The FDA Is Afraid Of Home DNA Tests

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pregnancy test

One of the largest selling over the counter items to come along in the past ten years is the home pregnancy test. It's simple, safe and for the most part, accurate. Without doubt, there are false negatives and certainly false positives. Regardless of that fact, women who want the test can drop on down to the drug store and pick up a kit. And for many, when they discover that they are with child, they seek immediate medical attention. They leap right into healthy pre-natal care or address the pregnancy in other ways. But the simple point is that the home test started them on a path toward better care and attention.

USA today reports a startling story about another kind of home testing -- done with a simple swab. It's the home DNA test.

WASHINGTON (AP) — The Food and Drug Administration is ordering genetic test maker 23andMe to halt sales of its personalized DNA test kits, saying the company has failed to show that the technology is backed by science.

In a warning letter posted online, FDA regulators say the Silicon Valley company is violating federal law because its products claim to identify health risks for more than 250 diseases and health conditions.

23andme test kit

I can't say that I have ever found need for a DNA test. But I'm sure there are many who do -- it's almost a staple test on Jerry Springer, Dr. Drew, Dr. Phil, and Maury Povich. Yet seemingly there's a large number of people who are using these home tests.

 The proliferation of consumer-marketed genetic tests has troubled many public health officials and doctors who worry that the products are built on flimsy science.

So the FDA is claiming that DNA is flimsy science. Tell that to the people in jail or freed from it because of that flimsy science.

Here's where the wheels of doubt and suspicion start working like the cogs at an old steampunk factory. Who's really against this and why?

The FDA warning takes issue with a number of claims the company makes for its saliva-based test kit, particularly calling it a "first step in prevention" against diseases like diabetes, heart disease and breast cancer. Regulators worry that false results from the test could cause patients to receive inadequate or inappropriate medical care.

Let's look at that for a second. You test positive for a possible disease and you're not going to follow up on it? I would think not knowing you had an illness would contribute more to complications and lack of care than knowing. And now with Obamacare and more  people having health coverage, it's as important as ever to have an idea you may be carrying something that can be cured so you'll seek out medical attention.

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.

Isn't no result (not being tested) worse than a false result? Early detection is key in curing. This FDA argument is a bogus one at best. What doctor is going to accept a home test result and operate on someone or give them radiation treatments without doing their own followups? If they do, they don't deserve to have a license.

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

The test also claims to predict how patients will respond to popular drugs, including the ubiquitous blood thinner warfarin, which is used to prevent blood clots. The FDA warns that an inaccurate reading there could "have significant unreasonable risk of illness, injury, or death to the patient," if they don't receive the appropriate drug dose.

Once again, it's time to apply some common sense here. Sometimes one doctor prescribes something and another doctor prescribes something else which in combination could cause a conflict. Don't we as patients want to know that so we can contact our physicians and ask.

Center For Disease Control:

In 2011, drug misuse and abuse caused about 2.5 million emergency department (ED) visits. Of these, more than 1.4 million ED visits were related to pharmaceuticals.

An educated and cautious patient is a good thing. Just accepting meds on face value is the real danger. Doctors should welcome this potential heads up. At the very worst, the patient can call the doctor and tell him/her what their home test revealed. Lives could be saved, not lost.

Why doesn't the FDG have the same problem with home pregnancy tests? It seems perhaps the FDA is showing signs of corruption. If they don't get their bribe, their payoff, they don't give their approval. It might be time for an investigation, a home test, on the FDA and see what kind of maladies they're suffering from.

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