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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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When Did We Let Digital Fat-Shaming be OK?

Imagine a person just standing there minding his or her own business, and that person happens to be fat. If you place a clever caption underneath of the photo pointing out just how fat that person is and suddenly, somehow it becomes funny, right? Wrong. I’m sure you’ve these photos floating around on the interwebs. This is what is referred to as fat-shaming.

fat shaming

Personally, I have never found any photos exploiting overweight individuals as a “joke” to be funny at all. Being overweight in itself is not funny. And I have to wonder why this type of discrimination and bullying is still so acceptable in our culture. Even in Hollywood, consider how much negative attention a celebrity gets when they gain weight. Their image is shown on the cover of a magazine with a caption stating something about how fat they’ve gotten, and we’ve allowed that to be acceptable!

I gained a great deal of weight in my early teenage years and in high school, I was somewhere over 200 pounds. My saving grace was that I was funny and well-liked, so I didn’t become the target of much bullying (and most people would never have made fun of me to my face). I thank my lucky stars that things like Facebook and Twitter (heck, even cell phones or texting!) didn’t exist back then, because it’s so much easier to bully someone when you’re sitting behind a computer.
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Conflict of Interest Colored Dietitians’ Annual Food and Nutrition Conference

Sponsorships are generally beneficial and non-controversial. They’re a way to keep doing business without having to worry about funds. But what happens when those sponsorships are in direct conflict with the mission of the sponsored?

AND sponsors

When this happens in the field of dietetics, advocacy groups like Dietitians for Professional Integrity (DFPI) are formed. Founded in February by a group of citizens and 14 dietitians, they were primarily a Facebook group discussing concerns like the connection between the Academy of Nutrition and Dietetics (AND) and Big Food.

Last month AND held their annual Food and Nutrition Conference and Expo. DFPI attended the event, commonly referred to as FNCE, and have now released a report entitled “The Food Ties that Bind,” summarizing and detailing the message Big Food shared with the attendees.

According to the report, the Expo hall was liberally peppered with information from AND’s various partners and sponsors, including but not limited to: Coca-Cola, Kellogg’s, Unilever, General Mills, PepsiCo and the National Dairy Council. Corporate sponsors of FNCE had the opportunity to include “educational materials” in the tote bag provided to each attendee.

One handout, “Aspartame: One of the Most Studied Ingredients in the World,” was provided by Coca-Cola’s Beverage Institute for Health and Wellness. It detailed how long aspartame has existed and stated that it is used in 100+ countries around the world. It failed to include information from a recent study that found artificial sweeteners can alter the food reward-system response in the brain. This after Coca-Cola got blasted for being the health and wellness sponsor at BlogHer by the social media community.
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No Fat Girls Allowed at Lululemon Athletica

It’s been a sour year for Lululemon Athletica. First, the company was forced to recall nearly 20 percent of their yoga pants because they were basically see through. As if the massive product shortage wasn’t enough, they proceeded to mock a domestic abuse charity in Dallas. And when Lululemon co-founder Chip Wilson was asked to reflect on the yoga pants fiasco, he offered this gem: “Frankly, some women’s bodies just don’t actually work for it.”

He just said that. That’s what he told Bloomberg TV earlier this week, when his wife and co-founder Shannon Wilson were on the air to talk about their 60 second meditation technique that they probably charge $100 for. Shannon quickly went into damage control, spinning Chip’s message into a “we’re more concerned with people using our pants in the wrong way” kind of thing. She literally blamed the “see through” pants fiasco on the fact that peopleĀ might be sitting on cement.

“Not every woman can wear a lululemon yoga pant?” said Trish Reagan, host of Bloomberg TV. “No I think they can,” said Chip. “I just think it’s how you use it.” Right.

It would be nice if that’s what the lululemon founders really meant. But this is the same elitist and discriminatory message they’ve been peddling for some time. This summer, the company posted a message to its Facebook page and acknowledged that their clothing is not meant for plus sized women.
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McDonald’s and Burger King Violate Children’s Advertising Agreement Making Up 99 Percent of All Fast Food Ads Aimed at Kids

McDonald’s and Burger King agreed to advertise only healthy food offerings as part of the Children’s Food and Beverage Advertising Initiative. Let’s see if they’ve kept their word.

INFOGRAPHIC

When it comes to child marketing, McDonald’s and Burger King are selling the experience, not the food.

The above study, funded and published by the Robert Wood Johnson Foundation, has found the two largest fast food corporations aren’t as dumb as they look. They’ve figured out that showcasing their food is actually a bad idea. Obviously McDonald’s and Burger King cannot self-regulate their ads aimed at children. The facts are anything but elementary, as the tactics of these fast food behemoths are prolonging the childhood obesity epidemic. One-third of our children remain obese.

99 percent of all fast food ads aimed at children came courtesy of two companies.

Any guesses? Not a tough one here, folks. McDonald’s and Burger King placed 44,602 and 37,210 ads aimed at kids, respectively. This is disconcerting. Despite big fast food’s efforts to increase healthy offerings, the burgers, fries, and nuggets peddled in kid’s meals are highly caloric, highly fatty, and highly processed. To this day, no one really knows what McDonald’s chicken nuggets are made of.

Side note: A 3.3oz serving of McDonald’s eggs, which should be one of their healthiest menu items, contains 20 ingredients and 173 percent of your daily cholesterol intake. Just sayin’.
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