I've never understood the dynamic between 23andMe and the FDA. It's just information - what's to stop someone from setting up the same service in Bermuda? Would they really stop Americans from mailing a spit kit somewhere?
And then people making decisions solely based on this number.
Plus most people are not able to interpret what these genetic risks mean for them, so delivering the results directly (not through a doctor or preferably genetic counselor) is risky. People tend to think of genes as laws or rules, as guarantees, when really our genomes are complex if-then clauses (if this chemical hits this receptor transcribe that bit there). What if someone decides to get a double masectomy because of BRCA mutations? That's a traumatic, expensive procedure, and maybe riskier than the cancer risk; in any case, it's a decision that should be made with a medical professional.
Finally, 23andMe inexplicably flipped a big old bird to the FDA, their own regulatory agency, by NOT RESPONDING TO THE FDA FOR 6 MONTHS before the warning letter. That's just irresponsible and foolish.
Biotech has a crazy amount of regulation, but I think 23andMe deserved this one
Read more here: http://venturebeat.com/2013/12/03/why-the-fdas-anvil-dropped...
Hank (the interviewee) is a really great writer and teacher if you want to learn more about bioethical issues
In this particular case, the FDA appears to be concerned that 23andMe are essentially providing the sort of information known as "medical advice" without sufficient context. And (regardless of whether they are correct in this case) that sort of thing can be dangerous.
You are right about the "context" of the information. Test results need to be shared with the individual by a trained genetics counselor. Interpreting genetic results requires knowledge of the subject and ability to express complex and emotionally charged information in a sensitive and ethically appropriate way. Not much fudge room there.
Another aspect is FDA standards of procedures and accuracy of test results for genetic conditions (where gene frequencies are known). Presumably 23andMe would have show that it meets those standards in order to provide the related results. Most likely to be more trouble than it's worth to them.
For example the Prostate-Specific Antigen test is a good example.
http://en.wikipedia.org/wiki/Prostate-specific_antigen#Scree...
While PSA testing may help 1 in 1,000 avoid death due to prostate cancer, 4 to 5 in 1,000 would die from prostate cancer after 10 years even with screening. Expected harms include anxiety for 100 – 120 receiving false positives, biopsy pain, and other complications from biopsy for false positive tests. Of those found to have prostate cancer, frequent overdiagnosis is common because most cases of prostate cancer are not expected to cause any symptoms. Men found to have prostate cancer usually (up to 90% of cases) elect to receive treatment. Therefore many will experience the side effects of treatment, such as for every 1,000 men screened, 29 will experience erectile dysfunction, 18 will suffer urinary incontinence, 2 will have serious cardiovascular events, 1 will suffer pulmonary embolus or deep venous thrombosis, and 1 perioperative death.[5]
According to 23andMe (or at least their marketing) it's accurate medical information. The FCC wants them to prove that or stop marketing it as such -- a request that is beyond reasonable.
http://singularityhub.com/2013/11/26/fda-tells-23andme-to-st...