Permitting DTC Access to Lower Risk Genetic Tests

An increasingly common suggestion is to regulate genetic tests in proportion to their risks. This intuitively sensible approach to regulation is not new and many regulatory frameworks assess products based on risk level, such as medical device regulation. The tricky aspect of this regulatory approach is in determining the nature and magnitude of risks associated with a particular activity. Regulation is easier when potential benefits and harms can be measured with some specificity and objectivity and more complex where there is debate and lack of evidence about harms and benefits.

Risk-based regulation has been advocated for regulation of DTC genetic tests. In a 2003 report on DTC genetic testing, for instance, the UK Human Genetics Commission advocated stricter controls on DTC genetic tests but suggested, in analogy to pharmaceuticals, that differing levels of control are appropriate for different types of genetic tests. The Commission argued at that time that: 'there is support for considering most genetic tests as if they were "prescription-only"', but attenuated that view 4 years later, acknowledging the growth in genetic testing services, including those in the 'relatively innocuous' category.

Assessing risks and possible benefits of DTC access requires speculation about emotional and behavioral reactions of consumers to genetic information and consequent social implications. The difficulty in predicting reactions to results of home tests has prompted some to argue that regulators should concern themselves only with regulating compliance of DTC providers with appropriate standards of test accuracy (see Chapter 4). In the context of home HIV test kits, for example, Salbu (1994) contended that weighing 'potential emotional reactions to reliable information ...' is outside appropriate regulatory purview and that regulators '... should consider only evidence that sheds light on whether the product is made so that consumers can use it without unreasonable risk of injury from the product itself and whether the product achieves its purported purposes within reasonable effectiveness parameters' (Salbu, 1994).

For DTC genetic tests, the sample collection is unlikely to cause injury, so the question is whether the test achieves its purposes. For nutrigenetic tests, this raises the blurry line between medical and lifestyle/enhancement tests. In a risk-based regulatory scheme where medical tests face more stringent scrutiny, companies may have an incentive to characterize their tests as offering lifestyle-oriented information that does not fall into a traditional medical paradigm. Indeed, some DTC genetic companies that received cease-and-desist orders from the States of New York and California in 2008 responded by arguing that they do not provide medical testing, but rather are 'enabling consumer access to research knowledge' (Avey, 2008), especially information emerging from genome-wide association studies.

To provide appropriate risk-based regulation of genetic tests, stakeholders will need to give more thorough consideration to the risks that are relevant and most likely to arise from DTC provision. Most debate about DTC genetic tests assumes regulators ought to consider how individuals react to and use information, but this assumption, too, might warrant debate. An editorial in Nature Genetics about DTC genetic tests for complex, common disorders queries 'whether this information will make a difference in their lives' (Editorial, 2007). If an individual undergoes nutrigenomic testing, will they actually adopt dietary modifications to lead healthier lives? As Bouwman and van Woerkum discuss in Chapter 7, numerous factors influence eating behavior and Caulfield and colleagues (see Chapter 12) point out structural barriers to healthy food access. But requiring genetic testing to make a difference in individual lives imposes a higher standard on it than many other services or products. Moreover, consumer reactions to and use of genetic information will vary and the actual influence of genetic information on personal behavior and attitudes may be difficult to measure, both in the short and long term.

Some research currently underway will help elucidate consumer reactions to and use of genetic information. The US Coriell Institute for Medical Research, a non-profit medical research group, offers free genetic testing to an anticipated 10000 volunteers through the Corriel Personalized Medicine Collaborative (see http://www.coriell.org/index.php/ content/view/92/167/). Participants will receive test results and advice about lifestyle modifications to reduce disease risks. As another example, Navigenics, a US-based DTC genetic testing company, is co-sponsoring clinical trials with researchers at the Mayo Clinic to 'examine how participants react psychologically and behaviourally to medical risk information based on different sources, including family history and genetic testing, and presented to them with or without counselling' (Pearson, 2008). These types of studies will improve understanding of individual responses to genetic information and the most effective means to communicate risk probabilities and counseling regarding recommended lifestyle changes.

Risk-based regulation of genetic tests is a step in the right direction yet likely a difficult area in which to reach stakeholder agreement. Nearly a decade ago, the US Secretary's Advisory Committee on Genetic Testing (2000) raised the problem of categorizing genetic tests based on assessment of risks and benefits. After much consultation and debate, the Committee concluded in a 2001 report on test classification that:

fundamental, irresolvable questions had been raised about the feasibility of categorizing tests for oversight purposes based on a limited set of elements in a simple, linear fashion. Thus, the Committee decided that further efforts to develop a classification methodology for genetic tests should be curtailed for the present (Secretary's Advisory Committee on Genetic Testing, 2001).

The wide variety of DTC genetic tests now available likely exacerbates the challenge of classifying genetic tests, but regulation must take account of the differences among tests to achieve a balance between consumer protection and autonomy goals, as well as to provide fair rules for companies.

The problems of categorizing genetic tests, when there is much flux in the DTC genetic testing industry and still a lack of data about consumer reactions to information obtained from testing, may stall regulatory restrictions on DTC access. Nonetheless, other tools can be used to protect consumers from unscrupulous companies who make false or misleading claims and to arm consumers with information to make informed purchasing choices.

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