In April of 2012. Mylan Specialty, which markets EpiPens, released a television commercial with the following script which caused great concern within the allergic community. As a result, the commercial was almost immediately discontinued. The script titled “Max’s Birthday” read:
Mom: So you’re excited for Max’s birthday party? It should be pretty awesome.
Son: Yeah!
Mom: Even with your peanut allergy and a cake made from who knows what, because we’re prepared, right James?
Son: Yup.
Mom: With EpiPen.
The commercial showed James being dropped off for the party, His Mom hands over an EpiPen as the camera sweeps over a table full of food and James runs off to play. The voice over advises to seek emergency medical attention immediately after using an EpiPen, which is followed by product information, contraindications, and side effects.
The scene switches to James being picked up by his Mom and leaving the party. The voice over says: You can’t be everywhere your child’s allergens are, but you can be prepared. Ask you health care professional if EpiPen or EpiPen Junior is right for you or your child. Visit epipen.com for more information. For an excellent series of screen shots along with the script and storyboard, click here.
As a lawyer, I felt that the commercial exposed Mylan to liability for implying that you can safely eat foods that may contain your allergens, as long as you have an EpiPen. What should have been made clear is that strict avoidance of your food allergens, even in trace amounts, is the only line of defense in preventing a food allergic reaction. While EpiPens are the appropriate treatment for a reaction, reactions can still be fatal, even if you use an EpiPen. Every effort must be made to avoid this medical emergency, and strict avoidance of your allergen is the only way to prevent a reaction.
Imagine my surprise the next week, when leafing through the May 14th edition of People magazine, I found this ad by Mylan. It seems that although they pulled the television commercial in response to pressure from the allergic community, they neglected to pull the print campaign:
It’s time for Mylan to get serious about the message they’re sending out. They obviously did not take the concerns raised by the allergic community very seriously, since they still ran the print ads. This is irresponsible, and if the campaign results in a consumer having a serious allergic reaction, they may well find themselves liable in negligence for their misleading and irresponsible messaging. In fact, now that they’re aware of the dangerous implications of their campaign, by failing to remove the print ads, their exposure to liability has increased.
UPDATE: The Office of Prescription Drug Promotion (OPDP), Division of Consumer Drug Promotion (DCDP) of the U.S. Food and Drug Administration (FDA) sent a warning letter to Pfizer/Mylan over these EpiPen ads. A conference call between Pfizer and The Office of Prescription Drug Promotion occurred on April 20th in response to the Max’s Birthday Party ad campaign, and the ads were pulled. For the details, click here.
BREAKING NEWS: 9 January 2013 Brava to Carolyn of Grateful Foodie for sharing this disclaimer commercial by Mylan. To read the paper version of the disclaimer, click here.
Here is the dialogue from the commercial. I look forward to reading your comments below and finding out how you feel about it.
Mom: You may have seen an EpiPen commercial that created the impression that a child who has peanut allergies can eat cake with unknown ingredients and be worry free from the risk of anaphylaxis, if prepared with EpiPen. The FDA said this was misleading and asked us to clarify. EpiPen cannot prevent an allergic reaction. The most important step is to avoid your allergen all together. If a reaction happens, use EpiPen right away, and immediately seek emergency treatment.
Voiceover: Epinephrine auto injectors are for the emergency treatment of life threatening allergic reactions (anaphylaxis) and for people who are at increased risk for these reactions. They are intended as supportive therapy and are not a substitute for immediate medical treatment. EpiPen is injected into the outer thigh. Do not inject intravenously or into your buttock. Always get emergency treatment after using EpiPen. Use with caution if you have heart disease or are taking medicines that cause heart related symptoms. Side effects may include faster irregular or pounding heart beat, sweating, nausea and vomiting, difficulty breathing, paleness dizziness weakness or shakiness, headache, nervousness or anxiety. If you have high blood pressure, overactive thyroid, Parkinson’s disease, diabetes, or have heart disease, these side effects may be more severe. Visit epipen.com for more information.
* If you found this post helpful, please use the “Sharing Is Caring” bar (below) to share this post via Facebook or Twitter. If you’re reading this as an e-mail message, you need to jump over to my blog first by clicking here.
Nancy,
My son is a normal, healthy, athletic, popular kid with food allergies. He always carries his epi pen, but he doesn’t take unnecessary risks and would never eat food without checking ingredients etc. you seem to be sending quite a message! Epi pen to the rescue! The epi pen doesn’t always save you. Strict avoidance is a major part of managing food allergies.
Additionally, your endorsing this type of campaign isn’t appreciated by all the parents who have struggled to keep their children safe at parties, school etc. We’re constantly trying to bring the message that our kids can’t eat home baked goods or bakery cakes or whatever.
