October 21, 2014
For the crowd that gathered at the Lucky Lab Pub, the Conversation came down to two things: 1) what is the balance between individual rights to information and Food and Drug Administration (FDA) device regulation with direct-to-consumer genetic testing like that provided by 23andMe? and 2) how will individuals interpret and act upon information they receive from direct-to-consumer genetic tests?
Summer Cox, from the Oregon Health Authority Genetics Program and Shaban Demirel, from Legacy Research Institute, facilitated this Conversation. Summer provided expert information and Shaban reflected on his personal experience using the 23andMe service before its range of health-related services were disallowed.
Some people felt an absolute right to be able to purchase a genetic testing service and receive information about their health risk for diseases, the way their body processes drugs like statins and caffeine and whether they have or ‘carry’ any inherited conditions. After all, “it’s not the FDA’s role to censor knowledge.” There was little debate in the room about the accuracy of genetic sequencing itself; rather people were concerned about the validity and reliability of the meaning of the genetic data provided by 23andMe. Some meaning for raw genetic data was based only on studies of 750 people, maybe not a large enough sample for statistical power; some diseases are not well-studied enough to have full knowledge of the genetic input. The more serious a condition, the higher the stakes for accuracy. Among those concerned, one laid bare the issue using a relatable gasoline analogy: “You want the government to protect you against the bad guys. If you pull into the gas station and buy a gallon of gas, you want it to be a gallon, and you want it to be gas!”—this is the same reason the FDA has ordered 23andMe to stop providing health-related genetic information to consumers—they want the genetic tests to do what they promise and do so accurately.
But then again…is genetic sequencing and interpretation really a device? Maybe the ‘book of regulations’ isn’t broad enough in scope to cover this kind of test.
Attendees were also mindful that once these test results land in your lap, how will you take the information? How will you respond? The company 23andMe is very aware of this concern and when they previously offered the health-related tests, they directed the consumer through a series of deeper and deeper consent to learn their genetic information on more and more serious conditions. As Shaban pointed out, “you cannot unlearn this information.” At one time, 23andMe offered predicted health risk for 122 diseases and 53 inherited conditions. That’s a lot of data to take in for oneself and/or ones children. “What if one of your results is really important? 122 traits? It’s overwhelming emotionally. It’s expensive to follow up on.” Attendees agreed that most people react emotionally first, before their rational brain kicks in to consider the information.
Along the same lines, attendees raised the concern that the meaning of predicted risk for a condition or disease will be read differently person to person. Most people lack a strong understanding of ‘risk.’ Some may be truly scared when they read of their three-fold increased risk for atrial fibrillation over the general population; some will read further and see this only elevates their risk from 1.7% to 5%, which is a small number—but others will be hung up on the three-fold higher risk and panic.
And yet, with all this, attendees acknowledged that there is uncertainty in all things like this—in the meaning of our genetic information and the meaning of health-related tests we take at the doctor’s office. “The public has an inflated sense that the answers our doctors give us are black and white. Maybe bringing to light the uncertainty is a good thing.”
We also shared some laughs. An attendee shared with the whole group that when he was diagnosed with glaucoma, he was in disbelief. He couldn’t process the reality of that diagnosis-given in his doctor’s office– and imagined that many people sitting with 23andMe data might feel the same way. He went so far as to say that he was proposing alternative diagnoses, “Maybe I just have a really big optic nerve!” And that is when another attendee urged from the other side of the room, “Own your phenotype!” The room erupted in laughter.
In the end, we weighed and applied the ethics principles of autonomy and beneficence, enjoyed our pints and chips, joked about hairy big toes—and Hobbits– and dry earwax, and got one another thinking. Some people sent away for 23andMe testing kits. Some wished they could still receive health-related genetic information from 23andMe. And the rest of us went away wondering if we really receive a gallon of gasoline when we pay for one.
Thanks Everyone! See you soon again in Portland…