Tag: Food and Drug Administration

Government Control of Our Precious Bodily Fluids

Remember as you read this folks: the Democrats are the party of science. We know this because they told us so. So there must be some sciencey reason for them to engage in two anti-technology policies designed to make people sicker, deader and more ignorant.

First, they are cracking down on 23andMe:

The Food and Drug Administration has ordered Google-backed genetic test maker 23andMe to halt sales of its personalized DNA test kits, saying the company has failed to show that the technology is supported by science.

In a warning letter posted online Monday, FDA regulators say that the Silicon Valley firm has not shown that its tests are safe or effective despite “more than 14 face-to-face and teleconference meetings” and “hundreds of e-mail exchanges.” The agency orders 23andMe to stop marketing its test immediately, warning that erroneous results could cause customers to seek unnecessary or ineffective medical care.

23andMe’s saliva-based test kit, launched more than 5 years ago, claims to tell customers if they are at risk for more than 250 diseases and health conditions. The FDA says only medical tests that have been cleared by the government are permitted to make such claims.

The government is claiming that a tube for saliva is a “medical device” that is is not necessarily safe. It’s impossible for a saliva tube to be “unsafe”. So that claim is rubbish.

Their second beef is that 23andMe can’t make claims about science unless the government has approved that statement. Now, the FDA may have a point here in that many experts think that 23andMe is reaching a bit with their analysis and bad results could make people panic or get unnecessary treatments. However, I suspect that is only part of it. Shaky tests with flimsy results are used all the time in medicine and no one objects to it because it funnels enormous amount of money into powerful healthcare interests. I suspect that if hospitals were doing this and charging $5000 for it, the FDA wouldn’t have a problem. I know this because we’ve done some genetic testing at hospitals at heavy cost.

If you want an illustration of why our healthcare costs are soaring, here you go. 23andMe is offering a genetic screen for $99. Maybe they promise too much but the FDA is insisting that only expensive tests should be allowed. Because we, the plebs, can not be trusted with our genetic information. (Read more from Tabarrok).

(The recent advances in genetic screening are nothing short of astounding, incidentally. When my wife and I found out that Hal 11000 Beta was under development, we were concerned about genetic issues because of our age. Thanks to Materni21, we were able to use a non-invasive technique to check Hal 11000 Beta’s programming at 10 weeks. We found out he was clear of trisomies and male within days at 99% confidence levels.)

Oh, but it gets better. One of the problems in modern medicine is a perpetual shortage of bone marrow donors. Five years ago, a new method of marrow donation was developed that is completely non-invasive. You get some drugs, you sit in a chair and marrow cells are harvested from your blood. But because it’s time consuming, there aren’t many donors. Marrow organizations wanted to offer money in exchange for marrow donation (much like money is paid for egg donation). Money for organs is strictly forbidden, lest it encourage a trade in trafficked organs. But this is clearly not organ donation, so the Ninth Circus ruled — unanimously — that it shouldn’t regulated like organ donation. Duh.

Enter … oh, fuck, you again? … Kathleen Sebelius’s beloved HHS:

But instead of respecting the court’s decision, HHS is trying to nullify Flynn v. Holder. HHS has proposed a new regulation that would redefine bone marrow as an “organ,” even if it’s gathered through regenerating blood stem cells. The proposed rule is currently facing an open comment period through December 2, 2013.

If enacted, this would re-impose the ban on compensation, turning some donors into felons. This regulation defies both the Constitution and common sense. As Doreen Flynn herself put it, “I don’t think that anybody should go to jail just for trying to save somebody’s life. If paying donors results in more marrow donations, we should pay them.”

Voluntarily agreeing to give someone bone marrow is worlds apart from having your organs violently harvested against your will. Medical compensation is hardly unusual. Blood, egg and sperm donors can earn cash. Doctors and surgeons are regularly rewarded for their efforts and are paid very well for saving lives. Why should bone marrow donors be any different?

Why? Because the HHS has to control all the things! Common sense, economics, ethics? Pshaw! There’s power to be had here! Why you should consider yourselves lucky that we don’t ban compensation for sperm, egg and blood donation too! (I wish I were joking about that last bit; some people in government want to regulate egg donation lest rich people exploit poor people for … their genes?)

This is a pattern. This is the course the Obama Administration has chosen over and over again. Whatever is not mandatory must be forbidden. If anything happens outside of the control of government (and its various regulatory captors), it must be stopped! Now! And yes, that includes your DNA, your spit and your blood.

What? You thought your body was your own? Unless you’re having an abortion or something, your body belongs to government.