Genetic Engineering and Biotechnology News have just published the first survey conducted by their Science Advisory Board, a project called SciPulse Perspectives which aims “to take the “pulse” of scientific minds all over the world”. The survey asked 500 US members “ to share their views on the direct-to-consumer (DTC) testing industry, specifically in the context of the FDA’s warning letter to 23andMe back in November of 2013.”
You can read the results of the poll, yourself, and I won’t bother to comment on them. What concerns me is the way the poll has been framed suggests a fundamental misunderstanding of the FDA’s action. The poll infographic states that the FDA’s position is that “there is a potential for harm when genetic testing results are presented without the counsel of a physician” and that the FDA decided “to stop 23andme from providing genetic interpretations directly to individuals without involving an intermediary physician for counsel.” This is a serious misrepresentation of the FDA’s action, which, as I stated in a previous post, is more concerned with the failure of 23andme to provide the Agency with data about the safety and effectiveness of their test, the traditional standard to which FDA holds medical devices.
Read the full, original story: Stop the poll, I want to get off
