The paucity of ethical analysis in allergology

Though the results from this literature review indicate ethical analysis in allergology appears quite limited, these results are not necessarily indicative of a true deficiency of knowledge or a lack of initiative in this area of study. It could be argued that ethical analysis in health science and policy (i.e., different from clinical or research ethics) is a relatively new domain of scholarship; thus, it is unsurprising that investigations concerning ethical issues pertaining to the particular disease of allergy are still in their infancy. Indeed, research in biomedical ethics only began to develop prominence in the 1960’s, and the sub-specialization of public health ethics gained notoriety at the beginning of the 1990’s [85] p. vi-viii. To address this possibility, the parameters of the literature search were replicated for the chronic disease of obesity in order to enable a simple comparison between the amount of ethics scholarship in relation to both diseases. (For a full listing of publications cited in the following paragraph [references denoted by ‘s’], see Additional file1: the corresponding supplemental file for this article.)

Obesity is a useful disease for comparison due to its similarities with allergy. Namely, both are chronic diseases that predominate in the developed world, both have a high population incidence (>25% of populations in developed countries), and both have recently exploded into epidemic proportions that pose a significant challenge to public health [s1-3]. From this less expansive literature search, over 60 manuscripts pertaining to obesity and ethics were identified, and accumulatively represent several hundreds of pages of published material on the subject (data not shown). Between 2007 and 2010, alone, 23 research articles were published on ethics and obesity [s4-26]. Moreover, unlike allergy where retrieved manuscripts were exclusive to academic articles, analysis of ethical issues related to obesity has been the focus of a book [s27] and the subject of several book sections [s28-35]. Comparing obesity to allergy, a reasonable conclusion derived from both literature searches is that ethical analysis concerning allergy is very limited and at an embryonic stage of academic development. Arguments that ethics in health policy and public health is too new a field of study for there to be extensive application when analysing recent epidemics of disease are not supported by these findings. Instead, the wealth of scholarship available for ethics and obesity should serve as inspiration concerning the future potential for ethics in allergology. Overall, the paucity of ethical scrutiny for allergy likely stems from other factors, such as lack of awareness, interest, or capacities to engage in interdisciplinary research that integrates ethical reflection with allergy research and clinical practice [86]. The following Discussion section will attempt to address these potential inhibitors to an applied bioethics in allergology; but first, inherent limitations of this analysis require a brief mention [86].

The analysis above has notable limitations in terms of the ethics content analysis of manuscripts identified in this review. Having been assessed by the sole author of this article, decisions concerning whether a manuscript is ‘of particular interest’ is not representative of a rigorous content analysis, but rather one expert’s opinion. Thus, a degree of disaccord in these opinions is possible. With that said, the classification of manuscripts based on ethics content provided herein serves to provide a basic assessment of the extent of ethical analysis of a given publication. This ‘ethics content assessment’ aims to solely aid readers in identifying publications that may be of particular interest for future reference.

While the above safeguards and broad ELSI scholarship are well established in legislation, in professional codes of ethics, and in medical practice guidelines, this general knowledge base is not all-encompassing. There are circumstances unique to allergology that require greater awareness, scrutiny, and debate in order to ‘fine-tune’ the decision-making capacities of clinicians and researchers. The following discussion will present three examples to exemplify ethical issues of particular significance to allergology, where these examples also serve to identify three specific areas in allergy research that merit future ethical analysis.

Consider the observation that visible minority patients in the United States, such as African Americans, are less likely to receive asthma treatment according to best practice guidelines and are less likely to receive adequate education concerning how to properly administer their asthma medication [92]. These inequalities in treatment provision do not necessarily arise because of endemic racism in medicine; instead, these inequalities might stem from patient characteristics such as socioeconomic status [9], where patients possessing a higher education level are more inclined to ask their physician necessary questions concerning their treatment [93]. Regardless, clinical allergists must be aware of the potential for inadvertent bias and thus strive to uphold principles of justice in the provision of appropriate information and asthma treatments to all patients. Future research should assess means to minimize unjust inequalities in the provision of asthma treatments and identify strategies to avoid inadvertent biases that may arise when attending to the needs of vulnerable patient populations.

