Allergy Shmallergy

Simplifying life for families with food allergies.

FDA Review of Aimmune Peanut Therapy September 13, 2019

 

I was so honored to be chosen as a speaker at the US Food & Drug Administration’s (FDA) Allergenic Products Advisory Committee (APAC) meeting (September 13, 2019).  The purpose of this groundbreaking hearing was for the APAC to have a discussion and make recommendations to the FDA on the safety and efficacy of Aimmune’s AR101 peanut allergy treatment at reducing the risk of severe allergic reaction (anaphylaxis) after accidental and unintended exposure in children and teens with peanut allergy.

 

Representatives of major food allergy non-profits, knowledgable doctors with deep experience with desensitization, experts in psychology, the underserved population, patient advocacy as well as affected families offered an honest and complete picture of the lives and challenges of living with food allergies to the APAC panel.  Testimony focused on quality of life, psychosocial impact of food allergy, daily challenges, and unmet needs.  Discussion also centered on medical guidance, patient choice in regards to risk/benefit of AR101, and education as it relates to AR101 therapy.

 

It is my hope that the committee approves this treatment.

 

Until now, food allergy families have had only one management option: avoidance.  If the FDA approves AR101, it will standardize dosage, treatment protocol and, hopefully, increase its accessibility.  AR101’s approval could pave the way for more treatment options down the road.

 

As of now, APAC is still debating and arriving at their decision.  Stay tuned for an update.

 

Here is the testimony I gave today:


Erin Malawer

Executive Direction, AllergyStrong 

 

Food allergies are a challenge that affect both the physical safety as well as mental health of patients and caregivers.  Bringing AR101 (Palforzia) to market as a treatment option has the potential to greatly improve quality of life for these families.

 

What is the experience of having food allergies for patients?  In the words of my 14 year old son, “it’s a second, full-time job.”  And it starts the moment patients wake up beginning with:

  • The toothpaste they use to brush their teeth;
  • The sunscreen they wear;
  • The laundry detergent they wash their clothes with; and
  • The lip balm wear when I kiss my son goodnight.

 

Everything is a risk.

 

And, then there’s the FOOD!  Meals, snacks at school, the baseball stadium, the movie theater.  Patients must be knowledgeable about ingredients; how and where food is prepared and processed; as well as how to communicate and educate others about their condition.  The burden falls on families and caregivers to prepare safe food for holidays, school celebrations, birthday parties, field trips, and travel.

 

The thought and preparation is endless.  Food allergies are always on our minds.

 

Anything misread, any small misstep could potentially endanger a patient’s life.

 

 

The solution we’ve been given to keep him safe is simple, but daunting:  Avoid.

 

In order to do that effectively, each patient and their caregivers must understand both the seriousness of food allergies and the risks of cross-contamination.   But, we also need to be intimately familiar with labeling laws and loopholes as well as manufacturing practices. 

 

That keeps my child relatively safe at home.  But what about when he – and millions of other allergic children – step outside and navigate the real world?

 

Avoidance is challenging – it relies on the understanding of others – who are less experienced – for our health and safety.  Avoidance is cumbersome – labeling laws are incomplete, manufacturers aren’t always forthcoming and decision-making, even at its best, is difficult.  Avoidance accepts food allergies and all the associated worry, guilt, and burden as a life sentence and – because we all make mistakes – it accepts reactions as an inevitable. 

 

From an early age, my son understood these risks.  He has lived under the stress and reality that the next meal could cost him his life. 

 

At age 8, my son educated his own grandparents on what it’s like to live with food allergies.  “Grandpa,” he said, “I can’t be careful 75 percent of the time.  I need to be perfect 100 percent of the time.”

 

AR101 has the potential to change that.  If only he could have undergone treatment to lessen that incredible emotional burden.  AR101 (Palforzia) has the potential to make childhood easier for food allergy families.

 

Food allergic children and caregivers often struggle with anxiety, depression, and social isolation.  Many children experience bullying at the hands of peers as well as adults. 

 

In desperation, families are sometimes driven to turn to unregulated alternative treatments that leave them vulnerable and at risk.  Allowing for well-studied, standardized, accessible food allergy treatment outlines an established course of action for those looking for help.

 

AR101 (Palforzia) would be life changing for patients.  It offers much-needed hope for food allergic families; relieves mental strain on the patient as well as caregivers; allows room for inevitable error; and it dampens accidental exposure and threat of severe reactions.

 

It could specifically be transformative for patients in underserved communities where food allergy resources are often lacking, where emergency room visits are more common, and where reliance on those outside the food allergy community is necessary. 

