It's your body and your health. It's also your data. But do you know what to do with it?
That is one of the byproducts of the recent dust-up between the U.S. Food & Drug Administration and 23andMe about whether the genetic testing company can continue to sell its $99 DNA sequencing kits directly to consumers. The kits offer insights into a patient's risks for cancer and other diseases.
Here is the crux of the FDA warning, issued November 22:
FDA is concerned about the public health consequences of inaccurate results from the PGS device; the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.
Four days later 23andMe posted a letter from CEO Anne Wojcicki:
It is absolutely critical that our consumers get high quality genetic data that they can trust. We have worked extensively with our lab partner to make sure that the results we return are accurate.
This is new territory for both 23andMe and the FDA.
This is also new territory for patients. And it goes well beyond 23andMe and genetic testing.
There are two big issues here — accuracy of the results and the context of communicating these data.
Data are everywhere. Patients are getting more comfortable tracking and analyzing their own health data — from reading their own blood pressure at machines in places like Walmart to wearing fitness trackers, like Jawbone Up, Nike FuelBand or the FitBit.
But when we deliver health data that requires context — such as your likelihood to develop some type of cancer, heart disease or neurological disease — that's where analysis and guidance from trained health care professionals becomes essential.
Self analysis works well when you're tracking calories. It has worked well for decades for diabetics who track their hemoglobin because they have been instructed in what to look for and what the different readings mean.
We are moving to a health care world that is data rich. It must also come with equal doses of caution, communication and compassion so that data are meaningful, useful and actionable.