The paradox of human milk doping for anti-doping

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The paradox of human milk doping for anti-doping Chantalle Forgues a,∗ , Jason Mazanov b,c , Julie Smith d a

College of Business Administration, Plymouth State University, USA School of Business, UNSW, Canberra, Australia c Department of Sport and Community Engagement, University of Chester, UK d School of Regulation and Global Governance, Australian National University, Australia b

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Article history: Received 11 February 2016 Received in revised form 27 May 2017 Accepted 9 August 2017 Available online xxx Keywords: Anti-doping Human milk Third party harms Drug policy

a b s t r a c t Human milk is employed as a reference substance to assess the equivocal language defining the three tests (enhancement, health and violation of the Spirit of Sport) for prohibiting substances and methods under the World Anti-Doping Code (the Code). Human milk is demonstrated to be consumed by athletes with intent to enhance performance, presents a non-trivial risk to health, and violates the Spirit of Sport. The implications of prohibiting human milk under the Code demonstrate the increasing complexity and unintended (sometimes absurd) outcomes that arise from the implementation of the anti-doping ideology. The discussion focuses on two outcomes of the analysis. Firstly, the trade-off between administrative convenience and a workable drug control system for sport is considered (e.g. transparency versus decision latitude). Secondly, the discussion raises questions about the extent to which anti-doping policy makers consider third party harms with trading athletes and sporting interests relative to others individuals (e.g. babies) and society more broadly. The plausible prohibition of human milk under the Code indicates that a much closer examination of how best to manage performance enhancing technology in sport is needed, especially with regards to the influence of anti-doping beyond sport. © 2017 Elsevier Ltd. All rights reserved.

1. Introduction Athletes across the globe are drinking human milk with an intent to enhance sporting performances, reporting that it increases their stamina, builds their muscle, and helps them recover faster after physical exertion (Alesci & Trafecante, 2015; Buia, 2015; Lieber, 2014; Lynch, 2014; see also Bahret, 2014). Human milk has been described as “liquid gold” for athletes looking to improve their sporting performances (Dutton, 2011; LaMotte, 2015) as an all-natural nutrient rich substance that contains human growth hormone (Kunz, Riodriguez-Palmero, Koletzko, & Jensen, 1999; Rodriguez-Palmero, Koletzko, Kunz, & Jensen, 1999). Given the rising moral panic around ‘doping’ in sport (Crichter, 2014; Coomber, 2014; McDermott, 2016), applying the rules that govern the prohibition of a substance or method under Articles 4.3.1.1–4.3.1.3 of the World Anti-Doping Code (the Code) leads to a conclusion that human milk could be listed as a prohibited substance. The consequences and implications of listing human milk as a prohibited substance raise questions about whether the Code and its supporting policy is flawed. The analysis also identifies third party harms

∗ Corresponding author. E-mail address: [email protected] (C. Forgues).

(e.g. depriving vulnerable infants of a lifesaving therapy) arising from both doping and anti-doping (indeed the Code could be contributing to the harms) need to be more fully considered by both policy makers and researchers. 2. Prohibition of human milk The colloquial use of the term ‘doping’ typically refers to using a substance, method or technology that enhances some aspect of the human condition, but does so with pejorative connotations (Mazanov, 2017). In sport, doping refers to the use of a substance or method to enhance sporting performance, and is seen as a threat to the integrity of sport. Since the early 20th century, doping has been perceived to undermine the integrity of sport by impugning the ‘level playing field’ (e.g. athletes with access to such substances would always win over those without access) and attribution of sporting excellence to individual effort (e.g. naturalness and authenticity) (Mazanov & McDermott, 2009). Efforts to control this perceived threat to the integrity of sport gave rise to the anti-doping ideology, which sought to exclude those using substances and methods deemed offensive from sporting communities. For much of the 20th century, the implementation of the anti-doping ideology was little more than a pantomime, until a series of drug-related athlete deaths and scandals in the late 20th