 

I’d like to end by saying, at the present time my own child is ineligible for this treatment.  No matter what the outcome is today, he will continue to live under the specter of food allergies.  But professionally, I must advocate for patients who lives can be improved by AR101 (Palforzia) and the possibility of leading a more normal life. 

 

With this treatment, it may be possible for food allergy families to thrive and not merely survive.


 

 

 

“Spell It Out” PSA – The ABCs of Food Allergies September 10, 2019

Food allergies are a life-threatening condition that know no race, gender or economic status.  However, lack of awareness, education and preparedness are disproportionately affecting underserved families and communities where there is a higher percentage of dangerous reactions as well as higher costs of emergency care.

Filmed at a school that serves this population using real students with food allergies, “Spell It Out” is a public service announcement aimed at school children and their caregivers that addresses several key concepts about food allergies that are often misunderstood:

 

  1. Food allergies are real.  

Food allergies can be serious and life-threatening – different from a food intolerance which is an uncomfortable digestive condition but not life-threatening.

 

  1. Anyone can be allergic to any food at any age.

Food allergies are not simply a passing childhood condition. In fact, recent findings tell us that 1 in every 10 adults have food allergies, too.  And, despite their reputation, peanuts are not the only food to cause a serious reaction – you can be allergic to almost any food.

 

  1. Food allergies should be monitored by a doctor.

If you experience symptoms after eating, it’s important to talk to a doctor or nurse.  They can confirm a diagnosis, teach patients how to manage their food allergy, and help them get epinephrine – the only medicine capable of slowing or stopping a life-threatening reaction.

 

“Spell it Out” comes straight from the thoughtful and generous heart of Sammi Mendenhall, an Emmy-nominated producer who admits to being “that person who demanded peanuts on airplanes.” But after seeing the tragic story of Elijah Silvera on the news, she knew she had to learn more and educate others like herself.  She envisioned a project that could help and give a voice to those most at risk.  This project is a result of an amazing collaboration between several powerful advocacy organizations: End Allergies Together, AllergyStrong, Change for Kids, Elijah’s Echo, Natalie Giorgi Sunshine Foundation and Red Sneakers for Oakley.

 

Please visit spellitoutpsa.org for more information.

 

Feel free to share “Spell It Out” with your school – and contact us if you’d like information about an educational school visit for AllergyStrong or one of our outstanding partners.

 

Open Sesame: Prevalence of Sesame Seed Allergy & Progress in Labeling August 22, 2019

hummus-1058001_1920

If you have a sesame allergy, you know how hard it can be to determine whether a food is safe for you or not.  [Read here for more information on the challenges of living with a sesame seed allergy:  Sesame: The 9th Food Allergen?]. Patients and caregivers need more transparency and advocates have been asking the government for this change for years.

 

Last year, the U.S. Food and Drug Administration finally listened and requested additional information to evaluate whether to require food manufacturers to include sesame seeds (and its derivatives) on their ingredient labels.

 

In response, researcher Dr. Ruchi Gupta, Christopher Warren, Avneet Chadha, Jialing Jiang, and Dr. Scott Sicherer got to work figuring out how prevalent a sesame allergy really is.

 

Warren, Chadha and Sicherer revealed that 0.49% of the total US population are allergic to sesame seeds and its derivatives – more than doubling previous estimates.  This equates to approximately 1.6 million patients in the U.S. alone.  This means, more people are allergic to sesame than some tree nuts – for which the FDA currently requires labeling.

 

Their research also found that:

  • 1 in 4 patients developed their sesame allergy as adults
  • Sesame allergies tend to co-occur with other food allergies:
    • Half with sesame allergy are also allergic to peanuts
    • 1/3 also allergic to tree nuts
    • 1/4 also allergic to eggs
    • 1/5 also allergic to dairy

Furthermore, reactions to sesame tend to be more severe.  In fact, sesame is one of the top three allergens for which doctors prescribe epinephrine auto-injectors.

[For a look at the original study by Dr. Ruchi Gupta, Christoper Warren, PhD; Avneet Chadha; Dr. Scott Sicherer, et al, please see Prevalence and Severity of Sesame Allergy in the United States.]

What’s being done to include sesame on food labels?

A lot, actually.

 

First, the FASTER Act (H.R. 2117).  FASTER, which stands for Food Allergy Safety, Treatment, Education and Research, is a federal bill which includes improving the health and safety of those living with food allergies. The bill covers a wide variety of things including adding sesame to the list of food manufacturers must label properly for.  The FASTER Act was introduced to Congress in April 2019.

