Direct-to-consumer (DTC) personal genomics services such as those currently marketed by 23andMe, Navigenics, and deCode, among others, occupy a small place in today’s biotech industry, but an enormously important position on the trajectory of the industry. This importance results not from the contribution such services make to consumers’ health and well-being, which is still subject to debate, but from the fact that DTC personal genomics constitutes the first instance in which the fruit of the biotech revolution is being explicitly marketed directly to the public.
This is not to downplay, of course, the significance of genetically engineered foods, which taken together, are clearly the biotech product with which most North American consumers have had the most direct contact. But genetically engineered foods, while clearly marketed directly to the public, are not marketed as genetically engineered. That is, they are not labeled—much to the chagrin of activists—as genetically engineered. Thus genetically engineered foods are not a product that consumers find offered to them as products of biotechnology, and hence consumers do not—cannot, really—seek them out on that basis.
Only personal genomics, so far, is offered directly to consumers, both as a product for them to use, and as a harbinger of things to come as the biotech revolution begins to make good on promises made.
Think of it this way: Ask the average consumer to name an example of biotechnology, and they may well cite examples such as stem cell research or gene therapy. But ask them what biotechnology they themselves have made use of, or would contemplate buying, and what else could they cite—if indeed an example comes to mind at all—other than some form of genetic testing?
So DTC personal genomics is, in a very significant sense, a leading-edge technology; it is, to a large extent, the biotech industry’s public face. This means a lot of pressure, really, for DTC genomics companies. The faith of the consuming public (not to mention regulators) rests on the shoulders of that segment of the biotech industry.
The ethical issues in biotech are not easy ones. As I’ve argued elsewhere, biotech companies face a double-barreled set of ethical issues. On the one hand, they need to deal sensitively with the difficult and controversial ethical challenges that arise in the realm of human health—issues ranging from those involved in doing research on human subjects, to dealing responsibly with health professionals, to putting a price on life-saving drugs.
On the other hand, biotech companies are commercial entities, and hence are forced to face another entire range of ethical issues arising in the conduct of business—issues including, but not limited to, those related to corporate governance, product safety, and honesty in advertising.
For personal genomics companies, the issues that are most pressing, from a business ethics point of view, are not questions about corporate governance, social responsibility, or accurate financial reporting, though of course all of those issues will arise. The key ethical issues for personal genomics companies have to do with the services they offer. To some extent, those questions are simply the same basic questions we would want to ask of any other kind of company. With regard to the product or service any company offers, three main ethical questions arise.
Ethical Questions for DTC Firms
First, does the product work? With regard to personal genomics services, this is a challenging question, because to date the various companies offering such services have been relatively vague about just what their product is supposed to do. Of course, the basic mechanics are clear: such services tell customers which of a range of trait- or disease-related single nucleotide polymorphisms (SNPs) they carry, and provide some information on whether those SNPs imply increased risk.
But less clear is just what this information is supposed to do for consumers. The most reputable companies make it very clear that they are not diagnosing or predicting disease, nor offering health advice. But given such disclaimers, it’s hard to know what to make of the fact that their websites are also full of references to health, well-being, and empowerment.
Overall, it’s still unclear what whole-genome scans are really for, so it’s hard for anyone to tell whether a particular product is actually good at getting the job done. A good hammer is good at driving nails. A good novel entertains us, and maybe gives us fresh insight into the human condition. What does a good whole-genome scan do?
Second, is anyone going to get hurt? Beyond basic efficacy, consumers of any product always need to know how likely a given product is to do harm, either to the consumer herself or to bystanders. In this regard, whole-genome scans of the kind marketed by personal genomics companies remain something of a question mark; worries among bioethicists are many, though concrete examples of harm (physical, psychological, or financial) resulting from genetic testing of any kind are few.
No company, though, can reasonably assume its product can only, ever, have positive effects: it is a nearly universal rule that, if a product is powerful enough to help you, it is also powerful enough to hurt you.
And finally, the third basic ethical question we need to ask about any product is this: has the company selling the product been up front with consumers about the answers to the first and second questions? This really is key. The ethical foundation of a market economy—namely the notion that exchanges by competent adults in a free market are necessarily mutually beneficial—requires, as a precondition, that consumers know what they’re getting when they lay down their money.
This, of course, raises special challenges for those who sell particularly complex products. The two basic options open to companies selling complex products are, on the one hand, to go to extraordinary lengths to educate customers, or to market their products to a “learned intermediary,” a professional possessing the knowledge-base required to assess the product at hand, and ethically committed to guiding the end consumer according to that consumer’s needs and wishes.
My final point will be about self-regulation. I’ve argued in this article that personal genomics companies are, in a sense, bringing biotechnology to the public for the very first time. The rest of the biotech industry—in particular, those branches of the industry that see a future in selling products directly to the public—ought to be watching personal genomics companies very carefully, for the entire industry has a stake in how those companies conduct themselves.
If companies like 23andMe and Navigenics handle ethical issues well, they’ll be doing the industry a great favor in terms of establishing best practices, in terms of the public’s perception of the industry, and in terms of regulator’s estimation of the wisdom of inviting various forms of self-regulation. But if they handle those issues poorly, the entire industry may find itself stumbling before it has a chance to stand and run.