Navigation Links
Walgreens Postpones Plans to Sell Do-It-Yourself Genetic Test
Date:5/13/2010

FDA challenged legality of product; experts worry consumers aren't ready for such information

THURSDAY, May 13 (HealthDay News) -- Drugstore giant Walgreens says it will postpone selling a controversial at-home genetic test that could purportedly gauge a person's risk for a variety of diseases and other health threats, such as Alzheimer's, diabetes, heart attack, certain cancers and whether a couple might produce a child with genetic disorders.

Walgreens, which planned to sell the test kits starting Friday at more than 6,000 of its 7,500 stores nationwide, making it the first U.S. retailer to offer such tests, said it made the decision after the U.S. Food and Drug Administration questioned whether the tests could be sold legally without the agency's approval.

"In light of the FDA contacting Pathway Genomics [the maker of the test] 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," said Walgreens spokesman Jim Cohn, the Washington Post reported.

Pathway said in a statement late Wednesday, "We respect and understand Walgreens's decision and we are communicating with the FDA about the Pathway Genomics Insight collection kit. Pathway works very diligently to ensure that our business is compliant with all applicable regulations and guidelines," the newspaper reported.

When Walgreens said Tuesday that it planned to sell the test kits, some genetic experts worried that consumers simply aren't ready for this new step forward in the age of "personalized medicine."

"This is kind of the leading edge of what will be personalized medicine, [but] we're not at a stage yet where we can take the information [these tests] give us and understand what the significance is," said Dr. Robert Marion, chief of genetics and development medicine and director of the Center for Congenital Disorders at Children's Hospital at Montefiore Medical Center in New York City.

"The technology is running way ahead of the ethical, legal and social implications of doing the testing, and we need to sort all this out before we can start to offer these tests on a mass scale," he said.

Without experts available to help interpret the results, "it will be utter chaos," Marion added.

Dr. Barry H. Thompson, medical director of the American College of Medical Genetics, added: "We at the American College of Medical Genetics are certainly concerned about direct-to-consumer testing. Genetic information obtained from reliable sources is valuable in terms of health care and family planning, and understanding what's ahead in one's life and one's medical care. But at the same time, any genetic test can have a downside if it's not reliable information or if it's not information that's understood."

Genetic tests are already available on the Internet, offering everything from paternity tests to tests that claim to predict whether baldness is in your future -- even tests that claim to tell how well you metabolize caffeine.

But Pathway's "Insight Saliva Collection Kit" would have been the first foray onto many neighborhood store shelves. (A New York law prohibits the sale of the test in that state.)

The test purportedly can predict individual risk for diseases (for example, Alzheimer's or prostate cancer); how likely parents would be to pass certain conditions on to their children; and how well people would respond to various drugs.

While the initial testing kit costs only $20 to $30, having the saliva sample analyzed by the company's lab would cost another $79 to $249.

A major concern is that people would panic and make unwarranted decisions based on test results, especially without professionals available to help interpret the meaning. Pathway has said it would offer genetic counseling over the phone to those who want it.

"There are psychological aspects to all kinds of genetic testing," said Thompson. "Obviously if you don't understand the results, or if the testing provides results that address issues that were not concerns of yours, or it provides information that has implications for other family members, it's certainly likely to cause apprehension, anxiety and undue concern."

Marion said such tests are likely to find some abnormalities but most will be medically insignificant.

There are also privacy issues.

"Who has access to this information? Who owns this information? Who's responsible? This opens a Pandora's box of questions that are not answerable," Marion said.

And understanding the results of genetic tests require a fairly sophisticated level of knowledge.

"We have a difficult time explaining risks and understanding risks as far as any of us are concerned," Thompson said. "I think the individual who takes a test such as this should learn as much as possible, and it's a good idea to [consult] a health-care professional."

More information

The Human Genome Project has more on genetic testing.



SOURCES: Robert Marion, M.D., chief of genetics and development medicine and director, Center for Congenital Disorders, Children's Hospital at Montefiore Medical Center, New York City; Barry H. Thompson, M.D., medical director, American College of Medical Genetics, Bethesda, Md.; Washington Post


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Brandeis University undertakes third national survey of health plans behavioral health services
2. Ivory Homes Plans Ahead for the April 30th Home Buyer Tax Credit Deadline with 100 New Homes Ready for Quick Purchase
3. Health Care Reform Law Could Improve Children's Oral Health, states Delta Dental Plans Association
4. DST Health Solutions Releases Enhanced ACG System to Help Health Plans Improve Member Health
5. Official Alkaline Diet Website Announces New Expansion Plans to Offer Natural Health and Dieting News
6. MEDNET and Hielix Awarded the State of North Dakota Contract for Statewide Health Information Exchange (HIE) Strategic and Operational Plans
7. Wound Management Technologies, Inc. Announces Conference Plans and Clinical Data Presentation at Leading Diabetic Foot Conference
8. Doctors Support Efforts of Employers and Health Plans to Improve Health of Patients
9. Study suggests need for broader use of individualized learning plans for physicians
10. Blue Cross Blue Shield of Michigan and Physicians Health Plan of Mid-Michigan Abandon Merger Plans
11. Popular Diet Plans Can Unclog Arteries
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/30/2016)... ... April 30, 2016 , ... Saturday, April ... veterinarians’ global impact on public health. The World Veterinary Association (WVA) and the ... year have selected continuing education with a One Health focus, which emphasizes how ...
(Date:4/30/2016)... ... April 30, 2016 , ... Orlando-based Maximized Living has selected Dr. Nick ... in Rio. Under the care of Maximized Living doctors at the London Olympics ... showing, Maximized Living is sending the largest contingent of elite chiropractors to Rio to ...
(Date:4/29/2016)... , ... April 29, 2016 , ... ... Ten Footwear Foundation, the national charitable foundation serving the footwear industry, has broken ... volunteers representing more than 130 companies across 23 states during the months of ...
(Date:4/29/2016)... (PRWEB) , ... April 29, 2016 , ... On Tuesday, ... hospitals across the Southeast, celebrated the signature of Gov. Nathan Deal on SB 258, ... Geoff Duncan (R - Cumming), offers a 70% tax credit to individuals and corporations ...
(Date:4/29/2016)... ... April 29, 2016 , ... Conditions were ideal for Global ... Park on Sunday, with sunny skies, a light breeze and temperatures in the 60s. ... , The 5k Run and Walk and 1-mile walk were held to increase ...
Breaking Medicine News(10 mins):
(Date:4/29/2016)... , April 29, 2016 ... Life Sciences, Product Development Capabilities in ... Customer Base . Indegene ( ... announced the acquisition of Skura Corporation,s life science ... in adaptive sales enablement technology for life science ...
(Date:4/29/2016)... April 29, 2016 Automation is ... laboratory due to the growing demands for productivity in ... contemporary automated systems are already adept of a wide ... tedious and manual labor. Instrumentation continues to evolve, and ... conceivable just a few years ago. Originally used mostly ...
(Date:4/28/2016)... 2016 Research and Markets has ... Products Market 2016-2020" report to their offering. ... The global plastic surgery products market is expected ... period 2016-2020. , ,The growing adoption of laser in ... of the market. Lasers are used to treat a ...
Breaking Medicine Technology: