Sheldon Baker07.20.12
Dr. Vladimir Badmaev is head of research and development for NattoPharma. Receiving his M.D. and Ph.D. in immunopharmacology in Bialystok, Poland, he achieved training in clinical and anatomical pathology at Kings County Hospital and Downstate Medical Center, New York from 1982-1985. Dr. Badmaev is the author/coauthor of over 70 scientific and popular scientific articles, 13 books, 13 U.S. and international patents and 9 successful IND applications with the FDA, several self-affirmed GRAS documents and NDI applications. He has also received many awards for his research on health ingredients and participated in several medical and scientific societies. Prior to his appointment with NattoPharma, Dr. Badmaev successfully served as vice president and medical and scientific director with Sabinsa, Inc. and PL Thomas, Inc., assisting those companies in building pre-clinical and clinical research on innovative standardized food supplements. His work helped propel both companies and their proprietary branded ingredients to a superior level of industry recognition and enviable sales numbers. Dr. Badmaev's life-long goal is to develop complementary and pharmaceutical treatments derived from traditional medical systems as a permanent element in the health care education and health care system in the West. Recently, in a joint venture with a group of international investors, he established American Medical Holdings, Inc., dedicated to developing natural and synthetic pharmaceuticals which he calls interactive nutrients.
Health E-Insights: Why do you consider your company the vitamin K experts?
Dr. Badmaev: Since its incorporation in 2004, NattoPharma has been consistently investing in pre-clinical and clinical research of its MenaQ7 brand of natural vitamin menaquinone-7 (K2). Prior to NattoPharma’s work there was no systematic research of vitamin MK-2, particularly menaquinone-7 (MK2-7). The research has been considered necessary to prove that vitamin K2 has sound healthcare applications, especially since effects of menaquinone supplementation cannot be readily appreciated, in a similar way as cardiovascular effects of baby aspirin could not be appreciated without systematic research. Menaquinone-7 exemplifies a natural supplement that may successfully address critical measures of bone and cardiovascular and which properties can only be appreciated with sound and systematic research program. NattoPharma has maintained a long-term and strategic associations with research institutions especially Maastricht University, The Netherlands, and the lead researchers there in the field of vitamin K2, Dr. Leon Schurgers and Dr. Cees Vermeer. The pioneering work of NattoPharma has led to important and first-time findings showing that menaquinone-7 may reverse arterial calcification in the process of atherosclerosis and that only long-term administration, at least two years, of menaquinone-7, is necessary for improvement of bone and cardiovascular health. NattoPharma's work resulted in rich peer-review literature and several patents in the fields of bone and cardiovascular health.
Health E-Insights: What good news did you determine from the recently completed vitamin K2 study?
Dr. Badmaev: What's newsworthy are the results of a new three-year study showing that supplemental vitamin K, especially menaquinone-7, improves bone mineral density, bone strength, and cardiovascular health (Cees Vermeer et al. 2012 VitaFoods Presentation). The breakthrough study was a double-blind randomized clinical trial evaluating the results of a three-year regular intake of menaquinone-7 in a daily dose 180 mcg by a group of 244 healthy post-menopausal Dutch women, 55 to 65 years old, randomly assigned to receive daily either MenaQ7 or identical looking placebo capsules. The brand new three-year study of MenaQ7 is a breakthrough study because it shows for the first time clinically statistically significant protection of the vertebrae and the hip (femoral neck) against osteoporosis, and cardiovascular deterioration. One of the most important findings from the study was that clinically relevant improvement became evident no sooner than after two and three years of MenaQ7 supplementation. This finding explains for the first time why shorter studies (12 month as cited above) typically failed to show benefits of vitamin K on bone health and cardiovascular health. Establishing a correlation between length of administration and efficacy of menaquinone-7 intake is a clinically significant breakthrough established in this three-year study of MenaQ7. The MenaQ7 trial additionally showed for the first time substantial benefits in preventing age-related stiffening of arteries resulting in statistically significant increase of the pulse wave velocity in the placebo group, but not in the MenaQ7-group. Previously the positive effects on bone and vascular health have been demonstrated only with a pharmacological dose of synthetic form of vitamin K, of up to 45 milligrams per day. The MenaQ7 study shows for the first time in the history of vitamin K evaluation the positive health effects with a nutritional dose of vitamin K (180 mcg/day for 3 years), a dose that can be obtained from a healthy western-type diet.
Health E-Insights: Natto is tied to Japan. Does Norway produce a better product in this category?
Dr. Badmaev: As the name of the company indicates, NattoPharma derives its inspiration and expertise in vitamin K2 from Japan's traditional food Natto, a source of natural vitamin K2. The major vitamin K2 in Natto and fermented cheeses of The Netherlands, such as Gouda, is menaquinone-7, which is the base of MenaQ7 product. The MenaQ7 product is result of a continuous research and development and distinguished by the following characteristics – a minimum 95% purity standardized for menaquinone-7, 100% -trans form, no other forms of menaquinone present except for 0.5% or less admixture of menaquinone-6 (a marker of natural fermentation product; a proprietary unique to NattoPharma non-soy based fermentation product; and available Drug Master File.
Health E-Insights: Where do you think significant growth will come from in your company over the next few years?
Dr. Badmaev: The important and significant growth of NattoPharma will come from exploring all the research on MenaQ7 and the relevant patents, especially in cardiovascular health area. The growth will occur also as a result of much needed education via peer review and popular scientific publications on the role of vitamin K2 in maintaining bone and cardiovascular health and fitness. In addition NattoPharma will benefit from new products derived from biotechnology, fermentation technology and green technology leading to several products that will work in synergy with vitamin K2.
Health E-Insights: How do you feel the business has changed since you first got into it?
Dr. Badmaev: The nutraceutical business evolved over the last 15 years into an industry that is much more about quality control and is science oriented but at the same time is increasingly scrutinized by world regulatory bodies, including the FDA, EFSA in Europe, Australian TGA and Japanese FDA. The visible change is also seen in forms of delivery of nutraceuticals from tablets and capsules to functional foods and beverage applications. The food and beverage applications have been greatly facilitated in the U.S. by an increasingly popular self-affirmed GRAS venue. The involvement of major universities in both preclinical and clinical research of natural products lead to increased awareness of health benefits from nutraceuticals by consumers and health professionals. The illustrative example of Lovaza, a highly purified fish oil, for lowering blood triglycerides developed by GSK shows increasing interest of pharmaceutical companies in standardized natural products. The changing patterns of the supplement and nutritional industry also call for better education of health professionals and end consumers about natural products, their proper indications, potential interactions with pharmaceutical compounds and safety profiles.
Health E-Insights: What excites you most about this company?
Dr. Badmaev: The international flavor and of course, my colleagues.
Sheldon Baker is well-known for creating nutraceutical brand marketing and public relations campaigns. For Health E-Insights interview consideration, contact him at Baker@CentralValleyTalk.com. And follow him on Twitter @NutraInk.
Health E-Insights: Why do you consider your company the vitamin K experts?
Dr. Badmaev: Since its incorporation in 2004, NattoPharma has been consistently investing in pre-clinical and clinical research of its MenaQ7 brand of natural vitamin menaquinone-7 (K2). Prior to NattoPharma’s work there was no systematic research of vitamin MK-2, particularly menaquinone-7 (MK2-7). The research has been considered necessary to prove that vitamin K2 has sound healthcare applications, especially since effects of menaquinone supplementation cannot be readily appreciated, in a similar way as cardiovascular effects of baby aspirin could not be appreciated without systematic research. Menaquinone-7 exemplifies a natural supplement that may successfully address critical measures of bone and cardiovascular and which properties can only be appreciated with sound and systematic research program. NattoPharma has maintained a long-term and strategic associations with research institutions especially Maastricht University, The Netherlands, and the lead researchers there in the field of vitamin K2, Dr. Leon Schurgers and Dr. Cees Vermeer. The pioneering work of NattoPharma has led to important and first-time findings showing that menaquinone-7 may reverse arterial calcification in the process of atherosclerosis and that only long-term administration, at least two years, of menaquinone-7, is necessary for improvement of bone and cardiovascular health. NattoPharma's work resulted in rich peer-review literature and several patents in the fields of bone and cardiovascular health.
Health E-Insights: What good news did you determine from the recently completed vitamin K2 study?
