My name is Alison Hoppin, and I am a physician specializing in the field of Pediatric Obesity Medicine. I am grateful for the opportunity to speak with you today about the “dietary supplements” that are marketed as weight loss agents for overweight children. I am concerned about the lack of scientific standards displayed in the marketing tactics of some members of this industry. The marketing claims are misleading at best, sometimes patently false, and these issues are of particular concern for the products that are marketed for use in children.
My specialty training is in Pediatric Gastroenterology and Nutrition, and for the past eight years the focus of my research and patient care has been on the problems associated with obesity in children and adolescents. I direct the Pediatric services at the Weight Center at Massachusetts General Hospital, one of the academic medical centers associated with Harvard Medical School. The MGH Weight Center is a multidisciplinary program for clinical treatment of adults and children with obesity. It is also a center for research into the underlying causes, consequences, and treatment of obesity. I am an instructor on the faculty of Harvard Medical School, where I teach medical students, residents, and fellows in Nutrition and Pediatric Gastroenterology. I am also the mother of two children—10 and 12 years old. It is with the dual perspective of a physician and parent that I speak today.
Our country is now facing an epidemic of obesity. It affects all socioeconomic and ethnic groups in our society, and all age groups. Indeed, rates of obesity in children have tripled over the past 30 years. This is not a benign or cosmetic problem. Obesity causes or worsens more than 40 different medical diseases, including diabetes and heart disease, depression, breast cancer, colon cancer, and prostate cancer. It is responsible for over 400,000 premature deaths annually in the United States, and over $100 billion dollars in health care costs each year. Added to this enormous disease burden is a heavy emotional burden from obesity, due to pervasive cultural preferences for thin body types. This leads to criticism, negative stereotypes, ridicule, and outright bias against individuals with obesity.
There are no consistently successful low-risk treatments for obesity. Many individuals with obesity lose weight in the short term with a wide variety of diets, exercise, and behavioral approaches. However, fewer than 5% of adults keep this weight off for five years or more, past and current diet fads notwithstanding. Against these odds, people that are facing the emotional and physiological burden of obesity understandably feel discouraged and desperate, and are therefore vulnerable to products making claims of success.
Children and adolescents are unique in the field of obesity. They are particularly vulnerable to the emotional consequences of obesity, as the impact of teasing from peers or criticism from adults is particularly damaging to their self-esteem. As they go through puberty, adolescents are acutely aware of their changing bodies and are strongly influenced by images of their idols in the entertainment world, professional sports, and in the popular press. They tend to act impulsively and often fail to consider long-term risks. They are therefore particularly prone to risky dieting behavior, including eating disorders.
I am very concerned about the misinformation that has permeated the field of obesity in the past, and in particular by the companies marketing “dietary supplements” that take advantage of the frustration, fears, and desperation that frequently arise in individuals fighting obesity, or in those who are merely dissatisfied by their body size. Some members of the dietary supplement industry develop products based on a very shaky foundation of pseudo-science. They then market these products to a vulnerable population. They frequently claim pharmacological effects of the products, but take no responsibility for assessing or communicating the possibility of pharmacological side effects or toxicities. In their marketing, many members of the dietary supplement industry display scientific standards that are well below that of companies in the pharmaceutical, food, or cosmetic industries.
Three “dietary supplements” were recently marketed as “weight loss” treatments for children. Each used combinations of herbal medicines that were previously marketed to adults with claims for weight loss. The very names of these products—the “Skinny Pill for Kids,” “PediaLoss,” and “PediaLean”—make claims of pharmacological effects, and supplementary marketing materials go further. The claims that the Skinny Pill “works overnight with a thermic formula to burn fat while you sleep” and “prevents starch from turning into sugar and then into fat” have no basis in scientific fact. I have reviewed the scant scientific material available to support or refute these claims. In most cases, the data consist of small studies in adults using single-ingredient preparations. The study designs fall short of standards required for scientific proof. Frequently, two studies on the same compound give contradictory results. Extrapolation of results from one study or group of studies is difficult due to highly variable nomenclature and lack of measurement standards for active ingredients. Moreover, one cannot assume that results of studies on a single-ingredient preparation will be valid for multiple-ingredient preparations, in which different active ingredients may might interact to change effectiveness or danger from toxicity.
In my review of the literature, I found no studies that tested the particular combinations of dietary supplements used in “The Skinny Pill for Kids” or “PediaLoss,” in either adults or children. Moreover, most of the individual ingredients in these preparations have not been adequately tested for safety in children. Children are not just small adults, and their responses to drugs or toxins may be quite different from those seen in adults. This raises serious concerns about the effects that ingesting these products could have in young children.
