This may be old news, but I just read it tonight. 23andMe has conceded to the FDA's request for them to NOT offer genetic testing to new consumers. In 23andMe's eyes, this is just a temporary hold on offering the kits, and they plan to continue to negotiate with theFDA to get clearance.

Consumers who purchased kits prior to November 22; 2013, will continue to have access to all reports and results as before the FDA intervention. A full refund will be offered by email.

Just thought this was interesting.I wonder what set this change of FDA to occur - we probably don't want to know. Read full letter dated December 5, 2013
Peggy

http://blog.23andme.com/news/23andme...FUMV7AodWTwAAA

[QUOTE 23andMe has conceded to the FDA's request for them to NOT offer genetic testing to new consumers. In 23andMe's eyes, this is just a temporary hold on offering the kits, and they plan to continue to negotiate with theFDA to get clearance. ...."

“The 500,000+ customers we have today have given us more than 250 million survey data points.”

… with open access of Big Data to researchers; and personal access to your own personal DNA map… for $99

In a few short years, they have built up a specific, focused data base that puts most of BigPharma to shame. Without taxpayers money; without charity donations.

Google co-founder and neuro patient Sergey Brin, and his wife, Anne Wojcicki, have the Google Empire to back them up. They have taken bio-research online, and personalized it on one side and universalized it on the other side.

Parkinson organisations talk about getting a Parkinson patient “at the table”, so “our interests will be heard”.

In this case, it was a Parkinson patient who designed the table, created it, paid for it, launched it out to the world without getting on their knees … half a million patients signed up, taking charge of their own health care – a PD e-mailing list of half a million people who sent in $99 each and would be willing to send more if new breakthroughs look possible…

Well that’s the kind of thing you want the government to protect you from.

It might slow down research if DNA analysis is ordered up by any Tom, **** or Harry. Clinics charge $4,000 for that – what’s this thing about $99? And what pills are being sold with it?

Amgen GDNF; the deliberately induced world-wide sinemet shortage that went on for 3 years; with supplied of sinemet being shifted from one country to another in secrecy; 50% of clinical trial results kept hidden; American pharma selling Duodopa for 15 years in Europe but not in America; while getting injunctions in Europe to keep its files secret; while proclaiming itself “proud Parkinson partner”; Medtronic class 1 recall (“danger of death”) revealed three months later by the business press…

23 and me shut down after 500,000 individuals voluntarily signed up and paid for… a Parkinson creation – a revolution in medicine..

… and what will be the reaction?
Just another brick in the wall. That dog-whistle sound you don’t hear is the silence of the lambs.
Move along now. Nothing to see here.
Don’t frighten the horses.

http://www.xconomy.com/national/2013...usiness-model/

Debi

http://www.entrepreneur.com/article/230125

Hate to keep playing devil's advocate (that's usually ST's role), but I'll give it a shot once again. Keep in mind that I am all for genetic testing and have done so myself several times. It's the inconsistency in my results that has me keeping an open mind with regard to the ongoing battle between 23andMe and the FDA.

First, let's get things straight. 23andMe is NOT shut down. For the 500,000 people who were tested prior to November 22, nothing has changed at all. You will have complete access to all data and the 23andMe interpretations of that data.

Second, for their new customers, they will still have access to their raw data and the ability to see their genotype for any of the million or so SNPs that 23andMe reports on. What they will not get to see is 23andMe's disease risk analysis and interpretation of those results. My point is, things are not so dire and desperate as some are reporting. There are any number of ways for customers to get interpretations on those results. Unfortunately, many of those analyses will differ from each other, and from the way 23andMe may have reported. But of course, that's the whole issue in the first place. Lack of consistency across the industry.

Didn't anyone find it strange that in both the letter that 23andMe sent to its customers as well as the more detailed blog on their site, they never actually addressed this issue. What they said was:

"We also want to make clear that 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. We decided several years ago to comply with CLIA guidelines to be consistent with other types of laboratory testing and to assure customers about the quality of data"

However, these guidelines refer to their testing techniques and the genotype results which they report. No one is questioning the accuracy of these results. It's the risk analyses and interpretations that are of concern. How come 23andMe doesn't come out and state that their risk analyses and result interpretations are valid. That's all I'm asking for. Yet, they don't even comment on that important issue. As they, and others on this board have stated, they have 250 million bits of information from 500,000 people collected over many years. That would seem to be more than enough information to validate some results and report them to us. We all keep asking for more open information, why does 23andMe get to slide from this responsibility. Why can't a customer, like me, be given a reasonable answer as to why one genetic testing company tells me I have a high risk for a disease and a competitor, using the same raw data, informs me I have lower than average risk.

Just some questions I would like answered and why I think the issue is more gray rather than black or white.

Thanks,

Gary

are you ready to take on global warming?

gotta think lawyers are directing all their p.r.'s.

