EpiPen Hearing Yields High Drama No Substance

Mylan’s CEO Heather Bresch and a Food and Drug Administration deputy director Doug Throckmorton testified before the House Oversight and Government Reform Committee on Wednesday, September 22, 2016, regarding the high price of the EpiPen®. The questions posed and answers provided were nothing short of high drama with no substance.

Since Mylan acquired the EpiPen® in 2007, the product’s price has increased more than 500%. Personally, I can recall the product being as high as $730 and currently it is riding at approximately $608.

It is apparent that Bresch believes the company has taken reasonable steps to relieve the financial burden from consumers by replacing the $100 coupon with a $300 coupon and announcing the upcoming launch of a generic which will retail for approximately $300. However, refusal to simply lower the price of the EpiPen® has consumers feeling betrayed and fuels the government’s perception that Mylan is playing the ultimate shell game. Plus, let’s not forget the only reason that the coupon was upped to $300 and the unprecedented (Bresch’s word) launch of the generic was due to consumer and finally government outcry with Mylan’s hand caught in the proverbial cookie jar.

Throckmorton was raked over the coals because the FDA approval process is oppressively burdensome. In addition, he was unable to report how many FDA applications were filed for competitors to the EpiPen® because it would go against the FDA’s rules.

While listening to the EpiPen® hearing, I started to think about the corporate value lessons learned during the Hobby Lobby case a couple of years ago. Here’s a sentence from Justice Samuel Alito’s opinion in the case that can easily apply to the EpiPen soap opera:

EpiPen Hearing Yields High Drama No Substance

As the bad and the ugly continued to unfold during the hearing, or not unfold for answers not provided, I couldn’t help but also think about the good that Mylan has done with regard to disease awareness, stock epinephrine in schools as well as other places such as zoos, museums, amusement parks, etc. However, any of the good that resulted from Mylan’s efforts is now overshadowed by the ugly. New questions arise such as, Was there even a glimmer of sincerity in those actions? Did Mylan really want to create more investor value and line executive pockets on the backs of food allergic children? Outraged congressional representatives used phrases like a rope-a-dope strategy, an unfair monopoly, a shell game, a sham, something smells fishy, numbers don’t add up, charts that seem dumbed down, and a simple but corrupt business model to describe their understanding of Mylan’s actions.

Just because the government is looking into Mylan’s practices, doesn’t mean our work is over. Continue to communicate with your legislators via calls, emails and letters and share your prescription drug pricing woes until change actually happens!

To truly understand the lack of answers provided, along with some great one liners delivered by government officials, view the full event below in its entirety.

Stay tuned…Heather Bresch and Doug Throckmorton are due to disclose more information in 10 days.

This drama is far from over.

88 Acres are a must for food allergy families

88 Acres are a must for food allergy families! Amanda Massello, Director of Digital Marketing and Ecommerce for 88 Acres, and I caught up on Twitter one morning and that tweety relationship turned into a sampling of 88 Acres at my front door. They are very delicious, and nutritious, so I thought you might like to learn more about this fairly new item that may be safe for your household. Keep reading to take advantage of the 15% OFF COUPON CODE at the end of the interview. How timely is this interview since so many of us are trying to find safe and tasty school snacks?!

Like so many food allergy businesses, Nicole and Rob Ledoux’s started with a dream…ok, maybe not a dream, but in this case an anaphylactic reaction on Nicole and Rob’s FOURTH DATE.

Kristin: Nicole (cofounder of 88 Acres) can you share your experience with Rob’s anaphylactic reaction on your fourth date? I can’t believe you were newly dating…what went through your mind?

88 Acres are a must for food allergy families

Nicole, Rob and Emmett Ledoux
Image courtesy of 88 Acres Instagram

Nicole: I met Rob during the fall of 2010 in the old fashion way, on Match.com. While our first date was amazing — Saturday brunch in Boston followed by taking a long walk around the city with my chocolate lab, Bear — it was our fourth date that stands out. We were grabbing dinner from my local pub, when Rob looked across the table and told me to get him to the Emergency Room as fast as possible. His meal was contaminated with nuts (thankfully it wasn’t my cooking!). For most of us, no biggie…but for Rob, his throat was beginning to close due to his severe allergy to nuts! So our romantic fourth date resulted in me speeding through the streets of Boston looking like a deer in headlights with Rob in the passenger seat, calling his parents with one hand and holding his Epi-Pen in the other.

