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As genetic testing companies look to enter the medical arena, criticism grows

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As genetic testing companies look to enter the medical arena, criticism grows

Genetic testing companies that once focused on heritage and physical traits are now moving into the realm of diagnosis and disease, raising questions about consumer trust and drawing ire from medical professionals.

Companies such as 23andMe Inc. and Ancestry.com LLC made their names shedding light on customers' lineage or details such as the probability of certain eye colors. Yet with 23andMe's recent approval to disclose certain breast cancer risks, a new window of personalized genetics has opened up.

The Mountain View, Calif.-based private company knows what consumers want, and their interests do not always align with medical practitioners' interests, 23andMe CEO Anne Wojcicki said in a session at the recent HLTH conference in Las Vegas.

That position is likely to lead to tension with traditional medical practices, according to Arthur Caplan, a bioethicist with the New York University School of Medicine and founder of the university medical center's medical ethics division.

"The whole area is ethically fraught," Caplan said in an interview, citing 23andMe's current ad campaign surrounding the 2018 World Cup championship in soccer as a potential tension point.

The "Root for your Roots" campaign, partnered with Fox Sports and airing on the channel as part of 23andMe's broadcast sponsorship, features a range of people watching national teams play the World Cup games while a narrator says, "You may not speak the language, or have visited the country … but we're all connected to a World Cup nation through our DNA."

To Caplan, the ads reflect an approach toward genetic data that could become a bigger problem as these companies expand their genetic disclosures and straddle the line between consumer focus and medical practice.

The idea of a national genotype is "scientifically false" and ignores national diversity, Caplan said, "which makes me not trust the company generally when it comes to health information."

"This is clearly a campaign that we're marketing to consumers, not health professionals specifically," 23andMe Vice President of Communications Katie Watson said in an email.

For Caplan, the ad campaign represents one aspect of mounting concern in the health system over the use of genetic data — and who has access to it.

"That backdrop has me very worried about where 23andMe and other companies are heading, generally: If they're willing to ignore science to drive business, that's very troubling when it comes to sensitive genetic information," he said.

Genetic data 'potentially saving lives'

"What the medical world thinks people want, or should want, or should have, is not reflective of what consumer interests' actually are," Wojcicki said in her HLTH session.

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23andMe recently won U.S. Food and Drug Administration approval to tell customers when they have certain variants of the BRCA gene that can raise the risk for breast and ovarian cancers. Since 23andMe's March approval, a number of women with the mutation have gone on to have mastectomies or hysterectomies, Wojcicki said. "A lot of these women really credit having this information with potentially saving their life."

Yet the approval has not been without controversy. The regulatory agency sent 23andMe a warning letter for the same test five years earlier, causing the company to halt disclosures. Earlier this year, the approval attracted more controversy when Wojcicki penned a Statnews editorial arguing that consumers did not need experts to help them interpret results. In a series of tweets, pediatric oncologist and bioethicist Steven Joffe said Wojcicki "made a critical error" in explaining the amount of cancer risk someone who has the BRCA gene mutation would carry compared to someone without the gene variant, "illustrating the challenges in this area."

Putting genetic risk to use

Consumers want this information and should have better access to it, Wojcicki argued in her April editorial.

This extends even to genetic data that may not have a straightforward treatment path, according to her comments at the HLTH session, where she noted that Alzheimer's disease risk is usually consumers' first priority after ancestry composition.

There is no standard prevention method for the neurodegenerative disease, and effective drugs to treat or stall its progress have evaded major drugmakers for years.

Yet the disclosure of APOE e4 gene variants, a tip-off to increased Alzheimer's risk, can still help consumers, Wojcicki said. "You might become proactive and exercise more, change what you're eating, decide to retire earlier. Some people then go and buy long-term care insurance."

The U.S. Genetic Information Nondiscrimination Act, signed into law almost exactly a decade ago on May 21, 2008, prevents discrimination in health insurance but does not extend to long-term care or disability insurance. The limits of that act could be tested in the current environment, critics now argue.

"There's a lot of information out there, and not all of it is subject to as many restrictions that people may like," Marcus Christian, a partner in law firm Mayer Brown's cybersecurity and data privacy division. Third-party use of user data is "absolutely a concern," he added.

"Alzheimer's and breast cancer — these are things that while it may be hard to discriminate in terms of health insurance, it's not impossible," Caplan said.

While 23andMe has sold aggregate forms of consumer data to pharmaceutical companies in a string of lucrative deals, it has previously said that personal identity is removed from the data and used with consumer consent. Still, the potential depth of that information could make it a high-value target for others and even cybersecurity threats.

23andMe's March BRCA approval prompted a statement from the American College of Medical Genetics and Genomics, an organization that develops genetic testing and ethics guidelines.

"The public deserves access to different types of medical information about themselves," the college said in a statement shortly after the approval. "However, consumers are better off when this type of information is provided through a healthcare system where informed consent is obtained and the privacy of individual health information is protected and only made available secondarily with explicit permission from those to whom the data relates."

Data ownership and law enforcement interest

The wealth of consumer information is not just valuable for insurers.

On April 24, the man accused of being one of the most prolific serial rapists and killers in the U.S. was arrested after authorities matched his DNA to a relative's in a public database run by GEDMatch.

Dubbed the Golden State Killer but also known over the years as the East Area Rapist and the Original Night Stalker, he is accused of committing more than 50 rapes and a dozen murders across California in the 1960s and 1970s.

Joseph James DeAngelo, the 72-year-old suspect in the case, never submitted his DNA to any genetic testing companies. It was a distant relative's DNA, shared publicly with GEDMatch, that gave Sacramento, Calif., law enforcement a strong enough match to trace his family tree and eventually lead them to DeAngelo.

While the behemoths of direct-to-consumer testing, 23andMe and Ancestry.com, were quick to assure the public that they did not and would not work with law enforcement, the case raised questions about the security of genetic data — and law enforcement's right to the information.

23andMe regularly releases a transparency report and has been clear that "we do everything that we can to fight law enforcement," Wojcicki said at HLTH. "I've always said: We have no business if I can't protect your privacy."

Yet it is one thing for companies to be adamant that they will not hand over data, Caplan said, and "another thing to admit that they have no power when it comes to subpoenas."

It is unlikely that most companies storing data can withstand court-ordered warrants, Mayer Brown's Christian said.

"There's no regulatory agency that is going to get in between and protect these companies from law enforcement, if [authorities have] search warrants," Christian said.

"With this much powerful information and the ability for that information to be bought, sold or exchanged — in ways that we perhaps haven't even thought about — comes risks and concerns," Christian said.