Background Information & Policy Report for Resolution 506
Resolution 506 calls on the AMA to “partner with relevant institutions to encourage the development of safety guidelines, regulations, and permissible uses of performance enhancing, non-therapeutic gene therapies.” While this is a great start, if we are to actively engage ourselves in this arena, there are multiple other avenues/questions/approaches to consider.
‘Gene-doping’ is what the Medical Student Section is referring to when discussing non-therapeutic gene therapies. Furthermore, the difference between gene therapy and gene doping is that the former alleviates suffering and disease (1) whereas the latter enhances bodily performance. Beyond this clarification, there are two central themes that emerge in relation to the ethics of using gene therapies for non-therapeutic use: safety and fairness. Within these themes, several inconsistencies arise when considering what types of safety guidelines, regulations, and permissible uses we should be encouraging. First, let’s look at the relevant institutions we have available to partner with.
The two main institutions to consider are the World Anti-Doping Agency (WADA) and our home-based signatory, the US Anti-Doping Agency (USADA). The most pressing issue found in literature concerning WADA is the variation relating to guidance given to healthcare professionals (2). Some have even argued that the Code offered by WADA infringes on a medical professional’s commitment to care and confidentiality for their patients (2) (3). As a signatory of the World Anti-Doping Code (WADC), the USADA follows such guidelines when deciding sanctions and banning of association between athletes and medical personnel in light of doping offences. There is not enough emphasis on what is known as the ‘networked athlete’ (4), which relates to the numerous staff members surrounding an athlete and helping to guide any decision the athlete might make (including the pressure to win being intertwined with money, fame, access to better resources, etc.). Current discourse also fails to adequately recognize the medicalization of sport (4), which notes that the addition of medical personnel to the staff of an athlete is a fairly recent development, only occurring in the last 35 years. Issues rose surrounding the involvement of medical personnel include patient confidentiality and justified cases of disclosure (3), both of which need to be taken into consideration when evaluating guidelines the AMA might decide to align with/put forth themselves, in accordance with both WADC and our Code of Medical Ethics. Along these lines, it would be imperative to ask ourselves: Does our Code align with theirs enough to partner with them? Who do we have the most interest in protecting (in terms of patient confidentiality and disclosure)? Or do we leave it up to the existing entities?
With that in mind, we can move on to the notion of safety. There are a few problems that derive from this theme, with the most prominent ones coming from the unregulated use of gene therapies in non-therapeutic settings. One side of this is that we do not yet fully understand the long-term implications of using such gene therapies, as it is still a new form of medicine (5). The American Society of Gene Therapy acknowledged in an article that “gene therapy, though a clinical reality, is still in its infancy” (6). This isn’t even addressing the use of gene therapies in a non-therapeutic context, which means that those effects are not being studied with the same rigor that gene therapies alone are. Many of these athletes have resorted to the black market to gain access to these gene therapies, and are therefore increasing their risk of serious health problems as they are using these gene therapies outside of a clinical setting. Other literature has compared athletes to pharmaceutical guinea pigs, seeing as if they do participate in some sort of clinical setting while using these gene therapies, they experience the same qualities as a vulnerable population, which of course raises several ethical flags. Most notably might be the fact that “the athlete-guinea pigs lack protection against the conflict of interest that can arise when the individual’s long-term health is not the goal of the innovations being introduced in the professional sport context” (7). The goal of this research is instead of the short-term gains surrounding competitive edge. Due to this, there is little to no visibility or welcoming of outside scrutiny, which leads to athletes being a vulnerable research population. Also, the issue of considering what constitutes ‘risk’ and ‘benefit’ arises, considering these words take on different meanings in the enhancement research context versus the clinical research context (7). Some questions to consider in reference to safety include: What is required to establish a proper governance framework in relation to enhancement research? Should enhancement research be banned and only clinical research allowed? How can we as a governing body interfere in these unregulated trials if there is little to no visibility? What protections do athletes deserve? What steps need to be taken to ensure they receive these protections?
