FDA panel wants doctors to supervise genetic testing

by jeeg 9. March 2011 19:08

Members of a Food and Drug Administration advisory panel convened to consider new government regulation of genetic testing offered directly to consumers said Tuesday that such testing should only be allowed under a doctor's supervision.

Personal testing, which is mainly available online from companies operating outside traditional medical institutions, can produce ambiguous or misleading results without proper analysis, members of the panel said.

"I would suggest that we are not ready yet to put this completely in the consumer's hands," said panelist Joann Boughman of the American Society of Human Genetics. "Each test is complex and when you have each provider doing slightly different tests, it complicates it even more."

The panel's consensus on new regulations is not binding on the FDA, but the agency usually follows the panel's advice.

The 21-member panel, predominantly a mix of physicians and academics, did not vote on specific questions during the first day of a two-day hearing which will conclude Wednesday. But members expressed general agreement that doctors should be in charge of ordering and interpreting the tests.

Panelists expressed particular concern that in current forms, testing provides incomplete results.

For example, a test to determine if someone is a carrier for cystic fibrosis might not screen for all of the genetic permutations that trigger the disease, meaning that a negative result could promote a false sense of security.

A negative test result is only part of the puzzle of assessing the probability of disease, said George Netto of the Johns Hopkins School of Medicine.

"It's very dangerous to get a false reassurance (from a test) when you don't know about environmental and other risk factors," Netto said.

The tests, and many other advances in genetic science, are a byproduct of the Human Genome Project, a 13-year international effort to identify and map the genes of human beings that was substantially completed in 2003.

Unlike genetic tests ordered by doctors, which are processed by a laboratory and delivered to the physician for review with the patient, direct-to-consumer testing allows individuals to get genetic information directly from a lab, without involving a health care provider.

Advocates of testing say it allows consumers to take a more active and better-informed role in their health care, and that consumers have a right to information about their genetic makeup.

"We're not trying to substitute for a physician, we're simply providing a service that doesn't exist otherwise" so that doctor and patient can factor in genetic information in planning health care, said Jeff Gulcher, of deCODE Genetics, of Reykjavik, Iceland.

Critics argue that personal testing still is more art than science and lacks the precision to be an effective mass-market health care tool.

Doubts were fueled last July by a Government Accountability Office report that found that different companies came to different conclusions about the meaning of the same DNA sample.

In one example cited by GAO investigators, four companies evaluating the same DNA reported that the person supplying it had a below average, average and above average risk for prostate cancer and hypertension.

Jeremy Gruber, of the non-profit Council for Responsible Genetics, said test makers are overselling what they currently can deliver.

"Every player in the industry makes both explicit and implicit claims that knowing your genetic information will demonstrably improve your health; with few exceptions science is still progressing towards being able to make that case," Grubman told the advisory panel.

Direct-to-consumer tests have been available online for several years, but assumed a higher public profile last May, when Walgreens announced that it would sell one brand of test in its stores.

That prompted the FDA, which previously had publicly said little about the tests, to step in and declare that they needed to meet regulatory standards as medical devices.

Walgreens has shelved plans to sell the test until the regulatory uncertainty is cleared up, according to a spokesman.

An FDA spokeswoman said the agency doesn't know how many companies offer the tests but sent letters to several firms last spring and summer advising them the need to meet regulatory standards.

"We've since met with most of these companies and several of them have decided to discontinue their (direct-to-consumer) model. Others have elected to move forward and are in discussions with the agency about how to proceed through our review process," spokeswoman Erica Jefferson said.

The companies are allowed to continue selling their tests while coming into compliance, Jefferson said.

Andrew Zajac, Tribune Washington Bureau

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