HEALTH

Aristides Spanellis prohibited from buying, selling LifeScan’s blood-glucose monitoring test strips

BY Michael Johnsen

MILPITAS, Calif. — LifeScan announced a major settlement regarding counterfeit packaged LifeScan blood-glucose monitoring test strips sold by Aristides Spanellis.

The settlement permanently prohibits Aristides Spanellis, a South African distributor, from buying or selling both genuine and counterfeit LifeScan blood-glucose monitoring test strips. Spanellis was one of the alleged architects of a sophisticated international operation in which authentic LifeScan test strips were purchased in such countries as Turkey, Saudi Arabia, Pakistan and Ghana and then illegally repackaged in counterfeit packaging designed to mimic authentic U.S. boxes. These products then were exported to the United States for sale through unauthorized distribution channels at a significant profit.

“In many cases, critical product performance information was altered during this process, including calibration codes, control solution ranges, lot numbers and expiration dates,” stated Roy Albiani, director of LifeScan’s global brand protection and channel compliance team. “This was particularly dangerous for patients using insulin and could result in serious injury.”

The settlement also includes a substantial monetary payment from Spanellis and an even larger financial penalty if he violates the terms of the court-approved permanent injunction.

LifeScan believed the counterfeit packaging scheme ended in 2008 when a number of lawsuits were initiated and court-ordered seizures were obtained in the United States, Europe and Africa. Since that time, there have been no known instances of LifeScan products with counterfeit packaging in the United States.

“Even though we believe we have stopped the flow of LifeScan products with counterfeit packaging into the [United States], it is critical that we continue to pursue any and all perpetrators of these illegal activities to protect patients,” Albiani said.

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Weight loss among women helps raise blood vitamin D levels

BY Michael Johnsen

SEATTLE — Overweight or obese women who have less-than-optimal levels of vitamin D and lose more than 15% of their body weight experience significant increases in circulating levels of this fat-soluble nutrient, according to a study released last week by researchers at Fred Hutchinson Cancer Research Center.

“Since vitamin D is generally lower in [people] with obesity, it is possible that low vitamin D could account, in part, for the link between obesity and [such] diseases [as] cancer, heart disease and diabetes,” said Caitlin Mason, lead author of the paper, published online May 25 in the American Journal of Clinical Nutrition. “Determining whether weight loss helps change vitamin D status is important for understanding potential avenues for disease prevention.”

According to the National Institutes of Health, vitamin D helps promote calcium absorption and is needed for bone growth and bone healing. Along with calcium, vitamin D also helps protect older adults from osteoporosis. The nutrient influences cell growth and neuromuscular and immune function, and also reduces inflammation. Many gene-encoding proteins that regulate cell proliferation, differentiation and apoptosis (programmed cell death) are modulated in part by the vitamin.

The yearlong study involved 439 overweight to obese, sedentary, postmenopausal Seattle-area women, ages 50 years to 75 years, who randomly were assigned to 1-of-4 groups: exercise only, diet only, exercise plus diet and no intervention.

Those who lost 5% to 10% of their body weight — equivalent to approximately 10 lbs. to 20 lbs. for most of the women in the study — through diet and/or exercise saw a relatively small increase in blood levels of vitamin D (about 2.7 ng/mL), whereas women who lost more than 15% of their weight experienced a nearly threefold increase in vitamin D (about 7.7 ng/mL), independent of dietary intake of the nutrient.

“We were surprised at the effect of weight loss greater than 15% on blood vitamin D levels,” said Anne McTiernan, director of the Hutchinson Center’s Prevention Center and principal investigator of the study. “It appears that the relationship between weight loss and blood vitamin D is not linear but goes up dramatically with more weight loss. While weight loss of 5% to 10% is generally recommended to improve risk factors, such as blood pressure, cholesterol and blood sugars, our findings suggest that more weight loss might be necessary to meaningfully raise blood vitamin D levels.”

About 70% of the participants had less-than-optimal levels of vitamin D when the study began; at baseline, the mean blood level of vitamin D among the study participants was 22.5 ng/mL. In addition, 12% of the women were at risk of vitamin D deficiency (blood levels of less than 12 ng/mL).

The optimal circulating range of vitamin D is thought to be between 20 ng/mL and 50 ng/mL, according to a recent data review conducted by the Institute of Medicine, which found that blood levels under 20 ng/mL are inadequate for bone health and levels higher than 50 ng/mL are associated with potential adverse effects, such as an increased risk of developing kidney stones.

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Carex’s new HQ reflects company’s expansion efforts

BY Michael Johnsen

NORWELL, Mass. — Carex Health Brands on Wednesday announced the opening of its new corporate headquarters in Boston.

As a reflection of the company’s growth and development, the new East Coast headquarters supports the expansion of Carex’s marketing team, an initiative planned to increase brand building efforts and double new product development, the company stated.

“We strive to produce high-quality and innovative products that bring convenience, dignity and ease of use to a range of consumers,” said Carex president Matt McElduff. “With the move to Boston, we are ramping up our team of driven and creative marketing professionals to elevate Carex Health Brands to an entirely new level of growth and success.”

Carex’s brands include Carex, Apex, Bed Buddy, TheraMed, Enablers and VitaSystem.

Carex Health Brands is a portfolio company of Ancor Capital Partners. In addition to its headquarters in Boston, the company holds an office in Sioux Falls, S.D. The Boston corporate headquarters is based at 600 Cordwainer Drive, Norwell, Mass., 02061.

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