Archive for May, 2010

More on Genetic Testing…

Wednesday, May 26th, 2010

Two recent developments with respect to mass genetic testing support the idea that we are not done debating how we want to handle such information as a society.

On May 19 the The House Energy and Commerce Committee and its subcommittee on oversight and investigations began efforts to collect information from Navigenics, Pathway Genomics, and 23 and Me regarding the methods, accuracy, and privacy of their tests (http://www.washingtonpost.com/wp-dyn/content/article/2010/05/19/AR2010051903079.html).  This follows on the request from the FDA to discuss with Pathway Genomics whether the company needs approval from the Agency to sell its tests at Walgreen’s.

Separately, UC Berkeley recently initiated a program in which the university is offering incoming students the opportunity to submit DNA samples for genotyping at three loci involved in alcohol, lactate, and folate metabolism.  This has raised concerns from groups, including the Council for Responsible Genetics, who would prefer to have the testing postponed, at least, until we can better address issues around misuse and privacy of this type of information.

The developments around these two events, the announcement of the imminent sale of OCT genomic tests and the testing of students at a large university, make it pretty clear that, as a society, we are not entirely OK with this type of large scale genetic testing yet.  In particular, I think that there is a feeling that we don’t really know what the true risk-benefit relationship is.

As with all situations where information is being revealed, once the cat is out of the bag there is no way to put it back in the bag.  I’m sure both of these genomic testing programs would work out just fine, but perhaps in this situation erring on the side of caution is appropriate.

Genetic Testing, Walgreen’s, and the FDA

Monday, May 17th, 2010

To read some of the initial reports on the FDA’s announcement that it would like to discuss approval of Pathway Genomics’ OTC genetic tests, one might conclude the FDA acted rashly.   Since Pathway Genomics was planning to sell medical information to large numbers of consumers via Walgreens, the nation’s largest drug store, it seems to me that this is the kind of situation that is well within the FDA’s charter.  How does this balance the right of individuals to know information about themselves, including their genetic makeup, and the FDA’s mission to protect public health?

It seems clear to me that individuals have every right to know information about their genes.  Certainly genetic testing is not new, witness Tay Sachs disease testing and BRCA testing from Myriad Genetics.  My feeling is that this type of patient empowerment can be a driving force in many facets of healthcare, including cost control and preventative medicine.  So, why not sell OTC genetic testing at Walgreen’s?

Tests such as Pathway Genomics is offering are a fundamentally new paradigm in testing.  I bet the FDA sees potential problems cropping up, including inaccurate test results that may also be of questionable utility.  So, it may be that the Agency is within its rights to insist on quality standards and improved relevance of the results, if that is what they are after. I am sure the companies that currently offer or plan to offer DTC genetic testing are capable of producing quality results.

The utility of this type of information is also within the Agency’s purview under that aegis of effectiveness.  If the information dispensed is not at all useful, then money spent on these tests potentially represents money needlessly spent on healthcare resources.  Even worse, if the information dispensed induces the recipients to undertake a harmful treatment course, then it is a public health problem.

I’m not sure we understand most of the genetic information sufficiently to dispense it en masse.  Witness an article published just this week in Nature describing five new breast cancer risk loci.  How would you handle a person who received their results, did internet searches on their gene variants, and discovered they might have a newly discovered breast cancer risk allele?  We should ensure that appropriate resources are available to recipients to help them interpret their results.  I agree with Archelle Georgiou (http://bit.ly/aHvWEu, thanks to John Sharp), I would rather if this wasn’t a prescription thing.  I don’t think that is essential, but some type of resource to assist individuals with interpretation is probably a good idea.

I am hoping the FDA will rise to its best service of the public and help ensure that what is ultimately available is accurate, useful, and readily available.