Why the Federal Government Is Cracking Down on 23andMe for Offering Personal Genetic Testing

23andMe helps customers understand what scientific literature says about their personal genome sequence. But the FDA and others are wary.

Until recently, if a person had about $100 to spare, she could purchase 23andMe’s Personal Genome Service. After sending in a swab of saliva she would receive a genetic breakdown, detailing ancestral background and risks for certain diseases.

23andMe, founded in 2006, offers customers personal genetics tests and helps them understand what existing scientific literature says about their personal genome sequence. In 2008 Timemagazine named 23andMe’s saliva test “Invention of the Year.”

Co-founder and chief executive Anne Wojcicki has promoted the company as offering the public an opportunity to take control of their health outcomes by understanding their DNA.

The Personal Genome Service (PGS) is a relatively affordable package–especially for one that claims to contain insight into the past and future–which the company argues restores agency to someone seeking personalized medical information. It’s been popular with adoptees looking to reconnect with biological family and with people interested in knowing whether they are genetically predispositioned for certain diseases. With high-profile celebrities like Angelina Jolie discussing the BRCA gene and breast cancer, interest in tests like PGS is growing.

But not everyone is enthusiastic about that prospect, including the U.S. Food and Drug Administration. While the Google-backed 23andMe does not prescribe drugs or medication, it is apprising its customers of certain health problems for which they are at more or less risk according to their genetic information. Therefore, according to the FDA, the company is subject to regulation.

On November 22, the FDA sent the company a second warning letter asserting that until 23andMe was granted authorization to market its PGS as a device for medical advice, the company could not carry on advertising the product as such.

As Michael Hiltzik wrote in the LA Times, “The reports issued by 23andMe prior to the FDA letter typically included pages of qualifications of the genetic results for every health issue, followed by a broad disclaimer stating that the information ‘is intended for research and educational purposes only, and is not for diagnostic use.'”

Critics contend that not everyone makes it to the disclaimer, and that this kind of information should be delivered by trained medical professionals.

“Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment,” states the FDA’ssecond letter.

The FDA’s concerns are not new.

The first warning letter was sent to 23andMe, along with four other prominent personal genomics companies, back in June 2010. Two years later, 23andMe applied for approval for a de novo classification–meaning a low-risk device of the PGS–with the FDA, but has yet to address the federal agency’s concerns.

The FDA’s November letter emphasized that it had been in ongoing communication with 23andMe since the company first applied for marketing authorization in the summer of 2012:

As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies.

The letter revealed that 23andMe had stopped responding to the FDA’s attempts to resolve the issue last May: “You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.”

Five days after the FDA letter was sent, 23andMe was slapped with $5 million class-action lawsuits claiming the company falsely advertised that its spit tests provided reliable health reports, with no scientific evidence to back its claims. The class-action complaint filed on November 27 in the Southern District of California includes a list of instances of such marketing.

On December 5, the seven-year-old startup company announced its plan to comply with the FDA. It issued notifications to its customers informing them of the reduction in services: customers could still receive their raw genetic information but no interpretation would be offered.

“The FDA will review the company’s plan to address the violations and, if necessary, help them to find the best path forward to correcting the issues,” Susan Laine, a spokesperson for the FDA, wrote in an email to AlterNet.

“23andMe will need to supply sufficient information about their tests’ analytical and clinical performance, and well as clear and non-misleading test labeling, to support clearance or approval of their test(s),” Laine wrote.

Michael Eisen, a member of 23andMe’s Scientific Advisory Board, wrote in an email to AlterNet, “I haven’t sensed that the FDA is trying to shut down genetic testing–rather they are just trying to make sure that it is presented and marketed honestly and accurately–something that will be good for both the public and 23andMe.”

In late November, Eisen wrote a blog post considering the complications of this issue. “I don’t think the FDA should restrict consumer access to their genotype or DNA sequence, but I do think the government has an important role to play in ensuring that consumers get accurate information and that the data are not oversold in the name of selling products,” he wrote.

Eisen believes that companies like 23andMe are necessary to facilitate the public’s access to and understanding of their genetic information, even though at this point our understanding of genetics is still “messy.”