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century saw governments force sport to formalize the ideology with rigorous administration (David, 2013; Houlihan, 1999; Hunt, Dimeo, & Jedlicka, 2012; Ritchie & Jackson, 2014). The result was the founding of the World Anti-Doping Agency (WADA) and the establishment of powerful (some argue, hegemonic; e.g. Gleaves, 2011; Jedlicka, 2014; López, 2014) regulatory and policy instruments to enforce the anti-doping ideology across jurisdictions, driven by the UNESCO (2005) International Convention Against Doping in Sport (see Mazanov, 2017, for a fuller description of the systemic governance framework). The main purpose of WADA is to develop and administer universal anti-doping policies, the centerpiece of which is the Code. The Code is a uniform framework of anti-doping regulations that is binding on its private signatories pursuant to contract law (McArdle, 2015; Sullivan, 2016). Based on the principles of international law, the Code is binding on governments that are signatories to the International Convention against Doping in Sport (UNESCO, 2005). At the time of writing, 186 of the 193 United Nations members and 570 national and international sports organizations were bound to the provisions of the Code by a complex set of conventions, contracts and agreements (Houlihan, 2014; McArdle, 2015; Sullivan, 2016). It is worth noting that there is no requirement to be Code compliant, although being non-compliant denies access to events (e.g. the Olympics) and funding (e.g. government support or institutional grants) (Mazanov, 2017). Code compliance means adopting a legalistic prohibitionist paradigm to achieve drug control for sport, a ‘zero-tolerance’ approach (Kayser & Broers, 2015, p. 363). The underlying antidoping policy principally is an absolute ban on objectionable substances and methods that appear on a Prohibited List. Under Article 4.3.1 of the Code, WADA has sole discretion to determine whether a substance or method can be prohibited if it is deemed to have transgressed against at least two of three tests: 4.3.1.1 Medical or other scientific evidence, pharmacological effect or experience that the use of the substance or method, alone or in combination with other substances or methods, has the potential to enhance or enhances sport performance; 4.3.1.2 Medical or other scientific evidence, pharmacological effect or experience that the use of the substance or method represents an actual or potential health risk to the athlete; 4.3.1.3 WADA’s determination that the Use of the substance or method violates the Spirit of Sport described in the introduction to the Code. Article 4.3.2 allows WADA to prohibit substances or methods deemed to have the potential to obscure or interfere with drug testing. The reasons behind the prohibition of a substance or method under Articles 4.3.1 and 4.3.2 are never made public (McNamee, 2012b). Further, under Article 4.3.3, the prohibition of a substance or method “is final, and shall not be subject to challenge based on an argument that the substance [did not meet the criteria for prohibition]” (WADA, 2015a). In practice, this means prohibition is never exposed to independent review. The three tests are applied to human milk as a case study to demonstrate potential problems that arise with the standards either stated or implied by Articles 4.3.1.1–4.3.1.3. Human milk was chosen as a substance being used by athletes with intent to enhance performance (one of the few public reasons given for listing mildronate; WADA, 2016), that has the potential to bring significant harms to athlete health and violates the stated ethical basis of sport (the Spirit of Sport). 2.1. The performance enhancing standard The language of Article 4.3.1.1 is elusive and, as such, creates a liberal standard by which WADA may judge whether a substance enhances performance. The Code does not explain enhancement or

otherwise define it. There is no language in this criterion that qualifies the level of enhancement necessary to merit prohibition. There is also no language explaining the type of enhancement necessary for prohibition, making it unclear exactly how much change in performance is deemed to be unreasonably performance enhancing. Code drafters, contributors, and stakeholders have indicated that the standard for enhancement is generous (McNamee, 2012a), such that almost any substance that benefits an athletic endeavour in any way can be deemed to satisfy this criterion. Indeed, a substance only has to be used with the intention to enhance performance, “regardless of whether the expectation of performance enhancement is realistic” (WADA, 2015b). The language of the 2015 Code captures this sentiment, even though this specific language was removed from the official commentary. As a case in point, the entry of mildronate to the Prohibited List occurred on the basis that there was “evidence of its use by athletes with the intention of enhancing performance” (WADA, 2016) despite an absence of clear clinical evidence the substance improved sports performance (Schobersberger, Dünnwald, Gmeiner, & Blank, 2017). A substance or method can also satisfy Article 4.3.1.1 if it has the “potential” for enhancement. This language is so broad as to be nearly meaningless given the near limitless universe of substances that have the potential to enhance athletic performance. McNamee (2012b) argues that this language was drafted to allow WADA wide latitude for assessing the enhancement qualities of a substance or method, and permits the placement of almost any substance or method on the Prohibited List. Absent qualifying language, therefore, it is reasonable to consider a substance for placement on the Prohibited List if that substance has any enhancing property that directly or indirectly provides an athlete with any type of physical or mental improvement. The measure by which to prove enhancement is equally generous. The Code provides that a substance may be prohibited if there is “medical or other scientific evidence, pharmacological effect or experience” to establish enhancement, or the potential therefor. This provision offers three specific measures by which enhancement may be proven: (i) medical or other scientific evidence; (ii) pharmacological effect; or (iii) experience. Each measure is indefinite. The first two, scientific or pharmacological, suggest an objective and impartial assessment of the ergogenic effects of a substance or method. However, Cornelius (2012) demonstrates that medical and scientific evidence of enhancement can be murky, being frequently inconclusive and sometimes contradictory. Further, evidence can be politicized through careful selection and interpretation, or by making conceptual leaps that substances or methods thought to have performance enhancing implications in non-sportive contexts generalize to reliably indicate performance implications in sportive contexts. For example, the performance enhancing effect attributed to human growth hormone appears to be a result of politicized extrapolation of non-sports related findings to the sports context, rather than direct empirical evidence (López, 2013). As a result, there are innumerable variables that could manipulate the evidence or effect of enhancement in an unknown number of ways, thereby demanding a broad application of the first two measures provided in this standard. The third measure in this standard, “experience”, is particularly liberal. The experience standard stands independently from the objective empirical tests as a singularly subjective test. The Code also does not require any specific type of experience, method of establishing the experience, or degree of experience to prove enhancement. Indeed, the concept of experience itself is without limit. While others have argued that anti-doping policy is necessarily vague (McNamee, 2012b), it is clear that, in this case, Code drafters elected not to qualify their language for this test to the same extent as other aspects of the Code (e.g. see Appendix One of the Code). Without limiting language in the text, therefore, it is reason-

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able to conclude that any experience of enhancement of any type or degree may satisfy this criterion, and empowers WADA with broad authority to prohibit substances. For example, any “experience” of performance enhancement (perceived or real) that coincides with the use of a substance or method could be the result of a placebo effect (see Carlino, Piedimonte, & Frisaldi, 2014; Köteles, Bárdos, Bérdi, & Szabó, 2011). As a consequence, the experience of enhancement may have nothing to do with the substance or method. (The placebo effect raises unsettling questions about whether athlete ‘lucky charms’ or other objects would qualify under Article 4.3.1.1). As such, a substance or method can be prohibited even if there is no objective evidence in relation to its performance enhancing effect (Cornelius, 2012). WADA stakeholders as well as Code drafters and contributors acknowledge that substances or methods are prohibited even when “the evidence base for enhancement. . . is not sufficiently robust” (McNamee, 2012a, p. 8). Anecdotal experience appears to be sufficient for WADA to determine that a substance or method enhances performance for the purpose of adding it to the Prohibited List (Cornelius, 2012). Based on the language and application of the Code, therefore, it seems that there is no standardized or objective ‘measuring stick’ for determining whether a substance or method enhances performance. 2.1.1. Human milk enhances sports performance When considering the standards, it seems that, like mildronate, the fact some athletes use human milk with an intention to enhance sporting performance is sufficient to determine it has transgressed Article 4.3.1.1. Athletes report that human milk gives them “incredible energy” (Lieber, 2014) and has given them “the greatest gains of [their] live[s]” (Easter, 2015). However, it is still relevant to consider whether human milk has other implications for athletic performance. Evolution has made human milk a complete source of food necessary to support infants and young children (Kunz et al., 1999; Rodriguez-Palmero et al., 1999; Smith & Harvey, 2011). It is replete with vitamins (A, C, E, and K), riboflavin, niacin, taurine, sugars, minerals, proteins, enzymes, antibodies, long fatty-chain acids and human growth hormone (IGF-1, which appears on the Prohibited List). Further, the alpha-lactalbumin in human milk can improve body composition and decrease recovery time. Human milk also contains high levels of whey and casein proteins, higher than found in animal milk or protein supplements, which support a longer response of muscle protein synthesis, enhancing weight training and helping an athlete add muscle bulk. Indeed, given the broad evidence base correlating individual or combinations of components of human milk with sports performance, it is only a small leap to make from the scientific understanding of human milk to conclude that human milk has potential to enhance sporting performances. The experiential and anecdotal evidence of enhancement, along with the scientific understanding of the properties of human milk, is sufficient to satisfy Article 4.3.1.1. That is, under the Code, human milk can be classed as a performance enhancing substance. 2.2. Risk to athlete health The second of the defeasible criteria for the inclusion of a substance is as broad as the first. Article 4.3.1.2 uses the identical measurement standards as the first criterion, which presents, as discussed above, a liberal standard of proof. The Code also employs the same expansive concept of ‘potential’, such that any substance that may potentially cause a health risk may be prohibited. Clearly there is a wide universe of substances that pose a potential health risk to athletes. For example, Mazanov (2017) argues that the misuse or abuse of any drug can raise potential health risks, citing athlete deaths arising from caffeine misuse.

