Lobbying for Sesame Labeling in Washington, D.C.

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.

November 18, 2014 Citizen Petition, pg. 2.  Note that this is different than amending 2004’s FALCPA to add sesame, that would be amending a law while this requests a rule-making approach.

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.

Meeting Folder and Teal Ribbon
Meeting Folder and Teal Ribbon

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!

My view by the Metro station on my way to meet my sister in law
My view by the Metro station on my way to meet my sister in law

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.

Senate Office Building
Senate Office Building

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.

With Laura MacCleery (left) at the Hart Senate Office Building
Me (right) with Laura MacCleery (left) at the Hart Senate Office Building

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!

Lego Capitol Building
Lego Building

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.

We then left the Hart building – we even walked past Senator Bernie Sanders (a presidential hopeful) as we headed to lunch which was really neat.  At lunch we were joined by CSPI Co-Founder and Executive Director Michael Jacobson, PhD. and Jane Welna, the Development Director at CSPI.  The conversation was great, especially since Michael Jacobson was at the forefront of CSPI’s efforts to get cochineal (aka carmine) labeled by the FDA 10 years after CSPI’s citizen petition was filed in 1998.  It is a red dye that can cause allergic reactions, aside from the fact that it is derived from an insect.  It, like sesame, was hiding on labels.  Carmine would previously be labeled as “color added” or “artificial colors,” which makes sense since people aren’t keen on bugs in their food.  I’d hate for sesame labeling to take 10 years but I do recognize that time shouldn’t be a barrier to trying to seek change.

Union Station
Union Station

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.

If you’d like to support food allergy labeling efforts, you can learn about donating to CSPI here.  I’m hoping to write more about labeling on the Allergy Law Project in the future but in the meantime, my posts on this blog about labeling are here, here, and here.

[Update 5/22/15: You can read FARE’s statement here.]

Advocates in Action – AB158 in the 2015 Nevada Legislative Session

Caroline Moassessi - 5/4/15
Caroline Moassessi – 5/4/15

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):

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!

Nevada Legislative Session 2015 – Making Your Voice Heard

It has been an interesting legislative session here in Nevada – every other year lawmakers get to their lawmaking and epinephrine is back on for discussion again!  (Posts about stock epinephrine in Nevada schools from last session are here, here, and here.)  The year between sessions is not without activity, as last April the subject of stock epinephrine was expanded upon and has progressed now to Assembly Bill 158.  We must not rest on our laurels as the resistance to AB158 feels greater than the initial stock epinephrine push (in my totally unscientific opinion).

Nevada Assembly Bill 158

The bill applies to:

“any public or private entity where allergens capable of causing anaphylaxis may be present on the premises of the entity or in connection with activities conducted by the entity. Such an entity may include, without limitation, a restaurant, recreation program, sports league, amusement park, stadium or arena. The term does not include a public or private school.”

Schools that are public and private aren’t included because of provisions for them elsewhere.  Just reading that passage gives me goosebumps because my pessimistic mind goes straight to thinking of people experiencing anaphylaxis in a restaurant or while playing sports after school.  And then I think of the lives that may be saved.  I think about vacationers in Las Vegas going out to eat and maybe leaving their epinephrine in their hotel room, something I tend to do when my routine is disrupted on vacations elsewhere, actually.

A lot of bases are covered in the bill – who may prescribe the epinephrine, protection from liability for those using the epinephrine in an allergic emergency, and more.

Submit a Comment (Nevada Residents Only, Please)

As you can see below, some folks have confused their bill numbers in making online comments as you can see by this remark “against” the bill that references the state retirement program (“PERS”):

PERS comment on the epinephrine legislation page

I am hoping the 20+ others in the graphic above are just confused, but wouldn’t it be great to have 20 “for” supporters for every “against” listed above?  The downside is the site won’t let me link you directly to the page for voicing support so I’ve got some screenshots to help you along so it is an easy process.

