Allergy parents and patients wonder about how their gut health diet influenced their condition to begin with and what they can do going forward. Jera Qianhui Zhang will address these concerns. She is a licensed dietitian, a certified lactation counselor, and trained in the Low FODMAP Diet Protocol for Irritable Bowel Syndrome. She is also a doctoral student in Behavioral Nutrition at Teachers College, Columbia University. Her research interests include digestive health, the gluten-free diet, and immune-related disorders. She currently serves as the Chair of AAPI Professional Development Committee in the Academy of Nutrition and Dietetics.
Food Allergy Corner
Conference Speaker: Anish R Maskey, BS, PhD student–IgE and Non-IgE medication options for EoE and potential treatment with Traditional Chinese medicine and compounds
Eosinophilic Esophagitis (EoE) has been a stubborn problem for many food-allergy sufferers. The esophagus is infiltrated by white blood cells called eosinophils–the same culprit involved in cases of allergic asthma–causing constriction, difficulty swallowing, and eventual tissue remodeling. Abstinence and swallowing oral steroids have been the only recourse, with the recent addition of the the biologic dupilumab. Mr. Maskey is PhD student in the Department of Microbiology & Immunology at New York Medical College. He has been working in Dr. Xiu-Min Li’s lab since 2018. Primarily his work focuses on understanding immunological mechanisms underlying Traditional Chinese Medicine formula and natural flavonoid purified compound improving clinical GI symptoms related to EoE. He has also been actively working on other collaborative projects with his NYMC colleagues.
Conference Speaker: Anna Nowak-Wegrzyn, M.D., PhD–Novel Therapies for Food Allergy
Those who have followed this website since its inception will remember the name Anna Nowak-Wegrzyn, M.D., PhD. In a long-ago post she discussed her work with the US Department of Defense on a food allergy policy for recruits*. She is now Professor of Pediatrics at the New York University Grossman School of Medicine, Department of Pediatrics at Hassenfeld Children’s Hospital and board chair of the American Board of Allergy & Immunology. Her research interests focus on egg and milk allergies, baked milk and baked egg diets, food-induced anaphylaxis in children, novel diagnostic and therapeutic approaches to food allergy, oral tolerance development, and in particular food protein-induced enterocolitis syndrome (FPIES). Anna is also chair of the Medical Advisory Board for the International FPIES Organization and has led the international effort to write the first Consensus Guidelines for Diagnosis and Management of FPIES, published in 2017. She is an Associate Editor for the Annals of Allergy, Asthma and Immunology.
*(Food allergic patients with military ambitions were disappointed.)
Conference Speaker July 24: Raj Tiwari PhD–Western diet and false alarm hypothesis in food allergy
The Western diet is high in substances called high-glycation end products that keep the immune system in a vigilant inflammatory state. When an individual is also food allergic, the presence of allergens may provoke an excessive response that mimics a normal mechanism for eliminating dead or dying tissue. The combination can be deadly.
Raj Tiwari, Ph.D., is the Interim Chair and Professor of Microbiology and Immunology, Associate Professor of Otolaryngology and Graduate Program Director. Dr. Tiwari joined the NYMC faculty in 1996 and has maintained an active, funded research program in immunological aspects of cancer biology. Dr. Tiwari received his M.S. and Ph.D. degrees in biochemistry from the University of Calcutta in India and completed his postdoctoral training at the University of Toronto in Canada and Memorial Sloan Kettering Cancer Center in New York City. Prior to joining the NYMC community, he held faculty positions at Memorial Sloan Kettering Cancer Center and at New York Presbyterian/Weill Cornell Medical Center.
Conference Speaker July 24, 2022: Nan Yang, PhD–Cross immune mechanisms between COVID and food allergy and potential therapy
Dr. Yang oversees the chemistry research group in Dr. Xiu-Min Li’s team and is highly involved in the designing research, new treatment formulation, active component identification, and biological activity investigation. He is going to talk about the immune linkage between two headline disorders and possible treatment for both. He is Research Assistant Professor, Department of Immunology and Microbiology, New York Medical College. Director of GMP facilities of General Nutraceutical Technology, LLC. Dr. Yang has accumulated tremendous experience in both biology and analytical chemistry, such as High Performance Liquid Chromatography (HPLC) and Mass Spectrometry (LC-MS). His research has focused on investigating the mechanisms underlying allergic diseases including allergic asthma and food allergies, and on developing new treatments for these diseases. He has isolated and identified several bioactive compounds from herbal medicines and investigated their activities and mechanisms both in vitro and in vivo. He has also been involved in several clinical studies and monitoring the quality and safety of novel interventions used as treatment for allergic diseases.
