Genetic Legislation: GINA

Today there are more than twenty companies that offer "personalized genomics" tests directly to consumers. These tests are designed for a number of uses including confirming paternity, predicting one's risk to develop certain diseases, determining personality profiles, and determining one's propensity to develop specific addictions.

There are companies like which will assist you in finding a DNA compatible mate at a cost of $995; their claim is that people are more attracted to those with very different or opposite immune systems. There are companies that claim they can identify an individual's specific nutritional needs and develop a dietary program, offering to sell the needed dietary supplements at a greatly inflated price compared to purchase over the counter.

Published in this month's issue of the American Journal of Human Genetics is the statement that there is insufficient scientific evidence that genomic profiles are useful in measuring risk for common diseases or in developing personalized diet for disease prevention.

Specific factors compound the concerns or dangers of direct to consumer (DTC) genetic testing. The Food and Drug Administration does not regulate most of these tests nor is there a proficiency standard required of these companies. Technology is changing daily, allowing the costs for these tests to drop significantly. At one time it cost several million dollars to have your entire genome analyzed; last year the cost dropped to about one million dollars and today a Massachusetts company will do it for $350,000. It is expected that cost will continue to drop.

A former director of the National Institutes of Health defined genetics as the "science of differences and can be used to categorize people or stigmatize them or subject them to social or economic discrimination", offering the 20th century eugenics movement as an example. The director of the National Human Genome Research Institute and leader of the public arm of the Human Genome Project, Francis Collins, shares concerns about employers using genetic information in hiring, firing, or promotion decisions on the basis of someone possibly developing a disease in the future. There are some in the life insurance field who argue that those with better genes should not have to pay the same premiums as someone with a profile showing susceptibility to disease.

A legislative bill, GINA for Genetic Information Nondiscrimination Act, has near unanimous support in the US House and Senate but is being held in committee by one opposing senator from Oklahoma. This bill would provide the protection needed from discriminatory actions based on genetic information. The future of personalized medicine and treatment requires passage of protective legislation before these concerns become realities. This should be a topic of political discourse in this year's elections.