First!  Go to http://www.leg.state.nv.us/AppCF/Opinion/78th2015/vwComments.cfm or use this handy short link: http://goo.gl/dRezms and click “Submit an Opinion.”

howtocommentonanevadalegislativebill1

Now, select AB158 from the drop-down menu like so…

howtocommentonanevadalegislativebill2

And the summary of the bill will pop up – helping you make sure you’re offering commentary (or not, it is optional to write a comment) on the right bill (yes, that was a gentle jab at the PERS commenter above).  However, you’ll see that you need to select the variant of the bill you’re supporting.  Today, April 17th, an amended version was posted (viewable here) and it impacts provisions not only in the original bill but in last session’s school stock epinephrine bill.  Be sure to fill out the Constituent Information before submitting so they know you’re a, well, constituent.

howtocommentonanevadalegislativebill3

This bill has not been on my radar as much as it might have been had there not also been two guardianship bills winding their way around, (guardianship is a main area of my law practice).  I mention the guardianship bills because my involvement in the process for both has shown me just what a dream team Senator Debbie Smith had in her camp last time around, including Senator Smith herself.  Everyone was poised, on point, and respectful of legislators’ time during the whole process.  In contrast, I was boo-ed when I made my statement to a legislative committee about AB325 the other day (right about at the part in my talk around paragraph 3).

SenS
Senator Smith speaking before a committee in April 2014

 

Senator Smith recently returned after a February 3, 2015 operable brain tumor diagnosis (read more on Grateful Foodie) and subsequent surgery and I think a great “welcome back” gift we could offer such a champion for individuals with food allergies would be support for AB158.

If you have submitted your vote of support for AB158, be sure to comment below.  Thank you for your help and thank you also to the team of food allergy advocates in both Northern and Southern Nevada for your continued hard work!

 

A Contract of Adhesion (or: Paying for Priceless Medicine)

A Contract of Adhesion (or: Paying for Priceless Medicine)

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.

At any rate, here’s the detailed comment that came through from a reader named Kelly:

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.

(In the interest of disclosure, as I’ve mentioned elsewhere, I did go in April 2014 to Mylan HQ on their dime for a gathering of food allergy advocates.  I found the experience informative.  Mylan and Sanofi were both sponsors of the Food Allergy Bloggers Conference here in Las Vegas in 2013 and 2014 before I stepped down from involvement.)

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.

There’s always the default answers one could turn to, like saying this is the state of medicine in the United States or it is just business.  I think at the end of the day I’m allowed to be frustrated, I’m allowed to vent, and then trot down to the local pharmacy and pay up like everyone else.  I just wish if I’m going to over-pay for a product I knew an actual injector was being put in the hands of someone that couldn’t afford it by virtue of my willingness and ability to pay that increasing price.  (Note: Selena Bluntzer at Amazing and Atopic does detail patient assistance programs that may assist some families in affording Auvi-Qs as well as information about generic epinephrine options that are worthwhile reads.)

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 Next?

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.

Road trip to Canada, anyone?

Update: 3/23/15 – Check out Danya Glabau’s post – Pricing Health: Skyrocketing Prices for “Drugs for Life” – she eloquently brings her perspective as a social scientist to the pricing issue.

When a School Tries to Split Up Epinephrine Auto Injectors

Have you ever been in a situation where something comes out of nowhere and you are too surprised to react?  A parent recently shared an experience that had all of us in a private Facebook group for parents of children with food allergies up in arms.  I asked if I could share it here on their behalf to prepare others for questions that would otherwise catch them off guard.

To set the scene, imagine you are at your school’s “meet the teacher” night and dropping off medication, paperwork, and of course epinephrine auto-injectors:

“[They] promptly took out the [EpiPens] and split the two pack and handed one back to me. I kind of had a mini-meltdown […] I said what are you doing? You’re not supposed to split a two-pack. She told me that was [District] policy. She then checked with the nurse who said she’d been doing this for 17 (?) years and that they don’t ever keep the second one because, according to [District] policy, only a nurse is allowed to administer the second dose and that a nurse will almost never be on campus. I was a little shocked and replied that I was told NEVER to split the two-pack. They told me they could keep the second one, if I insisted. They told me they had been splitting the two-packs all morning and I was the only one who said something. […] This was new to me as last year they took the two-pack, no problem.”

