As waistlines around the globe continue to swell, researchers and marketers struggle to find a rhetorical way to get their hands around the problem. First there was obesity, which became “diabesity,” adding diabetes to the mix. The latest entrant in the coin-a-disease-trend-word sweepstakes is “metabesity.”
The word adds the whole umbrella of metabolic disorders to the debate. Diabetes is only the end stage; as researchers and health practitioners focus more on prevention, prediabetic states become more of a focus. And “metabesity” does add the root “meta,” which has as one of its meanings something beyond or of a higher order.
All of these meanings are bound up in the way the word was used by Alexander Fleming, MD at a recent biotech conference in San Francisco.
“I am not sure I’ve heard the term used before,” Fleming told NutraIngredients-USA.
“You’ve heard the term ‘diabesity.’ ‘Metabesity,’ if I were to definite it, would be a way to refer to entire spectrum of disorders that lead to not only the recognized metabolic disorders like metabolic disease and obesity, but even cancer and Alzheimer’s, and cardiovascular disease as well to the extent that it is caused by various metabolic disorders,” he said.
“The difference between diabesity and metabesity is that metabesity is intended to cover a much wider range of conditions in human disease.”
A word for what ails you
Painting with a brush that broad, is metabesity just a word for the underlying malaise of the modern world where unlimited amounts of food of every type lie at consumers’ fingertips?
“To a large extent it is. It is a disorder of overconsumption or misconsumption. Not taking the right foods, not doing enough exercise or being active enough or perhaps not taking the right nutrients,” Fleming said.
Fleming is the principal in Kinexum, a scientific and regulatory consultancy based in Harpers Ferry, WV. Fleming, an endocrinologist by training, started the business after a 12-year stint with FDA where he worked with the approval process for drugs that treat metabolic disorders.
Fleming carried that training over into his work with Kinexum, where the company primarily aids pharmaceutical companies with drug development. But the company does work with nutraceuticals as well, and the experience with pharma clinical trials can be of benefit in the dietary supplement realm, he said.
“I try to help with the development of primarily of drugs but also medical devices and nutraceuticals. I do believe that we should have a broad open mind about the different tools that we can use for disease,” Fleming said.
The patent paradox
One of the key issues with researching dietary supplement ingredients that are potential candidates in the struggle against metabesity is the pallid patent protection afforded most compounds in the sphere. Without ironclad patents, and the revenue stream that comes from the filling of prescriptions, how does a company justify the expense of truly definitive research?
“This is something that we have often tried to help with in finding a reasonable commercial and regulatory pathway to work with a company that has a dietary supplement,” Fleming said.
There are ways around the patent conundrum, Fleming said, but they are still fraught with difficulty.
“You are not going to have a composition of matter patent and the best you can do is come up with a novel formulation or delivery approach which you can patent. There has been some success coming up with those approaches,” he said.
“But even then it’s relatively difficult for a small company to protect their market exclusivity by going after companies that are imitating their products.
“It’s a big challenge especially in the obesity space. You need realistically to have a minimum on the order of 60 patients who are treated for at least eight weeks to have a chance of measuring a statistically significant effect on total body weight. There are other things you can measure, such as inflammatory markers. But these are not nearly as compelling as being able to say that a product does have an effect on total body weight,” Fleming said.
"That’s a study that does cost a significant amount," he said.
A potential mid ground for some companies looking to play in the metabesity ballgame could be developing their ingredients for use in medical foods, Fleming said. Neptune Technologies and Bioressources, for example, is venturing down this route by developing its krill oil nutraceutical ingredient for use in its Onemia medical food.