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Walgreens won’t sell genetic test kit
Baptist Press
May 13, 2010
3 MIN READ TIME

Walgreens won’t sell genetic test kit

Walgreens won’t sell genetic test kit
Baptist Press
May 13, 2010

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.

(EDITOR’S NOTE — Compiled

by Michael Foust, an assistant editor of Baptist Press. With reporting by Tom

Strode, Washington bureau chief for Baptist Press.)