The parent here, let’s call them Pat, is entirely correct.  Epinephrine auto-injectors come in packs of two for very specific reasons.  In researching for this post, I stumbled upon a 2008 post from “Our Story: The Good, the Bad, and the Food Allergies” by Janeen Zumerling where she discussed being faced with a pharmacy trying to fill one prescription for a 2 pack of EpiPens instead of more because they figured two pens came in one box.  So while this is the first time I’ve heard personally about this happening, it could happen at school, at the pharmacy, or elsewhere.

Suggestions as to How to Respond

(The following come with the overall caution to remain respectful, polite, and evidence based in your appeals to the decision maker in question – it may also not be a good idea to have these discussions in front of your child, depending on their age, if they are present when the attempt to split injectors occurs):

1) “This is how my doctor prescribed it.”

Sometimes people will back off if you tell them the instruction comes from someone other than yourself, like an allergist or physician.  My daughter’s allergist writes her prescription for a “two pack” – does yours?  In the story above, Pat was told that the school nurse had been doing it this way for years and that no one else had complained, so this response may not work.

2) Stock Epinephrine Laws

If your state has a stock epinephrine bill, as Nevada does, you can point to the bill’s language.  Nevada specifically references “two doses” of injectable epinephrine.  NRS 388.424 (I’m so used to calling it Senate Bill 453, I had to look up the final Nevada Revised Statutes citation, it makes me happy to see it nestled in the law on the legislature’s website!) reads (in part) as follows:

Each public school, including, without limitation, each charter school, shall obtain an order from a physician or osteopathic physician for auto-injectable epinephrine pursuant to NRS 630.374 or 633.707 and acquire at least two doses of the medication to be maintained at the school. If a dose of auto-injectable epinephrine maintained by the public school is used or expires, the public school shall ensure that at least two doses of the medication are available at the school and obtain additional doses to replace the used or expired doses if necessary. 

(emphasis added).

3) Clarify – EpiPen and Auvi-Q versus Twinject

If your injector is the Auvi-Q or EpiPen, that the Twinject is the only injector where the first dose of epinephrine is an autoinjector and the second is a traditional injection that might cause the concern regarding a nurse administering it.  (Source)  Even so, the doses should be kept together.

4) Look into self-carrying

If your child is responsible, they may be able to carry both doses on their person instead of having to wrangle a school when it comes to attempts to split doses.

5) Turn to your 504 Plan (or IEP)

Depending on the makeup of your school (public schools fall under this, for example, it is dependent largely on the receipt of federal money), you may qualify for a “504 Plan” for your student.  (Source, I discussed school accommodations in my overview of the Fox Chapel case FARE amicus brief as well.)  This is a shorthand reference to the accommodation to which you are entitled for your student.  Don’t have one?  Request a meeting.  Even if the person trying to split your injectors is a novice on the food allergy front, they should know what a 504 plan is (stay tuned for a post on what to do when you get blank stares after mentioning it, as happened to a friend of mine recently).  Does your plan reference both doses?  The plan we have for my daughter references a second dose after 10 minutes if emergency services have not yet arrived.  Some schools may not permit a 504 plan where an IEP (Individualized Education Plan) is in place to cover other accommodations, so your allergy procedures should be contained in that document instead.

6)  Go higher up

You can speak to someone in the school district that may be more informed than the individual you’re dealing with.  If the person you’re facing is a school nurse, use data from the National Association of School Nurses.  They have a great guide about anaphylaxis here (aptly titled “Saving Lives at School“) and I’ve isolated the page about two doses of epinephrine below (click the image for a larger version).

