By Stephanie Lee
San Francisco Chronicle.
In March 1950, David Hochman, 16 months old, unscrewed an aspirin bottle and swallowed the pills.
His mother saw the empty bottle and called a doctor in shaky English. She and her husband, both Russian immigrants, were supporting three children in suburban Los Angeles on his earnings as an artist. Poor and intimidated, David’s mother didn’t object when the nurse on the phone suggested putting the boy to bed. Then he became violently ill.
The first hospital pumped his stomach and released him, still sick. The second turned them away because the Hochmans lacked proof of payment, a policy that’s now illegal. By the third, it was too late.
Esther, David’s then 10-year-old sister, never again trusted the health care system. But she believed that her parents, too, had failed — to question authority and make educated decisions on their own. When Esther later raised three daughters of her own, the youngest, Anne Wojcicki, took those lessons to heart.
“It was grilled into me: If you don’t take care of yourself, no one will,” Wojcicki, 41, said. “One of the things I find insulting in health care is how many decisions are made for you and you’re never given this chance.”
Wojcicki (pronounced wo-JIT-ski) made it her mission to upend health care. In 2006, she co-founded 23andMe, a Silicon Valley company out to pool the world’s DNA, give individuals access to their genetics, and in the process transform the way drugs are made, diseases are cured and patients are treated. In that crowd is her husband, Google co-founder Sergey Brin, who learned from 23andMe that he has a genetic mutation putting him at high risk for Parkinson’s disease.
“To be able to answer thousands and thousands of questions,” she said, “you want tons and tons of data.”
So far, 23andMe has attracted nearly 1 million customers and more than $126 million in venture capital, making it one of the most hyped health-technology firms in the world — and its CEO one of the most influential women in tech.
But not everyone thinks Wojcicki should be the one to collect their data.
Genetic profiles
23andMe, named for the 23 pairs of chromosomes in humans cells, uses DNA to tell people about their ancestral origins and risks for medical conditions.
Customers pay $99 to receive a kit in the mail, spit into a tube, send it back and later log onto a website for their results.
But in late 2013, the Food and Drug Administration forced it to stop offering information about risks of medical conditions, concerned that the interpretations were inaccurate and leading people to make rash decisions without proper guidance.
Giving people genetic information may sound straightforward, but it is uncharted territory for both the FDA and companies like 23andMe.
“They’ve had a very intense marketing campaign that’s made a lot of bold claims, both about the health benefits of their test and about a broader vision that they claim this thing will empower us and democratize health care,” said Marcy Darnovsky, executive director of the Center for Genetics and Society. “Those claims really need to be critically examined.”
Scientists traditionally test a hypothesis in a group of animals or people, and try to understand why it works or fails. 23andMe wants to flip that process on its head: to use enormous data sets — in this case human genomes — to identify problems, solutions and trends.
On top of submitting DNA, users answer seemingly never-ending questions about their backgrounds, health and lifestyles. Their 200 million responses can show how genes influence lives. Is it healthier to follow a low-fat or Mediterranean diet? What separates people who get cancer or Alzheimer’s disease from those who don’t? And then there’s the water-cooler fodder: What percentage Neanderthal are you?
Customers can withdraw from studies or the service altogether, taking their data with them. But more than 80 percent agree to participate in research, patents and other possible commercial endeavors for no compensation.
Wojcicki grew up in Palo Alto, not far from 23andMe’s Mountain View headquarters. Her father, a physics professor at Stanford University, and mother, a journalism teacher at Palo Alto High School, encouraged their children to pursue whatever interested them. The oldest, Susan, is CEO of YouTube, and the middle daughter, Janet, is an epidemiologist at UCSF.
Early learner
Anne learned to do everything young: ride a bike, read, swim, figure skate (she competed in college). She also became fascinated by science early, reading her parents’ medical textbooks. As the youngest child, she learned to get her way through charm, not force. “She actually managed to do more damage while being charming than any other way,” Esther Wojcicki recalled.
After graduating from Yale University in 1996 with a biology degree, she spent a decade as a Wall Street health care analyst, watching executives make billions off illnesses and, as she put it, claim it wasn’t their responsibility to figure out why their drugs didn’t work. Her disenchantment peaked when she sought treatment for a suspected intestinal blockage.
