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FDA Orders 23andMe to Stop Providing Genetic Analysis.

Esther12

Esther12

Senior Member
Messages
13,774
I think that it's a mistake to view genetic testing in primarily medical terms, rather than political. To a large extent, British and American societies are built upon myths about 'equality of opportunity', exaggerated claims about individual's control over their own lives, and so on. The more accurate information we have about reality, the more those myths are challenged. This is going to be important in medicine, for insurance (will insurance companies be able to insist people get tested?), pensions, for decisions about how people are valued, and so on. If people have genetic results which indicate a high probability of early death or disability, how will that affect their rights and responsibilities in society?

Currently this is just an emerging issue, but there will be a lot of interested parties with a lot of money and influence who have clear ideas about how they want things to go, and what outcomes they want to avoid. If genetic testing does end up providing the sorts of important information people expect, it will have a profound impact upon lots of areas of life, and this makes me instinctively sceptical of any attempt to control it (even if I currently think the FDA has some fair but minor reasons for concern with 23andMe)
 
biophile

biophile

Places I'd rather be.
Messages
8,977
I guess 23andMe may have to tone down some of the medical advice? I care more about the accuracy of the testing technique for data reuse. If I had the money I would send the same sample under two names and check for differences.

So when are letters being sent to CBT/GET practitioners who have charged money and mislead ME/CFS patients about the size and nature of the effects and the safety profile? Oh that's right, regulation is almost non-existant for that.
 
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B

barbc56

Senior Member
Messages
3,657
biophile said:
I guess 23andMe may have to tone down some of the medical advice? I care more about the accuracy of the testing technique for data reuse. If I had the money I would send the same sample under two names and check for differences.

So when are letters being sent to CBT/GET practitioners who have charged money and mislead ME/CFS patients about the size and nature of the effects and the safety profile? Oh that's right, regulation is almost non-existant for that.
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I forgot to cite my sources from my previous post. Someone did just this. This article also shows that there could be problems with the questionaire.

http://discovermagazine.com/2008/sep/20-how-much-can-you-learn-from-a-home-dna-test#.UpeLeajnaAhhttp://discovermagazine.com/2008/sep/20-how-much-can-you-learn-from-a-home-dna-test#.UpeLeajnaAh
 
alex3619

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
The problem with SNP testing is that its about the SNP technology itself. Each company builds a library of SNPs and tests for it. Different companies will have different SNPs in their library. Without a complete genome sequence there is no way to be sure of genetic accuracy as only SNPs are detected. Even with a complete genome sequence our understanding of the genome is still in development.

I expect there to be differences in testing from different companies. What should not be different is whole genome testing.

SNP interpretation is something else. Just by chance many predictions will be wrong, because in most cases they work on association not causation. If the published science says SNP A is associated with disease Z then they will put that in the profile. The biggest issue though will be the unknown, either SNPs we don't know about yet, or consequences from SNPs we don't know about.

Most of the companies creating such profiles will be struggling to keep their analysis software up to date. Its constantly evolving. The results you get on one set of SNPs one year might be different a few years from then.

This is not really science, its about issuing advice that might help you manage possible risks.

One thing people should be aware of, and I haven't looked at 23andMe for a long time, is the difference between absolute and relative risk. An absolute risk of 10% is worrying, and cause to look at prevention. A relative risk of 10% could be almost anything. If the average person has a risk of 0.01%, then a relative increased risk of 10% is only 0.011% in absolute terms. Small potatoes, don't panic. That's only 11 chances in 100000.
 
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Sea

Sea

Senior Member
Messages
1,286
Location
NSW Australia
barbc56 said:
I forgot to cite my sources from my previous post. Someone did just this. This article also shows that there could be problems with the questionaire.

http://discovermagazine.com/2008/sep/20-how-much-can-you-learn-from-a-home-dna-test#.UpeLeajnaAhhttp://discovermagazine.com/2008/sep/20-how-much-can-you-learn-from-a-home-dna-test#.UpeLeajnaAh
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Very interesting article, thanks Barb.

There was some confusion over the differing "results" from the different companies. On reading carefully though the differences were not in the raw data but in the interpretations of that data.

I don't have a problem with that. The risks are not absolute, they are based on whatever research on whatever snps the particular company is aware of. As long as they make clear it is preliminary research, that calculations will change as more research happens etc I'm good with that.

