In the largest ever health-care fraud settlement, GlaxoSmithKline has agreed to plead guilty to criminal charges and pay $3 billion in fines for wrongly promoting prescription drugs and not properly reporting important clinical data.
More specifically, Glaxo is pleading guilty to three misdemeanor charges. It is pleading guilty to marketing the anti-depressant Paxil towards children and Wellbutrin as a weight-loss aid, neither ways ever being approved by the FDA. Promoting uses for a drug that have not been approved by the FDA is illegal and is known as off-label marketing.
The other charges are for not reporting important clinical data on Avandia, a drug used in the treatment of diabetics, between 2001 and 2007.
The three misdemeanor charges included a criminal fine of $1 billion for the drugs Paxil, Wellbutrin and Avandia. The remaining $2 billion is connected to the way sales and marketing practices of several drugs, including the asthma drug Advair, were conducted. (more…)
UPDATE May 25, 2012: Yesterday’s vote regarding Senator Durbin’s proposed amendment to the pending FDA Safety and Innovation Act was tabled. A Senate vote of 77 to 20 has removed Durbin’s amendment from consideration in the overall bill.
Durbin sponsored an amendment that would change the current FDA regulation of natural supplements and potentially cause many products to be removed from shelves. His amendment was introduced on Tuesday, May 22 and the voting took place two days later. In two days’ time supplement industries, consumer rights organizations, along with the Natural Products Association (NPA), American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN) and Citizens for Health sent word to their supporters urging them to contact their Senators to oppose Durbin’s plan. As a result, the amendment was not passed and no change will occur to the current law regarding natural supplements. According to the Natural Products Insider, AHPA President Michael McGuffin is very pleased.
“I have worked with my colleagues from each of the other supplement trade associations over the last several days in this call for prompt and cooperative action, and I am pleased that this effort reaffirms the incredible unity of the dietary supplement industry when legislative threats to DSHEA emerge.”
Illinois Senator Richard Durbin has proposed an amendment that would require supplement manufacturers to register with the FDA. Due to the terms of this amendment, if passed, many supplements will be ripped from shelves within the next 30 days.
The vote is scheduled to take place this afternoon, Thursday, May 24. If Durbin’s plan is accepted, a mandate will be placed on supplements requiring information to be provided to the FDA. That information includes a description of the supplement, a list of ingredients, a label for all supplements, and updated information for each new, reformulated, or discontinued product. All of these requirements will fall under the Senate FDA Re-authorization for User Fees bill.
If this amendment passes, supplement companies that fail to register with the FDA within 30 days will be considered “mis-branded” and may be subject to severe financial fees and possibly even jail time.
Currently, supplements operate under the Dietary Supplement Health and Education Act of 1994 (DSHEA). This act states that the manufacturer is responsible for ensuring the safety of a supplement before it is marketed. The FDA is only involved if a product is found to be unsafe after it’s on the market.
While the amendment will affect pills and natural food supplements, Durbin seems to be most concerned about the content of energy drinks. He has even referenced a case of a young woman who died as a result of using an energy drink. The senator wants the FDA to evaluate the difference between a drink and a liquid dietary supplement, and feels energy drinks are dodging regulations by claiming to be a dietary supplement. If they were categorized as drinks they would have to be regulated like all other food and drink products.
Natural supplement suppliers and users have had a short window to petition their local senators and encourage them to vote against the amendment. Due to this, tomorrow may bring major change to the natural supplement industry as we know it.
If you purchased Skechers toning shoes after August 1, 2008 you may be eligible for a refund. Skechers USA has agreed to pay $40 million to settle the case filed again the Federal Trade Commission for making unfounded claims about its Shape-Ups, reporting these shoes would help people lose weight and strengthen their leg and butt muscles.
The amount of each refund will depend on the number and amount of shoes you claim, as well as total number of valid claims filed. The claims are based on the honor system and any claims under $200 will not require a proof of purchase.
The amounts are currently only estimates and the amount could change based on the number of people who apply for the refund.
The shoes cost roughly between $60 and $100, depending upon the style and sales outlet. (more…)
Dr. Pierre Dukan, the French founder of the controversial Dukan Diet, is facing an ethics hearing for his suggestion that French high school students should be rewarded on exams for not being overweight.
Dukan, who’s wildly successful high-protein, low-carb diet has a celebrity following that includes Kate Middleton, made a public recommendation that France’s baccalaureate exam include an “anti-obesity” section that students can pass by staying within their recommended weight range. The exam is required for 17 year olds to finish high school and enter college.
Health professionals immediately responded to the comment, outraged, and the French College of Physicians says Dukan violated the country’s medical ethics code that states “a doctor must be aware of the repercussions his views can have on the public.” The College claims Dukan’s statements were reckless and could do damage to overweight teens and those struggling with eating disorders.
“Everything about this is wrong,” Dr. David Katz, director of the Yale University Prevention Research Center, told ABC News. “It’s wrong because it invites eating disorders. It’s wrong because weight has nothing to do with academic performance… and the notion that weight is a behavior that should incentivized is just wrong. Weight is an outcome. We should incentivize things people can control.”
There have been a couple of cases in the news of social services moving children to live with family members after parents have seemingly ignored doctor orders to help the child lose weight for health reasons, not just in the United States but in Scotland and Canada as well. Nutrition and a healthier environment is also an argument used to determine custody and/or primary residence for a child. The courts are paying attention to the childhood obesity crisis in the United States, which can cause physical and emotional issues for children that extend into adulthood. It is certainly a controversial and inflammatory topic for many.
I admit to having high nutritional standards and being pretty opinionated about what the children in my family are fed. There are certain ingredients that can be considered contraband in my house. As a therapist specializing in adoption, particularly children from hard places, I am familiar with how attention to diet can greatly impact behavior and symptoms of several disorders including ADHD, autism, Aspberger’s, and depression. I think nutrition is vitally important to physical and mental health. In the same way, as a therapist specializing in adoption, I never take separating a child from his or her family lightly. While there are times it is necessary for the health and safety of a child, and times it is outside of anyone’s control, it will have a lasting impact on the child. (more…)