Safeguards Against Misuse of Genetic Data Urged

Posted: May 30, 2012 at 12:10 am

Statement Highlights:

EMBARGOED UNTIL 3 pm CT/4 pm ET, Tuesday, May 29, 2012

DALLAS, May 29, 2012 (GLOBE NEWSWIRE) -- Rapid advancements in genetic disease research necessitate innovative safeguards for patients, according to new American Heart Association policy recommendations published in Circulation, an American Heart Association journal.

Recent scientific progress includes the mapping of the entire human genetic code, or genome, which was completed in 2003, and new accelerated gene-sequencing techniques. These discoveries have led to cheaper, more readily available genetic tests, but regulations have lagged behind.

"The potential of the new technologies is incredible," said Euan A. Ashley, M.R.C.P., D.Phil., chair of the policy statement writing group and assistant professor of medicine in the Cardiovascular Division and director of the Center for Inherited Cardiovascular Disease at Stanford University School of Medicine, in Stanford, California.

"Genetic testing provides a tremendous opportunity but also a challenge in being responsible with that information," Ashley said. "If the information is available, how best do we use it to really improve care for individual patients?"

Focusing on heart and blood vessel diseases, the policy statement recommends:

In the modern era, gene sequencing simply involves observation of the natural world and not invention, therefore genes should not be patentable. The investigators cite a controversial case, now before the Supreme Court, of a company that patented the two primary genes -- BRCA1 and BRCA2 -- linked to an increased breast and ovarian cancer risk. The company has a monopoly on testing related to these genes and some believe this monopoly has reduced access to this test for women.

Establishing federal oversight of genetic tests

All genetic tests should be regulated for quality. The Food and Drug Administration (FDA) is well suited to this task because it has statutory authority, scientific expertise and experience in regulating genetic tests.

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Safeguards Against Misuse of Genetic Data Urged

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