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The concepts of ‘health’ and ‘risk’ further broaden this criterion. This raises an ongoing concern with how those who implement the Code understand health. Commentators in the field (e.g. Mazanov, 2016) argue that health is understood from a Western biomedical point of view (physiological functioning), which stands in contrast to other interpretations of health. For example, the World Health Organization takes a holistic approach, articulating health as a combination of physical, mental, social and spiritual elements. Even being confined to biomedical health risks, there is no indication of the degree to which health needs to be compromised before a substance or method is considered to have transgressed against this criterion. Without qualifying language, it seems that any level of risk, posing any impact on health, and any kind of physical, mental, or other deprivation could satisfy this standard. 2.2.1. Human milk health risks The scientific and medical evidence indicating health risks associated with consuming contaminated human milk plausibly extrapolate to athletes, and may be exacerbated by training-based immunosuppression. The purchase of human milk in the United States, Canada, and in certain European and Asian nations is primarily governed by generic commercial code and common law (e.g. where a seller causes harm to a buyer). Existing law, however, has yet to offer a viable remedy for a transaction involving the private purchase of human milk, making it an effectively unregulated market. Athletes seeking human milk typically purchase it over the internet from a stranger who places a personal advertisement with an asking price for her milk (the exchange price may be different) (Only the Breast, 2016). They may also prefer unpasteurized milk. Expressed human milk is not sterile, but pasteurization results in considerable degradation of the immunologic and anti-infective properties of human milk (Peila et al., 2016). Mother to child transmission of viral infections through breast milk is well established across human immunodeficiency virus, cytomegalovirus (noting milk transmission rarely leads to sequelae) and hepatitis B (in the absence of immunization) (see Peters, McArthur, & Munn, 2016), with transmission of flaviviruses (e.g. Dengue fever, West Nile fever and yellow fever) acknowledged to be plausible but yet to be conclusively established (Colt et al., 2017). This is highly relevant to human milk markets, with a Californian study (Cohen, Xiong, & Sakamoto, 2010) finding 3% of potential donors were positive for a range of pathogens. There is also a risk of bacterial contamination during collection, storage or transportation (Peters et al., 2016). For example, a study of contaminants in human breast milk purchased anonymously through the internet in Ohio (Keim et al., 2013) found 74% of the samples were contaminated with bacteria, typically correlated with poor quality transport (e.g. unsterilized containers, incorrect packaging, and no refrigeration). While the design and methodology of Keim et al.’s study has attracted criticism (Stuebe, 2013; Tawia, 2013), its findings make the point that there is a non-trivial bacterial contamination risk associated with purchase of human milk in comparable circumstances, such as in the adult market used by athletes in markets similar to that used in the Ohio study. Noting that the risk of illness arising from the levels of bacterial contamination observed by Keim et al. is dependent upon a range of factors, transient immunosuppression from intense training or overtraining by elite athletes is well established (e.g. Schwellnus et al., 2016), placing them at increased risk of bacterial or viral infection. This line of reasoning suggests a case can be made that consumption of human milk purchased on the open market places athletes at risk of infection; of course, such a claim needs to be verified inductively rather than deductively. Notably, contamination risks prompted both the United States Food and Drug Administration (FDA, 2015) and Health Canada (2014) to issue warnings about consuming human milk purchased

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on the open market. Such warnings should constitute de facto satisfaction of Section 4.3.1.2 of the Code. The evidence from the United States represents a ‘best case’ scenario. The relative health risk in less well-develop countries is likely to be higher. For example, the relative risk of blood borne infections arising from blood transfusion is significantly higher in developing economies or third world countries than first world countries (Towns & Gerrard, 2014). Even if human milk is consumed immediately after the mother has expressed the milk in developing or third world countries (mitigating transport based bacterial contamination), there is still an increased risk of viral transmission due to the reduced access to advanced healthcare in those countries (e.g. HIV in African countries). An obvious response is that the health risks could be mitigated with stronger regulation around screening and pasteurization procedures. While this may work well for first world athletes sourcing milk from licensed rather than ad hoc or black market providers, screening may still fail to detect viral or bacterial contamination, reducing rather than mitigating health risks. Doing so also raises questions about whether such regulation would be a proportionate response (e.g. the creation of an administrative burden) on the grounds of enabling athletes to consume human milk for sportive purposes. It is less certain what effect stronger regulation may have in non-first world contexts. As a result, in terms of Article 4.3.1.2, human milk purchased on the open market represents a potential health risk to adults who consume it. As such, it satisfies even the strictest interpretation of the second criterion for WADA’s Prohibited List. 2.3. The spirit of sport The Code defines the 11-values that make up the Spirit of Sport statement as the fundamental rationale for anti-doping (WADA, 2015a, p. 14). The Spirit statement has two roles within the antidoping movement. The first is to provide an ethical and moral basis to sport that justifies the time and resources necessary to implement the anti-doping ideology. Whether the Spirit statement justifies the investment has been challenged (see Mazanov, 2017). However, it is the second role for the Spirit statement that is of interest here, the final of the three criteria by which a substance is judged for inclusion on the Prohibited List. Like the first two criteria, the Spirit statement has been criticized for being ambiguous and imprecise (Loland & Hoppeler, 2012). Kornbeck (2013) observes that the Spirit statement has the character of a ‘catchall’ test that enables anti-doping administrators a stunning degree of elasticity to prohibit any substance or method. This intent is perhaps more clearly captured by the changes to the introductory section of the 2015 version of the Code in which the Spirit statement appears. The revisions indicate that the list of exemplified values present an expansive, rather than a limiting, framework. The previous language of the Code explained that the list of examples “characterized” the Spirit of Sport (WADA, 2015b, p. 3). The revised Code, on the other hand, explains that the list more broadly “reflect[s the] values” that make up a universal Spirit of Sport concept. The drafters of the revised Code, therefore, changed the language describing the Spirit statement to clarify that the concept is not considered finitely “characterized” by the list; rather, the concept “includes”, but is not limited to the broader “values” that are “reflected” in the list. Given the absence of transparency around how any of the tests are applied, it is open to speculation as to how the Spirit test is executed. We speculate that, as an ethical test, the Spirit test can be executed in one of two ways. The first is to acknowledge that, as an ethical test, what is considered ‘right’ varies both over time and across contexts. For example, the ethical evaluation of human research is typically based on a set