Another example pertains to research, where emerging clinical trials show promise in the development of immunotherapy for food sensitivities [94]. The expected success of these trials will encourage further development of additional food allergen vaccines and novel treatment modalities. Yet, how ought future clinical trials be constructed to investigate these novel drugs and treatments, and what population(s) ought to compose the primary study group? Since food allergy and associated risks of anaphylaxis disproportionately afflicts children [95, 96], ought trials focus on establishing appropriate dosing schemes for this population? While children will stand to benefit most from clinical developments from these trials, including this vulnerable population in research is typically discouraged and often encounters significant ethical challenges (e.g., informed consent with young children is often impossible) [55, 97]. The allergy research community will need to debate these ethical issues. At the very least, such ethical reflection will help avoid possible challenges concerning innovation in immunotherapy and assist in securing public, academic, and political support for these much needed research endeavours.

As a final example, consider the link between technological innovation, the commercialization of novel therapies, and access to essential drugs. For many people with allergies and related atopic disorders, uninhibited access to therapeutic interventions is indispensable to achieving an appreciable quality of life. It is therefore disquieting that numerous social, legal, and political factors limit access to essential therapies. Consider recent innovations that enabled the transition to chlorofluorocarbon (CFC)-free asthma inhalers. Ozone depleting CFCs were banned in manufacturing except for the production of essential products, such as metered dose inhalers of drugs used in the treatment of chronic lung disease [98, 99]. The purpose for this exception, however, was to allow time for research to uncover suitable replacements. Indeed, the discovery of novel, non-aerosol administration techniques and the propellant hydofluoroalkane (HFA) enabled a gradual phase-out of CFCs in asthma medications [100‐102]. But these cumulative innovations have not been exclusively beneficial. The patenting of these novel drug administration methods has resulted in pharmaceutical companies regaining monopoly rights in the production of once common, and inexpensive, generic asthma drugs [103]. Such monopoly privileges restrict access and impose cost-barriers [104, 105] to medications that many impoverished people require to live free of severe disability (elevated costs of treatment are also a major factor in patient non-compliance to therapy [106]).

Surely these turn of events were not the intended goals of the academic researchers that contributed towards developing these CFC-free drug varieties. Moreover, inadvertent restrictions in access to essential drugs runs counter to core values that the application of research knowledge should serve to benefit society while avoiding the potential for harm whenever possible. Now cognizant of these contradictions in values, researchers ought to assess whether there are more ethical strategies to transfer research knowledge into clinical application. Such strategies would likely uphold and be guided by principles of benefit maximization, harm reduction, and justice in the provision of treatment; indeed, the choices made by senior investigators and directors of research institutions can help determine the success of these laudable strategies. For one, investigators and directors of research institutes could re-evaluate conditions that define patents on innovations developed through their efforts or at their institutions. Recent policies concerning the patenting of innovations discovered at the University of British Columbia (Canada) is a notable example [107]. Known as the Global Access Initiative, some university polices mandate that patent rights are transferred to corporations under the condition that products commercialized from patented technology will be available to populations of the developing world. To enable such access, corporations must provide discount pricing of products destined for developing world markets. Future investigations by allergy researchers should consider devising similar policies concerning patenting and assess whether these models will uphold their core values of maximizing access to, and the benefits of, medical innovations made at their institutes.

The above examples of ethical issues in allergology demonstrate the need for specific ethical analysis in this field of health science. At a more general level, these examples also demonstrate three topics within allergology that merit future research and debate amongst allergy experts. Greater ethical scrutiny in allergology will undoubtedly uncover numerous additional issues of interest. The remaining segment of this article will now discuss tentative strategies allergy specialists and research directors could employ in order to advance knowledge in this largely overlooked area of investigation. The following recommendations aim to be readily straightforward and will focus on encouraging interdisciplinary collaborations between allergologists and experts in applied ethics. Lessons learned from the establishment of successful ELSI programmes for human genetics and nanotechnology will serve as examples for how research institutes and funding bodies can help promote ethics scholarship within allergology at a broader level.

