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:6/24/2016)... ... June 24, 2016 , ... A recent article published ... unfamiliar with. The article goes on to state that individuals are now more comfortable ... less common operations such as calf and cheek reduction. The Los Angeles area medical ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out ... family verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers ... would throw rocks at my other children and say he was going to kill them. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. ... accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas of orthodontics, ... and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening their ... Award, an essay contest in which patients and their families pay tribute to a ... the 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & Innovative Solutions ... initiated cultivation and processing operations at its production facility, and opened its first ... is the manufacturer of a complete system of proactive air and surface purification ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 24, 2016  Arkis BioSciences, a leading innovator ... more durable cerebrospinal fluid treatments, today announced it ... funding is led by Innova Memphis, followed by ... private investors.  Arkis, new financing will accelerate the ... market release of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... a startling report released today, National Safety Council research ... proven plan to eliminate prescription opioid overdoses. Prescription Nation ... tackling the worst drug crisis in recorded U.S. history, assigned a ... , New Mexico , Tennessee ... failing states, three – Michigan , ...
(Date:6/23/2016)... Bracket , a leading clinical trial technology and specialty ... Bracket eCOA (SM) 6.0, at the 52 nd ... in Philadelphia , Pennsylvania.  A demonstration of ... its kind to fully integrate with RTSM, will be held ... a flexible platform for electronic clinical outcomes assessments that is ...
Breaking Medicine Technology: