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New Test For Safer Biomedical Research Results
In cancer research, as in most other biomedical sciences, they are playing a key role: living cells, kept in sterile plastic containers with red culture media populating incubators in laboratories around the world. But do researchers always know what is really living in their culture dishes? Under the microscope, different cell lines are almost impossible to distinguish from each other. When these important research objects stop growing without apparent reason - is it because of the manipulations by the scientists or because of an invisible viral or bacterial infection?

Hospital Industry May Cut Billions To Help With Reform
The hospital industry is close to agreeing to cut $150 billion to $170 billion over the next decade as part of a deal with the White House and congressional democrats to help pay for health care reform. While not final, the deal could be announced within days.
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Psychiatrists Begin Revising Diagnostic Manual For Mental Illnesses
Over the next 18 months, psychiatrists will revise the American Psychiatric Association"s Diagnostic and Statistical Manual of Mental Disorders, which is used to determine how U.S. residents" mental health is assessed, diagnosed and treated, the Los Angeles Times reports. Since the manual was last updated in 1994, technologies such as brain imaging and new understandings of the biological and genetic causes of many disorders have "almost guaranteed alterations" in the number of mental disorders included in fifth DSM volume, which is scheduled to be published in 2012, the Times reports.While some psychiatrists argue the manual should be broad enough to determine treatment for those who need it, others are concerned that if too broad, the manual will diagnose conditions that would otherwise be considered normal human behavior. David Kupfer, a psychiatrist at the University of Pittsburgh"s Western Psychiatric Institute and Clinics and chair of the DSM-V task force, said the DSM-V will recognize variations of disorders that have not been seen as part of "classic" illnesses, and will describe disorders in more detail, including how they differ based on race, gender, age, physical health and culture. Health insurance companies use the manual to determine coverage options for certain treatments.People involved in the revisions said the manual will be a better reflection of mental conditions of "real" people, rather than just those with the most severe cases of disorders or obvious diagnoses, the Times reports (Roan, Los Angeles Times, 5/26).
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Both Phase III Pivotal Trials Begin Enrollment In May 2009; Reinforces Lilly's Commitment To Alzheimer's Disease And Biotech Product Research

