WASHINGTON -- Walgreens, the nation's largest drug store chain, reversed course May 12 and said it would not sell a controversial over-the-counter genetic test kit after the Food and Drug Administration raised doubts about its legality.
The DNA test by Pathway Genomics of San Diego was set to go on sale in many of the nearly 7,500 Walgreens stores nationwide this month and would have allowed consumers to send the company a saliva sample supposedly to test for a person's risk for Alzheimer's disease, diabetes, multiple sclerosis, obesity and various types of cancer. The kit itself would have cost around $30, while the actual testing by the company would cost between $79 and $249, depending on the test.
Critics called it irresponsible and argued the kit provided incomplete information because, they say, there are limitations to genetic testing. With Walgreens choosing not to sell it, the product only will be available on the Pathway Genomics website. Other companies sell similar kits, but none in chain stores.
"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," Jim Cohn, a Walgreens spokesman, said, according to The Washington Post.
The FDA had sent Pathway a letter dated May 10 saying the kit "appears to meet the definition of a device" that would require FDA approval.
"If you do not believe that you are required to obtain FDA clearance or approval for the Genetic Health Report, please provide us with the basis for that determination," the FDA's James L. Woods wrote.
The company -- which says the kit does not need FDA approval -- also had claimed the test could reveal a couple's prospects for producing children with genetic disorders such as cystic fibrosis, diabetes and Tay-Sachs disease. Critics said the kit could have led to couples unnecessarily choosing not to having children or even to more abortions. For instance, a couple might have a very remote chance of passing on a disease that perhaps should not be of significant concern. Without a doctor's counsel, critics said, the couple might now know that.
Prior to Walgreens' announcement, C. Ben Mitchell, professor of moral philosophy at Union University in Jackson, Tenn., called the test "just irresponsible."
"First, this particular test may be illegal, since it does not have [Food and Drug Administration] approval," said Mitchell, a consultant to the Southern Baptist Ethics & Religious Liberty Commission. "Second, the role of genetics and lifestyle is not sufficiently understood to help patients make reliable decisions. Third, the danger of misinformation means that some people will not see their physicians because they think they already know their genetic risks. Finally, who will protect the very sensitive genetic data that may be discovered through these tests?"
Hank Greely, the director of Stanford University's Center for Law and the Biosciences, called the test "reckless."
"Information is powerful, but misunderstood information can be powerfully bad," Greely told The Washington Post.