Tuesday, May 18, 2010

Should the FDA regulate direct-to-consumer genetic testing?

Last week, Walgreens reversed its decision to provide "spit kits" for Pathway Genomics' genetic tests due to a letter from the FDA requiring Pathway Genomics to either get FDA approval or explain why they are exempt from approval.  This week, CVS also made a similar decision to postpone selling of the Pathway tests.

Recently, I have noticed a number of blog posts that seemed to side with the FDA.  For example, 80beats has criticized the Pathway Genomics tests in terms of usefulness, legality, and unpredictable public response.  Genomeboy has complained that Pathway Genomics is not being very transparent in terms of explaining their analysis (especially in comparison to 23andMe).

I agree that a lack of transparency and usefulness would be serious problems for genetic tests.  As mentioned in my first blog post, there are indeed many problems with the current accuracy of genetic tests (in terms of discrepancies between companies, incorrect prediction of clearly known characteristics such as eye color, etc.).  I think it is also essential that companies provide you with your SNP data so that you can try to seek alternative opinions regarding how to interpret the genetic test.  I was also very disturbed that the CSO of Pathway Genomics claims that "[Pathway Genomics] don't feel that [they are] practicing medicine" even though they wish to sell genetic tests in a drugstores.

That said, I think FDA regulation should only be used as an absolutely last resort.  First, I think many other criticisms are not warranted.  For example, the Wall Street Journal has a nice article about how the negative public response to genetic tests has been exaggerated.  Second, I think it will be valuable for consumers to have access to objective analysis of the accuracy and usefulness of commercially available genetic tests (either conducted through public or private means), but I don't think that necessarily has to be done through FDA regulation.  For example, a large database (perhaps something like PatientsLikeMe) of genetic test results, medical history, and lifestyle changes can help provide the necessary information to consumers.  It will take a significant amount of time to throughly examine these genetic tests, and I think this analysis can be conducted much quicker (and perhaps even better) if the public has direct access to the tests.

I would be ok with some sort of warning label that the tests are not completely accurate and other analysis should taken into consideration when making medical decisions, but I think it would be too extreme to completely remove these tests from the market.

No comments:

Post a Comment

Creative Commons License
My Biomedical Informatics Blog by Charles Warden is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 United States License.