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The FDA, Irate Customers and 23andMe again

23andme fda

23andme and the FDA

A recap of the past day: 23andme has stopped including the health reports section of the test because apparently people are not smart enough to understand the results as presented: High, Low, and Typical risk category. The FDA is worried people will be rash based on what they read.

Agreed – people don’t understand risk. Over the past three years I’ve watched many 23 consumers begin a thread on the forum with: “23andme got it wrong! I don’t have arthritis or (fill in the blank) – melanoma, blue eyes, gout, etc. They thought high risk meant: YOU HAVE IT! If they were placed in high risk that’s how the results were interpreted, similar for low risk: “23andme got it wrong! I have breast cancer, (curly hair, psoriasis, etc) and they say I don’t.”

No, they never said that at all. They associated your genetic output with published studies. They did a literature search for us.

No matter how many responded to explain the word ‘risk’ and what the numbers meant, the problem continued. I wonder why 23 didn’t explain this issue more clearly before giving the results in the same manner they make people jump through hoops to learn the most serious breast cancer or Alzheimers risk (are you sure? really sure you want the results?) This was a perfect place to have a few slides that must be read before results are given. I also think the LOW RISK category should have been first. I suspect low risk calms the mind enough to deal high risk with a better frame of mind leading to a less dramatic (and incorrect) reading

What People Are Saying Now

Furious, angry, so upset. Those are word used by 23andme customers against 23andme. I’m in shock and awe. 23andme would LOVE to give results for those who bought after November 22nd. The FDA is responsible for the current hold from Nov 22 on. But anger is directed at 23andme. Lesson here: to some, they bought a product from a corporation and want what was promised. The reason it can’t be is not understood or appreciated. These may be the same people who fail to understand RISK as in 23andme is at greater risk in giving the health reports than not doing so. RISK – a word people need to understand.

The best analysis of the situation I have currently seen is here at the Law and Science Blog from Stanford.

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