Oct 2013 News Round Up

Peanut Allergy Research

In the October 2013 industry news round up – we bring you information about the Peanut Allergen Threshold Study (PATS), our recent presentation in Indonesia to a study that reports families are bearing the financial burden of food allergies.

The Peanut Allergen Threshold Study (PATS)

A multi-centre study involving three national level referral and teaching centres (Royal Children’s Hospital Melbourne, Australia; Cork University Hospital, Ireland; and Massachusetts General Hospital, Boston, U.S.A) has commenced with the aim of using a new single-dose challenge protocol to determine an internationally-standardised eliciting dose at which 5% of the peanut-allergic population will exhibit symptoms (ED05).

It is not always possible to determine whether an allergic reaction during oral food challenge has occurred to a discrete threshold dose of allergen or rather has been the result of the cumulative dose consumed by the allergic person. The current study will therefore test an oral food challenge protocol based on a single dose (6 mg peanut = 1.5 mg of peanut protein, approximately 1/100th of a peanut kernel).

The study will recruit a total 375 participants (125 in each centre) during their follow-up appointments in the Department of Allergy in each respective centre. The results will be used to inform the reference doses used in the Voluntary Incidental Trace Allergen Labelling tool (VITAL®), the current version of which (VITAL® 2.0) uses ED01 (0.2 mg of peanut protein). ED01 is the eliciting dose at which 1% of the peanut-allergic population will exhibit symptoms. This study will therefore examine whether 95% of peanut-allergic consumers are tolerant of an amount that is more than 5 times higher than the VITAL ED01 threshold. If proven, this would suggest that if 95% of participants are tolerant to an ED05, the probability they would react to an ED01 would be extremely low.

The single dose oral food challenge promises an efficient approach to identify the most highly sensitive patients within any given food-allergic population. The protocol would not replace current clinical food challenges for the diagnosis of food allergy, but where precautionary labelling of food is based on VITAL® 2.0, the protocol would help patients determine their level of risk associated with consuming food labelled according to this system.

Reference: Zurzolo et al. 2013. Allergy Asthma and Clinical Immunology. Vol. 12;9(1) pp35. DOI:10.1186/1710-1492-9-35
Download for free from: www.aacijournal.com/content/pdf/1710-1492-9-35.pdf

Making VITAL® progress in the UK

The Allergen Bureau has been engaging with the UK Allergen Steering Group made up of Members of the Food and Drink Federation (FDF) as well as the British Retail Consortium (BRC). A VITAL® working group has been formed as part of this initiative and Kirsten Grinter and Rob Sherlock from the Allergen Bureau Board met recently with FDF and BRC in the UK to discuss VITAL® as we continue to invest and evolve the program.

It was exciting to see the enthusiasm of this group as we work together with an increasing global focus to achieve a standardised approach of harmonised action levels across the industry. The commitment and support of the team is strong and the Allergen Bureau will continue to collaborate and promote VITAL® as an industry cross contact management Standard.

Allergen Bureau presentation in Indonesia

The Allergen Bureau has been engaging with the UK Allergen Steering Group made up of Members of the Food and Drink Federation (FDF) as well as the British Retail Consortium (BRC). A VITAL® working group has been formed as part of this initiative and Kirsten Grinter and Rob Sherlock from the Allergen Bureau Board met recently with FDF and BRC in the UK to discuss VITAL® as we continue to invest and evolve the program.

It was exciting to see the enthusiasm of this group as we work together with an increasing global focus to achieve a standardised approach of harmonised action levels across the industry. The commitment and support of the team is strong and the Allergen Bureau will continue to collaborate and promote VITAL® as an industry cross contact management Standard.

VITAL® 2.0: Reference doses for precautionary labelling of allergens

The international team of experts working to revise the Allergen Bureau’s Voluntary Incidental Trace Allergen Labelling tool (VITAL®) recently published a paper describing their work to establish reference doses for the most common food allergens. The aim of this work was to provide standardised, evidence-based guidelines upon which food manufacturers could base their decisions for precautionary labelling of allergens that may be unintentionally present in food products.

The data was derived from individual thresholds of patients published in more than 55 studies of clinical oral food challenges. The data was used to develop reference doses based on statistical dose-distribution modelling. The team developed reference doses for peanut, milk, egg, and hazelnut as sufficient valid published data were only available for these food allergens. Sufficient numbers of adult challenge data were only available for peanut and hazelnut.

For these allergens, the eliciting dose for an allergic reaction in 1% of the population (refer Allen et al. 2013, Table 1) was estimated as follows: 0.2 mg of protein for peanut; 0.1 mg for cow’s milk; 0.03 mg for egg; and 0.1 mg for hazelnut.

These reference doses have been incorporated into the revised VITAL® tool (VITAL 2.0). Now the thresholds have been updated, use of VITAL® 2.0 will enable food manufacturers to apply credible, standardised precautionary labelling. As use of this version of the tool becomes incorporated into practice throughout the food industry, the authors maintain it will help to provide increased consumer confidence in their validity and reliability, as well as improving consumer safety.

Reference: Allen et al. 2013. Journal of Allergy and Clinical Immunology. pii: S0091-6749(13)01059-2. DOI: 10.1016/j.jaci.2013.06.042

Families bear the financial burden of food allergies

Researchers who surveyed parents with food-allergic children in the US have estimated the total economic burden associated with the disease as close to US$25 billion a year. The costs included in the tally included doctor’s appointments, hospital stays, trips to the emergency room and other direct medical expenses, which collectively account for US$4.3 billion each year. Expenses associated with catering for special dietary requirements, placing children in specific schools and childcare facilities that accommodate the needs of allergic children were calculated at $5.5 billion.

A large amount of the calculated cost was incurred through lost productivity of parents who had to take their children to medical appointments, plus opportunity costs which saw parents staying out of the workforce, taking lesser jobs or otherwise restricting their careers to accommodate their children’s medical condition. This included not being able or willing to take a job that requires travel, or many hours away from their child, in case of an emergency. Over 9% of the parents surveyed said they had incurred some type of work-related opportunity cost.

The grand total for all expenses came to US$24.8 billion a year, or US$4,184 per child, with most of this (US$20.5 billion) borne directly by families. Interestingly, when caregivers were asked what they would be willing to pay for an effective food allergy treatment their responses equated to US$3,504 per year per child (US$20.8 billion annually).

Reference: Gupta et al. 2013 JAMA Pediatrics. DOI:10.1001/jamapediatrics.2013.2376

Purchasing patterns and idiosyncrasies of food-allergic people in Great Britain

New research as part of the series ‘Advances in food allergy’ has been published in the journal Clinical and Translational Allergy and is available as a free access article. The research was based on an online survey undertaken to understand the characteristics and buying behaviours of food-allergic consumers in Great Britain, as well as that of people who buy food for them.

The survey included responses from 500 food-allergic consumers and 500 people who buy for allergic individuals. The most commonly mentioned food allergens for adults were fruit and vegetables, whereas cows’ milk was most commonly mentioned in school-age children and eggs in younger children. Just under half (45%) of the respondents reported having received a formal allergy diagnosis, with approximately half of these having been diagnosed by a specialist.

In terms of their purchasing behaviour, nearly two-thirds of respondents always read product labels the first time they bought a certain food. However, only one third read the label on every occasion. Only a third of respondents always avoided products that featured a precautionary ‘may contain’ label. Respondents who reported experiencing severe allergy symptoms showed significantly more cautious buying behaviours.

The results of this survey suggest the incidences of food allergy and food allergy reactions are under-estimated. In addition, the results confirmed that many people with food allergy regularly take risks when purchasing food, including those reporting severe reactions. This supports the widely-held view that the food industry’s current use of precautionary labelling to mitigate and communicate risk is of limited effectiveness. Given that most food-allergic consumers do not read labels on every occasion, the study authors also suggest that changes to a product’s allergen status should be flagged on the front of the pack to alert allergic consumers.

Reference: Cochrane et al. 2013 Clinical and Translational Allergy Vol. 3(1) pp. 31. DOI:10.1186/2045-7022-3-31. Access this article for free via www.ctajournal.com/content/3/1/31/abstract