Allergy as a diagnosis, its conception as a set of symptoms, and research into its aetiology, have a long history (Jackson, Reference Jackson2006), but the idea that allergy is a peculiarly modern disease reaching epidemic proportions is more recent. In 2003, the Royal College of Physicians (RCP) published a report, which claimed that the UK had ‘one of the highest rates of allergic disease in the world’ (Holgate and Ewan, Reference Holgate and Ewan2003: xiii). They reported that over 18 million in the UK had been diagnosed with an allergy, and that in any given year over 20 percent of the population was in receipt of treatment (2003: 7). These claims have resonated throughout the UK media ever since (see Hope, Reference Hope2004; Revill, Reference Revill2007; Willey and Sadler, Reference Willey and Sadler2006). Along with asthma and hayfever, food allergy is perceived as a growing problem. Although the actual prevalence of food allergy and food intolerance is difficult to measure and is contested (Mills, Reference Mills2007), the charity Allergy UK (2008) has estimated that 2 percent of the UK population have a food allergy and 45 percent experience some form of food intolerance.
Much of the debate within the UK on the presumed ‘allergy epidemic’ has taken its lead from the RCP and focused on the inadequacy of health service provision, and the need for specialized allergy services and better training for General Practitioners (GPs). However, this current debate has also cast food allergy and intolerance as largely psychosomatic conditions afflicting mainly middle-class women (Bailey, Reference Bailey1995; Prentice, Reference Prentice1985) too ready to accept the ‘fashionable’ diagnoses of allergy by alternative practitioners. The media and some medical commentators use this observation to further justify the need to expand free-at-the-point-of-use National Health Service allergy services, arguing that these alternative, complementary or pseudo-scientific private clinics/companies are selling diagnostic tests and allergy treatments that are at best ineffective and at worst dangerous (Marber, Reference Marber2005; Senna et al., Reference Senna, Bonadonna, Schiappoli, Leo, Lombardi and Passalacqua2005). In contrast, the leading test providers do not consider themselves to be alternative practitioners; in fact they have constructed themselves as healthcare providers that employ conventional scientific instruments and methods and ultimately aim for acceptance by the medical profession, distancing themselves from other ‘non-reputable’ practitioners and services. Strategic alliances with prominent nutritionists such as Patrick Holford (Holford and Braly, Reference Holford and Braly2005), as well as charities such as Allergy UK and Action Against Allergy, and commercial companies such as Lloyds Pharmacies and Moss Chemists (Mansfield, Reference Mansfield2006), mean that these tests are endorsed and sold widely, despite continuing doubts about their efficacy amongst the medical and political establishment (Carling, Reference Carling2005; House of Lords, 2007).
Allergies in general, and food allergy in particular, certainly speak to an array of concerns about the modern condition, from the ‘worried well’ to the industrialization of food production and home environments which are too sanitized (Jackson, Reference Jackson2006). Allergy is a disease of both affluence and interference in the natural world. As the American social historian Greg Mitman (Reference Mitman2007) has argued, there is a sense that the search for biomedical solutions to these problems is counterproductive, as it not only fails to engage with the complexities of the biosocial and environmental conditions of health and illness, it also exacerbates the problem by focusing upon commercial gain, as well as being overly reductionist and short term in its approach and thinking. Food allergy/intolerance tests sit within this complex as a contested practice—for some the prime purveyor of risk, for others its solution.
Food allergy/intolerance testing is also part of a much wider range of direct-to-consumer health tests that have burgeoned in recent years. Recent estimates suggest that the industry is worth an estimated £99 million a year in the UK (BBC, 2007). There are many concerns about the accuracy of these tests, the lack of regulation, and the dangers of basing a diagnosis upon their limited findings, as well as the production of harmful effects for individuals who change their diet unnecessarily, or increasing levels of anxiety among the ‘worried well’ more generally (Sense about Science, 2008). NHS doctors are particularly concerned about the rise of costly and potentially harmful testing and the challenge it might pose to social medicine, as well as their expertise and diagnostic jurisdiction per se. From a more theoretical perspective, Chrysanthou (Reference Chrysanthou2002) has suggested that this inward gaze and the project of the perfect body has replaced the communitarian visions of modernity. Others have suggested that it creates new forms of citizenship, such as ‘genetic citizens, fighting for specific rights while shouldering and contesting concomitant duties and obligations … [involving] social practices and power relations that cut across online and off-line worlds to co-produce genetic knowledge and genetic citizenship in multiple contexts’ (Shaffer et al., Reference Shaffer, Kuczynski and Skinner2008: 145; see also Novas and Rose, Reference Novas and Rose2000). These new forms of citizenship and individualism are part of what has been called the biosociety, or bioeconomy. As Nikolas Rose (Reference Rose2006) has suggested, this economy is structured around the search for biovalue, alongside a strong ethos of corporate social responsibility, new classes of expert—particularly pastoral experts such as counsellors and nutritionists—as well as new forms of subjectification, where people take on new duties and responsibilities for their health. Rose points to the project of optimization, specifically the duty of individuals to consume knowledge of their susceptibility for the future, and the blurring of the boundary between the treatment of disease and the enhancement of the norm, as key aspects of these trends, noting that this process has meant that previously low-level ailments such as irritable bowel syndrome (IBS) have now come into view as in need of identification and treatment. This is based upon a new moral economy of hope for the future that is far from just a matter for individual patient-consumers, but also of significance for collectives of active patients and support groups working at the frontiers of biomedicine to identify and ultimately cure their condition. He has also distinguished these aspects of biocapital from the capitalism of the past, because of what he deems the molecularization at their heart—the trade in the molecules of life, specifically DNA and proteins, as opposed to the ‘molar’ body of blood, limbs and hormones.
Although food intolerance/allergy testing does not utilize the new methods of genomics or trade the genes or stem cell lines that are at the forefront of biotechnology on international markets, we argue that it does fall within the remit of biocapital (Rajan, Reference Rajan2006; Thacker, Reference Thacker2005; Walby and Mitchell, Reference Walby and Mitchell2006) in that it is carving out a new market for unhealthy subjects beyond the bounds of conventional medicine, using new techniques of bioscience and biomedicine which are premised upon the study of one particular protein—Immunoglobin G (IgG). Rajan (Reference Rajan2006: 6) argues that biotechnology is a form of enterprise inextricable from contemporary capitalism, characterized by rapid commercialization of basic research in the biomedical and life sciences. Food intolerance/allergy companies have certainly expanded at a rapid pace and have been commended for their entrepreneurship. One of the leading companies in the UK has been praised by government ministers and received numerous business awards, ranging from the Deloitte Technology Fast 50 and the Technology Company of the Year to the Queen's Award for Enterprise (Innovation) and Entrepreneur of the Decade.
