FDA halts sales of 23andMe DNA test kits
 

http://www.usatoday.com/story/news/n...andme/3699329/

Big brother intervenes.

Why don't I feel safer?
 

The FDA is a malignant bureaucracy which serves as an entry portal into a land of wealth for those who write the rules in a way that pleases their Masters.

While shutting down an entity that assists individuals in assessing, predicting and remedying health issues, the wonderfully protective agency has rescinded restrictions on an anti diabetic drug fraught with cardiovascular adverse effects. My first thought was what committee member just received a speaking gig for the pharmaceutical industry, or has received new grant money?

http://www.medpagetoday.com/Endocrin...&mu_id=5531052

The FDA has loosened restrictions on the diabetes drug rosiglitazone (Avandia) -- under fire since 2007 because of potential cardiovascular risks -- and will allow drugmaker GlaxoSmithKline to drop the TIDE trial comparing rosiglitazone to pioglitazone (Actos), the only other thiazolidinedione available.

Just received my kit...does that mean I can't proceed with the test???

there"s nothing keeping you from sending it in.
23ANDME will work this out with the FDA. They can store your sample if they think they can't analyze it right now. The FDA has no problem with analyzing your DNA, the problem is how far 23ANDME is going in claiming they can predict the chances of you developing a certain disease. They analyze for much more than PD, breast cancer for example. You can't do much to change your chances of getting PD but for breast cancer you can have your uterus and/or breasts removed, take tamoxin(?), so the way they present their data to customers now has major consequences. Noone cared when they just told you where they think you were born, etc.

Welcome to the biggest issue in healthcare next to OBAMACARE imho.

Another point of view
 

As anyone who knows me is aware, I am not a big fan of the FDA or Big Pharma. However, there are times that one must look closely at an issue before just rapidly rushing to opinions and I think this is one of them. I have been tested by several of the Direct-to-Consumer (DTCs) genetic companies like 23, and have analyzed the results with multiple genetic software programs. It was only when I saw discrepancies that I really started to investigate. Basically, there are two issues involved here:
1. The first is how accurate are the raw data results of the DTCs. From what I was able to find, this is not an issue at all. Correlations of results on individual markers tend to range between 99 - 99.7%, or nearly perfect, among the DTCs and private entities. Therefore, you can be fairly confident that your raw data results from 23andMe, or other DTCs, are accurate.
2. The second issue is how accurate are the reports these companies provide regarding disease "relative risk". This is where the problem lies, and it’s a big one. I became aware of this when I had the exact opposite disease risk assessments using the same raw data set. If you have seen these reports, these assessments will categorize you for diseases as high, normal or low risk. Then, they will assign risk ratios. There are very complicated formulas used by these companies for determining the risk ratios, and clearly, they don’t agree. Unfortunately, I have to apologize that I don’t have research links to provide at this time, but I will be happy to get them. Suffice is to say, that the research I have read showed that for many diseases, there was little correlation among the DTCs in there disease assessment of "relative risk". This means, for example, that one DTC can report to you that you have an above average risk for Crohn's disease with an odds ratio of 3.7, while another DTC, using the same actual genetic data, can report that you have normal risk with a 1.1 odds ratio.

I have clearly simplified the issue above as the algorithms used to get odds ratios for genetic markers and associated alleles are quite complicated. However, in the end, if you get a report from one of these companies, wouldn't you like to know that there is some degree of accuracy and validity to their assessments? That is the issue right now between the FDA and 23andMe, and ultimately all of the DTCs. They are sending people reports that describe in detail their risks, or lack of, for many diseases and illnesses, for which they have NEVER validated their results. We, the public, the patients, our families, may act on these results which may be clearly invalid. For example, I had one report tell me I was at an above average risk for Type 2 Diabetes. Using the exact same markers and alleles, another company reported to me that I had a below average risk for Type 2. My suggestions to anyone who has used the DTCs is to download the raw data set, which will be accurate, and run it through multiple genetic analysis software programs.

The FDA has been trying to get 23andMe, and the others, to validate their reports for five years to no avail. Maybe their move yesterday will put some more pressure on these companies to do the right thing. If not, we will lose an important vehicle made available to us at a low cost. Then, we will really be stuck in the hands of Big Pharma, where women have to pay upwards of $1,000 to a company like Myriad Genetics just to find out their results on one gene: BRCA.

Thanks and Happy Thanksgiving to everyone,

Gary

there have been deaths due to breast cancer in my family so i was interested in seeing what BRKA alleles i have. 23ANDME i believe does say you should speak to a genetic counselor before making any decisions based on their data.

my sister was charged i believe $4300 for her BRKA testing/counseling because one company had the patent, i think the courts have ruled you can't patent a gene test anymore?

my brother died of lung cancer, the doctors weren't even sure if he had small cell/large cell cancer and gave him an experimental treatment costing over $100,000/year, DNA analysis will save $billions hopefully as more and more expensive treatments get approved for specific genotypes.

DNA analysis/analyzer sales is already a huge business, sounds like FDA finally getting pressure to regulate it.

as an aside, there is a huge scandal about a cime lab tech who falsified results
 

http://www.csmonitor.com/USA/USA-Upd...-herself-video

every medical lab test has to be done accurately, the data kept private and the lab has to have quality control.

law and order
 

soccertese, I recall an episode of law and order in which the pathologist is sentenced to a jail term for the same misdeeds. Life imitating TV. The chemist in the article you cited should have watched more law and order. madelyn

My 2 cents worth
 

Add the scientific evidence that for many illnesses (like PD) that genetics only "load the gun" but environmental factors "pull the trigger" and all the mathematical models go (farther) out the window.

For me the real question is:

Do you take DTC genetic testing off the market to protect the small percentage of uninformed people that might act irrationally and thereby penalize the overwhelming majority who might benefit from it ?