Posted: Tue, November 26, 2013 | By: Genetics
The FDA is cracking down on personal genomics testing company 23 and Me. 23 and Me sells affordable testing kits that allow people to examine their own genomes. The FDA is telling them that they aren’t cleared to allow people to receive and interpret their own genetics results, but they say differently. Is this an instance of Google and 23 and Me taking a libertarian-like stance, or are they just a little late with some of their paperwork with the FDA?
If we lose too many big personal freedoms with incoming advances in science and technology like this, then strides they could take with a more open world could be slowed and hold humanity back for years. It could cost untold numbers of people a chance to make it to a time when there are potentially ways to live indefinitely. It would cause countless people to miss their chance to experience this glorious universe and the future of it all. Why does everybody need a nanny telling them what to do with their tools, resources and potentials? Aren’t these open labs of innovation by trial and error what drives progress in various areas? What could be more dangerous than discouraging of experimenting with progress and frontier pushes? If you think this is important then you can sign the petition linked below. If you think this is really important then sign and spread it with as much time and effort as you can muster for the issue.
How important do you think it is that the barbarians don’t pull Rome down piece by piece again? Bans in the US on many kinds of stem cell research in the 2000’s created stagnancy in the field. The lifts that have occurred since have created an atmosphere of praise from many Nobel laureates. The US stem cell banking industry is booming. Stem cell research at universities and start ups is on the rise. Stem cell breakthroughs seem to be hitting the news like never before.
The future us sucking us in and we have to keep up if we are to harness this power for what it’s worth. Places like 23 and Me are a big part of that, and all the groundbreaking and pioneering that goes into it.
The following is from a petition page where you can sign and get the link to spread.
23andMe has brought the genomics revolution to countless Americans at prices that would have been unimaginable just a few years ago. Already, over 500,000 people have used its innovative products to learn more about their ancestry, health risks, and genetic predisposition to a wide variety of factors.
But the Food and Drug Administration has just shut down further sales of 23andMe’s $99 saliva home-test kit. The FDA seems to think that Americans can’t be trusted with more information about their potential health risks because some people might make rash decisions with it. But banning personal genomics isn’t the answer.
We haven’t all used 23andMe yet, but those of us who have know the real problem is that doctors themselves are behind the curve. When 23andMe sent us our results, we followed their advice: we asked our doctor to talk about them. Most doctors didn’t know where to begin. But the more of us ask, the more the medical profession is catching up: brushing up on genomics, taking the time to understand the site, and talking to us about our results and what, if anything, to do about them. By prompting such dialogue, 23andMe has sparked a revolution in how the medical profession uses genetic information.
We urge you not to short-circuit this revolution. Please trust us — and our doctors — to make responsible use of our own genetic information. Instead of banning new technologies, the FDA should focus on educating doctors and patients about the benefits, and limitations, of genetic testing.
On the other hand, if we can’t have some basic regulations to prevent snake oils from being labeled to fool consumers, then where does it stop? If we give exception to some, then what money hungry person won’t exploit that in demanding lax rules with them? Profiteers already abuse the system by rudely forcing endless ads upon everybody at every turn. Everybody thinks they can fool an audience with mimicry of an ad lib day time show interview in order to sell people false promise beads in placebo capsules. These kinds of people often damage peoples lives with monetary things like fees and recurring charges, and physical things like false positive diagnosis leading to unnecessary surgerys and treatments.
The [23andme] website promises reports on 254 health conditions and traits as well as offering to help people trace their genealogy.
Under FDA rules, the company must provide proof about how accurate its detection methods are as well as supplying the error rates from its personal genome service (PGS).
In a public letter the FDA said that 23andme had not supplied this information, despite increasing its marketing campaign and the scope of its tests.
“FDA is concerned about the public health consequences of inaccurate results from the PGS device - the main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work,” said Alberto Gutierrez, director of the FDA’s centre for devices and radiological health, in a letter to the company.
“Patients relying on such tests may begin to self-manage their treatment through dose changes or even abandon certain therapies depending on the outcome of the assessment,” he added.
What do you think they should do?