Merging the terms ‘ethics’ and ‘allergology’ is a straightforward indication that advancing scholarship in this hybrid domain will necessitate interdisciplinary research, and thus collaborative initiatives are inevitable (e.g., the combination of neuroscience and ethics to form the field of neuroethics[108]). Undeniably, it would be an overly demanding claim that specialists in allergy become equally specialized in another, unrelated domain of scholarship, that is applied ethics. The need for expertise beyond a level of general awareness and interest concerning ethical issues, however, is not essential [109]. This expertise is already available through specialists in fields such as business ethics, bioethics or environmental ethics. Having raised arguments for greater awareness and interest in ethical analysis in the previous sections, this section will now discuss issues pertaining to establishing capacities to promote cross-disciplinary investigations in allergology.

With the realization of the complex aetiologies of most pathologies that challenge public health, experts agree that effective policy strategies for these diseases will require knowledge sharing between multiple disciplines in health research [110, 111]. A growing call for training in health sciences to become more interdisciplinary and inclusive of academic disciplines outside of science are also voiced as strategies to improve academic training of new scientists and clinicians [112‐114]. Overall, encouraging interdisciplinary research that integrates ethics and allergology would be consonant with this more general movement. Indeed, establishing greater ties between the biomedical and applied ethics communities sounds simple enough, though it does require a sustained initiative to bridge divides and build capacities that enable real collaboration.

In practice, establishing the groundwork for interdisciplinary research is not simple and many experts voice the need for greater support to foster communication and interactions across disciplines [86, 110, 112, 115]. In particular, numerous administrative, cultural, funding allocation, and geographical factors favour research specialising in one discipline. However, there exist means to break down barriers to interdisciplinary research [110]; as noted by Robillard and colleagues [86], the establishment of dedicated ethical, legal and social implications (ELSI) programs, such as those fully integrated into genetics and nanotechnology, provide models for reforms in other domains in the biomedical sciences. These models merit further discussion here.

From the start, leaders in the field of genetics understood that the race to map the human genome would require both the promotion of capacities in science and technology as well as careful attention towards the ethical, legal, and social issues that would arise from revolutionary understanding of human genetics [4]. Such foresight motivated the National Human Genome Research Institute and the Department of Energy of the United States government to establish in 1990 a dedicated ELSI research programme for the Human Genome Project (HGP). This programme allocated over $30 million in research and education grants to fund ELSI scholarship in human genetics. Integral to the ELSI programme was the establishment of a network of leading experts in ELSI scholarship (the ELSI Working Group). This network facilitated discussion and collaboration between scientists and ELSI scholars, which in turn served to promote knowledge transfer between research bodies and facilitate the development of policy recommendations regarding the regulation of novel genetic technologies. The establishment of the ELSI programme for the HGP has since created a ‘snowball effect’. Similar ELSI programmes have been replicated in additional domains of science and technology, as exemplified by the recent establishment of an ELSI division within the National Nanotechnology Program in the United States [116]. Similar to the HGP, funding of nanotechnology research includes grants dedicated specifically for investigations concerning the broader ethical and societal concerns that may arise from nanotechnology. Such macro-level programmes that promote ELSI research in health have set precedence, one that could be replicated for allergy and related disciplines. Indeed, similar initiatives now exist, one example being a division of the Canadian Network Centres of Excellence, AllerGen[117]. This research network provides funding support and networking opportunities for interdisciplinary training and research in allergy, where one its three specific goals is to advance knowledge in the domain of “Public Health, Ethics, Policy and Society” [117]. The funding and network opportunities provided by AllerGen represents a step forward in the promotion of research initiatives that target the ethical, legal, and social implications within allergology.

The take-home message here is that individual clinicians and researchers do not have the sole responsibility to establish contacts and build capacities in interdisciplinary research. Rather, research institutes and departments in allergology have an equally important responsibility to establish programmes and administrative infrastructure that will favour fruitful collaborations with other domains, including applied ethics. Despite administrative, cultural, and geographical barriers to interdisciplinary research, members of the allergology community do not need to wait for broad administrative changes in their organisations and research institutes before initiating interactions with specialists in applied ethics. For one, most allergy specialists will likely have had some association and familiarity with ethicists in their place of work through evaluations of research protocols by institutional review boards, or ethics consultations within clinical contexts. The value of this established professional network should not be underestimated and should be seen as an opportunity. Merely engaging in conversations with these colleagues – outside contexts of evaluating research proposals or participating in ethical consults for particular dilemmas – would be a simple means to exchange ideas, and initiate future collaborations and shared learning opportunities.