Special thanks to Anna Luke, Manager of Online Community for FARE for going above and beyond to secure the following statement just after a busy period of time post-FARE conference in California at the end of Food Allergy Awareness Week. Thank you, Anna!
The title below is mine, but everything after that is unedited and complete as provided to me today via e-mail:
May 22, 2015 Statement from Food Allergy Research and Education Regarding Sesame Labeling
Sesame allergy can be severe — individuals who are allergic to sesame can experience potentially life-threatening reactions such as anaphylaxis. A 2010 survey showed that hundreds of thousands of Americans are affected by sesame allergy, and several reports have shown that sesame allergy has increased significantly in the worldwide population over the past two decades.
Currently, the inclusion of sesame as a stated ingredient in processed food is not explicitly regulated by the U.S. Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), making it difficult for those with sesame allergy to determine which products may contain this allergen.
Given the importance of education and awareness about this important health issue, FARE will be releasing new information and resources regarding sesame allergy in 2015, including a webinar dedicated to sesame allergy and a tip sheet on how to read a label to help consumers determine if a product contains sesame.
Improving education and awareness are critical first steps, but FARE is also engaged in advocacy efforts to determine how FALCPA can allow for the addition of new common allergens, including sesame and other seeds. FARE is committed to working directly with law makers, government bodies, and our food allergy community leaders to advance these efforts to help improve the quality of life and health of patients with sesame allergy.
In January 2013 I first became involved in the Center for Science in the Public Interest (“CSPI“)’s efforts to petition the FDA to require labeling of sesame in a manner similar to labeling requirements of the “top 8” allergens under FALCPA. By November 2014 when their petition was lodged, they had put together a solid argument and gathered support from allergists as well as families impacted by the lack of sesame labeling under current law. The Citizen Petition specifically requests that the Food and Drug Administration issue a rule that would:
1) require sesame-based ingredients to be listed by name (“sesame”) in the ingredient lists of all foods and;
2) add sesame to FDA’s list of allergens in Sec. 555.250 of its Compliance Policy Guides Manual, “Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens” to address both labeling and cross contact issues related to food manufacturing practices.
In March of this year, Laura MacCleery, Chief Regulatory Affairs Attorney for CSPI reached out and inquired about my availability to attend a proposed meeting with the FDA near Washington, D.C. I didn’t know any particulars but I discussed the expense of the plane ticket with my husband, knew I could find a friend’s (comfy) couch on which to crash, and just needed the date to put everything in motion (and secure my mother in law to watch the kids). By the time I did buy the ticket to D.C., I was able to fly for an approximately $11 fee each way, plus the $99 annual fee for the credit card that afforded me the bonus points I needed to fly. That helped a great deal when it came to justifying a trip that put me in Washington for about only 28 hours.
Unlike other advocacy opportunities I’ve had in the food allergy arena when I wanted to make my voice heard regarding an issue, I wanted to make listening my priority (instead of speaking) on this trip. Coming from a standpoint of believing disclosure of allergens is not remotely partisan, I wanted to know why there might be resistance to the idea of labeling for the presence of sesame in food products. I’m not sure I have an answer at this point but I know where and with whom to start looking (I’m hoping to update on those efforts soon). I also now understand the long process we may be in for.
I landed in Washington at about 3:30 p.m. on Tuesday, May 12th, and navigated the Metro to CSPI’s office to meet my friend (and possessor of the above-referenced comfortable couch) Jessica Almy, who is the Senior Nutrition Policy Counsel at CSPI though we met a while before that role as a result of her website Vegbooks.org (where I’m a contributing reviewer). She introduced me to Laura and we went over the itinerary for the next day. We’d all have folders with information about everyone in our group as well as the individuals we’d be meeting. I’d brought a teal scarf for Laura as a gift – she knew it was Food Allergy Awareness Week so it was neat that the upcoming “Lobby Day” fell during that time.
I got to have a lovely dinner with Jessica, her family, my friend Jennifer from college and Chris from high school that evening on the rooftop of a pizza place in Adams Morgan. I should have been tired but there is something electrifying about the capitol even after a day of travel. There’s a line in Jane Austen’s “Persuasion” that comes to mind:
‘My idea of good company…is the company of clever, well-informed people, who have a great deal of conversation; that is what I call good company.’
‘You are mistaken,’ said he gently, ‘that is not good company, that is the best.’
