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23andMe Broke the FDA’s Rules. Dr. Richard Besser Explains the Violation and Why This isn’t About Blocking Your Rights

UPDATE 12/7/13: 23AndMe may no longer support new clients in accordance with the FDA directive delivered to the personal genome testing company last month. Our interview, below, with ABC’s Dr. Richard Besser explains, as does this message on the company’s homepage.

23andme suspended

This week the FDA took action against 23andMe, the popular home genome testing kit, to discontinue marketing its product until years of unresolved requests from the government agency can be addressed.

“Since July of 2009, we have been diligently working to help you comply with regulatory requirements regarding safety and effectiveness and obtain marketing authorization for your PGS [Personal Genome Testing] device,” wrote the FDA in a letter made public on its website. The company has failed to comply with all of the FDA requests to receive proper validation and approval by the agency, something required of medical devices and tests.

23andme

According to Dr. Richard Besser, Chief Health and Medical Editor at ABC News and author of Tell Me the Truth, Doctor, that’s exactly what 23andMe is. He thinks a lot of people online are missing the point about what is going on with the FDA’s motion, explaining “the way our system works, medical tests used for diagnosis, treatment, or prevention need to be approved by the FDA to make sure it does what it says.”

There in lies much of the problem – these genetic home testing kits aren’t always accurate. Dr. Besser cited a government study conducted in 2010 that used 10 kits from four different companies and had a group of volunteers submit their tests. He explained that the results varied not only by company, but within tests from the same company. Some tests showed positives for some genetic markers and diseases, while others showed negatives. The inconsistency can be incredibly misleading and disconcerting for consumers.

“These tests are fine if you want to look at your ancestry or for male pattern baldness,” explained Dr. Besser, who went on to say that when a test like this shows a woman that she is a carrier for the BRCA gene (the marker for breast cancer), “she needs to know that it’s right.” Some serious, sometimes life-altering, decisions have to come from the results of these tests.

What has happened in this instance is that 23andMe hasn’t just marketed this test as a cellular way to track your ancestry and family history, but instead with the intention of “diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body,” per the FDA letter. 23andMe’s website tells customers the test will provide health results for 254 diseases and conditions, and that’s a red flag for the FDA, who has been trying for the better part of five years to get 23andMe to relinquish the pertinent data, testing, and information necessary for validation and approval.
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The Procrastinator’s Guide to Weight and Kicking Bad Habits on The Doctors

Today, The Doctors are covering some great topics. From new techniques to ending bad habits, an unexpected side-effect from a heart medicine, and how to lose weight without ever hitting the gym, you’ll walk away with some valuable information.

The cast will be digging deep into the idea of a “gluttony gene” and helping people discover if they have this so-called gene. Also, a medical explanation and reason for binge eating will be discussed. While the docs are on the subject, they will introduce the audience to a man who lost 160 pounds without ever going to the gym. This fantastic weight loss story will also include a “how-to” for those watching at home.

Since the good doctors are always trying to help the viewers look and feel their best, they will be describing an at-home miracle peel that can rejuvenate sun-damaged skin. The cast will discuss safe treatments for the skin as they welcome guest Renee Graziano, the star of the reality show Mob Wives. Together they will discuss her plastic surgery misfortune and how to avoid such mishaps.
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Genes Found to Increase Obesity Risk in Children

A study that compared data in children has found the presence of two genetic variations that may increase the risk of childhood obesity.

The researchers used data from 14 studies that used meta-analyis from North America, Australia and Europe. The team compared genetic data from 5,530 obese children and 8,318 non-obese kids.

The researchers uncovered two new childhood obesity related genes, one on chromosome 13, near the OLFM4 gene and the other one on chromosome 17 within gene HOXB5. The results are published in Nature Genetics.

Even though the factors of nutrition, physical activity and environment play a role in childhood obesity, the study shows there is also a genetic relationship.
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A Few Thoughts on The Fat Trap by Tara Parker-Pope

two overweight people with exercise ballsTara Parker-Pope may not a household name, but anyone writing about health news is sure to be familiar with author and columnist and editor of The New York Times Well blog. Just in time for New Year, she took one the question of weight loss in a long-from article title “The Fat Trap,” published in The New York Times Magazine this Sunday. Parker-Pope shifts through the research and combines it with personal interest to deliver a survey of the current understanding of the underlying genetics that cause obesity.

Much of the article focuses on the ways in which weight gain is caused by genetic and biological factors. This is not only important for understanding how to treat those who suffer from being over weight and obese not only physically, but also emotionally. As a society, we all too often see weight gain as a moral failing.

“Many times even health professionals view individuals who are overweight as lazy and unable to follow through with strict dietary recommendations because they don’t have strong enough will-power,” says R.D. Kati Mora. “I think as more people begin to realize that its not simply a matter of will-power and that other factors are at play, we will approach weight loss in a more compassionate, caring way. This will hopefully help individuals struggling with weight feel more supported by their healthcare team and be more successful in the long run at implementing the recommendations they are given.”



Diet Beats Genes in Heart Attack Risk

If you are genetically predisposed to a health condition, it may make you feel hopeless. According to a new study, you may be able to beat genetics with a healthy diet.

The researchers found the gene that is the biggest indicator for whether or not a person will be predisposed to heart disease can be modified simply by eating a good amount of fruit and raw vegetables.

“We know that 9p21 genetic variants increase the risk of heart disease for those that carry it,” said Dr. Jamie Engert, joint principal investigator for the study, and a cardiovascular disease researcher at the Research Institute of the McGill University Health Centre. “But it was a surprise to find that a healthy diet could significantly weaken its effect.”

“Our research suggests there may be an important interplay between genes and diet in cardiovascular disease,” says the study’s lead author Dr. Ron Do.
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