ObesityHelp

(December, 2011)

The U.S. Food and Drug Administration and the Federal Trade Commission (FTC) today issued seven Warning Letters to companies marketing over-the counter (OTC) HCG products that are labeled as “homeopathic” for weight loss.

Human chorionic gonadotropin (HCG) is a hormone produced by the human placenta and found in the urine of pregnant women. HCG is FDA-approved as an injectable prescription drug for the treatment of some cases of female infertility and other medical conditions.

The letters warn the companies that they are violating federal law by selling drugs that have not been approved, and by making unsupported claims for the substances. There are no FDA-approved HCG drug products for weight loss.

The joint action is the first step in keeping the unproven and potentially unsafe products from being marketed online and in retail outlets as oral drops, pellets, and sprays.

The labeling for the “homeopathic” HCG products states that each product should be taken in conjunction with a very low calorie diet. There is no substantial evidence HCG increases weight loss beyond that resulting from the recommended caloric restriction.  Consumers on a very low calorie diet are at increased risk for side effects including gallstone formation, electrolyte imbalance, and heart arrhythmias.

“These HCG products marketed over-the-counter are unproven to help with weight loss and are potentially dangerous even if taken as directed,” said Ilisa Bernstein, acting director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “And a very low calorie diet should only be used under proper medical supervision.”

“Deceptive advertising about weight loss products is one of the most prevalent types of fraud,” said David Vladeck, director of the FTC’s Bureau of Consumer Protection. “Any advertiser who makes health claims about a product is required by federal law to back them up with competent and reliable scientific evidence, so consumers have the accurate information they need to make good decisions.”

According to the Warning Letters, the companies have 15 days to notify the FDA of the steps they have taken to correct the violations cited. Failure to do so may result in legal action, including seizure and injunction, or criminal prosecution. 

Consumers and health care professionals are encouraged to report adverse events (side effects) that may be related to the use of these products to MedWatch, the FDA's voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

For more information go to:

www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm282161.ht m

www.fda.gov/ForConsumers/ConsumerUpdates/ucm281333.htm

www.fda.gov/ICECI/EnforcementActions/WarningLetters/default. htm

www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedic ineSafely/MedicationHealthFraud/ucm282465.htm

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So, here’s the bottom line on this “hCG Diet“.

Human chorionic gonadotropin (hCG) is a hormone approved by the FDA for use in pre-pubertal boys to help aid normal sexual development, and in women to treat fertility problems. hCG is produced by the placenta and is also found in pregnant women’s urine. It is not approved for weight loss and has never been proven by credible peer reviewed science to cause weight loss. So how did hCG surface as a weight loss solution?

Back in the 1930′s, a physician named A.T.W. Simeons was using hCG for the standard reproductive medical conditions for which it was approved. He observed that some of his patients dropped weight while on the hCG injections. Thinking that perhaps the hCG was the cause, he administered the injections along with a dietary plan to overweight patients and noted weight loss. Please note that subsequent researchers repeated his clinical study and were never able to replicate any association between hCG and weight loss.

Since then, most independent, peer-reviewed studies have shown no difference in weight loss between subjects on a low-calorie diet *****ceived hCG injections and subjects *****ceived a placebo. In 1975, the FDA noted that hCG is not a weight loss drug. In 1995, the British Journal of Clinical Pharmacology published a summary of research showing no hCG related weight loss association. The American Society of Bariatric Physicians does not recommend hCG for weight loss as noted in a December 2009 position paper.

Flash forward to 2007 when Kevin Trudeau published his book “The Weight Loss Cure ‘They’ Don’t Want You to Know About“, in which he concocted a weight loss plan whi*****luded hCG injections. Trudeau has no professional training in medicine, health or science. He is widely known as a controversial businessman who has tangled with the law regarding false health claims related to his books and products. You’d think that common sense would dictate running the other way when this guy hawks anything. But, people are desperate and when they are promised rapid weight loss and an end to their misery, they’ll often line up to sign up.