of centrally proscribed values (e.g. Australia’s National Statement on Ethical Conduct in Human Research) relative to prevailing social and cultural norms (e.g. Lavery, Grady, Wahl, & Emanuel, 2007). There is no sense that each value is or should be objectively measured and compared on a like scale, such as equating a clinical drug trial for aggressive pancreatic cancer with a leadership survey in the tourism sector. From this point of view, the Spirit statement is a broad set of values that guide decision making on what is considered ethical within the context of sport. However, unlike the Code, ethical evaluation of human research is a rigorously transparent process, with decisions open for debate. This transparency ensures decision-makers get feedback on whether their assessments are consistent with the prevailing social and cultural norms around what is considered ethical for human research. The Code grants WADA sole discretion to determine what is considered ethical in sport. Given the existing problems with governance with regards to anti-doping and sport more generally (see Mazanov, 2017, Chapter 7), that which is considered ethical in sport appears to be a decision made by old, white male elites of various persuasions (typically political, administrative or educational). This makes it difficult to have confidence that the people WADA consults in coming to a decision to enter or remove a substance or method from the Prohibited List are representative of prevailing social and cultural norms of what is considered ethical in sport. The second is for the Spirit test to be consistent with the standards established for the first two tests. The other two tests include a reference to medical, scientific or pharmacological evidence (noting the “potential” or “experience” negate the need for evidence). Making the standard of evidence consistent across the three tests points to some of the problems associated with operationalizing the Spirit statement (cf Loland & Hoppeler, 2012), with three immediately apparent problems discussed here. Firstly, despite the Code being replete with official commentary that readers are instructed to use when interpreting the language (Article 24.2), there is no official commentary discussing what any of the values mean. For example, it is unclear exactly what the triptych ‘ethics, fair play and honesty’ means, and how a substance or method might violate that principle. The same might be said of any of the values. This problem magnifies when considering potential cultural variation in how any of the values might be interpreted; what might be deemed a transgression in one cultural context may be deemed acceptable in another. There is no indication of how cultural context is accounted for by the Code. Secondly, operationalizing the Spirit statement compels an indication about what might constitute a failure of the Spirit test. For example, Mazanov and Huybers (2016) suggest the 11-values that make up the Spirit statement are presented in order of importance, with ‘ethics, fair play and honesty’ (the first value) more important than ‘health’ (the second value), or ‘community and solidarity’ (the 11th value). Alternatively, Mazanov and Huybers observe the Spirit values could be considered equally important, or could be constructed using some other weighting (e.g. the first value is twice as important as the second, three times as important as the third, and half as important as the fourth). Assuming the values are equally weighted, the Code gives no indication whether a substance or method has to transgress only one or some combination of values (e.g. six of the eleven). Thirdly, there is no standard of evidence established in terms of determining how the Spirit test has been failed. Operationalization implies some way of establishing how a substance or method impugns, for example, ‘fun and joy’, for whom (e.g. athletes, fans, anti-doping administrators, sponsors or broadcasters), with regards to direction (e.g. how much the sense of ‘fun and joy’ has diminished) and/or magnitude (e.g. the volume of stakeholders for whom ‘fun and joy’ is diminished).

