FDA bans preventative medicine to hide the cost of Obamacare?
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27-11-2013, 05:39 PM
FDA bans preventative medicine to hide the cost of Obamacare?
Last year I discovered a revolutionary new service, 23andme, founded by the wife of Sergei Brin (google's co-founder). For $99 they send you a DNA collection kit (swab the mouth), and they sequence your DNA and report what gene sequences you have that predispose you to certain diseases. I learned I have a sequence that makes me 3x more likely to develop diabetes, and they even gave me links to the research to prove the connection. So I took some tests which showed I was starting to develop insulin resistance, which, likely would have led to diabetes 20 years from now. Empowered with this knowledge, I cut out all refined sugars and now know what to look for, significantly improving my odds of living to a ripe old age, so that I'll be able to taunt @Chas and @Cjlr for many years to come.

But, what's REALLY significant about 23andme is that they collect a database of millions of people's DNA, and provide a health portal to report what medical conditions you suffer, so that over the coming decades, they'd be able to run the data through pattern recognition algorithms and discover links between certain diseases and genetic markers, which could lead to radically advanced medical care, and early diagnosis.

This month, however, the FDA has banned all such genome research and ordered 23andme and all other genetic testing outfits to shut down. Of course, if the FDA wasn't allowed to use guns and violence, then they'd only be able to publish a “recommendation”, letting informed consumers decide for themselves. Sadly stupid voters have empowered them to use violence, which means that no matter how much I want their product, and how much they want to offer it, they've got a gun to their heads.

What justification does the FDA give for “regulating” genetic testing, since their charter is for food & drugs only? None. They're out of control and just did a power-grab and took over, with no Congressional authorization, and thus no authorization from the people.

What excuse does the FDA give? They say the science of predicting diseases through DNA sequences is unproven. Well no shit, every new breakthrough is unproven at first. It would have taken decades to collect enough data to know how accurate the predictions are. Thankfully the FDA didn't exist in the 19th century or they similarly would have banned germ theory for the same reasons, under pressure from the 'blood-letting' industry, and today we'd still be dying at the age of 39 with drill holes bored into our skulls.

So let's look at the effects of these anti-science, anti-intellectual, club-wielding neanderthals:

1. Likely millions will die who otherwise would have taken the test and, like me, been able to take preventative measure. It will never go down in history like the tyrants who openly killed millions of people for their political ambitions. But just because you can't see or count the deaths doesn't mean they're not there.
2. Who knows what revolutionary medical advances would have come from having decades of medical history cross-referenced to DNA sequences. We'll never know now, and maybe millions, or even billions, will die as a result. Of course it's impossible to ever measure a negative; we'll never know what breakthroughs went undiscovered.
3. Imagine you're an investor or entrepreneur considering starting up a venture like this. Surely the fact that you can invest millions of dollars and years of your life developing a great product that people love, and the Feds can take it from you in an instant for political ambitions, puts a damper on this. Over the next 40 years, how many new high-tech, say, Chinese companies, would have been American companies if the Feds weren't so anti-progress?

The big question is why shut down something that poses zero health risks, harms nobody, and can only lead to new knowledge? While nobody knows for sure, there is a compelling theory. See, everybody knows Obamacare is going to drive health care costs through the roof, and this is already costing the Democrats dearly. Today's poll shows they're likely to lose seats in both the House and Senate because of the Obamacare backlash, and, next year, as Obamacare kicks in and drives costs through the roof, it's only going to get worse. Preventative medicine, like this genetic testing, of course saves both lives and dollars in the long run by helping people, like me, nip problems in the bud early. But, naturally, there is a modest cost NOW, both for the genetic testing, and also for the diagnostic tests (MRI's, etc.) it triggers. So, by banning preventative medicine today, it will likely reduce health care expenditures now, in 2014, and when the time comes to pay the price, it will be years in the future and people will have forgotten all about this mess and blame it on others. Typical.
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27-11-2013, 05:45 PM
RE: FDA bans preventative medicine to hide the cost of Obamacare?
There was an article about this in my local paper yesterday. According to that source, 23andme failed to provide necessary documents to the FDA and has only been ordered to temporarily cease sales she they comply with these regulations. I believe it had to do with providing the evidence of this product's accuracy. I don't know anything other than what was printed but I don't believe they have been shut down.

Believe nothing, no matter where you read it, or who has said it- not even if I have said it- unless it agrees with your own reason and your own common sense. - Buddha
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27-11-2013, 06:08 PM
RE: FDA bans preventative medicine to hide the cost of Obamacare?
The FDA regulates test kits such as pregnancy tests. How is this different?
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27-11-2013, 06:17 PM (This post was last modified: 27-11-2013 06:25 PM by frankksj.)
RE: FDA bans preventative medicine to hide the cost of Obamacare?
(27-11-2013 05:45 PM)Ohio Sky Wrote:  According to that source, 23andme failed to provide necessary documents to the FDA and has only been ordered to temporarily cease sales she they comply with these regulations. I believe it had to do with providing the evidence of this product's accuracy.

