HEALTH

Reckitt Benckiser poised to drive growth within VMS space

BY Michael Johnsen

SLOUGH, England — Reckitt Benckiser has realized a greater value out of its 1-year-old acquisition of Schiff, which moved the consumer product goods conglomerate into the dietary supplement arena, and expects to push that VMS business to greater heights in the coming year, Rakesh Kapoor, Reckitt Benckiser CEO and executive director told analysts during a conference call Tuesday. 

"We’ve been owners of this business for less than a year," he said. "And during that period of time, what we have done is get the basics on this business executed well, improving our distribution, improving the shelving … streamlining the core piece."  

Reckitt Benckiser also has increased the historical media investment behind the brands in the Schiff portfolio, Kapoor suggested. Before the acquisition, Schiff typically bought 15-second spots. Reckitt Benckiser has been investing in longer commercials that will be better able to convey the value quotient associated with each brand. "What we had is a much more comprehensive explanation of what, for example, MegaRed does for you. And we’ve also performed very clever digital and other 360 marketing programs, like working in close collaboration with Dr. Oz and talking about VMS in a much more holistic way," Kapoor said. 

"We have not fully run the course of improving the execution mechanics on the VMS franchise," he added."We also have taken stock of what the VMS opportunity looks like for us, how we can actually create value here for ourselves and for our business and for our shareholders. … VMS is a good story."

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Study: Vitamin D deficiency may increase a child’s risk of anemia

BY Michael Johnsen

BALTIMORE — Low levels of vitamin D appear to increase a child’s risk of anemia, according to new research led by investigators at the Johns Hopkins Children’s Center. The study, published online Oct. 10 in the Journal of Pediatrics, is believed to be the first one to extensively explore the link between the two conditions in children.

The researchers caution that their results are not proof of cause and effect, but rather evidence of a complex interplay between low vitamin D levels and hemoglobin, the oxygen-binding protein in red blood cells. The investigators say several mechanisms could account for the link between vitamin D and anemia, including vitamin D’s effects on red blood cell production in the bone marrow, as well as its ability to regulate immune inflammation, a known catalyst of anemia.

To capture the interaction between the two conditions, researchers studied blood samples from more than 10,400 children, tracking levels of vitamin D and hemoglobin. Vitamin D levels were consistently lower in children with low hemoglobin levels compared with their non-anemic counterparts, the researchers found. The sharpest spike in anemia risk occurred with mild vitamin D deficiency, defined as vitamin D levels less than 30 ng/mL. Children with levels below 30 ng/mL had nearly twice the anemia risk of those with normal vitamin D levels. Severe vitamin D deficiency is defined as vitamin D levels at or less than 20 ng/mL. 

Both mild and severe deficiency requires treatment with supplements.

When investigators looked at anemia and vitamin D by race, black children had higher rates of anemia compared with white children (14% vs. 2%) and considerably lower vitamin D levels overall, but their anemia risk didn’t rise until their vitamin D levels dropped far lower than those of white children. The racial difference in vitamin D levels and anemia suggests that current therapeutic targets for preventing or treating these conditions may warrant a further look, the researchers reported.

"The clear racial variance we saw in our study should serve as a reminder that what we may consider a pathologically low level in some may be perfectly adequate in others, which raises some interesting questions about our current one-size-fits-all approach to treatment and supplementation," stated lead investigator Meredith Atkinson, a pediatric kidney specialist at the Johns Hopkins Children’s Center.

Untreated, chronic anemia and vitamin D deficiency can have wide-ranging health consequences, including organ damage, skeletal deformities and frequent fractures, and lead to premature osteoporosis in later life.

Long known for its role in bone development, vitamin D has recently been implicated in a wide range of disorders. Emerging evidence suggests that low vitamin D levels may play a role in the development of certain cancers and heart disease and lead to suppressed immunity, the researchers noted.

Anemia, which occurs when the body doesn’t have enough oxygen-carrying red blood cells, is believed to affect 1-in-5 children at some point in their lives. Several large-scale studies have found severe vitamin D deficiency in about a tenth of U.S. children, while nearly 70% have suboptimal levels.

"If our findings are confirmed through further research, low vitamin D levels may turn out to be a readily modifiable risk factor for anemia that we can easily tackle with supplements," said senior study investigator Jeffrey Fadrowski, also a pediatric kidney specialist at Johns Hopkins.

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FDA seeks shutdown of James G. Cole for masquerading adulterated drugs as supplements

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, on Monday sought a permanent injunction against the dietary supplement manufacturer James G. Cole; its president, James Cole; and its general manager, Julie Graves, following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug and Cosmetic Act.

If granted, the injunction would stop the company, based in Hood River, Ore., from promoting and distributing its products until it complies with current good manufacturing practice requirements for dietary supplements and all disease claims are removed from its websites, product labels and all other products and websites under Cole’s custody and control.

“This company has ignored the multiple warnings they have been issued by the FDA by continuing to make unsubstantiated drug claims about the products it sells and by failing to conform to the cGMP requirements for dietary supplements,” stated Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs. “We are taking this action to protect the public health.” 

James G. Cole has marketed products online, with some sites linking to the company’s Facebook page. Cole has claimed that the dietary supplement products treat serious medical conditions, such as cancer, heart disease, rheumatoid arthritis, autism, Alzheimer’s, fibromyalgia and high cholesterol. Under federal law, products offered for such uses are considered to be drugs, in that they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease.

The company’s dietary supplement products have been unlawfully marketed as drugs that have not been approved by the FDA for their claimed uses. The products include PCA, PCA-Rx, C-60, ACAI Resveratrol, Cytomune, Anavone, Liver Rescue, Probiotics and several other products, which are marketed under the brand names Maxam Labs, Advanced Sports Nutrition and Maxam Nutraceutics. 

Additionally, during inspections of James G. Cole’s facility in 2012 and 2013, the FDA found that the company distributed dietary supplements that were not manufactured in accordance with the cGMP requirements for dietary supplements. For example, the company did not establish an identity specification for each component and did not conduct at least one appropriate test to verify the identity of a dietary ingredient. 

The complaint was filed in the U.S. District Court for the District of Oregon, Portland Division.

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