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While operationalizing the Spirit statement creates a significant burden (although probably no more significant in terms of time and money than developing a biomedical test for a newly prohibited substance), neither of the two approaches offered indicate the Spirit test is any more rigorous than the previous tests. Like the other tests, the Spirit test appears to be administratively flexible enough to prohibit any substance or method without being troubled by recourse to a defeasible standard. 2.3.1. Human milk and the spirit of sport The broad and equivocal nature of the Spirit test means that human milk consumption can be constructed as violating the third criterion for prohibition. Under the first method, the Spirit of Sport is violated so long as a sufficiently influential proportion of those charged with making the decision find consumption of human milk for athletic purposes offensive (whether one powerful member, an organized minority or a majority). Under the second method, there may be some scope for the use of human milk to be considered consistent with the Spirit statement. This suggests a deeper examination of the ethical implications of athletes consuming human milk to enhance sporting performances. History suggests that purchasers of human milk can create incentives or social institutions and norms which induced destitute women to have “neglected, abandoned, and even deliberately smothered” their babies so they could better earn money as a wet nurse (Waldeck, 2002, p. 399). This is one of the reasons why societies dating from Hammurabi (circa 1790–1750 BCE) have regulated human milk markets (see Stol & Wiggermann, 2000). It is worth noting that there were other factors that led to mothers neglecting, abandoning or smothering their children, such as women who were otherwise destitute and powerless being forced to give up caring for their own babies (Golden, 2001; Wolf, 1999). However, the point here is that history shows changes to milk markets (e.g. demand driven price increases in the context of poverty) can increase the risks to both mothers and their babies. It is such risks that inform the potential ethical risks associated with athletes consuming human milk. Where human milk banks in the United States are intended to support babies who might otherwise be unable to breastfeed or access their mother’s own milk (e.g. adoption, mothers who have undergone mastectomy or mothers undergoing chemotherapy), there is a growing market for non-baby related sales (e.g. pharmaceutical companies or athletes). On a single day at just one milk bank in the United States, approximately 1300 women advertised supply of human milk in a market category designated for non-babies ranging in price from USD1 to USD17.50 per ounce (onlythebreast.com, January 31, 2016). With pharmaceutical companies paying donors USD2 per ounce (Taylor, 2015) and a steady market for milk at around USD5 an ounce, the potential profit margin from on-selling is significant. The entry of athletes’ demand for human milk presumably increases commercial pressure either to increase supply or to raise prices. Research has shown that a lactating mother can increase the amount of milk she supplies well beyond the needs of a single infant (Hartmann, Kulski, Rattigan, & Saint, 1980), suggesting that, in principle, the availability of human milk for sale could be responsive to increasing market demand, thus keeping the price stable. However, if demand such as from athletes is substantial in these markets, it could push up the price per ounce and encourage women to sell their milk rather than donate it to milk banks or to other mothers. Well-resourced athletes might be able to afford to pay more for human milk than not-for-profit or hospital milk banks, which typically rely on donations rather than purchasing milk. By increasing the demand, and/or the price, for human milk, athletes may divert milk away from the babies that are most entitled to it, and away from the most vulnerable infants who desperately need access to

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it; need takes second place to capacity to pay in such market-driven allocations (Smith, 2015). Health system costs may also be inflated by the need to compete with private purchasers who divert supplies away from clinical or therapeutic uses for children (or even adults, see Tully, 2002). Athletic consumption of human milk, as characterized here, potentially violates a number of Spirit values, and may transgress prevailing social and cultural norms. For example, athletic consumption of human milk may be constructed as violating the notion of ‘community and solidarity’ that puts the potential to enhance sports performances above the interests of vulnerable populations. Further, athletic consumption of human milk also raises questions about the ‘character and education’ and the ‘ethics’ of athletes who would divert human milk. At a broader level, athletic consumption of human milk leads to sport being engaged in a market framework that potentially deprives needy babies of milk. This stands in stark contrast to efforts to promote corporate social responsibility in sport (e.g. Paramio-Salcines, Babiak, & Walters, 2013) and sport as, among other things, a social health movement (Ritchie, 2013; Rowe, 2015). 2.4. Human milk as doping When human milk is consumed by athletes to enhance sports performances, it creates a potential health risk to athletes, and violates the responsibility of sporting institutions to preserve and promote the integrity of communities they come from, as set out by the Spirit of Sport. Since a substance need only meet two of the three aforementioned criteria, it is clear that human milk could (should) be added to WADA’s Prohibited List. 3. The consequences of human milk as doping The sensational claim that human milk could (should) be plausibly entered onto the Prohibited List points to the critical problem that none of the tests appear to be objectively discriminatory; that is, none of them are tests at all. This observation suggests that it is all three tests rather than just the Spirit statement that has been drafted to give administrators a stunning degree of elasticity with regards to the Prohibited List (cf Kornbeck, 2013). Doing so raises the unsettling question about whether the Code prioritizes administrative convenience over rigor. A consequence to the analysis of human milk is the general failure by both the anti-doping movement and its critics to meaningfully consider third party harms (especially with babies unable to speak for themselves) in relation to drug control for sport. This omission implies the underdeveloped state of integrity management in sport and the failure of sports administrators to take account of their responsibilities to the societies they inhabit. 3.1. Administrative convenience It is perhaps unsurprising that the attempt to formalize the anti-doping ideology would create administratively wicked problems. The objective of anti-doping is straightforward; preventing presumed distortions to competition that violate virtues such as fairness, authenticity and naturalness. Finding a way to operationalize the concept administratively is the more complex problem handed to the architects of the World Anti-Doping Code, the Code Project Team. One complex problem with which they had to contend was the competing interests of stakeholders from sporting institutions (the International Olympic Committee) and governments; the former saw anti-doping as a way to arrest performance distortions and the latter using sport as a vehicle to strengthen public health initiatives (e.g. physical activity and drug

