Mice, for example, can be bred to have certain genes deleted or inserted in order to create a certain type of disease. Then you can use these mice to test certain therapies to see if they work well enough to test in humans.
How do we want genetic testing to be regulated? By Michael Eisen Published: November 26, Yesterday the US Food and Drug Administration sent a letter to the human genetic testing company 23andMe giving them 15 days to respond to a series of concerns about their products and the way they are marketed or risk regulatory intervention.
I am a member of the Scientific Advisory Board for 23andme, but I am writing here in my individual capacity as a geneticist who wants to see human genetic data used widely but wisely although I obviously have an interest in the success of 23andme as a company — so I can not claim to be unbiased.
I fall somewhere in the middle — I think there is great promise in personalized genetics, but at the moment it is largely unrealized. Looking at your own DNA is really interesting, but it only rarely provides actionable new information.
I think the answer is obviously yes. Again, putting aside questions about the accuracy or utility of this information, there is a lot of published scientific literature that is potentially relevant to people with a particular genotype including genome-wide association studies as well as a lot of classical human genetic literature and other functional studies.
But few people have the technical savvy to be able to analyze their own genome in this way. So, assuming there is interest, there is a great niche for third parties to step in an provide services to people to help them interpret their own DNA. Is this a bad thing? Should this third party be a doctor, as some mostly doctors are arguing?
There are certainly doctors out there who have a great grasp of human genetics. This is a job for software, not for people. If you accept points 1,2 and 3 above — which to me seem inarguable — then you accept the right for companies like 23andme to exist.
You might not think they provide a valuable service. You might not think they do a good job at providing these services. Should direct-to-consumer genetic testing companies be regulated? I think this is also a no-brainer. Obviously they should be regulated — and fairly tightly so in my opinion.
It is vital that the FDA protect consumers in two ways: The former seems relatively easy — validating genotyping and sequencing is well-trodden turf.
The latter is a bit more complicated.
However, we are far, far, far away from this. We have an incomplete catalog of human genetic variation; known genetic variation can explain only a small fraction of the heritable component of most phenotypes of interest; we have a poor understanding of how different genetic variants interact to affect disease risk or other phenotypes; and we have essentially no capacity to incorporate environmental effects into predictive models.
In many cases current, incomplete, data may point to someone having an elevated risk of some disease, when they really have a lower than average risk. And, to top it all off, there are very few cases where knowing your risk status or other phenotype points to genotype-specific actions with the BRCA status referred to in the FDA letter a notable exception.
The data are, at this point in time, very very messy.
The question is what to do about that. One the one side you have people who argue that the data are so messy, of so little practical value, and so prone to misinterpretation by a population poorly trained in modern genetics that we should not allow the information to be disseminated.
I am not in this camp. But I do think we have to figure out a way for companies that provide this kind of information to be effectively regulated.Yesterday the US Food and Drug Administration sent a letter to the human genetic testing company 23andMe giving them 15 days to respond to a series of concerns about their products and the way they are marketed or risk regulatory intervention.
This action has set off a lot of commentary/debate about. A single meal of meats, eggs, and dairy can cause a spike of inflammation within hours that can stiffen one's arteries. Originally, this was thought to be the result of saturated animal fat causing our gut lining to leak bacterial toxins into our bloodstream, leading to endotoxemia.
Here are the top five reasons why it needs to stop: 1. It’s unethical. It’s unethical to sentence million thinking, feeling animals to life in a laboratory cage and intentionally cause .
This book describes PAGE (Poor, Average, Good, Excellent) Testing of Fruits & Vegetables for True Quality by utilizing a simple tool, the hand refractometer.. The quality of fruits & vegetables served to themselves and, particularly, their children, concerns everyone.
The EPA’s addiction to animal testing is so strong that even when evidence from human epidemiological studies implicates a chemical in the spread of a disease, the results are ignored by the EPA for the sake of conducting more and more animal studies.
Imagine your pet dog or cat sitting terrified in a small, nondescript cage inside a clinically cold laboratory, just waiting to be poked, prodded and experimented on – all in the name of advancing human health or at least making better beauty products.