Also, you comment that most anaphylaxis self resolves, the problem is that you don’t know which time it will and which time it won’t.
I have a child with an allergy and I guess I’m not understanding what is so upsetting about this ad. To me it is saying that your kids are going to be going to birthday parties and other events where allergens will be present. This doesn’t mean they are EATING the cake or whatever it is- it just means it’s present and yes, accidental ingestion or exposure can occur. My nut-allergic niece ingested a peanut-butter chocolate candy at an Easter Egg hunt that was supposed to have only nut-free candies in it. It’s impossible to avoid things sometimes and I think the ad is telling parents to be prepared by having the Epi-pen on hand…not telling them to feed their kids allergen-laden birthday cake! Like someone else said…it’s common sense.
Nancy,
Thank you for your comment. May I ask you to clarify this particular thought? I think it is the main crux of the issue and I want to be certain I am interpreting what you said correctly.
“Our kids and adult children have a life threatening condition and they live in the real world of birthday parties, family reunions, picnics, field trips, playgrounds and school where if accidental food allergy ingestion happens, you’d better be prepared. And we need to teach them to be prepared.”
When you say “accidental ingestion” are you referring to eating unlabeled and homemade foods like birthday cake, or are you referring to accidental ingestion that happens when a young child rubs his eyes, or puts his fingers in his mouth to wiggle a tooth with allergens on his hands for example? Those exposures are both ingestion, but the former is avoidable by not eating food with unknown ingredients and not taking risks. I would only consider the latter accidental ingestion wherein the allergic individual has been educated properly.
The people upset by this ad want others to be educated correctly. We all work hard to teach parents, schools, caregivers and allergic individuals NOT to eat food unless they can verify ingredients. This print ad is in the same spirit as the TV commercial (both are part of the Max’s Birthday campaign). Just because some people are undereducated or ignore medical advice and DO eat cake at parties putting themselves at risk, is not a reason to LEGITIMIZE this practice, or to encourage it with an ad like this which gives the wrong impression that it’s ok to eat the cake. Instead, Mylan should help to educate people NOT to eat the birthday cake. Then, if little Johnny wiggles his tooth with contaminated hands and a reaction occurs, thanks goodness for the Epi Pen. “Teaching them to be prepared” means not eating the cake, not taking the risk of eating homemade food and not counting on an epi pen to save the day. Instead, Mylan is alienating their consumer base by watering down the message so that it is unrecognizable to those of us who work so hard to communicate the RIGHT message since all our lives depend on it.
Obviously, with so many people perceiving this ad campaign negatively, there is a problem with Mylan’s current marketing strategy. With other injectable epinephrine products on the horizon, they would do well to listen to the food allergic community’s concerns and do a better job of representing the facts about living successfully with anaphylaxis.
There are many parents out there who probably never even fill their child’s epipen prescription. And they are letting their allergic kid eat the cake anyway because there are no obvious peanuts in it. They are risking a reaction and they don’t even have an epipen at all. I suppose, if this ad is directed at those people, then there is a positive message here. It’s asking them to please, if they are going to be eating the cake, at least have an epipen. On the other hand it seems to say that risking a reaction is okay because having an epipen can magically make it all fine again. Like taking a claritan or something. But they don’t mention what anaphylaxis can do to someone and certainly don’t emphasize avoidance in the first place. On the one hand I understand the intent here, on the other hand, it sort of misses the mark.
Nicole
Have to add…this reminds me an awful lot of the “abstinence only” campaign for sex education.
Are we going to insist on the purity of our message, even when research shows the majority of parents skip the Epi but not the cake? Or are we going to support what’s practical and works?
Surely we care about protecting these kids, even if their mothers don’t fully get it. Don’t we?
I see both sides of this. However, I hate to see the food-allergy community knee-jerk reacting that this is HORRIBLETERRIBLEAWFUL like they did to the TV commercial. We have to keep in mind that the parents this ad is targeting are likely attending that party and eating that cake *without an Epi-Pen in hand.*
The world is not perfect. If this motivates more mothers to get Epi-Pens, shouldn’t we support the outcome?
http://foodallergybitch.blogspot.com/2012/04/converting-slacker-allergy-moms.html
To be quite honest, I am not sure what Mylan’s message is supposed to be. One thing I do know is that Epipen is a useful tool in treating a reaction, but only if it is used EARLY in a reaction. As an Emergency Medical Technician explained to me, once the veins collapse the epinephrine just pools in the leg and goes no where.
I am quite concerned about the amount of false information “out there” (on blogs, in news articles, on websites and on Facebook)
We need to go back to the basic message:
ANAPHYLAXIS only takes one bite.