“Looking at your own DNA is really interesting, but it only rarely provides actionable new information,” Eisen wrote on his blog.

But that doesn’t mean people shouldn’t pay attention to their genetics, Eisen told AlterNet. “I think the fact that this information is not all that useful at the moment actually makes it a better time for people to start exploring the information, as it begins the process of education without people having to deal with the complexity of pressing medical decisions.”

With the prompting of 23andMe’s own PR strategy, the narrative emerging in defense of the biotech company’s services is that it popularizes and democratizes health information, relieving the lay population of their reliance on the medical establishment for clinical information by diversifying the gatekeepers of genetic information.

“You’re going to hear stories of people really taking ownership of health prevention, directed by their genome, and hear less and less the fear of ‘Oh, my grandmother died of Alzheimer’s. It’s a horrible disease I hope I never get,’” Wojcicki said in a November New York Timesinterview.

“There’s a big societal shift where we’re putting the onus of your health onto you, the individual. One of the best aspects of healthcare reform is it starts to emphasize prevention,” Wojcicki continued.

Technology news site VentureBeat writes that “23andMe… frequently describes [the gene testing] process in ads and blog posts as ’empowering’ and ‘fun’.”

Following this lead, Business Insider reporter Megan Rose Dickey wrote critically of the FDA’s regulatory move, stating “the FDA has a history of preventing ordinary members of the public from getting their hands on self-diagnostic devices that would improve their health or let them make informed choices about their bodies.”

Meanwhile, some medical professionals are endorsing the FDA move. Writing in Forbes, Jay Won Joh argued that “not all clinical data is useful” and that “filtering and interpreting” by a trained medical professional is “absolutely key.”

Eisen explained to AlterNet that in practice 23andMe is “careful to remind [its customers] that the data for most conditions are incomplete and that in virtually all cases the genetics speaks to relative risk, not certainty. 23andMe never makes medical recommendations–they tell people to consult with their physician.”

Tim Spector, a professor of genetic epidemiology, and Barbara Prainsack, an associate professor in the Department of Social Science, Health and Medicine at King’s College in London, argue that the conflict between 23andMe and its detractors “is indicative of larger power shifts in the organization and practice of health and medicine.”

The pair notes that by encouraging wide data sharing, 23andMe is contributing to “citizen science.”

Citizen science is a term coined by Alan Irwin in the 1990s. Its refers to the collaboration between the public and scientific communities, and it’s enjoyed a recent resurgence. In a chapter of the upcoming book, Genetics as Social Practice,Barbara Prainsack writes, “Digital media and open-source databases, for example, have broadened the scope and number of people who now contribute to science, and accelerated the pace at which they can do this.”

23andMe is an example of this trend that blurs the traditional boundaries between science, technology and the general public. In Wojcicki’s blog postannouncing her company’s decision to comply with the FDA, she refers proudly to the “crowd-sourced” research database the company has collected.

In 2008, 23andMe launched a research division called 23andWe, which the website ambitiously states, “gives customers the opportunity to leverage their data by contributing it to studies of genetics. With enough data, we believe 23andWe can produce revolutionary findings that will benefit us all.”

But 23andMe is still a for-profit company, and who exactly will “benefit” from these findings may indeed reflect that.

Prainsack explains that in 2008 23andWe asked customers to vote for diseases they wished to see the company prioritize research on and then “contribute their own lifestyle and other relevant information for research purposes.”

The company soon started to offer free saliva tests to individuals who had the diseases the company was researching. According to Prainsack, the company then began publishing academic results from its research finding associations between genes and phenotypic traits.

But in 2012, 23andMe began applying for patents based on the information it had collected.

“In other words, the free labor that the customer base had put in, in the name of communal benefit, was ‘rewarded’ by the realization that the company not only did not intend to share any financial profits with those who had provided the data, but also that it could be erecting barriers to research by charging licensing fees for patents that were granted,” writes Prainsack.

23andMe has built a brand around providing an affordable medical testing kit that gives individuals the capacity to assess their risks for certain diseases, enabling them to request further medical tests or even surgeries based on this information. But ultimately how much people can act upon the information they are given will remain dependent on their access to medical care after the PGS test.

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Source: Alternet