Allergy Shmallergy

Simplifying life for families with food allergies.

What the PFDD Meeting for Food Allergy Means for You September 23, 2021

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Early this month, the Food Allergy Collaborative (of which AllergyStrong/AllergyShmallergy is a founding member) and its generous sponsors hosted the Externally-Led Patient Focused Drug Development (PFDD) meeting for Food Allergy. This impactful event was held for the benefit of the U.S. Food & Drug Administration (FDA) who governs therapies for this condition and sets labeling policy.

The purpose of a PFDD meeting is to present the patient’s experience and perspective to the FDA so that they consider the needs and priorities of our community as they approve new treatment and set regulations. The PFDD for Food Allergy meeting enlightened the FDA about the challenges and hardships faced by patients of all ages and backgrounds, the types of treatments and therapies we would like to see approved, as well as the risks we are willing to face vis-a-vis treatment options.

Watch the Externally-Led PFDD

We encourage you to watch and share the video using this link: https://foodallergycollaborative.org/pfdd/.

We heard from patients from all over the country who voiced their experiences with food allergy. Throughout the meeting, some themes echoed over and over again:

  • The need for more accurate and informative diagnostics that are less invasive;
  • The need for accessible, affordable food that is contains easy to evaluate, accurate labeling;
  • The need for less invasive, easy to carry emergency medication; and
  • The need for long-lasting therapies that treat allergies beyond the peanut.

Another topic that was mentioned again and again was a priority to find and approve treatments for the 26 million adults living with food allergy. As one participant stated, “…current treatment is oriented towards children. Those children DO grow up.” Another panelist described her adult on-set food allergies with chilling effect. “One day, I was eating this food without any issues. The next day… it nearly took my life.”

The Food Allergy Collaborative captured the broadest experience possible to represent the incredible diversity of patients and their individual journeys with food allergy. This included patients of different socioeconomic backgrounds as well as those who live in different communities across the country. We had representation from young and older patients, those with and without multiple food allergies, within and outside the Top 9 most common allergens, with and without related conditions (like eczema, asthma and EoE), those who have undergone treatment and those who have not.

The Food Allergy Collaborative is looking for more voices and additional perspectives using the link below. Comments will be accepted for up to 30 days (October 8, 2021) for inclusion in the Voice of the Patient report.  Patients impacted by food allergy are asked to think about:

  • the burden of food allergies;
  • their diagnosis journey and the challenges associated with diagnosis and oral food challenges;
  • the challenges with avoidance and finding safe food;
  • the challenges and experiences with epinephrine auto-injectors;
  • their experience with treatment and clinical trials (how did it improve – or not – their lives? If they dropped out, why? What would they like to see in a treatment option?);
  • Acceptable/unacceptable risks for food allergy treatment; and
  • Desired goals for food allergy treatment/management.

We want to hear from you! Please submit your comments here: PFDD Patient Comments.

With this portion of the PFDD process behind us, the Food Allergy Collaborative is focused on the Voice of the Patient report. This report – to be published in Spring 2022 – will combine relevant research and survey data with the testimonies from the PFDD meeting and digital submissions.  This will offer the FDA the fullest picture of patient experiences possible, which will assist them as they review products which meet our communities’ needs.  The Food Allergy Collaborative has high hopes that our patients’ testimonies and the information that follows in our Voice of the Patient report will serve as an excellent resource for the FDA and other agencies as they evaluate treatments and consider policy for patients with food allergies.

 

AllergyStrong Presents at the Food Allergy Fund Summit January 28, 2020

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(My apologies! I am well overdue in posting about this excellent and always informative event.  Please be sure to see the full list of presenters and agenda on the Food Allergy Fund’s site.)

 

FAF Summit DC 2019 Erin Capitol

 

[Click here to watch the Agents Of Change panel video – Food Allergy Fund Summit DC.  AllergyStrong begins around 33:00/34:00 minutes in.  But be sure to watch the entire video – every advocate and their efforts are highly impressive and so vital to our community.]

