Too Big to Feel


We don’t often write editorials in this space. Normally, you will see nothing but news in the DNA Consultants Blog. Some sparse marketing messages may appear whenever we have a new product or study. But the FDA’s “stop and desist” letter last Friday to personal genomics giant 23&me has sent shock waves through the industry. Although we are not in the business of providing medical information to customers, only ancestral background analyses, we feel compelled to weigh in on the FDA’s warning, which we think is overdue.

First, it is important to note that the FDA took action against 23&me because the company has been selling an unapproved diagnostic device and medical service. The FDA demanded 23&me “immediately discontinue marketing the Personal Genome Service” after years of protracted and unsuccessful requests for proof of safety and efficacy to back up the company’s marketing claims.

A check of 23&me’s website on November 26 showed little change in the promises it makes to consumers. Splashed across the welcome page in large letters was “Get to know you.” The site boasted having “Reports on 240+ health conditions.” In language that sure sounds medical to us, it speaks of carrier status, health risks and drug response.

An appeal to parents suggests, “Find out if your children are at risk for inherited conditions, so you can plan for the health of your family.” Under “drug response,” the company advises that you can take “information on how you might respond to certain medications” from your $99 DNA test to your next doctor’s visit.

The FDA found “some of the uses for which Personal Genomic Service is intended are particularly concerning.” A false positive result for the BRCA gene, for instance, could cause a patient to remove breasts or ovaries to avoid getting cancer. A false negative could lead patients into an unfounded sense of security and make them ignore that an actual risk exists. An inaccurate result for warfarin drug response could lead a patient to self-manage their dosage or skip it altogether, leading to “illness, injury, or death.”

Some pretty dire concerns.

DNA Consultants simply does not do DNA testing for medical information. If a customer calls and asks for such a service we explain that is something they should discuss with their healthcare provider. Neither our marketing nor fulfillment of tests contains any medical language.

We specialize in ancestry analysis exclusively and believe we do that better than anybody else.

Of course, the field of genetic screening has made enormous progress over the past ten years. We monitor many of those advances in our blog. But we do not believe the field is by any means “there” yet, certainly not ready to be packaged and hawked to consumers. We doubt it ever will be. Or at least we hope not.

Despite popular anthems of genetic determinism, your health is not all in your genes. But your ancestry certainly is. Find out what your ancestry is and you will be able to form an idea of what your ancestral medical history might look like, going beyond the two generations of family medical history covered by standard questionnaires at the doctor’s office. But that part is entirely up to you and your healthcare providers.

No company is too big to fail. Even the largest are subject to oversight by the government as well as consumer pressure and the natural forces of the market. Nor is any company too big to feel. We hope 23&me will respond both to the FDA and the public with understanding and responsibility, not indifference and arrogance.

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