Suppose further that the Japanese government convinces your largest importer the US, say to strengthen its currency to avert a further Japanese economic disaster, and that the prices of your export goods become relatively unattractive because your currency is pegged to the dollar.
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 Aap bioethics essay contest 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 Aap bioethics essay contest 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. The challenge is to come up with a regulatory framework that recognizes the fact that this information is — at least for now — intrinsically fuzzy.
The FDA wants to classify genetic tests like those offered by 23andme as medical devices, and to apply the appropriately strict criteria used for medical devices to genetic tests.
Genetic tests are simply not — at least not yet — medical devices in any meaningful sense of the word. They are far closer to family history than to an accurate diagnostic. The FDA and companies like 23andme need to come up with standards for accurately and honestly describing the current state of knowledge for genotype-phenotype linkages and their application to individual genotypes.
This entry was posted in genetics and tagged 23andmeFDA.
Both comments and trackbacks are currently closed.Your points about “very very messy” data and an “incomplete catalog of human genetic variation” are–as you know, from that first meeting long, long ago in your office–what sparked the start of .
Know what's next when you read AAP Journals, view the new Catalog. Trainees, enter the SOPT Essay Contest for a chance to be published in Pediatrics! Advertising Disclaimer». Kyle Bertram Brothers (continued) Jun - Present: Fellow, American Academy of Pediatrics ; First Place Winner, AAP Section on Bioethics Essay Contest ; Apr Scholars Abstract Award, Clinical and Translational Research and Education Meeting ;.
Yahoo Lifestyle is your source for style, beauty, and wellness, including health, inspiring stories, and the latest fashion trends. Her essay, "WHO follows The Precautionary Principleand who doesn't?" received Honorable Mention in in the American Academy of Pediatrics Section on Bioethics Essay contest and was published in the May Section on Bioethics Newsletter.
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