AHA Recommends More Safeguards for Genetic Testing

Recommendations urge more research; no gene patenting; confirmation of the validity of tests

TUESDAY, May 29 (HealthDay News) -- While genetics show promise for improving health, more safeguards are needed to protect patients and allow scientific and clinical research to continue, according to recommendations issued by the American Heart Association and published online May 29 in Circulation.

Euan Ashley, D.Phil., from the Stanford University School of Medicine in California, and colleagues examined the moral, ethical, and legal challenges associated with use of genetic information in clinical medicine, the current regulatory landscape of genetic testing, and how genetic testing may impact cardiovascular medicine and research.

The researchers recommend that patents should no longer be awarded for observing a gene, such as the controversial Myriad Genetics Inc. patents for BRCA1 and BRCA2 to screen for breast and ovarian cancer risk. They also recommend that there be federal oversight of genetic tests and that antidiscrimination legislation be expanded beyond the 2008 Genetic Information Nondiscrimination Act. Other recommendations include the need for independent review to confirm the validity of genetic tests; specialized centers for genetic testing and counseling; a transparent, consistent, and evidence-based policy from the Centers for Medicare & Medicaid Services regarding payment for genetic testing; and more studies investigating genes that affect the risk of cardiovascular disease and response to drugs.

"The rapid pace of advancements in genetic technology offers great promise in its potential to transform patient care," Ashley and colleagues conclude. "We have laid out a framework to guide policy makers in the way we believe will best support our patients, as well as the scientists and physicians focused on cardiovascular health around the world."

Several authors disclosed financial ties to the health care and pharmaceutical industries. One author has provided expert testimony is cases pertaining to heart disease.

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