Marginally scientific? Genetic testing of children and adolescents for lifestyle and health promotion

‘Genetic testing can reveal crucial information to guide your training and nutrition strategies based on predispositions built into your DNA. Genetic testing identifies the ideal nutrition, training and recovery strategies for you and helps explain why athletes given the same training and nutrition plans respond differently. In short gene testing provides the ultimate in personalized nutrition and training guidance…’1 Direct-to-consumer (DTC) genetic testing has been in the news in recent years, especially since November 2013, when the US Food and Drug Administration (FDA) shut down 23andMe, one of several firms that offered people general health information based on their genetic test results.2 Much attention has been paid to the accuracy of these tests in predicting future risk of disease. This is understandable as the first wave of DTC companies, including 23andMe, eventually focused on providing genetic information of this nature. And much of the existing literature on the possible harms and benefits of DTC testing is largely an analysis of disease-oriented testing.3 But it should not be forgotten that many other DTC genetic testing products are being marketed throughout the world that are not focused on disease risk but instead offer information—of varying degrees of scientific legitimacy—relevant to things like fitness, diet, and athletic ability. In addition, non-traditional providers, such as homeopaths,4 naturopaths,5 and chiropractors,6 increasingly are offering genetic tests for the purpose of providing health and lifestyle advice. It seems inevitable that, unless the regulatory environment changes, this trend will continue, with genetic testing being offered to the public for an ever-increasing range of reasons not directly related to disease. In this paper, we map the policy issues associated with the marketing and use of genetic testing products outside of the context of disease risk. We focus on companies and providers that offer testing for a wide range of genetic traits, and consider the potential implications of offering these products for use in children and adolescents. While the size of the market for these services remains unknown, it is probably still relatively small.7 Nonetheless, an analysis of genetic testing in this broader context provides an opportunity to consider issues that are likely to increase in significance as genetic testing technologies become more affordable and as the idea of genetic testing becomes more socially acceptable.8 For example, the present analysis affords an opportunity to consider the possible harms, if any, and available policy options for regulating genetic testing services not focused on disease risk and that reside on the margins of credibility. As we will see, some tests are being marketed for purposes that are clearly scientifically absurd (eg for targeting homeopathic therapies and naturopathic detoxification regimens)9 while others have more scientific plausibility, at least theoretically (eg testing for genes related to obesity and athletic characteristics like sprinting ability). Obviously, not all of these services will raise the same issues. But what they do have in common is the provision of genetic information. Are most of these companies and providers simply leveraging the excitement surrounding genetics to market services with unproven utility that are largely harmless? Is there something about genetic testing, as opposed to other forms of equally predictive information, which justifies heightened regulatory oversight? Looking at these, and other,10 issues through the lens of children and adolescents highlight potential policy challenges that may be especially problematic.11 While one could argue that legally competent adults should have the right to choose whatever service they have an interest in (however useless), this may not be the case in the context of children and adolescents who lack legal capacity and may be particularly vulnerable to DTC industry marketing strategies. We will examine whether, in the context of genetic testing services that have little scientific data to support their purported uses, any regulatory or policy response is appropriate and the potential forms such a response could take. Numerous policy guidelines have addressed the genetic testing of minors in the clinical context. Most of these guidelines were crafted in response to the availability of disease and predisposition testing. If a minor is suspected of having a condition where obtaining genetic information is considered clinically useful—be it for diagnostic or treatment purposes—testing is, in general, viewed as an appropriate course of action.12 However, many existing guidelines have stressed that predictive and pre-symptomatic genetic testing during childhood or adolescence should only be performed for conditions for which preventive or therapeutic actions could and should be initiated.13 The underlying rationale is that minors should benefit directly from testing. In the absence of obvious health benefits, support for genetic testing of minors erodes, largely because of the belief that individuals should be able to make autonomous decisions about genetic testing when competent adults and that testing may have an unknown psychosocial impact.14 Given these concerns, it is not a surprise that most clinical guidelines and position papers are also critical of DTC genetic testing companies that test minors. The most recent guideline on the testing of minors was published by the American Academy of Pediatrics and the American College of Medical Genetics and Genomics. In