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Combination Therapy Appears Helpful For Short-Term Treatment Of Insomnia; Cognitive Behavior Therapy May Be Better For Long-Term
For patients with persistent insomnia, a combination of cognitive behavior therapy (CBT) and the medication zolpidem for 6 weeks was associated with improvement in sleep, although for a longer treatment period CBT alone was more beneficial, according to a study in the May 20 issue of JAMA.
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Teens Need To Hear About 'More Than Abstinence,' Philadelphia Inquirer Editorial Says
Although it is "important for other young people to hear" Bristol Palin"s message "about how hard it is to be a teenage mother," her "lesson falls short by suggesting that any teen can successfully avoid premarital sex," a Philadelphia Inquirer editorial says. Palin, who gave birth in December 2008 after an unintended pregnancy and is the daughter of Alaska Gov. Sarah Palin (R), has "changed her tune" since she said in a February interview that teen abstinence is ""not realistic at all,"" the editorial states. It adds that Bristol Palin -- now an "abstinence ambassador" for the Candie"s Foundation -- recently said that abstinence is "realistic" and that it is the "harder choice, but it"s the safer choice."The editorial continues that Palin is correct that "[a]bstinence is the only foolproof way to avoid pregnancy" and sexually transmitted infections. However, "any viable lesson about avoiding teen pregnancy should include methods besides avoiding sex, including the use of condoms," the editorial says. Recent studies have shown that abstinence-only sex education programs have had "no measurable impact on delaying teens from having sex for the first time," according to the editorial, which adds that teen pregnancy rates rose 5% between 2005 and 2007 after years of declines. Additionally, three out of 10 U.S. girls will get pregnant by age 20, a figure that increases to more than 50% for Hispanics and blacks. The editorial concludes that teens "need frank talk about premarital sex that includes all of the viable options to avoid pregnancy" (Philadelphia Inquirer, 5/15).
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Academy Publishes New Volume Of Essays Examining The Use Of fMRI To Recognize Deceit
The American Academy of Arts and Sciences has published a new collection of essays, "Using Imaging to Identify Deceit: Scientific and Ethical Questions," examining the scientific support for using functional magnetic resonance imaging (fMRI) to recognize deception.
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Pfizer And Medivation Initiate Phase 3 Trial Of Dimebon In Patients With Huntington Disease

Pfizer Inc (NYSE: PFE) and Medivation, Inc. (NASDAQ: MDVN) announced the initiation of a Phase 3 trial of the investigational drug dimebon (latrepirdine) in patients with Huntington disease. The international safety and efficacy trial, known as HORIZON, is designed to evaluate the potential benefits of dimebon on cognition (thinking and memory) in patients with Huntington disease. The companies also announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to dimebon for the treatment of Huntington disease. "Based on the promising results of our Phase 2 trial of dimebon in Huntington disease, we are pleased to advance dimebon into late-stage clinical development," said Lynn Seely, M.D., chief medical officer for Medivation. "Huntington disease is a fatal genetic disease for which no medications are currently approved by the FDA to treat the cognitive impairment associated with the condition." Orphan status is granted by the FDA to promote the development of products that demonstrate promise for the treatment of rare diseases affecting fewer than 200,000 Americans annually, such as Huntington disease, which affects 30,000 individuals in the United States, with another 150,000 at risk. Orphan drug designation entitles Pfizer and Medivation to a seven-year period of marketing exclusivity in the United States for dimebon if it is approved by the FDA for the treatment of Huntington disease. It also enables the companies to apply for research funding, tax credits for certain research expenses, and a waiver from the FDA"s application user fee. Latrepirdine is the proposed generic (nonproprietary) name for dimebon. Design of the HORIZON Study The double-blind, placebo-controlled Phase 3 trial will enroll approximately 350 patients with Huntington disease at approximately 50 sites in North America, Europe and Australia. Patients will be randomized to receive either dimebon (latrepirdine) 20 mg three times daily or placebo for six months. The primary endpoints of the trial are the Mini Mental State Examination (MMSE), which measures cognition, and the Clinician"s Interview-Based Impression of Change, plus caregiver input (CIBIC-plus), which measures global function. The trial will include only patients who have cognitive impairment, as subjectively assessed by an investigator and objectively by MMSE score. Secondary endpoints include the Neuropsychiatric Inventory (NPI), which measures behavior; the Alzheimer"s Disease Cooperative Study Activities of Daily Living (ADCS-ADL), which measures self-care and daily function; and the Unified Huntington Disease Rating Scale (UHDRS"99) Total Motor Score, which measures motor impairment; and safety. The trial is being conducted in collaboration with the Huntington Study Group (HSG) and the European Huntington"s Disease Network (EHDN). The HSG is a non-profit group of experienced clinical trial investigators from medical centers in the United States and abroad dedicated to clinical research of Huntington disease. The EHDN is a non-profit network of professionals providing an infrastructure for large scale Huntington disease clinical trials throughout Europe. About Dimebon Dimebon (latrepirdine) is an investigational drug in Phase 3 development for the treatment of Alzheimer"s disease (AD) and Huntington disease (HD). In preclinical studies, dimebon has been shown to protect brain cells from damage and enhance brain cell survival, potentially by stabilizing and improving mitochondrial function. The dimebon mechanism is distinct from currently available AD and HD medications. About Huntington Disease Huntington disease is a rare, neurodegenerative disease that is caused by the death of specific brain cells. The genetic disorder is characterized by the gradual development of involuntary muscle movements, cognitive impairment and severe behavioral disturbances. No medications are currently approved to treat the cognitive impairment (thinking and memory) of Huntington disease. About the Pfizer/Medivation Dimebon Collaboration Medivation and Pfizer have a global collaboration to develop and commercialize dimebon for the treatment of Alzheimer"s disease and Huntington disease. Under the terms of the agreement, the companies are working in partnership to seek FDA approval for dimebon and bring it to market in the United States. In addition, following FDA approval, Medivation will co-promote dimebon to specialty physicians in the U.S. Pfizer has responsibility for development, regulatory and commercialization outside of the U.S. PFIZER DISCLOSURE NOTICE: The information contained in this release is as of July 30, 2009. Pfizer assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about certain potential indications for dimebon, including their potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any new drug applications that may be filed for such indications as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of any such indications; and competitive developments. A further list and description of risks and uncertainties can be found in Pfizer"s Annual Report on Form 10-K for the fiscal year ended December 31, 2008, and in its reports on Form 10-Q and Form 8-K. MEDIVATION DISCLOSURE NOTICE: This press release contains forward-looking statements, including statements regarding potential clinical indications for dimebon, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Medivation"s actual results to differ significantly from those projected, including, without limitation, risks related to progress, timing and results of Medivation"s clinical trials, difficulties or delays in obtaining regulatory approval, enrollment of patients in Medivation"s clinical trials, partnering of Medivation"s product candidates, manufacturing of Medivation"s product candidates, competition with Medivation"s product candidates should they receive marketing approval, the adequacy of Medivation"s financial res, unanticipated expenditures or liabilities, intellectual property matters, and other risks detailed in Medivation"s filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarter ended March 31, 2009 filed on May 11, 2009, with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Medivation disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release. Pfizer


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