And so, I had an evening with the best of company, not to mention yummy pizza!
The next morning I had made plans to meet my sister in law – we had never met in person before so I was thrilled to be able to coordinate breakfast on short notice. My brother introduced us over the phone right before he deployed last year (he won’t be back stateside until late 2015). She was incredibly sweet and our breakfast together breezed by at a place near the Senate office buildings where my first meeting had been set. She even gave me a ride to the Hart Building which was great because we got to visit a little longer that way.
Once inside the Hart Building, I navigated the marble halls to find the office of Senator Murphy of Connecticut. Laura was waiting along with Rachel Clark, the legal fellow for regulatory affairs at CSPI, and two other parents of a child with sesame among his allergies, Rob and Christine (Rob asked me to just use their first names in my post, I’m happy to oblige though it feels very informal). Brian Heller, who operates a change dot org petition started 9 months ago seeking sesame labeling and which was cited in CSPI’s Citizen Petition to the FDA, had e-mailed to indicate he’d skip the morning meetings (and lunch) but link up with us at the 3 p.m. FDA meeting later in the day.
Laura handed me a small red cloth bag, remarking “one good turn deserves another,” and inside was a turquoise ring she’d handmade. I know it may seem off topic to mention these details but each time I try to write this post without the personal aspects it just doesn’t match the way my brain processes experiences. I think understanding people as both professionals and as people has always been a crucial part of advocacy to me. I love that so many aspects of ourselves can co-exist in a given person. We can be mothers and crafters and lawyers all rolled into one. Her personal connection to food allergy is that her husband has an allergy to shellfish – I think if we include just one degree of separation with the 1 in 13 affected by food allergy, we’d have a very big portion of the population included, indeed.
At any rate, we met with Senator Murphy in his office and told him our stories. My story focused on label reading and touched upon when E was diagnosed, but Rob and Christine’s story of their son got to the heart of the issue. Encouraged by a pediatrician to expose their approximately 8 month old son to other flavors when he wasn’t interested in solid foods, they’d touched the tiniest bit of hummus (which contains tahini, derived from sesame) to his lips when he began vomiting, breaking out into hives, and swelling. He thankfully survived the experience but their lives were forever changed.
Senator Murphy was gracious and attentive, but also compassionate especially since his own family had been touched by food allergy in the past. (He did ask about the support of other food allergy groups which has spurred me since to contact AAFA’s Kids With Food Allergies and FARE to see where they stand regarding sesame labeling. Responses are still pending and I’ll update when I hear back with something official.) I managed to tweet after each meeting at the Hart building though the day became so much more fast paced afterwards that I didn’t get much documented online.
Next we were able to meet with staff at Massachusetts Senator Markey’s office – it felt strange to tell our stories again but each time we’d find more of a rhythm. Christine had to run an errand so Rob and I took turns sharing our history with sesame allergy and food allergies in general.
The response we got was inquisitive and receptive. I was really enjoying getting to see all the offices and take in the questions that people were offering. I had a printed picture of my kids with me at Laura’s suggestion – it was from a recent comic book convention we’d attended so they were in costume as Gandalf and Galadriel from Lord of the Rings. I so closely guard their identities online that it felt strange to be showing off their picture but I think they would have liked that they were there with me in that way. Plus, my mother in law is pretty great at making costumes!
Our final meeting “on the hill” (see, I’m using the lingo!) was with staff from (CT) Senator Blumenthal’s office. I had to snap a picture of the Lego display in the waiting area!
For this round of storytelling I took out the expired Auvi-Q set I carry in my purse (I always carry the most recently expired auto-injector set we have just in case it is of use) and offered information about needing not one, but two doses and how that related to emergency service response times. I wanted to convey the seriousness of exposure and how lack of disclosure puts us all at risk. Rob also was sure to share the fact that even restaurants trying to do the right thing for food allergic patrons would often have to correct themselves when they learned that bread items could contain sesame even if the familiar seeds were not seen on their exteriors.
The group that headed to the Metro to go to the FDA’s Center for Food Safety and Applied Nutrition included myself, Laura, Rachel, Rob, Christine, and Michael. Unfortunately we didn’t get to meet Brian in person as planned as we discovered he’d mapped his way to a different FDA office location 20 minutes away just as we were being called into the meeting room by April Kates and Carol D’Lima with the FDA. We were able to get Brian on his cell using the speaker phone system in the conference room so he could participate, however.