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control) (cf Houlihan, 2001; Park, 2005). The practicalities of testing substances or methods against either performance or health risk to the athlete was deemed insufficient, and so the Spirit test was introduced – interpreted as an administrative compromise with profound unintended consequences by critics (Kornbeck, 2013; Ritchie, 2013). It seems that the administrative compromise extended to administrative convenience based on the failure to specify defeasible standards argued above. It is unfair to assume the Code Project Team had anything but good intentions when designing the three tests, and so given the emergent wicked nature of the ambiguous tests it would be hoped that revisions which strengthen the conceptual basis and application of the Code would remedy problems. Noting that the three tests have remained largely unchanged across the first iteration of the Code in 2003 and three subsequent revisions (2006, 2009 and 2015), administrators in control of the anti-doping system see no issue with the administrative latitude given under the Code. Of course, this is a conflict of interest, magnified by WADA being given sole discretion over a decision making process denied public scrutiny (WADA, 2015b). This line of argument points to a worrying trend with regards administrative convenience over rigour. Instead, revisions to the Code come in the form of a growing list of possible violations that become more distal to the use of substances or methods appearing on the Prohibited List (Mazanov, 2017). Only two of the prescribed anti-doping rule violations (ADRV) relate directly to use or attempted use of a drug (Articles 2.1 and 2.2). The remaining eight ADRV relate to protecting the administrative integrity of the anti-doping system. For example, out-of-competition testing is protected by sanctioning athletes for missing drug tests (Article 2.4), or from associating with people sanctioned or guilty of a sanctionable offence (e.g. imprisoned for trafficking veterinary steroids) (Article 2.10). Despite the implications for human rights (e.g. freedom of movement and freedom of association), these are seen as reasonable steps to ensure the administrative integrity of the anti-doping ideology (cf Byrnes, 2016; Houlihan, 2004). Such an approach is suggestive of an interest in prioritizing administrative interests. The foundation to the (lack of) evidentiary standards in the three tests has a very strong pragmatic element. Experience shows that there is a gap between entering a substance or method on the Prohibited List and developing valid and reliable testing (Harrison, 2013; Mazanov & McDermott, 2009). Extrapolating this to the entry of a substance or method to the Prohibited List, waiting for a consensus based on objective evidence to emerge would mean it could take many years before a critical mass of evidence one way or the other is achieved. Given the speed at which substances and methods with sports performance implications both appear and disappear from a cluttered market (especially the supplements industry), waiting for a critical mass of evidence would rapidly make the Prohibited List, and anti-doping, obsolete. Hence, the ambiguity is administratively convenient in terms of enabling a viable Prohibited List to exist at all. This argument loses some strength given the level of investment in developing objective tests to detect prohibited substances or methods; the anti-doping movement could invest more heavily in developing the science around the performance and health implications of prohibited substances and methods rather than relying on general research efforts. The tendency towards administrative convenience can also be seen in substances and methods which have been removed from the Prohibited List. Caffeine was removed from the Prohibited List when it became apparent it would be unfeasible to administer such prohibition despite clear evidence the substance enhance sports performances (see Burke, 2008). It is a small step to see that, despite failing the three tests, human milk might never appear on the Prohibited List for similar reasons; prohibiting human milk leads to a range of absurd administrative consequences. A pregnant or lac-

