FEEDING OUR FEARS ...
When a disease gets its own berth in the calendar and campaign gimmick you know it has hit a sweet spot in the public mind. SIDS' red nose day in June. Men's health's Movember five months later. Breast cancer's pink ... The new kid on the block? Food allergy's "one in 10" campaign.
In its second year this May, the campaign hopes to raise awareness about food allergies and anaphylaxis - its most severe form - through a week's activities. Comedian Peter Helliar and The Wiggles' Anthony Field are the ambassadors and its gimmick is asking supporters to paint one in 10 of their fingernails - or one in 10 of their painted nails a different colour - to represent the number of children it claims have a food allergy.
After more than a decade of horror stories about kids dying, and the increasing ubiquity of nut-free kindergartens, schools and parties, the food allergy campaign has gone from fringe to mainstream with remarkable speed. But some critics believe the widespread anxiety about allergies may be out of all proportion to actual risks to public health.
A Fairfax Media investigation reveals exaggerated claims about food allergies are being made by support groups and are going uncorrected by doctors who get some of their funding from companies that profit from allergy fears. These include pharmaceutical companies that sell adrenalin autoinjectors such as EpiPens, carried in case of anaphylaxis.
Meanwhile, the exaggeration of risk and consequent anxiety is also fuelling the prescription of EpiPens beyond the Pharmaceutical Benefits Scheme guidelines. And there is growing evidence that while autoinjectors do save lives, this hyped-up anxiety and reliance on prescribing the devices is costly to the public health budget, often ineffective, and can even damage people's health.
"My wife says she loses sleep and worries about losing [our anaphylactic son] one day. Our biggest concern is what happens to him on school camp in future, or going out as a teenager, or that someone would 'dare' him. We worry a little about getting 'the phone call'." (Tim Dunshea, father of Pacey, 7, who has nut allergies)
Food allergies stake their claims to the public's hearts and minds through the terrible threat of child mortality. People who are highly allergic to certain foods may react severely after ingesting even a tiny amount of the allergen. In extreme cases they can become anaphylactic - where a cascade of chemical reactions causes symptoms throughout the body, including compromised breathing and/or spiking heart rate and blood pressure. It can be fatal. But the risk of dying from anaphylaxis is extremely remote.
Reliable studies of anaphylactic deaths from any cause - allergy to medicines, insect bites, and, very rarely, latex and even exercise - are limited worldwide. But a study of anaphylaxis deaths and hospital admissions in Australia, published in the Journal of Allergy and Clinical Immunology in 2009, found that of 112 fatalities over nine years, only seven - 6 per cent - were due to food.
That's fewer than one a year. Nor were deaths from food-induced anaphylaxis found to be rising. Deaths from anaphylactic shock were overwhelmingly due to drugs, antibiotics and anaesthetics in particular. Insect stings caused 18 per cent of deaths, three times that of food.
Figures in the United States are broadly similar. A report last year in The Huffington Post indicated 11 people died from food-related anaphylaxis in 2005, based on the most recent data from the Centre for Disease Control. The US has a population more than 13 times Australia's. "More people died from lawnmower accidents," the author concludes.
The extremely low risk of death from food-related anaphylaxis is not a statistic highlighted among the information on the dedicated Food Allergy Awareness Week website. Instead, it emphasises the "one in 10" estimate of babies with food allergies to which it has pegged its nail-painting awareness campaign - as though this was an indication of the prevalence and risks associated with the phenomenon. In reality, many such infant hypersensitivities are not severe and resolve with time. Most of those allergic to cow's milk, soy, wheat or eggs, for example, will be able to tolerate these foods by the time they reach school age, and often before. The website also frequently misrepresents the statistic as applying to all children, rather than just infants.
It also maximises alarm with its claim that 10 people die from anaphylactic reactions each year in Australia, which it presents under the heading "Food Allergy Basics", when in reality food-induced fatalities are a 10th of that. (These misrepresentations remained at the time of publication, but changes to the website were being made after Fairfax contacted the organisation for comment.)
Food Allergy Awareness Week is an initiative of the charity, advocacy and support group for sufferers, Allergy and Anaphylaxis Australia. Its chief executive, Maria Said, defends her organisation's statistics. She argues official data under-represents the actual rates of allergies, as well as the true risk of death from food-induced anaphylaxis.