One of these products, “PediaLean®,” makes its claim based on a purported clinical study of the product in Italian children over ten years ago, published in an Italian medical journal. It appears that someone, presumably the company that makes PediaLean, had the study translated into English. Selected excerpts from the study were then published in marketing materials for PediaLean, under the statement that this product is “Clinically Proven Safe and Effective.” However, I have serious concerns about the study design, particularly the lack of a true control group, and therefore I have serious doubts about the validity of the authors’ conclusions. There is no placebo control, and no discussion of how the control group was selected, so apparently there was no randomization process. Thirty-eight percent of the subjects dropped out of the study, and results from these drop-outs was apparently ignored. The study states that at least 14% of patients given PediaLean “stopped taking the fiber capsule because they complained of abdominal discomfort or because they had not noticed any reduction in appetite.” Ignoring drop-outs like these can greatly bias the results of a study, and is not an accepted approach to analysis.
The Italian study makes no effort to assess for side effects or toxicity from this product, although it does mention, in passing, that a significant number “complained of abdominal discomfort.” The active ingredient, glucomannan, is known to swell in the body after it is taken, and several cases of esophageal and gastrointestinal obstruction reported in the literature. I have concerns about the possibility of esophageal obstruction in patients taking a compound containing glucomannan, but the Italian study makes no mention of monitoring their subjects for this or other side effects or toxicity. The so-called “micronization” process with which the glucomannan is treated provides no reassurance against the possibility of obstruction. A compound can swell and stick together in an obstructive mass regardless of the size of the particles. I have seen no evidence, in the company’s own materials or elsewhere, that micronization changes the tendency of glucomannan to clump and form an obstructive mass when mixed with water.
Despite these obvious flaws in study design, the marketing claims for this product include such inappropriately definitive statements as “Klein-Becker’s proprietary micronization process guarantees that PediaLean® is not only safe, but is the one and only weight-control compound designed, manufactured, and clinically proven safe and effective for use by overweight children and adolescents.” On the contrary: there is no valid clinical proof here that the product is either safe, or effective for weight loss.
Another product, the “Skinny Pill for Kids®,” includes Uva Ursi (also known as bearberry), an ingredient that in several objective sources is specifically not recommended for children under 12 years of age because of concerns for liver toxicity. , , A second ingredient, Juniper Berry, may cause kidney damage with “prolonged use” or if high doses are used. These and one other ingredient are considered weak diuretics, meaning that they increase water loss in the urine, and this might conceivably cause transient minor loss of water weight, which might deceive a patient into thinking that it was helping with weight control. However, there is no biological reason to believe that this diuretic effect would cause any loss of fat, which would be the only “real” type of weight loss.
Another product, “PediaLoss®” contains just one ingredient that might conceivably cause weight loss (HCA), although two studies on this ingredient give contradictory results. A second ingredient, lecithin, has no support for use as a weight loss agent, and indeed weight gain is reported as a possible side effect of this ingredient.
I am not here to make any statements disparaging alternative medicine in general, or the fields of herbal medicine or dietary supplements in particular. The field of herbal medicines struggles with such issues as lack of standardized nomenclature and dosing standards, and suffers from a dearth of data on which to base clinical decisions. However, I applaud the trend towards creating such standards and improving evidence-based techniques for determining effectiveness and toxicities of medicines in this field.
My concerns are specific to the marketing practices that have been used for some dietary supplements, including those I mentioned earlier. There is no scientific reason to believe that any of these supplements has true effectiveness for short- or long-term control of obesity. Children and adolescents are particularly influenced by advertising or marketing and are less likely than adults to take a skeptical view of unproven advertising claims. To market these to the public with claims of effectiveness is therefore exploitative. The absence of carefully collected follow-up data provides little reassurance about the safety of these preparations when used in large numbers of children and adolescents. To target children and adolescents, a group particularly likely to engage in untested or extreme dieting practices, and a group particularly likely to be influenced by advertising, is particularly irresponsible. This, combined with the lack of safety standards in this field, is certainly risky, and may be downright dangerous.
I am pleased to see that preliminary inquiries by this Committee requesting further information on these products were met by abrupt withdrawal of the product from the market in two of the three cases. However, these events do not alter the legislative climate that allows for unbridled and irresponsible marketing of dietary supplements with minimal standards of accountability for potential hazards. In each of the instances noted above, there is inadequate information to provide a reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury in children. I support stronger regulation of these products, based on at least some minimal scientific standards. Stronger regulation is particularly important when products are marketed to vulnerable populations such as the elderly, or the children and adolescents targeted by the products described her
Dr. Hoppin is Associate Director for Pediatric Services at the MGH Weight Center of Massachusetts General Hospital. The FTC has acted against the three products identified in her testimony. The Skinny Pill case was settled in 2004. The PediaLoss case settled in 2006. The PediaLean case appears likely to settle in 2006.
This article was posted on April 16, 2006.