any health care provider should be able to prefill a syringe with epinephrine and give it to a patient for future use. Another advantage of a prefilled syringe is that the dose can be lowered for a child or increased for someone with obesity. Prefilled syringes last three months under normal conditions, even in a tropical environment (people who live in climates with high heat and low humidity, like the desert, should replace their prefilled syringe every two months).1
Let’s be clear; each of these devices has about two dollars worth of epinephrine in them. And, all of these currently available commercial epinephrine injectors are highly overpriced.
They are also overused. Epinephrine is an old and effective drug that is vitally important for people with life-threatening allergies, because it buys time before additional medical care is needed. Most people carrying EpiPens have food allergies, however, which are usually not life-threatening.2,3 ; Some people do have life-threatening reactions to nuts, seafood, or another food; most of the time, though, food allergies cause a rash, an itchy mouth, or nausea. These symptoms are best treated with over-the-counter diphenhydramine (Benadryl), not with epinephrine. A recent British study found that half of epinephrine autoinjector prescriptions were inappropriately given to children without a previous relevant allergy or anaphylaxis diagnosis.4
Industry-funded patient advocacy groups may contribute to excessive prescribing of epinephrine by overstating food allergy risks. For example, 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.”5 That makes it sound like two kids per class are at risk of dying from food allergies, but food is the least common cause of death by allergy. Antibiotics, cancer drugs, and drugs used to enhance contrast for CT scans are the most common cause of fatal allergic reactions.6 Among food-allergic people, the risk of dying from fatal food anaphylaxis — 2 deaths per 1 million allergic people per year,7,8 is about 20 times lower than the risk of dying from an accident.9
The treatment action plan on FARE’s website exaggerates the importance of mild allergic symptoms, advising an epinephrine injection for a combination of a runny nose and itching, or for “feeling something bad is about to happen, anxiety, confusion.”10 For highly allergic people, FARE’s treatment plan actually includes an option to administer epinephrine to someone who is having no symptoms and who is not sure they actually ate something to which they are allergic.10,11 ;Use of antihistamines to treat an allergic reaction, is presented unenthusiastically, and is only recommended “if ordered by a healthcare provider.”12
The Asthma and Allergy Network (AAN) also warn against using antihistamines, instead recommending the 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.”13 That’s not true. Epinephrine increases blood pressure and can trigger heart arrhythmias, strokes, and heart attacks. Accidental injection into bone has been reported as well.
It’s probably not a coincidence that both FARE and AAN have received substantial financial support from EpiPen’s manufacturer. Since 2011, Mylan has provided more than $10 million to fund various “educational efforts” including donations to these two groups.
In January, the National Institute of Allergy and Infectious Diseases (NAIAD) released guidelines encouraging parents to incorporate peanut products into their children’s’ diets at about 6 months of age. A government-funded trial found that children who were at high risk of allergies (because they already had egg allergies or severe eczema) who consumed 6 grams of peanut protein a week, starting at 4-11 months of age, had an 81 percent reduction in peanut allergy, compared to high-risk children who avoided all peanut products.14
Even those who are already allergic can benefit from oral immunotherapy (OIT); this is a process in which tiny, gradually increased doses of peanuts or another allergenic food are administered to an allergic person in a medically monitored environment. The OIT technique is akin to the process by which allergy shots are used to desensitize patients with other allergies, such as bee venom. Although studies have shown this technique can desensitize people to the extent that their allergy stops being life-threatening, few patients—or doctors—know about it.
In other words, OIT is an effective treatment for allergies, and not one that makes any company money. So why aren’t food allergy groups touting that? Well, follow the money. FARE and AAN accept money from pharmaceutical companies. OIT isn’t mentioned by AAN at all and is barely mentioned (with caution) at FARE.
In contrast, OIT 101, an organization founded by Liseetsa Mann, an activist mother of two highly allergic children, does not. The organization’s website provides information about multiple research studies, a list of physicians who do OIT, and much more (visit http://www.oit101.org).
Naturally, a commercial pharmaceutical version of peanuts (peanut flour in a capsule or patch) is being developed, although there is no evidence that there’s any advantage over, well, peanuts.15
Consumer advocacy groups that provide misinformation about drugs and that tell their constituents only about commercial therapies do consumers a disservice. Aren’t you glad you’re a member of the NWHN, which takes no money from pharma and thus has a truly independent voice?
