me and 23andMe and the FDA

Over the past weeks one cannot have failed to hear about how 23andMe were basically given a cease and desist order by the FDA. The whole issue just makes me wonder what will the FDA go after next? Will it be devices that track our exercise, sleep, nutrition – where is the line they are crossing going to end? I support the very important role the FDA has to keep us safe on so many fronts but I also realize they are over-stretched and under-funded and here they are telling us we cannot spit in a tube (and pay for it) and find out whether we are derived from neanderthals, (and oh by the way get some idea of traits and disease risk at the same time). I just wished the FDA would focus more on approving drugs that are urgently needed.

Earlier this year I actually spent $99 and did the whole spit in a tube for 23andMe after reading Eric Topol’s “The creative destruction of medicine”. I think I knew what I was getting for my money. I also realized that 23andMe were getting another very important datapoint. I was investing in them. For me the most interesting findings were the Clopidogrel (P450 2C19) poor metabolizer status and caffeine (p450 1A2)  poor metabolizer status.I was also alerted to my apparent decreased sensitivity to pain,  inability to smell sweat and the prediction that I was European..Not really useful information to me I have to add.

In his book Eric described personal consumer genomics and the companies involved but also how the companies struggled. He  mentioned the AMA and their influence over the FDA from their 2011 letter requiring genetic testing  to be under the supervision of a “qualified health professional” (p119). Which makes me wonder whether the FDA has been influenced by their “lobbying” more than anything else. Lets be clear, tests for ancestry like those from the National Geographic do not appear to have come under scrutiny. Its because 23andMe have stretched the analysis to include all the various GWAS studies and not hold peoples hands on the interpretation or over interpretation of risk that they have come under fire. While not definitive by any stretch of the imagination they are probably as ‘state of the art’ as we currently have. But can the average person really understand what they have bought?

As a customer I have been getting emails from 23 and Me : First Nov 27th.

Dear 23andMe Customers,

I wanted to reach out to you about the FDA letter that was sent to 23andMe last Friday.

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. We stand behind the data that we return to customers – but we recognize that the FDA needs to be convinced of the quality of our data as well.

23andMe has been working with the FDA to navigate the correct regulatory path for direct-to-consumer genetic tests. This is new territory, not just for 23andMe, but for the FDA as well. The FDA is an important partner for 23andMe and we will be working hard to move forward with them.

I apologize for the limited response to the questions many of you have raised regarding the letter and its implications for the service. We don’t have the answers to all of those questions yet, but as we learn more we will update you.

I am committed to providing each of you with a trusted consumer product rooted in high quality data that adheres to the best scientific standards. All of us at 23andMe believe that genetic information can lead to healthier lives.

Thank you for your loyalty to 23andMe. Please refer to our 23andMe blog for updates on this process.

Anne Wojcicki
Co-founder and CEO, 23andMe

Then Dec 6th:

Dear 23andMe Customers,

I’m writing to update you on our conversation with the U.S. Food and Drug Administration and how it impacts you.

If you are a customer whose kit was purchased before November 22, 2013, your 23andMe experience will not change. You will be able to access both ancestry and health-related information as you always have.

23andMe has complied with the FDA’s directive and stopped offering new consumers access to health-related genetic results while the company moves forward with the agency’s regulatory review processes. Be sure to refer to our 23andMe blog for updates.

We stand behind the data we have generated for customers. Our lab partner adheres to strict quality standards that are part of the Clinical Laboratory Improvement Amendments of 1988 – known as CLIA. These are the same standards used in the majority of other health and disease-related tests.

You are among the first people in the world to ever get access to their genomes. You are genetic pioneers. Thank you for your ongoing support and we look forward to continuing to serve you.

Anne Wojcicki
Co-founder and CEO, 23andMe

currently their website lists the following on the front page:

Welcome to 23andMe.

At this time, we have suspended our health-related genetic tests to comply with the U.S. Food and Drug Administration’s directive to discontinue new consumer access during our regulatory review process.

We are continuing to provide you with both ancestry-related genetic tests and raw genetic data, without 23andMe’s interpretation.

If you are an existing customer please click the button below and then go to the health page for additional information, including information about refunds.

We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives.

Upon entering the site, please confirm you understand the new changes in our services.

I understand that 23andMe only sells ancestry reports and raw genetic data at this time. I understand 23andMe will not provide health-related reports. However, 23andMe may provide health-related results in the future, dependent upon FDA marketing authorization.

So I do not think anyone questions the quality of the analytical data, the meaning of the data is another thing altogether. Over time this may change as bigger studies are published. But surely this is the same problem we have with science in general. Hypotheses shift, our understanding increases and we get to a different place.23andMe cannot do anything about this, because its called PROGRESS.

I wonder how much longer 23andMe are viable if they become just another genealogy service? Will someone buy them, maybe a diagnostics company? They have a potentially useful database from customers and their backgrounds. Or will they go for FDA approval and add some sort of genetic expert layer for interpretation on a 1:1 basis? The latter will be costly, the approval by the FDA will take time and be costly too and it remains to be seen whether these steps will really change the outcome. Will the data presented today have any increased meaning (no) and will confidence in the data increase (no). The stamp of approval by the FDA would mean something probably only to the FDA and the AMA. And how much has this cost the tax-payer already?

Do I really need the FDA to tell me I cannot spit in a tube and get some rough idea of disease risk? Because if I need definitive health advice and if I am feeling sick I will go to a doctor anyway. But like hundreds of thousands of people who are curious about our health in the age of the personal genome, why should we go to a health provider, pay inflated costs and get the same fuzzy data from CLIA labs? Science is moving faster than the FDA can likely keep up. I liken the situation to the FDA trying to do “industrial age regulation in the information age”. 23andMe is expected to play by the rules but do I really need the FDA to look out for me as a consumer on this matter, knowing full well that like many I am just testing the personal genome waters and not making any health decisions based on the data. Unfortunately, for the moment others cannot get the same data until 23andMe comply with the FDA. In the meantime I wear my new found knowledge of deriving from neanderthals with pride and hope that if I ever need to take drugs metabolized by P450 2C19 and P450 1A2, that my doctor will understand what they are and why he might want to listen to my request to test my metabolizer status before giving me those drugs. Thank you 23andMe and good luck.



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