 

In November, I had the good fortune to attend and participate in the always-fascinating Food Allergy Fund Summit held at the Newseum in Washington, DC.

 

With the Capitol in the background, CNN’s Chris Cilizza moderated a day that brought together a diverse group of speakers.  Researchers, legislators, doctors, advocates, innovators, journalists and celebrities treated attendees on the current state of food allergies.  Themes of the day included:

  • The role of the FDA and state of federal funding
  • The psychology behind food allergy management during adolescence
  • The intricacy and mystery surrounding immune cell response
  • The latest immunotherapeutic innovations
  • The gut and microbiome’s role in immunology
  • Advocacy efforts

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A major theme of the day was the underserved community.  Dr. Hemant Sharma, Director of the Food Allergy Program at Children’s National Medical Center and Chief of the Division of Allergy and Immunology, spoke at length about health and racial disparities in food allergy.  Dr. Sharma outlined the unmet needs to the underserved community and how Children’s National Medical Center has set out to address them.

 

The subject of the underserved community is near and dear to my own heart.  I began AllergyStrong to address the needs of the underserved community.

 

As such, AllergyStrong was proudly featured on the Agents of Change advocacy panel alongside passionate and driven advocates like Mary Vargas, Lianne Mandelbaum, and JJ Volupas, moderated by Allergic Living Editor, Gwen Smith.

 

The word “underserved” is an industry term that refers to patients who lack access to critical resources – in this case, access to food, healthcare and education.  The underserved community encompasses low income patients as well as food insecure families, minority populations – especially those who lack adequate language skills to navigate the healthcare system, rural communities where resources are not easily accessed as well as at-risk patients such as those who find themselves using public assistance due to extreme weather, fire, or other natural disasters.

 

AllergyStrong exists to help bridge the gap in health education and awareness.  Several disparities we try to address:

 

  1. Access to medical care and resources.
    We work to promote and provide food allergy education to communities through community health clinics and school nurses.
  2. Lack of education and awareness.
    To promote education and awareness, we filmed a public service announcement this summer in partnership with some outstanding organizations.  Our PSA, Spell It Out aims to clear up misconceptions about food allergies and inform students and caregivers about the basic facts of living with the condition.  AllergyStrong works with organizations such as schools and food pantries to bolster support and protection for patients with food allergies.
  3. Access to affordable safe food.
    We also work with social services and case workers who serve clients with food allergies to help usher families through a difficult time.

 

To stay in-the-know about AllergyStrong’s activities and how you can help or participate, please subscribe to our newsletter here.

 

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What a day!  And, the perfect quote!

 

Click here to watch the Agents Of Change panel video – Food Allergy Fund Summit DC.  AllergyStrong begins around 33:00/34:00 minutes in.  But be sure to watch the entire video – every advocate and their efforts are highly impressive and so vital to our community.

 

Food Allergy Treatment: OIT 101 January 21, 2020

[DISCLAIMER: Oral Immunotherapy is always conducted under the direction and supervision of a medical doctor.  It is an individualized plan.  Please talk to your doctor if you’re interested in learning more about OIT.  This is not an endorsement of OIT and is for informational purposes only.]

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UPDATE:  Palforzia was approved by the FDA in late January 2020 and is use today.  If you choose to pursue OIT, discuss whether Palforzia or other OIT programs are best for you with your healthcare provider.

While the U.S. Food and Drug Administration considers whether to approve Aimmune’s  Palforzia – possibly the first drug to be approved for peanut allergy, let’s get an overview of OIT.

Oral immunotherapy isn’t a new concept.  In fact, it has been discussed in medical journals for over a century and used for decades to help patients desensitize to environmental and drug allergies as well as build a tolerance to venom.  OIT has been studied in food allergy (mostly for peanut allergy) for the last 20 years and been in medical trials for just over 10 years.

