FDA setback alters course, but not mission, for Wojcicki and her 23andMe

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Courtesy of the Associated Press

(c) 2014, The Washington Post.

MOUNTAIN VIEW, Calif. — In early May, Anne Wojcicki flew into Washington accompanied by two other well-connected Silicon Valley women intent on shaking up the health-care industry.

Her genetic profiling start-up, 23andMe, a darling of the tech industry, had recently run into trouble with the Food and Drug Administration (FDA). It was a setback for the company, but it had given her an important lesson in the power of government.

Wojcicki, 40, who is recently separated from but still legally married to Google co-founder Sergey Brin, was attending the White House Correspondents' Dinner with her "team of girls," as she called them. One was Lucy Page, wife of Google's other co-founder, Larry Page. The other was Laura Arrillaga-Andreessen, wife of Netscape founder Marc Andreessen. It was Wojcicki's first time at the soiree, a coming out for her on the political scene, and she had a lot to say.

The first is that the U.S. health-care system is broken.

It was something she had been angry about since she was 27 years old, a Yale graduate armed with a degree in biology and working as a health-care analyst on Wall Street. She remembers a stomach-churning event she attended where insurers and accountants talked about how to "maximize the billing opportunity" when sick people sought care. She couldn't help but think of the patients dying of cancer at the hospital where she volunteered.

"I had this panic-attack moment," she said. "I just suddenly realized that there are so many people trying to make money off the inefficiencies in the system that it's never going to change from within."

"It was bull---," she said.

Now Wojcicki is a fabulously wealthy philanthropist, mother and chief executive of 23andMe, and if things work out as she hopes, many of us will live longer, healthier lives — and those medical billers she met years ago will be out of work.

The cornerstone of Wojcicki's strategy is spit. 23andMe's customers mail a test tube containing their saliva to the company, which analyzes their DNA. And for $99 they get back a report detailing any risk for more than 240 health conditions. In 2008, Time magazine named it invention of the year and celebrities gleefully tweeted their results — whether their genes made it more likely for them to love or hate cilantro or whether they have the BRCA gene mutation that is linked to a higher risk for breast cancer.

But in November, the FDA ordered 23andMe to stop marketing its personal genome service because the company had failed to prove its technology. Regulators also expressed concern that the company might be misleading consumers with false negative or false positive results that could encourage people to self-medicate or make lifestyle changes for conditions they don't have.

Wojcicki acknowledges that the company made mistakes. It didn't fully understand the FDA's deadlines or the documents it wanted. But she says the science itself is sound and she's hopeful that, given time, the company will persuade the FDA to let it put the kit back on the market.

Wojcicki is "impatient." She's also determined.

In the past month, she has launched a full-fledged Wojcicki charm offensive in Washington.

The place is more familiar to her husband and an older sister — YouTube chief executive Susan Wojcicki — both strong supporters of the Democratic National Committee. Anne Wojcicki has always kept her distance.

"I really like raw connections," she said, "and so I've always had a harder time in politics because I feel there's a lot of veneer around everything."

She's put those qualms aside, she said, because "if health care is a $2.7 trillion industry and a huge percentage is paid by the government, then you have to be involved in politics to make a difference."

Last month she attended the White House Summit on Working Families and spoke before the House Energy and Commerce Committee, predicting that technology was going to disrupt health care as it has transformed the media.

Committee Chairman Fred Upton, R-Mich., seemed impressed. "Wow," he said after she spoke.

Wojcicki considers herself a "freshman" in Washington. "I'm clearly just learning the system," she said.

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The youngest of three daughters born to a Stanford physicist and a high school journalism teacher, Wojcicki is a self-described super geek. Friends and co-workers say she delights in the unconventional, has a wicked sense of humor and goes all out when she has a goal in mind.

As a young analyst on Wall Street, Wojcicki had been frustrated by how a country with such wealth could fail to provide even the most basic medical needs to its citizens. By 2006, she had the connections to do something about it.

Wojcicki had moved to California to be with her then-boyfriend Brin and grew convinced that Silicon Valley, with its wonky algorithms and expertise in big data, could help.

For Wojcicki and her peers, disease wasn't an inevitable part of the human experience. It was more like a math problem. "I think this is something the Valley can solve for," Wojcicki said.

At a TED conference that year, she met an acquaintance of Brin's named Linda Avey, a longtime biotech executive, and the two hit it off. Along with one of Avey's friends, Paul Cusenza, a management expert, they pitched the idea of a DNA profiling company to Google, which invested $3.9 million. Others — Genentech, New Enterprise Associates and Mohr Davidow Ventures — soon followed.

They dubbed the company 23andMe, for the number of pairs of chromosomes in a human cell.

The company's goals were two-fold. The first was to empower consumers with information about their own bodies. Wojcicki believed that the widespread availability of the spit test would change the relationship between health providers and patients for the better — giving consumers control over their own destinies like never before.

