I was first exposed to the concept of genetic testing companies in a Biology 172 lecture my freshman year. The professor at that time stated, “This was one of the things I fear most about revolutionary genetic technology.”
Since the late 2000s, 23andMe has emerged in a brand new field of accessible genetic testing. Individuals can simply buy a $99 ancestry kit or $199 ancestry and health kit from the company’s website, deposit their saliva into a vial, send it in and wait for the results. The company can then look at thousands of microscopic regions of your DNA or sites in your genome. At first, this was for discovering quirky traits that indicated you were genetically predisposed to have flat feet, hair photobleaching, motion sickness, a unibrow, etc. There isn’t any inherent issue with this, but this phase of interest did not last long because there is much more intriguing information to extract from your DNA.
23andMe soon began including purchasable packages that would allow the consumer to know if they were a carrier of certain potentially life-changing traits. The “Health Predisposition report,” found on 23andMe’s website, includes results for the BRCA1/BRCA2 gene, Celiac Disease, late-onset Alzheimer’s, Type II diabetes and more. The genomic regions up for analytics are often telltale signs of the impending onset of metabolic diseases or increased risks for breast cancer, among hundreds of other examples.
However, any product that is intended by the company as a way of preventing or diagnosing a disease needs to be deemed safe and effective by the Food and Drug Administration. So when 23andMe shifted their marketing ploy closer to diagnoses and individual health knowledge, the FDA stepped in. In July 2012, the company finally began the process of obtaining clearance from the FDA to sell the kit they had been selling since 2007. Fast forward another six years to Oct. 31, 2018, when the FDA finally “authorize(d) first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism.” The FDA recognized that consumers were increasingly interested in using genetic information to help make decisions about their health care, but they also pushed that these tests needed to be designed in a way that still heavily encouraged consumers to seek out medical care by a licensed physician or health care provider and to confirm problematic test results using clinical pharmacogenetic testing.
However, the FDA is missing the point. The purchasable options 23andMe provides are not primarily intended to be utilized as medical devices, which was the FDA’s cause of concern. The kits offered are façades for an immense gathering of personal information that is taking place directly under the noses of those who participate. Doesn’t sound like a big deal? Perhaps collecting the DNA of thousands of consumers, analyzing their genomes and learning what traits and diseases they are disposed to is not particularly scary. The problem arises when this information is stored within the company’s databases permanently. Once this information is gathered, it could potentially be made available to pharmaceutical companies, insurance brokers, employers or family members. Your genetic information could be used against you and is just another step towards the total infringement of privacy.
Think about huge search engines like Google. The amount of information stored within their databases exceeds numbers comprehensible to a normal human being. Every search query entered into the Google search engine is stored, right along with the individually identifiable information oozing from everyone’s laptops and networks. This massive store of data has undoubtedly become Google’s best asset over time. Patrick Chung, a board member of 23andMe, stated, “Once you have the data, (the company) does actually become the Google of personalized health care.” Eerily analogous to Google’s growth, Chung also mentions that “the long game here is not to make money selling kits, although the kits are essential to get the base level data,” the goal of 23andMe is to create and sustain mass data-gathering operations.
There are many pros and cons to a database full of millions of human genomes. Co-founder of 23andMe Anne Wojcicki stated, “I want 25 million people. Once you get 25 million people, there’s just a huge power of what types of discoveries you can make. Big data is going to make us all healthier.”
When you think about hospitals, pharmaceutical companies and even the government, genetic information on a monumentally accessible scale is very likely to be an excessively valuable commodity. Of course, you consent to give your genetic information away. You buy the kit, deposit your spit in the vial and mail it in for analysis. Maybe you read the privacy policies, stating that they implement measures to ensure confidentiality and integrity of 23andMe data and they do not share customer data with any public databases. Specifically, 23andMe states they “will not sell, lease, or rent your individual-level information to any third party without your explicit consent.”
Revisiting the Google analogy, we’ve all heard 23andMe’s pledge before. In the online world of storing personal information, companies that strive to obtain individually identifying data do not deeply care about consent, whether it be explicit or implicit. While the FDA focuses on whether or not the kits produced by 23andMe are safe, they fail to address the issue looming over all of our heads: What are they doing with all the data?
Think about your relatives: There is probably one aunt, uncle, cousin or grandparent who has sent in their vial of spit. Even if you haven’t, the company on the receiving end has valuable genetic information about you through the participation of blood relatives. You never consented to handing over your genomic information. You may be heavily uncomfortable with that idea. Things could be discovered that you didn’t want to know and this knowledge could add vast amounts of anxiety to your life. Someone could eventually use this data against you: insurance companies could deny you for a pre-existing health condition, same with employers. Surprisingly, 23andMe’s terms of service even states if you are “asked by an insurance company whether you have learned Genetic Information about health conditions and you do not disclose this to them, this may be considered to be fraud.”
Ironically enough, they also include that “Genetic Information you share with others could be used against your interests. You should be careful about sharing your genetic information with others.”
Except for them, naturally.
Brittany Bowman can be reached at babowm@umich.edu.