Laura talked about the Citizen Petition from November and stated our purpose in being present was to find out what the FDA thought of it and to learn if there was anything we could do to assist in processing it. We were informed that there were other petitions ahead in line and that responses were of late in excess of 40 pages (some even 70(!) pages) – the implication being a response takes time to get to and time to draft even when its time has come. We pressed on. I knew from the packet we’d been given that Carol D’Lima, FDA Compliance Officer, had a background that included work researching undeclared food allergens and their impacts. From the discussion it sounded like she had already began researching data from which to prepare the FDA’s response so it is encouraging that she understands the interplay between labeling and hidden allergens.
There were two points of confusion that I made note of during the over one hour meeting. One was the distinction between the change dot org petition administered by Brian and the Citizen Petition filed by CSPI. A few times the FDA representatives looked confused when a piece of information was referenced regarding the change dot org petition because that same request or information was not a component of the Citizen Petition before them for review.
The other issue was that it seemed as though the FDA wanted to find out if they needed certain forms of data to support adding sesame to labeling – the law doesn’t seem to mandate it but they referenced needing information for a preamble a few times. The resolution ended up being that they would verify what data may be needed, if any, before efforts are made to mobilize and provide the information. They seemed concerned about putting anyone through the trouble of marshaling resources before they’d verified what they may (or may not) need. So no call to action at this particular instant, though they kept circling back to the concept of showing the harm that not labeling for sesame would be causing.
Some other takeaways from my notes… Though many arguments for labeling sesame begin with pointing up north (Canada) and across the point (the UK) for the proposition that it would not be burdensome for many manufacturers to comply if the FDA mandated sesame labeling stateside, the suggestion was met with the remark that the FDA has to look at US data/needs. Which I understand, though I don’t think it negates the extent to which worldwide impacts are instructive, especially since one of the things implicated by increasing US sesame allergies is exposure to ethnic foods featuring the seed and its derivatives. There’s also immigration and international travel to consider to a much lesser extent.
Finally, I got the feeling that the pending response to the Citizen Petition wasn’t what it promised with the term “response.” What I mean is that I had envisioned that the FDA was preparing to dispute or agree with points in CSPI’s filing when instead they were trying to anticipate push-back depending on whatever position they take and address that commentary in advance. I get into that trap when I draft legal briefs, I anticipate the response to my words and try to head off those arguments while also making my own. It is a tough spot to be in but I can see how wanting to get something right would benefit an underlying cause even if it front loads a lot of the waiting time. And let’s hope we’re not talking about 10 years like labeling carmine, especially with “Dear Colleague” letters hopefully coming from the legislative branch voicing support for sesame labeling.
By the end of the meeting, as we were being walked to the exit to return our security badges/stickers, our hosts had warmed up considerably and thanked us for our time. My first thought as we walked out was that as encouraging as the Capitol Hill meetings had been, receiving resistance on the issue with the FDA made taking the effort to have the meeting all the more important. Better to know now what concerns there are and how to counteract them (even if their basis seems more related to industry than to being legally enabled to make the regulation).
People have asked me how the day went and I’d say it was fascinating and amazing. I feel like I made new friends and connected with existing ones. I made it to my plane on time for my trip home and arrived in the wee hours of the morning on Thursday so that I could be there for my daughter’s school musical debut as a member of the ensemble – keeping that promise to my baby girl was incredibly important to me.
I’m sorry it took so long to get something online about the whole day. I wrote notes and typed drafts of this post and would put them away. I’d return and tinker and tinker again. I sent emails to KFA and FARE, I messaged back and forth with other advocates. I had no idea what to expect from a “Lobby Day” and now feel like I’ve learned a great deal – hopefully some of it has been of interest!
Even with listening as the theme of my trip, I did find myself honing my story as May 13th progressed. For example, some don’t even realize that not all ingredients have to be listed for a given food. Sesame can hide under alternative names (tahini and the like) but the scarier situation is one where sesame hides as “natural flavor” or “spice.”
Also, there’s the idea that my daughter, at almost age 7, is reading labels for herself and I want, I need, for those labels to tell her the truth. I will not always be here for her and traveling across the country to talk about labeling is an outgrowth of the fact that I can’t actually keep her safe now or in the future.