We got to the hospital where he was whisked through triage and into the ER. His parents arrived about an hour later, which was an awesome way to meet them for the first time…”Hey nice to meet you future in-laws, your son is in anaphylactic shock.” I stayed by his bedside all night, watched him the entire next day, and rid my house of nuts as soon as I got home.

This experience not only cemented my love for this guy, but spawned a pretty awesome food startup as well. And now we are married, started 88 Acres together, and have a 6-month old baby boy named Emmett!

Continue reading

Save on EpiPens and Other Household Prescriptions

Save on EpiPens and Other Household Prescriptions

Save on EpiPens and other household prescriptions? It’s a question that most of us ask ourselves. As you know, healthcare in the United States can be very expensive. While our premiums continue to rise each year, our benefits seem to dwindle. We’re paying more for less coverage, alternative foods are more expensive and the lifesaving medication cost of EpiPen® feels more expensive than ever for many families.

Many are quick to point the finger at Mylan, the maker of the EpiPen®. However, just as health insurance plans are complicated, so is the the pharmaceutical supply system. The pharmaceutical supply chain not only involves pharmaceutical manufacturers, but also multiple parties such as wholesalers, pharmacy retailers, pharmacy benefit managers and payors. These parties all play a role in determining access to, and the ultimate retail price of prescription drugs.

Dan Hammer of 790 AM Fargo Moorhead interviewed me on the high cost of EpiPen®. I prepared a variety of information to share with Dan on the topic of food allergies and epinephrine, but there’s only so much time in an interview, to be exact 13 minutes and 52 seconds. ; ) Click here to listen to the full interview.

Here’s a list of suggestions on how to save money on the EpiPen® as well as other prescription drugs in your household.

Continue reading

Teaching your child to care for his food allergies

Teaching your child to care for his food allergies is like creating a stepping stone path. Parents and caregivers take a highly complex topic (food allergy care and independence); break it down into incremental steps to meet the child where he/she is – physically, mentally, emotionally and developmentally.

My life with food allergies began almost 11 years ago with the birth of my son. He was vomiting before we ever left the hospital from delivery and I was told that was due to a poorly developed digestive tract. Fast forward 11-months later, after struggling with reflux, transitioning to baby and table food, unexplained hives and eczema and labeled as borderline failure to thrive; we finally had a diagnosis of food allergies to milk, eggs, peanuts, tree nuts and sesame. I’ve learned a lot along the way, so I thought I would share some tips on how to steadily grow your child’s independence in an age appropriate way.

THE BEGINNINGS: Teaching Your Child to Care for His Food Allergies

Teach your child what he/she is allergic to using different methods.

Teaching Your Child to Care for His Food Allergies

Image courtesy of photobucket / How to Ask Me

Teaching your child to care for his food allergies means bringing it down to your child’s level. Place pictures, along with the words, of your child’s allergens onto a piece of paper and tape it to the back of the headrest in the car. This teaches a child in two ways (1) visually seeing the pictures and words and (2) verbally, by periodically asking, “What are you allergic to?” My son rattled off his list of allergens in no time. This is also a great tool for learning a home address and phone numbers. Google Images and Photobucket are great places to gather images.

A second way is to casually, and by casually I mean in a non-alarming way, introduce your child to his allergens while you’re at the grocery store. It’s important for him to see the allergen in the bag, e.g., these are peanuts. The jug on this shelf is cow’s milk. The cartons in this display case are eggs, etc.

Explain to your child why his food is sometimes different than what other people are eating.

It’s natural for your child to see certain foods and want to try them, even if they are unsafe. At a very young age, explain that certain foods are not good for him because it will make him sick, and then divert him to the large variety of foods that he can partake of. It’s important to focus on what one can have rather than what one cannot have, concentrating on the positive versus the negative. For example, instead of saying, “You cannot have that ice cream because you’re allergic to milk.” Say, “That ice cream does look delicious, but this soy ice cream is just as yummy and safe for you.” 