The notion of fairness can become a little muddy, in terms of what is considered fair in the world of sport. WADA uses interference with the spirit of sport as a requirement for a performance enhancement to be placed on the Prohibited List, but what is the spirit of sport? It has been argued that “sport organisations should consistently emphasize that drug-taking behavior is fundamentally contrary to the principles and precepts of sport, that is, against the spirit of sport” (8). On the other hand, it has also been argued that “it is possible for a performance-enhancing technology to be of o detriment to the spirit of sport, but simply involve a reskilling of the activities an athlete undertakes in order to remain competitive” (9). On this line of thinking, the point of lack of access has been raised and addressed, “while it might seem that this would give an unfair advantage to athletes able to access these agents, it can be argued that specialist gum apparatus, advanced nutrition, and psychological coaching are also expensive and thus – like performance-enhancing drugs – not available to all athletes” (5). The questions to evaluate here are: How do we define cheating? If it is as something that is against the rules, what are the rules? Where does lack of access come into play? How do we define the spirit of sport?
Final things to be considered in the ethical debate surrounding gene therapies being used in non-therapeutic settings are the fact that there is no official protocol for use, or standards of efficacy or safety when dealing with gene therapies (9). In this light, use of gene therapies in non-therapeutic settings would be considered to be medical malpractice. We need to consider the limits of medicine, medical ethics, and justification of treating healthy humans (athletes) with medical technology (9). We must also take into account what is already happening in sports, the widespread use of gene doping (4), and the blatant risks posed to vulnerable groups involved (9). We need to question ethical policy making in the world of sport and how this might differ from ethical policy making at the broader societal level. The Brazilian Journal of Medical and Biological Research frames the ethical issues surrounding sports doping as having two avenues in which to approach. The first holds that sports ethics is subservient to medical ethics, which forces a physician to answer the question: how best to treat the athlete-patient – more as an athlete or more as a patient? The second approach would be to consider sports ethics as a separate entity from medical ethics, which would force sports to be seen as a moral practice. This article concludes with the most important question to be considered before any approach is made in this general direction: “should gene doping be banned, controlled, or liberalized?” (5).
References
(1) American Medical Association. Opinion 7.3.6 Research in gene therapy & genetic engineering. Code of Medical Ethics. https://policysearch.ama-assn.org/policyfinder/detail/7.3.6?uri=%2FAMADoc%2FEthics.xml-E-7.3.6.xml. Updated 2017. Accessed July 24, 2018.
(2) Mcnamee M, Phillips N. Confidentiality, disclosure and doping in sports medicine. British Journal of Sports Medicine. 2009;45(3):174-177. doi:10.1136/bjsm.2009.064253.
(3) Pappa E, Kennedy E. ‘It was my thought … he made it a reality’: Normalization and responsibility in athletes’ accounts of performance-enhancing drug use. International Review for the Sociology of Sport. 2012;48(3):277-294. doi:10.1177/1012690212442116.
(4) Connor JM. Towards a sociology of drugs in sport. Sport in Society. 2009;12(3):327-328. doi:10.1080/17430430802673676.
(5) Oliveira R, Collares T, Smith K, Collares T, Seixas F. The use of genes for performance enhancement: doping or therapy? Brazilian Journal of Medical and Biological Research. 2011;44(12):1194-1201. doi:10.1590/s0100-879x2011007500145.
(6) Baoutina A, Alexander IE, Rasko JE, Emslie KR. Potential Use of Gene Transfer in Athletic Performance Enhancement. Molecular Therapy. 2007;15(10):1751-1766. doi:10.1038/sj.mt.6300278.
(7) Camporesi S, Mcnamee MJ. Performance enhancement, elite athletes and anti doping governance: comparing human guinea pigs in pharmaceutical research and professional sports. Philosophy, Ethics, and Humanities in Medicine. 2014;9(1):4. doi:10.1186/1747-5341-9-4.
(8) Dvorak J, Baume N, Botré F, et al. Time for change: a roadmap to guide the implementation of the World Anti-Doping Code 2015. British Journal of Sports Medicine. 2014;48(10):801-806. doi:10.1136/bjsports-2014-093561.
(9) Miah A. Rethinking Enhancement in Sport. Annals of the New York Academy of Sciences. 2006;1093(1):301-320. doi:10.1196/annals.1382.020.