Along with toilet paper, lipstick and allergy meds, an over-the-counter genetic test claiming to offer a window into consumers’ medical future was supposed to hit Walgreens shelves on Friday.
But Walgreens is rethinking the plan.
Though the personal genetic test from California-based Pathway Genomics has been marketed online for years as a way to determine whether a person is at risk for certain diseases, local medical geneticists and doctors say the product’s move to retail stores raises some red flags.
The U.S. Food and Drug Administration has its own set of questions for Pathway Genomics, so Walgreens is taking a slower approach to selling the test.
“In light of the FDA contacting Pathway Genomics about its genetic test kit and anticipated ongoing discussions between the two parties, we’ve elected not to move forward with offering the Pathway product to our customers until we have further clarity on this matter,” Tiffani Washington, the manager of media relations for Walgreens, said Wednesday evening in an e-mail.
Local doctors say they’re not against the test as a whole, but people who use it need a better understanding of exactly what it can and can’t tell them.
“I wouldn’t say people shouldn’t have access to this test,” said Dr. Sanford Sharp, pathologist and medical director of the cancer risk counseling program at Memorial Hospital’s MaryEllen Locher Breast Center. “It’s just I’m worried about people having access without guidance.”
Pathway says its Insight genetic tests can provide an assessment of risk for dozens of diseases, from breast cancer to arthritis to obesity, based on a saliva sample.
“We’re revolutionizing the way people access information about their genetics, and through thousands of convenient Walgreens locations, we’re making it easier and more affordable than ever before to order a personalized genetic report,” company CEO Jim Plante said in a news release.
The test kit costs from $20 to $30, but the actual results cost more. After sending off a saliva sample, consumers could pay hundreds of dollars, depending on what kind of information they order.
For $179, consumers can get a risk assessment for 70 conditions. A pre-pregnancy planning assessment is also $179, and an overview of how a person’s genetics might make them resistant to certain drug treatments is $79. A combination of all three assessments costs $249.
Spokesman Robert Blodgett said in an e-mail that the company encourages consumers to speak with one of Pathway’s genetic counselors about their results.
Some experts argue that such information will be at best confusing and, at worst, seriously misleading to users who don’t understand the results. They point out that genes are only one factor in predicting illness, along with lifestyle and environmental factors.
Art Caplan, director of the Center for Bioethics at the University of Pennsylvania, said genetic testing can be important to people with a significant family history of a disease, but he’s concerned about mass marketing such testing.
GENETIC TESTThe Insight genetic test is not approved by the U.S. Food and Drug Administration, but the agency is investigating Pathway Genomics’ medical claims and whether the test should require FDA approval.”FDA has concerns because the test is being marketed as a tool to make determinations about medical treatments and FDA has no record of the test being submitted to the Agency for approval or clearance,” spokeswoman Erica Jefferson in an e-mail.
“They’re basically saying, ‘Come on in, spit in a cup, let’s see what you got.’ They’re churning fear to sell tests that are not ready for prime time yet,” he said. “But the understanding of what role genes play (in disease risk) is still vague, and the risk information can be deceptive.”
Ethical issues include whether parents will start testing their children, said Dr. Cathy Stevens, medical geneticist at Erlanger hospital.
“Is that ethically right to test a minor rather than letting that person decide when they turn 18, ‘Do I want to know this about my own health?'” she asked.
Dr. Caplan said testing could cause unnecessary anxiety, since everyone is at risk for something.
“Everybody will flunk this test because everybody has some risk factors since we’re all mortal,” he said. “For a huge number of these risks, you don’t need to take a test to find out what to do. You need to eat better, exercise more, get enough sleep, don’t abuse drugs.”
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