to know if you will get breast
cancer, Alzheimer’s disease, become obese, or suffer from a
range of other maladies? It's all in your genes. Currently
you would have to go to doctors to test for genetic abnormalities
that could lead to various illnesses. An enterprising San Diego
startup called Pathway
Genomics has compiled a variety
of these tests, though, and is about to start
selling them at retail giant Walgreen.FDA spokeswoman
Karen Riley was surprised by the news and said that the company has
not yet received approval for the devices and must first get
approved. Approval would involve a lengthy and expensive
process of submitting evidence of the device's efficacy and could
shelve the retail plans for years. However, if the company does
not comply, Riley warns that the FDA may order the devices pulled
from Walgreens' store shelves.Gene testing has to date
exclusively been conducted in the medical setting. The new
Walgreen test, though, allows buyers to take a saliva sample and then
send it back to the lab for analysis. The company say that the
results can help people make informed medical decisions.The
kits are set to go on sale at 6,000 of Walgreens' 7,500 stores.
Individual gene tests will retail between $19.99 and $30. Combo
tests are also available such as the drug-response test for $79, the
"pre-pregnancy planning" test for $179, and the health
condition test for $179. All three of the combo tests are
available for $249.FDA's Riley warns, "The claims have
limitations based on existing science, and consumers should not be
making important medical and lifestyle decisions based on these tests
without first consulting a health-care professional."Jim
Plante, CEO of Pathway Genomics refutes that his company has done
anything wrong, stating, "There are people who need or want to
know more about their genetic makeup, and we recognize that, for
some, genetic reports are becoming a more important component in
managing their personal health care. The value of knowing how
genes play a role in our personal lives, and potentially the lives of
our children, is critical for making well-informed health and
wellness decisions."Ed MacBean, vice president of
product development for the company says that his firm will "be
happy to share with the FDA any data that is requested", but
that, "We’re still going to sell the kits at Walgreens because
at this point, we're not aware of any reason we are unable to."The
FDA according to a
report in The
Sun Times may
also be considering action against online retailers of the test
kits. While Walgreens is the first brick-and-mortar retailer to
offer the kits, they've been available previously online.
quote: There goes our wonderful nanny state again, protecting us from the dangers of unrestricted genetic tests.
quote: I agree that FDA is needed and is a good way to prevent snake-oil products or even damaging products from cheating consumers out of money or health. Sometimes it is better to be late than getting it early and being screwed for rest of the life.
quote: Orly? Why don't you ban real cigarettes then?
quote: The FDA does a lot of good work, dude. I can base this on more than watching daytime TV ads. Lawsuits didn't stop Merck & Vioxx; the FDA did.
quote: "In 2005, advisory panels in both the U.S. and Canada encouraged the return of rofecoxib to the market, stating that rofecoxib's benefits outweighed the risks for some patients. The FDA advisory panel voted 17-15 to allow the drug to return to the market despite being found to increase heart risk."
quote: "Merck & Co.'s arthritis drug Vioxx may have led to more than 27,000 heart attacks and sudden cardiac deaths before it was pulled from the market last week, the Wall Street Journal reported Wednesday, citing an unreleased study by government regulators."
quote: Man I love how people here really seem to hate the FDA. If it weren't for the FDA, we'd have the quality control of China.
quote: That's assuming the consumer is aware that a product is killing or damaging them. If it weren't for a regulating agency, what incentive would a company have to perform long term testing? What incentive would they have to list potential side effects?
quote: I'd love the hear the reasons from whoever voted that down.
quote: Why does the government think it has the right to tell us what tests we can and can't take? Whatever happened to freedom?