Sunday, April 24, 2011

"Progress": Regulation for Genetic Testing?

Matt Ridley makes a rational call @ WSJ (thank goodness; I already did it @ 23andme):

Food and Drug Administration is in the process of demanding the power to regulate genetic tests marketed directly to consumers as if they were medical devices. This proposal has produced contrasting reactions. Physicians predictably are all in favor. They see the opportunity for a closed-shop power-grab of the kind professionals love: a gatekeeping role. The American Medical Association wants the law changed so that people can get their genes tested only on prescription from a doctor.

Many genetic commentators, on the other hand, are dead against. They see this as an unnecessary intrusion of cost and hassle between the customer and his or her own genes. Besides, physicians often complain that they know too little of genetics—even as they demand to be put in charge. In its letter to the FDA asking for a gatekeeping role, the AMA bizarrely confessed: "The number of genetic tests available directly to consumers has proliferated rapidly, and several studies have reported that physicians find it difficult to keep up with the pace of genetic technology."

If freedom does not appeal, the clinching argument for allowing consumers unfiltered access to their own genes is a scientific one. The only way slight genetic influences on health are going to emerge is if thousands of people submit their genomes for testing, and the only way that is going to happen is voluntarily. Academic research projects cannot promise to create the huge databases that an enthusiastic populace applying to an entrepreneurial testing industry can spawn. Genetic knowledge, whether the high priests like it or not, is going to be a crowd-sourced phenomenon.

No comments: