Year: 2013
FDA warns Google-backed 23andMe to halt sales of genetic tests
The U.S. Food and Drug Administration has warned 23andMe, a company backed by Google Inc, to halt sales of its genetic tests because they have not received regulatory clearance. 23andMe, which was founded in 2006 by Anne Wojcicki, sells a $99 DNA test that the company says can detect a range of genetic variants and provide information about a person's health risks. Wojcicki recently separated from her husband, Sergey Brin, a co-founder of Google. In a warning letter dated November 22 and released on Monday, the FDA said products that are designed to diagnose, mitigate or prevent disease are medical devices that require regulatory clearance or approval, "as FDA has explained to you on numerous occasions." The privately held company, which is based in Mountain View, California, acknowledged receipt of the letter and said in a statement that "we recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission." The FDA said some of the intended uses of the company's Saliva Collection Kit and Personal Genome Service (PGS) are particularly concerning, including risk assessments for certain cancers.
Clues To Alzheimer’s Risk Can Be Detected In Infancy, Study Suggests
By Rachael Rettner, Senior Writer Published: 11/25/2013 04:03 PMEST on LiveScience People who are genetically predisposed toAlzheimer's disease may have differences in their brains that canbe detected as early as infancy, a new study suggests. Researchersscanned the brains of 162 healthy babies, including 60 who hadinherited a gene called APOE-e4, which increases the risk ofdeveloping Alzheimer's after age 65. …
Republicans put spotlight on Obamacare critics in Georgia
By Steve Norder GAINESVILLE, Georgia (Reuters) – Republicans went to the American South on Monday to press their opposition to President Barack Obama's signature healthcare law in a U.S. congressional hearing that the law's supporters called a one-sided political attack. The hearing, chaired by Republican Representative Rob Woodall of Georgia, heard from witnesses picked by the panel's Republicans who said that the healthcare law – intended to help millions of uninsured and under-insured people get affordable medical insurance – actually will raise insurance costs and reduce coverage choices for many people in rural America. Michael Boyette, a 28-year-old businessman from Ellijay, Georgia, said his insurance premium was increasing by almost $200 per month for his family of three. This is not affordable to me." Supporters of the law, also known as Obamacare, complained that the hearing was merely the latest attempt by Republicans to denigrate it.
FDA overturns safety limits on diabetes drug
FDA lifts constraints on Glaxo diabetes drug Avandia
Health regulators said on Monday they would lift restrictions on the use of GlaxoSmithKline Plc's once widely prescribed diabetes drug Avandia, after determining that it did not increase the risk of heart attacks. The U.S. Food and Drug Administration, following its review of a large clinical trial aimed at determining the drug's heart safety called Record, said it found that the trial showed no elevated risk of heart attack or death in patients being treated with Avandia when compared with standard-of-care diabetes drugs. These data do not confirm the signal of increased risk of heart attacks that was found in an analysis of previous clinical trials first reported in 2007, the FDA said in a statement.
Yoga: How We Serve the Larger Woman
This is an interview with Vilma Zaleskaite, who slipped into a yoga career by accident. In the late 1990’s, her American husband was introducing yoga to Lithuania, Latvia, and Belorussia. Vilma grew up in Lithuania and served as an assistant and interpreter for him. Soon she began teaching on her own, both in Vilnius, Lithuania, and in Portland, Oregon.
People Who Experience Migraines And Allergies Could Have Worse Headache Symptoms
Having allergies could make headache symptoms worse for people who experience migraines, according to a new study. The research, published in the journal Cephalalgia, showed that people with both migraines and rhinitis experience more frequent headaches compared with people who have migraines but not rhinitis. "We are not sure whether the rhinitis causes the increased frequency of headaches or whether the migraine attacks themselves produce symptoms of rhinitis in these patients," study researcher Vincent Martin, M.D., a professor of medicine at the University of Cincinnati, said in a statement.
Black Friday: Is Shopping A Workout?
By Hanna Brooks Olsen for Blisstree.com The day after Thanksgiving,the last thing you'll be thinking about is weight loss. And ifyou're debating about whether or not you should hit the gym to makeup for yesterday's edible indiscretions, if the alternative isgetting up and moving long before the sun shines for Black Friday,you may actually want to skip your run and go shopping instead –it burns more calories than you think. Assuming that all you do iswander the aisles from the hours of 5 a.m. until 11 a.m. or noon,you'll have been walking,
The Power of Bearing Witness
Black Friday Fitness: 10 Ways To Move More
There's the walking from store to store, the stretching to reachthe good stuff on the top shelf, maybe some heavy lifting onceyou're carrying all those bags — it's tempting to consider yourBlack Friday shopping adventure actual exercise. Before you go andskip your workout for the day, let's just say there are moreefficient ways to fit in a sweat session. But that said, if you'replanning to spend the day (or night… or both!) at the mall, itcertainly can't hurt to try to make the experience a bit moreactive. We've polled some of our