Conference Speaker: Dr. William R. Reisacher, inventor of toothpaste for allergen immunotherapy
Our first speaker on July 24 will be Dr. William R. Reisacher, professor of Otolaryngology of Weill-Cornell Medical Center in New York City. This website has been following Dr. Reisacher’s invention, Intrommune for years as it makes it way through the labyrinth of clinical trials as an alternative to OIT and SLIT. Like many other novel medical ideas, Intrommune sprang from a Eureka moment, which Bill described in a Q&A we conducted in 2018:
My “eureka” moment came when I was brushing my teeth one morning. I was thinking about an article I just read about the immune cells in the mouth and, as I stared into the mirror I realized that the foam was coating all the areas of the mouth where special cells, called Langerhans cells, are in highest numbers. If I could just get these extracts into a great toothpaste, then I could have a really safe and effective treatment for allergies that would also be easy to use every day from home. I almost choked on my toothpaste!
For the full Q&A,click here
Food Allergy Management in the Age of COVID-19
Our friend and contributor Anne F. Russell, MS, BSN, RN, AE-C , along with several collaborators, has published a new study to help nurses and doctors work with parents of food allergy patients on negotiating the challenges of feeding their families and themselves in the face of a the COVID-19 pandemic. They distributed a survey to parents, of whom 359 respondents met inclusion criteria. They found: “Concerns about COVID-19 exposure were expressed in 65.7% about accessing an emergency department and 73.6% had school reentry concerns; 66% had not discussed recommended anaphylaxis management algorithm changes with a provider; 85.8% had not discussed the temporary U.S. Food and Drug Administration food labeling policy with a provider. Most (62%) reported shortages of preferred safe food brands. 62% spent more time cooking safe foods from scratch. With regard to the recommendation by the U.S. Centers for Disease Control and Prevention (CDC) for classroom dining, 57.7% planned to request modifications. With regard to the CDC’s recommendation to use inhalers versus nebulizers, 37.7% had not discussed the topic with a provider. Ninety-two written comments were analyzed and grouped into seven themes.”-
They concluded: “New pandemic-related regulations, food supply chain disruptions, and evolving medical recommendations resulted in intensified burdens for respondents, including the increased time needed to complete food allergy management and school reentry concerns. Study results can inform clinical team members (e.g., physicians, nurses, dieticians) of effects that pandemic-related changes may have on this patient population, with subsequent consideration of patient-specific screening, education, and shared decision-making with regard to risk mitigation needs.”
The full paper “Parent perspectives on food allergy management and safety during the COVID-19 pandemic” is available free of charge from the Journal of Food Allergy. We asked Anne to share her thoughts about how this paper came about and ideas for parents.-Henry Ehrlich
AAC How did you come to write it? How did you assemble the team of co-authors?
Anne Shortly after WHO declared COVID-19 a pandemic, I conceptualized the study. At that time states had instituted stay-at-home orders, schools and universities ceased in-person instruction and food chain supply disruptions occurred. Evolving medical recommendations also ensued. I wanted to investigate how these abrupt and startling changes were impacting decision-making and safety of patients managing food allergies with risk for anaphylaxis. I was interested in transposing their reported experiences into concrete recommendations for allergy/immunology clinical teams (e.g., physicians; nurses) aimed at best assisting these patients. I selected a nurse co-author with vast experience practicing in school settings as I wanted to include school-related questions in the study survey. I also included another nurse as co-author with experience in informatics to assist with practical aspects of research. Both co-authors made useful contributions to the research project.
AAC Since the primary audience is medical professionals with a food allergy focus, how did you make decisions about what they needed to know, and how did you write the questionnaire accordingly?
