July 4, 2020

The Niche

Knoepfler lab stem cell blog

23andMe and the FDA: Perspectives on Warning Letter

23andMeWhat’s the deal with this week’s FDA Warning Letter to 23andMe?

I’m a researcher who studies stem and cancer cell genomics and epigenomics. I’m also a human being who has battled prostate cancer and is curious about my genome.

With this background, I decided some time ago to take the plunge and experience what 23andMe has to offer in the way of personal genomics analysis. I thought of it as an experiment.

I contacted them with my interest and background.

We agreed to do an interview on my blog based on my experience with them. I got the tube, spit in it, and fairly soon thereafter got my results from 23andMe.

You can read my 3 pieces on HuffPost about my experiences and my interview with 23andMe leaders Dr. Joanna Mountain, Senior Director of Research, and PR Manager Catherine Afarian (here, here and here).

In my last piece on HuffPost I expressed some concerns about personal genomics services including cost, security of data, and the potential risks of patients making medical choices based on what they see in terms of “results” on personal genomics sides.

It seems to me that the FDA is most concerned in their letter with 23andMe customers possibly thinking they have solid information based upon which they can make major health decisions. I never viewed the info from 23andMe that way, but I can see how it could happen.

The FDA and 23andMe have had a relatively long history so I can’t say I’m shocked that the genomics company got dinged, but I am surprised at how the FDA so publicly slammed 23andMe. One can almost sense the apparent frustration of the FDA with 23andMe.

Part of my reaction to the letter’s severity no doubt comes from how the FDA seems, by contrast, to have practically infinite patience with dubious stem cell operations that are putting hundreds or thousands of patients at risk. FDA, why so little action on the stem cell front, but you body slam 23andMe with this tough letter? The FDA has basically said 23andMe cannot continue with its personal genome service (PGS) any longer until issues are resolved as indicated in the FDA warning letter to 23andMe CEO Ann Wojcicki:

Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device.

As a person who had the 23andMe analysis and does genomics research, what’s my thinking on all of this?

I enjoyed my experience with 23andMe, but I can definitely see the risks associated with the false sense of some of their customers having seemingly powerful information, which may not really be so concrete as they are led to believe. The FDA uses a real world kind of example of potentially devastating consequences of a customer making decisions based on overinterpreting 23andMe results:

For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.

These risks of patients taking actions based on what could be incomplete information are real and serious. 23andMe needs to do a lot more in this area.

Keep in  mind too, however, that 23andMe is not the only player out there and direct-to-consumer personal genomics is going to continue in many forms.

The personal genomics age is upon us. There is a great demand from people wanting to know more about their genomes. We’ve all got our blood types and we want to know our genotypes. We just have to understand that much like anatomy, genotype is not destiny when it comes to our health. In fact, most of the time genotype features that we each possess on their own mean very little.

I believe that the appropriate path to developing a framework for how a personal genomics company should conduct business is not clear cut. It is also not going to be based on some textbook type stepwise plan that is already established. It must be determined empirically based on actual real world experience.

The FDA letter is not the end, but just another part of the beginning of the personal genomics era. 23andMe needs to do far better and I’m betting it will. In fact, I would be very surprised if the 23andMe PGS was not back up and running in a new and improved form in 2014.

Expect a bumpy, but interesting path forward.

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