LONGECITY

The Food and Drug Administration is cracking down on 23andMe and other companies that sell genetic tests directly to consumers.

The F.D.A. sent letters this week to five companies involved in that business, saying their tests are medical devices that must receive regulatory approval before they can be marketed.

http://www.nytimes.c...ome.html?src=mv


Well, let me know if you need a lawyer.

Oh, Boy. I wish I'd taken advantage of the $99 test.

Now I wonder if this sort of genetic testing will be around much longer.

Glad I got mine done not too long ago. Plus I paid extra to get the raw data, which is a must IMO.

This is unfortunate. However I just visited the 23andme website and they are still offering the tests for sale, so maybe they are planning a legal challenge to the FDA's position.

This doesn't help

Concern about the tests was also raised this week when 23andMe said that because of a laboratory mix-up, up to 96 customers might have received information on someone else.

Hopefully they can track exactly who received the incorrect information and will notify them accordingly.

This doesn't help

Concern about the tests was also raised this week when 23andMe said that because of a laboratory mix-up, up to 96 customers might have received information on someone else.

Hopefully they can track exactly who received the incorrect information and will notify them accordingly.

Ah, one of the perks of coming from a small ethnicity: I know my results are correct, it's improbable that the results they sent me were from somebody else with an Ashkenazic Jewish mtDNA haplogroup.

As far as the FDA ruling, I'm kind of equivocal about it; if the tests are put under stricter regulation, it will drive prices up. Because the prices are trending downwards anyways, I imagine the market will correct this over time but it might be a bit of a setback to the ubiquity of testing. If any form of medical genetic testing requires a prescription, I have a serious problem with that. OTOH, a possible upswing is that GP's will start to order this sort of testing to establish baseline health risks and the insurance companies will be pressured into covering testing... of course that sort of wanders into a separate can of worms.

Glad I got mine done not too long ago. Plus I paid extra to get the raw data, which is a must IMO.

I got genetic testing via www.heartfixers.com (Dr. Roberts/Yasko). It costs $1100. but covered 30 genes connected with the methyl cycle, folate cycle, neurotransmitter metabolism, and high blood pressure genes. I am trying to digest it to get my money's worth, but I have 18 mutations out of 30. I am frustrated because it gives a name for the gene mutation, but that is not necessarily the name I'd find any studies regarding it under. For instance, I get AHCY-01, and I may find a study regarding AHCY but hrdly anything, and it turns out this gene may be references as At4g13940 (maybe). So I am preparing a list of questions, which I have to fax to the doctor, and for additional money he will answer my questions. Numero uno question has to be to list the names I might find these genes under in studies.

What sort of raw data did you get? I got just the names of the mutations and the doctor's advice about nutritional supplements to get around the genetic bottlenecks. (However I already have my own protocol, which I believe is superior).

I got genetic testing via www.heartfixers.com (Dr. Roberts/Yasko). It costs $1100. but covered 30 genes (...) What sort of raw data did you get?

when you take 23andme's full dna test it is much cheaper, tests many more genes, is nicely explained, and if you want to go study deeper, your row data looks like this http://www.snpedia.c...F1_example.html and you there is an easy and free supersmart program called PROMETHEASE that analyzes tons of papers for you and give you this type of digest: http://www.snpedia.c...F1_example.html Are you aware of something heartfixers does that 23andme or competitors do not do?

I wouldn't feel like I were exceptionally abnormal or in bad shape compared to others concerning your gene mutations, madanthony. In Ray Kurzweil and Terry Grossman's book, "Fantastic Voyage", it states that the average person has over a million Single Nucleotide Polymorphisms (SNPs, pronounced "snips") in their body. It is due to improper methylation. SNPs are not too adverse. When there is a double nucleotide polymorphism, however, then you have big trouble.

The current administration continues its war against citizen access to their personal genetic information. Message: You're too stupid to handle it. Why not allow people to get their genetic tests, and just prosecute bad/fraudulent companies when they are discovered?

I wouldn't feel like I were exceptionally abnormal or in bad shape compared to others concerning your gene mutations, madanthony. In Ray Kurzweil and Terry Grossman's book, "Fantastic Voyage", it states that the average person has over a million Single Nucleotide Polymorphisms (SNPs, pronounced "snips") in their body. It is due to improper methylation. SNPs are not too adverse. When there is a double nucleotide polymorphism, however, then you have big trouble.

