Abstract artistic license: what if errant labeling statements and descriptions led to public excoriation and regulatory seizure?
Erica Herbert, MD, JD, moderator: "Good morning ladies and gentlemen. I'm Dr. Erica Herbert and I'm on faculty at the University of Orbitron, Department of Molecular Medicine and Nutrition. This year we're going to do something different for the next 90 minutes of Inside informant. We have selected some advertising campaigns that claim to be 'science-backed' and given them to our three independent judges to validate the claims. They went through the scientific references, called the companies and asked for any more evidence (posing as a medical doctor who was checking up on a nutritional product one of their patients had asked about), and then evaluated the claims against the evidence. We selected products whose advertising campaigns were focused on the actual product. One product we chose was Lipoduction, which claims to selectively reduce body fat and not muscle. Stefan Ulf, PhD, of the University of Orbitron, Department of Molecular Medicine and Nutrition, will review this product. Dr. Ulf ..."
Dr. Ulf: "Good morning! Looking at the registration composition we have about 50% trade/industry professionals, and 50% consumers. Excellent. How many of you have seen the advertisements for Lipoduction: 'Forget the suction--get Lipoduction!' (More than two-thirds of the audience raises their hands.) Well we performed a deep dive on the product and its evidence--namely two published studies on the actual product. What was quite striking was the disparity between what the study abstracts stated and what was actually described inside the article. An 'abstract' is a one-paragraph summary of the results of a scientific study--usually at the beginning of a research article--intended to provide the key findings and even describe the implications. As background, several excellent research articles have appeared during the past decade, showing that up to 40% of medical research articles have abstracts that either describe data that are NOT found in the study, errantly report what is described or omit what some would deem as key findings that are present in the body of the article. For you medical and nutrition journalists out there--BEWARE if you rely solely upon abstracts to do your 'research.'
"The abstract from one of Lipoduction's published studies claimed 4.4 kilos of fat loss over a two-month period of time, which indeed was corroborated by what was reported in the heart of the article. However, the egregious omission was that this applied to 14 of the 20 subjects who were assigned to take Lipoduction. The other six were 'conveniently' excluded from the statistical evaluation because they admitted to taking pain relievers--for different reasons e.g. PMS, tension headache, muscle strain--through the study. If these Subjects were added in to the statistics then the effect of Lipoduction would be slightly inferior to the placebo group. Is it 'coincidental' that five of these six 'excluded' subjects lost only 0.6-1.2 kilos of fat or that one of them actually gained 0.7 kilos of fat mass? The authors of this study--one being a consultant to the company, we found out--did not provide any evidence indicating a mechanism as to how over-the-counter pain relievers could 'block' or blunt the fat-reducing effects of Lipoduction. The second study was rejected because there was no placebo control group. This product should be sucked off the shelf and given a proper label and advertising campaign. How about 'Forget Lipoduction--try exercise and calorie reduction!'"
Nutraceuticals Multiverse A quirky account of what could/may be happening in parallel universes/dimensions.
Anthony L. Almada, BSc, MSc, FISSN, is the president and CEO of GENr8, Inc., an innovator/marketer at evidence-based performance nutrition products, and of Fein Innovations, LLC, an innovator/marketer of taste-free caffeine food products. He has worked throughout the entire, value chain in the nutrition industry since 1975. Mr. Almada can he reached at 32565 B Golden Lantern, PMB 477, Dana Point, CA 92629; 949-218-9779; E-mail: email@example.com; Websites: GENr8speed.com; GetFein.com
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|Title Annotation:||Nutraceuticals Multiverse|
|Date:||May 1, 2011|
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