About the title — that’s the FDA talking, not me. It’s their apparent attitude toward people who dare learn about their genes.
For $99, 23andMe analyzes your saliva and tells you about your DNA. Their site includes plenty of caveats about the possible emotional impact of the information, the possibility of errors, the limits of what one can infer about health tendencies, the advisability of taking no remedial action without further testing and consultation.
Nevertheless, the FDA has sent a WARNING LETTER to 23andMe co-founder and CEO Ann Wojcicki expressing concern that customers may, for example, rush to have dangerous prophylactic surgery like breast removal if they learn about some genetic risk factor. The company must stop marketing its product until it satisfies FDA regarding false positives, recipients with no common sense, etc. Otherwise, the agency just may have to seize 23andMe and impose penalties.
Yet, as Harry Binswanger notes, “A false positive does not force you to obey it.”
Wojcicki has now spoken up about the FDA’s letter, allowing that 23andMe is “behind schedule” in providing FDA with information, calling the bullying agency a “very important partner,” and in general speaking very carefully while stressing that new technology is not per se a bad thing.
What she doesn’t say is that any FDA interference with our ability to buy and evaluate information about our DNA, and Wojcicki’s right to discover and sell it to us, would be a very bad thing.
This is Common Sense. I’m Paul Jacob.
5 replies on “You Ignorant Fool”
Obamacare is a false positive and we have to obey it. Unless our states or cities nullify it. NYC can nullify the parts of the 2nd Amendment that they dislike. Should be able to do the same for Obamacare.
This DNA testing is not for diagnostic purposes. If the results indicate a possible disease, 23andMe recommends that the person seek medical care and get more specific tests. Since the DNA testing is only for informational purposes, the FDA does not have the authority to regulate it. This holds true for other non-diagnostic tests. For example, lab testing used by health and life insurance companies to assess risk is not regulated by the FDA even though the insurance-related tests are identical to those used in hospital labs.
The attitude of these government officials brings to mind (to my mind anyway) the concept floated by Amazon recently wherein they are considering delivery via drone aircraft. Apparently, Amazon needs permission from the FAA to send these presumably slow, low flying aircraft into our neighborhoods. One can only wonder whether that same august and all powerful government agency will require us to file flight plans for our radio controlled models. Then perhaps they will also require flight plans for football passes baseball pitches? After all, we can’t have things just flying around unregulated, can we?
http://www.scientificamerican.com/article.cfm?id=23andme-is-terrifying-but-not-for-reasons-fda
23andme has also been doing a box office business with Adoptees & birth parents searching. I know because I get newsletters. Now all the adoptees, etc are nervous about using the service. I hate big government & its growing invasion in all our lives.