At a young age, teach your child how to read labels because it’s confusing and takes some time to learn.

Teaching Your Child to Care for His Food Allergies

Teaching your child to care for his food allergies means discussing how to read ingredient and manufacturing labels at a very young age. When the time comes for him to take the reins…HE’LL BE READY! : )

Reading labels is confusing for parents, let alone children. Show labels to a child early not only to instill the habit of looking, but learning the variety of names for an allergen, i.e., milk isn’t just milk, it’s casein, whey, etc. Your child will be able to help make educated decisions, along with your help, so that one day he will make well-informed decisions on his own.

In addition, it’s just as important to understand how to read manufacturing labels. Your child needs to know that anything “manufactured on shared equipment,” “in a facility that manufactures” their allergen or “may contain” labels are not safe food options. Moreover, just because a label does not disclose their manufacturing practices, doesn’t mean it’s safe, rather it requires a telephone call to the manufacturer to inquire about their manufacturing processes. Continue reading

EpiPen® hold time is now 3 seconds

The EpiPen® hold time is now 3 seconds and there are other administration guidelines that the FDA has changed due to lacerations and injuries related to usage. There are three points of change listed below; however, you can read the FDAs document in its entirety:

  1. Restrict Patient’s Leg, limit movement during epinephrine administration

    EpiPen® hold time is now 3 seconds

    Image courtesy of Mylan

    Lacerations, bent needles and embedded needles have been reported when epinephrine has been injected into the thigh of a young child that is moving, kicking or uncooperative during administration. To minimize the risk of an injection-related injury it is advised that caregivers hold the child’s leg firmly in place and limit movement prior to and during the injection.

  2. EpiPen® hold time is now 3 seconds

    The EpiPen auto-injector should be held firmly in place for 3 seconds prior to removal.

  3. Serious Infections at the Injection Site

    Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site

This information came on the heals of the Minnesota Children’s Health Network finishing a revamp of their Anaphylaxis Action Plan, it was an honor to serve on the committee that examined and enhanced this Plan. The FDAs new administration guidelines will be included in the revamped Anaphylaxis Action Plan that is set to release just in time for the 2016-2017 school year.

If you’re looking for more information, be sure to: check out Mylan’s EpiPen® website, read the box insert of a newly filled EpiPen® prescription, contact a Mylan Customer Relations Representative at 800.395.3376 or speak with your physician.

PLEASE SHARE THIS IMPORTANT LIFE SAVING INFORMATION WITH OTHERS!!!

Food Allergy and Inclusion

Kristin Beltaos interviewed by Katja Rowell, M.D. for Extreme Picky Eating Help

Food Allergy and Inclusion: Introduction by Katja Rowell M.D.: Children may face eating challenges for various reasons. Children with extreme picky eating tend to experience higher levels of anxiety, around food and in general. Perhaps the most anxiety-provoking feeding challenge that parents face is life-threatening food allergies. Some children with extreme picky eating also struggle with food allergies, which can complicate the picture even further. Kristin Beltaos has made it her mission to help parents and children not just be safer and healthier, but thrive. We were intrigued and impressed with Kristin Beltaos’ work with parents, children, and schools (A Gift of Miles). She has graciously agreed to share some wisdom in our first guest blog post.

1. Food Allergy and Inclusion – Spotlight of Difference intrigues us. Can you tell us more?

First off Katja and Jenny, thank you for the opportunity to communicate with you and your followers.

food allergy and inclusionUsually when you think of placing a spotlight on a child you think of something positive, i.e., accomplishing an awesome grade, playing a great sport game, writing a wonderful paper or doing well in a recital. These are all great ways to shine a positive spotlight on a child.

It’s fascinating how when we are confronted with a challenging situation, such as creating a safe environment for a food allergic child, our initial instinct is to determine how a child will adapt to our environment, rather than how the situation can be modified so that it’s safe for everyone. When we only address the individual child it will almost always create a Spotlight of DifferenceTM.

In our efforts to create safe environments for children with food allergies, parents and schools alike often shine an unnecessary Spotlight of Difference TM on these children that I believe is a catalyst for anxiety in food allergic children as well as food allergy teasing and bullying. We need to understand that safety does not always equal separateness and vice versa. I believe it’s our inability to view the picture creatively and holistically that causes us to go the easy route and shine an unnecessary Spotlight of Difference TM.

