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After FDA Objections, 23andMe Won't Offer Health Information
sciencehabit writes "The company 23andMe will no longer provide health information to people who purchase its DNA testing kit, it announced last night.The change was 'to comply with the U.S. Food and Drug Administration's directive to discontinue new consumer access during our regulatory review process,' the statement said. While current customers will still have access to a 23andMe online database noting the health issues associated with their particular DNA, the company will not update that information, and customers who purchased its Personal Genome Service (PGS) on or after 22 November will receive only information about their ancestry and their raw genetic data without interpretation." It would be great to see a secondary market in this kind of analysis emerge.
Perhaps this is why the FDA put the kabosh on it
The FDA was very clear about why they stopped it. It wasn't necessarily that the information was misleading, but that it would lead patients to make decisions about their own care without necessarily consulting a doctor, which the FDA thinks is not a good idea -- and I totally see their point, frankly.
For example, one of the things that 23andMe can tell you is how well you might respond to one drug versus another, because of your specific genetic makeup. If you take that advice and change the dosage of your medication or switch to a different medication without discussing the issue with your doctor, you could cause yourself serious harm.
On the far end of the scale, "false positives" for some diseases could be catastrophic -- say, if a woman was erroneously told she had a high chance of contracting a certain type of breast cancer and decided to have a double mastectomy, like Angelina Jolie had done.
23andMe claimed that all it was doing was giving people information. But really, the way the information was structured and presented to the customer made it clear that it was designed to be diagnostically relevant and that they should use it to make decisions about how to proceed with health care. Any service that performs that function clearly falls under the jurisdiction of the FDA, IMHO.
Breakfast served all day!
One company, for example, offers 166 tests in one of its testing packages where approximately 60% of the tests (99) are categorized as âpreliminary researchâ(TM) because the genetic-association data have not yet been replicated (www.23andme.com/health/all/). These tests are given 1, 2, or 3 stars based on the size of the study that supports the genetic association for which they test. Information for each of these tests cites references for the original ïnding of the genetic association, including the journal where it was published and the study size. It also provides the number of attempted replications and the number of contrary studies that have been published. Although transparent, examination of the scientiïc evidence provided for many of the genetic associations in this category raises the question of whether these tests should even be included in a genetic-testing package. Two of the ïve genetic tests with 1-star status (those for âavoidance of errorâ(TM) and âobsessive compulsive disorderâ(TM)) are based on single studies with fewer than 100 participants (https://www.23andme.com/you/health/). In both cases the variants map to the D2 dopamine receptor, a gene that has repeatedly been associated with human behavioral traits and attracted newspaper headlines, only to have the associations refuted in later studies [8]. Eight of the 37 (22%) available 2-star-rated genetic associations (originating from a single study with less than 750 participants) have a âcontrary studyâ(TM) indicated. Two different 3-star tests, one for Lou Gehrigâ(TM)s Disease (ALS) and another for obesity, utilize variants that have been positively associated with disease in one or two studies, respectively. However, both these variants have failed replication in four additional studies (https://www.23andme.com/you/health/). Although, the company boasts of its 'systematic vetting processâ(TM) used to determine which research ïndings to include in its genetic-testing package, a number of highly questionable tests continue to be offered to consumers.
http://www.ncbi.nlm.nih.gov/pubmed/20828856