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Genetic tests, an early fruit of the Human Genome Project, are being used more and more in the diagnosis and treatment of human health conditions. However, there is very little regulation or oversight of genetic tests, especially when compared to other high tech products such as pharmaceuticals. In fact, many people compare the developing world of genetic testing to the Wild West where just about anything goes, where tests are not validated adequately and may be purchased directly from laboratories without any input or interpretation by health care professionals.
Lately, there have been rumblings from agencies such as the Food and Drug Administration within the US Government that it is time that the Wild West is tamed. Naturally, the purveyors of these genetic testing projects are concerned that regulation will be heavy handed and will stifle innovation. Others feel that these developing tests should be governed by the free market and be available to consumers who want them. Regulators and many withing the medical community are concerned that consumers will be given information that is not accurate and be harmed in the process. The only thing that is really clear that this is the beginning of a process that will almost certainly end with some type of regulatory framework in place.
In the February 18, 2007 issue of the New York Times, Denise Caruso reflects on many of these issues in a thoughtful essay. She raises more questions than she answers but she frames many of issues in useful ways that account for the many relevant perspectives Ms. Caruso is the is executive director of the Hybrid Vigor Institute, which studies collaborative problem-solving.