Anne First a literature review was completed revealing sparse research on effects of the pandemic on daily food allergy management. The U.S. was only a couple of months into the pandemic at the time, so this result wasn’t surprising. Next, I thought about features of anaphylaxis prevention and preparedness, the cornerstone of daily food allergy management, to highlight in the parent study survey. Parent responses would determine how pandemic related challenges were or were not impacting these patients. Once survey responses were submitted and analyzed, I thought about subsequent recommendations to clinical teams based on study findings. The Journal of Food Allergy, which published the study, is a peer-reviewed medical journal targeting physicians, nurses and dieticians that specialize and practice in allergy/immunology with a sub-specialty in food allergy.
How do professionals utilize an article like this? Do you envision dramatic changes in the way they practice?
A pandemic involving a novel virus constitutes a public health crisis. However, I am optimistic we will have an endpoint sooner than we may expect, and strides have been made toward that goal. Thus, this research highlights time-sensitive findings unique to a specific period during an extraordinary global event. Typically practice changes occur slowly and incrementally. However, an abrupt public health crisis does not allow for such time and clinical teams must quickly adapt accordingly to assist patients facing unforeseen challenges. For example, I created table 5 in the article to provide clinical teams with recommendations for patient education discussion points to consider emphasizing during the pandemic based on patient needs revealed in study findings. Additionally, study findings can inform clinical teams of patient screening needs and risk mitigation discussion points unique to the pandemic to consider proactively discussing with patients.
AAC Did any of the data surprise you?
Anne I expected parents would be concerned about school re-entry prior to a COVID-19 vaccine. However, I was surprised the majority reported being highly concerned. Many of these families already struggle with school-related food allergy accommodation issues and adding COVID-19 concerns on top of those baseline challenges increases their burden. I was also struck by captured data indicating the pandemic led to additional health concerns for this patient population. For example, disruptions in the food supply chain meant many families experienced shortages of their food allergy safe and familiar food brands. Several aspects of this concerned me. First, it could create risk for nutritional deficiencies if shortages are prolonged while alternative safe brands are not found. Second, it meant many families had to seek unfamiliar food brands necessitating more time spent calling manufacturers regarding ingredients and other due diligence. Such time-intensive tasks also add to their burdens. Third, having to try new food brands may heighten fears of anaphylaxis, which adds to parental stress levels.
AAC Again, since this is a pretty technical article directed at a professional audience, are there any takeaways that would be useful for lay readers, such as patients and families?
The pandemic underscored the need for patients with food allergies to prepare ahead for potential emergencies. Consider having a home back-up supply of nonperishable food allergy safe foods. Cooking and baking ahead to store or freeze a supply of food allergy safe foods may be beneficial. Consider contacting food manufacturers directly to purchase preferred food allergy safe brands. Having a several month supply of prescribed medication refills ensures availability for the near future. It’s also imperative to always have accessible unexpired prescribed epinephrine auto-injectors.
I encourage parents to be proactive in preparing for appointments with physicians, nurses, and dieticians. Have questions and concerns written down beforehand prior to telehealth or in-person appointments. Do not be shy about raising topics of concern in discussions with healthcare professionals. Telehealth and in-person clinic appointments are often scheduled for specific timeframes so make the most of that limited time.
Anne F. Russell, MS, BSN, RN, AE-C is a researcher, nurse scientist, nursing faculty and food allergy specialty nurse. She has sub-specialized in the field of food allergy for over 20 years including clinical allergy/immunology practice. Nurse Russell has published food allergy related articles including studies and has created food allergy patient educational materials for clinical use and public health education. She serves as peer-reviewer and editorial board member of the Journal of Food Allergy. Nurse Russell is also an active member of the American Academy of Allergy, Asthma & Immunology serving on several committees involved with advocacy, continuing medical/nursing education and research projects related to the food allergy patient population.
Misdiagnoses Happen. Medical Gaslighting Should Not
Anne Maitland, MD
As a non-psychiatrist, I really cannot tell you the difference between the diagnoses of hypochondriasis, malingering, Munchausen/Munchausen by proxy, or the disorders of conversion and somatization. I can, however, tell you that the third leading cause of patient mortality in this country is medical error, and, as an allergy/immunology specialist, I know that even the most common, immune-mediated disorders, such as rhinitis, asthma, and food allergies are not commonly recognized by general practitioners and specialists, leaving children and adults under-diagnosed and untreated.