When I use this in my training, I have attendees actually work through real life examples on how to create more inclusiveness and diminish the Spotlight of Difference TM. It’s really stirring to see people get creative and excited about how to make life for a food allergic child better. I think so often we don’t like what is happening, like an allergy table, but we don’t take the time to think about how we can do it differently.

2. Food Allergy and Inclusion – How does this relate not just to food allergies, but also children with extreme picky eating, and even beyond food, to other differences?

I think we shine a spotlight more often than we think. Let’s examine when treats are used for incentives, rewards and celebrations.

Food Allergy and InclusionI always like to share about the first year when my youngest son was old enough to eat Halloween candy. My youngest son sat down to Twix®, Milky Way® and Hershey® candy bars while my child that has food allergies had in front of him Starburst®, DOTS® and Smarties®. You cannot look at these treats and equate them as being in the same category. You can’t “sex up” the non-chocolate treats, there’s just no comparison, unless of course you aren’t a chocolate fan.

My point is, you wouldn’t have your child’s three friends over and provide three of the children with delicious chocolate and one child with the other variety. How do we solve this dilemma? If you’re having a school-wide celebration, then that means finding a treat that is safe for all based upon all the dietary restrictions whether that be food allergy, food intolerance, diabetes, Celiac disease, autism, extreme picky eating, ADD, ADHD, etc. If you’re having a classroom celebration then that means finding a safe treat based upon the dietary restrictions within each classroom.

Spotlights don’t always have to be related to food. Each child may learn to read or understand math at a different pace. Stickers, colors, or Popsicle sticks may be used to track progress. Peers will know what level you are at in reading based upon the tracking system utilized. Children may be called out in the hall, to at a separate table or moved to a different classroom for assistance. If a child is learning at a slower pace, he/she may feel embarrassed. I don’t have the answer to this type of spotlight, but as you can see, often times we probably don’t even know that we’re shining a spotlight on a child.

While it may require additional planning, many schools have successfully found ways to socialize, celebrate, incentivize, reward, learn and craft without food or within restrictions surrounding food. It simply takes a little extra effort, and more importantly; just imagine the difference you make in a child’s life that is dealing with a challenge.

To read the rest of the interview about Food Allergy and Inclusion, click to enter the Extreme Picky Eating Help website.

Food Allergies Are More Than An Awkward Moment

Food Allergies Are More Than An Awkward Moment or Two

Food allergies are more than an awkward moment, yet when you are a parent to a child with a food allergy, or you are the person who has the food allergy…most of the time you feel like you’re asking for special treatment rather than a safety requirement. We’ve all seen the eye rolls, the teasing, the telling glances and even some “friends and family” that are embarrassed of our constant questions. I have always said, “Who would ever choose to live this way?”

John Espinosa messaged me over LinkedIn and shared with me his recent food allergy experience that opened his eyes and caused him to find his voice! I’d like to share his post with you because as I advocate for my son and for other children that have food allergies I realized John’s message needs to be heard LOUD AND CLEAR. He exemplifies everything that we want our kiddos to be…to be confident enough to know who they are and what they need! We want our children to believe and communicate his same messages: “My life should be worth more to you than an awkward moment or two.” and “I’m empowering those who are peer pressured towards death to fight for their lives.”

Join me in READING his story and be sure to SHARE HIS BRAVENESS with others:

“Friday Feburary 26th was a wake up call. A white chocolate chip macadamia nut (… really cashew) cookie landed me square in the hospital. That Friday, I learned to be adamant when it comes to food allergies. Show me an ingredient list. Call out friends that snicker or roll their eyes when I ask the waiter to clarify whether kitchen equipment is scrubbed well between meals. Shut down people who bother me about how my epipens make my pants look clunky.

I AM DONE feeling like an “inconvenience. Continue reading

ALLERGY PETITION: Please Sign!

Allergy Petition — Your signature is needed!