Following a successful presentation to the U.S. FDA in September 2019, we stand on the cusp of seeing the first oral immunotherapy drug (Palforzia) approved.  Until now, food allergic patients have had no other option but to avoid their allergen for the life of their allergy.  FDA-approved drugs, like Palforzia, and other therapies would offer some patients progress, giving them much-needed treatment options to increase tolerance and protect them from life-threatening reactions for the very first time.

What is OIT?

Oral immunotherapy – or OIT – is a treatment option for some with food allergies that is managed and is strictly monitored by a patient’s allergist.  [NOTE: OIT and desensitization should ONLY be done under medical supervision and with guidance from your personal doctor.]

Oral immunotherapy is a safeguard.  It is a therapy intended to protect patients should they accidentally be exposed to their allergen.  It can also bolster a patient and caregiver’s mental health by reducing anxiety and stress caused by the heavy burden of food allergy management and unexpected, potentially life-threatening reactions.

Immunotherapy (whether oral, epicutaneous, sublingual or otherwise) is a treatment option to help patients tolerate a higher level of allergenic protein and is NOT a cure for food allergies.

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Photo by cottonbro on Pexels.com

How does it work?

OIT is a form of desensitization – that is, the process of retraining a patient’s body to tolerate a larger amount of the allergen to which they are allergic without causing a reaction.

For example, if a patient is allergic to peanuts, a doctor would give a patient an amount of peanut protein (beginning with a tiny dose of 1/100th of a peanut or three milligrams). That dose is gradually increased until that patient can safely eat a level of protein that would otherwise cause a reaction.  The goal of many OIT programs is to get the patient to tolerate at least 600 mg of peanut protein (or the equivalent of 2 peanuts), although these goals vary from practice to practice and patient to patient.

milk OIT

Dairy OIT solution – photo by OakleyOriginals via Flickr (CC BY 2.0)

Is OIT only for those with a peanut allergy?

Although the FDA is currently only reviewing a drug aimed at peanut allergy, oral immunotherapy trials are available for those who suffer from other food allergies as well.

How effective is oral immunotherapy?  Does it work?

Peanut, egg and milk OIT has been studied most closely and shown to desensitize 60-80% of participants.  Studies related to peanut oral immunotherapy specifically have between 85-90% success rates.  Other food allergens have not been studied as thoroughly and initial results show they may not be as effective at increasing a patient’s tolerance.  These  numbers are the result of oral challenges and not real-world accidental exposure.

Can anyone pursue oral immunotherapy?

If you’re interested in OIT, it’s best to speak with your doctor.  The process of going through OIT can be demanding and does not fit every lifestyle.  And, there are certain food allergy-related conditions (such as eosinophilic esophagitis – EOE – and others) that might make immunotherapy more difficult.

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Photo by Negative Space on Pexels.com

Consider this…

There are a few side effects that are possible while undergoing OIT.  The most common issue patient’s experience is gastrointestinal (reflux, cramping and vomiting), followed by oral itching, hives, and wheezing.  The risk for anaphylaxis is higher for those going through immunotherapy due to a patient’s regular exposure to their allergen.   Patients also risk  developing/inciting EOE – which often goes away when therapy discontinues.

The process of oral immunotherapy can be rigorous.  It requires an oral challenge, frequent doctor’s visits, and a comfort with using an epinephrine auto-injector.  Therapy also puts some restrictions on the life of patients as a precaution. For example, after dosing patients are required to rest to keep their body temperatures steady for 2 to 4 hours. And, daily monitoring is required.

Patients often need to take a daily or weekly maintenance dose indefinitely to keep up their tolerance.

Finally…

Oral immunotherapy is a much-needed treatment options for those seeking some protection and relief from the demands of living with food allergies.  Safeguarding patients against cross-contamination and accidental exposure is important for a patient’s physical as well as mental well-being.  But OIT is not for everyone.  If you’re interested, talk to your doctor about OIT and see if it’s a good fit for your lifestyle.