"There are so many people out there who know they can't eat shellfish or nuts. But they've never been properly diagnosed by an allergy specialist," she says. If they suddenly collapse or go into respiratory arrest, these may be signed off as respiratory, cardiac or asthma-related deaths, she argues.
"I'm certainly not saying death from anaphylaxis is common. But I don't think we have clear evidence about just how rare or frequent it is."
Food-related deaths and prevalence in kids are not the only alarming figures. A&AA (which has the web address allergyfacts.org.au) also claims that one in every 50 Australians - about 460,000 people - suffer from allergies.
This estimate is double that of the peak professional body, the Australian Society for Clinical Immunology and Allergy. ASCIA's website says one in 20 children and one in 100 adults have allergies. Yet ASCIA's logo appears as a "supporter" of the Food Awareness Week and, by implication, its claims.
The ASCIA logo is not as prominent as the chief sponsors of the initiative, which include: Coles supermarkets; Alphapharm, a subsidiary of the US drug giant that makes EpiPens; Link Pharma, the distributor of rival device Anapen; Nutricia, which makes hypoallergenic baby formula; and Nestle, which also makes formula and has a fast-growing division developing drug-food hybrids.
The inter-connected interests of doctors, drug and food manufacturers and the charity-lobby group A&AA are extensive.
Alphapharm and Link Pharma are also top-level "diamond" sponsors of peak body ASCIA (committing $40,000 or more per year to the organisation), while Nestle is a "platinum" ($25,000-40,000) and Nutricia a "gold" ($15,000-$25,000) sponsor.
Meanwhile, each of the doctors advising the charity is also an active member of ASCIA, including its current president, Dr Richard Loh, past president Dr Raymond Mullins and multiple committee member Dr Mimi Tang.
And the connections don't end there. Tang, for example, who is the director of the Royal Children's Hospital's department of allergy and immunology in Melbourne, has also served on advisory boards for Nestle and Nutricia, and received lecture payments from both Alphapharm and Link.
Such associations are mostly available to anyone who wants to check details on websites and read the small-print disclosures in medical publications. But they are a symbol of how interconnected the webs of professional advancement and medical research are, and point to potential conflicts.
Given how potent - and potentially lucrative - anxiety can be as a marketing tool, should eminent doctors be endorsing exaggerated claims about allergy rates and risks that are sponsored by drug and food commercial interests that may profit from them?
Ray Moynihan, the author of four books on the business of medicine, says just because an organisation takes industry money doesn't mean everything it says is distorted. But it does raise a red flag about the extent the public can rely on its advice. "The public debate gets subtly distorted because industry money ... amplifies certain opinions and certain science," Moynihan, now a senior research fellow at Bond University, says, speaking in general terms about the intermingling of marketing and medicine.
Pharmaceutical companies often rely on third parties that appear to be independent to endorse their views or products, because their ability to market directly to consumers is constrained, he argues. "Patient foundations and consumer groups that may be motivated by the best of intentions often get caught up in sophisticated marketing campaigns being run by their sponsors."
"For a good two years post diagnosis I was severely anxious and [later] went on a downward spiral and was really depressed. I presented myself to emergency departments a few times because I was having a panic attack over what were probably minor psychosomatic conditions, and I withdrew socially." (Aidan S, who suffered anaphylaxis while jogging and tests positive for wheat and grass allergies)
Exaggerated claims about food allergies and the absence of context that would minimise anxiety has become something of a hallmark in Australia and around the world.
But much like the fatal risks, the "epidemic" of food allergies and spiralling rates of "killer foods" may also have been overstated.
A number of Australian studies have suggested food allergies - to peanuts in particular - are rising, but many also conclude the broad increase in diagnosis may be due to rising awareness and anxiety, rather than proof of an epidemic.
Epidemiology - the study of disease patterns in populations - is a complex area that requires significant survey samples over time. The problem with allergy research is surveys are often limited.
Academic researchers can aggregate small surveys to discern trends, but discrepancies in the clinical diagnoses of food allergies means, in this case, such extrapolation is unreliable.
According to a systematic international review of 13,000 relevant studies published in the Journal of the American Medical Association in 2010: "The evidence for the prevalence and management of food allergy is greatly limited by a lack of uniformity."
"Food allergy affects more than 1-2 per cent but less than 10 per cent of the population," the report's 11 authors, led by Jennifer Schneider Chafen, conclude. "It is unclear if the prevalence of food allergies is increasing."
