July 15, 2015
Liana Meffert, a student at Emory University, is interested in the unique ethical issues that present themselves in connection with genetic testing for neurodegenerative diseases. In a blog post, Meffert notes the lack of substantive data of how knowledge of one’s results, where that information was gained in a non-clinical setting, affects one’s psyche. Studies to date, showing relatively benign outcomes, were performed in conjunction with genetic counseling and other support systems. Meffert also highlights the unpredictability of individual outcomes among those tested as a result of environmental factors. A person’s environment may play a significant role in terms of whether a genetic variant produces the anticipated disease. Meffert is not a fan of direct-to-consumer (DTC) genetic testing, where results having psychophysical repercussions are supplied online without professional intermediary advice and assistance. She supports regulatory intervention for DTC genetic testing and cites 23andMe as an example of a company that was reprimanded and sanctioned by the FDA for offering DTC genetic testing without conforming to FDA standards, requirements and approvals. 23andMe was prohibited from marketing its DTC genetic testing kit for health information purposes and was limited to providing online ancestral information. In 2015, the FDA authorized 23andMe to market the Bloom syndrome carrier status report.
As a personal side note, having completed the 23andMe genetic test (prior to the FDA’s slap on the wrist) and having received a potentially life altering result, I am glad I am equipped with the information that was provided and have no regrets. Information, including genetic information, is power. Power to alter one’s lifestyle accordingly — I now know I must continue to keep my mind engaged, exercise and eat well. I am extremely grateful to 23andMe for expanding my health horizons.