Reasons for this stem from the lack of training received during medical school and postgraduate residency training: allergy/immunology is barely featured in the undergraduate medical school curriculum, which is when the foundation of most clinicians’ working knowledge is formed. Further, the clinical specialty has a minimal presence in most hospitals and medical centers, which often translates to suboptimal care and poor outcomes of pediatric and adult patients — in the ED, in the operating theaters, in the ICUs, and on the floors.
Recently, one of my patients, who had a pain syndrome from tumors wrapping around her spine (as well as a long list of drug allergies and intolerances), landed in the ED of an Ivy League medical center. The physician assistant could not call for an allergy/immunology consult because there was no in-house allergy/immunology department. In the same week, another young adult, female patient with cervical spine instability, ulcerative colitis, and a history of migraines presented to a community hospital with symptoms worrisome for anaphylaxis — but because the patient did not have hives (acute inflammation of the skin), the medical resident asked me if I thought this patient had Munchausen or conversion disorder. The conversation began with, “She has so many diagnoses and is taking so many medications ….” I informed the medical resident that upwards of 10% of anaphylaxis cases will not have obvious skin symptoms.
Asthma is one of the top three reasons for pediatric hospital admissions in the United States. In Harlem, from 110th St. to 168th St., from the Hudson River to the East River, home to over 116,000 residents, not one allergy/immunology practice exists. Only the clinics attached to two medical centers, which are on the outskirts of the community, attempt to provide a home for this chronic medical condition, in supervised residents’ clinics. Rhinitis, often considered a nuisance of an ailment, affects nearly half of urban dwellers and is one of the most common reasons for absenteeism from school and work.
Food allergies, occupational allergies, and eczema are also on the rise. Indeed, research indicates that in any given room containing 100 people, at least two have been treated for anaphylaxis — and many more carry epinephrine auto-injectors, given the risk of this potentially life-threatening, hypersensitivity condition.
A report from the Royal College of Physicians states that allergic diseases are so complex, involving multiple organ systems, that patients are often referred to “a succession of different specialists.” After inflammation of the gastrointestinal tract and skin, inflammation of the brain, the spinal cord, and peripheral nerves is a commonly reported symptom of aberrant mast cell activation. So, it is not surprising that patients with the newly-described chronic hypersensitivity disorder, mast cell activation syndrome (MCAS), or syndromes that mimic or can travel with MCAS, such as Postural Orthostatic Tachycardia Syndrome (POTS) or Ehlers-Danlos Syndrome (EDS), have neuropsychiatric symptoms that come and go, and often receive one of the above-mentioned psychiatric diagnoses.
According to an article written in 1984, “It is known that the majority of antidepressants and minor tranquilizers are prescribed by non-psychiatrists.” In a more recent 2017 New York Times article, the author noted that non-psychiatrists — even if they are medical doctors in other fields like cardiology or gastroenterology — “are often ill-equipped to recognize and treat emotional symptoms related to a physical ailment.” And, by the same token, “psychiatrists may not consider the possibility that a patient with symptoms like palpitations, fatigue or dizziness really has a physical ailment.” There are countless examples of patients who are given psychiatric diagnoses before their underlying organic disorder is uncovered. Granted, physical ailments do cause neuropsychiatric conditions and some of these medications have indications for non-psychiatric disorders. However, there seem to be few reports on the follow-up care of pediatric and adult patients, who were previously given a functional disorder diagnosis – such as conversion disorder, hypochondriasis, malingering, Munchausen, or somatization – and then found to have an organic ailment. The fate of these patients has already been captured by Francis Peabody, one of the godfathers of modern medicine, in his 1927 classic article, “The Care of the Patient.” He wrote, “[T]hese patients [with nothing wrong with them] constitute a large group, and their fees go a long way toward spreading butter on the physician’s bread. Medically speaking, they are not serious cases as regards prospective death, but they are often extremely serious as regards prospective life. Their symptoms will rarely prove fatal, but their lives will be long and miserable, and they may end by nearly exhausting their families and friends. Death is not the worst thing in the world.”
