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Witness Testimony
Mr. Keith Ayoob
Parents Be Aware: Health Concerns about Dietary Supplements for Overweight Children.
Good Morning and thank you for the opportunity to speak with you on a topic of such concern to me: children's health. My name is Dr. Keith Ayoob and I thank you for the opportunity to testify. I hope you will find my comments useful. First, a summary about my credentials and background: " I am an associate professor of pediatrics at the Albert Einstein College of Medicine in New York and the Director of the Nutrition Clinic at the Rose F. Kennedy Children's Evaluation and Rehabilitation Center there. " For nine years, I served as a volunteer media spokesperson for the American Dietetic Association, and gave over 800 interviews for print, television, radio and the Internet on timely nutrition topics in the media. " I have been on the Board of Editors of the Journal of the American Dietetic Association for four years and was an outside reviewer for the Journal for 12 years prior and I am very familiar with the evaluation of scientific research. During this time, I have reviewed hundreds of proposed articles for publication in the Journal about clinical trials conducted in the field of diet and health research. " I am also on the advisory board of the Children's Advertising Review Unit of the National Advertising Review Board. In this capacity, I advise the Unit about the accuracy and appropriateness of food advertising claims for foods targeted for consumption by children. I first learned about the "Skinny Pill for Kids" back in early December 2002, when Barbara Hoffman, a reporter with The New York Post, asked if I'd heard of a new diet pill being marketed to children 6-12 years old. At first I thought she'd misinterpreted a press release-because as a pediatric nutritionist, I could not imagine someone coming up with a pill for young children that promised healthy, safe and effective weight loss - but she referred me to a web site called "www.skinny.com" that had all the details about these supplements. I reviewed the website and was both angry and disgusted by the information contained on the website about the "Skinny Pill for Kids." The information was scientifically baseless, blatantly exploitative, and potentially very harmful to children. When Ms. Hoffman's story ran in the Post on December 6, 2002, the television media picked it up and I was invited to debate the marketer of the pills, Edita Kaye, on NBC's "The Today Show" the following Monday, approximately the same time the product was to begin shipment. I said on that program, and I will reiterate it today, the Skinny Pill for Kids, as well as these other dietary supplements for children that the Committee has looked at are "junk science." Before I say a few words about the Skinny Pill for Kids, I would like to note that I was extremely relieved that, due the pressure put upon Edita Kaye (the creator and marketer of the pill) by the medical community and the media, the Pill was pulled from the market before any child had actually taken it. Further, I also felt vindicated in my efforts to counteract Ms. Kaye's public claims about the product on national television. And now, I'd like to summarize some concerns I had about the ingredients in the product, as well as the marketing claims Ms. Kaye made: " There is no scientific basis for ANY of the claims made about the Skinny Pill for Kids on Ms. Kaye's website. There is however, scientific evidence AGAINST many of the claims she made. The pills were a concoction of a few vitamins and minerals, along with fiber and herbs. A few examples of false claims, in my opinion:
As for the vitamins, the amounts of niacin, folate, and vitamin B12 in the Skinny Pill for Kids, can be obtained far more economically in any standard, over-the-counter multivitamin supplement that would also contain many other vitamins and minerals. There is no need to take separate amounts of them. As for the herbal ingredients, she makes false, unproven claims about many of them, for example: " Uva ursi: "Acts as a diuretic and helps diabetes. It has also been shown to strengthen heart muscle." She's only right about it being a diuretic herb, and that's a huge concern. The Physicians' Desk Reference for Herbs (a standard reference text, well accepted by health professionals) stated, with scientific backing, that uva ursi was CONTRAINDICATED for children under the age of 12 years - the very target population of these pills - as it has been associated with liver damage. " Glucommanan: "This substance actually picks up and removes fat from the colon wall. It is good.for obesity because one of its primary functions is the removal of fat. It has been recognized for normalizing blood sugar and it expands up to sixty times its own weight and, in so doing, helps maintain a feeling of fullness and curbs appetite." Glucommanan is just a food thickener that has never been proven safe or effective for weight loss. " Buchu Leaf: "Aids in controlling diabetes and digestive disorders and fluid retention." For weight loss, it has never been shown to be effective. It can however, function as a diuretic and should not be given