In Australia, hospital admissions or drug prescriptions are sometimes used as proxies for evidence of increased allergy rates. Prescriptions for adrenalin autoinjectors (such as EpiPen) have quadrupled in the nine years they have been available on the Pharmaceutical Benefits Scheme, according to the Department of Health. Hospital admissions for food-induced anaphylaxis soared 350 per cent in the nine years to 2005, according to research published in 2009.
Tang, lead author of the research on hospital admissions, believes such increases do reflect rising rates of allergies but acknowledges there is no conclusive proof.
"It is also possible, although less likely, that the increase in anaphylaxis admissions does not reflect a true increase in prevalence but rather an increase in community anxiety, awareness and recognition of anaphylaxis," her research, published in the Journal of Allergy and Clinical Immunology, concludes.
"We get party invites on Facebook and don't even get a phone number ... to tell them [our son's] allergic to nuts. I think he is probably anxious about seeming different and about making a fuss. It's harder now he's a teenager. I would quite like to get him one of those med alert bracelets but I don't think he will wear it." (Bronwyn Williams, mother of a 13-year-old with nut allergies)
The spectre of an "EpiPen epidemic" fuelled by increased anxiety rather than actual increased risk was first raised in Australia in 2002 - after prescription rates trebled in five years - by Dr Andrew Kemp, then head of the allergy department at Sydney's Westmead children's hospital. He put a crude cost then on the life of every child under 16 saved by an EpiPen at $51.7 million.
Prescribing guidelines were introduced a few years later, but prescriptions continued to grow from 21,482 in 2004 (the first full year they were listed on the PBS) to 81,239 in 2102. Assuming each script was for two devices - standard prescribing practice - and all were filled, the cost of auto-injectors last year was about $17 million.
Each device costs $106 and their available shelf life is only 12-15 months and sometimes less.
PBS guidelines indicate EpiPens, or rival device Anapen, should be prescribed only if someone has certain risk factors: they have had anaphylaxis before, or they have had a systemic reaction to an allergy test - not just local reactions - and, in addition, have factors such as poorly controlled asthma, a nut allergy, are in their teens or 20s, or if medical care is remote.
Yet specialists admit that many doctors ignore the guidelines, writing scripts for people who have had a skin prick or blood test only — something the guidelines specifically indicate is not a strong enough basis on its own.
Mimi Tang says skin and blood tests are actually poor predictors of allergy - and useless for predicting anaphylaxis. About 50 per cent of children with a positive skin test to egg or milk are sensitised but not clinically allergic, she says.
"They can eat the food and there's no reaction. So a bigger [skin or blood test response] tells you they're more likely to have an allergy but they don't tell you that they're more likely to have a severe reaction, or more likely to have anaphylaxis."
Specialists acknowledge that prescribing beyond the guidelines is often to medicate fear rather than potential physical symptoms. Dr Michael Gold, the head of the Women and Children's Hospital's department of allergy in Adelaide, says: "We know that having a child with a peanut or food allergy does engender anxiety ... and prescription may help with that.
"There are times when you definitely would prescribe an autoinjector; other times you definitely wouldn't. Then, like a lot of things in medicine and life, there is an in-between. Some one can define easily, others may come down to a discussion with parents to understand whether this is something they are very anxious about or not."
Despite the obvious strain overprescribing causes to public health budgets, clinical guidelines are not absolute so cannot be enforced.
"The guidelines are by necessity broadly descriptive rather than highly specific," Tang says. "They're just a set of recommendations to assist and support physicians in prescribing." She says doctors commonly prescribe things "off label", prescribing drugs for conditions other than the ones the drug is approved for.
What is the benefit to public health in terms of lives saved or severe anaphylactic episodes averted by autoinjectors? The PBS requires doctors to record whether a previous autoinjector was used or expired when writing subsequent scripts for patients. But a spokeswoman for the Department of Health and Ageing said that while this data was collected, "We do not report it as a matter of course as it is time consuming and labour intensive".
Without such data it is difficult to analyse how effective the prescribing regime may be in preventing sickness and death. There is evidence, however, that the prescribing regime is no fail-safe protection against anaphylaxis.
In 71 per cent of severe reactions, parents failed to use devices appropriately, according to research published in the Medical Journal of Australia in 2007, while 30 per cent of parents did not always carry it, and 40 per cent worried about using it in emergencies. Only two of 100 doctors in a major Australian paediatric teaching hospital could correctly demonstrate EpiPen use.