I can’t guarantee that she won’t be exposed to her allergens, or that in my efforts to keep her safe I’m not opening her up to censure from her peers. In the same way that I didn’t know if I’d always be around to make meals for her (this blog was meant to chronicle recipes she could actually eat), I won’t be there to call companies or ask questions on her behalf. I need to teach her what I can but also see what I can do to change the world around her.
My mother often told us that the reason she worked to teach her fellow nurses was because she wouldn’t always be around and she wanted to help the next generation of nurses so they’d be effective caregivers for her children even as adults. I feel the same way about access to affordable epinephrine, stock epinephrine, labeling, and disability rights for those with food allergies. And to be honest, much like hand washing is beneficial for the health of all students, not just those with food allergies, disclosure on labels benefits so many. Even those who may react to foods for the first time and have no way to even begin to inquire whether something like sesame is the culprit because it simply isn’t on the label.
When someone leaves an allergist’s office with a food allergy diagnosis, they are given a prescription for (often costly) epinephrine but they’re also given a prescription that is harder to fill – allergen avoidance. In that sense it is fitting that regulation of both foods and drugs come under one organization’s control, because they are entwined. I’ve referenced this quote before, but it continues to be apt:
‘Let food be thy medicine and medicine thy food.’ – Hippocrates
Avoiding certain foods is a minute to minute prescription when you live with food allergies and knowing where sesame may lurk is a medicine whose time has come.
Caroline Moassessi and Kacey Larsen (among many others in Nevada) drop everything and spring into action multiple times a month when the legislature is in session. Last minute hearings? They’re there and rallying everyone else behind the scenes.
The best part is that I’ve had the chance to see them blossom into seasoned agents of legislative change just between last legislative session (2013) and this one. They get to the point but manage to bring personality and passion into the mix.
Thanks to my colleague Marc Randazza, I’ve learned it is easy peasy to get video from legislative hearings downloaded and made readily available. As Marc says, it is “[n]ice sunshine,” a reference to the sunshine act (in Nevada it is known as the open meeting law):
@woodrumlaw You look on the specific bill agenda on the legislative website, they’re all videotaped. Nice sunshine.
I’ve done just that with Monday’s AB158 hearing regarding epinephrine in camps, restaurants, and other public non-school areas (since schools have already gotten the stock epi treatment in Nevada). I wasn’t able to watch it stream live since I was at an appointment with my son but it was posted online in about two days.
Senator Hardy gets things started and is followed by Marsheilah Lyons from the Legislative Counsel Bureau, Michael Hackett, who is so kind to continue donating his time to this cause, then Caroline Moassessi of Grateful Foodie, her daughter, RN Kacey Larsen, and Dr. Stuart Stoloff. The clip is not that long and gives some great talking points as well as showing “how it’s done” when it comes to legislative testimony. Keep it brief, clear, and informative but also give it a little heart.
Did you catch Dr. Stoloff’s point about reactions to medications? And the percentage of reactions that occur outside of the home? Very useful tidbits if you’re putting epinephrine access in a broader scope. People often pre-submit written testimony so their spoken testimony supplements the written remarks a lot of the time. I’ve linked to some of the testimony that was submitted for this particular hearing (and this is the news article Caroline shows briefly in her testimony):
Thank you to everyone working on this, including those who’ve submitted comments on the legislative website and who have written notes of thanks to their representatives in the Senate and Assembly. This enabling legislation will make such a difference. Go Nevada!
Yesterday I gave a short statement to the Nevada Assembly Judiciary Committee regarding a bill making its way through the legislature, Senate Bill 444. Before I include it here, I wanted to give some background information that I think would be useful to fellow bloggers.
Generally, defamation is a term used to include publication of spoken (spoken) or written (libel) words that are false. So, in theory, if you wrote something false about someone on your blog, they might have a cause of action in court against you for defamation. There are specific rules beyond that but as a rule of thumb, as a blogger, you want to be writing things that are truthful (and, given FTC rules, not likely to cause confusion). Easy enough, right?
Strategic Lawsuit Against Public Participation
There is a lot of nuance to a successful defamation claim, but I always caution people that just because you’re in the right at the end of the day, it doesn’t mean someone can’t drag you into court. Because of the risk of plaintiffs with deep pockets (able to pay legal fees, etc. even though they may not actually have a chance at winning) filing suits (or threatening them) just to get content they don’t like removed, some states have made laws to protect against them. These laws are called anti-SLAPP laws.