These companies are also engaged in a process of translation from biological material to bioinformation. They are realizing the latent value of IgGFootnote 1 —an entity which conventional medicine does not consider to be harmful. Although this information is not explicitly commodified and sold on to third parties for re-use, it has been utilized by academics conducting evaluations and these companies have sought to transform the results of these evaluations into a market advantage. These companies are also involved in intangible values, of the hype and promise of their own success as a company and of freedom from food intolerance for their clients. As such they have reached subjects who are increasingly taking responsibility for self-monitoring and lifestyle changes, which also form the mainstay of direct-to-consumer genomics and even some conventional clinical genetic tests for conditions where the only ‘treatment’ is surveillance and lifestyle change for those permanently ‘at risk’. As Rose (Reference Rose2006: 31) has suggested of biocapital more generally: ‘This is less a matter of the manufacture and marketing of falsehoods than of the production and configuration of truths.’
In this article, we focus on the efforts of one of the leading food intolerance/allergy testing companies in the UK to produce, market and justify their test for food intolerance/allergy in the context of considerable controversy about the methodology of the test and the implications of its results, as well as the aetiology, diagnosis, treatment and social implications of the so-called ‘allergy epidemic’ in general. We argue that these controversies, and the companies’ routes through them, are markers of wider shifts in relationships between medical and scientific expertise, the market and lay people and, as such, this study forms a case study with which to explore the shifting terrain of biocapital in contemporary society, as well as its implications for how scholars study and engage with contemporary debates and practices in these areas. We explore one company’s efforts to extract the latent value of IgG and to deal with its troublesome status beyond the laboratory. This, we argue, has gone alongside efforts to make the business credible in terms of quality standards and product development: combining scientific methods with business practice. We also explore how the company has both sought to create a division between its own practice and that of conventional allergy services (which deal with Immunoglobin E, IgE), while at other times building bridges between them. This has taken various forms, from the notion of ‘delayed onset food allergy’, to the conduct of a clinical trial, to drawing attention to uncertainty about the function of both IgG and IgE. We explore how the company draws upon, and feeds into discourses on how people have been ‘let down’ by conventional medical science in the search for a diagnosis for their problems, at the same time as it has sought to enrol and engage with conventional standards, methodologies and regulatory regimes to justify the efficacy of its approach. At the same time as the company has presented the diagnosis and aetiology of food allergy and intolerance as fundamentally ambiguous and stepped back from claiming to provide a diagnosis itself, it has also offered up the certainties of the test that it sells. In contrast to the cutting-edge fields of genomic research, drug development and tissue economies around embryos and stem cells, in this more mundane sphere of biocapital, we argue that novelty is not so much at issue as conventionality within existing frameworks of medical practice. The predominant discourse for consumers is one of relief from the past, not hope for the future. And these arrangements are also fundamentally local rather than global: they are embedded in particular spheres of UK policy and expert communities, self-help groups, the NHS and alternative practitioners. We go on to suggest that, alongside these aspects of conventionality, relief and localization, strategic ambiguity around the expertise and responsibilities of patient-consumers and experts-service providers, as well as the meaning of diagnosis and illness in itself, are key (but often overlooked) features of the institutional and technological assemblages of biocapital. We end by reflecting upon the implications of our analysis for the study of biocapital and biomedicine more generally.
The study
The data we present here is drawn from a larger ESRC-funded study on the sociology of food allergy/intolerance.Footnote 2 This exploratory study used a flexible mixed method approach drawing on and combining ethnographic observation, semi-structured in-depth interviews, focus groups and documentary forms of analysis. Our main ethnographic site was the private company that is the subject of this article. The company is one of the market leaders for food intolerance tests and exports tests to both Europe and the United States. The researcher Brian Woods observed laboratory practice, scientific and management meetings, and engaged in one-to-one (informal) meetings with six key members of the company, visiting it around once per month over a period of 14 months over the course of 2006–7. The research team also completed another 46 semi-structured, in-depth interviews, with a range of other professionals and lay people. In this article we supplement our discussion of the material from the company and its employees with interviews with some of our sample of allergy consultants (3) and allergy charities (5), as well as an interview with an academic researcher who has worked with the company. We do not discuss here material from 28 interviews with individuals with food allergy and/or food intolerance—this is explored elsewhere (Nettleton et al., 2009). In addition to interviews, the research team also drew on and analysed documentary materials from a number of sources. We examined: 13,521 different articles, letters and commentaries in newspapers (local and national) and professional and trade publications using LexisNexis; 39 witness statements from the House of Lords Committee on Allergy; and 349 scientific/clinical journal articles on food allergy and food intolerance. In a classical sense, the majority of these were secondary sources, but for this project the distinction between ‘primary’ and ‘secondary’ was often blurred because of the ways in which we analysed the accounts contained within them. Here we draw on a limited amount of this material that concerns the company in question, as well as the background to the current understanding of food allergy and intolerance and debates about the clinical validity of the test we discuss. The transcripts and all of the material noted above were managed and analysed using Atlas.ti. All of the data was coded thematically, by subject matter, and by ‘actors’ (both material and social).
Food allergy and food intolerance testing in context: excavating IgG
Allergy and intolerance have long been entangled and used in a range of ways to describe, define, explain and pull together various manifestations of altered biological reactivity (Jackson, Reference Jackson2003, Reference Jackson2006; Johansson, Reference Johansson2003). This multiple and interchangeable usage of terminology has been blamed by some for confusions currently surrounding allergy diagnosis and science (Johansson et al., Reference Johansson, Bieber, Dahl, Friedmann, Lanier and Lockey2004). Within the boundaries of contemporary thought and practice, clinical allergy, allergy in general, and food allergy in particular, is defined as a disease arising from a consequent response by the immune system to an otherwise harmless antigen (Janeway et al., Reference Janeway, Travers, Walport and Shlomchik2001). The antibody considered responsible for nearly all allergic reactions is IgE (Johansson et al., Reference Johansson, Hourihane, Bousquet, Bruijnzeel-Koomen, Dreborg and Haahtela2001; Kimber and Dearman, Reference Kimber and Dearman2002; Sampson, Reference Sampson2004; Sampson and Burks, Reference Sampson and Burks1996; Sicherer, Reference Sicherer2002). The centrality of IgE antibodies and the redefinition of allergy in limited immunological terms is part of a process of standardizing both the terminology and the methods of diagnosing food allergy. In contrast, food intolerance has been used historically to capture a variety of causes and effects, including allergic reactions, enzyme defects and other non-defined idiosyncratic responses (Buttriss and Schenker, Reference Buttriss and Schenker2002; Lessof, Reference Lessof1983, Reference Lessof1985). Recently the idea that food intolerance is solely related to non-immune responses has gained wider acceptance (FSA, 2007). This has gone alongside conventional medicine’s rejection of IgG antibodies as a causal agent in food intolerance/allergy. Although this demarcation jars with lay experiences of food allergy (Woods et al., Reference Woods, Stoney, Raven, Walters, Abramson and Thien2002), the dominant clinical view is that food-specific IgG antibodies ‘have no relevance to the diagnosis of food allergy’ (Lessof, Reference Lessof and Buttriss2002: 87), ‘no predictive value for dietary management’ (Strobel, Reference Strobel and Buttriss2002: 135), and ‘are not of clinical importance’ (Johansson et al., Reference Johansson, Bieber, Dahl, Friedmann, Lanier and Lockey2004: 835). This means that nearly all of the IgG tests for food intolerance/allergy sold on the private market are dismissed by the vast majority of conventional healthcare practitioners, especially allergy specialists.
In the early 1980s, the direct-to-consumer allergy testing market was largely based upon the cytotoxic test, which was proposed by Arthur Black (Reference Black1956) and developed by Bryan and Bryan (Reference Bryan and Bryan1971). This involved laboratory staff looking down a microscope and observing how leukocytes (white blood cells) reacted when placed on slides coated with dried food extract. If the leukocytes changed their shape or disintegrated, then this was presumed to be a positive result, with the patient being deemed to have an allergy to whatever allergen was coated onto the slide (Barrett, Reference Barrett2002; Brostoff and Gamlin, Reference Brostoff and Gamlin1998). The test was sold by numerous ‘high street’ clinics in Europe and the United States (Thompson, Reference Thompson1984). Concerns about the reliability of cytotoxic testing were eventually voiced by the Joint Council of Allergy and Immunology in the USA, who drew it to the attention of the US Food and Drug Administration (FDA) in 1984. In 1985, the FDA followed the ‘the consensus of scientific opinion’ and concluded that the test was unproven and unreliable as a diagnostic tool (FDA, 1985). According to Barrett (Reference Barrett2008), regulatory actions and unfavourable publicity, eventually drove cytotoxic testing out of the marketplace. However, other ventures around food allergy diagnosis quickly developed, of which the ELISA food-specific IgG test was one. In developing this test, practitioners drew upon conventional research on what appeared to be IgG-mediated allergy (Parish, Reference Parish1970) and sought to measure raised IgG levels to help with the diagnosis of delayed food allergy and/or food intolerance (see especially Dockhorn, Reference Dockhorn1987; Shakib et al., Reference Shakib, McLaughan and Stanworth1977). Into the late 1990s, Hamilton Dixon (Reference Dixon, Trevino and Dixon1997a, Reference Dixon, Trevino and Dixon1997b, Reference Dixon2000) and James Braly (Reference Braly2001; Holford and Braly, Reference Holford and Braly2005) became ardent champions of the idea. Neither of these individuals are alternative practitioners: both hold medical doctorates and both believe in the scientific value of in vitro IgG testing for delayed food allergy.
We now turn to consider the processes involved in extracting the latent value of this troublesome entity, which are at the heart of the intolerance testing process, and the wider controversies about the meaning of food intolerance and food allergy for individuals and society at large. We do this to establish food intolerance/allergy testing as a form of biocapital, but also to explore the various ways in which convention and novelty, patienthood and ill-health, and business practice are negotiated in the process. Our concern is to illuminate the dynamics around expertise and responsibility in this sphere of the biocapitalist world.
The test: capitalizing on IgG
In this section, we draw on what we know of the company we have studied and its product in order to construct an ideal typical version of the procedure; we do this not just as an analytic strategy but also in order to preserve anonymity.
The company advertises its test widely, especially on the internet. You can also buy its products in big chains of chemists and through the websites of prominent nutritionists such as Patrick Holford. The company also exports its test to other companies across Europe and the USA, and these companies market the test as their own product, subcontracting the testing process to the company we studied. The company also has its own comprehensive website to sell the test directly to consumers, alongside regular news, information on the test, endorsements, patient testimonials and links through to a range of support and further information. This intolerance test is also part of a wider portfolio of so-called ‘lifestyle tests’, including liver function tests. The company presents itself as ‘pushing the boundaries of scientific research’, but also as involved in empowering people to ‘take control’ of their health. It draws attention to its partnerships with universities and charities, and makes a point of underlining its commitment to accuracy and audit. The patient testimonials are especially rich examples of the subtle evocation of personal responsibility for health, and the failures of conventional medicine within which ‘relief’ is a dominant theme.
These themes were also apparent in the interview with the former CEO of the company, where she told of her own personal experiences prior to joining the company:
I came along, had had arthritis for 26 years; I'd taken I calculated well over 30,000 pills during that time; I had a variety of steroid injections, variety of treatments, never actually got better but just got relief from symptoms all the time one way or another. The two people who worked in the laboratory at that time had suggested to me that something I was eating would be contributing towards my arthritic symptoms. I hardly wanted to know, I have to say I wanted to just get away from them; I just said it was really spooky stuff and I wasn't, wasn't really interested. But they did take a sample of my blood. They then told me some foods that I should look at withdrawing from my diet, one of them was actually tea, the drink of tea, and I was actually sitting having a cup of tea when they were saying that it's something food or drink related. Anyway I cut the foods from my diet and after about three or four months gradually, having more good days than bad days, I eventually found myself totally symptom free within about three or four months after 26 years of quite … bad, bad arthritis … at times I got upstairs on my hands and knees and … so I got better and I only got the symptoms back again when I ate the offending foods; one of the offending foods was white fish and the other one was white of an egg.
In this extract, relief via conventional medicine was presented as transitory and dependent upon repeated medical intervention, whereas the relief experienced after the dietary changes recommended following the test was more lasting, provided the regime was maintained.
The process of extracting these results is relatively simple, and does not require large amounts of high-tech equipment. When customers purchase a test for around £250, they receive a kit through the post, which comprises a plastic box containing a set of instructions, an antiseptic wipe, a lancet, an absorbent wand and container, a plaster, a pair of plastic gloves and a pre-paid plastic envelope. The box is itself encased by a cardboard box, which has the company logo printed on it, an image of some food and the tag line ‘clinically proven’ on the front. Underneath the front flap, there is a customer details form and some customer testimonials, and an endorsement from a practising GP and a medical broadcaster. On the back are some contact details and the tag line ‘Better health begins at home.’ The plastic box has the company logo and contact details on the front and a CE mark (which guarantees the product conforms with relevant EU directives) on the back. Printed instructions direct the customer to wash their hands, wipe the side of their finger with the antiseptic wipe, prick the side of their finger with the lancet, hold their hand at waist level and massage the pricked finger to produce a droplet of blood, then soak up that blood with the wand, place the wand in the container and place the container into the plastic envelope, with the customer details form, and post it back to the company.
On arrival at the lab a technician labels the blood sample with an identification number, re-hydrates it and puts the diluted blood sample on a pre-prepared ELISA plate. This is composed of wells set out in rows and housed in a plastic rectangular container, around 100 of which are coated with the foodstuffs to be tested, and less than 10 of which are controls. The foodstuffs are actually the allergenic protein extract of the food, which the company source externally, then standardize. The control wells contain the allergenic protein extract of cow's milk to which sera (blood) samples that the company has also sourced externally are added. The laboratory has previously tested the purchased sera samples against the cow's milk to produce identifiable reactions, which they then translate into a low, medium and high reaction result. Another well is left empty to provide background.
The plate is shaken to speed up the reaction of IgG antibodies binding to food antigens, it is then washed to remove excess and antihuman antibodies are added. These bind to the human IgG. The plate is washed again to remove excess and a chemical dye is added: the darker the colour the stronger the reaction. These are bunched into six categories and scored. The patient receives a covering letter, a results sheet, a plastic (credit card-like) card printed with the results, information about the telephone nutritional consultation they are entitled to, a mail order form for books about food allergies, and a plastic folder containing guides and advice on how to change their diet. The results sheet is set out as a table, with four columns and six rows. The rows list food types, e.g. grains, meats, etc., and each intersecting box contains a single food, a list of foods, or nothing. The second, third and fourth columns tell the client what to avoid and what can be eaten freely, or eaten less frequently. If a food is entered into the avoid column, the strength of the reaction is also indicated. The covering letter sets out an explanation of the results, with green indicating that all these food can be eaten without restriction (although the proviso that ‘if you suffer classical allergic reactions to any of these foods do not eat them’ is added in block capitals). The amber is explained as indicating a slight reaction and that eliminating them from your diet every three to four days may be of benefit. The red or avoid column is explained in detail, in this kind of language:
… you have raised IgG antibody levels to these foods and you should try to eliminate them completely from your diet. A grading of 1 to 5 is used (with 5 as the highest) to indicate the strength of your reaction, although this grading does not necessarily equate to the severity of the symptoms. You may benefit from removing all foods in the ‘Avoid’ column from your diet. It is recommended that you try eliminating those with the highest number first.
The company claims that if the patient follows the recommended diet they should experience symptomatic relief within two months.
Following recent criticisms after their involvement in a clinical trial (discussed below) the company does not always call this information a diagnosis, but makes statements such as: ‘Please note that this validated test is not diagnostic of any condition. It is to be used by people with chronic symptoms, with advice from a qualified nutritonist, as an aid to dietary management.’ However, elsewhere, on the company’s website, the emphasis is placed more firmly on diagnosis, as in the following type of statement:
Food intolerances are on the increase but many sufferers have never actually been tested or diagnosed. There is a surprisingly diverse range of foods which people are now intolerant to. By taking a simple and clinically proven test consumers can diagnose culprit foods within a couple of weeks, saving months of guess-work and hours trying to get an appointment with their doctor.
Note also that the company is positioned as responding to consumer need for a diagnosis, and conventional medicine is, by implication, found wanting.
So far we have shown that the process of extracting latent value from IgG involves transforming blood into immunological reactions into a sheet of dietary recommendations. This goes alongside several other important steps: transforming the consumer into an active patient, taking responsibility for improving their health; being ‘in control’ and experiencing relief after a period of ambiguity and doubt, usually involving conventional medicine's lack of response to their concerns; and persistent problems which interfere with their quality of life that, although mundane, are ever present. We have also seen the company's links to pastoral experts, in the form of nutritionists, who the company has contracted to provide telephone consultations to customers (and the company also distributes further promotional materials on their behalf). The company is not providing a standard diagnosis but its test is clinically proven as an aid to dietary management with the guidance of pastoral expertise. This both sets it apart from, and aligns it with the practices and discourses of conventional medicine. While the company purports not to invade the conventional realm of true diagnosis of a medical condition, it also wants to work alongside conventional medicine, using the same techniques, such as elimination diets, with the guidance of qualified experts. But the company goes further still, when it seeks to harness some of the certainties and some of the ambiguities of conventional medicine in the promotion of its product. We now go on to explore three key dimensions of this dance of certainty in more depth, beginning with the blurred boundary between food intolerance and allergy, and exploring what this tells us about contemporary forms of biocapitalism.
From intolerance to allergy?
As we have already noted, food intolerance used to be the umbrella term for food-related problems, including food allergy. More recently a stark divide has been drawn by conventional medicine between classical allergy, involving an immunological response, usually via IgE, and food intolerance which does not involve an immunological response. When it developed its IgG test, the company marketed it as a test for delayed food allergy, looking at an immunological response via IgG (rather than IgE—the domain of ‘classical allergy’). However, the notion of IgG-mediated delayed food allergy has been roundly rejected by conventional medicine. The company also faced criticism from allergy campaigners such as the Anaphylaxis Campaign, as the quote from an interview with a long-standing activist demonstrates:
… the test is controversial 'cos they used to sell it as an allergy test, and we had a go at them and said, ‘You're not testing for allergy, you're testing for IgG and you should call it an intolerance test’, but they don't want that, 'cos that's not fair to people 'cos everybody wants allergy testing.… I just feel that when your life might be at risk, you're entitled to hang on to the proper word. That's the … political [aspect] …
The hardening of the boundary between IgE-mediated allergy and intolerance has meant that the company now markets its test as a test for food intolerance. This has left it with a lasting dilemma in that its test looks for an immunological response, but the company must present it as a test for a condition that conventional medicine considers not to involve an immunological response. The company finds itself in this position partly because of its long association with nutritionists and alternative therapists, who continue to promote the idea of delayed food allergy/intolerance. There are a number such ‘lifestyle gurus’ who have secured a high media profile, one such is Gillian McKeith who states on her website:
Allergies tend to cause immediate and dramatic reactions such as skin rashes, hives, itching, swollen mouth or tongue and difficulty breathing. Food intolerances, on the other hand, can have delayed and wide ranging reactions that can build up over time. Whilst food allergies tend to be for life, it is potentially possible to overcome food intolerances if the gut and immune system are sufficiently healed.… Any of the above digestive disorders can leave you more susceptible to developing food intolerances. An overgrowth of candida or bad bacteria can damage the gut wall making it more leaky to food particles. This means foods get absorbed into the body before they are fully broken down. The immune system does not recognize these particles and develops antibodies against the offending foods. Food intolerances are thus born.Footnote 3
Here food intolerance is being distinguished from allergy because it is delayed and wide-ranging, but it still involves an immunological response. This is within a discourse of self-improvement and healing, in contrast to food allergies which are presented as ever-lasting and untreatable. Patrick Holford puts it slightly differently, focusing upon ‘hidden food allergies’, but he nevertheless emphasizes the delayed, systemic nature of these reactions, as well as the immunological response, noting that, in contrast to classic food allergy: ‘In most cases … you can reverse—and even lose—delayed-onset IgG food allergies.’Footnote 4
The key point about this focus upon delayed food allergies is that it presents them as mutable and open to individual intervention. This is the raison d'être of the IgG test, which focuses upon empowerment and relief from a food intolerance. Consequently, the company must maintain both a claim to be within the realm of food intolerance testing, and a claim to be testing for delayed onset food allergies. This means that although it clearly states in promotional literature that its tests identify food intolerance, it also goes on to describe the test as a matter of delayed food allergy. For example, in the second page of a leaflet on its test, the company makes a statement such as the following:
Food intolerance can be caused by problems with enzyme deficiency or reactions to particular chemicals in food. It can also be caused by what is known as delayed food allergies. This is linked to the IgG antibody.… Delayed food allergies can lead to chronic illness but because of the delay between eating the food and the onset of symptoms, it is difficult to identify the cause of the reaction without accurate laboratory testing.… Our tests can provide this accuracy. We can pinpoint delayed allergic reactions to food, so that these foods can be avoided. This leads to a more stable immune response and relief for the sufferer.
For the company, this alternation between presenting its test as a test for food intolerance and/or delayed food allergy serves to enrol nutritionists and their clients into their project and avoids some of the stronger condemnation of its product from conventional medicine. Yet, as we shall describe below, the company has nevertheless faced a lot of criticism from conventional medical opinion, perhaps especially so when it seeks to formalize and legitimate its product within the limits of conventional science and medicine.
Science as business, business as science
Extracting the latent value of IgG does not just depend upon enrolling patient-consumers or even nutritionists. As is suggested above, it is also important to enrol medical science. When the company began, it performed and marketed the now discredited cytotoxic food test, but when the previous CEO joined the company in the late 1990s she was concerned about the reliability of the test. At the time, the company was also developing its current test using the ELISA methodology, which it saw as a legitimate scientific tool with high reproducibility. As described above, the ELISA methodology is a standard biochemical technique used in a variety of laboratories worldwide. However, ELISA tests, as with any immunoassay detection system, can produce false positives or false negatives if they are not designed and developed thoroughly. The company therefore had to put a significant array of quality assurance mechanisms into place to deal with this problem. As an ISO consultant at the company noted:
[they] realized that they needed to up the ante in terms of their quality assurance, and that coincided with the appointment of a new technical director … [who] was keen to develop and have a more robust quality system.
The technical director confirmed how he had to allay his scepticism about the reliability of the test in a mass produced environment:
When I started with the company I wasn't convinced, I mean I was, I was sceptical.… to me—in order to prove something you have to provide good evidence that something works.… And part of, to me, in order to understand a product and the way that a product performs … so if you think about if you develop a test for something, [you have to know] is it sensitive enough to tell the difference between whether somebody can react to grapefruit or not at a very low level, and is it meaningful—is it reproducible enough, are you going to get the same result every time, is there any interference from other drugs or from other different types of antibodies, is it accurate, does it deliver a true result?
With a background in science in both the NHS and the private sector, the technical director brought with him a broad range of knowledge and experience of immunoassays and diagnostic tests. For him, the routes to a successful test (i.e. reproducibility) were standardization and validation—standardization of the protocols, the antigens, the solutions, the wells, etc. and validation of the equipment, such as microplate coating and washing equipment. One strategy the technical director employed to determine standardization was to instigate measures to ensure that the company complied with both ISO13485:2003 Quality Management Certificates and with the European in vitro diagnostic directive 98/79/EC Annex III, Section 6, which gives the test a CE mark. Through establishing standard operating procedures and documentation (which detail how to conduct the test, from the manufacture of the ELISA plate, to production of all the solutions and reagents, and the maintenance and calibration all the instruments, through to the monitoring of quality control), the company sought reproducibility. For the technical director, reproducibility was paramount—the test becomes scientific when the results can be reproduced irrespective of time and space. For the company this was not only important within its laboratory in the UK, but because the company exports its test globally.
Here we see business credibility and scientific methods being built simultaneously to optimize the extraction of latent value from IgG. Although these good laboratory practices have not been challenged, they were not sufficient to secure credibility on a wider public stage; credibility that the company sought in order to retain and build alliances with patients and professionals more widely, thereby enhancing the biocapital of their product. These ventures have, however, brought the company into direct confrontation with conventional medicine.
Managing uncertainty: the clinical trial and beyond
In seeking to manage lay–expert relations in their favour, the company also sought to enrol patient groups, clinicians, general practitioners and academics to observe, endorse and undertake clinical trials and clinical research on their test. This was a bold move, given their place on the boundaries of conventional medicine and the rigorous standards of clinical trials, but it was one that was viewed by the CEO as vital to their credibility in the long term. A primary move in this direction occurred when the company came into public confrontation with a leading allergy charity on a popular radio programme. Initially, the charity was critical of the company, as its CEO recalled in an interview: ‘We took the official party line … that there was no scientific or clinical evidence to support IgG testing.’ He recollected that after the radio programme the company's CEO phoned:
[She] rang me and said that ‘You, you did us a lot of damage on that programme’, and my attitude was: ‘Well put your money where your mouth is. You're making a lot of profits, go into clinical trials’, and she said: ‘Fine, I will (laughs) but equally, can I ask you to at least consider the evidence of people who have had our test?’ I said: ‘Well for me to look at it, I you know, if … I come out and say it’s still a load of rubbish, you're going to say well you would say that because you’ve publicly said that.’ So we agreed that we would get a professor of health sciences … to carry out an audit.
Building strategic alliances with the leading patient advocacy group in this sector was an important step in securing future consumers in this growing field. It was also important to enrol credible experts to conduct the trial. Building on local links, the company's CEO recruited a professor to conduct an audit of the company's own internal customer survey and organize the conduct of an independent telephone survey with both responders and non-responders to the original survey. The report concluded that roughly half of the clients said that their symptoms had reduced a lot or quite a lot after they had changed their diet, and that nearly three-quarters of them said that this effect had continued.
The charity’s chief executive remembered taking the report to his Board of Trustees:
To our amazement, something like, if I remember rightly, 72 percent came out saying that sort of six months on they had benefited from it. You, I took it to my Board and said, ‘Look we, we can't ignore this.’ They said: ‘Whoa, where do we go from here (laughs), because if we come out and say look, you know, we've carried out this audit of 4,000 people and this high percentage of people say they've benefited, we're going to be massacred by the medical profession.’ And I said, ‘Yes, but equally, you know, if you are going to be a patients’ organization, you can't kowtow to the medical profession and you have to come out and say.’ And they very bravely said, ‘You are absolutely right, we've got to go and admit we've got it wrong and that the people are telling us that there is something in this.’
Although the report's conclusions had a number of important caveats, such as that the reported improvements in symptoms could not necessarily be attributed to the test or dietary change, and other factors could be at play including the placebo effect, its author considered it important that many people came to the company with long histories of chronic symptoms and the results did justify further evaluation by means of randomized control tests.
The company and the professor thus forged an alliance around the view that, in order to demonstrate clearly the efficacy of the test, it was necessary to conduct a randomized control trial. The professor justified this by emphasizing his academic stance as a ‘therapeutic nihilist’ in an interview. He explained that his starting position was, and is, that ‘nothing works’ unless it can be shown to work empirically and, if a ‘well-designed trial shows something works’, then there is something there that needs to be considered. He was not concerned that ‘we don't understand why beforehand, because that assumes we have all the biology models’, which is a position that he does not accept. However, in his efforts to secure funding to conduct a trial, he came up against a very different set of beliefs:
It was very difficult to get funding.… We tried several times to get funding but it was impossible.… We had put in grant applications … but it is very difficult, because there is a group of allergists, immunologists, who will reject absolutely that there is any possible causal pathway … and some of them just say, can't happen, this is ridiculous, there is no point in funding a trial.
The lack of funds functioned as an effective block on the company's expansion by limiting its opportunities to legitimate its product. With no funding available, the professor proposed a relatively simple trial. The company's customers generally came in six broad groups: gastro-intestinal disorders; skin disorders; migraine/headache disorders; respiratory disorders; and musculo-skeletal problems, such as arthritis and fibromyalgia. A randomized control trial on all these symptoms, while not impossible, would be complicated in terms of comparison and outcome measures. It was thus decided to focus on a single group. By this time, the audit was showing migraine and IBS as two significant groups. At the time, the company had some difficulties in convincing the Migraine Trust to become involved, partly because migraine researchers and clinicians were heavily involved in drug trials, which not only brought in money to clinical services, but also occupied most of their resources. Attention thus focused on IBS, and another professor of gastroenterology, who had a particular interest in this condition and access to an ‘uncomplicated IBS’ patient sample, joined the research and they began a clinical trial to ‘assess the therapeutic potential of dietary elimination’ for IBS patients ‘based on the presence of IgG antibodies to food’, as shown by the test. The results of the trial were published in a leading journal of gastroenterology, showing a clinically significant improvement in IBS symptoms in patients who eliminated from their diet foods to which they were found to exhibit sensitivity, as identified by the test for the presence of IgG antibodies to these foods.
However, the trial soon drew criticism from allergists in particular, but also a wider group of scientists and medics who were concerned to challenge the growth of alternative therapies and the expertise of popular entrepreneurs and broadcasters in this area, especially nutritionists. A particular concern centred on the methodology of the trial and the use of so-called ‘sham’ and ‘true’ diets. This involved staff at the company producing a ‘true’ diet sheet (that is an elimination diet based on the test result) and a ‘sham’ diet sheet for every patient. The sham diet eliminated an equal number of foods to which the patient showed IgG sensitivity, but not the actual foods. For example, cow's milk was replaced with rice, wheat with egg and yeast with potato. The company then sent both the ‘true’ and ‘sham’ diets to the academic team involved in the trial and patients were given one of the two diets through random selection. All patients, clinical and company staff were blinded to the assignment of diet sheets for the duration of the study. However, critics questioned whether the test actually involved a control, or identified benefits arising from action taken as a result of the diet rather than general dietary habits. The harshest critique came from a prominent consultant physician in gastroenterology, who argued that IgG testing for either food intolerance or food allergy has no predictive value. This position echoed the judgement of the majority of mainstream clinical allergy: IgG was irrelevant. While acknowledging some of these criticisms, the research team considered that they had provided evidence that the IgG-based test and diet did improve people's condition. Their confidence also emanated from their knowledge of IBS as a complex disease, the mechanisms of which are still unclear. They called for further research and argued that the current dogma should not be immune to challenge.
Various rhetorics of empiricism, progress and biological complexity were present in some of the key actors' reflections after the event and the debates that unfolded around the clinical trial at the time. The company, and its partners in the trial, including the patient organization, argued against medical dogma and intransigence, mobilizing the authenticity of people's experiences and humility in the face of complex biosocial systems to defend the staging of the trial and their interpretation of the results. In so doing, they sought to occupy some of the terrain of scientific expertise and knowledge, notably faith in the empirical and an open-minded approach to knowledge seeking. At the same time, they sought to undermine some of the ground on which conventional medicine stood, questioning its objectivity and commitment to extending the bounds of knowledge. These types of claims were important to the company in gaining credibility as a business. To market its test successfully, the company had to be able to defend itself against accusations of pseudo-science and quackery. Although the closing of ranks in conventional medicine has sought to exclude IgG from the food allergy story, the company has been able to muster enough support from academics and some clinicians, as well as support groups, to challenge this attempt to banish it from the field entirely.
The company also began to draw parallels between the uncertainty of the mechanism for IgG-mediated food allergy and conventional IgE-mediated allergy in a subtle attempt to deflect general criticism of measuring IgG. Indeed, it is widely recognized that, despite the appearance of a clear mechanism demonstrating the links between antigen exposure, IgE production and allergic symptoms, two broad puzzles remain. First, that levels of IgE do not necessarily correspond with severity of symptoms and, second, that the presence of IgE antibodies does not necessarily translate into clinical symptoms (Asero et al., Reference Asero, Ballmer-Weber, Beyer, Conti, Dubakiene and Fernandez-Rivas2007; BSACI, 2006). These puzzles pose diagnostic difficulties for the positive predictive value (PPV) of both skin-prick tests and blood tests. By themselves, neither test can categorically determine whether an individual is clinically allergic (Clover Reference Clover2006; Lessof, Reference Lessof and Buttriss2002). With the skin-prick test, the PPV varies according to the clinical context, the type of food allergy, the allergen extract used and the age of the patient (Asero et al., Reference Asero, Ballmer-Weber, Beyer, Conti, Dubakiene and Fernandez-Rivas2007; Sporik et al., Reference Sporik, Hill and Hosking2000; Strobel, Reference Strobel and Buttriss2002), and with the RAST (radioallergosorbent test), IgE levels below 100 kilounits of allergen-specific IgE per litre (kUA/L) only measure immunological sensitization, not clinical reactivity (Ortolani et al., Reference Ortolani, Ispano, Scibilia and Pastorello2001; Osterballe and Bindslev-Jensen, Reference Osterballe and Bindslev-Jensen2003; Sampson, Reference Sampson2001; Sampson and Ho, Reference Sampson and Ho1997). The company pointed to these types of conundrum when noting in general that the presence of antibodies does not, in and of itself, signal that disease is present, but the result must be considered as part of a much wider picture. The company used this to argue that there was a need for further research, which it has tried to find partners to conduct, but has been rebuffed. In short, the company argued that although they faced similar conundrums to those working with ‘true allergies’ (i.e. IgE-mediated allergy) it ultimately faced a blinkered medical profession.
However, this effort to trouble IgE and conventional diagnostic strategies by acknowledging and extending the troubles of IgG has not been wholly successful. Within clinical allergy, it is argued that there is no real debate here. Clinicians spoken with at a major conference in 2006 all acknowledged the problems with both the skin-prick test and IgE blood tests, but maintained their usefulness as negative predictors (i.e. if a patient does not show specific IgE, then they do not have an allergy). A positive diagnosis of food allergy relies on other diagnostic methods in addition to tests for IgE, including detailed clinical history and physical examination, elimination diets and oral food challenges, of which the double-blind placebo-controlled food challenge (DBPCFC) is considered as the gold standard (Asero et al., Reference Asero, Ballmer-Weber, Beyer, Conti, Dubakiene and Fernandez-Rivas2007; Crespo et al., Reference Crespo, James and Rodriguez2004). They argue that these diagnostic tests are useful only when employed together with clinical judgement, as the following account from one allergy consultant illustrates:
People come in and say, I've got a food allergy and all that means is that they react to some food and they get some sort of symptoms, it doesn't tell you what their problem is. And so, very often when you see people in the clinic, what you have to do is say, well hang on a minute, what is the problem that you have, do … you get asthma, do you get anaphylaxis, do you get a thick lip. If so, when do you get it, what's the pattern of this, does it happen close to meals, is it plausible that it could be related to food, and if so then how do we define by skin testing or blood testing which are the foods that are responsible for the pattern you're seeing? And then when you get the results back you need to then go back and do a reality check, which says, you know, you've come up positive to garlic, right … well … does that fit? … I had somebody in clinic on Tuesday who got a [positive] blood test for garlic. She eats raw garlic every day and doesn't get a problem, and once every six weeks she gets a thick lip, well that's not due to garlic.… OK, she makes some antibodies against it, so she's sensitized but [she is] not getting clinical symptoms.
This meant that, although the company's proposition that IgE testing faces the same uncertainties as IgG testing has some merit, it also worked to expose the fragility of the company's own test because the uncertainties they pointed to supported the use of other diagnostic methods in tandem. This is a point underscored by Dr Glenis Scadding (2007), consultant allergist at the Royal National Throat, Nose and Ear Hospital, when asked to give evidence at the House of Lords on regulation for private allergy tests:
They should be banned. … [I]f you do a test only about half the people with that positive test will have clinical disease, so you cannot have self-testing kits, they are going to lead to misdiagnosis, mis-allergy avoidance. You need both the test and a detailed history taken by somebody who has some experience of allergies to be making an interpretation of tests. (House of Lords, 2007: 38–39)
In conventional terms, clinical judgement is what matters in interpreting in vitro testing, regardless of whether these are IgG or IgE tests.
The company tried to manage these claims by placing their own test results within the broader context of professional judgement, and encouraging their clients to speak with their medical practitioners about the results, in addition to taking up their entitlement to a telephone consultation with a nutritionist when they received their results. The company is also keen to position itself as working in partnership with its customers to educate the medical profession, as the following extract from the interview with the CEO demonstrates:
Now … many, many people are taking greater responsibility for their own health, many doctors are now saying there is perhaps something in it and are prepared to give patients the choice and not be so dismissive. In many respects you have the … slightly ridiculous scenario where patients are going to their doctors and saying ‘I'm getting better’, so the doctors are learning from the patients, which is actually, it's quite crazy but that is actually what is happening. So patients are actually teaching doctors and doctors are having to listen because they're faced with patients who didn't get better for many years in most cases and who now do get better.