Charlea T. Massion, MD, is a practicing physician in Santa Cruz County specializing in hospice and palliative care. Charlea brought her passion for improving women’s health along with 40+ years of health care experience to the NWHN as a member of the board for 8 years. She also co-founded the American College of Women’s Health Physicians.
Adriane Fugh-Berman, MD, is a former NWHN Board Chair whose research presents a critical analysis of the marketing of prescription drugs. Adriane educates prescribers on pharmaceutical marketing practices as Director of the PharmedOUT program, and created the Health in the Public Interest program at Georgetown University School of Medicine where she trains a new generation of consumer advocates.
The continued availability of external resources is outside of the NWHN’s control. If the link you are looking for is broken, contact us at email@example.com to request more current citation information.
1.Pepper AN, Westermann-Clark E, Lockey RF, “The High Cost of Epinephrine Autoinjectors and Possible Alternatives,” J Allergy Clin Immunol Pract 2017; in press.
2. Ma L, Danoff TM, Borish L, “Case fatality and population mortality associated with anaphylaxis in the United States,” J Allergy Clin Immunol. 2014;133(4):1075-83. doi: 10.1016/j.jaci.2013.10.029.
3. Umasunthar T, Leonardi-Bee J, Hodes M, et al., “Incidence of fatal food anaphylaxis in people with food allergy: a systematic review and meta-analysis,” Clin Exp Allergy 2013; 43(12):1333-41. doi: 10.1111/cea.12211.
4.Diwakar L, Cummins C, Ryan R, et al., “Prescription rates of adrenaline auto-injectors for children in UK general practice: a retrospective cohort study,” Br J Gen Pract 2017; bjgp17X689917. DOI: https://doi.org/10.3399/bjgp17X689917.
5. Food Allergy Research and Education (FARE), Food Allergy Facts and Statistics for the U.S., McLean (VA): FARE, no date. Available online at: http://www.foodallergy.org/facts-and-stats
6. Jerschow E, Lin RY, Scaperotti MM, et al., “Fatal anaphylaxis in the United States, 1999-2010: temporal patterns and demographic associations,” J Allergy Clin Immunol. 2014; 134(6):1318-1328.e7. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4260987.
7. Umasunthar T1, Leonardi-Bee J, Hodes M, et al., “Incidence of fatal food anaphylaxis in people with food allergy: a systematic review and meta-analysis,” Clin Exp Allergy 2013; 43(12):1333-41. doi: 10.1111/cea.12211.
8. Ma L, Danoff TM and Borish L, “Case Fatality and Population Mortality Associated with Anaphylaxis in the United States,” J Allergy Clin Immunol. 2014; 133(4): 1075–1083. doi: 10.1016/j.jaci.2013.10.029.
9. Kochanek KD, Murphy SL, Xu J, “Accidents or Unintentional Injuries 2014,” National Vital Statistics Reports 2016; 65(4):1-122. Source: Deaths: Final Data for 2014, tables 9, 18. Available online at: http://www.cdc.gov/nchs/fastats/accidental-injury.htm.
11. Turner PJ, DunnGalvin A, Hourihane JO, “The Emperor Has No Symptoms: The Risks of a Blanket Approach to Using Epinephrine Autoinjectors for All Allergic Reactions.” J Allergy Clin Immunol Pract. 2016; 4(6):1143-1146. doi: 10.1016/j.jaip.2016.05.005.
12. Food Allergy Research and Education (FARE), Food Allergy and Anaphylaxis Emergency Care Plan, McLean (VA): FARE, 2016. Available online at: http://www.foodallergy.org/file/emergency-care-plan.pdf.
13. White M, “Epinephrine of Benadryl? Understanding Anaphylaxis,” in Understanding Anaphylaxis: How to prevent, treat and manage life-threatening allergies, Vienna (VA): Allergy & Asthma Network, 2016, p. 27. Available online at: http://www.allergyasthmanetwork.org/cms/wp-content/uploads/2014/06/UnderstandingAnaphylaxis.pdf
14. Du Toit G, Roberts G, Sayre PH, et al., “Randomized trial of peanut consumption in infants at risk of peanut allergy,” NEJM 2015; 372:803-813. doi: 10.1056/NEJMoa1414850.
15. OIT 101, Common OIT Questions: But OIT isn’t FDA-approved?, OIT 101, no date. Available online at: http://www.oit101.org/?s=OIT+FARE.