Early Allergen Introduction Reverses Food Allergy Epidemic
TL;DR
- Medical guidance recommending avoidance of common allergens for infants, based on the precautionary principle, inadvertently exacerbated the food allergy epidemic by preventing immune system tolerance.
- The "hygiene hypothesis" suggests that increased cleanliness in modern households reduces exposure to microbes, leading to less robust immune systems that are more prone to developing allergies.
- Early introduction of allergenic foods, such as peanuts, to infants as young as four months significantly reduces the risk of developing food allergies by promoting immune tolerance.
- The EpiPen, a life-saving device for anaphylaxis, became a controversial blockbuster drug due to Mylan's aggressive price increases, highlighting systemic issues in US drug pricing.
- Despite evidence supporting early allergen introduction, parental fear and ingrained beliefs in hygiene continue to impede widespread adoption, contributing to persistent high allergy rates.
- Allergen immunotherapy, or exposure therapy, shows promise in treating existing food allergies by gradually increasing tolerance to specific proteins, offering an alternative to strict avoidance.
Deep Dive
The prevailing medical advice to avoid common allergens for infants, based on the precautionary principle, inadvertently fueled a dramatic rise in food allergies over the past few decades. This shift from cautious avoidance to early, controlled exposure has profound implications for public health, healthcare economics, and parental practices, demonstrating how well-intentioned but scientifically unsupported recommendations can create widespread negative consequences.
The historical trajectory reveals a critical misunderstanding of immune system development. Initially, anaphylaxis was understood as an extreme reaction, and the discovery of epinephrine's life-saving properties led to the development of devices like the EpiPen for emergency treatment. However, the prevailing medical consensus in the late 20th and early 21st centuries, particularly the American Academy of Pediatrics' "one, two, three rule," advised delaying the introduction of foods like dairy, eggs, and peanuts. This avoidance strategy, intended to prevent allergies, paradoxically sensitized developing immune systems, leading to the epidemic of food allergies witnessed in recent generations, exemplified by individuals like Alex who live with multiple severe allergies.
The reversal of this advice, driven by groundbreaking research like the LEAP study, highlights the scientific process and its impact on public health. This study demonstrated that early and consistent exposure to peanuts, even from four months of age, significantly reduced the incidence of peanut allergies. This evidence-based approach, championed by researchers like Dr. Gideon Lack, directly contradicted decades of avoidance recommendations, necessitating a significant shift in pediatric guidance and parental education. The implications extend to the pharmaceutical industry, particularly for products like the EpiPen, which became a blockbuster partly due to the increased prevalence of allergies. Mylan's aggressive price increases for the EpiPen, despite the drug's low manufacturing cost, underscore the complex economics and ethical considerations surrounding life-saving medications, and how market dynamics can create significant financial burdens for patients.
Ultimately, the story of food allergies and the EpiPen serves as a powerful case study in the evolution of medical understanding and the consequences of acting on incomplete or flawed scientific consensus. It underscores the importance of rigorous, evidence-based research, the need for humility and willingness to change course when new data emerges, and the ongoing challenges in making essential medications affordable and accessible. The shift towards allergen immunotherapy and early exposure products signals a move towards more proactive and effective management of food allergies, but the legacy of the avoidance era continues to impact healthcare costs and public perception.
Action Items
- Audit current food allergy avoidance guidelines: Identify 3-5 specific recommendations that may exacerbate sensitization and propose evidence-based alternatives (ref: LEAP study).
- Implement early allergen introduction protocols: Develop and disseminate guidance for introducing common allergens (e.g., peanuts, eggs) to infants between 4-11 months old.
- Analyze Epipen market strategy: Evaluate Mylan's pricing and distribution tactics to identify systemic vulnerabilities and potential for future price gouging.
- Track food allergy incidence rates: Establish a system to monitor the prevalence of food allergies in a target population over 1-3 years to assess the impact of new guidelines.
