Government & Technology Medical Technology

FREE THE 23! FDA Halts 23andme Genetic Tests logo

People have a right to all information about their bodies and health.  Real stats, genetics, risks, things that can be done that don’t require paying someone in a white coat to do.  It belongs to us.  “They” can medicalize and monetize it and they have and will, but it is always ours.

The FDA  had to be sued before they would inform the public that trans fats are bad. Yes, that’s how that came to be. They were sued so they (legally) had to respond with the facts (evidence) that they are indeed a toxin to the body.

Now, this icon of quackery, fraud, greed, and well, you get the picture…has told Anne Wojcicki’s that it has to stop marketing the genetic test they sell for $99.00 You don’t need an Rx to take your temperature (yet) but we need permission to find out if we are high or low risk for heart disease? Cancers? If warfarin dose should be reduced in certain populations? Oh spare me the paternalization of the already deathly medicalization of the body.

The FDA might have some value but when their own researchers out the place for systemic fraud, it’s time to step back, stop bowing, and ask some hard questions.   Too many people think a double blind, peer reviewed study given a blessing by the FDA means “all is well”.  These are just the asleep at the wheel consumers the drug companies like to have.

The FDA isolated 23andme and the drug warfarin (rat poison) as problematic saying only an FDA approved test can let people know if they are unduly sensitive to this drug. I happen to be one of the sensitive ones – meaning if you give me warfarin, I need less than most because of my genetic makeup. This isn’t a maybe. This are my genes, IRL, and would be the same no matter where I get the test.

Speaking of warfarin, here is what 23andme says about it in their blog and you may find a hint of why the FDA targeted this result:

The mostly commonly used blood thinner, warfarin (Coumadin®) has proven to be a godsend for millions of people at risk, but this study suggests that as many as half of those who use the drug do not benefit from it because of challenges related to finding the proper dose.

Calibrating the right prescription of warfarin is notoriously difficult because the right amount depends not just on such things as a person’s size, their diet and age, but also, importantly, their genes.

The new study isn’t about genetics. It’s by researchers at Duke Medical Center, who suggest that the new blood thinner apixaban is safer than warfarin and more effective at preventing strokes in people who have atrial fibrillation, a common heart rhythm disorder.

Apixaban hasn’t yet received FDA approval. That may soon change, but the study reminds us of all the challenges with current drugs and the tremendous amount of resources invested into finding drugs that are safe and effective for more people. Another complementary way to achieve that goal is by learning more about how individual patients may respond to specific drugs. Your genetics are a big part of that equation.

In the case of warfarin, a person’s genetics directly impacts how sensitive they are to the drug. Although there are a number of factors that influence a person’s optimal dose of warfarin, genetic variations in the CYP2C9 and the VKORC1 genes play an important role in how the body responds to the drug. More than two years ago the FDA updated the labeling on warfarin to make note of this genetic influence but genetic testing is not req

Some think the insurance companies are behind this step. Maybe. If it benefits them, sure. One might think (hope) that the insurance companies should be delighted with genetic testing. Your genes say you don’t respond well to a drug such as a certain SSRI? – then your insurance company will not be paying for drugs that don’t work.

And if we got the important information out such as – if you do have Jolie’s genes, the last thing you want to start doing is radiating those breasts. Radiation is carcinogenic. Every exposure damages DNA. When the DNA repairs, there is the possibility it repairs incorrectly with mutations. Radiate those possibly cancerous breasts and you turn on the gene and make the possibility a probability. See what Lawrence Berkeley Lab scientists have to say about radiation and cancer .

High risk for colorectal cancer? Start with what you can control epigenetically – stop eating red meat. That alone saves lives. If I were insurance companies I’d get the word out on the number of deaths each year from colonoscopy and tell people to make an INFORMED decision before rushing to get scoped. I’d also show the evidence that polyps can go away and how slow growing they are. It is important that every data point gets out as well as those from people saying, “Colonoscopy saved me!!!!!”

Don’t forget DNA is ME (get your flipboard app to appreciate this. It is ‘s magazine on genetics.

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    Disruptive Tech Creates Backlash | The Silicon Valley Story
    January 14, 2014 at 4:52 pm

    […] FDA – R U LISTENING?  You may be King of the Infrastructure now and make the rules and stop the flow of info and you certainly have your apologists that want you to control, oversee, manage and otherwise look out for your children but health care was one of the examples used by Matt to say, “This is not always easy.” Stifling innovation through complex infrastructure and rules as you do now with 23andme is paternalistic and dangerous. […]

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