Second Dose of Epinephrine Referenced in School Nurse Guidelines
Second Dose of Epinephrine Referenced in School Nurse Guidelines

7) Research Response Times

This may take some google searching on your part but some areas may have response times for emergency services (ie, 9-1-1) that exceed 5-10 minutes.  If you’ve ever been in a traffic jam near your child’s school, you probably won’t be surprised when you do find the stats you need.  You’ll see that this is even more important when you see my notes on biphasic reactions below.

8) Know Some of the Reasons Why Epinephrine Autoinjectors Come With Two Doses

Not only could the first injector malfunction, there may be user error (or inexperience) at play in addition to the risk of biphasic (subsequent) reactions from the same exposure or the epinephrine wearing off before help can arrive.  I’ve broken this final suggestion down with supporting information I was able to find – sometimes just knowing why a protocol is in place will help you if someone down the line challenges you.

Background Research

Here is some additional information (background research that I did) that could come in handy if someone tries to force split your two pack of injectors:

A second Dose of epinephrine is required For At Least 1 in 10 patients

While the percentages vary, a second dose is required for 10%-35% of patients experiencing an allergic emergency to deal with the symptoms of the reaction.  (EpiPen says 20%, Auvi-Q says 10%-20%, and Twinject says 35%)  Remember, of course, I am not a physician and none of this is a substitute for medical advice.  I just want to arm people with information that they could use if they find themselves in Pat’s shoes.  A study spanning 2001-2006 records for two hospitals in Boston found that 12% of children required two doses of epinephrine as opposed to one per Susan Rudders, MD, of Children’s Hospital Boston. (Source:  “Kids With Food Allergies May Need 2 EpiPens” – WebMD Health News, March 26, 2010)  The article goes on to quote Dr. Rudders as saying, “The problem is, we really don’t have good ways of identifying who will and will not need an extra dose.”

The effects of one dose of epinephrine may wear off after 10-20 minutes

Epinephrine suppresses the progression of a reaction. (Source)  It may wear off after 10-20 minutes, however, which may not be enough time for emergency help to have arrived.  (Source)  Remember, use epinephrine by injecting it into the outer thigh, call 911, also remembering to keep the patient lying down with their feet elevated and be prepared to use that second dose.

User Error And Device Malfunction

 Not that anyone wants to consider making a mistake when the situation calls for epinephrine, but in a high stress situation the person using the product may not know how or may make a mistake.  I found an interesting article from 2010 that compared four injectors (it was funded by the makers of the Intelliject, later called the Allerject in Canada or Auvi-Q in the United States) entitled: “A comparison of 4 epinephrine autoinjector delivery systems: usability and patient preference” from the Annals of Allergy, Asthma & Immunology (by Stephanie Guerlain, PhDemail, Akilah Hugine, MS, Lu Wang, MS, in Volume 104, Issue 2, Pages 172–177, February 2010 – the manuscript version is here).

The manuscript mentions that when a device malfunctioned, the likelihood of failing to follow instructions was higher.  What I was searching for were stats on malfunction but the reference here admits it is a possibility in a test setting at least:  “Studies have shown that patients and caregivers do not always correctly administer epinephrine autoinjector devices. […] There may also be a large time lapse (several years) between when a person is trained on an autoinjector and when it must be used during an allergic reaction. Finally, a patient or care provider may be under significant stress while attempting to provide the potentially life-saving dose of epinephrine when it is used.”  Id.

As an aside, I was surprised that the most common error for use of an epinephrine injector was not holding it for the correct amount of time.  In the study I looked at,  versions of what would become the Auvi-Q (INT02 and INT01 in the study)  were used as well as the EpiPen and the TwinJect.  “The INT02 device resulted in participants committing this [(not holding long enough)] error 11 times compared with 27 (INT01), 40 (EpiPen), and 42 (TwinJect) times.”  Training across devices was held to be crucial, with the manuscript indicating that “[t]he fact that less than 50% of participants across all devices could follow the labeled instructions without committing a single error provides confirmation that the need for training on the use of epinephrine autoinjectors is still important.”