The second goal was even more wildly ambitious — to amass genetic information from as many people on the planet as possible. Wojcicki believed the cure for countless diseases and conditions was hidden in those strings of As, Cs, Ts and Gs. If we could figure out how to decipher the patterns, she said, we could cure countless diseases. As of June (the company continued to collect DNA through a service that offers ancestry information), it had amassed samples from 700,000 people — a data set that is believed to be the largest in the world and that has led to the discovery of numerous genes associated with illness.

Avey recalled that Wojcicki liked that 23andMe was a "crazy idea" that challenged the health care establishment.

"We knew it was something people would push back on," said Avey, 54, who now works at a start-up called Curious Inc. "We felt like we were rebels."

Wojcicki and her co-founders had anticipated myriad concerns about their product — privacy, reliability, even controversy about designer babies. But they weren't prepared for everything.

Shortly after the company was set up, Brin volunteered as an alpha tester for the spit test and Wojcicki was shocked to discover that he had the LRRK2 gene, which had been associated with Parkinson's disease. She tested Brin's mother, Eugenia Brin, a former computer scientist at NASA, and found that she, too, had it. Wojcicki wondered about her future children's fate.

Wojcicki reached out to the Michael J. Fox Foundation, and she and Brin poured more than $150 million dollars into the cause. Perhaps their most important contribution was a result of a collaboration between 23andMe and Parkinson's researchers: the identification of a community of more than 12,000 people who, like her husband, have the gene for Parkinson's and are willing to do survey after survey about everything from how much they sleep to environmental hazards near their home to provide data points for scientists that might turn up a breakthrough.

Deborah Brooks, a co-founder of the Fox Foundation, said Wojcicki is the person others turn to when they want an ambitious idea executed.

"I have watched her artfully and passionately balance the fantasy of what you wish these things could be and what it's going to take to get there," Brooks said.

Arrillaga-Andreessen, who has advised many young philanthropists and teaches a class at Stanford on the subject, said that Wojcicki's approach to creating change is unique because she working through three channels — her company, charitable contributions and political influence — to achieve the same goal. She called it Wojcicki's "trifecta approach."

"What she's doing is trying to be the force that enables us to turn data into wisdom," she said.

But it wasn't long before Wojcicki's passion for saving her family brought controversy.

Wojcicki had heard about another gene that she believed may be protective against Parkinson's disease and moved to patent it. When the news came out in May 2012 that the patent was granted, the company faced widespread criticism. Wojcicki explained in a blog post that she did it to make sure no one could obstruct research in that field, but customers said they felt she'd changed the spirit of the endeavor, which was promoted as work for the public good. The patent positioned her for financial gain. They felt betrayed.

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In the hallways of 23andMe, Nov. 22 is a day that is referred to in infamy, like Pearl Harbor.

That's when a scathing letter addressed to Wojcicki arrived via email from the FDA. It contained an ominous heading — "Warning Letter" — that was centered and in bold type. It ordered her to halt sales of the company's personal DNA analysis kit because it had not been cleared by the federal agency. The officials took an exasperated tone, punctuating sentences with clauses such as "as FDA has explained to you on numerous occasions."

The regulator threatened "seizure, injunction and civil money penalties."

Wojcicki recalled that she was shocked and confused.

23andMe's genetic profiling test is a new animal when it comes to medicine.

Somewhere between a diagnostic and a medical device but neither one exactly, it had been unclear, at least in the early years, how it should be regulated. The kit had been on the market since 2007, but it wasn't until 2010 that the FDA announced it would oversee the marketing of direct-to-consumer genetic tests. Since then, 23andMe had been working with the agency to gain formal approval for the product. The FDA had allowed the company to sell its product in the meantime, and, Wojcicki said, had given no indication of the depths of its concerns.

"Clearly we weren't clear on what they were objecting to," Wojcicki said.

In its letter, FDA officials said that after 14 face-to-face meetings and teleconferences, hundreds of e-mail exchanges and dozens of written communications about what it needed, 23andMe inexplicably stopped responding to its requests for more information in May. That coincided with the timing of the company's first national TV ads — slick commercials featuring attractive people of various races talking about their results — seemingly in direct defiance of the FDA's concerns.

An FDA spokeswoman said the agency couldn't comment on a pending review. In a June 26 blog post, Jeffrey Shuren, director of the agency's Center for Devices and Radiological Health, said that while the FDA "supports people's interest in having access to their genetic information," it must ensure the tests are accurate.

"Concerns about the need to demonstrate accuracy were at the heart of our five-year effort to work with the firm 23andMe that resulted last year in the company ceasing marketing its disease risk and drug dosing tests until it could demonstrate their accuracy," he wrote in the agency's first public comments on the issue.

