54 replies to this topic

[Turnbuckle]

Looks like the Obama administration is finally winning its war against health freedom, been three years in the making.

It's been far longer than three years.

The FDA (Food and Drug Administration) is the government police force which approves experimental studies for those it favors and hinders approval for those it dislikes.--The Suppression of Alternative Medical Therapies (1999).

I would agree with this, except there's more than like and dislike involved. Like corruption and payoffs.

[Mind]

Just this thread is 3 years in the making. The FDA has been in a war against LEF since the mid 1990s at least.

[Jakare]

Worrying news! I was planning on having my DNA tested shortly. At the present moment they are still offering their services so I am not sure what kind of ultimatum they have been given.

While I do not particularly like the FDA, if 23&me has been selling fake or highly unreliable products then they are doing the right thing, but is it true? Are there any similar options available at the moment anyway?

[nowayout]

Looks like the Obama administration is finally winning its war against health freedom, been three years in the making.

I am no fan of Obama, but blaming Obama for decisions by a bureaucracy that is largely independent of the administration, and has made more than one decision lately that was later overruled by the administration, is a bit disingenuous. In any case, would you rather trust Obama's opponents, the type of people who would take away the freedom of access to birth control and women's choice whether to carry a fetus to term? Or who would take away the freedom to have access to health care at all when you lose your job? It is always funny how selectively conservatives employ the word "freedom."

Edited by nowayout, 26 November 2013 - 09:23 PM.

[Turnbuckle]

I'm pretty sure that the FDA is only concerned about the accuracy of the information. That's basically their job, so in this case, it looks like they're on our side, as long as they aren't gumming up the works by insisting on some sort of ridiculous standards. They've been talking with 23andMe for a while now, and it sounds like 23andMe hasn't held up their end of the deal.

That's exactly the point. The fact that 23andme oviously wasn't able or willing to verify the accuracy of their methodology should make everyone think.

To hallucinate about a "police state" in this context rather illustrates the need for a psychiatric evaluation than for a DNA analysis.

It's more the case of the FDA not liking their marketing and not bowing to their power. As for your comment about a "psychiatric evaluation," take your insults elsewhere.

[Hebbeh]

http://health.yahoo....tests-overhyped

However, there are many other genetic tests, available only through medical providers, that have received FDA approval or clearance. That means their safety and effectiveness have been rigorously evaluated in clinical studies.

There you have it...the doctor needs to have his cut....

[YOLF]

Since this seems to be the FDA bashing thread and I am on a roll, how about this one: FDA says your own stems cells are a "drug" that they need to regulate. Essentially, you can't go to a clinic and have your adult stem cells cultured (hmmm, what about at home?) and then have them re-injected into your body. Not without the FDA giving you permission, even though they are your own cells and it is your own body.

Sounds like this one might interfere with anti-aging. Maybe they're trying to keep us all old.

[YOLF]

Anyone knows how to culture adult stem cells at home?

Well the first thing we need to do is learn to culture cells. I'm in the process of building culturing some nonhuman cells, but the equipment should get me halfway there when I'm done doing it. So after that it's just a matter of sourcing the right growth factors and what not and taking samples of the necessary cells. This stuff is described in the research papers, so it's actionable.

[Gerald W. Gaston]

While I do think the company has to take the blame for the way they market themselves, I don't believe for a moment that the FDA would assume users bright enough to buy this service would make life or death decisions based solely on the SNP data (or 23andme's attempt at helping us interpreting it). I suspect most here know about the multiple issues with the FDA as it exists today, and that it needs to be fixed for far more reasons than this one.

As for this issue there are two petitions that can be signed if interested (I'm not sure they will be much use but I signed them none-the-less):


https://petitions.wh...c-kits/96BRCYNB

https://www.change.o...e-genomics-kits





Edit:Typos

Edited by gwgaston, 27 November 2013 - 05:54 AM.

[Hebbeh]

Dear 23andMe Customers,

I'm writing to update you on our conversation with the U.S. Food and Drug Administration and how it impacts you.

If you are a customer whose kit was purchased before November 22, 2013, your 23andMe experience will not change. You will be able to access both ancestry and health-related information as you always have.

23andMe has complied with the FDA's directive and stopped offering new consumers access to health-related genetic results while the company moves forward with the agency's regulatory review processes. Be sure to refer to our 23andMe blog for updates.

We stand behind the data we have generated for customers. Our lab partner adheres to strict quality standards that are part of the Clinical Laboratory Improvement Amendments of 1988 - known as CLIA. These are the same standards used in the majority of other health and disease-related tests.

You are among the first people in the world to ever get access to their genomes. You are genetic pioneers. Thank you for your ongoing support and we look forward to continuing to serve you.

Anne Wojcicki
Co-founder and CEO, 23andMe

[olaf.larsson]

Will the testing be reassumed? Since 23andme:s buisness model is not bound to US in any way it shoud not be difficult for 23andme to move their buisness to another country, one that will be very happy to have them there and could not care less about what they are doing? What alternatives to 23andme do you know?

[niner]

As I understand it, you can still get testing done, but 23andMe will not analyze your data. However, you can browse your own data, download it and submit it to various low cost analysis sites. For all intents and purposes, 23andMe is still as useful to me as it ever was, since their analysis wasn't that interesting. Their ancestry analysis and relative finder is also still in place. I've played with it a little, and it's kind of cool.

For what it's worth, I learned a bit more about this particular FDA crackdown. The FDA was fine with 23andMe selling their services to interested people like us. However, not too long ago, 23andMe put together a glitzy advertising campaign that was reminiscent of the DTC ads out of Big Pharma. They were basically making a ton of unfounded health claims. Not only am I not the least bit surprised that FDA intervened, but I think it was the right call. The FDA is charged with protecting noobs from charlatans, which means that claims need to be validated. I know that some people think that's totally wrong, and that we'd be better off without the FDA. It's possible that I personally would be better off if there was no FDA, but I can't say the same thing about a lot of my friends, family, and neighbors.

[nowayout]

As I understand it, you can still get testing done, but 23andMe will not analyze your data. However, you can browse your own data, download it and submit it to various low cost analysis sites. For all intents and purposes, 23andMe is still as useful to me as it ever was, since their analysis wasn't that interesting. Their ancestry analysis and relative finder is also still in place. I've played with it a little, and it's kind of cool.

For what it's worth, I learned a bit more about this particular FDA crackdown. The FDA was fine with 23andMe selling their services to interested people like us. However, not too long ago, 23andMe put together a glitzy advertising campaign that was reminiscent of the DTC ads out of Big Pharma. They were basically making a ton of unfounded health claims. Not only am I not the least bit surprised that FDA intervened, but I think it was the right call. The FDA is charged with protecting noobs from charlatans, which means that claims need to be validated. I know that some people think that's totally wrong, and that we'd be better off without the FDA. It's possible that I personally would be better off if there was no FDA, but I can't say the same thing about a lot of my friends, family, and neighbors.

Even non-noobs. Much was made of how ridiculous it would be if someone actually did chop her breasts off based on a false positive BRCA test just on 23andme without confirming. But what they missed was the real medical consequences of other plausible behaviors following from inaccurate tests. What if, say, someone tests falsely negative for the BRCA breast cancer mutation on 23andme and took no further steps to prevent cancer? Or if someone tested falsely positive for being homozygous for the CCR5-Delta32 mutation and therefore believed himself to be HIV-immune and acted accordingly?

I am not a noob, I use 23andme, and I have to say even I have an interest in the accuracy of their testing being verified by a disinterested third party.

Edited by nowayout, 27 December 2013 - 06:08 AM.

[rwac]

Even non-noobs. Much was made of how ridiculous it would be if someone actually did chop her breasts off based on a false positive BRCA test just on 23andme without confirming. But what they missed was the real medical consequences of other plausible behaviors following from inaccurate tests. What if, say, someone tests falsely negative for the BRCA breast cancer mutation on 23andme and took no further steps to prevent cancer? Or if someone tested falsely positive for being homozygous for the CCR5-Delta32 mutation and therefore believed himself to be HIV-immune and acted accordingly?