In Nevada, there has been a form of an anti-SLAPP law on the books since the late 1990s but in 2013 the law was made stronger. Among other things, a defendant in a defamation suit can file an anti-SLAPP motion within 60 days of being served with a defamation complaint and challenge the plaintiff to show their case is legitimate. This is a pretty neat framework because in Nevada if you wanted to write a review about a restaurant that hadn’t accommodated your allergies safely or perhaps refused service because of allergies, the restaurant would need to think twice before trying to make you remove the review or suing you. If they did sue, you’d be able to have a remedy for having to hire an attorney to help you (if the anti-SLAPP motion was successful).
Nevada Senate Bill 444
The bill currently before the Assembly in Nevada would shorten the time a defendant has to bring an anti-SLAPP suit and also limit the types of speech protected. It would also change the penalty framework that has been in place since 2013. I read the following yesterday before the Assembly Judiciary Committee and I think it highlights how the food allergy community is impacted when it comes to being willing to share stories and concerns online. The unique thing these days is that where you might have told a few friends about an experience in the past, now when you share information online it is going to make its way back to the company you’re talking about and they might not be happy.
As an example, a blogger who goes by the moniker “Gluten Dude” recently wrote a post about Udi’s Bread (a gluten free bread on which many with celiac disease and food allergies rely). He used photos of bread that people have purchased that have holes in them and wrote about trying to reach out to the company about what people are reporting to him. Like many bloggers, he is using the reach of his readership to magnify a message and get the attention of a large company. This is the kind of grassroots coverage of an issue that bloggers try to offer that contributes positively to the community at large.
Looking further at the connection between free speech and online content, we have sites like AllergyEats and apps like YoDish specifically catering to the food allergy community. They encourage honest feedback about dining experiences, so we know there’s an interest in getting good information. And then there are mainstream review sites like Yelp that can make or break a reputation.
Remember, through all of this, that there is always a party to a lawsuit more prepared for the road ahead. I recall in a mediation course in law school that this comes up even in the divorce context because one person has already come to terms with a decision even as the other may still be reeling and that changes the balance for negotiation. In Nevada a plaintiff has two years to sue, but the defendant may not even be aware the suit is coming. At any rate, all things to keep in mind when considering whether a potentially unjustified defamation suit is going to have a chilling effect on blogging, reviews, and even comments on facebook.
I have been in the little teleconference room once before regarding a guardianship bill (you can read more about that here) – you can see to the left the committee members in Carson City. Another time I offered testimony was when an interim committee was sitting in Las Vegas and I was in the audience for a similar interim committee in town last year. I have to credit the stock epinephrine legislative process with giving me the courage to take on opportunities to offer my two cents in the legislative process. Thank you, Caroline for the encouragement on all things legislative! At any rate, here are my notes going into my testimony:
My Prepared Remarks
Good morning to the Chair and members of the committee. My name is Homa Woodrum and I’m an attorney in Las Vegas. I’ve lived in Nevada for 15 years in both Las Vegas, and (a point of pride having lived both north and south) in Winnemucca.
Though my practice largely focuses on elder law and guardianship, I am also a food allergy blogger and co-founder of the Allergy Law Project – a blog with a focus on disability rights related to individuals with food allergies. I mention this because the intersection of being an attorney and being a part of an online community results in contacts who reach out to me when they receive requests to remove content on personal blogs. These individuals wonder about their rights but may opt to take down information rather than wrangle threatened, just threatened, legal action.
Other individuals contact me after anaphylactic reactions wondering what they can and can’t say about their experiences out of a desire to keep others in the specific food allergy community safe. A mother whose son was served real milk instead of soy milk, a college student served his allergen by a barista, a visitor to Las Vegas for a convention served nuts and left to administer his own epinephrine by hotel staff…every single one of these individuals opted not to share their stories because of the commonly held notion that you can’t speak out about companies with big pockets without risking suit. With SB 444 as written, I would have to advise them all that the risks are too high.
A suit can still be filed and the expense of a defense incurred even if you’ll ultimately prevail. I am here to add my voice because I think this is an access to justice issue. I imagine some attorneys would see SB444 as job security, but I for one would rather see continued protective measures available to those who would be crushed by the expense of defending litigation.
A plaintiff always has a choice and can do a cost-benefit analysis before initiating suit. NRS 41.670 is, I submit, a necessity in the digital era. As a Nevadan, and attorney, and, though I bristle at the term, a “mommy blogger,” I thank you for your time and urge you to reject SB444.