to children. " Juniper Berry: "Helps regulate blood sugar and aids in fluid retention." This is another diuretic herb. Children who need diuretics should be under the care of a physician, not Ms. Kaye. One statement on her website was true regarding glucommanan: "It is important to drink a large glass of water with this ingredient, as it can lodge in the throat and expand thereby causing breathing problems." This should be an indicator to the Committee that this is an inappropriate supplement to give to children, especially those 6 years of age. The issue is simple: the Skinny Pill for Kids should never have been even thought about for children, let alone marketed to them. Since fiber pills have not been shown to have much effect on weight loss, I am also concerned about another supplement for overweight children called PediaLean. Again, there is no scientific basis for the claims about this product, although the marketers, Klein-Becker, seem to want you to believe otherwise. I have reviewed the website for the product, www.pedialean.com, and have concerns about their purported "clinical evidence" for safety and efficacy. These are a few comments I have about the cited "clinical evidence" that PediaLean helps children lose weight: " The study was not published in any journal I have ever heard of. I have been on the Board of Editors of the Journal of the American Dietetic Association for several years. I read and review numerous manuscripts, good and bad, all the time. I would never have had the chance to review this one however, because this would never have made it to my desk. The associate editor or the editor-in-chief would have screened this and rejected it out of hand and I am very grateful that they do not waste my time with this type of study. " This study was a single study, done in the early 90's on a small number of children. The copy I received was translated from Italian and the full name of the journal was not revealed, only an abbreviation. This is highly unusual for a translated study that being used to make specific claims, as it limits the ability of the reader to verify the publication. " There are not even any units assigned to the numbers associated with the claimed weight loss. I have no idea if they are indicating pounds or kilos when they refer to weight loss. " The study has never been replicated. It has no controls. Without controls, I have no idea if the results were due to the pills or to the fact that children had to take two pills with a large glass of water before meals. Every researcher knows you need controls to make your study meaningful. This is research 101. When you do not include control groups, it suggests that you may not want the reader to know the results. This is a study that suggests that the researchers didn't want the results to be accurate. They just wanted them Tuesday, so to speak. For a company to rely on a study conducted in Italy over ten years ago, of such poor quality and questionable conclusions, to support their marketing statements that a product is safe and effective for a 6 year old, is disturbing. The makers of Pedialoss also developed a pill with ingredients that promise but cannot deliver weight loss. The ingredients in Pedialoss, inulin and lecithin, have never been scientifically shown to aid in weight loss. Once again, this is a sham product that cannot deliver what it promises because its claims are baseless and yet another example of junk science. Products like these should never exist. Even if they cause no harm that is reported, they serve only to exploit children and their caregivers by fostering the illusion that these products work, perhaps preventing them from seeking real solutions. These supplements are also expensive. The Skinny Pill for Kids were to cost $40.00 per month. PediaLean cost almost $80.00 a month. I'd rather see parents put their hard earned money towards buying healthy food and taking their children for healthy physical activities. Childhood overweight is a serious issue. It needs a serious solution. True lasting results to the obesity problems of children and adults are not going to be found in over-the-counter supplements. If they are, then a body of sound, scientific evidence should come before the claims. It is completely inappropriate to allow people to market "supplements" with no evidence that they work, and then wait until there is a complaint or even harm, before they are investigated. The loopholes in the laws that permit these types of supplements to be marketed should be closed. They should be closed and nailed shut. My only regret in the judgment imposed on Ms. Kaye is that the multi-million dollar fines attached to the judgment were forgiven for her lack of ability to pay. That makes for a rather weak judgment. Only if she, and others of her ilk, were hit in their pocketbooks, where they'd feel it most, and were held responsible for paying back the fine, even over the course of many years, might they think twice about marketing junk supplements to vulnerable children and their families. Thank you for you time and I am prepared to answer any questions you may have on these or other matters. 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