“I went to the doctor, he sent me out and told me to go find a radiologist myself,” Wojcicki recalled. “I was literally on the street corner, my pants are undone and I’m vomiting in a trash can. And I was in so much pain. … It was one of those moments, like, ‘That’s health care.'”
Around 1998, Wojcicki met Brin and Larry Page, Stanford students who were working on a search-engine startup in her sister Susan’s Menlo Park garage. That startup eventually became Google.
Having invested in some of the first genome-sequencing companies, Wojcicki was toying with the idea of starting her own by the time she left Wall Street.
In 2006, Wojcicki, biologist Linda Avey and business executive Paul Cusenza bonded over an excitement for new saliva-based DNA-extraction kits. Maybe the technology could be used to interpret genetics for customers, the three thought, and they founded 23andMe. (Avey and Cusenza have since left.)
From the beginning, 23andMe’s hefty financing and high-profile backers set it apart from other startups. Aside from personal investments by Wojcicki and Brin — the couple married in 2007 — Google put up a combined $6.5 million in the early years, and its venture arm later invested as well.
Shared mission
The two companies are intertwined in mission, too. 23andMe wants to do for health what Google has done for search: make massive quantities of information digital, accessible and personal.
“The vision is if you have all this data in the world, research should be like a data query,” Wojcicki recently said at a conference. “It should be like going online and just running a search.”
On Nov. 22, 2013, the FDA ordered Wojcicki’s company to stop selling its health reports.
23andMe, the agency said, had not submitted clinical data that proved it lived up to its claims. The FDA worried that inaccurate results, or results given without a medical professional’s guidance, could lead patients to, for instance, seek chemotherapy or surgery for nonexistent breast cancer.
To some, it was a textbook example of Silicon Valley’s credo: moving fast and breaking things without heed for rules. “The FDA is a public agency, charged with protecting public health, doing its job in a way that gave 23andMe every opportunity to comply, and (it) finally lost patience with a company that seems to think it doesn’t have to play by the rules,” Darnovsky said.
‘So many uncertainties’
But president Andy Page said 23andMe wasn’t trying to deceive. Page, who came from the luxury-retail site Gilt Groupe, said he and his team were so naive, they had to double-check to confirm that the FDA’s letter meant an end to the health interpretations. At the start of 2014, Wojcicki recalled, “Andy and I would sit here and be like, ‘We just don’t even know what direction to go because there’s just so many uncertainties.'”
23andMe stayed afloat by selling its ancestry tests. Hustling to make up lost revenue, it began selling health reports in Canada and the United Kingdom, and opened its genome database to deep-pocketed drug developers hunting for genetic disease factors.
Direct-to-consumer genetic tests have been uniquely challenging for the FDA. Should information about your own body be regulated just like a pill or a medical device? “The FDA is trying to make sense of how these innovative technologies fit into the existing legal structure and the existing regulatory scheme,” said Patti Zettler, a fellow at Stanford Law School’s Center for Law and the Biosciences.
Fewer conditions
Part of 23andMe’s strategy is to scale back on what it can reliably predict in an apparent attempt to improve the data it can give to the FDA, Zettler said. Customers in Canada and the United Kingdom can learn about 100 health conditions, far fewer than the 250 originally offered in the U.S.
In June, 23andMe sought the FDA’s permission to tell customers about their inherited risk of Bloom syndrome, which can cause short stature and cancer. Wojcicki happens to be a carrier for the rare disease. (She says that had nothing to do with the FDA submission.)
She learned her carrier status from the same 23andMe test that told her about her high risk for breast cancer, which she confirmed with a breast cancer-specific test from another firm.
Seeking a second opinion seems obvious to Wojcicki. A doctor once told her to take medications for high cholesterol, but she was sure her results must have been mixed up. A second test proved her right. “Errors can happen, and I think that’s where there always has to be a little of that common sense,” she said.
Different results
But there have been media reports about different genetic tests providing different interpretations of health risks, raising the question of just how many errors there are.
