23 and Me Get FDA Warning Letter, Who is Next?

23 and me recently got an FDA warning letter. A copy of the letter is here. Customers of the direct to consumer genetics marketing group are not happy. They cite the very high cost of other genetic testing and their right to test their own bodies to find their genetic tendencies. They are nervous and ask who is next to hit the FDA chopping block? Consumers are worried that all testing might be at risk.

An FDA warning letter  description as shared by the FDA “When it is consistent with the public protection responsibilities of the agency and depending on the nature of the violation, it is the Food and Drug Administration’s (FDA’s) practice to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. Warning Letters are issued to achieve voluntary compliance and to establish prior notice

2020 science produced a great video on the pro’s and con’s of the 23 and Me technology

To bring some balance to the 23 and Me development it makes sense to see what the FDA is concerned about. They state they have invested in working with the company for several years to adjust marketing claims and their technology to be FDA compliant. 23 and ME state on their blog:

This is new territory for both for 23andMe and the FDA. This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future. It will also provide important reassurance to the public that the process and science behind the service meet the rigorous standards required by those entrusted with the public’s safety.

I am committed to making sure that 23andMe is a trusted consumer product. I believe that genetic information can lead to better decisions and healthier lives — a goal that all of us share

Hilda Bastion in a guest blog for Scientific American asks how much monitoring is too much? One of the challenges consumers face is how to understand research numbers and terminology and make sense of them in their every day lives.  Dr. Amanda Burls, Founder of ThinkWell shares how genetic testing can be misconstrued to be of more value than it actually is and then shows us what a genetic test for Celiac disease reveals. This video was constructed way in advance of any 23 and Me FDA warning letter.

One major issue the FDA raises is that of false positive  and  false negatives results from testing. False positive means that people will falsely test positive for the disease when actually they don’t even have it. Picture yourself or a loved one being told you have HIV or a disease that means certain death, that would be tough to bear wouldn’t it? On the other hand maybe the test tells you that you are absolutely fine. You still feel sick but try to shake it off and then you go home and get too sick to get back to a hospital and there are life changing consequences. This happened to me I had a brain injury, internal injuries and a broken neck.

This article at Med City gives clear examples of why the FDA is targeting 23 and me http://medcitynews.com/2013/11/heres-fda-targeting-23andme/ Serious concerns after genetic testing and rash decisions too.I see this as a powerful tool that could work for or against someone dependent of their training and skills level. Accuracy in the product and the marketing are a must.  When we offer a diagnostic tool should we not also make the results and consequences plain? Genetic counseling is important because a bad gene is not always a death sentence and wayward results can really impact public and private life.

Often times a test we use boasts they are 100% sensitive at diagnosing a health problem ( sensitivity rules in a condition)  ….sure maybe they are but the question to ask is how many people without the condition are being diagnosed  as having the problem along with those who do have the condition.

Slide11

Some tests claim to be absolutely 100% specific and these tests are great at ruling out conditions but some times they miss people who have the condition

 

 

 

The best tests are sensitive AND specific

Slide13It will be wonderful if things can be worked out so consumers get inexpensive accurate tests that are validated with good Scientific data and that this becomes a model relationship of regulatory function protecting the health of citizens and business doing their best to produce a quality driven reliable product.

23 and Me are involved in a MOOC  (Massive Open Online Classes) on genetics. They have partnered with Udacity to offer the free online course. Lets hope they do more than scratch the surface and exercise due diligence in teaching the materials so consumers can use this tool safely and with good judgement.his article offers an eye-opening perspective on the difficulties associated with interpreting the 23&Me results.

The author Bernard Munos titles his post  “23 and Me A fumbling Gene in its Corporate DNA”  http://www.forbes.com/sites/bernardmunos/2013/11/29/23andme-a-fumbling-gene-in-its-corporate-dna/ He raises the issues of sample size and the complexity of disease causation along with accuracy and identity. There seems to be a desire to tighten up on labeling, risk and expectation with clear language  along with  calling it a screener rather than a definitive diagnostics. 23 and Me feel they have been clear on this; The FDA disagrees.

Another interesting post here by Dr Katz  that raises some interesting points that reach even to patents for designer babies held by  23 and me hold and to methods buried in their literature for DNA testing minors.  http://e-patients.net/archives/2013/12/matthew-katz-on-23andme-return-to-sender-genome-unknown-seven-reasons-i-will-return-my-personal-genome-kit.html

23 and Me  has apparently been hit with a class action law suit  http://www.fiercemedicaldevices.com/story/23andme-hit-lawsuit-over-meaningless-gene-tests/2013-12-03 over efficacy of their genetic diagnostics kits.

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