Genetics testing startup 23andMe announced plans last week to start using its massive DNA database to develop new medical treatments, but some experts have questions about what that means for the more than 850,000 people who have submitted their data to the company.
The Google-backed company collects genetic info through $99 “spit kits” customers voluntarily send in for testing, touting an interest in DNA collection for customer’s general “self-knowledge,” and to “empower individuals and develop new ways of accelerating research.” However, it faced ethical questions after partnering with major companies for drug development, and the scrutiny remains as it begins in-house, potentially lucrative drug development.
The move was seen by many as a “big shift” for the company, but Marcy Darnovsky, executive director Center for Genetics and Society, a nonprofit devoted to responsible uses of genetic technologies, suspects this was 23andMe’s plan from the outset.
“This wasn't a change in their business plan, it was the fulfillment of the next phase of the plan they’ve had since the beginning,” she told Motherboard. “To some people, it was clear all along what the business plan must be because they can’t keep up a business selling spit kits, especially at only $99. It was buried in the fine print for years, and it was only after they got established that they talked about what their business model is: sharing this information with pharmaceutical companies.”
With the largest DNA database in the world, the company’s venture into drug development could mean big things for the treatment and cure of major diseases.
Josiah Zayner, a biotech research scientist at NASA who has sent his own information to 23andMe, said the ability to survey individuals makes the DNA data the company keeps especially useful for medicine.
"Their marketing rhetoric about democracy and empowerment needs to be taken for what it is: it’s marketing language."
“You can’t just make a drug for something because of data, you have to test it verify it,” he said. “So they’re going to be able to verify all this genetic info off the surveys people took. It’s almost creating a more trustworthy company by using more than just using statistics. They’ll be able to find treatments more effectively, perhaps.”
But 23andMe’s business model raises legal and ethical questions for the company and its customers, according to Darnovsky.
“They are a commercial enterprise, and their marketing rhetoric about democracy and empowerment needs to be taken for what it is: it’s marketing language,” she said. “There hasn’t been much conversation, and I think it’s urgently needed, about what alternative models there might be for doing this research. It is important research, and we want it to go forward, but is having a private company that is profit-driven by its nature, is that the best model?”
Mike Caprio, a software developer who considered using 23andMe himself, messaged the company with concerns about what rights he would retain over his own DNA if he opted into research with the company in 2011. The company replied that it was possible for 23andMe or one of the third party companies it works with to file a patent associated with his genome.
“23andMe conducts research both itself and with third parties, some non profit and some commercial,” the company told him by email at the time. “On the basis of any of this research, which could include data you supply, to be derived from your survey responses and any correlation with your genetic data in aggregate form with others, any of those parties could file patents.”
23andMe emphasized in an email to Motherboard that data sent into the company can only be used for research if the customer consents to it.
“Participating in research is an opt-in process, and customers can always opt-out at any time,” the 23andMe spokesperson told Motherboard. “We will review our policies and practices as the therapeutics group is established to ensure our customers are informed and have choice over how their information is used.”
The representative said more than 80 percent of its customers do opt in, answering more than 1 million follow-up survey questions each week. Darnovsky said she has questions about whether customer consent in these cases is truly informed.
“I don’t know if [customers] understood what they were agreeing to, and it does have potentially serious consequences of all sorts,” she said. “It’s very new and it’s asking people to hand over genetic information to be used in ways they may have not originally anticipated and may not be comfortable with. So, serious questions need to be raised about the way 23andMe goes about things.”
Ifeoma Ajunwa, an assistant professor of law at the University of the District of Columbia and a doctoral candidate at Columbia University, said the company does, in fact, have legal rights to genetic information customers who opt into research submit. She said DNA data could be used in a variety of ways, including marketing.
Another potential adverse effect for customers is discrimination, should the data collected by 23andMe fall into the hands of insurance companies. Although a law to prevent this exists in the US, it has a variety of loopholes. 23andMe also ships its kits to more than 40 countries other countries that may not have the same protections.
“The Genetic Information Non-Discrimination Act (GINA) protects Americans from genetic discrimination by employers and health insurance providers,” Ajunwa said. “However, the law has limits and exceptions. The law does not cover life, disability or long-term care insurance. The law also does not apply to the military, although the military may have its own rules that offer the same protections.”
"The risks are outweighing the benefits... hackers will hack it, and it will be just like losing all your credit card information, except it’s your life."
Caprio said when he expressed privacy concerns, the company told him that personally identifiable data would not be sold. But there is a major question as to just how anonymous this data is. In 2013, one researcher identified five people and nearly 50 of their family members using supposedly anonymized genetic data and Google searches.
In addition to the concerns about voluntarily shared data, others have raised concerns about the potential for security breaches.
“The risks are outweighing the benefits,” Caprio, who ultimately decided not to send in his own DNA swab kit, said. “When you aggregate all that data in one place, it just becomes a target, and hackers will hack it, and it will be just like losing all your credit card information, except it’s your life.”
But the benefits of drug testing are a huge draw. 23andMe has not yet announced specific treatment research, but the spokesperson said the company plans to address “unmet medical needs” in areas including metabolic disorders, ocular diseases, immunological disorders, oncology and neurology. The company also hired Richard Scheller, who headed research and development at biotech company Genentech for 14 years.
"I have dedicated my life to research aimed at fulfilling unmet needs for very sick people," Scheller said in a statement. "I believe that human genetics has a very important role to play in finding new treatments for disease. I am excited about the potential for what may be possible through 23andMe's database. It is unlike any other."
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