FDA Panel: Physicians Key in DTC Genetic Tests
From the FDA's Molecular and Clinical Genetics Advisory Committee Meeting
“There is an alternative to this highly paternalistic approach; that information in and of itself is not harmful,” said Ms. Pendergast.
A government-sponsored study that was presented at the meeting seemed to back her assertion. The National Human Genome Research Institute's Multiplex Initiative found that people who underwent tests for eight common diseases were highly satisfied with the results – regardless of what those results showed – and that they felt as if they understood the implications and limitations of the tests.
The 266 people who took the tests tended to have more positive than negative emotions in the wake of receiving results, said Colleen McBride, Ph.D., the study's designer and a senior investigator at the institute's Social and Behavioral Research Branch.