You're correct that the stated reason was the requirement for 23andme to prove the product's accuracy. However, that's impossible to do. It's a new technology, designed to build a genetic database, and over the course of 20 years or so, they'll be able to see how accurate it is. Plus, the FDA wrote: "[23andme must] immediately discontinue marketing the [Personal Genome Service] until such time as it receives FDA marketing authorization for the device." Of course it can take many years to get FDA approval. And the FDA has been going on the warpath against everyone in this space, like Pathway Genomics, whose DNA tests they recently got pulled from Walgreens.
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27-11-2013, 06:25 PM
RE: FDA bans preventative medicine to hide the cost of Obamacare?
(27-11-2013 06:08 PM)black_squirrel Wrote:  The FDA regulates test kits such as pregnancy tests. How is this different?

I'm not saying it's any different. The FDA wants to have control over every aspect of your body. For example, they also recently banned the Regenexx-C procedure which harvests stem cells from your body and injects them in damaged joints to repair the cartilage. Obviously this is totally outside the FDA's jurisdiction, since no drugs are involved--just your own cells. But the FDA's argument was that OUR OWN CELLS are drugs, and thus they have total control over our whole body.

The only thing that makes me so irate about their ban on genetic testing is that, unlike a pregnancy test, this time the scientific research that the FDA banned could have led to cures to diseases like cancer and increased the quality and duration of our lives. Without a crystal ball we'll never know what medical breakthroughs would have been made were it not for the FDA. But I imagine it's a lot.
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27-11-2013, 07:07 PM
RE: FDA bans preventative medicine to hide the cost of Obamacare?
While I may share your outrage on this, your thread title is really fucking stupid.

Skepticism is not a position; it is an approach to claims.
Science is not a subject, but a method.
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27-11-2013, 07:18 PM (This post was last modified: 27-11-2013 07:22 PM by sporehux.)
RE: FDA bans preventative medicine to hide the cost of Obamacare?
I'm pro 23andme . But Anti conspiracy theory.
The thread tiltle may as well say "tides come in, tides go out"

I just ordered a kit for my mum, I hope this ban only relates to Mericans.

The privacy aspect is a concern, I could see why it could be temp/banned if they are not taking reasonable steps to protect the data.

Theism is to believe what other people claim, Atheism is to ask "why should I".
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27-11-2013, 07:28 PM
RE: FDA bans preventative medicine to hide the cost of Obamacare?
(27-11-2013 07:07 PM)Chas Wrote:  While I may share your outrage on this, your thread title is really fucking stupid.

I think he has an agenda. It's subtle....but he may be a republicunt.

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27-11-2013, 07:46 PM
RE: FDA bans preventative medicine to hide the cost of Obamacare?
(27-11-2013 06:17 PM)frankksj Wrote:  
(27-11-2013 05:45 PM)Ohio Sky Wrote:  According to that source, 23andme failed to provide necessary documents to the FDA and has only been ordered to temporarily cease sales she they comply with these regulations. I believe it had to do with providing the evidence of this product's accuracy.

You're correct that the stated reason was the requirement for 23andme to prove the product's accuracy. However, that's impossible to do. It's a new technology, designed to build a genetic database, and over the course of 20 years or so, they'll be able to see how accurate it is. Plus, the FDA wrote: "[23andme must] immediately discontinue marketing the [Personal Genome Service] until such time as it receives FDA marketing authorization for the device." Of course it can take many years to get FDA approval. And the FDA has been going on the warpath against everyone in this space, like Pathway Genomics, whose DNA tests they recently got pulled from Walgreens.

Hmmm... no. If there was no evidence for the products efficacy, it would be nothing but a waste of money to purchase it. The FDA isn't demanding that they prove that individuals who have used this product in specific have been found to have the exact circumstances predicted for each individual. They want some evidence of the link between the known genetic markers for certain conditions, and the results given by the test. 23andme hasn't shown that they even know jack about these genetic markers, let alone that they have the knowledge to develop a test for said markers. If anyone could run out and develop these tests, which could have serious consequences for consumers, without any sort of background or education in genetic or disease research, there would be no standard or reliability for these products. That's why the FDA exists. This company has failed to live up to its responsibilities as a dispenser of medical information, plain and simple.

Believe nothing, no matter where you read it, or who has said it- not even if I have said it- unless it agrees with your own reason and your own common sense. - Buddha
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27-11-2013, 08:23 PM
RE: FDA bans preventative medicine to hide the cost of Obamacare?
(27-11-2013 07:07 PM)Chas Wrote:  While I may share your outrage on this, your thread title is really fucking stupid.

Of course I use inflammatory language so people actually read it. Smile

However, it's not inaccurate. It's true that DNA testing is preventative medicine, and the FDA has banned it. What political agenda drove that ban is anybody's guess. That's why I put a ? at the end of the title, and disclosed that the connection with Obamacare was just a theory with no substantiation.
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