Archive for Sunday, March 22, 2009

Medical experts wary of mail-order DNA tests

March 22, 2009

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With a little spit and a few keyboard strokes, you can unlock the secrets of your DNA.

At least, it seems that simple at an array of Internet sites that are pitching genetic tests directly to consumers.

The businesses claim to examine customers’ genes for conditions grave or mundane — from their risk of cancer to their likelihood of baldness.

They offer a tantalizing peek at the most personal facets of health. But the tests have raised eyebrows among genetic counselors and government regulators, who are skittish about consumers tapping into their DNA without a doctor’s involvement.

“Genetic counselors are very concerned about people ordering some of this predisposition testing on their own on the Internet,” said Becky Althaus, a genetic counselor at Texas Health Dallas hospital. “A lot of times, this stuff is very complicated. And the results are not that easy to interpret.”

Alex Wong, director of products at a California-based company named 23andMe, said consumers have a right to access their own genetic details.

“We try to make it understandable to the average person,” Wong said. “We don’t just say that your risk has been increased by X number percent and that’s that.”

Wong’s business markets do-it-yourself kits that are supposed to reveal details about buyers’ genealogy and health traits. The company, which includes Google among its investors, invites customers to “get the latest on your DNA with $399 and a tube of saliva.”

The 23andMe test addresses dozens of conditions, from life-threatening diseases to genetic curiosities. Among them: whether you have a genetic predisposition for breast cancer, your risk of celiac disease, what type of earwax you have and whether you’re resistant to malaria.

Some of the tests are well-established among scientists, while the significance of others is far less certain.

“We’re actually very careful to educate our users about the relative reliability of that information,” Wong said.

Among the other tests available to consumers:

l Colorado-based Sciona sells “personalized genetics assessments” that purport to reveal how your genetic makeup affects metabolism, diet, nutritional processing and lifestyle.

l California-based HairDX says its test, only available from certain doctors, can predict the risk of baldness.

Government warnings

Skepticism abounds about the tests.

The Federal Trade Commission — together with the Food and Drug Administration and the Centers for Disease Control and Prevention — issued a warning in 2006 against at-home genetic tests.

The federal Government Accountability Office also sounded caution in 2006 after the agency investigated four DNA-testing Web sites — including one that sold “personalized” dietary supplements and another that said its pills could repair DNA.

Its findings: The businesses made misleading, medically unproven predictions. And they offered ambiguous recommendations based on consumers’ lifestyles — not any unique genetic profile.

Last year, regulators in California and New York stepped up their scrutiny of the industry. And in April, a federal advisory committee concluded that there’s insufficient oversight of the labs that market genetic tests to consumers and raised concern about potentially “adverse patient outcomes.”

Jame Restau, a clinical nurse specialist at Baylor Medical Center at Irving, Texas, said patients are often curious about which genetic tests may become available.

“I think you have to be one of those cautious consumers,” Restau said. “If it sounds too good to be true, it probably is.”

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