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Lobbyists Play Ball, Flex Muscles On Health Care Reform
The Associated Press reports on lobbying around biotechnology legislation. A letter urging the protection of biotech drug makers from generics from "the private National Health Council, sent to House leaders drafting health overhaul legislation, said the plea was on behalf of "the more than 133 million Americans living with chronic diseases and disabilities and their family caregivers." It urged lawmakers to protect the makers of high-technology biological medicines against early competition from lower-cost generic copycats. The letter did not mention that nearly $1.2 million of the council"s $2.3 million budget in 2007 came from the pharmaceutical industry"s chief trade group and 16 companies that sell or are developing the brand-name biotech drugs."
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GTx-758, An Oral LH Inhibitor For First Line Treatment Of Advanced Prostate Cancer, Advances Into Second Phase I Clinical Trial
GTx, Inc. (Nasdaq: GTXI), announced the initiation of a Phase I multiple ascending dose clinical trial evaluating GTx-758, an oral LH inhibitor for first line treatment of advanced prostate cancer. A Phase I single ascending dose clinical trial in 96 subjects was successfully completed in June.
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Sites Continue To Expand Their Capabilities With Digisonics
HeartCare Cardiovascular Specialists in Libertyville, IL has expanded their CVIS capabilities with a new DigiNet Pro system. This system will provide the site with web access enabling users to have full CVIS capability from anywhere at anytime.
Mental Health

Study Finds Association Between Sudden Death And Stimulant Medications Among Children And Adolescents

Researchers found support for an association between the use of stimulants and sudden unexplained death among children and adolescents, according to a study released today by The American Journal of Psychiatry. The rate of stimulant use among 564 children and adolescents whose sudden deaths were attributed to cardiac dysrhythmia or unknown causes was 1.8 percent, compared to 0.4 percent for youth who died as passengers in motor vehicle accidents. Although stimulant use had a greater association with sudden unexplained death, the overall incidence of sudden explained death was still rare. For some time, concerns have arisen that stimulants may increase the risk for sudden unexplained death in children. "Sudden Death and Use of Stimulant Medications in Youth" by Madelyn S. Gould, Ph.D., M.P.H. and colleagues is the first study to rigorously address concerns that the therapeutic use of stimulants, like amphetamine and dextroamphetamine, may increase the risk for sudden unexplained death in children. Most, but not all, of the stimulant use was prescribed for attention deficit hyperactivity disorder (ADHD). In an accompanying editorial, Benedetto Vitiello, M.D., and Kenneth Towbin, M.D., of the National Institute of Mental Health state that the findings of the study "should underscore that stimulants are not innocuous and that their therapeutic use requires careful diagnostic assessment, diligent safety screening, and ongoing monitoring. However, it is equally clear that sudden unexplained death is a rare event, this is only the first such study, it relies on small numbers, and it is not possible to quantify the risk beyond estimating that it is very small." Both the study and editorial were published online at AJP in Advance, the online advance edition of The American Journal of Psychiatry, the official journal of the American Psychiatric Association. This study was supported in part by a contract from the Food and Drug Administration and a grant from the National Institute of Mental Health. Other funding received by the individual authors is disclosed in the article itself. The American Journal of Psychiatry is the oldest continuously published medical specialty journal in the United States and was recently named one of the "Most Influential Journals in Biology & Medicine of the Last 100 Years." Statements in this press release or the articles in the Journal are not official policy statements of the American Psychiatric Association. American Psychiatric Association


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