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Side Effects Block Approval of Drug Combo for Treating Obesity

GAITHERSBURG, MD. — A Food and Drug Administration advisory panel voted 10 to 6 against recommending the approval of a combination of phentermine and topiramate as a weight-loss agent because of concerns over the treatment's risk-benefit profile.
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Loss of Consult Codes Hammers Revenues, Access to Medicare

The elimination of consultation codes under Medicare has resulted in a loss of revenue for many physicians and forced some to cut back on appointments with Medicare beneficiaries, according to a survey commissioned by the American Medical Association and several other medical specialty societies.
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Insulin Might Have a Role In MCI, Early Alzheimer's: The hormone improves blood flow to the brain and works to block beta-amyloid aggregation on neurons.

Intranasal insulin boosted cognitive function and even brain activity in patients who had mild cognitive impairment and early Alzheimer's disease in a 4-month, randomized, placebo-controlled trial.
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Vital Signs: Mean Hospital Bill for Uninsured Stays Went Up 88% While Cost Rose 37%, 1998-2007

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Obesity Drug Sibutramine Flunks Safety Trial

STOCKHOLM — When European drug regulators called for a study to push the safety profile of the sympathomimetic weight-loss drug sibutramine to its limit, the drug failed the test.
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Bias and the Lack of Anti-Obesity Therapies

DR. BAYS is an endocrinologist practicing in Louisville, Ky., and chairman of the AACE Pathogenic Adipose Tissue Task Force. He has received research grants and has served as an adviser or consultant for Vivus and numerous other pharmaceutical companies.
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Is Widespread Vitamin D Supplementation Advisable for the Adult Population?

DR. ROBERT P. HEANEY is John A. Creighton University Professor and professor of medicine in the division of endocrinology at Creighton University in Omaha, Neb. He was a member of the Institute of Medicine's Calcium and Related Nutrients Panel of the Food and Nutrition Board, which set the intake recommendations for vitamin D in 1997. He reports no financial disclosures.
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Nonobese PCOS Patients Also Need the OGTT

Major Finding: Impaired glucose tolerance was found in 8 of the NIH-defined PCOS adolescent patients (14.5%) and 10 of the AES-defined group (16%). When the AES group was divided into obese and nonobese subgroups, IGT was present in 16% of both groups.
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Early Menopause Tied to Increased CVD Risk

Major Finding: Women who had menopause before age 46 were 2.1 times more likely to have a CVD event later in life, compared with those who had menopause later.
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Revision Rates Dim Enthusiasm for Roux-en-Y: The high rates suggest that the distal procedure is a poor first-line treatment for morbid obesity.

LAS VEGAS — Distal Roux-en-Y gastric bypass surgery led to excellent long-term weight loss in superobese and morbidly obese individuals, but researchers found a high incidence of protein-calorie malnutrition requiring revision, in a study of 49 patients.
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Banded Gastric Bypass May Improve Weight Loss Over Time

Major Finding: Banded gastric bypass may lead to better weight-loss maintenance compared with the nonbanded procedure in superobese patients.
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Ghrelin Increased Desire for High-Calorie Foods

Major Finding: Subcutaneous administration of the hormone ghrelin mimicked fasting in biasing food appeal toward high-calorie foods.
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Elderly Chew Up Calories Playing on the Wii

BALTIMORE — The Wii video-game system helped seniors burn calories and become more active in a pilot study of 24 adults aged 66-78 years. Group members burned 17-176 kcal during 30-minute games of Wii baseball, tennis, or team or individual bowling, Elizabeth Orsega-Smith, Ph.D., reported in a poster at the meeting.
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Menstrual Phase Key in Tracking Hs-CRP Levels

SEATTLE — Careful timing in measuring high-sensitivity C-reactive protein during the menstrual cycle can make all the difference in classifying young women's risk of cardiovascular disease, new data show.
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Metformin Cut Deaths in Patients at Risk for CVD

Major Finding: Patients with type 2 diabetes and cardiovascular risk factors who took metformin had a 24% decrease in the risk of death over a 2-year period.
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Investigational Insulin Analogue Effective, Safe in Early Trials

ORLANDO — A novel investigational ultra–long-acting insulin analogue produced glycemic control similar to insulin glargine when injected once daily or three times weekly, with better postdinner control.
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Pump+Sensor Beats Daily Shots to Trim HbA1c: Gains in glucose control must be weighed against demands the high-tech pumps place on patients.

