Special Edition: Blood sugar management
Panoply of metabolic diseases continues to proliferate, expert says
Alexander Fleming, MD, coined the term several years ago to try to capture the constellation of problems that increasingly afflict populations around the world. He uses it in his discussion on the topic in 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,” Dr Fleming told NutraIngredients-USA.
“Metabesity as a term embraces a much broader range of conditions. I wish I could say that term has caught on.I still use it to refer to the constellation of metabolic diseases. It’s not just cardiovascular disease, but diabetes, dementia and even some cancers that are associated with metabolic disorders,” he said.
Fleming said in the several years since he coined the term, the obesity problem has continued to worsen, though it is not uniform picture.
“I would say that we are leveling off on the prevalence of obesity in this country but it is actually getting worse in places like India and China,” he said.
“We don’t seem to be losing ground here but it is not a particularly good picture when you see such a high prevalence of obesity in young people. Today they might feel perfectly fine but in a decade or so they can cross over into full blown diabetes,” Dr Fleming said.
Dr Fleming advocates the broader application of certain pharmaceuticals to treat metabolic conditions earlier in their gestation. As matters stand, he said, physicians are loathe to prescribe these drugs before full blown diabetes has manifested itself. Supplements to address the condition could be helpful, too, he said, but lack the kind of rock solid data that would sway most MDs. That restrains their broader uptake, along with the issue of patient compliance.
“There is no doubt about it that there is huge inertia among health care providers because they see so little success,” he 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.
NIU's Blood Sugar Management Forum
Barry Ritz, PhD, VP of scientific and regulatory affairs at Atrium Innovations, attorneys Justin Prochnow and Ivan Wasserman, as well as Nielsen's Health & Wellness expert Andrew Mandzy will discuss the opportunities and challenges in the sector at the NutraIngredients-USA Blood Sugar Management Forum on February 23. For more information and to register for this FREE event, please click HERE.