 
PLEASE sign this allergy petition! Whether you take allergy shots or not, I AM ASKING FOR YOUR HELP! Patients are in jeopardy of not being able to start or continue in their current therapy! Allergists must be able to offer this therapy to their patients. Please read further and sign the petition, IT ONLY TAKES A MINUTE! You will be doing a service to many patients who depend on this treatment, including my son, husband and myself!
Allergy shots, also known as immunotherapy, are an important treatment that has improved the quality of life for many allergy patients: reducing symptoms, decreasing medication costs, and reducing hospitalizations and trips to the emergency room.
However, new regulations threaten to make allergy shots unavailable to many patients in the United States.
The United States Pharmacopeia (USP) is introducing new regulations that would change the procedures for mixing the allergen extracts used in immunotherapy treatments. The new requirements would make it highly unlikely that allergists would be able to continue to mix allergen extracts for their patients in the office setting. Having to use outside facilities to obtain the allergen extracts will make it very difficult or impossible for most allergists to continue offering this treatment for their patients.
How can we help?
The American Academy of Allergy, Asthma & Immunology (AAAAI) is circulating a petition to tell the USP that allergy patients are considered about the proposed changes impacting access to immunotherapy, and that the current regulations should remain in place. You can also submit a public comment to the USP to voice your concerns. To submit a comment, visit the USP website, scroll to the second to last paragraph, and click on the link to the submission template you must use. Download the template, write your comments under the general comments section, and email it to CompoundingSL@usp.org by January 31st.
I appreciate your involvement both personally and professionally!
Kristin Beltaos, M.A.
Consultant and MNCPD Licensed Trainer
612.845.7585
Kristin@agiftofmiles.com
http://www.agiftofmiles.com

Create A Support System You Want and Need

Create a support system that you want and need sounds like an enormous undertaking, especially in the sometimes-harsh, female environment of snobbery and cattiness. I have wondered, is there room for friendship with women who are self confident, yearn for a true connection and mutual support through all phases of life while making beautiful and fun memories together?

Creating a support system is challenging, but can be done.

Who wouldn’t want friends like the women from Sex and the City?! They laugh, cry and fight…but are always supporting one another through it all.

I’ve spent a good portion of my life trying to find my Sex in the City version of best friends. I’ve had plenty of friends in my life; but I’ve never had the feeling, deep in my heart that these girls were here to stay. Many of my friendships felt temporary, like a new tube of mascara, short-lived as it clumps, flakes and dries out in due course. I want women who, despite our different natures, find one another inseparable as we live out the storylines of our everyday lives.

Now that I’m in my, ahem, late 40s I can finally say that I feel like my Carrie, Samantha, Miranda and Charlotte are found…and I’m grateful that there are more than four fabulous women that have agreed to take me on as friends for life. ; ) A friend of mine (MK are her initials) once said to me, “I’m in this for the long haul.”

Many women have confided their difficulty in developing close friendships. I’d like to share how I managed to create a support system of beautiful women.

To create a support system means examining what kind of friend you are.

To have good friends, you must be a good friend. Be sure to clean up your clutter in order to create a support system you want and need!

To have good friends, you must be a good friend. Be sure to clean up your clutter!

“Maybe the past is like an anchor holding us back. Maybe you have to let go of who you were to become who you will be.” ~ Carrie Bradshaw

I read this interesting entry from Karol Ladd several years ago and it has stuck with me ever since, The Seven Qualities of a Good Friend. Take the time to read her entry as it’s a great way to examine what kind of friend you are. Be sure to commend yourself for your greatness and clean up the clutter that is preventing you from being the very best you can be. To create a support system, this is the first step.

Be brave enough to ask for what you want and need.

“Be bold enough to use your voice, brave enough to listen to your heart, and strong enough to live the life you’ve always imagined.” ~ Carrie Bradshaw

This one is a toughie for many, including myself. Recognize that it’s ok to ask for help, a listening ear, a closer friendship, an afternoon or night out on the town. If you don’t ask, you won’t get and if you don’t get, you’ll just continue to feel unfulfilled.

My parents are deceased, my in-laws are out of state and elderly, my brother is in California and my sister is in Massachusetts so family support is not readily at my fingertips. I had to start asking a few of my close friends if they would be my family, aunts to my boys or I would continue to feel isolated and lonely. This wasn’t easy for me…but the positive end result outweighed any anxiety I had in putting myself out there.