Major Finding: Mean HbA1c decreased from 8.3% to 7.5% with the use of a sensor-augmented pump vs. 8.1% with multiple daily injections.
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Gestational Diabetes Flags Elevated Risk for Hypertension

Major Finding: Women who had gestational diabetes were 41% more likely to develop hypertension during a 14-year follow-up, compared with those who had not had the condition.
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Tapentadol ER Effective for Neuropathic Pain: The investigational analgesic also performed well in treating chronic nociceptive pain of osteoarthritis.

ROME — Tapentadol extended release, an investigational centrally acting analgesic, proved effective both for moderate to severe diabetic peripheral neuropathy and for similarly severe chronic nociceptive pain due to osteoarthritis or low-back injury in a series of five phase III clinical trials.
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Type 1 Survival Rates Improve, Though Challenges Remain

Major Finding: Patients with childhood-onset type 1 diabetes are living longer than they did 40 years ago, but still face a sevenfold increase in the risk of death, compared with those without the disease.
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Vandetanib Slows Medullary Thyroid Cancer

Major Finding: 32% of the vandetanib arm had disease progression vs. 51% of the control group.
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Agency Cautions on PPI-Related Vulnerabilities

The Food and Drug Administration issued a warning to physicians and consumers that proton pump inhibitors may increase the risk of hip, wrist, and spine fractures. The agency said that it is changing the labeling for prescription and over-the-counter versions of proton pump inhibitors (PPIs) to reflect new safety information that is the result of the FDA's review of seven epidemiologic studies. Most of the observed risk was in people older than age 50 years and those who took high doses or used the drugs for more than a year, said the agency.
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Fracture Risk Spikes With Thiazolidinediones

Rosiglitazone and pioglitazone are both associated with an increased risk of fracture in postmenopausal women with type 2 diabetes, according to a matched case-control study that used data from the Translating Research into Action for Diabetes trial.
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Lupus Patients Need 2,000 IU Daily Vitamin D

Major Finding: Five of six black lupus patients who were given 2,000 IU vitamin D daily repleted serum 25-hydroxyvitamin D to 30 ng/mL or more at 3 months.
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ACGME Plans to Cut First-Year Resident Hours

The Accreditation Council for Graduate Medical Education has revisited its standards for resident duty hours and determined that some modifications should be made, mostly for first-year residents. All other residents should still be subject to an 80-hour work week and up to 24 hours of continuous duty, according to an article published online in the New England Journal of Medicine.
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Insurers' Report Card Deems Claims Process More Accurate

CHICAGO — Twenty percent of health insurance claims are processed inaccurately, according to the American Medical Association's third annual National Health Insurer Report Card, which rates the nation's largest commercial insurers on timeliness and accuracy of claims processing.
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U.S. Health Care Ranks Last on Several Measures

Major Finding: The health care systems of six other industrial countries outranked the U.S. system in measures including quality, efficiency, patient safety, access to care, and equity.
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The Independent Payment Advisory Board

Tucked within the Affordable Care Act is a provision that creates the Independent Payment Advisory Board (IPAB), a panel of 15 experts charged with slowing the growth of Medicare and private health care spending, and improving health care quality. By law, the board's recommendations will automatically take effect unless Congress enacts its own cost-cutting plan that achieves the same level of savings. The board isn't expected to submit its first recommendations to Congress until 2014, but already the medical community is crying foul.
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Policy & Practice: Want more health reform news? Subscribe to our podcast – search ‘Policy & Practice’ in the iTunes store

The Food and Drug Administration concluded that Abbott Diabetes Care Inc. exercised inadequate quality control in manufacturing its FreeStyle and FreeStyle Navigator blood glucose monitoring systems, in a July warning letter based on the findings of a month-long inspection at Abbott's Alameda, Calif., plant. Abbott also failed to have properly trained personnel overseeing FreeStyle device manufacturing, the agency said. The director of quality systems at the plant, for example, should have a bachelor of science or an equivalent degree, but the person in that post holds a business administration degree. Abbott recalled 5,449 of its FreeStyle Navigator units earlier this year after an investigation indicated that the device's plastic housing could crack, causing inaccurate readings. The company told the FDA that it was addressing the quality issues.
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