Silicon Valley's breakneck pace of innovation has long outrun the plodding bureaucracy back east. And among tech entrepreneurs the regulatory apparatus, at times, has been characterized as a barrier to innovation. In recent years the two sides have clashed: on oversight of companies that go public on the stock market, on capital gains taxes, on net neutrality, the idea that Internet service providers should not charge different rates for service to different sites or users.

In the wake of the FDA announcement, bloggers and analysts lined up on both sides. "Deciding what information I can or cannot handle shouldn't be up to the FDA," wrote one commenter. Kevin Drum, writing in Mother Jones, had a different perspective: 23andMe "apparently believes federal laws apply only to mortals."

Wojcicki compares the concerns about the spit test to breakthrough technologies in history. Google and the Internet, for one. Then there were Britain's "red flag" laws in the late 19th century that required "self-propelled" cars to be accompanied by a person waving a red flag or lantern to warn people ahead.

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On a recent weekday, Wojcicki is still on a high from riding her elliptical bike the few hilly miles from her home in Northern California when she steps into her company's headquarters in shady spot of an industrial park surrounded by buildings Google has bought up. She smiles as co-workers greet her.

Dressed in running shorts and a jacket emblazoned with the 23andMe logo, she looks young, pretty and slim — without a hint of the trouble of past months.

For most of the past seven years, Wojcicki has been better known as one half of Silicon Valley's golden couple. She and Brin — nicknamed "the twins" by friends because they are so similar in age, appearance and smarts — were known for being in sync about everything from their views on the future of technology to the format of their unconventional wedding. At a secretive affair that was later widely reported in the Silicon Valley press, the bride is said to have worn a white swimsuit and the groom a black one. The couple swam to a sandbar to exchange their vows.

The couple has made headlines for their charitable donations to local causes ranging from education to poverty. They are also credited with revitalizing downtown Los Altos, the closest urban area to their home, with child-friendly establishments such as an upscale restaurant with a play area that they could go to with their son, now 5, and daughter, 2.

The fairy tale ended when news leaked of Brin's affair with a Google colleague working on the Glass project with him. The couple remain married, but he moved out. In August, news of her marital troubles went viral.

Three months later, the FDA came knocking.

Wojcicki said it's early for her to have specific policy prescriptions for Washington. On health care, though, she's clear: The need for change is urgent and great. It starts with the billing system, which she says creates perverse incentives for doctors, hospitals and insurers.

Wojcicki said one physician complained that the problem with 23andMe is that it "generates non-billable questions" in that many of the concerns the DNA reports raise can't be solved simply by doctors ordering up drugs or operations.

In her view that's a good thing.

As she sees it, doctors don't need to be involved with all aspects of a patient's care. They can fail to let consumers know all the choices they have or be unduly influenced by drug company marketing campaigns or overly paternalistic.

"The heart of the problem has to do with the fact that there is a third-party intermediary. You know the game of telephone you played when you were little?" she said. "The message never fully translates."

Her face wrinkles in disgust: "Did you know that there was a study in 1961 that found that 90 percent of physicians wouldn't tell you if you were diagnosed with cancer?"

The point, she continues, is that if a person is at high-risk for diabetes the most helpful thing for them may not be to go to the doctor but to make lifestyle changes. "The best thing for me to do is to go to Wal-Mart or Target and buy a workout DVD and buy different food," she said.

On the other hand, Wojcicki says that when you do need a doctor it should be easier to see one. Lately she's been obsessed with Wal-Mart's plan to put doctors in its stores. "Your health care should be more a part of your daily life than this once-a-year-checkup," she said.

Another issue that irks her, she said, is the lack of choice in health care in the United States. In hospitals and care centers she has visited in the Middle East, India and Singapore, she said customers are presented with a menu of choices with prices — such as the type of eye surgery they could get and the kind of recovery room they will be in — and they are told the possible risks and benefits and encouraged to choose.

Wojcicki said her goal is to spread these and other out-of-the-box ideas to Washington.

Five days after the White House dinner, on May 8, Wojcicki hosted President Barack Obama for a fundraising event for 20 tech executives at her Los Altos Hills estate. With tickets starting at $32,400 a person, the event was extravagant, even for these hills packed with billionaires. An Obama fundraiser the day before at the home of Walt Disney Studios chairman Alan Horn's seemed modest at $10,000 per person.

Wojcicki said the conversation with the president was wide-ranging — from foreign policy to privacy. Her older sister Janet, a medical epidemiologist, raised the issue of food security. Wojcicki asked about the future of genetic information.

Correspondents traveling with the president to Wojcicki's marveled at the "fantastical rolling grounds" of the estate.

"The rich live differently," tweeted Angela Greiling Keane, a reporter for Bloomberg News, attaching a picture. After the event, bloggers called her a "major tech star" and a "new tech A-lister."

bc-wojcicki (TPN)