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Shire Has Filed A Treatment Protocol For Velaglucerase Alfa For Gaucher Disease
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that, at the request of the FDA, in view of a potential restriction on the availability of the current approved and marketed treatment for Gaucher Disease patients, it has filed a treatment protocol for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Gaucher Disease.
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Anxious Parents Misdiagnose Milk Formula Intolerance
Some parents may be unnecessarily switching infant milk formulas for their healthy infants. A study published in BioMed Central"s open access Nutrition Journal, found that many parents misinterpret common baby behaviors as milk intolerance and needlessly switch formulas without consulting a health professional.
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Sixteen States, DOJ Join Whistle-Blower Lawsuits Alleging Wyeth Defrauded Medicaid Programs
The U.S. Department of Justice and 16 states have joined two whistle-blower lawsuits filed in federal District Court in Massachusetts alleging that Wyeth defrauded the government by not offering the same discounts on two medications to Medicaid that it offered to hospitals, the Wall Street Journal reports. The lawsuits were initiated following a grand-jury investigation by the U.S. Attorney"s Office in Massachusetts (Johnson, Wall Street Journal, 5/19). The other states included in the lawsuits are California, Delaware, Florida, Illinois, Indiana, Louisiana, New York, Michigan, Nevada, New Hampshire, Tennessee, Texas, Virginia, Wisconsin and the District of Columbia (Barrett, AP/Austin American-Statesman, 5/18).According to the lawsuits, Wyeth from 2000 to 2006 sold hospitals a bundled package called the Protonix Performance Agreement, which included its acid-reflux drugs Protonix Oral and Protonix IV. The suits allege that Wyeth gave hospitals up to a 94% discount for the oral version under the deal, with the understanding that when patients were released from hospitals they would be switched from the intravenous version of the drug to the oral version. According to the complaint, Wyeth hoped to gain an edge in a competitive market for acid-reflux pills by taking advantage of its standing as the only company offering an IV acid-reflux drug. The Journal reports that Wyeth charged hospitals $20 per vial for the IV version of Protonix and $3 for the oral version.Medicaid rules stipulate that the program is entitled to the lowest price on prescription drugs, and drugmakers are required to pay states rebates if they offer discounts to any other entities. The lawsuits state that Wyeth avoided paying hundreds of millions of dollars to state Medicaid programs because it did not offer the programs the same discounts or provide rebates (Wall Street Journal, 5/19).The lawsuits are seeking financial penalties against Wyeth of up to three times the amount lost by Medicaid. Assistant Attorney General Tony West said, "By offering massive discounts to hospitals, but then hiding that information from the Medicaid program, we believe Wyeth caused Medicaid programs throughout the country to pay much more for these drugs than they should have." Wyeth spokesperson Doug Petkus said that Wyeth "believes that its pricing calculations were correct and intends to defend itself vigorously in these actions" (AP/Austin American-Statesman, 5/18).
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Atrial Fibrillation Linked To Increased Hospitalization In Heart Failure Patients

Patients with atrial fibrillation, common in those with advanced chronic heart failure, have an increased risk of hospitalization due to heart failure, according to new research from researchers at the University of Alabama at Birmingham (UAB). The findings, published in June in the European Heart Journal, also suggest that atrial fibrillation is not associated with an increased risk of death in heart failure patients, contradicting previous assumptions. "Our findings show that the presence of atrial fibrillation in heart failure patients did not increase their risk of death, as has been previously suggested, but did increase the risk of hospitalization due to worsening heart failure," said Mustafa Ahmed, M.D., a physician-scientist at the UAB American Board of Internal Medicine Research Pathway Program and the study"s lead investigator. Atrial fibrillation is a condition with irregular heart rhythm and is often accompanied by increased heart rate. "Importantly, atrial fibrillation significantly increased hospitalization due to heart failure only in patients not receiving a beta-blocker or drugs that block the beta-receptors in the heart but not in those receiving a beta-blocker," said Ali Ahmed, M.D., MPH, associate professor in the division of gerontology, geriatrics and palliative care medicine, director of UAB"s Geriatric Heart Failure Clinic and the study"s senior investigator. "In patients with heart failure and atrial fibrillation, beta-blockers, which help reduce heart rate, may be useful in reducing the risk of hospitalization due to worsening heart failure." Ahmed and colleagues matched 487 pairs of heart failure patients with and without atrial fibrillation from the Beta-Blocker Evaluation of Survival Trial. All-cause mortality occurred in 38 percent of the patients with atrial fibrillation against 37 percent of patients without. However, 44 percent patients with atrial fibrillation were hospitalized for worsening heart failure over the course of the trial, against only 38 percent without. The research was supported through a grant from the National Heart, Lung and Blood Institute, one of the National Institutes of Health, and a generous gift from Ms. Jean B. Morris of Birmingham, Alabama. Ahmed"s co-researchers were Mustafa Ahmed, M.D., James Ekundayo, M.D., DrPH, Inmaculada Aban, Ph.D., Bo Liu, MB, MPH, all from UAB; Michel White, MD, Montreal Heart Institute; Thomas Love, Ph.D., Case Western Reserve University; and Wilbert Aronow, MD, New York Medical College. About UAB Health System The UAB Health System includes all of the University of Alabama at Birmingham"s patient care activities, including UAB Hospital, the Callahan Eye Foundation Hospital and The Kirklin Clinic. UAB is the state of Alabama"s largest employer and an internationally renowned research university and academic health center whose professional schools and specialty patient care programs are consistently ranked as among the nation"s top 50. University of Alabama at Birmingham


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