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Heart Disease Health Center

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FDA Panel Urges Caution on Genetic Test Kits

Advisory Panel Is Wary of Genetic Testing That Is Sold Directly to Consumers

Genetic Role in Disease continued...

At the heart of the FDA’s dilemma is how to balance patients’ rights to information about their risks for disease with the need to have professionals involved in the interpretation of results that can cause consumers to worry or to seek out medical care.

“Medical students don’t understand it and practicing docs don’t understand it,” says David Rahsohoff, MD, an epidemiologist from Yale University and a member of the panel. “We certainly can’t expect consumers to do that.”

But companies warned that aggressive regulation would stifle patients’ ability to improve their health by dealing with known health risks. Just because the connections between many gene mutations and disease are poorly understood doesn’t mean patients should not have access to tests, says Mary K. Pendergast, a board member of the drug company AesRx.

We can’t live our lives where we can’t know anything until everything is known,” said Pendergast, a lawyer and industry consultant who served for seven years as FDA’s deputy commissioner.

FDA Scrutiny of Genetic Testing Kits

Last year, FDA scrutiny prompted Walgreens to pull back on a decision to sell genetic testing kits from a company called Pathway Genomics.

Ed MacBean, the company’s vice president of product management, acknowledged his company had “treaded into” an uncertain business situation, given the FDA’s move.

Other companies, like 23andMe, offer consumers genetic testing kits directly to consumers over the Internet. The company’s web site promises consumers insight into traits from baldness to muscle performance and the chance to “discover risk factors for 95 diseases” for $199.

The company was founded by Anne Wojcicki, wife of Google co-founder Sergey Brin.

Alberto Guttierez, PhD, director of the FDA’s office of in vitro diagnostics, says the agency would look at tests on a case-by-case basis to decide if they should be available directly to consumers.

Tests for genes that affect prescription drug metabolism are likely to remain restricted since the drugs themselves can only be obtained under a doctor’s care. But other tests helping predict metabolism of certain foods would probably have fewer safety implications and may enjoy easier sales for companies.

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