 

supermarket-949912_1920

 

Thanks to the amazing efforts of State Representative Jonathan Carroll, Illinois is now the first state to require sesame labeling on all foods just as they would under the federal law FALCPA.  Rep. Carroll hopes that law HB2123, now Public Act 101-0129 (July 26, 2019), will inspire other states to follow Illinois’ lead in protecting its citizens with food allergies.  Illinois is doing a lot of things RIGHT for their residents with food allergies!

 

So what can YOU do to help get sesame labeled under the Food Allergen Label and Consumer Protection Act (FALCPA)?

 

Right now, representatives are back home hearing from constituents.  Now is a great time to contact your local congressman or woman and encourage them to support the FASTER Act (H.R. 2117).

  • Tell them about the challenges of living with a sesame allergy.
  • Let your representatives know that the U.S. is one of the only industrialized nations that does NOT label for sesame at present.  The EU, UK, Australia and Canada already include sesame seeds on their labels.
  • Ask them to consider sponsoring a state bill, like the one in Illinois – this is how the stock epinephrine program became so successful.

 

And, please leave a comment below so that others can benefit from your experience advocating and listening to your local representatives as they speak to theirs.

 

 

Crafting a Comprehensive Food Allergy Policy at School July 23, 2019

cafeteria education-662458_1920

 

Across the country, schools create and reshape policies to balance the needs of their many students.  Every school should – but so often don’t – have a food allergy policy.  This policy should protect students with life-threatening food allergies – and it should be noted that although peanut allergies tend to provoke some of the most severe reactions, an allergy to ANY food can turn deadly. [Read about other allergic reactions here and here, for example.]

 

A food allergy policy is critical to give parents and their food allergic students guidelines about what to expect while their children are at school.  In addition, policies surrounding food allergies allow parents to prepare their children to safely manage their allergies in their school’s setting and gives parents and teachers time to prepare anything they need to keep their student both safe and included at school.

 

Where should schools begin?  And what should schools consider as they think of updating their current policy?

 

Some factors schools may wish to consider when formulating an inclusive food allergy policy and procedures:

 

  1. Creating a culture of inclusion and empathy:  What kinds of lessons are students receiving as part of their social-emotional learning?  What kinds of messages are students taking away from role models?  Does the behavior they see match the kindness and inclusion the school expects?  Read Including Food Allergic Students at School to review the many simple ways to begin the process.
  2. How and where to store epinephrine: Is the nurse’s office centrally located or would it be wise to also store epinephrine with a trained administrator closer to a lunchroom or classrooms?
  3. Keeping stock or unassigned epinephrine: In many states, schools are allowed to store epinephrine auto-injectors that are not prescribed to a particular student.  These stock epinephrine auto-injectors may be used with anyone who experiences a severe allergic reaction.  In a nationwide study, stock epinephrine is used in 38 percent of reactions that happen at school. That means approximately 30% of reactions happen to students and staff without a known allergy.
  4. Nursing schedules and availability: Who is trained to recognize the signs of a food allergy reaction? Do they know what to do in an emergency?  If the nurse is unavailable, who is responsible for handling this kind of crisis? Severe allergic reactions (called Anaphylaxis) are extremely serious and require IMMEDIATE attention.
  5. Hand washing:  Hand sanitizer does not remove food protein.  So actual hand washing is required when handling a student’s allergen to prevent cross-contamination. When and where should teachers enforce this habit?
  6. Communication with parents: Families of food allergic students need advance notice to make alternative arrangements for their children.  Schools benefit from this type of forethought as well.  For example, an upcoming in-school event which appeared to a teacher to be a problem for my food allergic son, turned out to be easy to manage with a few easy tweaks to the plan after we discussed the details involved.
  7. Availability of food storage space (for food allergy-friendly snacks and treats): whether the school supplies allergy-friendly snacks or families send them in, deciding where to store them for convenience and how to label them so that they are easy to identify is helpful.
  8. Field trip protocol: How will epinephrine accompany a student when he/she is off school grounds?  Who is trained to recognize symptoms of an allergic reaction and know what to do in such an emergency?
  9. The bus ride:  Are the students allowed to eat on the bus?  Do they anyway?  Is the bus driver prepared or trained to administer epinephrine if needed? Are students allowed to carry their own medication on the bus?  Is this feasible for your students based on age, maturity, income level, etc (epinephrine auto-injectors are costly in some cases)?
  10. Classroom events:  birthdays, celebrations, holidays, and special events.  Specific guidelines for what is and is not allowed must be set as well as strict adherence to the policy established. Food allergies are NOT a preference. They can result in hospitalization in a matter of minutes.
  11. Nut bans: Worthy of a separate article and discussion, schools need to weigh the burden/reward of banning nuts entirely.  And they need to discuss the extent of the restrictions (will it extend to cross-contamination warnings like, “made in a factory with…”) and how to enforce them.

