banner by Amanda Nichols
by Helen Richard
It was an innocuous afternoon: sunlight streamed through the windows as the kitchen warmed from a pre-heating oven, while a woman prepared a pecan pie. As she chopped the nuts, she gave her daughter a piece small enough for a toddler to consume. In the coming minutes, her daughter started to struggle to breathe, and the woman frantically called the pediatrician’s office. “Your daughter is having an allergic reaction to pecans,” they inform her bluntly, “and if she eats them again she could die.”
While I do not remember the specific events of that day, I do remember the needle pricks and moments of paralyzing fear that came one after another. After rounds of testing, I learned my allergies were to peanuts and tree nuts, including almonds and walnuts. Though it seemed daunting, I learned that living with food allergies is manageable by exercising caution and employing the safety net of an EpiPen, a medical device manufactured by Mylan. The injectable treatment contains a set of two epinephrine shots that can delay the onset of full anaphylactic shock until medical help can arrive.
Since EpiPens expire, every new school year began with another set of epinephrine authorization forms and a new EpiPen. As far as I was concerned, it was not a question of whether I was getting a new one or not since it is a necessity. I grew up with nightmares not about the boogeyman, but cross contamination. In fact, despite informing wait staff and managers at restaurants, I have found allergens on my plate a startling number of times. I have been lucky on many fronts though, as the nuts in my food were spotted before I consumed them, and I carry an EpiPen with me everywhere just in case. Yet, I know this is a privilege. The cost of an EpiPen was something I hardly, if ever, thought about; I just assumed my family’s insurance would cover it. As a result of my own blissful ignorance, the news of the numerous articles outlining the over 700 percent price increase over the last 12 years of the EpiPen this summer was extremely startling.
As of May 2016, the cost of an EpiPen was $608.61, which can then be reduced to a zero-dollar co-pay with medical insurance and a coupon. For those who are uninsured, the coupon takes off a mere $100 dollars, leaving the price to around $500. This price can be astronomical for the average American because it could be equivalent to a month of food or over a month of gas. For those with more severe allergies, multiple EpiPens have to be purchased to exercise extra caution, but similar to the previous scenario, this can pose as a problem: deciding if two shots of epinephrine or a month of groceries is more important.
In the face of this, perhaps then the answer to dealing with allergens lies within immunotherapy. Allergy shots have been largely effective in controlling seasonal allergies, but there are no shots available for those with food allergies. There are a variety of methods that have been proposed, but studies suggest the largest degree of efficacy lies with epicutaneous immunotherapy (EIC), sublingual immunotherapy (SLIT) and oral immunotherapy (OIT).
EIC works by increasing people’s tolerance to allergens by having subjects wear a patch with powdered allergen on their arm. A study conducted in 2010, which focused on those with cow’s milk allergies, showed that EIC was effective in improving allergic reactions and lessening chance on anaphylactic shock. While there have been other studies conducted more recently, including ones that test the method’s efficacy in dealing with peanut allergies, the results of one 2012 study revealed that there were no “statistically significant differences” in either the number of subjects who had reactions in the placebo or treatment groups, nor between those with mild versus severe allergies. There also appear to be drawbacks in the design of the patch, for the main reported side effect was skin irritation at the sight of wear and there is uncertainty as to how much of the allergen can be applied using the EIC method. Evidently, the EIC has not been perfected.
Another way researchers have proposed to deal with severe allergies is SLIT. In this method, small doses of allergens are held under the tongue before being consumed or spit out. The University of North Carolina, Chapel Hill is currently enrolling children ages one to four in a study that aims to determine if SLIT is an effective measure for those with peanut allergies to “induce clinical desensitization.” This is only one of the many SLIT studies currently being conducted, and from previous studies there appears to be evidence that SLIT followed by another high efficacy immunotherapy has the greatest impact on improving food allergies.
OIT is currently the most prominent form of immunotherapy. Much like classical desensitization, it is implemented by controlling the amount of allergen that subjects ingest. Over time, the amount of allergen administered is increased incrementally. While OIT has shown to be effective, as seen in a study from 2010 where 14 subjects were desensitized, eight of the members of the study were unable to finish the study because of side effects that impacted their health. The risk, anaphylactic shock being the most extreme, associated with OIT, and to a lesser extent SLIT and EIC, makes it difficult not only to recruit participants for studies, but more importantly, to retain them.
To determine the efficacy of OIT or the other forms of immunotherapy as with any study, a large sample group is very important. Yet, with the current conditions of the studies, the retention rate is not high enough to make the results representative of the entire population of those with allergies. Despite the work that has been done in the last decade, immunotherapy for allergies still is not recommended by the National Institutes of Health (NIH) as a form of allergy treatment. In fact, the NIH guidelines recommend avoidance as the best method of allergic reaction prevention.
Immunotherapy may not be a viable option now, but as research progresses there is an optimistic undercurrent to the work. Until there are more successful findings, the price tag for the EpiPen remains problematic because inadvertent exposure can, and does, happen. While Mylan’s Chief Executive, Heather Bresch, stated during the company’s congressional hearing on Sept. 15, 2016 that Mylan is looking to extend the shelf life of EpiPens, this is merely a deferment of cost.
Unless EpiPens are manufactured not to expire for years, the total sum people pay is barely impacted. Therefore, it is crucial for Mylan to lower the price of EpiPens, not with coupons, but actually decreasing the price to a manageable amount, as it ought to be something that anyone with a life-threatening allergy has access to. For the future, immunotherapy is a promising alternative to the Epipen and could work toward ensuring future generations never need to know “blue to the sky, orange to the thigh, and hold for ten.”