5 ms·

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

by bthomas 12y ago

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?

deleted 12y ago
[deleted]
raverbashing 12y ago
The issue with the FDA is saying "Since you have this gene your chance of X disease is 5%" when there are other factors that influence this and this hasn't been evaluated by a doctor. And then people making decisions solely based on this number.
- jonknee 12y ago
  It's because they're a bureaucracy and they are protecting their turf. They call the spit kit a medical device and want to regulate it as such.
lmkg 12y ago
23andMe has not proved that the information it provides is sufficiently accurate. It makes claims about an individual's susceptibility to various diseases, and furthermore it markets itself as a reliable source of information (which the FDA takes to mean, a tool for making decisions). The FDA's mandate is if someone makes that claim, consumers should be able to rely on it. That has not been satisfied.
npizzolato 12y ago
> It's just information 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.
- eurleif 12y ago
  If that's the only issue, why did 23andme remove all medical information, rather than simply adjusting their marketing to say "this is all experimental, take it with a grain of salt"?
  - Harelin 12y ago
    If they did that before the FDA came knocking, and/or hadn't ignored the FDA until it was too late, that very well may have worked.
  - SEJeff 12y ago
    Because the FDA _told them to_: http://singularityhub.com/2013/11/26/fda-tells-23andme-to-stop-marketing-dna-sequencing-service/ http://singularityhub.com/2013/11/26/fda-tells-23andme-to-st...
joshuacc 12y ago
Because "just information" can be incredibly damaging in lots of ways. This is why most ethical systems include guidelines for determining when it is okay to share information with others and when it is not. 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.
- jrapdx3 12y ago
  At least two issues involved. 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.
myleskeating 12y ago
As other people have said, genetic information is powerful and scary to most folks. Most diseases have a host of genetic factors that also interplay with environmental factors, and the outcomes of these interactions are not rigorously understood. So 23andMe is a cool idea but may be overstepping the data. 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-on-23andme/ 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
UrMomReadsHN 12y ago
Information isn't always "good" in medicine. For example the Prostate-Specific Antigen test is a good example. http://en.wikipedia.org/wiki/Prostate-specific_antigen#Screening 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]

by bthomas 12y ago

deleted 12y ago

[deleted]

raverbashing 12y ago

The issue with the FDA is saying "Since you have this gene your chance of X disease is 5%" when there are other factors that influence this and this hasn't been evaluated by a doctor. And then people making decisions solely based on this number.

jonknee 12y ago
It's because they're a bureaucracy and they are protecting their turf. They call the spit kit a medical device and want to regulate it as such.

lmkg 12y ago

23andMe has not proved that the information it provides is sufficiently accurate. It makes claims about an individual's susceptibility to various diseases, and furthermore it markets itself as a reliable source of information (which the FDA takes to mean, a tool for making decisions). The FDA's mandate is if someone makes that claim, consumers should be able to rely on it. That has not been satisfied.

npizzolato 12y ago

> It's just information 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.

eurleif 12y ago
If that's the only issue, why did 23andme remove all medical information, rather than simply adjusting their marketing to say "this is all experimental, take it with a grain of salt"?
- Harelin 12y ago
  If they did that before the FDA came knocking, and/or hadn't ignored the FDA until it was too late, that very well may have worked.
- SEJeff 12y ago
  Because the FDA _told them to_: http://singularityhub.com/2013/11/26/fda-tells-23andme-to-stop-marketing-dna-sequencing-service/ http://singularityhub.com/2013/11/26/fda-tells-23andme-to-st...

joshuacc 12y ago

Because "just information" can be incredibly damaging in lots of ways. This is why most ethical systems include guidelines for determining when it is okay to share information with others and when it is not. 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.

jrapdx3 12y ago
At least two issues involved. 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.

myleskeating 12y ago

As other people have said, genetic information is powerful and scary to most folks. Most diseases have a host of genetic factors that also interplay with environmental factors, and the outcomes of these interactions are not rigorously understood. So 23andMe is a cool idea but may be overstepping the data. 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-on-23andme/ 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

UrMomReadsHN 12y ago

Information isn't always "good" in medicine. For example the Prostate-Specific Antigen test is a good example. http://en.wikipedia.org/wiki/Prostate-specific_antigen#Screening 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]