What is involved with the hCG “diet”:

1) Daily injections of hCG, with online prices ranging from $30 to more than $600 for a month’s supply. One side effect is pregnancy, as hCG increases fertility among women.

2) 500 calories per day of highly restrictive food intake, including coconut oil. One tablespoon of coconut oil contains 13.6 g total fats, 11.8 g of which are artery clogging saturated fats, according to the U.S. Department of Agriculture National Nutrient Database for Standard Reference.

3) A range of body “flush and detox” regimens. Here’s my quote from a prior WebMD interview about this regimen. “All the flushes and cleanses are pure nonsense, unnecessary, and there is no scientific basis for these recommendations,” says nutrition and metabolism expert Pamela Peeke, MD, chief medical correspondent for Discovery Health channel. “Your body is well equipped with organs, such as the liver and kidneys, and the immune system, to rid itself of potential toxins and do an excellent job of cleansing itself without needing flushes or cleanses.“

Here are other concerns related to this “diet”:

1) You’re starving yourself. Your brain alone requires 600 calories per day to function optimally. By consuming only 500 calories per day, of course you’ll drop weight. But at what price? You’re cannibalizing your muscle mass, reducing your metabolism and consequently the effectiveness of your calorie burning. If I had you consume only 500 calories per day and then injected you with water, should I now call this the amazing water cure for weight loss? hCG has nothing to do with your weight loss. Starvation does.

2) It’s impossible to do. So you blame yourself (and not the author) when you cannot complete his plan. This is a core element of the scam. People who are overweight already feel guilty and are often filled with shame. After having laid down a lot of cash and not being able to successfully comply for a month or more, they figure “Oh well, just another diet I’ve failed at”.

3) It is unsustainable. This regimen is almost impossible to adhere to for more than a very short period of time. There are no healthy eating or physical activity behaviors to learn. Eventually you would have to enter the real world. And then, what do you do?

4) It’s unsafe. You cannot meet your baseline survival nutritional requirements on a starvation plan. You can seriously alter your healthy intestinal bacterial flora with repeated “cleanses and detox” regimens. This can lead to altered bowel function and inability to appropriately absorb food nutrients, which can then impair immune function.

Further, many of you have a lot of weight to remove. You may also have associated medical problems, including high blood pressure, elevated cholesterol and high blood sugar levels. You could also be on medications to treat these as well as mental conditions like depression and anxiety. When people buy into a diet scam like hCG, they usually don’t tell their medical team. Rapid weight loss, radically altered food consumption, cleanses and detox regimens can seriously affect your underlying mental and physical conditions and alter the clearance and blood level of medications you’re taking.

Don’t turn yourself into a science fair project. Beware of these radical scam approaches as they can deleteriously affect your health and wellbeing. In the best of all worlds, you’re working with credible health professionals to remove your excess weight.

5) You’re not breaking food addictions. The promise is that you’ll no longer be addicted to food and any abnormal eating behaviors. Credible research has clearly shown that starvation and useless injections are not the solution to food addictions. Behavioral modification, healthy eating practices and regular physical activity have clearly been shown to control food addictions.

6) You’re broke. Take a moment and add up the total costs of the books and products required. That’s why I’ve renamed this “diet” the High CostGame scam.

Finally, there will always be an endless supply of frauds and scams created to prey on your desires to drop weight. To help guide you, here are the Food and Nutrition Science Alliances’ “Ten Red Flags of Junk Science“:

• Recommendations that promise a quick fix.
• Dire warnings of danger from a single product or regimen.
• Claims that sound too good to be true.
• Simplistic conclusions drawn from a complex scientific study.
• Recommendations based on a single study.
• Dramatic statements that are refuted by reputable scientific organizations.
• Lists of “good” and “bad” foods.
• Recommendations made to help sell a product.
• Recommendations based on studies published without peer review.
• Recommendations from studies that ignore difficulties among individuals or groups.

Always remember that if it sounds too good to be true, it is. Anything worth doing in your life requires time and effort to achieve and succeed. Run from false promises like the hCG scam. Stick with life-giving whole foods and physical activity. Now, that’s better living through your own chemistry.