tating athlete, coach, agent or physician would unavoidably violate the possession, trafficking, and sometimes even the use (e.g. testing the temperature of stored human milk) prohibitions of the Code. It seems disproportionate for an athlete-parent to seek an administrative exemption (e.g. physician’s prescription and Therapeutic Use Exemption) to store human milk for their baby, especially given anti-doping organizations have denied athletes access to lifeenabling prescribed substances felt to impugn the integrity of sport (e.g. testosterone supplementation for hypogonadism; Henning & Dimeo, 2015). The complications that arise under Article 2.10 (given possession of human milk is sanctionable) become diabolical. The problem of listing human milk on the Prohibited List also raises questions such as how prohibition of human milk might interact with sex discrimination legislation in countries such as Australia, or even how it affects States duties as signatories to the United Nations Convention on the Rights of the Child. In the end, the ambiguity in the three tests and absence of transparency and accountability means placing a significant level of trust in the integrity of those charged to make decisions with regards to entry or exit from the Prohibited List. Unfortunately, it appears that anti-doping, like much of sport, is a politically charged environment with a longstanding and unenviable reputation for acting in organizational interests at the expense of individuals (Bennett, 2013; Donnelly, 2015). For example, Mazanov (2017) notes the potential for pharmaceutical companies to ‘game’ the Prohibited List to increase sales or impugn a competitor. Given the increasingly strong relationship between WADA and pharmaceutical companies (e.g. WADA Pharmaceutical Conference 2015 and WADA Pfizer Agreement 2014; see also Rabin, 2011), it is unclear how much influence they have in decisions regarding the Prohibited List. Møller (2014) goes on to offer evidence that anti-doping administrators risk making decisions biased by ‘corrupt idealism’ – where ethical harms (e.g. human rights) are permitted in pursuit of an overarching ethical ideal (the anti-doping ideology). This situation does little to give confidence about rigorous application of the three tests over administrative convenience. Resolving the threat of administrative convenience with regards to listing a substance or method on the Prohibited List is readily remedied. One approach is to operationalize each of the three tests, a call made in relation to the Spirit statement (Loland & Hoppeler, 2012) readily extrapolated to the performance and health tests. For example, the definition of performance enhancement could be established using the average for placebo effects – where changes in performance can be attributed to changes in mental state rather than the substance or method. Health criteria could be established relative to existing safety data from clinical trials (cf Mazanov, 2017). While such operationalisation would be methodologically complex and invariably resource intensive, the cost is unlikely to be more burdensome than the cost of developing new drug tests (Lippi, Banfi, Franchini, & Guidi, 2008). Another approach is to strengthen governance procedures around transparency and accountability. This both reduces (rather than mitigates) the risks associated with corrupt idealism and increases the diversity of the evidence base in reaching a decision to enter or remove a substance or method from the Prohibited List. 3.2. Third party harms Examining the implications of athletes consuming human milk with regards to the Spirit test drew out significant harms to third parties to sport. The value in this observation arises from the general failure to consider third party harms in the context of antidoping. The anti-doping movement tends to construct the issues in terms of sportive interests (e.g. the public health implications of amateur athletes using anabolic steroids), rather than how decisions within sport influence the societies they inhabit negatively

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(see Mazanov, 2017, pp. 4–11). Even when disciplines have gathered to discuss the phenomena of substance use in sport (Mazanov, 2012), they neglect to confront meaningfully the impact on anyone outside of athletes and their “sportsnet” (pp. 26–27). For example, the growing literature around health-based harm minimization approaches to drug control in sport tend to focus on avoiding the negative consequences associated with the use of a substance or method as part of a general effort to manage the health and welfare of athletes (Stewart & Smith, 2015; Waddington & Smith, 2009). The problem with both the anti-doping and harm minimization approaches to drug control for sport is that they focus on reducing the harms to either sport or the athlete from drug or chemical use, a conceptual framework which is problematic in application to performance enhancing food, and neglect to address principally the harm to third parties. When discussed, third-party harm is only briefly mentioned as a “harm to society” (Kayser & Broers, 2015, p. 370), or emerges as a consequence to minimizing harms within sport. For example, Stewart and Smith’s (2015, p. 275) harmminimization proposal to regulate the supply chain to ‘help’ remove harmful supply elements merely balances the rights of athletes against the rights of others. Stewart and Smith are clear that “overall social value is maximized when priority is given to athletes’ basic rights, which revolve around freedom, autonomy, and well-being” (p. 268). However, it is difficult to justify any equilibrium between prioritizing athlete autonomy and the potential tragic harms to infants and young children from the distortions and diversions of an athlete-dominated consumer market for human milk. Third-party harm does not appear to be an important consideration for debate around the anti-doping ideology. The discussion around human milk makes it clear that third party harms needs to become an important consideration in debating drug control for sport, especially among those advocating in favour of health-based harm minimization over anti-doping.

4. Conclusion Under the 2015 Code, anti-doping administrators have broad discretion to prohibit athletes from using substances like human milk based on subjective and ideological standards. The equivocal language and context of the Code demonstrates that the Code prioritizes administrative convenience and ideology over reason, sound judgement and, perhaps, integrity. This results in the failure to consider third-party harms in the context of anti-doping. As such, the focus of anti-doping policy remains on political and sportive interests rather than on how sport may negatively influence the societies it inhabits. The problem with human milk doping presents an opportunity to consider issues of social significance in the context of performance enhancement in sport. In particular, researchers (particularly advocates of harm-minimization), policy-makers, administrators, commentators, the sports community, and other interested parties might consider:

• How third-party harms may be better addressed in the context of ‘doping’; • Whether anti-doping policy contributes to third-party harms; • Whether existing anti-doping policy could be more scientifically operationalized or is better off discarded; • Whether current harm-minimization theory has properly addressed third-party harms; and, • Whether there are benefits or consequences to increased transparency and accountability in formulating policies on ‘doping’.

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