It’s also unclear to what extent genetics cause some of the conditions covered in a 23andMe test. Mutations of a single gene virtually guarantee contracting or passing on some diseases, including Bloom syndrome, cystic fibrosis and Huntington’s disease. But others, like Type 2 diabetes, most heart diseases and asthma, are influenced by lifestyle as well as genetics.
Customers discover their risks by logging onto 23andMe’s website, without a medical professional at the ready to offer comfort or context. The company encourages users to seek additional counsel, but doctors and genetic professionals are intentionally left out of the process. Wojcicki is sometimes accused of overestimating the ability of patients to make good decisions.
“For a lot of people, genetic information is just very difficult to grasp, and life already has enough major issues to care and really worry about,” said Dr. Cecile Janssens, an epidemiologist at Emory University. “Think of relationships, jobs, kids, school, finances, all sorts of things. Complex health information comes on top of that. And even if they want it, I am not sure they really do understand it. They often think they do, but they don’t.”
Many people don’t even follow basic health advice, like exercising or eating well, but Wojcicki believes that’s because the health care system often fails to clearly explain information. “There’s a lot of aspects of health care where people don’t understand why they’re doing it, and they don’t understand the science behind everything,” she said.
Medical opinions
Building doctors into the equation wouldn’t necessarily be helpful, Wojcicki argues, because many of them don’t understand genetics. In a survey of 10,000 physicians, 98 percent agreed that genetic variations may influence how patients respond to drugs, but only 10 percent knew how to test for those responses.
Another problem: It would be expensive to pay potentially hundreds of thousands of medical professionals to counsel customers.
Changing habits
Quick to laugh, laid-back and fond of biking with a backpack and sneakers, Wojcicki does not obsess about tracking her every biometric with a Fitbit. But she uses genetics to make decisions about health, as she believes others should.
She has cut back on alcohol, which increases risk of breast cancer. Her grandmother had macular degeneration, a largely genetic eye disease that can be prevented by blocking ultraviolet light. So Wojcicki gave $50 sunglasses to her nieces and nephews. “Holiday presents,” she said with a laugh, “have more meaning.”
In 2008, Brin learned of his high risk of Parkinson’s disease, and, after reading studies and talking to scientists, began diving and drinking green tea.
The couple, who separated in August but see each other almost daily and have two children together, have put enormous energy and resources into combatting the disease.
23andMe has also enrolled 10,000 patients in a study about how genes and environment influence Parkinson’s. In 2012, Wojcicki made the controversial decision to patent the company’s Parkinson’s-related genetic discoveries. Such a move is not rare in the pharmaceutical industry, but to some users, it was a profit-seeking measure at odds with 23andMe’s pledge to “democratize personal genomics.”
Wojcicki said the patent was the only way to assure drug developers that their work would be protected if they used those discoveries to create therapies. “I understand how it looks,” she said. “The reality is, anybody who has Parkinson’s, they come to 23andMe, and they want us to do whatever it takes to actually make improvements in the disease and make discoveries.”
Fox foundation
She and her husband have also given about $150 million to the Michael J. Fox Foundation for Parkinson’s Research, where their tech world principles stand out.
“We in the medical community usually deal in sample sizes that are in the tens and hundreds if we’re lucky, and obviously, in Silicon Valley, they’re used to dealing in the millions and hundreds of millions,” said the foundation’s CEO, Todd Sherer. “Sometimes you’ll just get a look from Sergey and Anne that’s like, ‘Are there more zeros at the end of that?'”
New year
So far, 2015 has been kind to 23andMe.
Genentech is paying the company up to $60 million to sequence the genomes of 3,000 Parkinson’s patients or their immediate relatives.
Pfizer is also paying to study the DNA of 5,000 lupus patients. There are deals in the works with a dozen biotech companies and 31 academic institutions that will ensure 23andMe won’t be hurting for cash.
And in February, the FDA granted 23andMe permission to sell health reports for Bloom syndrome to consumers.
Though there is a relatively small market for Bloom syndrome, the decision was a milestone, establishing the regulatory framework for selling direct-to-consumer carrier screening tests.
There are many other conditions that 23andMe wants to test for, and getting them all approved could take years, if it happens at all.
Wojcicki ultimately wants people to have more authority in their health care choices. All that stands in her way is the very institution she seeks to uproot.