Key Quotes
"The story of epipen is also a story of unintended consequences and unexpected discoveries one that goes from the azores some islands in the middle of the pacific ocean to sweden the home of the nobel prize to israel today epipens are in schools they're in malls they're on airplanes they may even be in your backpack or purse or glove compartment just in case and there's also the biggest unintended consequence of all it turns out that for many of the millions of people like alex who live with food allergies and the risk of anaphylaxis well their condition may in fact be the result of one of the biggest blunders of the past century of medicine and public health."
Thomas Gettys highlights that the history of the EpiPen is intertwined with unforeseen outcomes and surprising revelations. He suggests that the current prevalence of food allergies, a condition managed by the EpiPen, might stem from significant errors made in medical and public health practices over the last century.
"The precautionary principle still held sway and food allergy rates they continued to rise and and just remember the fear here it's very real in 2001 the journal of the american medical association estimated that between 500 and 1 000 people die every year in the us from anaphylaxis thankfully there was something that could help should a child or an adult to consume a food they're allergic to this was a simple device called the epipen it administered a small but effective dose of epinephrine with a simple stab the trick was to make sure there was an epipen at hand at that moment of need."
Thomas Gettys explains that the "precautionary principle," a strategy of avoiding potential risks, continued to influence medical advice, contributing to rising food allergy rates. He notes that despite the fear and the significant number of annual deaths from anaphylaxis, the EpiPen offered a critical emergency treatment by delivering epinephrine.
"The only problem was this recommendation wasn't based in science it was based on the precautionary principle with more children allergic to foods it seemed sensible to delay the introduction of those foods to children and it turns out that scientifically biologically this was exactly the wrong advice what the aap had done was to unintentionally create a feedback loop as more children avoided foods at an early age more children would be sensitized to those foods later and more children would be diagnosed with food allergies and that rise in food allergies created more concerns and more fears about the foods which led to more avoidance less exposure and yes more allergies."
Thomas Gettys points out that the American Academy of Pediatrics' "one two three rule," which advised delaying the introduction of certain foods to infants, was not scientifically grounded but rather based on the precautionary principle. He argues that this advice inadvertently created a cycle where avoidance led to increased sensitization and a subsequent rise in food allergy diagnoses.
"The leap study recruited 640 children between four and 11 months old and the plan was to carefully expose half of them to peanuts regularly and consistently until they turned five and then to compare the rates of allergies between the two groups of children talking to dr lack though i was curious how exactly did they convince 640 parents to enroll their babies in this study a lot of resources went into screening and talking to the families and explaining to the parents what the situation was people respond to data and common sense and realized that the guidelines were not working and that there was a significant chance that by doing nothing their baby would develop peanut allergy anyway here was the possibility of an intervention that would actually reduce peanut allergy."
Thomas Gettys describes the LEAP study, which involved exposing infants to peanuts to assess its impact on allergy development. He notes that parents were convinced to participate by the compelling data, common sense reasoning, and the realization that existing guidelines were ineffective, offering a potential intervention to reduce peanut allergies.
"The leap study found that at five the rate of allergies in children who had avoided peanuts was nearly 14 percent about what it was in the general population but in the group that had been consistently consuming peanuts since those first few months the rate of allergies was just 1.9 percent compared to 14 percent that's a huge difference exposing babies early as early as four months was clearly and profoundly beneficial this prevented food allergies."
Thomas Gettys presents the findings of the LEAP study, highlighting a significant difference in peanut allergy rates. He states that children who consistently consumed peanuts from an early age had a dramatically lower allergy rate (1.9%) compared to those who avoided them (nearly 14%), demonstrating the profound benefit of early exposure.
"The precautionary principle is still holding us back what's more the belief in hygiene and sterility it hasn't gone away many parents are probably still bathing their infants too much and so food allergies and other sensitivities they're still common and prevalent meaning there is still a very big market for the epipen and the epipen is still a huge money maker in 2023 the epipen and the generic they brought in nearly 2 billion in revenue yes that's double the amount from 2016 and the price of a two pack it's now about 700 that's 15 percent higher than when the mylan ceo was called in to testify in front of congress."
Thomas Gettys observes that the precautionary principle and a persistent belief in hygiene continue to hinder progress in combating food allergies. He notes that despite updated guidance, allergy rates remain high, sustaining a significant market for the EpiPen, which generated nearly $2 billion in revenue in 2023, with prices increasing since 2016.