 

food-2589686_1920 StockSnap

 

Faculty and staff should be educated and re-educated about food allergies each year.  They must learn to recognize the signs of severe allergic reactions (called anaphylaxis) and what those symptoms might sound like in the words of a young child. They need to learn how to react to an allergic reaction.  Understanding the basics of cross-contamination and ingredient label reading, among other lessons, will help protect food allergic students in their classrooms.

 

Clear policies that are consistently enforced, as well as appropriate and reasonable accommodations,  will help teachers, administrators and students alike have a safe and fun school year.

 

Effects of Heat and Cold on Epinephrine Auto-Injectors June 24, 2019

It’s that time of year again!  Camp, beach time, days at the pool…    Does weather change how you carry your epinephrine?  It should.

swimming-170608_1920

 

Available in auto-injectors, epinephrine is the only medicine available that will slow or stop the life-threatening symptoms of a severe allergic reaction, called anaphylaxis.  Because no one plans for an emergency and allergic reactions can be both variable and unpredictable, patients must carry two epinephrine auto-injectors  (EAIs) with them at all times.  Yes, even to the pool.

 

The Ideal Temperature

Epinephrine is temperature sensitive, making it a tricky accessory to carry in the summer and winter months.  To remain 100 percent effective, epinephrine must stay at room temperature (68-77 degrees Fahrenheit or 20-25 degrees Celsius). Short trips between 59 and 86 degrees Fahrenheit won’t harm the product, according to researchers.

 

sun-1651316_1920

Effects of Heat

Research has shown that prolonged exposure to heat can degrade the strength of epinephrine.  And, constant heat resulted in bigger change in epinephrine.

 

 

Confusion

Although short-term exposures outside room temperature conditions are safe – researchers and doctors don’t often define what “short-term” means.  A few studies looked at “real world” temperature fluctuations, mentioning that little or no significant change in epinephrine was observed under these circumstances.  But, what constitutes “real world” and how many degrees outside of the ideal window (68-77 degrees Fahrenheit) is too high?

 

It IS, however, worth noting that keeping an EAI in the car is not a good idea as it often puts the auto-injector FAR outside that ideal room temperature and affects the quality and effectiveness of the epinephrine.  Temperatures inside parked cars even on a mild can soar well beyond 100 degrees in just a few minutes (read more here).  

winter-1127201_1920

Effects of Cold

Recent studies have shown that epinephrine doesn’t appear to degrade if accidentally frozen.  However, if the medicine is kept below freezing, the epinephrine can freeze despite the fact that the auto-injector may still fire – making it useless in an emergency.

 

To Each Injector His Own

Each epinephrine auto-injector is constructed slightly differently.  Extreme heat or cold may not only affect the epinephrine – it might interfere with the mechanism that delivers this life-saving medicine.

 

Watch the effects of extreme heat and cold on EpiPens: please see Allergy Superheroes post, Epinephrine Abuse Experiments – it is very enlightening.

 

Discoloration

Many who carry EAIs point to the color of their epinephrine (shown in a little window on EpiPen brand EAIs) as a way to judge if it’s still potent or viable.  According to manufacturers and pharmaceutical companies, this method isn’t a sure bet.  If your epinephrine is discolored or cloudy, then it is no longer good.  However, if it appears clear, this does not necessarily mean it hasn’t degraded or otherwise expired.

Words to Carry By?

Don’t judge an auto-injector by it’s [lack of] color.  The best way to ensure your epinephrine auto-injector will work properly and at full strength is to keep it as close to room temperature as you can and within its expiration date if possible.

 

Do your best and get out there and enjoy the weather whatever it is!

 

 

 

Join the Food Allergy Fighters – Race for Every Child June 3, 2019

 

**Registration is FREE until Wednesday, June 5th!**

 

Come join us!  All are welcome to join the team, The Food Allergy Fighters, for this year’s Race for Every Child.  The Race for Every Child 5K will be held on October 19, 2019 beginning at Freedom Plaza in Washington, D.C.  You can participate in person or virtually, as a walker or a runner, individually or with the whole family.  Children ages 3 to 10 can also participate in the 100 yard Kids’ Dash.

 

When you support the Food Allergy Fighters, you are making a difference for all food allergy patients – here and around the world. Our team will specifically raise funds to advance food allergy research.

 

Children’s National Medical Center in Washington, D.C. is on the forefront of both clinical medical as well as psychological research as it pertains to food allergies.  They run an exemplary program that is always evolving for the better.