Have you ever decided not to write about something because you didn’t want to face someone else’s reaction? Have you been asked to pull a blog post, or edit it, by someone else?
Remember, of course, that what I’ve discussed here is related to work that is original to you – if you’ve used a photo without credit or have copied and pasted someone else’s work, you’re treading into copyright issues (also, just don’t do that sort of thing!). A request to remove content may be related to that content having been stolen but a truthful review of a product or experience may, depending on your state (Washington, for example, has anti-SLAPP laws on the books), have a little more protection than you thought before.
Hopefully Nevada can keep its reputation for strong anti-SLAPP protection!
I had this idea for Food Allergy Awareness Week (coming in May) but both of the people I wanted to honor have birthdays between now and then so in the spirit of not being able to wait on gifts one apron is already on its way and the other will be heading out in the mail in a week or two!
Much like when I first began navigating food allergy friendly cooking and baking, the Teal Apron Awards are a joint effort between my mother in law and myself. I’ve made this apron pattern myself before for a bridal shower gift but this time around I selected the fabric combination and my mother in law did the sewing.
It wasn’t until I had gotten to know some of my favorite allergy friendly cookbook authors that I learned the amount of time and expense that goes into recipe creation and cookbook writing. We may complain about the expense of allergy friendly ingredients but these ladies buy those ingredients many times over as they test and re-test their recipes and tips. It is part of what makes me trust it will be worth it if I have to go find a suggested ingredient.
That said, I’d like to honor the contributions of Cybele Pascal and Colette Martin to food allergy kitchens everywhere. I know an apron is not much in the grand scheme of things but most of all I wanted to say “thank you.”
Cybele (www.cybelepascal.com) – I still remember the day you commented on my fledgling blog, I forwarded the email notification to more than one member of my family. There were weekly recipe link ups and you visited all the contributors’ sites to offer them encouragement. One of your recipes that became a staple in our home is from your first cookbook, vegan stuffed cabbages. When you signed my cookbooks you were glad the pages were stained and crinkled because they had been used – they’re even more worn today!
Colette (www.learningtoeatallergyfree.com) – thank you for not only answering my questions but the questions of those I send your way. Even when people are just adapting a recipe in general I know I can tell them to reach out to you and you’ll brainstorm with them until they figure out how to adapt their recipes for their needs. I love that you wrote a book focusing on food staples, fully understanding how non-top 8 allergens impact cooking for so many. And getting to see Donny and Marie with you last year was a blast!
Through the magic that is the internet I am so proud to call both of these women my friends. They are incredible human beings and inspirations as business women and mothers. Happy April birthday, Cybele, and happy May birthday to Colette. I hope you both enjoy your aprons!
I was at Sprouts (formerly Sunflower Farmer’s Market) the other day and spied a new (to me) label calling to me with its promises of being nut free and allergy friendly. Tree Hugger All Natural Bubble Gum checked out ingredient-wise for our family and I’m happy to report it also passed some thorough taste testing by my 4 1/2 and 6 1/2 year old kids.
Each flavor is unique and matches its naturally colored exterior quite well, though I couldn’t really tell you the difference between “tangerine” and “orange” but you’ll have fun trying to find one.
The variety we tried was “Citrus Berry Mix” and 2 pieces comes in at 10 calories. The colors, flavors, and texture remind me of gum ball machines when I was a kid – something my kiddos don’t get to experience because of cross contamination risk (and lack of labeling). I’m going to be on the lookout for a gumball machine bank for my office. I think it might be a fun feature especially for clients bringing kids along to meetings.
In law, the term “contract of adhesion” refers to a deal between parties that are so disparate in their bargaining power as to leave one of them with all the say-so and the other with no other option but to go along with the terms. Contracts need not be written, a contract is an enforceable promise. So while some specific laws may require something to be in writing (say, an agreement regarding selling or buying a house), other contracts can exist just from the moment promises are exchanged (like one person promising to do work and the other person promising to pay when the work is performed).
In its own way, purchasing an item at the store is a contract. You are paying some agreed upon amount and in exchange you receive rights to that item. Sometimes the rights are broad, such as if you buy a tomato you can eat it right away, cook it, give it away, or forget about it on your counter. Other rights are limited, such as if you pay for prescription medication, you have the right to use it as directed for the named person.
