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Regulators consider more rigorous examination of consumer genetic tests for serious diseases

The views expressed are those of the author and are not necessarily those of Scientific American.


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consumer genetic testWhether you have questions about your ancestry, earwax or Alzheimer’s risk, a recent slew of genetic tests promise to give you highly personal answers. Since this summer, however, the U.S. government has been taking a closer look at establishing standards of availability—and accuracy—for direct-to-consumer (DTC) genetic tests. Some 90 percent of these tests have not been subject to outside regulation for efficacy or safety.

Despite a lack of external vetting and the Federal Trade Commission’s (FTC) assertion that these tests should be taken with "a healthy dose of skepticism," many consumers do take their at-home test results to heart, noted the authors of a new essay published online October 7 in Science.

In one 2008 study, some 40 percent of subjects whose genetic test revealed an increased risk for Alzheimer’s disease started taking more medication and vitamins after learning of the result. The issue of iatrogenic harm, injury coming from medical treatment, is potentially a "more serious concern" than even the psychological or emotional strain that might come with getting information about one’s disease risk, noted the authors of the essay, led by Amy McGuire, of the Center for Medical Ethics and Health Policy at Baylor College of Medicine in Houston. They added that, "given that all medications carry the potential for adverse effects, the scope of potential harm from unnecessary or unproven treatment after genetic risk assessment is an important unstudied question."

This risk does not mean, however, that the Food and Drug Administration (FDA) should pull genetic tests from the market, as the German government has done, McGuire and her colleagues argued in the essay. Instead, they advocated for a scaled approach to regulation that would increase in rigor with the seriousness of what was being assessed. So tests for cancer or other major disease risks might need to pass through pre-market approval processes much like those applied to other medical tests or devices. A service that only provides info on ancestors or earwax type, however, might only be subject to safety and efficacy surveillance after it hits the market.

One of the big questions that remains, however, is how well the government, in particular the FTC, can ensure that every test is providing results that are as accurate and scientific as promised. "We expect truth in advertising from all marketers of consumer products," Wylie Burke, of the Department of Bioethics and Humanities at the University of Washington School of Medicine in Seattle and coauthor of the new essay, told Medscape in September. So far, he noted in the interview with Medscape, "it seems that this standard of truth in advertising is not being achieved."

Image courtesy of iStockphoto/dra_schwartz





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