"Just providing the device is an inadequate measure and education and reinforcement ... and avoiding relevant allergens are critical," lead author Dr Wendy Allen concluded. Six years later, Allen, now paediatric allergist at Royal North Shore Hospital in Sydney, says the problems remain.
So, what is a fail-safe protection against death from anaphylaxis? That's the fundamental issue driving the zealousness of the food allergy campaign. The truth is, anaphylactic reactions are unpredictable. Those with prior severe reactions may have another of comparable severity in up to 70 per cent of subjects; but 20-45 per cent of mild reactions may be followed by a severe one.
It is thought that many of those who die have never been diagnosed. Six of the seven Australians who died from food-related anaphylaxis between 1997 and 2005 had a previous allergic reaction to food but did not have an adrenalin autoinjector, indicating a diagnosis had never occurred. Four of them died despite the administration of adrenalin by medical staff.
"I think anxiety causes more severe reactions to occur. I can accidentally eat the wrong foods, not panic and only get a mild reaction, while other times I have panicked and caused the anaphylaxis to come on." (Tegan Jones, 26, with dairy allergy)
Excessive drug prescribing puts a burden on already stretched public health budgets. But many parents and those at risk themselves might well consider that cost worthwhile for their peace of mind. New research, however, shows that there may be a health cost - rather than benefit - in taking that approach.
In January, the RCH's Tang published research showing children with food allergies who have an autoinjector have a poorer quality of life than allergic kids without a device, independent of their age, anaphylactic episodes, or number of allergies.
Fear, uncertainty about using the device and the burden of having to carry it at all times may be factors, the study suggests.
Tang says where doctors might have taken parental anxiety into account when considering whether to prescribe, now they also need to consider the flip side. "We should be the advocate of the child," she says.
"We know autoinjectors can be beneficial because they can provide early treatment, they can reduce morbidity and they can prevent death. But the reality is the majority of children with food allergy may not benefit from having one because they may never have a severe reaction."
It's the latest piece of evidence in a picture that shows that, when it comes to food allergies, our public health conversation is, well, nuts. Exaggerations may be fuelling anxieties, in turn fuelling prescribing and social behaviours out of proportion to scientific evidence about the risks and medical evidence of what works.
The danger in pointing out flaws in the food allergy panic is that it encourages those who want to dismiss the entire phenomenon as faddish or malingering.
Food allergies are real, and deserve public education and research. But it could be argued that hyping the risks is potentially distorting scant health resources and creating unnecessary - and harmful - fear.
"Overall, public anxiety around food allergy may be greater than warranted," Tang concedes. "There are some groups that should be reassured to reduce anxiety and avoid overexaggeration . . . but at the same time there is a lack of awareness of situations of real risk - such as food handling, and teenagers not carrying their epipens."
She says greater attention needs to be given to the food industry and to secondary schools, over primary schools or childcare.
"The point is now to find a balance [between] increased awareness of risk situations without generally increasing anxiety across the board," she says.
"We need to focus on supporting children and families emotionally and socially, in addition to medically."
FOOD ALLERGY FACTS
■About one in 20 Australian children has a food allergy but many resolve with time.
■About one in 100 Australian adults has a food allergy.
■Food allergies may be increasing, but there is no conclusive evidence.
■Fewer than one person a year dies from food-induced anaphylaxis in Australia.
■Mortality rates are not increasing.
■Those most at risk of death have had anaphylaxis before, or have significant allergic reactions and are in their teens and 20s, eating away from home, have a nut allergy, poorly controlled asthma, and are remote from medical care.
■Free online anaphylaxis training courses for carers, the public and health professionals are available at allergy.org.au
FOOD ALLERGY FICTIONS
■Touching a contaminated surface has not been shown to cause anaphylaxis. One British specialist spreads peanut butter on allergic children's arms to prove to anxious parents such exposure is harmless.
■A kiss that results in the transfer and ingestion of a known allergen could hypothetically trigger anaphylaxis, but no such case has been recorded. Cases reported as such were later proved wrong.
■Reading food labels is important. However, the widely used label "may contain traces of nuts" (or other allergens) means nuts are present where a product is processed. Doctors advise foods containing this label should not be excluded from allergic children's diets, as the contamination risk is lower than the danger of inadequate nutrition and social isolation that would result. Items labelled "contains traces of nuts" should be excluded from allergic people's diets.