Resources
External Resources
Books
- "The Story Behind EpiPen, The Rise of Food Allergies, and What Doctors Got Wrong" - Mentioned as the title of the podcast episode.
Articles & Papers
- "best american science writing and best technology writing anthologies" - Mentioned as anthologies where Thomas Gettys' writing has been selected.
- "jama" (Journal of the American Medical Association) - Mentioned for a 1964 report on a man with a mango allergy and a 2001 estimate of anaphylaxis deaths.
- "new england journal of medicine" - Mentioned as the publication for the LEAP study results.
People
- Thomas Gettys - Host of the "Drug Story" podcast, senior impact fellow at UC Berkeley School of Public Health, former executive editor at Wired.
- Alex (Alexander Hadju) - 19-year-old with severe food allergies, featured in the episode.
- Dr. Gideon Lack - Professor of Pediatric Allergy at King's College London, hero of the episode, researcher on food allergies and the LEAP study.
- Dr. Anthony Fauci - Announced new recommendations for early exposure to allergenic foods.
- Solomon Solis Cohen - Prominent doctor who conducted early experiments with adrenaline for allergies.
- Sheldon Kaplan - Engineer who invented the combopen, the precursor to the EpiPen.
- Heather Bresch - CEO of Mylan Pharmaceuticals, testified before Congress regarding EpiPen pricing.
- Henry Shuckman - Past podcast guest, authorized to teach Sombo Zen, creator of "The Way" app.
- Lauren Gillmer - Featured in the episode, experienced a severe allergic reaction at age eight.
Organizations & Institutions
- Drug Story - New podcast launching, episode featured in this podcast.
- University of California Berkeley School of Public Health - Affiliation of Thomas Gettys.
- Wired - Publication where Thomas Gettys was executive editor.
- FDA (Food and Drug Administration) - Mentioned for classifying EpiPen as a drug device combination and adjusting guidance on EpiPen packaging.
- American Academy of Pediatrics (AAP) - Issued the "one two three rule" for introducing foods to babies.
- National Institute of Allergy and Infectious Diseases - Announced new recommendations for early exposure to allergenic foods.
- Mylan Pharmaceuticals - Maker of EpiPen, acquired the rights to EpiPen and raised its price.
- Pfizer - Unit that merged with Mylan to form Viatris.
- Viatris - New company formed by the merger of Mylan and a unit of Pfizer.
- National Institutes of Health (NIH) - Mentioned in relation to official recommendations on food allergy avoidance.
- NHS (National Health Service) - Mentioned in relation to official recommendations on food allergy avoidance.
Websites & Online Resources
- drugstory.co - Website for the "Drug Story" podcast.
- thewayapp.com/tim - Website for Henry Shuckman's app, "The Way."
- faceyourrisk.com - Website mentioned in a disease awareness ad for food allergies.
- epipen.com - Website for information about EpiPen.
Other Resources
- EpiPen - Auto-injector device for emergency treatment of anaphylaxis.
- Epinephrine (Adrenaline) - Synthetic hormone used in EpiPen to treat anaphylaxis.
- Anaphylaxis - Severe, potentially fatal allergic reaction.
- Hygiene Hypothesis - Theory suggesting reduced exposure to microbes increases allergic conditions.
- Precautionary Principle - Idea of "better safe than sorry" in decision-making, applied to food allergy recommendations.
- "one two three rule" - AAP guidance for delaying introduction of certain foods to babies.
- Bamba - Peanut-flavored snack popular in Israel, associated with lower rates of peanut allergy.
- Combopen - Invention by Sheldon Kaplan for administering antidotes, precursor to EpiPen.
- LEAP (Learning Early About Peanut Allergy) Study - Randomized controlled trial on early peanut exposure and allergy rates.
- Palforzia - FDA-approved prescription treatment for peanut allergies.
- Allergen Immunotherapy (Exposure Therapy) - Treatment involving supervised exposure to allergens.
- Mission Mighty Me - Company co-founded by Dr. Gideon Lack, offering products for early allergen introduction.