HL20: Anne Wojcicki—Unlocking Consumer Access to Genetics

Anne Wojcicki, CEO of 23andMe, received unexpected news in November 2013 when the FDA told her company that it would not be able to market its genetic sequence technology to consumers as personalized health reports. Since then, she has been leading the company's efforts to satisfy the FDA's concerns while making sure that 23andMe's services are accessible and affordable to consumers.

In our annual HealthLeaders 20, we profile individuals who are changing healthcare for the better. Some are longtime industry fixtures; others would clearly be considered outsiders. Some are revered; others would not win many popularity contests. They are making a difference in healthcare. This is the story of Anne Wojcicki.

This profile was published in the December, 2014 issue of HealthLeaders magazine.

"The more we empower individuals to take ownership of their health and their wellness, the better outcomes they will have. People want this information because they want to learn about themselves."

Wojcicki, CEO of 23andMe, unexpectedly received word in November 2013 from the FDA that 23andMe would not be able to market its genetic sequencing technology to consumers as personalized health reports. Since then, the company has focused on satisfying the FDA's concerns—learning in March that its corrective actions met those concerns—and relaunching at a date yet to be determined. Meanwhile, the company is still selling ancestry and raw genetic data.

"When we got the FDA letter, it was definitely a surprise, but it was never sort of out of the blue," Wojcicki says. "We were obviously working with the FDA to figure out a path toward approval, so in some ways, this letter really just reprioritized the company. We've had some incredible hires, and we're really focused on relaunching and having a much, much better product out there that will have an FDA clearance. So in some ways, we've seized the opportunity with it." One of those hires is Kathy Hibbs, who now runs 23andMe's legal and regulatory operations. "It has definitely opened up doors for us because we're now speaking the right language," Wojcicki says.

23andMe's service delivers a customer's genetic code to them, but interpretation of that code is primarily limited to clues about the customer's ancestry. Still, that hasn't stopped customers from sharing their sequences and insights. "We have more than 750,000 customers, and I get a story probably every other day about someone where genetics has really transformed their life."

Wojcicki is intent on remaining consumer-facing. "Healthcare should be accessible to individuals, and it should be affordable," she says. "We are $99 now. We will be in that affordable range. The more we empower individuals to take ownership of their health and their wellness, the better outcomes they will have. People want this information because they want to learn about themselves."

Although 23andMe could have made great strides financially by focusing elsewhere instead of targeting consumers, its business is gradually broadening thanks to government grants. In July, the National Institutes of Health awarded a $1.37 million grant to 23andMe to discover rare variants associated with disease and to improve its survey tools for use by researchers. The ultimate goal, though, remains connecting those researchers with consumers, whose questions and conditions can drive genomic research; streamlining the delivery of results, also to the benefit of consumers; and accelerating the discovery process, Wojcicki says.

"There's a disconnect where people walk into their physician's office or they walk into a hospital, and they don't know yet how to use this information," she says. "Those are the two worlds that at some point have to be married."

23andMe's travails with the FDA, however, have highlighted the question of whether FDA regulation has put a damper not just on genetic research, but on all manner of healthcare innovation. "People are terrified right now of the regulation in healthcare," Wojcicki says. "There's clearly a role for the FDA. I think that the challenge is figuring out what that right structure is going to be. We want to be able to encourage innovation in a safe way that has the right risk/benefit ratios."

Towards that end, Wojcicki is going to Washington more often. She is urging the FDA to open an office in Silicon Valley, and agrees that the FDA needs a funding boost to jump-start a range of industry-friendly initiatives.

Like many others, she also wants fundamental change in the way clinical trials are conducted in the United States. "Once something's on the market, the public needs to be better educated about the fact that just because it's approved and it's on the market doesn't mean it's entirely safe," Wojcicki says. "There's an incredible potential for us to really understand how are therapies being used, and then detecting adverse events or side effects much, much faster, and hopefully then that will enable a process where you could have smaller clinical trials and you could get drugs out faster."

At the same time, there's a need for better vigilance of approved drugs. "We still need to have extensive phase 4 monitoring and vigilance about how is it that people are actually using therapies, and what is the right way that they should be used," Wojcicki says.

Still, in a year in which some massive healthcare information breaches have occurred, some might be surprised to learn that given a choice between revealing her genetic information and her credit card information, Wojcicki would choose the former.

"There's always a vulnerability with all these big data sets," she says. "Part of it again is understanding the balance between risk and reward. One of the things that 23andMe has always believed strongly is that people should always have the ability to opt out. So if you do not want to participate in our research, you don't have to."

Having said that, the majority of 23andMe customers opt to allow the company to continue to use their genetic data to further research. "More than 80% of our customers participate in the research, and that's part of what we're trying to do, is make sure people understand that there is a risk/reward," Wojcicki says. "If you have 10,000 people who all have sarcoma, and there's a high rate of mortality with it, but you can all use your data together to try to develop a cure, there's a risk of a data breach, but there's also a potential that you're going to have something transformative that comes out of all that data. Then I think it's a personal choice of do you want to weigh in, do you want to participate in making your data available, and is that risk/reward appropriate for you? For me, overwhelmingly. I'm more willing to have all my data come out there, because I feel like there's a real benefit of having my data combined with all the other data sets out there, because it's going to impact someone's health."

Wojcicki's philanthropy foundation, founded with her husband Sergey Brin, cofounder of Google, received $187 million in 2013. According to Philanthropy.com, it devotes most of its grant making to a handful of nonprofits, including Ashoka, an organization that brings together social entrepreneurs to work on education, the environment, and women's issues; the Human Rights Foundation; and Tipping Point Community, a charity that seeks to eliminate poverty in northern California.

Like most healthcare leaders, Wojcicki wonders how soon healthcare reimbursement will change to encourage awareness of one's genetics information, even as the cost of accessing that information drops to zero.

"That is a five- to 10-year project," Wojcicki says. "One of the things that we talk about all the time is, if you're high risk for Type 2 diabetes, and I prevent you from developing Type 2 diabetes, no one really makes money. But if you're diabetic, it's very easy for me to look at all the ways that you're monetized. It's a fundamental conflict that we have in the healthcare system, and I don't know how to resolve that either, but I do think that there's some interesting movement in that area, and one thing that I point to is the fact that Walmart is putting physicians in all their stores, because if you think about where you start to get your lifestyle, and if you think about how you want to prevent a disease, it has to do with your lifestyle, and if you're shopping at Walmart, that's sort of your lifestyle store, and you're high risk for heart disease, okay, you look for low-sodium foods, and you go to Walmart. You buy running shoes. You do other kinds of behavior modifications. So how does your retail world merge with your healthcare world? When I think about things like that, it becomes interesting."

"What keeps me up at night right now is the fact that I don't see any movement on the part of physicians or hospital systems in adopting genetic information, and so that vision, as much as it would be feasible for a child to have their full sequence at birth, if it's not adopted by institutions and by physician groups, that's never actually going to happen, and we're not going to reap the benefits of preventive care based on the genetic foundation until that adoption actually happens."