Case Study in Personal Genome Services
By Andrea Tunnard and Laura RIvard
Note: Regular visitors to our forum will notice that this post is the second in recent weeks to feature the direct-to-consumer genetics company 23andMe. It is not our intention to single out 23andMe or give them undue coverage. Rather, we strive to make our case studies relevant by drawing from current events, and 23ndMe has been in the news lately.
Introduction: California based 23andMe advertises testing for 260 genetically inherited diseases and traits, available directly to the consumer. For $99, customers receive a "spit kit" designed to collect saliva. Subsequently, DNA is extracted from the saliva, and genetic testing is performed. Results are then made available to the customer through a personal homepage on the 23andMe website. The conditions screened for are divided into "carrier status", "drug response", "traits", and "disease risks" and include everything from the innocuous (finger length ratio) to the potentially fatal (sudden cardiac arrest). On their website, 23andMe touts the benefits in having this information; in promotional videos they showcase people who have changed their eating habits or made reproductive decisions based on the personal genome service (PGS). Below is a portion of a 23andMe webpage purporting the utility of their PGS.
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Last month, we reported that 23andMe was awarded a US patent for its "Family Traits Inheritance Calculator", which includes language protecting its use in fertility clinics. Once again, 23andMe is back in the headlines. Last week, the Food and Drug Administration (FDA) sent a strongly worded letter demanding that 23andMe immediately discontinue the marketing and sales of their "spit kit" and accompanying genomic analysis until FDA approval is obtained. In the letter, the FDA first expresses concern that consumers will take inappropriate actions after receiving their genetic results, for example after learning about their sensitivity to the anticoagulant drug warfarin.
"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. For example, false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect."
The letter goes on to detail the FDA's unsuccessful multi-year effort to bring 23andMe into compliance. These efforts included "....more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications". Despite attempting to work with the company, the FDA asserts that 23andMe did not meet the regulatory requirements, leaving the FDA to conclude that "we still do not have any assurance that the firm has analytically or clinically validated the [Personal Genome Service] for its intended uses".
Critics of the FDA's decision say that people are entitled to information, and that if technology allows genomic information to become readily available, the FDA is out of line in attempting to regulate the spread of information. Additionally, some question whether the FDA has purview over this industry since the companies are not selling drugs or medical devices. The FDA and its supporters disagree and believe that 23andMe are overstating the utility of the information they provide and are presenting results on disease risks to consumers based only on preliminary research or small-scale studies. Additionally, the information can be misleading and confusing, and some believe the interpretation of PGS test results needs to include a genetic counselor. Genomic technology is advancing such that we have access to more information than ever before, but our ability to produce DNA sequence has far outpaced our ability to understand what the sequence means.
Please take our poll and leave a comment. We are particularly interested in hearing from people that have utilized 23andMe's PGS.
References:
23 and Me: This is Me. Youtube. N.p., n.d. Web. 1 Dec. 2013.
Callaway, Ellen. "Personal Genetics Firm Denies Pursuit of 'Designer Babies.'" Scientific American 2 Oct. 2013: n. pag. Web. 5 Oct. 2013.
FDA was right to block 23 and Me. Scientific American, n.d. Web. 1 Dec. 2013.
Inspections, Compliance, Enforcement, and Criminal Investigations. Food and Drug Administration, n.d. Web. 1 Dec. 2013
Wojcicki, et. al. "Gamete Donor Selection Based on Genetic Caluclations." FPO IP Research and Communities. N.p.: n.p., n.d. United States Patent US8543339. Web. 5 Oct. 2013.
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