 

hospital-79605_1920

 

Every dollar raised through the Race for Every Child enables Children’s National to advance pediatric health and provide world-class care to every child, regardless of illness, injury or ability to pay.

 

Please join us – register here!

 

Once you register, please create a profile and share with friends and family – all are welcome!

 

Thank you for your participation and we look forward to seeing you at this meaningful, family-friendly event this fall!

 

 

 

 

 

 

Food Allergy Advocacy – A Day on Capitol Hill May 16, 2019

When you live with a chronic disease like food allergies and asthma, you need support – the support of family and friends, but also support from the outside world.  Fifty-eight million people suffer from either asthma or food allergies.  Every year, 3,600 people die from asthma.  And, every 3 minutes someone is rushed to the hospital suffering from a severe food allergy reaction.  They are both serious and life-threatening conditions.

 

There are so many issues that need our collective attention – including legislative ones that support and protect patients with food allergies, asthma and other atopic diseases. We expect and are entitled to equal access to healthcare, research funding and education among other things.

When given the opportunity to join the Allergy & Asthma Network and contribute to the effort to better the lives of all food allergy and asthma patients, I jumped.  Over the course of one day, we visited fifty percent of all Senators and nearly 100 member of the House of Representatives.  We heard from doctors and nurses, families who have struggled within the existing healthcare system and those who have lost loved ones prematurely, and we were inspired by others striving to make lasting change.

Among the issues that need our attention are:

  • Access to quality, affordable healthcare
  • Access to affordable prescription medication and treatment
  • Continued and increased funding for federal health and research funding
  • Accurate and up-to-date food labeling

These issues translated into support for the following pending legislation that pertain to food allergy:

H.R. 1243/S. 523: Climate Change Health Protection and Promotion Act of 2019

Directs HHS to develop a national strategic action plan to help health professionals prepare for and respond to the public health effects of climate change.

My take:  Researchers are considering whether the way in which we produce and process our food has contributed to the rise in food allergies.  The nutrients that nourish our good bacteria in our microbiome has changed over the last 100 years.  Climate change has and will undoubtedly change the way we grow our food and the way in which our bodies respond to these changes.  

 

H.R. 2117:  Food Allergy Safety, Treatment, Education and Research (FASTER) Act

Requires that sesame be added to the current list of allergens that manufacturers are required to label for.  The bill would also provide the CDC funding to conduct data on allergy prevalence.

My take:  Sesame is the 9th most common allergen (and one of the fastest growing allergies in terms of prevalence) and it’s a particularly difficult one to avoid.  Ground into flour and paste, used as oil in beauty products, in addition to whole seeds, current labeling guidelines allow for sesame to be hidden in ingredient lists under general terminology like “spices,” “natural flavors,” and “seasoning.”  Customers want transparency in their food and beauty products.  And, labeling for sesame would bring the US closer to the [more thorough and higher] standards set in the UK, EU, Canada and Australia.

For more information on sesame seed allergies, please see Sesame: The 9th Food Allergen?

 

H.R. 2468  School-Based Allergies and Asthma Management Program Act

Increases grant preference to states that implement school-based asthma and allergy management programs (including student action plans and emergency medication administration education/training for staff).

My take:  Schools are concerned with how to handle the increasing number of students with food allergies.  And they should be.  Studies show that 30 percent of stock epinephrine use was for students and staff with no known history of allergies.  But schools lack the funds to improve and increase training on the emergency medication [epinephrine] that will ensure administration when it’s so critically needed.  Immediate administration of epinephrine is associated with more favorable outcomes during anaphylaxis.  Familiarity with the signs and symptoms of a severe reaction leads to accurate, faster treatment, better protection for students and reduces school liability.

 

Not in D.C.?  How you can advocate from where you are:

  1. Call your state’s representatives and encourage them to support these and other legislation that protects patients.
  2. Start local!  There are towns, cities and counties across the country that are doing things right.  For example, there are a few places where police and bus drivers are trained to carry and administer epinephrine.  Is your town one of them?
  3. Work with your state senators and local representatives to allow stock epinephrine to be placed in public venues.
    • In Connecticut, Representative Robin Comey is trying to pass legislation that does just that through Senate Bill 706. If you live in CT, contact your legislators and ask them to support 706 to give entities access to stock epinephrine and the ability to protect those experience life-threatening reactions.
    • In New York City, Elijah’s law (NY S218A) proposes to mandate training  and establish emergency procedures for early child care centers and preschools in New York City.

 

It is an honor and a privilege to help improve rights for patient and families like ours and to play a part in our government at work.  By representing all our voices, it was clear we illustrated what is important to constituents and elevated these important issues for our representatives.

 

Find your own way to keep the momentum going!