Missteps and misunderstandings, even by well-seasoned medical professionals, are human, but medical gaslighting is not. Medical professionals must take a step back and recognize that the interpretation of test results is only as good as the practitioner glancing at the numbers. Moreover, normal test results in patients with chronic pain, unexplained sensitivities to the world, or fatigue should provoke more investigation, rather than a weak handoff to a mental health provider. One potential remedy to avoid these misdiagnoses and medical misdemeanors may be to rebuild the patient-practitioner partnership: the medical home. We should be empowering the patient to take charge of their health care, and we should be reminding the practitioner to be a mindful partner in health, rather than a patriarchal purveyor of prescriptions and procedures.
Dr. Anne Maitland is an allergist/immunology specialist. She is an Assistant Professor at the Icahn School of Medicine at Mount Sinai and is the medical director of Comprehensive Allergy & Asthma Care, in Tarrytown, NY. She earned an MD and PhD from the Perelman School of Medicine at the University of Pennsylvania and has been in practice for 20 years. She serves on the AAAAI Committee for mast cell-mediated disorders and the committee for the unmet need. Dr. Maitland was named one of New York Times 2011 Super Doctors and one of America’s Top 21 Women’s Doctors by Lifescript.com in 2009. She is a Fellow of the American College of Allergy, Asthma and Immunology and a member of the American Academy of Allergy, Asthma and Immunology.
Join Dr. Maitland for Webinar Wednesdays through her practice website!
Note: This article was first published on the website Doximity, although we saw an early version of it and are reprinting with Dr. Maitland’s cooperation.
Palforzia Revisited–AAAAI Podcast a Quick and Enjoyable Introduction to New OIT Product
The new AAAAI podcast is about Palforzia–surprise surprise. It was recorded just three days after the introduction. Like all these podcasts the host is our friend Dr. David Stukus. Appropriately the interviewee is Dr. Andrew Bird from Dallas who contributed a piece to this website five years ago called Food Allergy Testing in the Coming Age of Prescription Immunotherapy. Dr. Bird wrote at the time, “The response from the medical community must be to ensure that patients are appropriately diagnosed and diagnostic methods are used intentionally in patients with a history supporting a role of immediate reactivity following food ingestion.” Five years later, that remains a key concern as this first-ever drug enters the market and is clearly explained, as are such issues as cost, dosing, maintenance, overall efficacy for certain patients, reactions, goals of treatment, and why patients choose to discontinue treatment. There’s also forthright discussion of the pros and cons of offering the treatment for allergists and shared decision making in choosing to start the treatment or not.
First Food Allergy Treatment Approved by FDA
BRISBANE, Calif.–(BUSINESS WIRE)–Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies, today announced that the U.S. Food and Drug Administration (FDA) approved PALFORZIA™ [Peanut (Arachis hypogaea) Allergen Powder-dnfp]. PALFORZIA is the first approved treatment for patients with peanut allergy. It is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial dose escalation may be administered to patients aged 4 through 17 years. Up-dosing and maintenance may be continued in patients 4 years of age and older. PALFORZIA is to be used in conjunction with a peanut-avoidant diet. PALFORZIA is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
“This is a defining moment for the peanut allergy community and for Aimmune Therapeutics, and we are excited to bring the first FDA-approved treatment for peanut allergy to patients and their families,” said Jayson Dallas, M.D., President and CEO of Aimmune Therapeutics. “Our commercial field team is ready to begin engaging with allergists to help them prepare to safely incorporate PALFORZIA into their practices and, with approval in hand, our payer team can also immediately begin work to secure formulary access to PALFORZIA. We view this approval as just the beginning for Aimmune, and it underscores our continued commitment to bringing innovative treatments to people with potentially life-threatening food allergies.”