For more information, please read:

The Current State of Oral Immunotherapy from AAAAI

 

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.

 

APAC has recommended AR101 for approval.  Stay tuned for the full-FDA update.  Approval expected January 2020.

 

Here is the testimony I gave today:


Erin Malawer

Executive Director, 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.


 

 

 

Highlights from the Inaugural Food Allergy Fund Summit – April 2019 May 7, 2019

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If you couldn’t attend the Food Allergy Fund’s inaugural summit last week, you’re in luck because I took copious notes!  In addition to the highlights below, the Food Allegy Fund posted my official summary over on their site.

 

So many areas of food allergy converged at the Paley Center in New York City on April 4th:  research, immunology, pediatrics, psychology, product innovation, advocacy, professional chefs and restauranteurs.  And each attendee arrived with their own lens through which they view food allergies.  Needless to say, interesting people provoke interesting conversations.  I nearly filled a notebook with all the information I gleaned that day, but here are some of the stand-out highlights:

 

Dr. Patrick Brennan, recipient of FAF’s first $100,000 Innovator’s Research Grant, kicked the summit off by stating optimistically and quite matter-of-factly, “Food allergy is a solvable problem” and later continued to encourage patients about the future of food allergy research by declaring, “Innovation really comes through philanthropy.”

 

Next, Linda Herbert took the stage. As the Director of Psychosocial Program for the Department of Allergy and Immunology at Children’s National Medical Center, I could listen to her talk all day.  Of the many, many fascinating things she said, here are two big ideas to think about:

  • Human nature dictates that we crave predictability and human connection. Food allergies get in the way of both of those innate desires.
  • With immunotherapy on the rise, it is expected that families will be more anxious and will need the help of mental health professionals even more frequently.

FAFSummit 2 Innovators Pitch

 

Susie Hultquist, CEO and Founder of the app Spokin, likened the current status of food allergy innovation to renting VHS tapes.  Of where innovation stands, she says, “We’re in the Blockbuster age.  We need to take this in the Netflix era.”

FAFSummit Parent Advocates

An emotionally charged panel of parents turned advocates dominated the stage, moderated with both kindness and generosity by CNN’s Chris Cillizza, a fellow food allergy parent.

  • Lianne Mandelbaum of No Nut Traveler talked about airlines and their policies towards food allergies:  “They are consistently inconsistent”.  
  • Clearly, we need practical procedures that can be consistently enforced across entire fleets and around the world.  For example, of carrying epinephrine auto-injectors on airplanes, Lianne stated, “We have the tools and we need to be able to use them.”
  • Georgina Cipriano of Love for Giovanni Foundation reminded the audience, “Please stress that epinephrine is safe.  Please stress that it only hurts you when you DON’T use it.”

 

The amazing Dr. Ruchi Gupta hit the stage to talk about the lens-changing research she and her team have accomplished and what they are working on next.  Importantly, if you have ideas for school and community-based food allergy research – let her know.

 

Dr Hugh Sampson, COO of DBV Technologies and Director Emeritus of the Jaffe Center at Mt. Sinai described the development of a new diagnostic tool to test not only for the presence of food allergy but for the possibility of reactivity as well as response to immunotherapy.  In other words – it could show how someone’s immune system sees each food and create a unique “fingerprint” for food allergic response.

FAFSummit 3 Chefs

Celebrity chefs and restauranteurs Elizabeth Falkner, Amanda Freitag and Ming Tsai took the stage with so much experience and a lot of humor.  Ming Tsai is a food allergy parent and pioneer; Amanda Freitag, allergic to hazelnuts, understands food allergies firsthand; and Elizabeth Falkner is a longtime food allergy advocate.  The chefs agreed that having a system in place to handle food allergies in a restaurants kitchen is critical.  “Five or six food allergy requests can shut down a line if you don’t have a system,” according to Ming Tsai.  Amanda Freitag spoke about her own family’s experience dining out with food allergies.  Like many families, she and her family are loyal customers of certain establishments. “We frequent these restaurants because they take care of us.”  And with refreshing perspective, Elizabeth Falkner stated that she welcomes food allergy requests in her kitchen, “As a chef, I like challenges! I view it as a creative exercise.” Don’t we wish every chef was more like her!