These types of agreements exist and are often enforceable because there are situations where the bargaining power is unfairly held and there’s nothing one can do about it. Contracts of adhesion are on my mind as I contemplate rising costs for epinephrine here in the US and a dearth of choices in response. In other words, I am wrestling with news that Auvi-Qs in the United States have gone up in price.
Increasing Costs (Approx. $200 Increase!)
I read every comment that comes through on the blog and so appreciate the updates I get from readers about food allergy issues. One hot topic in this space centers around epinephrine auto-injectors. A while back I was upset to find that I could not buy an injector for my daughter that did not expire too soon. I have to pay cash prices for medication under our insurance so all the coupons and promotions out there would not defray the costs we faced. Some families have multiple sets of auto-injectors, we have one set and my daughter also has self-carried (when away from me) since age 4.
I’m coming into this thread of comments almost a year late, but I wanted to share how helpful Sanofi was regarding the short expiration dates on Auvi-Q. I purchased a 2-pack of Auvi-Q in August 2014 with a March 2015 expiration date. The retail cost at that time was $396 at RiteAid. I purchased another 2-pack in September 2014 with an expiration date of May 2015. Same price…$396 at CVS. I contacted Sanofi by telephone and told them I was disappointed that the expiration date was so soon, and they connected me to someone who asked a few questions, then gave me an email address and instructions to send a picture of the Auvi-Qs with the expiration date and the pharmacy receipt and that they would send me a coupon for $400 per pair to be used between January 2015 and June 2015. Within two weeks I received two $400 coupons toward my next couple of Auvi-Q prescriptions. Just last week I used the first coupon, assuming at $396 the new set would be at no cost to me. I was shocked to learn that the retail price of a set of Auvi-Qs was now $569.99! [Sanofi] covered $400, my insurance covered $120, and my co-pay was $50. I’m not sure if there’s a “game” with the cost of prescription meds when a coupon is being used, but I was quite surprised at the increase in price in only six months. But then again, epinephrine is priceless when it comes to anaphylaxis…
It was Kelly’s last line that got me thinking – how even after appreciating the process for the $400 voucher, and detailing the price increase as observed, there’s acceptance of the cost, whatever it may be, for epinephrine.
Epinephrine is priceless. We can agree on that point for certain. You can’t put a price on a life, etc. etc. but going back to the idea of disparate bargaining power, therein lies the imbalance. Taking it a step further, and to an issue that troubles me, there are those that are prescribed epinephrine and never fill the prescription. (Source) The 2013 Medscape article “Anaphylaxis Death Rate Down, but Epinephrine Use Poor” looks at some statistics out of Canada:
“Of the 80 deaths recorded in Ontario, Canada from 1986 to 2011, only a quarter involved the administration of epinephrine prior to cardiac arrest, including that by emergency medical personnel, Ya Sophia Xu, MD, from McMaster University in Hamilton, Ontario, reported […]
Of the 80 people who died, 47 had a known or suspected allergy to the fatal allergen, but only 18 had been prescribed an epinephrine autoinjector and only 9 had their autoinjector at the time of the reaction.
Additionally, at least 8 of these people received epinephrine that was either expired or administered incorrectly.“
I’d take it an anecdotally based step further and add that there are also those that hesitate to use the injectors they have when every minute is crucial and even those that split up injector two packs to avoid the cost of purchasing a second set. (See my prior post: When a School Tries to Split Up Epinephrine Auto Injectors). There are also those that just don’t make the initial purchase at all.
Education regarding recognition of anaphylaxis and use of epinephrine is very important. Even so, I’ve even had allergists remark that people hesitate to use epinephrine because they don’t want the ER bill that may follow hospitalization secondary to use of the injector. This of course would be a fallacy where the use of the injector is associated with the hospitalization rather than the allergic emergency, but I know there’s a tendency to convince ourselves a reaction isn’t really happening because we just don’t want to be in that situation.
Dollars and Sense
Operating from the starting point that we should absolutely have and use epinephrine auto-injectors as prescribed and as indicated by circumstances, practice with them, and refill prescriptions when they expire – do we have any voice when it comes to the out of pocket costs imposed by a food allergy diagnosis?