“Not only is PALFORZIA the first approved therapy for peanut allergy, but it is the first approved therapy for any food allergy,” said Daniel Adelman, M.D., Chief Medical Officer of Aimmune Therapeutics. “We truly appreciate the efforts of the peanut allergy community who contributed to the development of PALFORZIA – including the more than 1,200 patients and their families who participated in our clinical trials, the study investigators and their staff, the advocacy community, and our dedicated employees – all of whom have helped us develop and deliver this first-of-its kind therapy.”
Peanut allergy is one of the most common food allergies in the world, affecting more than 1.6 million children and teens in the United States alone.i,ii It can be a chronic and life-long condition, and reactions to peanut can range from mild to potentially life-threatening,iii with one in five peanut-allergic patients visiting emergency rooms each year due to accidental exposures.iv
“Peanut allergy is more common now than ever before and has become a serious public health concern. The food allergy community has been eagerly awaiting an FDA-approved treatment that can help mitigate allergic reactions to peanut and, as allergists, we want nothing more than to have a treatment option to offer our patients that has demonstrated both the safety and efficacy to truly impact the lives of patients who live with peanut allergy,” said Christina Ciaccio, M.D., Associate Professor of Pediatrics and Medicine and Chief of Allergy/Immunology and Pediatric Pulmonary Medicine at the University of Chicago Medical Center and Biological Sciences. “With today’s approval of PALFORZIA, we can – for the first time – offer children and teens with peanut allergy a proven medicine that employs an established therapeutic approach.”
PALFORZIA is a complex biologic drug used with a structured dosing approach that builds on a century of oral immunotherapy (OIT) research.v With OIT, the specific allergenic proteins are ingested initially in very small quantities, followed by incrementally increasing amounts, resulting in the ability to mitigate allergic reactions to the allergen over time. PALFORZIA is a rigorously developed, pharmaceutical-grade OIT for peanut allergy with a well-defined allergen profile to assure that every dose, whether 0.5 mg (equivalent to 1/600th of a peanut) or 300 mg, has been prepared and analyzed for consistency.
The Biologics License Application (BLA) for PALFORZIA included efficacy and safety data from seven clinical studies, including the pivotal Phase 3 PALISADE and RAMSES clinical trials. In addition, data from the Phase 2 ARC001 study and the ARC002 open-label follow-on study were included, as well as data from ARC004, ARC008 and ARC011, which are ongoing studies.
PALFORZIA is available only through a Risk Evaluation and Mitigation Strategy (REMS). Requirements of the REMS include: the prescribing physician and patient must be enrolled in the REMS prior to initiation of treatment; the initial dose escalation and the first dose of each up-dosing level must be administered in a certified healthcare setting; epinephrine must always be immediately available to patients; and pharmacies/distributors must be certified with the REMS and dispense PALFORZIA only to certified healthcare settings or to patients who are enrolled in the REMS. Consistent with approved immunotherapies indicated to treat allergic conditions, the Prescribing Information for PALFORZIA contains a boxed warning.
Aimmune will provide resources to patients and families who, upon consultation with their physician, wish to seek treatment with PALFORZIA. These resources will include educational materials, a dedicated call center, a co-pay program for eligible patients, and a Patient Assistance Program to provide PALFORZIA at no cost to eligible patients.
“Peanut allergy carries an overwhelming psychosocial burden that impacts patients and their families daily – peanuts are everywhere, and the threat of a severe reaction related to an accidental peanut exposure dominates families’ daily lives,” said Lisa Gable, Chief Executive Officer, Food Allergy Research and Education (FARE). “The risk of accidental exposure is real, and we, as a community, have long awaited an option beyond avoiding peanuts alone. As one of the organizations that originally highlighted the need for an FDA-approved oral treatment approach to food allergy back in 2011, we are thrilled with today’s FDA approval of PALFORZIA as it fills a long-standing need in the treatment of peanut allergy.”
Aimmune Therapeutics was founded directly in response to a united call to action by leading stakeholders in food allergy. At an advocacy-sponsored research retreat in 2011 aimed at reaching consensus on the direction of food allergy treatment research, a group of parents of children with severe food allergies, patient advocacy organizations, leading clinical and academic physicians, representatives from government, and members of the pharmaceutical industry recognized the need for a structured approach to OIT and approved treatments. This meeting eventually led to the formation of Aimmune Therapeutics to specifically address that need.