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HCG Worthless as Weight-Loss Aid

Stephen Barrett, M.D.

Human chorionic gonadotrophin (HCG) is a hormone found in the urine of pregnant women. More than 50 years ago, Dr. Albert T. Simeons, a British-born physician, contended that HCG injections would enable dieters to subsist comfortably on a 500-calorie-a-day diet. He claimed that HCG would mobilize stored fat; suppress appetite; and redistribute fat from the waist, hips, and thighs [1]. There is no scientific evidence to support these claims [2-13]. Moreover, a 500-calorie (semi-starvation) diet is likely to result in loss of protein from vital organs, and HCG can cause other adverse effects. Gabe Mirkin, M.D., has noted:

At one time, HCG was the most widespread obesity medication administered in the United States. Some doctors liked it because it assured them of a steady clientele. Patients had to come in once a week for an injection [14].

HCH is also marketed in sublingual (under the tongue) form. No scientific tests of sublingual HCG have been published, but it is safe to assume that it would be no more effective than injected HCG.

In 2009, the American Society of Bariatric Physicians issued a position statement which stated:

Numerous clinical trials have shown HCG to be ineffectual in producing weight loss. HCG
injections can induce a slight increase in muscle mass in androgen-deficient males. The diet used
in the Simeons method provides a lower protein intake than is advisable in view of current
knowledge and practice. There are few medical literature reports favorable to the Simeons
method; the overwhelming majority of medical reports are critical of it. Physicians employing
either the HCG or the diet recommended by Simeons may expose themselves to criticism from
other physicians, from insurers, or from government bodies [15].

Government Regulation

In 1976, the FTC ordered the Simeon Management Corporation, Simeon Weight Clinics Foundation, Bariatrics Management Corporation, C.M. Norcal, Inc., and HCG Weight Clinics Foundation and their officers to stop claiming that their HCG-based programs were safe, effective, and/or approved by the FDA for weight-control. Although the order did not stop the clinics from using HCG, it required that patients who contract for the treatment be informed in writing that:

THESE WEIGHT REDUCTION TREATMENTS INCLUDE THE INJECTION OF HCG, A DRUG WHICH HAS NOT BEEN APPROVED BY THE FOOD AND DRUG ADMINISTRATION AS SAFE AND EFFECTIVE IN THE TREATMENT OF OBSITY OR WEIGHT CONTROL. THERE IS NO SUBSTANTIAL EVIDENCE THAT HCG INCEASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR "NORMAL" DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTIVE DIETS [16].

Since 1975, the FDA has required labeling and advertising of HCG to state:

HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity. There is no substantial evidence that it increases weight loss beyond that resulting from caloric restriction, that it causes a more attractive or "normal" distribution of fat, or that it decreases the hunger and discomfort associated with calorie-restricted diets.

Promotion By Kevin Trudeau

Negative studies and government action reduced the use of HCG injections for weight control close to zero. However, promotion by infomercial king Kevin Trudeau has caused their use to increase. His 2007 book, The Weight Loss Cure They Don't Want You to Know About, claims that "an absolute cure for obesity was discovered almost fifty years ago" but was "suppressed" by the AMA, the FDA, and "other medical establishments throughout the world." Trudeau further claims that until now, "this miracle weight loss breakthrough has been hidden from the public so that drug companies can make billions of dollars selling their expensive drug treatments and surgical procedures for obesity." The alleged cure consists of HCG injections plus 50 to 60 required and recommended do's and don'ts [16].

In 2007, the FTC charged Kevin Trudeau with violating a court order by misrepresenting the contents of the book [17]. In infomercials, Trudeau falsely claimed that the book's weight-loss plan is easy to do, can be done at home, and ultimately allows readers to eat whatever they want. Previous FTC action had led to a court order banning from using infomercials to sell any product, service, or program except for books and other publications The order specified that he not misrepresent the content of the books. In 2008, the Court ruled that Trudeau had violated the previous order and ordered him to pay more than $37 million.