Not exactly. SNPs are the points in the genome that typically vary from one person to the next. Everyone will have some base in that position. In some cases, one base is particularly hazardous, but usually there isn't much difference between the possibilities. SNPs have nothing to do with methylation; SNPs are at the fundamental nucleotide level of the genome, while methylation, which could occur at any position, affects the degree to which a gene is ultimately expressed. The goodness or badness of a SNP varies from instance to instance. A double polymorphism is not necessarily a problem. It depends on the situation.

The current administration continues its war against citizen access to their personal genetic information. Message: You're too stupid to handle it. Why not allow people to get their genetic tests, and just prosecute bad/fraudulent companies when they are discovered?

This is pretty disgusting and misguided. Some of the sordid details are in a blog posting by Daniel MacArthur. He relays some comments by Dan Vorhaus, and his take on it is that things are maybe not so bad: (bolds are mine)

…we should be careful not to inflate the importance of the MCAP’s recommendations. While they will be the most recent, and certainly the most public (by statute, MCAP meetings are open to the public absent a specific reason for closure) DTC recommendations, they will remain one set of non-binding recommendations among many sets of recommendations, solicited and unsolicited, received by the FDA.

[...]

Ultimately, while it’s hard to find fault with the FDA for holding a public meeting on a topic of such public interest, it has been even harder to locate any indication that this meeting, or the MCAP’s recommendations, will significantly alter the agency’s thinking on the topic of clinical DTC genetic testing. Barring something completely unexpected tomorrow, I’m standing by my prediction (most recently here and here) that industry-wide DTC regulation by the FDA in 2011 is unlikely. Whether or not that’s a good thing, however, remains to be seen.

This suggests that the FDA might benefit from unsolicited comments from the likes of us.

Wonder if this is one of the reasons why even Terry Grossman is, to a certain extent, reconsidering the real benefits of testing. See his article on H+ magazine (http://hplusmagazine...omise-genomics/):

"...Whole genome sequencing is still a case of "too much information" and will require a large database and sophisticated numbers crunching to provide clinically relevant, actionable suggestions. Above all, we need to realize that no matter whatever genes we hold — good and bad — the environment in which we live, largely determined by the lifestyle choices that we make, minute by minute, day by day, year by year, is far more powerful in determining the weave and weft of the tapestry that is our life...."

Any update on FDA's action that you know of?

I haven't heard yet. But in reference to Grossman's comment, he is alluding to the usefulness of the test results, not to what should be the fundamental right to know what your genes are. There cannot be a more fundamental right than to know information about yourself/health/body. That any government would assert that you cannot "read" your own genes and make decisions about your health is pure unadulterated arrogance and tyranny.

The single easiest way to improve American and world health is to abolish the F.D.A. And make the drug companies criminally responsible for their actions

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.

have your adult stem cells cultured (hmmm, what about at home?)

Anyone a protocol on how to do that?
If the forbid continues, that's a very promising DIY@home thing, for LongeCity members to contribute to life extension!

Anyone knows how to culture adult stem cells at home?

I suggest this issue be taken to Avaaz:

http://www.avaaz.org/en/highlights.php

http://en.wikipedia.org/wiki/Avaaz

I suggest this issue be taken to Avaaz:

? Very interesting association but I don't see the point. Btw, while their courage is great, imo increasing healthy lifespan is much better than the (very nice) causes they defend.

Anyone knows how to culture adult stem cells at home?

Well its easy to start a petition with them to perhaps stop the FDA from regulating DNA testing and perhaps all the other things, like P5P regulation.
As a member you can start campaigns and get millions of signitures on petitions easily.

http://www.avaaz.org...art_a_petition/


It'd be nice to know how to culture stem cells @ home tho!

http://www.bloomberg...st-service.html

I wonder if they will still honor existing purchases.
23andme page is still accepting orders right now.

Hopefully just a temporary hiccup..?
Edited by blood, 25 November 2013 - 06:53 PM.

I worry about the FDA getting into stuff like this... All I'm concerned with is, does it accurately read DNA? If it does that, it works. Maybe some things change here and there with new discoveries, but their plan is to continuously update their customers with new info.

How long will it take for them to get approval? Will the FDA be able to manipulate or withhold test results? That would suck.

I worry about the FDA getting into stuff like this... All I'm concerned with is, does it accurately read DNA? If it does that, it works.

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.

More police state crap, unfortunately.

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.

Well, there is a lot of misunderstanding of test results by clients of 23andme based on a number of posts I have read on these forums and elsewhere.

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