June 24, 2014
The FDA’s obesity “logic” hurts Americans—and endangers supplements. Action Alert!
On June 17, an FDA advisory panel moved closer to full FDA approval on VBLOC—a new implant designed to curb appetite by electrocuting stomach nerves. The device is implanted under the skin of the chest, and delivers electrical shocks down the two trunks of the vagus nerve(the nerve that controls the digestive system, heart, lungs, and some glands). The jolts stun nerves around the stomach, decreasing hunger pangs and simulating a feeling of fullness.
The panel voted 8-to-1 that the device is safe, 6-to-2 that the device’s benefits outweigh its risk, and 4-to-5 that the device will effectively help patients lose weight (that is, a majority voted that it would not help patients lose weight). The side effects of VBLOC, produced by EnteroMedics, Inc., include pain, heartburn, constipation, nausea, depression, diarrhea, infection, organ or nerve damage, device movement, and device malfunction. Keep in mind that the vagus nerve is one of the body’s most important organs. If it is damaged, the effects will be horrendous for health.
Please also keep this in mind: the committee found that the device’s benefits outweigh all these side effects, yet most of the committee said it doesn’t help consumers lose weight. So what, exactly, are the benefits—besides adding to Big Pharma’s coffers?
Another new tool in the obesity battle, the AspireAssist, is a thin tube that is placed into the stomach through the abdominal wall in a “reversible” procedure. It connects the inside of the stomach directly to a poker-chip sized port on the outside of the abdomen with a valve that can be opened or closed to control the flow of stomach contents. About twenty minutes after eating, the patient is supposed to empty a portion of stomach contents into the toilet after each meal through this tube by connecting a small, handheld device to the external port. Aspiration is intended to remove about a third of the food, leaving sufficient calories for nourishment.
The AspireAssist is currently available in some European countries and, according to Dr. David Williams’s Alternatives Newsletter, appears headed for FDA approval in the US. The AspireAssist will be offered as an alternative to gastric bypass surgery, though more than one critic has called it a high-tech, medically assisted form of bulimia. Why change your food choices or your lifestyle when, like some overfed ancient Roman, you can simply get rid of what you’ve just eaten and then feast some more?
Although we question what the FDA and mainstream medicine consider to be “safe” weight loss tactics, there’s no denying that obesity is an American epidemic: 35.1% of adults are obese, while 69% of adults are overweight. Obesity accounts for 18% of deaths between the ages of 40 and 85, and costs our healthcare system nearly $150 billion dollars a year.
Further, nonalcoholic fatty liver, which is mainly triggered by poor diet resulting in obesity, now occurs in 10% of children and at least 20% of adults. It’s currently the country’s second leading cause of liver transplants, second only to liver failure caused by acetaminophen (i.e., Tylenol). By 2025, if nonalcoholic fatty liver continues to increase unabated, 5 million Americans will need new a liver. Currently, just 6,000 liver transplants are conducted per year—there is no way that supply can meet this future demand, and of course transplants introduce a host of risks, since, among other parts of the procedure, the immune system must be suppressed for a long time to control rejection of the foreign organ.
But instead of encouraging lifestyle changes and programs that tackle the causes of America’s weight problem—sedentary lifestyles; the side effects of risky drugs; stress; lack of sleep; chemicals in the environment such as BPA; processed, sugary foods and other poor diet choices; persistent misconceptions about diet (i.e., “a calorie is just a calorie” and “fat is bad”)—the FDA continues to champion drugs and surgery that treat just one symptom: fat.
Being obese is one manifestation among many of a body that is out of balance. Unfortunately, the FDA and mainstream medicine ignore this:
- The FDA officially classified obesity as a disease in 2000. It is believed to have done this because supplements are not allowed to make disease claims, and big drug companies wanted the treatment field to themselves.
- In 2008 the Obesity Society officially supported classifying obesity as a disease.
- In 2013, the American Medical Association’s House of Delegates followed suit. While the AMA has no legal authority, it holds tremendous sway over public policy makers, insurance companies, and the public. It seems clear that the AMA is eager to classify obesity as a disease in order to give doctors a larger market base for their lucrative obesity treatments.
- The European Court of Justice is currently considering whether or not obesity should be classified as a disability.
- The IRS has ruled that obesity treatments qualify for tax deductions—if you itemize, you can deduct your weight loss program under medical expenses.
For now, supplements are allowed to make weight loss claims that don’t refer to obesity—for example, “Adequate protein intake can help you feel full, which can help you maintain a healthy weight.” However, Big Pharma giant GlaxoSmithKline has already petitioned the FDA to remove weight loss supplements from the market so it can sell its weight loss drugs without competition.
If the FDA were to grant GSK’s petition, weight loss supplements would be banned. At worst, we would lose access to such important weight loss supplements as garcinia cambogia or green tea extract. At best, supplements may remain on the market but the public will be ignorant of their benefits as manufacturers won’t be able to say what conditions the supplements can affect.
Action Alert! Please tell the FDA to reject GSK’s petition and keep weight loss supplements safe!