Comment · Fri, December 6, 2013 · Ceretropic
The Methylation cycle, Methylation analysis, and the 7 days you have left to get tested (cheaply) thru 23andme.
Original post in this thread
Rage_Boner · 82 points
It’s estimated that 45% of the population have a methylation cycle dysfunction. The [methylation cycle]( http://i.imgur.com/kRb0G3R.jpg) is one of the most important biochemical pathways in the body. It’s a chemical process that happens billions of times per second in our bodies and is responsible for many things, including:
* To produce vital molecules such as Co Q-10 and carnitine.
* To switch on DNA and switch off DNA. This is achieved by activating and deactivating genes by methylation. This is essential for gene expression and protein synthesis. Proteins of course make up the hormones, neurotransmitters, enzymes, immune factors and are fundamental to good health. When viruses attack our bodies, they take over our own DNA in order to replicate themselves. If we can't switch DNA/RNA replication off then we will become more susceptible to viral infection.
* To produce myelin for the brain and nervous system.
* To determine the rate of synthesis of glutathione which is essential for detoxification.
* To determine the rate of synthesis of glutathione which is an essential anti-oxidant as glutathione-peroxidase. Furthermore oxidative stress blocks glutathione synthesis - yet anot…
What they were answering
YoohooCthulhu · 1 points
Limiting the availability of a useful service because unsophisticated customers might get confused is wrong
Whatever the morality, that's sort of exactly the purpose of the FDA. Snake oil doesn't harm anyone and sophisticated consumers can tell it's not effective. Sure, the FDA has a safety mission, but it also has a marketing mission. The average consumer is not equipped to tell the difference between claims made in biomedical literature and clinical trials.
And the reason for the FDA directing them to stop all sales wasn't just on a whim, it was because of their previous non-response to the FDAs requests for information. (i.e. they had been having an ongoing conversation with 23andMe before the company mysteriously stopped responding early this year) The burden of proof is on medical device manufacturers to prove that their device meets claims, not on the FDA.
Now 23andMe presumably decided earlier this year that they weren't a "medical device", and that's the reason they stopped responding to the FDA. But they legally conceded the fact when they submitted the first round of 510k paperwork to the FDA last year (http://blog.23andme.com/tag/510k/).
u/MisterYouAreSoDumb · Ceretropic
Does submitting the 510k paperwork actually mean they legally conceded that their product was a medical device? If so, that will pose a problem for them.