Saturday, February 11, 2006

Should OTC Gene Tests be Regulated?

Genetic testing kits, sold in stores and through the internet in over a thousand varieties, have been booming in both number and popularity in recent years. When researchers discover new genes with a suspected link to a particular disease it’s only a matter of time before that gene is integrated into any number of test kits available for home administration. This despite the fact that the gene-disease “links” are often speculative, attenuated, and poorly understood.

But the genetic tests keep coming, despite a recent report presented by researchers at a meeting on genomics and public health at the Royal College of Physicians in London that there is no evidence that the tests provide any benefits to patients.
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A recent Guardian article points out that
The tests have emerged because regulations only require them to be safe and measure the genes they claim to. As yet, there is no requirement for companies to prove that finding genes has any bearing on the person's future health.
Which begs the question, “Should we demand tighter regulations for over-the-counter genetic testing?” OTC genetic tests strike me as a paradigmatic example of an emerging technology which has leapt out ahead of the political and legislative framework required to successfully integrate it into society and make it available for mainstream consumption.

It appears, at least at the moment, that most if not all of the OTC genetic tests are benign at best; and misleading and confusing at worst. While I don’t think that OTC genetic tests are a bad idea per se, I do think that full and accurate disclosure of what a genetic test can and cannot disclose about one’s current or future health is even more important in the OTC environment than it is in a clinical setting.

When we consider the extensive disclosure and informed consent requirements that are in place, in most instances, before a genetic test can be administered by a trained profession, it's almost stunning that there are not similar requirements for OTC genetic tests.

There’s no question that it’s important for bioethicists to think about the future – but that doesn’t mean there aren’t pressing problems that need to be solved today.


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