HEALTH

JAMA report criticizing calcium supplementation in men raises eyebrows among supplement associations

BY Michael Johnsen

CHICAGO — A JAMA report released Monday afternoon that suggested a high intake of supplemental calcium is associated with an increased risk of cardiovascular disease death in men was criticized by several dietary supplement agencies for being inconclusive. According to the Council for Responsible Nutrition’s most recent survey of U.S. adults, 17% indicated they take a calcium supplement.

"This study has the same unfortunate design defects as previous studies yielding mixed results," stated Taylor Wallace, senior director, scientific and regulatory affairs, CRN. "The National Institutes of Health–AARP Diet & Health Study was originally designed by researchers at the National Cancer Institute to look specifically at epidemiologic investigations of diet and cancer, not to measure cardiovascular or cerebrovascular outcomes," he said. "The science behind the safety and benefit of calcium supplementation is well-established; and this study proves inconsistent with a recent wave of new research that concludes that calcium supplementation is beneficial to bone health, and also poses no risk to cardiovascular health."

"While this study includes a large population and a long follow-up time, it also has weaknesses in that it doesn’t capture all the pertinent information regarding duration of calcium supplementation or other nutrients," commented Cara Welch, SVP scientific and regulatory affairs Natural Products Association. "The Natural Products Association does not believe that this study should cause anyone to stop taking their calcium supplements. We have long recommended that you should discuss your calcium intake with your healthcare professional.”

Taylor noted that dietary supplement usage has increased dramatically over the course of time encompassed by the study and subsequent follow-up. "This includes calcium supplement usage which has increased among men in the past two decades as dairy consumption has decreased and the incidence of osteoporosis among this population has become increasingly evident," he said. "The results of this study are most likely confounded by the lack of data collected during the 11-year follow up because the number of baseline nonusers who became users of calcium supplements was likely to have increased substantially."

The study consisted of more than 388,000 participants from the National Institutes of Health–AARP Diet & Health Study between the ages of 50 and 71 years, according to a report published online first by JAMA Internal Medicine, a JAMA Network publication. During an average 12 years of follow-up, researchers noted that 7,904 cardiovascular disease deaths in men and 3,874 cardiovascular disease deaths in women were identified and supplements containing calcium were used by 51% of men and 70% of women, respectively. “In this large, prospective study we found that supplemental but not dietary calcium intake was associated with an increased CVD mortality in men but not in women,” the authors concluded. For women, supplemental calcium intake was not associated with CVD death, heart disease death or cerebrovascular disease death. Dietary calcium intake also was not associated with CVD death in men or women.

“Whether there is a sex difference in the cardiovascular effect of calcium supplement warrants further investigation. Given the extensive use of calcium supplement in the population, it is of great importance to assess the effect of supplemental calcium use beyond bone health,” the authors concluded.


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Merz North America names VP Merz Aesthetics unit, moves OTC under Aesthetics umbrella

BY Michael Johnsen

GREENSBORO, N.C. — Merz North America on Monday named Jim Hartman VP of the Merz Aesthetics business unit, which includes Xeomin, Radiesse and Belotero Balance. 

Hartman was hired in June 2012 to lead the U.S. Dermatology Business Unit, which includes Naftin, Mederma and the recently launched Onmel. Prior to joining Merz, Hartman was VP global marketing and business development at Obagi Medical Products, a provider of topical skin care treatments. 

As part of the move, the U.S. OTC business that includes Mederma will continue to report into Hartman under the direction Jessica Wright, associate director of OTC franchise, and will move to the Aesthetics Business Unit. Wright joined Merz in June 2001 as associate brand manager. Throughout the 11 years that she has been with the company, she has held several roles within marketing, marketing communications and brand management for the company’s OTC franchise. Prior to Merz, Wright worked as a medical editor with Sandler & Recht Communications. 

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Perrigo: Already-strong private label growth will get additional boost from Rx-to-OTC switch

BY Michael Johnsen

ALLEGAN, Mich. — Perrigo chairman, CEO and president Joe Papa on Friday shared with analysts that private label OTCs are trending strong and that growth will be sustained going forward with the number of projected Rx-to-OTCs on the horizon. 

"The mega trend shift from national brand to store brand continues," he said. "The overall OTC consumer market was up more than 2% versus last year. National brands were down almost 2%, but store brand gained 9.7% on the strength of new product launches, national brand recalls and increased store brand acceptance and nearly every category store brands drove the growth." Two high points were diabetes and gastronintestinal. "The diabetes category experienced growth of more than 14% [and] the gastrointestinal market, the category was flat while store brands grew 12.2%," Papa said. 

"Sales in the analgesics category were up more than 8% year-over-year led by sales in children and infants liquid analgesic products in a period where a specific branded competitor has not fully returned to the market," added Judy Brown, Perrigo CFO and EVP. 

Perrigo in January launched the store brand version of Nicorette Mini Lozenges and is preparing for the launch of the store brand version of Mucinex 600 milligram, which the company noted has annual branded sales of approximately $135 million. "As of today we currently expect to launch this product in our fiscal year 2013 and specifically March 2013," Papa said. 

That likely places a Mucinex launch after the critical cough-cold season. "Relative to the question of whether we miss the season or not, we look at Mucinex as being certainly important for cough/cold/flu season but also obviously for the allergy season," Papa said. "The bottom line is, as we look at our revenue guidance for consumer healthcare for a 16% to 20% growth for the full year, we did that with the knowledge of how we will probably realize the launch of all of our products and certainly the Mucinex 600 milligram was front and center in [that calculation]."

Looking forward, Papa projected that $10 billion in branded prescription sales would likely switch in the next five years, not including statins, with half of that dollar volume switching in the next three years. "Just take the example of what happened in the past week, the fact that Oxytrol has moved from prescription to OTC, that’s an important product not just for that individual product but it’s a brand new category with overactive bladder," Papa said. "There are some big products in that category: Detrol, Detrol LA, Ditropan, are all examples of products that are in that category. … I am not suggesting today all those will move, but certainly it is another potential example of what we are expecting."

Papa didn’t include statins in those Rx-to-OTC calculations, however. "I do believe that statins are something like a 60:40 probability, that would be 60% positive, 40% negative, but because of the size of the statin category we do not include it in our numbers," he said. "It’s just too uncertain at this time.

Papa expects that Oxytrol will get a three-year exclusivity barring store brand competition through 2016. Papa also expects another likely switch candidate — Pfizer’s Nexium — will be granted a three-year exclusivity if approved by the Food and Drug Administration. Papa estimated the soonest Pfizer could bring that to market is 2014, which would push the introduction of a store brand equivalent out to 2017. 


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