Read your labels, consider cross contamination and if in doubt, DO NOT EAT! Anything else is playing Russian Roulette.
But know that even if you do all of this, there is always a slim chance that somewhere… along the line, something was missed or an error was made.
No Epi=No eating!
This is what the message should have said.
FYI-My daughter was diagnosed about 10 years ago. We have gone to birthday parties, weddings, traveled by planes, trains, buses, boats and cars. We have discussed menu options with executive chefs in fancy country clubs, interogated managers at McDonalds and heated up meals along side the kitchen staff on a tall ship!
I am concerned that the message that, “Don’t worry-you’ve got your Epipen to fall back on”. Is to our detriment as we push for clearer labels. Remember that currently precautionary labelling of “may contains” is voluntary and many medications and toiletries only label for active ingredients the rest being considered proprietary. This message is dangerous to those campaigns.
Nancy, I’m concerned about the comment you made when recounting one of your daughter’s reactions. “The episode subsided on its own (that’s the way most anaphylactic reactions go)”. In my opinion, that is an even worse message to send than the Mylan ad. Anaphylaxis should never be assumed to subside on its own because “that’s the way most anaphylactic reactions go”. Any allergist would tell you that if you think your are having a reaction to the point where you need to go to the ER and sit in the parking lot, then she should have given herself an Epi pen. Where was her epi pen during this and why didn’t she use it? I’m glad she is alive and well today, but her actions with that particular reaction were dangerous and I have never seen an emergency action plan with instructions to “drive to the nearest hospital, sit in the parking lot and wait for the reaction to subside on it’s own”. I would hope that your organization does not promote such dangerous advice.
I respectfully disagree with Nancy Sander of AANMA, and am pretty confident that other large organizations including AAAAI would also disagree. “It was the right action to take. The print ad is accurate and does not imply anything other than reality.”
Nancy and others: Strict avoidance is key. This is fundamental education to the food allergy community. Part of that which comes directly from board certified allergists is that we (the food allergy community) not eat foods from bakeries (i.e. a birthday cake that may contain xyz), we not eat foods that are homemade by others due to cross-contamination and not being able to read their ingredient labels for each ingredient used, taught to bring our own “safe” food to special engagements i.e. birthday parties, and if something doesn’t have a label – do not eat it!
This ad is just as poor in taste as the commercial that was pulled.
I’m actually quite apalled that someone in your position would publicly claim that this is okay and “life happens”. Nancy, yes life happens, HOWEVER, there are safety measures in place that the food allergy community is and should continue to be educated about. Including first and foremost, STRICT AVOIDANCE. When we are strictly avoiding allergen causing foods to the best of our abilities and then an accidental reaction occurs, then thank goodness for being prepared with an Epi-Pen or Twinject etc.
My child never misses a birthday party either. However, we teach him to strictly avoid anything that could cause a reaction, take his own cupcake, etc.
As far as “It was screened by our medical advisory board and parents of children with food allergies. We really can raise healthy, happy kids with food allergies and anaphylaxis as long as they and the adults responsible for their care are prepared.”. I would have to question those that approved it, and follow by saying that they are not fit for future screenings of appropriate ads for public consumption. Might I add that yes, children and adults need to be prepared as you say, and that most certainly does not mean eating whatever you want such as a cake clearly labeled as “may contain nuts” and thinking its “a-ok” because you have your handy-dandy epi.
You really need to thoughtfully reconsider this position as the speaking party on behalf of AANMA.
The television commercial was removed immediately after Allergy & Asthma Network Mothers of Asthmatics and other organizations contacted Mylan expressing concern. It was the right action to take. The print ad is accurate and does not imply anything other than reality. Our kids and adult children have a life threatening condition and they live in the real world of birthday parties, family reunions, picnics, field trips, playgrounds and school where if accidental food allergy ingestion happens, you’d better be prepared. And we need to teach them to be prepared.
My daughter grew up with multiple food allergies that changed as she got older. She’s had numerous episodes, all of them frightening but she was always prepared. She never leaves home without both epinephrine auto-injectors. But she’s not afraid to embrace all that life has to offer. Once at a gathering with friends (as an adult), someone handed her a glass of water. Within moments of taking a sip, her lips started to swell. A hospital was five minutes away. She had no idea how quickly the episode would progress but knew from prior experience she needed to go to the hospital parking lot just in case…A friend drove, she called me en route, calm but focussed. The episode subsided on its own (that’s the way most anaphylactic reactions go) but she was ready and parked outside the emergency department just in case.
Point is, life happens and the birthday cake print ad is right on target. The time to think about how to be ready and what to do is before you need to do it.