Another confounding factor for this reporter is her mixed ethnicity. The research is in it's infancy in all races, but even more so in those who are a mixture. Until much larger populations are studied conclusions will not yet be reliable.
 
biophile

biophile

Places I'd rather be.
Messages
8,977
I only skimmed through the Discover Magazine article, but it seems like early days yet for genetic testing. Last time I checked, 23andMe graded the strength of the evidence/research cited. People shouldn't start panicking over flimsy evidence.

I mostly got the 23andMe test out of curiosity and the possibility of insight into methylation tendencies. My friend also sent off a sample before me and then told me about a special offer. I never really expected it to be the gospel on my genetic makeup, and it only tests 10% of the DNA or something, so more of a mere glimpse or guide unless better testing is available?

If the data says I am 20% less likely to get disease X, or 30% more likely to get disease Y, I am not going to start worrying about it. 23andMe claim that I am twice as likely to get Alzheimer's disease. My great grandmother had that so I already was prepared for it. There isn't much I can do about that right now whether it happens or not.

23andMe may be useful for finding obscure genetic problems?
The ancestry part of 23andMe was also interesting.

I received this email from 23andMe recently:

Dear 23andMe Customers,

I wanted to reach out to you about the FDA letter that was sent to 23andMe last Friday.

It is absolutely critical that our consumers get high quality genetic data that they can trust. We have worked extensively with our lab partner to make sure that the results we return are accurate. We stand behind the data that we return to customers - but we recognize that the FDA needs to be convinced of the quality of our data as well.

23andMe has been working with the FDA to navigate the correct regulatory path for direct-to-consumer genetic tests. This is new territory, not just for 23andMe, but for the FDA as well. The FDA is an important partner for 23andMe and we will be working hard to move forward with them.

I apologize for the limited response to the questions many of you have raised regarding the letter and its implications for the service. We don't have the answers to all of those questions yet, but as we learn more we will update you.

I am committed to providing each of you with a trusted consumer product rooted in high quality data that adheres to the best scientific standards. All of us at 23andMe believe that genetic information can lead to healthier lives.

Thank you for your loyalty to 23andMe. Please refer to our 23andMe blog for updates on this process.

Anne Wojcicki
Co-founder and CEO, 23andMe
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B

Bob

Senior Member
Messages
16,455
Location
England (south coast)
According to this article, the FDA has not banned the sale of testing kits, but has only ordered the suspension of marketing activities. The current situation seems to be part of an ongoing dialogue between the FDA and 23andMe, and is not necessarily permanent:

23andMe suspends marketing after failing to meet FDA requirements
At-home genetic testing kits still for sale on company website while FDA questions claims made by marketing material
Tuesday 3 December 2013
http://www.theguardian.com/science/2013/dec/03/23andme-suspends-marketing-fda-order
 
Firestormm

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
Bob said:
According to this article, the FDA has not banned the sale of testing kits, but has only ordered the suspension of marketing activities. The current situation seems to be part of an ongoing dialogue between the FDA and 23andMe, and is not necessarily permanent:

23andMe suspends marketing after failing to meet FDA requirements
At-home genetic testing kits still for sale on company website while FDA questions claims made by marketing material
Tuesday 3 December 2013
http://www.theguardian.com/science/2013/dec/03/23andme-suspends-marketing-fda-order
Click to expand...

Bob, did you notice the class action lawsuit referred to at the foot of that report?
 
B

Bob

Senior Member
Messages
16,455
Location
England (south coast)
Firestormm said:
Bob, did you notice the class action lawsuit referred to at the foot of that report?
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Yes, I did, and the article includes a link to the details of the class action.
But I'm not sure why you asked me that question?
I haven't taken much interest in 23andMe, so I don't have any meaningful insight into the significance of the class action, or the FDA action.
 
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WillowJ

WillowJ

คภภเє ɠรค๓թєl
Messages
4,940
Location
WA, USA
Waverunner said:
My main point is this, when a full genome costs 1,000 to 3,000 dollars, then it should be possible to sequence 3,000 times less for 100 dollars without subsidizing it.
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Not necessarily. I'm not 100% sure of all the implications, but it still takes expensive equipment and many steps to do any sequencing.

While a full human genome is, I'm sure, enormously complicated, and probably has some additional costs over doing short sequences, the cost for sequencing is not going to be directly related to the length of sequence; some of the time and steps involved would the same (just differing amounts of what you add, and possibly differing amounts of incubation time but again, time not multiplied by amount of DNA--you increase the other materials which compensate for more DNA) no matter how much DNA is being handled.
 
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beaker

beaker

ME/cfs 1986
Messages
773
Location
USA
question about the kit. To ensure your privacy -- did you register under a fake name or your real name.
 
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