Tupelo3 asks:

"Why can't a customer, like me, be given a reasonable answer as to why one genetic testing company tells me I have a high risk for a disease and a competitor, using the same raw data, informs me I have lower than average risk. "

A possible answer can be found in the article pointed to by Debbi, to whom my thanks. It is by John Wilbanks. He writes [1]:

"[A] “traditional” submission to the FDA would be of a very specific kind of analysis based on randomized controlled trials. It is designed to keep bad things from happening to people, not to make sure good things happen to people... Modern tech culture doesn’t work that way. Bayes’ rule is about probability. It’s a different way of knowing that you know something, and it’s one in which there is far more tolerance for uncertainty than the FDA is accustomed to."

I suspect the differences stem from whether frequentist inference or Bayesian inference is used and, if the latter, what prior distribution is used.

As the sample size increases these measures converge, but for small samples the different methods can give very different results.

Normally in mathematics there is a clear consensus as to what is right and what is wrong, but this is an area where there is much disagreement.

To get a flavour of the problem, let's look at the calculation of the probability of getting a head in a coin toss, where the coin is possibly biased. To keep things simple, we will toss the coin just once (i.e. a sample size of 1). Note: I'm simplifying both approaches.

Suppose we get a tail.

The frequentist would tally the results: heads 0, tails 1 and conclude that the probability of heads = 0/1 = 0

The Bayesist says, we don't know specifically about this coin, but we know from past experience that coins are not usually biased, so we start with an estimate of 0.5 for the likelihood of a head. After the coin is tossed we adjust this value. We could do this in many ways. For instance, we could say that our past experience has the same value as one toss of the coin. This leads to an update of the likelihood to 0.5*0.5+0.5*0 = 0.25

Reference

[1] http://www.xconomy.com/national/2013...iness-model/2/

John

John, I agree with you that the use of Bayesian probability models is a very possible cause for this and other issues that have come up. I read John Wilbank's blog and thought it was well written and I agree with most everything he said. I studied the wonderful theories of Rev. Thomas Bayes in graduate school and subsequently lectured on them at the university.

It was actually because of the Bayesian models that I pointed out another major problem with the genetic company reports in a previous post. Most of the diseases predicted in the reports by these companies have extremely low population risk. One report I read was that 80% of the diseases 23andMe reported on had average population risk of about 1%. If your genotype put you at 2%, you would be considered high risk. So, since you used a Bayesian example to prove a point, so will I.

Consider this common Bayes example: .005% of people have a genotype, lets say, AA, that is practically guaranteed to cause a disease. 99,5% of the population do not have this genotype. Furthermore, our genetic test is 99% accurate, such that it will produce 99% true positives for AA and 99% true negative for AT,TA and TT.

You would think in the above example if a 1,000 people were tested and you received a report that your were AA, then you were basically guaranteed that you would get the disease. However, in actuality, the odds of someone with an AA genotype getting the disease would only be 33%. The fact of the matter is that in this example, there would be twice as many false positives as there are true positives.

Getting back to basic English, although I loved the reports provided by 23andMe, and the other companies, I'm just not convinced on the accuracy, or relevancy, of some of their disease risk assessments. I'm very comfortable as to the reliability of their tests. I just wish they can make me feel more comfortable as to both the validity of their assessments and, ultimately, their relevance.

Sorry to everyone if I'm going overboard on this issue and will be more than happy to drop it now......

Gary

This will be the first of a torrent of lawsuits.

23andMe Faces Class-Action Suit

The complaint was filed days after a scathing FDA letter to the Google-backed firm

http://business.time.com/2013/12/03/...s-action-suit/

Watch the process unfold over time. It's always the same.

FDA letters and statements have provided all the information needed for the plaintiff to easily, easily win this law-suit. The only potential way out is for 23 and me to argue that this is neither a Food nor a Drug; therefore the Food and Drug Administration has no jurisdiction.

But any lawsuit takes years; in the meantime, 23 and me has been forbidden to sell their only product, and the hit to their reputation will likely prove fatal. And who else would dare pick up the torch and run with it, if even mighty Google could not run the gantlet? Leave healthcare to Old Pharma.

Here is the plaintiff's complaint, miraculously produced a few days after the FDA called in the journalists to announce that, after 6 years, the spit-test is deemed to be illegal:

http://static.squarespace.com/static...0complaint.pdf

In the next round, plaintiff will demand punitive damages, for emotional and psychological suffering. The lawyers typically get 50% of any reward if they win; but they get nothing if they lose.
So everybody who used the product will be encouraged to sign up. It costs you nothing, not even legal fees, if you lose. If you win, you share the loot with your fellow victims, after the lawyers take their half.
It's a bidness, you unnerstand? Got nothin' to do with sick folks.