SXSWORLD February 2014


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Rights Versus Risks: Personal Genome Testing Sparks Controversy by Dan Solomon 30 SXSWORLD / FEBRUARY 2014 JEAN PHILIPPE PITER W hen the personal genome testing company 23andMe—named for the 23 sets of chromosomes in human cells—launched its debut product in late 2007, it immediately attracted a lot of attention. Time, writing about the company's saliva-based gene-testing service that determined a subject's predisposition for more than 90 different traits and conditions—"from baldness to blindness"—declared it to be the "Invention of the Year," exclaiming: "We are at the beginning of a personal-genomics revolution that will transform not only how we take care of ourselves, but also what we mean by personal information." In the years that followed, 23andMe recorded half a million genotyped customers, split into three different products—an "ancestry edition" that allowed users to look at their DNA ancestry; a "health edition" that provided information on genetic variations; and a "complete edition" that offered both—and raised more than $50 million in new financing. It also found itself the subject of two class action lawsuits for misleading advertising. And, perhaps more critically, it stopped offering its health-related product in response to a warning letter the company received from the FDA in late November 2013. 23andMe's founder, Anne Wojcicki, has her company at a flashpoint between those who believe that accessing all of one's information is a basic right, and those who argue that there are unconsidered risks involved in obtaining that information. Passionate advocates for the company's product are easy to find. Larry Downes and Paul Nunes declared in a January's Wired article, entitled "Regulating 23andMe to Death Won't Stop The New Age of Genetic Testing," that the company is "a 'Big Bang Disruption,'" or "a product or service innovation that undermines existing markets and industries seemingly overnight by being simultaneously better and cheaper than the competition." Downes, who is also the co-author of the new book, Big Bang Disruption: Strategy in the Age of Devastating Innovation (with Nunes), explains that position. "We are clearly at the beginning of a medical revolution associated with the successful sequencing of the human genome, and with continually better, faster and cheaper technology for doing so for more people," Downes says. "The best case scenario is nothing short of a complete restructuring of the health care industry, with large-scale improvement for patients and providers on every dimension." That sort of big-picture thinking is certainly exciting, and it holds a lot of appeal, which may be why so many people have rushed to both champion the company's product and to call out the regulators who seek to restrict it. Forward-thinking writers have argued in the pages of USA Today, Washington Examiner, and Huffington Post that the "FDA oversteps on genetic testing" and that "red tape stifles genetics-based advances in women's health." Proving that there's a year-end top-10 list for everyone, the Heritage Foundation think tank put the FDA's response on its list of "The 10 Worst Regulations of 2013." Still, just because the regulations on 23andMe are unpopular among tech enthusiasts and conservative think tanks doesn't mean that the people who support the regulation are strictly "incumbents" who fear change. James P. Evans, a professor of Genetics and Medicine at the University of North Carolina, has testified before Congress about home genome testing and published articles critical of the company's product, and he says that all of the enthusiasm is misplaced. Anne Wojcicki "What these companies are peddling is an inaccurate and unrealistic view of our ability to interpret them, and an inaccurate and unrealistic view of what the information means in the big scheme of things," Evans says, explaining that what the test is liable to find—a slightly higher or lower risk for heart disease, cancer, diabetes or hypertension—are so common, and contain so many risk factors, that a genetic predisposition isn't particularly useful information. And while possessing that information isn't necessarily a bad thing, Evans finds the marketing of that information as valuable to one's health to be misleading. Evans describes himself as "a very enthusiastic geneticist," and he sees a future in which products similar to 23andMe's could offer real benefits to the people who use them. "One way is to quit focusing on common diseases and say, 'About half to one percent of people in the population are actually at very high risk of very preventable diseases,' " he says, citing Lynch syndrome, a genetic predisposition to colorectal cancer. "I could see a day when targeted genes are screened in people in order to detect that minority of people." Ultimately, the decision about whether and how to proceed with things like home genome testing will be made slowly—to the frustration of companies like 23andMe, and the supporters who hope to build a healthier world with the power of information immediately. But it's possible that the slow route is what it will take to ensure that world will be a safe and accurate one. n Anne Wojcicki will be the Keynote speaker at SXSW Interactive on Sunday, March 9 at 2pm.

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