Need for Increased Treatment Options

 

AllergyHealth for Allergenis  

 
 
 


Food allergies have been documented for centuries and a diagnosable condition since the early 20th century. But despite many decades of research on the subject, the main strategy to manage this life-threatening condition is still strict allergy avoidance. Strict avoidance of a food allergen sounds simple in concept but is quite challenging in practice. 

Until January of 2020, there were no approved treatment options for the 32 million Americans diagnosed with food allergies in the United States. Although there are now several effective but unapproved treatments in use today, too few are available to those with food allergies. The food allergy community needs more treatment options; ones that are affordable, accessible, and reach more people. Individuals with food allergies want treatments that provide lasting results with benefits beyond “bite protection.” People with allergies to food other than peanut as well as those who have co-existing health conditions (like asthma and eosinophilic esophagitis among others) deserve treatment options that keep them safe. 

The following testimony - delivered in front of the FDA’s Allergenic Products Advisory Committee in the fall of 2019 urging the FDA to approve an oral immunotherapy treatment called Palforzia - highlights the social, emotional, and financial burden of food allergies and stresses the need for increased treatment options for the entire food allergy community. 

 

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 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 I 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.” 

Palforzia has the potential to change that. If only he could have undergone treatment to lessen that incredible emotional burden. 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. 

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 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 

 
Samantha Penn