their statement, both societies ‘strongly discourage the use of direct-to-consumer and home kit genetic testing of children because of the lack of oversight on test content, accuracy, and interpretation’.15 In the technical report supporting the recommendation, Ross et al. refer to the risks of inaccurate results, inaccurate interpretations, potentially harmful interventions, issues of privacy, self-determination, and (non-) disclosure, as well as to the importance of professional involvement in any type of genetic testing on minors.16 Similar and additional concerns have been raised in other guidelines and position papers on DTC genetic testing,17 including the European Academies of Science Advisory Council, the Federation of European Academies of Medicine, and the European Society of Human Genetics.18 Existing policy documents, however, also note that not all concerns apply equally to all types of tests. The UK Human Genetics Commission, for example, acknowledged the importance of considering both the type of test provided and the impact of that test. In situations where tests could have a ‘significant or potentially detrimental impact on consumers’ appropriate support and professional advice is more important than in situations where testing might not create that type of impact.19 This also has consequences for genetic testing in minors, where the Human Genetics Commission would limit genetic testing in children for diagnostic tests, pre-symptomatic tests, carrier tests, susceptibility tests, and pharmacogenomics tests, but is not against allowing nutrigenomic tests and lifestyle/behavioral tests that have not been evaluated as ‘high impact’.20 Similarly, the Canadian College of Medical Geneticists described rather clearly that their statement applies to ‘medically significant genetic testing’ and stated in this line that ‘professional guidelines related to the practice of medical genetics should be adhered to, particularly with respect to genetic testing of children’.21 This distinction between ‘medically significant’ genetic tests on one hand and lifestyle-oriented, recreational, or informational types of genetic tests on the other hand creates room for a policy debate. Do these latter types of services that are aimed at issues not tied directly to health—such as athletic ability—or do not relate to something of immediate clinical relevance—such as diet—but that are often based on less-than-robust science, give rise to similar potential harms as ‘medically significant’ tests? Are the potential harms significant enough to trigger regulatory oversight? Most policy debates have focused on tests pertaining to predisposition to disease offered by DTC companies such as 23andMe and there has been little attention, at least from a policy perspective, on these more lifestyle-oriented genetic testing services. Indeed, many of the policy responses, such as those by professional societies, seem to assume, without much, if any, discussion, that there is potential for real clinical or health relevance, which requires oversight. Below we review in greater detail some of these ‘lifestyle’ types of tests and the potential policy issues they raise, especially when made available for use in children and adolescents. Companies throughout the world offer genetic testing for the purpose of assessing athletic ability. Atlas Sports Genetics, for example, provides a testing service that promises to ‘show athletes, trainers and interested individuals where their genetic advantage lies’.22 A UK company, DNA Fit, provides a test that will allow you to ‘explore your natural ability’.23 And Gonidio promises to ‘Identify your athletic strengths and weaknesses!’ and allows consumers to ‘Choose a sport that suits you!’24 The premise behind these companies is straightforward: get your genes tested and uncover your specific athletic potential (or lack thereof). We know of no evidence about how many minors (or their parents) are using these services.25 Indeed, an analysis of the marketing strategies of these companies found that they generally do not explicitly market their services to parents and kids,26 although some companies do specifically market to parents, encouraging them to test their children in order to discover their ‘inborn talents’, including—among other things—athletic abilities.27 Additionally, there have been reports of plans to use the technology on children in order to facilitate ‘sports selection at the molecular genetic level’.28 That said, it seems reasonable to assume that there is a potential market in this area.29 Many families invest huge sums in the sport activities of their children. They pay for expensive lessons and training programs, all in the hope of boosting their children's athletic careers. The cost to have one child play high-caliber minor hockey in Canada ranges from $8000 to $15,000 per year.30 The cost of having a child train as an aspiring Olympian can be even more significant. It has been estimated that competitive gymnastics, for example, averages about $15,000 per year.31 Sport is often a family commitment and the pressure to perform can come from the parents.32 Given this context, there seems a real possibility that some parents will want to maximize their child's odds at achieving athletic success through genetic testing.33 In addition, abundant evidence shows that adolescents will often go to great lengths to gain a competitive edge in their chosen sport. Given that a significant portion of teenagers are willing to take illegal performance enhancing drugs,34 getting a genetic test seems well within the scope of strategies some teenagers may pursue. 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