Eli Lilly and Company (NYSE: LLY) announced it will begin enrolling patients this month in two separate but identical Phase III clinical trials of solanezumab(i), previously referred to as LY2062430, an anti-amyloid beta monoclonal antibody being investigated as a potential treatment to delay the progression of mild to moderate Alzheimer"s disease. The trials, called EXPEDITION and EXPEDITION 2, will each include a treatment period that lasts 18 months and are expected to enroll a total of 2,000 patients age 55 and over from 16 countries. In 2008, Lilly began enrolling patients in two Phase III clinical trials called IDENTITY and IDENTITY 2 for a different potential treatment for Alzheimer"s disease, a gamma-secretase inhibitor that also affects amyloid beta, which is believed to be one of the underlying pathologies of the disease. Patients or caregivers interested in learning how to enroll in either EXPEDITION trial or the IDENTITY trials should visit http://www.clinicaltrials.gov or call +1-877-CTLilly (+1-877-285-4559). In combination, the EXPEDITION and IDENTITY trials will include approximately 4,600 patients with Alzheimer"s disease in over 30 countries around the world. EXPEDITION and EXPEDITION 2 - EXPanding AlzhEimer"s Disease InvestigaTIONs The EXPEDITION clinical trials are identical multicenter, randomized, double-blind, placebo-controlled trials. Patients enrolled in the trials will be randomized in a 1:1 ratio (500 patients in each trial arm) to receive intravenous infusions of either placebo or 400 mg of solanezumab once every four weeks. Patients who are taking currently available symptomatic treatments for Alzheimer"s disease can continue treatment during their participation in the EXPEDITION trials. The primary objective of both trials is to test whether solanezumab will slow the cognitive and functional decline of Alzheimer"s disease patients as compared with placebo. These outcomes will be analyzed using measures of the Alzheimer"s Disease Assessment Scale-Cognitive subscore (ADAS-COG(11)), which measures cognitive function with an emphasis on memory, and the Alzheimer"s Disease Cooperative Study - Activities of Daily Living scale (ADCS-ADL), which measures the ability to independently perform daily activities such as eating, bathing, and using the telephone. Secondary objectives of the trials include different clinical benefits as measured by several brain-scanning and biochemical biomarkers and ratings scales, and quality of life impact. "Current therapies available to treat Alzheimer"s disease may help with symptoms, but they haven"t been proven to change the disease progression," said Eric Siemers M.D., Medical Director, Alzheimer"s disease research for Eli Lilly and Company. "Biomarker results from a Phase II solanezumab trial give us hope that Lilly is on a path toward a treatment that may slow the rate of progression of Alzheimer"s disease." EXPEDITION will be conducted in Argentina, Brazil, Canada, Japan, and United States. EXPEDITION 2 will be conducted in Australia, France, Germany, Italy, Japan, Korea, Poland, Russia, Spain, Sweden, Taiwan, United Kingdom, and United States. About Alzheimer"s Disease Alzheimer"s disease is a progressive neurodegenerative condition that is the most common cause of dementia, accounting for 60 to 80 percent of cases(ii). Estimates show that 6-8 percent of people over age 65 are affected by Alzheimer"s disease(iii), totaling approximately 5.3 million people in the United States alone(ii). Every 70 seconds, an American is developing Alzheimer"s disease(ii), and it is the sixth-leading cause of death in the United States(ii). The direct and indirect health care costs associated with Alzheimer"s disease and other dementias in the U.S. are estimated to be about US$150 billion(ii). In 2005, the total cost worldwide of dementia, of which Alzheimer"s disease is the most common cause, was estimated at US$315.4 billion(iv). The burden to caregivers and health care costs can increase dramatically in the late stages of Alzheimer"s disease, when patients cannot maintain independent function and are frequently bedridden(ii). About Solanezumab Alzheimer"s disease theory suggests that amyloid beta clumps together and eventually kills brain cells. Solanezumab binds specifically to soluble amyloid beta and thereby may draw the peptide away from the brain through the blood. In short-term clinical studies, solanezumab appeared to have dose-dependent effects on amyloid beta in blood and cerebrospinal fluid. The clinical studies to date have been too short to evaluate any potential delay in the progress of Alzheimer"s disease. To date, the only side effect experienced in clinical studies that appeared to be associated with solanezumab treatment has been mild chills consistent with an infusion reaction; other side effects reported in the Phase II study include nausea, vomiting, headache, back pain, and cough. For a more complete listing of potential side effects, prospective clinical trial participants should refer to the informed consent document. i. USAN (United States Adoptive Name council) adopted, INN (International Non-proprietary Name) pending ii. "2009 Alzheimer"s Disease Facts and Figures." Alzheimer"s Association. Available here. May 13, 2009. iii. Small, GW, Rabins, PV, Barry, PP, Buckholtz, NS, DeKosky, ST, Ferris, SH, Finkel, SI, Gwyther, LP, Khachaturian, ZS, Lebowitz, BD, McRae, TD, Morris, JC, Oakley, F, Schneider, LS, Streim, JE, Sunderland, T, Teri, LA, Tune, LE. Diagnosis and Treatment of Alzheimer"s Disease and Related Disorders: Consensus Statement of the American Association for Geriatric Psychiatry, the Alzheimer"s Association, and the American Geriatrics Society. JAMA 1997; 278: 1363-1371. iv. Wimo A., Winblad B., Jonsson L. An estimate of the total worldwide societal costs of dementia in 2005 (2007) Alzheimer"s and Dementia, 3 (2), pp. 81-91 Eli Lilly and Company


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