As to solid policies in our schools, Allergy & Asthma Network Mothers of Asthmatics and nearly 200 Anaphylaxis Community Experts are dedicated to helping schools incorporate policies. In the summer issue of Allergy & Asthma Today magazine, you can read the story of an ACE Team allergist whose training paid off at a school where a child had an anaphylactic reaction and was treated by a school administrator saving the child’s life.
All states in the US except two now have laws protecting the student’s right to carry and self administer epinephrine auto-injectors. Mylan is actively supporting school programs aimed at increasing anaphylaxis awareness and treatment.
ACE Teams are also working to ensure legislation permitting schools to obtain “entity” prescriptions – that is a prescription for devices that can be used on any student presenting with symptoms whether diagnosed or not. Imagine how challenging and delicate this is – from funding to contraindications (some children with food allergies may have conditions in which epinephrine is contraindicated) – however, as leadership within the National Association of School Nurses advises, parents and school leadership cannot just assume it’s okay to use another student’s device in case of emergency. The time to know what to do is before the emergency happens. The time to be prepared – whether you are a parent, student, teacher, school nurse or administrator – is before the emergency happens. There is incredible peace of mind knowing you are prepared.
The print ad shown above will run in Allergy & Asthma Today magazine. It was screened by our medical advisory board and parents of children with food allergies. We really can raise healthy, happy kids with food allergies and anaphylaxis as long as they and the adults responsible for their care are prepared.
I used to teach my daughter that dealing with food allergies was like crossing the street. If she doesn’t look both ways before crossing, if she runs after a ball, things could end very badly. If she doesn’t look at her food, ask questions, read labels and always carry her epinephrine auto-injectors, things could go badly.
Fortunately, she’s a happy, healthy grown lady now. Still has food allergies but never misses a birthday party. I hope this helps. http://www.aanma.org
It seems I am the only one that doesn’t feel that they are implying to eat the cake…but I deal with an egg allergy, so there is no way that cake would get eaten if the ingredients weren’t known to us. That is just common sense in our family.
Getting people to understand that an egg allergy can be just as serious as a peanut allergy seems to be our big roadblock. It just seems to always be about the peanut….but from where we stand, it’s just really good to see any awareness being made in Alberta.
I wish all this energy were directed elsewhere. Like maybe solid policies in our schools before we have more laws to name.
In addition to all the misinformation these ads give to parents of kids with allergic children, it just contributes to the uphill battle that us parents face. Others unfamiliar with allergies will see the ads and think it’s no big deal. Just use the Epi and carry on. We all know that there is so much more involved. It is so sad that a company that is supposed to help us and that we all contribute to financially could trivialize these allergies.
Another big problem with this message is that other parents of non-allergic students in schools or even school administrators themselves get the wrong message about how to keep allergic children safe at school. This message of saying “it’s ok to have any kind of food served in class as long as the allergic kid has their Epi pen” makes it extremely difficult for parents and physicians to convince them otherwise. I would really like to see Mylan Specialty come out with an ad that publicly acknowledges the errors they have made with this campaign.
In the UK we lost a teenage girl who ate a ‘may contain’ chocolate, apparently BECAUSE she had her pen with her. Auto-injectors are the LAST resort after VERY careful avoidance. There are many practical reasons why they may not be sufficient to save a life.
I completely agree that the message implies that it is safe to eat whatever you want as long as you have your trusty epi-pen handy. What kind of message is that sending to the allergic kids that are just taking responsibility for their food choices? My child knows that 1. we carry our epi-pen everywhere we go and 2. if mom didn’t cook it, check it, or give approval, we don’t eat it. While we do carry our epi-pen, it is my goal to never have to use it. This ad is sending the entirely wrong message. It could potentially cause confusion among young adults with food allergies and it certainly doesn’t help our efforts in teaching the public that food-allergic children MUST avoid the allergens. It is NOT okay to eat whatever foods look enticing just because they carry an epi-pen.
This actually infuriates me. And, I might add, that I know parents who choose to give their children products that “may contain” because their child has not YET had a reaction to these products. It is irresponsible and ignorant. This ad, due to the wording, implies to me that: “its okay to eat the birthday cake, as long as you have your epi pen.” Absolutley NOT okay!!!!
Parents of children with life-threatening allergies need to take precautions, other than just having an epi pen. We must make intelligent and informed decisions on food choices, especially at Birthday parties. If it says “may contain”, or it does not say PEANUT FREE, then do NOT eat it.
That is the best way to reduce exposure.
Educate yourself and protect your children.
Thanks, I agree that the info marketed is misleading people to believe that with Epipen they are safe no matter how many peanuts are contaminating your food… And unfortunately that reflects what the public with non-allergy issues think about the kids with life-threatening allergies.