I am not a noob, I use 23andme, and I have to say even I have an interest in the accuracy of their testing being verified by a disinterested third party.

I would imagine that that's your responsibility to check up on such consequential news with a third party. I mean, people should know enough to double check things like pregnancy and HIV tests.

[nowayout]

Even non-noobs. Much was made of how ridiculous it would be if someone actually did chop her breasts off based on a false positive BRCA test just on 23andme without confirming. But what they missed was the real medical consequences of other plausible behaviors following from inaccurate tests. What if, say, someone tests falsely negative for the BRCA breast cancer mutation on 23andme and took no further steps to prevent cancer? Or if someone tested falsely positive for being homozygous for the CCR5-Delta32 mutation and therefore believed himself to be HIV-immune and acted accordingly?

I am not a noob, I use 23andme, and I have to say even I have an interest in the accuracy of their testing being verified by a disinterested third party.

I would imagine that that's your responsibility to check up on such consequential news with a third party. I mean, people should know enough to double check things like pregnancy and HIV tests.

What you are proposing is a Darwinian survival of the educated elite conservative position.

But even for those of us who are of the educated elite, in the first place, we want to have assurances that these tests are reliable. Why should one have to spend more money rechecking everything a second time with a different lab?

Also, people seldom recheck negative tests, so false negatives (say a falsely negative BRCA breast cancer gene test), that can have consequences if you do nothing about them, are a concern.

Edited by nowayout, 27 December 2013 - 04:29 PM.

[rwac]

What you are proposing is a Darwinian survival of the educated elite conservative position.

But even for those of us who are of the educated elite, in the first place, we want to have assurances that these tests are reliable. Why should one have to spend more money rechecking everything a second time with a different lab?

Also, people seldom recheck negative tests, so false negatives (say a falsely negative BRCA breast cancer gene test), that can have consequences if you do nothing about them, are a concern.

All tests (including HIV I believe it's 0.2%(?) ) tests have a nontrivial rate of error. So anyone would be wise to double check before making life-altering decisions.

What do you think would be an acceptable error rate for 23andme, which is explicitly non-diagnostic and only deals with probabilities?

[olaf.larsson]

Does anyone of you know what 23andme does to the data and samples they obtain? Is it possible to test yourself anonymously? If the data and samples are stored indefinitly who knows what purposes someone could be using this information for in the future..

Edited by olaf.larsson, 27 December 2013 - 07:16 PM.

[BlueCloud]

Does anyone of you know what 23andme does to the data and samples they obtain? Is it possible to test yourself anonymously? If the data and samples are stored indefinitly who knows what purposes someone could be using this information for in the future..

Isn't 23andme owned by Google ? There's your answer......

[Hebbeh]

http://www.nytimes.c...gewanted=1&_r=0

[ymc]

As I understand it, you can still get testing done, but 23andMe will not analyze your data. However, you can browse your own data, download it and submit it to various low cost analysis sites. For all intents and purposes, 23andMe is still as useful to me as it ever was, since their analysis wasn't that interesting. Their ancestry analysis and relative finder is also still in place. I've played with it a little, and it's kind of cool.

For what it's worth, I learned a bit more about this particular FDA crackdown. The FDA was fine with 23andMe selling their services to interested people like us. However, not too long ago, 23andMe put together a glitzy advertising campaign that was reminiscent of the DTC ads out of Big Pharma. They were basically making a ton of unfounded health claims. Not only am I not the least bit surprised that FDA intervened, but I think it was the right call. The FDA is charged with protecting noobs from charlatans, which means that claims need to be validated. I know that some people think that's totally wrong, and that we'd be better off without the FDA. It's possible that I personally would be better off if there was no FDA, but I can't say the same thing about a lot of my friends, family, and neighbors.

