Friday, December 6, 2013

Who's Behind F.D.A. Director Mansfield's Ignorant, Absurd, and Ultimately Misguided Attack on 23andme?

From the New York Times, an article here says: "Elizabeth A. Mansfield, director of personalized medicine in the F.D.A.’s medical device division, said the agency agreed that people had a right to their genetic information. The concern, she said, was that 23andMe was also providing interpretations of what that data meant medically."

This is the opposite of the truth of what happens to the clients of 23andme. The Director at the F.D.A. would know if she had only taken the test for which she sits in judgement, as she obviously hasn't done. Makes me angry. Elizabeth Mansfield doesn't know her stuff, and yet she is making a stiff judgment when other gene testing companies go unregulated.

23andme actually does do the responsible act of sifting through 5,000 studies in spades, and links them to the gene and related health implications far more efficiently than would be expected for the price, or than any other company has had the knowledge and experience to organize ever before in the history of humanity and medicine. 

After the patient becomes familiar with the 23andme website, and climbs an admittedly steep learning curve, one that anyone who's taken introductory genetics has already taken, the information becomes understandable, and a huge amount of helpful advice in this deep website is straight ahead already collected as a service. This website has further resources such as the interactive features for group memberships and I have visited those groups every day since joining several months ago. It has a special site page for genes and SNPs, a site for blogs from geneticists and scientists about research results, and videos and written advice from medical doctors who are experts in their fields in links to pages. I can't begin to express all the gratitude I have for all the hard work the company has done.

The nebulous mystery I have is why the F.D.A. is picking on this company when Americans spend billions on psychics and vitamins and unnecessary medical tests every year. Exactly who is pushing Director Mansfield? The medical doctors who have invested thousands in screening machines for medical tests of all kinds, including mammogram machines that squeeze women every year (and their pocketbooks in America) when small matchbox-sized electronics could do the trick

23andme is growing in popularity mostly through word of mouth and has clients around the world. It's not "cold reading" or "psychic powers" or "folklore" but the science of genetics that will lead to innovations in biotechnology and also down the same road to the practice of medicine. Genetics could help with making some of these invasive and expensive tests unnecessary and cause disruption but it would be short-sighted, stubborn, inflexible, and inexperienced if the F.D.A. misunderstands the complex nature and extraordinary usefulness of 23andme.

UPDATE:
An email from the founder of 23andme kindly says that we are among the first people in the world to ever get access to our genomes. We are "genetic pioneers." I love that phrase! It's been a privilege and a pleasure to serve an incredibly brave new pioneer of business: 23andme.

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