[mrsD]

Another blow to consumers who want to be proactive in their
own care and life:

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

[Kitt]

An interesting article if you read the whole thing.

[doubleagle15]

Again our government who loves and protects us strikes again.
Remember what President Reagan said the scariest words you can hear are
"We're from the government and we're here to help"

[JoanB]

I think that the government regulating things like this is a good thing. I've been employed in the medical device industry for companies that work very hard to get FDA approval. Why should this company get a pass?

[pabb]

Originally Posted by JoanB

I think that the government regulating things like this is a good thing. I've been employed in the medical device industry for companies that work very hard to get FDA approval. Why should this company get a pass?

I would think all the tests that they run/ran are already proven, they didn't invent anything. I saw on another site, 4000$ quoted as the price for checking for the gene for breast cancer, how many of us can afford that?
frankly, I think it is "nanny state" strikes again! also, all those companies charging 4000 dollars, probably weren't too happy either, and had an in with the FDA.

[Dr. Smith]

The [FDA] did not take an interest in the technology until 2010, when it issued letters to several testing companies, warning that their products must be approved as safe and effective.
....
Once the kit arrives by mail [consumers] are instructed to spit into a small tube, providing a saliva sample which is sent back to the company for analysis.

Spitting into a small tube could be very unsafe. Yegads, what if someone missed the tube‽ They—or someone else—might slip on the spittle and get injured!

Regulators worry that false results from the test could cause patients to receive inadequate or inappropriate medical care. For instance, 23andMe says its test can identify women who carry the BRCA gene mutation that significantly increases the risk of breast and ovarian cancer. But a false result could lead women to undergo unnecessary screening, chemotherapy and surgery.

...And monkeys could fly out my butt. Is the FDA acknowledging here that doctors/hospitals would perform chemo and/or surgery based on a mail-order test without due diligence?

due dil·i·gence (dū dil'i-jĕns)
In health care, making certain that rules and procedures are followed to avoid harming patients and staff.

Medical Dictionary for the Health Professions and Nursing © Farlex 2012

I thought (but I could be mistaken) that cancer screening (e.g. Pap smears, mamograms) is pretty standard these days(?)

The FDA's concern with 23andMe appears to center on its marketing approach, which sidesteps doctors and health professionals.

BINGO. There it is.

The AMA has one of the largest political lobbying budgets of any organization in the United States.
http://en.wikipedia.org/wiki/America...and_operations

Doc

[mrsD]

That is why the FDA reasons sound just like propaganda.

It seems to me that learning about MTHFR and then seeing your doctor would be a good idea. Have the test redone then, (the doctor would balk less than if you asked out of the blue), and then it would be in your record. I do think the MTHFR genetic issue will someday be linked to cancer etc. Better to know your status now and use methylfolate and methylB12 to become healthier and less at risk. (methylation is involved in cancer protection too but less is known at this time clinically about it).

Best to learn you have hemochromatosis so you can GO TO YOUR
DOCTOR for treatment and evaluation for organ damage etc. (BEFORE YOU DIE or end up on dialysis.)

As far as accuracy? Well Quest has TWICE sent out inaccurate Vit D test results over 1yr in the first case and MONTHS in the second case. Labs that do tests for medical places are known for errors etc. That is why doctors RETEST often!

The FDA is being pressured by some entity to stop these tests IMO.

[zygopetalum]

My sister did that and it was fun but I couldn't see anything on the results that we didn't know from family history.

judi

[JoanB]

OK, I guess what I'm really reacting to is the sentiment that the government can't or shouldn't do anything with regard to regulations. Are they perfect? No. Are there sometimes politics involved? Yes. My personal pet peeve is the goverment's crazy, obsessive war on marijuna use when there's little or no evidence that it's even a problem. And you want to talk about Quest and similar labs? It's nuts the amount of money they make from unnecessary drug testing that often yields faulty results and negatively affects real people's lives.

But even for all of that, I'd still rather live in a country where there are at least some (admittedly imperfect) rules that protect people. If the system isn't good enough, then I think the answer is to hold their feet to the fire to make it better, not absolve them of responsibility. </soapbox>

[Chemar]

Interesting reading the actual letter the FDA sent 23&me

http://www.fda.gov/ICECI/Enforcement.../ucm376296.htm

I do wonder if we will ever know the real story behind this sudden "regulatory" move to stop a service that was doing no harm, and providing something beneficial at an affordable rate to many