Dr. Badmaev: What's newsworthy are the results of a new three-year study showing that supplemental vitamin K, especially menaquinone-7, improves bone mineral density, bone strength, and cardiovascular health (Cees Vermeer et al. 2012 VitaFoods Presentation). The breakthrough study was a double-blind randomized clinical trial evaluating the results of a three-year regular intake of menaquinone-7 in a daily dose 180 mcg by a group of 244 healthy post-menopausal Dutch women, 55 to 65 years old, randomly assigned to receive daily either MenaQ7 or identical looking placebo capsules. The brand new three-year study of MenaQ7 is a breakthrough study because it shows for the first time clinically statistically significant protection of the vertebrae and the hip (femoral neck) against osteoporosis, and cardiovascular deterioration. One of the most important findings from the study was that clinically relevant improvement became evident no sooner than after two and three years of MenaQ7 supplementation. This finding explains for the first time why shorter studies (12 month as cited above) typically failed to show benefits of vitamin K on bone health and cardiovascular health. Establishing a correlation between length of administration and efficacy of menaquinone-7 intake is a clinically significant breakthrough established in this three-year study of MenaQ7. The MenaQ7 trial additionally showed for the first time substantial benefits in preventing age-related stiffening of arteries resulting in statistically significant increase of the pulse wave velocity in the placebo group, but not in the MenaQ7-group. Previously the positive effects on bone and vascular health have been demonstrated only with a pharmacological dose of synthetic form of vitamin K, of up to 45 milligrams per day. The MenaQ7 study shows for the first time in the history of vitamin K evaluation the positive health effects with a nutritional dose of vitamin K (180 mcg/day for 3 years), a dose that can be obtained from a healthy western-type diet.
Health E-Insights: Natto is tied to Japan. Does Norway produce a better product in this category?
Dr. Badmaev: As the name of the company indicates, NattoPharma derives its inspiration and expertise in vitamin K2 from Japan's traditional food Natto, a source of natural vitamin K2. The major vitamin K2 in Natto and fermented cheeses of The Netherlands, such as Gouda, is menaquinone-7, which is the base of MenaQ7 product. The MenaQ7 product is result of a continuous research and development and distinguished by the following characteristics – a minimum 95% purity standardized for menaquinone-7, 100% -trans form, no other forms of menaquinone present except for 0.5% or less admixture of menaquinone-6 (a marker of natural fermentation product; a proprietary unique to NattoPharma non-soy based fermentation product; and available Drug Master File.
Health E-Insights: Where do you think significant growth will come from in your company over the next few years?
Dr. Badmaev: The important and significant growth of NattoPharma will come from exploring all the research on MenaQ7 and the relevant patents, especially in cardiovascular health area. The growth will occur also as a result of much needed education via peer review and popular scientific publications on the role of vitamin K2 in maintaining bone and cardiovascular health and fitness. In addition NattoPharma will benefit from new products derived from biotechnology, fermentation technology and green technology leading to several products that will work in synergy with vitamin K2.
Health E-Insights: How do you feel the business has changed since you first got into it?
Dr. Badmaev: The nutraceutical business evolved over the last 15 years into an industry that is much more about quality control and is science oriented but at the same time is increasingly scrutinized by world regulatory bodies, including the FDA, EFSA in Europe, Australian TGA and Japanese FDA. The visible change is also seen in forms of delivery of nutraceuticals from tablets and capsules to functional foods and beverage applications. The food and beverage applications have been greatly facilitated in the U.S. by an increasingly popular self-affirmed GRAS venue. The involvement of major universities in both preclinical and clinical research of natural products lead to increased awareness of health benefits from nutraceuticals by consumers and health professionals. The illustrative example of Lovaza, a highly purified fish oil, for lowering blood triglycerides developed by GSK shows increasing interest of pharmaceutical companies in standardized natural products. The changing patterns of the supplement and nutritional industry also call for better education of health professionals and end consumers about natural products, their proper indications, potential interactions with pharmaceutical compounds and safety profiles.
Health E-Insights: What excites you most about this company?
Dr. Badmaev: The international flavor and of course, my colleagues.
Sheldon Baker is well-known for creating nutraceutical brand marketing and public relations campaigns. For Health E-Insights interview consideration, contact him at Baker@CentralValleyTalk.com. And follow him on Twitter @NutraInk.
