PHARMACY

Senate opens health-reform debate

BY Jim Frederick

WASHINGTON After months of wrangling in committee meetings and weeks spent rounding up support from his Democratic colleagues, Senate majority leader Harry Reid Monday morning gaveled the opening round of what is expected to be weeks of debate on a massive health-reform bill.

Reid was successful last week in rounding up a 60-vote majority to allow the legislation to come before the full Senate for debate. But the bill faces a tough battle in a bitterly partisan fight that could push any chance of passage into next year.

The Reid bill would overhaul the U.S. health system by providing coverage to millions of uninsured Americans, mandating that all Americans have coverage, creating a publicly funded insurance option to compete with private insurance plans and setting up new incentives and processes to promote healthier lifestyles and disease prevention. To help defray the expected cost of the overhaul — estimated to be $848 billion over 10 years — the Senate bill would levy a tax on the highest-value insurance plans dispensed by employers, and create a review system to seek out the most cost-effective treatments and reduce waste and unneeded medical procedures in government-funded health programs.

Republicans are almost unanimously opposed to many of the health-reform measures proposed in the Reid bill. Debate is likely to center on hot-button issues like federal funding for abortions, the public insurance plan option and the taxation of premium health plans.

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FDA accepts NDA for new Aricept formulation

BY Allison Cerra

WOODCLIFF LAKE, N.J. Eisai and Pfizer announced that the Food and Drug Administration has accepted for review Eisai’s new drug application for its Alzheimer’s disease treatment.

Once daily 23-mg Aricept (donepezil HCl extended release) tablets is a new higher dose formulation contains 23-mg of donepezil HCl in an extended release, matrix-type tablet with a delivery system that allows for gradual release of the drug. The NDA is based on a head-to-head clinical study comparing the 23-mg Aricept extended release tablet to the currently marketed once daily 10-mg Aricept (donepezil HCl) immediate release tablet. More than 1,400 patients with moderate to severe Alzheimer’s disease were enrolled in this global study.

 Acceptance of the NDA indicates that the FDA has found the company’s submission to be sufficiently complete to review. Eisai and Pfizer believe this new formulation will potentially provide physicians, patients and their families with another option for the management of Alzheimer’s disease, the companies stated.

 

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Study finds spike in morbid obesity rates among Type 2 diabetics

BY Allison Cerra

NEW YORK A Loyola University Health System study has found that 1-out-of-5 Type 2 diabetics is morbidly obese — approximately 100 lbs. or more overweight.

“The rate of morbid obesity among people with diabetes is increasing at a very alarming rate, and this has substantial public health implications,” said Dr. Holly Kramer, a kidney specialist and lead author of the study published online in the Journal of Diabetes and its Complications.

 

Kramer and colleagues examined data from the National Health and Nutrition Examination Surveys completed during the years 1976 to 2006. The surveys, known as NHANES, included interviews and physical examinations of representative samples of the U.S. population.

The study found a 141% increase in the rate of morbid obesity among adults with Type 2 diabetes between 1976 to 1980 and 2005 to 2006. More than 60% of U.S. adults with Type 2 diabetes are obese, and 20.7% are morbidly obese. Further, 1-in-3 African-American adults with Type 2 diabetes is morbidly obese.

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