I didn’t mean to get sidetracked but I found it interesting.  At any rate, someone administering the medicine could not hold it long enough, the device itself could malfunction, the person may not be adequately trained, or the stress of the situation could cause errors as well.  With these things in mind, a second device is a very important thing to have.

Biphasic Reactions

The first time I heard of biphasic reactions I was fairly shaken.  It isn’t enough to worry about accidental exposure to an allergen without now thinking that you could have the reaction, be stabilized, only to have it return like an aftershock even hours later.  A biphasic reaction is defined as “a worsening of symptoms requiring new therapy after resolution of anaphylaxis.”  (Source)  (This Post Updated 12/1/14 to include this post by Dr. Anne Ellis about Biphasic Reactions: “Biphasic Anaphylaxis: What You Should Know“)

Final Notes

I hope some or all of the above is useful!  I also hope you don’t run into push back when you work with your school.  Pat was able to get the school to retain both EpiPens and I really appreciate the talking point the story provided (thank you!).

As I stated in my post regarding EpiPen and Auvi-Q expiration dates (people are reporting in the comments that they’re receiving their $400 Auvi-Q savings cards in the mail in about 2 weeks after reporting short dated injectors, check out Amazing & Atopic and Food Allergy Pharmacist for even more if you’re following the issue), I have connections at both Mylan and Sanofi (I am the co-founder of the Food Allergy Bloggers Conference and they are both sponsors and my travel, hotel, and some food was covered for my attendance at the Mylan Summit earlier this year) – see my disclosures page as always for more.

The opinions herein are my own, do not constitute legal advice or medical advice, and are provided merely as discussion points.  I am an attorney and parent of a child with food allergies living in Southern Nevada. 

UPDATE – Epi-Pen and Auvi-Q Expiration Dates

(Note: see my latest post about the cost of Epinephrine here)

I wrote to both Mylan (EpiPen) and Sanofi (Auvi-Q) and shared my previous post “Epi-Pen and Auvi-Q Expiration Date Frustrations” along with the wonderful and informative comments I received from readers and received the following responses I wanted to share here.  Please, depending on which product you purchased with an expiration date that was unsatisfactory, read below (for Auvi-Q purchasers, you may be able to get a savings card that offers an up to $400 benefit and for EpiPen purchasers, be sure to call customer service).  Both companies understand that expiration dates are very valid concerns for purchasers of epinephrine auto-injectors.

AuviQandEpiPen
Child doses of Auvi-Q and EpiPen

________________________________________

Epi-Pen

From makers of the EpiPen, Mylan Specialty:

To help facilitate consumers providing us with the necessary information, please share our customer service contact information. Consumers can call Mylan Customer Relations to speak with a representative at 1-800-395-3376 or email at Customer.Service@mylan.com.

We also wanted to provide additional information related to product expiration dates to support you and your readers.

When picking up epinephrine auto-injector prescriptions, we encourage patients or caregivers to check what is dispensed at the pharmacy prior to leaving. If there are concerns about the expiration date, they should speak to the pharmacist immediately.

________________________________________

Auvi-Q

From makers of the Auvi-Q, Sanofi:

Patients or caregivers who, within the last 31 days, purchased an Auvi-Q that expires in less than 12 months are eligible to receive a savings card with a maximum benefit of $400 off one two-pack of Auvi-Q for each Auvi-Q purchase that meets the terms and conditions. Savings cards are valid for useJanuary 1 – June 30, 2015.  Patients or caregivers who purchased an Auvi-Q in the past 31 days with 6 months or less of dating may receive a replacement Auvi-Q or they can opt to receive a savings card.  For more information, including terms and conditions, patients or caregivers should call Sanofi Customer Service at 1-800-633-1610.

________________________________________

Our collection of expired Epi-Pens and Auvi-Qs, the ones in the belt are current through early next year.
Our collection of expired Epi-Pens and Auvi-Qs, the ones in the belt are current through early next year.

In the meantime, it is my understanding that both companies are following issues about epinephrine expiration dates and are taking all consumer comments and concerns into consideration.  They want to hear about issues people may or may not be having as they get prescriptions filled.

