HEALTH

CVS Caremark study shows drug therapy helps osteoporosis patients

BY Michael Johnsen

WOONSOCKET, R.I. Data released Monday by CVS Caremark indicated that 87% of women 18 years and older with osteoporosis who were taking a drug therapy to treat the disease did not experience a fracture during a two-year study period.

The CVS Caremark data also found that those women with osteoporosis between the ages of 18 and 64 who were not on therapy were 5.7 times more likely to experience a fracture.

“Osteoporosis impacts millions of women in the United States and the resulting fractures due to bone loss associated with the disease can have a significant impact on the individual’s quality of life and increase overall health care costs for the patient and the payor,” stated Troyen Brennan, chief medical officer, CVS/Caremark. “Our research suggests that the medications available today to treat osteoporosis are effective in combating the disease and those women who take and remain adherent to therapy are better able to maintain their mobility and quality of life while avoiding costly fractures.”

According to the National Osteoporosis Foundation, approximately 8 million women in the United States have osteoporosis and an additional 27.2 million women are estimated to have low bone mass, which places them at increased risk for developing the disease. In addition, the NOF reports that one in two women with osteoporosis over the age of 50 will experience an osteoporosis related fracture in their remaining lifetime. The NOF also reports that in 2005, osteoporosis-related fractures were responsible for an estimated $19 billion in costs, which is predicted to increase to $25.3 billion by 2025.

The study analyzed women diagnosed with osteoporosis over a two-year period. Untreated women less than 65 years of age were 5.7 times more likely to experience a fracture than those treated with a bisphosphonate, estrogen, or other hormone-related osteoporosis therapy. This study evaluated aggregated and de-identified data for almost 400,000 women from the CVS Caremark Health Management Claims Database who had incurred claims between 01/01/07 and 12/31/08. All study participants were continuously eligible for medical and pharmacy benefits throughout the evaluation period. This analysis is an observational study only, and the results demonstrate a relationship between osteoporosis, osteoporotic pharmacotherapy, and fractures; however, as in most observational studies, the causal nature of this relationship cannot be strictly determined.

“The National Osteoporosis Foundation emphasizes the importance of patient adherence and persistence to a prescribed treatment regimen in order to get the maximum benefit from a medication,” stated Robert Recker, NOF president. “NOF is proud to sponsor National Osteoporosis Awareness and Prevention Month in May as an opportunity to raise awareness of this disease, help women understand their risk for developing osteoporosis and provide information about the treatments available today to help manage osteoporosis and reduce the risk of fracture.”

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FDA grants clearance of market, sale of new allergy-friendly latex condom

BY Michael Johnsen

WILMINGTON, Del. Vystar and Alatech Healthcare on Friday announced that the Food and Drug Administration granted 510(k) clearance to market and sell Alatech’s Envy condom manufactured with Vytex Natural Rubber Latex.

The Envy condom will be the first consumer medical product available in the U.S. made from Vystar’s patented Vytex NRL, which has less than 2 micrograms/dm2, virtually undetectable levels, of the antigenic proteins that can cause an allergic response, while retaining and improving upon all the desirable qualities of latex.

The Envy condom will carry labeling that will reflect the lowest antigenic protein content currently available in a natural rubber latex medical device in the U.S. Natural rubber latex contains more than 200 proteins, similar to other natural plant materials, of which 13 are known allergens. The Vytex NRL process was created to significantly reduce these known proteins. Vystar’s business model is to assist all manufacturers in marketing the Vytex component of their products.

Alatech will market and sell the Envy NRL condom to retailers and through other distribution channels, and expects the product to be available to consumers in the coming months.

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Food intake may contribute more to obesity than lack of exercise, study suggests

BY Alaric DeArment

AMSTERDAM Conventional wisdom has it that the American obesity epidemic results from lack of exercise, but a study presented in the Netherlands Friday suggests otherwise.

The study, led by researchers in Australia and presented at the 17th European Congress on Obesity in Amsterdam, indicates that while exercise remains important, the main cause of the obesity epidemic is that Americans eat too much.

“To return to the average weights of the 1970s, we would need to reverse the increased food intake of about 350 calories a day for children and 500 calories a day for adults,” lead study author Boyd Swinburn of Australia’s Deakin University said in a statement. That would mean eliminating a can of soda or small portion of French fries from a child’s diet or a large hamburger from an adult’s.

The researchers started by testing 1,399 adults and 963 children to find how many calories they burn on an average day. They combined those results with national food supply data on how much food Americans ate between the 1970s and early 2000s. They then calculated how much weight they would expect Americans to have gained in the 30-year period if food intake were the sole influence, using national survey data that recorded the weight of Americans during that period.

“For adults, we predicted that they would be 10.8 kg heavier, but in fact they were 8.6 kg heavier,” Swinburn said. “That suggests that excess food intake still explains the weight gain, but that they may have been increases in physical activity over the 30 years that have blunted what would otherwise have been a higher weight gain.”

According to the Centers for Disease Control and Prevention, more than 30% of American adults are obese, which health experts define as having a body mass index of 30 or greater.

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