Even non-noobs. Much was made of how ridiculous it would be if someone actually did chop her breasts off based on a false positive BRCA test just on 23andme without confirming. But what they missed was the real medical consequences of other plausible behaviors following from inaccurate tests. What if, say, someone tests falsely negative for the BRCA breast cancer mutation on 23andme and took no further steps to prevent cancer? Or if someone tested falsely positive for being homozygous for the CCR5-Delta32 mutation and therefore believed himself to be HIV-immune and acted accordingly?

I am not a noob, I use 23andme, and I have to say even I have an interest in the accuracy of their testing being verified by a disinterested third party.

Well, 23andme is not sequencing the whole BRCA gene. Therefore, given the autosomal dominant nature of BRCA, if you are positive in their test, then you are very likely to be positive. However, if you are negative in their test, you can't be truly sure about it because only a few points (aka SNPs) in the gene are genotyped. I think people who understand what 23andme is doing will get this. Unfortunately, this is a very minor set of their customers.

[david ellis]

I remember reading somewhere on the net that 30 copies of DNA were needed to have an accurate human DNA genome. I did a internet search, and found calculations of the DNA sample size could be 30.

I am wondering, obviously knowing very little about this stuff, if 23and me compares 30 copies of the DNA. I want to understand the quality of what 23and me is providing. Thanks for replies.

[ymc]

I remember reading somewhere on the net that 30 copies of DNA were needed to have an accurate human DNA genome. I did a internet search, and found calculations of the DNA sample size could be 30.

I am wondering, obviously knowing very little about this stuff, if 23and me compares 30 copies of the DNA. I want to understand the quality of what 23and me is providing. Thanks for replies.

30x genome is the minimum for research grade accuracy. For clinical level accuracy, you need 100x.

23andme is using microarray technology which is a much more mature technology. Its accuracy is closer to that 100x I mentioned than the 30x you read somewhere.

So the accuracy of microarray genotyping is good enough. The problem is we don't have a consensus on how to calculate risk yet. Even if we do, at the current level of genetic understanding, only a handful of the tests have utility, e.g. Alzheimer, Muscle Performance, Bitter Taste Perception, etc.

[olaf.larsson]

I remember reading somewhere on the net that 30 copies of DNA were needed to have an accurate human DNA genome. I did a internet search, and found calculations of the DNA sample size could be 30.

I am wondering, obviously knowing very little about this stuff, if 23and me compares 30 copies of the DNA. I want to understand the quality of what 23and me is providing. Thanks for replies.

The amount of DNA they get from the customer is more then enough. By "30 copies of DNA" it is ment that the DNA is copied 30 times so that if there will be x*2^30 copies of DNA where x is the number of copies from start.

There is no reason to believe their technology anything else than good and reliable, which of course is not 100% reliable but maybe 99%. The big problem is to interpret the results not doing the genotyping.

Edited by olaf.larsson, 19 January 2014 - 08:57 AM.

[david ellis]

There is no reason to believe their technology anything else than good and reliable, which of course is not 100% reliable but maybe 99%. The big problem is to interpret the results not doing the genotyping.

So the accuracy of microarray genotyping is good enough. The problem is we don't have a consensus on how to calculate risk yet. Even if we do, at the current level of genetic understanding, only a handful of the tests have utility, e.g. Alzheimer, Muscle Performance, Bitter Taste Perception, etc.

Thanks very much for your replies, ymc, and olaf. It is good to know that microarray genotyping is accurate.

[uralsky]

this publication explains what the issue is with genetic testing as a health diagnostic.
http://news.emory.ed...t_results_vary/
http://www.ncbi.nlm..../?term=23807614

They do not claim that the genetic data are not correct. Rather that the interpretation is not always accurate.
I think that FDA tolerated 23&me testing without health related claims. It is only when 23&me started active marketing campaign FDA objected.
So far I believe 23&me provide the most value of testing. Some important SNPs are not tested unfortunately. I personally ordered four tests for myself and my family. Found consistent results for all, matching by various ways.

On a side note I find it surprising that apparently intelligent people sometimes seemingly hold ill informed believes. like: "police state regime taking out our freedoms through FDA mingling with genetic testing".
FDA is a bureaucratic organization doing their job. If one believes that the balance between public safety and freedom needs correction feel free to work the fix through democratic process.