No matter what hurdles you face in filling the prescription, by the way, you need to be carrying epinephrine.  See this great post by “Marketing Mama” Missy Berggren: Why do people need to carry EpiPens? Why not just call 911?

___

Disclosure: I attended Mylan’s Summit in April but my opinions are my own – more detailed disclosure here and here.  Sanofi and Mylan have both been sponsors of the Food Allergy Bloggers Conference, of which I am a co-owner.  My opinions, as always, are my own and are not representative of my position at Food Allergy Bloggers Conference LLC or the real or perceived benefits from either company.  Representatives from both will be at the conference this September 2014.

EpiPen and Auvi-Q Expiration Date Frustrations

(Update from 7/30/14: Click here to read statements from both companies referenced below)

When we re-fill epinephrine auto-injector prescriptions it feels a little like checking a scratch card – what will the expiration date be?  I think many of you are in the same situation.

Auv-Q Purchased 5/12/14 with 1/2015 Expiration Date
Auvi-Q Purchased 5/12/14 at Target Pharmacy with 1/2015 Expiration Date

This is not a new issue, I mentioned it in my post about the most recent Legislative Healthcare Committee Meeting and in my Mylan Summit post, but as I type this is I have just returned from paying $233.86 (after the $100 copay card, Mylan has one as well) for an Auvi-Q epinephrine auto-injector set  of two that expires January 2015.  The last Auvi-Q I obtained had an expiration date fourteen months out from the date of purchase and this one is 8 months.  So I know it is possible to be 12-14 months out on an auto-injector.  Anything less than a year is a problem considering the costs for families alone and that the high cost may cause families to stop filling their prescriptions.

Our Voices are Louder Together

I am fortunate that I can pay the cost of the medication (our insurance does not cover or alleviate prescription drug costs) but that does not mean it is ideal.  I specifically requested that they order the Auvi-Q last week in hopes of getting a newer one but it was not enough.  I would love to gather your experiences and submit them to both Mylan and Sanofi as there has to be a better option in all of this. 

When I saw the Auvi-Q expiration date I asked to see an EpiPen one and it was February of 2015 to the Auvi-Q’s January 2015.  I stuck with the Auvi-Q because the voice guidance puts my daughter’s teacher at ease and because the expiration date was not that much better (February 2015).  Still a significant amount of time less than the 12 months we all aim for.  After, I called Jenny and vented and she suggested that I should have left the medicine there and called around town to find a better expiration date but we’re already 12 days into May and my daughter’s injector expired April 2014.  So here I am, hoping that when the time comes in January to obtain a refill that there will have been true changes in the system so that other families as well as ours are not in the same boat.  Also feeling grateful that I have people I can call and know they will share my frustration about things like this.

Anecdotal reports include hearing that pharmacies in town offering a discount on injectors that expire sooner (like 50% off on one that is six months out) but I don’t know which pharmacy that would be.  We only buy one set every time we need a refill because of the cost and because my daughter self carries.  I carry an expired set in my purse just because something is better than nothing as a backup.

Let’s Discuss…

At any rate, please let me know either at my email homa at woodrumlaw dot com or here in the comments about your experiences and I would like to put together a letter to both Mylan and Sanofi asking about our options.  I have a feeling that the issue is on the pharmacy side of things because reps from Mylan and Sanofi have mentioned that the dates should be at least a year out.  I am not placing blame as much as feeling baffled that if companies are telling me all pharmacies have to do is exchange older injectors for newer ones, why are they not doing it?  Why discount them or force them on consumers that aren’t going to risk not having them in the event of an allergic emergency.

Thank you in advance for your input on this one, I will keep you posted.

Disclosure: I attended Mylan’s Summit last month but my opinions are my own – more detailed disclosure here and here.  Sanofi and Mylan have both been sponsors of the Food Allergy Bloggers Conference, of which I am a co-owner.  My opinions, as always, are my own and are not representative of my position at Food Allergy Bloggers Conference LLC or the real or perceived benefits from either company.