When you ask for what you need, be sure to clarify what family means to you and how you want to create a support system of mutual comfort. If you’re really nervous, use your sense of humor to deflect any discomfort, “I would like to have you as my family, not in a Jerry Springer way, but more along the lines of Oprah.” You get the same point across, yet explain there’s no crazy to be had. ; )

Be vulnerable enough to share.

“Maybe we can be each other’s soul mates.” ~ Charlotte York

Be vulnerable enough to share your life with others. It's the first step to create a support system you want.

Be vulnerable enough to share your life with others. Letting people in is the second step to create the support system you want.

Life has given us all a bunch of lumps along the way. Many times these lumps are truly blessings, becoming a part of our fabric and forming us into who we are.

Our ability to be vulnerable defines the closeness of our friendships. Check out this entertaining, funny and candid TED Talk from Brené Brown, she is a personal favorite of mine, on The Power of Vulnerability.

Remember after you watch the 20-minute video: We are all storytellers. We are all worthy. We all have the ability to fully embrace vulnerability. We are enough. We all want to create a support system.

Friendship needs more than a 90-minute download.

A BFF and I excited for our trip to Seattle. Create a support system by traveling with your friends.

A BFF and I excited for our trip to Seattle.

Friendships don’t magically last for forty years, you have to invest in them. ~ Carrie Bradshaw

I spoke at a conference in Seattle recently and one of my Sex and the City girls agreed to travel with me and be my Karen, Grace’s personal assistant from the show Will and Grace. In my 46 years, it was the first time that I had ever traveled with a girlfriend. In addition, it was the first time I had left my children since my eldest was 18-months old, he’s now 10.

The trip to Seattle made me realize, there is so much more past the 90-minute download. Whenever I would meet up with a friend for lunch or dinner, shopping, a movie whatever…there’s this 90-minute download that always happens to get one another caught up with what is happening in each other’s lives.

After the 90-minutes, that’s where your friendship’s story begins…

You laugh, you begin to enjoy yourself in a different way and a bond forms that one cannot experience in the traditional 90-minutes. Circling back to my Seattle trip…there were memory burns made on that trip. We were able to get outside of our roles as mothers, wives, cooks, bill payers, and of course, Queen of the Toilet Scepter. We were able to step outside of these roles and become women, our truest selves who were travelling and fulfilling our own needs, talking about what is important to us and just plain being silly.

For those of you with young ones yet, I know it sounds like it might never happen…but it will. It did for me finally at 46! Speak with your husband or partner on how to create this kind of opportunity, it doesn’t have to be a travel trip but even just day away with a friend or friends. To create a support system, you need to invest time. Continue reading

Self Carry Epinephrine: When Can My Child Carry?

Lots of questions arise when a child should self carry epinephrine.

As a child grows in independence when should a child start to self carry epinephrine? Image courtesy of Photobucket

“When should a child self carry epinephrine?” I’m asked this question a lot. First of all, it’s a decision between you and your spouse, your child and your allergist or pediatrician. It’s important to remember that we need to meet our child where he/she is developmentally and from a maturity standpoint. School staff often say to me, “We have a kindergartener that is able to self carry epinephrine, why not this child?” Ok, that’s fine if that is what the parents, physician and child have decided. However, just as 504 accommodations are not cookie cutter, meaning what works for one child may not work for another child, either is self carrying epinephrine.

When your child is ready to take on a more active role in his/her food allergy management, consider reading these posts. From the American Academy of Allergy Asthma and Immunology: age appropriateness for self-administering epinephrine and when a child assumes responsibility for self-treatment of anaphylaxis.

I haven’t come across anything written on when to transition your child to self carry epinephrine and so I decided to share with you how I have started to navigate this path. Hopefully it will give you some ideas on how to handle your child’s growing independence.

When is my child ready to self carry epinephrine?

As with many food allergic children our son is an old soul who is mature beyond his years. We were able to explain complex information, at a very young age, and knew it was understood. As a result, he became well-organized in his daily routines and knows how to take care of himself and manage his food allergies. Continue reading