This line of reasoning takes as its starting point the notion of the ‘expert’ patient, empowered to challenge the ignorance and lack of support from conventional medicine in their search for enlightenment. Armed with their results and positive experience of dietary change, the idea is that these patient-consumers will be able to educate their care providers, giving them the ‘reality check’ that is more often their own prerogative rather than that of their patients. In presenting their mission in these terms, the company casts ‘patient entrepreneurship’ alongside its own ‘commercial entrepreneurship’, in challenging the outmoded conservatism of conventional medicine. Patient-consumers and commercial providers are thus partners in the project of biocapitalism. At the same time, both seek to transform conventional medicine, and to be accepted within it. For patients this inclusion means being taken seriously by their doctors, for the company it means being a legitimate service provider, being recommended by GPs to their patients, as the endorsement on their website by a well-known TV GP illustrates.
Conclusion
We have identified considerable tensions at the heart of this company's project; tensions which we argue are necessary to maintain good relations with a range of key partners—prospective patients, nutritionists, other test providers, allergy support groups and charities, academics and business organizations—and to manage criticism from conventional medicine and government at the same time as the company seeks their embrace. On the one hand, the company suggests that the test provides a diagnosis, and stresses that it is clinically proven and scientifically validated. It seeks verification through clinical trials, and looks for the endorsement of charities and GPs and clinicians. It presents the test as an aid to dietary management alongside conventional medical advice and wants to convince the NHS of the cost benefits of the test, as opposed to years of drug intervention with indeterminate efficacy. It also promotes the values of conventional medical science—empiricism, freedom of thought and enlightenment—and stresses the complexity of the biosocial, as does conventional medicine with its language of multifactorial determinants of health and illness. It even echoes conventional medicine's recent engagement with ‘expert patients’ and personal responsibility for health. Yet it also challenges conventional medicine on the grounds of its failures to take people's chronic conditions seriously, and its dogmatic approach to the division between allergy and food intolerance. It presents itself as on the side of patients who find it difficult to be taken seriously by their doctors. In many ways, it offers consumers relief, not just from physical symptoms but also from their indeterminate social position as neither ‘well’ nor ‘conventionally ill’ (Nettleton et al., 2009). At the same time, it enrols consumers in its entrepreneurial project as a partner in this challenge to convention, who can take its message directly to their GP. Moving between presenting its test as a test for food intolerance and delayed onset food allergy is also a means by which the company seeks to hold trenchant criticism from conventional medicine at bay and to enrol the usual subjects of such criticism in their project—namely nutritionists. Speaking to the failings of conventional medicine to care for patients, and emphasizing the rights and responsibilities of patients to find out about their condition and ultimately to change their life, is also an important means of maintaining supportive alliances with this important conduit for their product.
We began this article by noting that IgG and the food intolerance test is not a typical example of biocapitalism, as envisaged by writers in this area, who tend to focus upon newer and perhaps more ethically problematic developments in genomics and stem cell research. But we maintained that the story is one of the extraction of latent value from ‘the molecular’ domain; it is also one of rapid commercialization, active patients and pastoral experts engaged in the project of optimization of health, focusing upon chronic, low-level complaints that are often ignored or dismissed but are a source of considerable discomfort and anxiety for a significant proportion of the population. This makes it worthy of exploration as a form of biocapitalism. Although we do not claim that these developments are especially unique when set within a broader historical context of the boundary disputes around the meanings of disease, professional jurisdiction and patient–doctor relations, we note that Rose (Reference Rose2006) and other authors (Roberts and Franklin, 2006) are also cautious about the transformative nature of biocapital more generally. We are nevertheless prepared to admit that we have deliberately chosen a particularly mundane corner of biocapitalism to explore, spurred on by a general concern about the tendency among scholars of contemporary bioscience and biomedicine to be drawn to the horizon rather than the present, and to overemphasize the future at the expense of the past (Kerr, Reference Kerr2004).
Like Graham (Reference Graham2008: 241), we found many ‘ambiguities in the norms of appropriateness and legitimacy’ of the key actors. Graham's case study was a drug, but the same doubts about its efficacy and the ways in which to judge this through regulatory technologies or the everyday experiences of patients were also at issue, and the effectiveness of the drug remains in doubt, even after it has been licensed. However, ambiguity in our case seemed to facilitate the development and expansion of the market for food intolerance. We therefore suggest that the dynamics we have identified constitute what we might call the company's strategic ambiguity around the expertise and responsibilities of patient-consumers and expert-service providers, as well as the meaning of diagnosis and illness in itself. We suggest that this pattern of ambiguity may be linked to the emphasis upon convention rather than novelty or innovation at the heart of our story, although we note that the extension of more novel forms of entrepreneurial patients and partnerships also feature. We are also struck by how these debates and positionings play out on a fairly local stage, with a limited set of actors engaging and re-engaging in disputes over the authenticity and legitimacy of the test. Of course the test sells across the world, but often in a hidden rather than an obvious way—its provenance is essentially ‘black boxed’. These arrangements, alongside the relatively simple trading relations, which do not encompass further extraction of latent value involving patents or standardized ‘allergy lines’, mean that the global dimensions of this corner of biocapitalism are less important than the local controversies around patients, trials and the ‘science’ of nutritionism. Our findings also echo those of Wahlberg (Reference Wahlberg2008: 37), who has argued that herbal medicine has been normalized rather than colonized by industrial, scientific and commercial logics, through the ‘mundane collaborative efforts of herbalists, botanists, phytochemists, pharmacologists, toxicologists and clinicians to standardize and develop certain herbal remedies’.
These local contexts shape the companies’ strategies for success more profoundly than issues of global trade, commercial exploitation and compatibility.
We therefore argue that we have identified some relatively mundane but nonetheless important features of the institutional and technological assemblages of biocapital in its less glamorous domains. As Woolgar (Reference Woolgar and Woolgar2002) and elsewhere Latour (Reference Latour2005) have argued, the mundane is more important than we think—its ubiquity means that it shapes many people's experiences, often in ways we overlook. Food intolerance is also similarly everywhere and nowhere—low-level ailments of gut, skin and sinus affect many of us but evade conventional diagnosis and treatment. Viewed in this light, disputes about a test for these troublesome flows of bodily fluids and membranes, and its place in the conventional realm, are perhaps inevitable. But this study has implications beyond its immediate domain, given that the project of contemporary bioscience and medicine is conceived as having implications for the stuff of ‘life itself’. We therefore suggest that the routine, low-level translations of novelty into convention and local contingencies into global trends are worthy of further exploration as both a topic and a resource of biocapitalism.
