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
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
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
“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
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
(EDITOR’S NOTE — Compiled
by Michael Foust, an assistant editor of Baptist Press. With reporting by Tom
Strode, Washington bureau chief for Baptist Press.)