 

The Food Allergy Summit had something for everyone.  Thank you to the Food Allergy Fund and a special thank you to all the presenters and panelists for a very stimulating day.  For a full summary of the inaugural Food Allergy Fund summit, please read here.

 

FDA Approves First Generic EpiPen September 6, 2018

The U.S. Food and Drug Administration (FDA) has recently approved the first generic EpiPen to be made by Teva Pharmaceuticals.  There are currently several brands of epinephrine auto-injectors available to patients:  Mylan makes EpiPen, EpiPen Jr. and its own brand-sponsored generic; kaléo offers Auvi-Q; and Impax Laboratories markets Adrenaclick.  However, this generic EpiPen by Teva Pharmaceuticals will be the first time a non-brand alternative is available.

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Obtaining approval from the FDA for a generic was complicated by the fact that both the medication (epinephrine) as well as the device itself had to be reviewed.  There is no firm estimate on when to expect this new generic on the market or the cost of the product once it gets there.

 

The competition generated by a generic should help the epinephrine auto-injector market. To date, Mylan’s EpiPen has nearly monopolized the market but its exorbitant cost has gained unwanted attention.  Mylan’s EpiPen price has risen over 400% in the last 10 years to over $600 a set.  To counter the negative press, Mylan created their own generic EpiPen which still average $300 per set.  Patients and families are hoping the introduction of a true generic device will drive down the cost of the absolutely necessary, life-saving devices as well as help to prevent epinephrine auto-injector shortages like the one we’re experiencing presently.  They’re also hopeful this generic will help expand options covered by their insurance plans.  Doctors, emergency workers and advocates are also optimistic that this may help get epinephrine in the hands of patients who may otherwise be unable to afford it.

 

 

 

Help Fund a Cure for Food Allergies January 10, 2017

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“Why can’t I just be like everyone else?”

If you have a child with food allergies, you’ve likely heard this heartbreaking sentiment from your kid.  We’ve all had to console this same child who just wants to put aside his/her food allergies and anxieties even if only for a single day.

Parents would go to any length for the sake of their kids.  Food allergy parents often do by preparing safe food, educating others, strategizing for school, holidays, play dates, and celebrations.

 

But how many of us have done 3,000 burpees for them?

 

That’s what fellow food allergy parent, Mike Monroe, plans to do on January 25th in order to raise money for ongoing research for a cure for food allergies.  Mike’s goal is to raise $50,000 to support cutting-edge research examining novel applications of cellular therapy for the millions of kids with food allergies being explored at Children’s National Medical Center in Washington, D.C.

 

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marines_burpee by U.S. Embassy Tokyo via Flickr

 

What’s a burpee, you might ask?  It’s a combination of push-up/plank, squat and jump performed in combination.  Try one right now!  Do another.  I think you’ll agree: it’s NOT easy!  Mike plans to complete 3,000 of these in under 12 hours.

What can you do to support Mike?

 

1.  Watch this video about Mike’s incredible motivation – his son, Miles:

 

 

2.  Consider a donation:  Every little bit helps get us all closer to a cure for food allergies.

3K Burpee Challenge for Food Allergies

3.  Share this post!  Please share this with your family and friends, share via Facebook, Twitter, Instagram and other social media channels.  Let’s support Mike and researchers to help our own kids and the millions who face life threatening food allergies every day!

 

 

Donate:

http://childrensnational.donordrive.com/campaign/BurpeeProject

Blog:

http://www.3kburpeechallenge.com/

Facebook Page:

https://www.facebook.com/3KBurpeeChallenge/

YouTube Video:

https://www.youtube.com/watch?v=KSVGTkFtnyk&feature=youtu.be

 

 
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