An article from August 2014 delved a little deeper into the money issue and found that the price actually went from $35.59 for an EpiPen in 1986 to $333.00 in 2014. I paid, with a $100 copay assistance card, $233.86 for the Auvi-Q (with a deficient expiration date), last year. In the article, “Anaphylactic Sticker Shock” by Terry J. Allen, the focus is on the cost of the EpiPen in the United States versus Canada:
[…] I thought of the nice Canadian pharmacist’s sadness at my having to fork out $94—until I told him how much more EpiPens cost only 10 miles south. “But why?” he asked. Good question, monsieur.
Ms. Allen’s article references a 2012 New York Times article entitled “Tiny Lifesaver for a Growing Worry“. I went looking and found that the article appeared in the business section of the NYT. In the piece, Heather Bresch, Mylan’s Chief Executive, refers to just 7 percent of those who need it carry a prescription. That was a statistic referenced just 3 years ago and seen as not only a market opportunity for Mylan, but for competitors.
As a consumer I read the market opportunity as one for competition that would benefit consumers but what if everyone is competing for that 7% (or what have you) of users instead of expanding into untapped groups? I hesitated to post any of this as Nevada’s legislature is working on expanding stock epinephrine (a measure I wholeheartedly support). I also, much like the debate I referenced in a recent post, didn’t want to be perceived as harming entities that do take supportive actions of the food allergic community. Then I thought to myself that the barriers to access presented by expense are a strong reason to continue to support stock epinephrine even though the push for these measures comes from dollars in the coffers of companies paid hundreds of dollars for their devices.
Mulling it Over
As usual, I don’t have a conclusion that satisfies me here. I turn to research and try to make sense of my own feelings at the same time. Am I re-directing anger at my powerlessness every time my 6 year old utters, “Mama, I feel left out” at what should be innocuous childhood interactions? Am I veering into politics on the subject of business and whether a free market can exist where the big is favored over the small?
I worry that my agitation over the expense of food allergies, whether it is for special food or life saving medication, means I am not grateful that the special food exists or that there are companies willing to provide easy to use auto-injectors and pour staggering amounts of money into marketing them, even assisting with legislative efforts to support stock epinephrine. I worry that I’m putting a price on my daughter’s life. Should I gladly pay whatever is necessary for a six to twelve month safety measure?
I have justified paying an already higher cost for the Auvi-Q in the past because I genuinely like it. My daughter likes it. I’ve met representatives from both Sanofi US (Auvi) and Mylan (Epi) and they’re just hardworking people like anyone else. On an individual level, I’m not saying there’s a lack of care. But I’m also a businessperson, and a glass half empty sort at that. A narrative is a story but it is also a sales pitch. If companies are happy to extol the success stories of lives saved by injectable epinephrine, where are the initiatives for access beyond stock epinephrine legislation for limited spaces? There’s a disconnect as well between the physicians who prescribe medication and the delivery of the medication to the patient. I always tell physicians what the tests or medications they specify end up costing and they show surprise. But those doctor’s visits carry a cost in and of themselves, after all, so the joke’s on me.
The way I feel right now, I want to walk away from our Auvi-Q and go to the most cost-effective option, but the rub is that I have a 6-year-old that doesn’t see her medication as some liquid in a tube or credit card shaped case, she sees a lifeline. Given that my hope is that each year’s supply passes unused into our medicine cabinet stash of expired auto-injectors, the Auvi or Epi is not so much about the epinephrine inside but instead the symbol of being prepared for what may happen in the wide world. Even I can feel the difference in the weight of my purse with or without her injectors, and know she’s somewhere else by the absence of it. I was explaining what “ATM” meant to my daughter on Saturday and how the “auto” prefix also appears in words like “autobiography.” She interrupted me to offer that it was also in “auto-injector.” Auto-injectors are a huge part of our daily life and are here to stay.
What I want to do is something useful, something concrete. I don’t know what that is yet but I wanted to put this out there for discussion before I talk myself in too many circles.
Now that I’ve railed on for several hundred words my blood pressure is calming and I can see myself refilling our prescription for the Auvi-Q because I don’t feel like I have a choice. I am suddenly presented with the thought that refill time is an especially sensitive time for food allergy families because it often coincides with an anniversary of a diagnosis. I remember so vividly getting the call that my daughter’s blood test results were in and I needed to immediately get her an EpiPen. With that in mind, I want to look back next year at refill time and have accomplished something even for just one other family who may be struggling to afford epinephrine but doesn’t qualify for assistance that may already be out there.