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The US Food and Drug Administration (FDA) today issued a proposal designed to assist companies focused on the development of new treatments for patients in the early stages of Alzheimer's disease (AD). "The scientific community and the FDA believe that it is critical to identify and study patients with very early Alzheimer's disease before there is too much irreversible injury to the brain," Russell Katz, MD, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a statement announcing the draft proposal. "It is in this population that most researchers believe that new drugs have the best chance of providing meaningful benefit to patients," he added. The  guidance document  outlines the FDA's current thinking about how best to identify and select patients with early AD, or those who are at risk of developing the disease, for enrollment in clinical trials, the FDA explains. The proposal ad

There is no link between work-related stress and several common cancer types, according to a meta-analysis  published online  February 7 in  BMJ . An international team of researchers, led by Katriina Heikkilä, PhD, from the Finnish Institute of Occupational Health in Helsinki, found that it is unlikely that job stress is a risk factor for colorectal, lung, breast, or prostate cancer, and it is not associated with an overall risk for cancer (hazard ratio [HR], 0.97). The researchers note that approximately 90% of cancers have been linked to environment and lifestyle, but evidence of associations with other factors, including psychosocial ones, is tentative. However, it is possible that one psychosocial factor — stress — plays a role in the development of cancer. The physiological stress response is characterized by the secretion of more hypothalamic and pituitary stress hormones, the researchers explain. These stress biomarkers trigger and maintain chronic inflammation, which

New estimates suggest that there were 4.7 million individuals aged 65 years or older with Alzheimer's disease dementia in the US in 2010 and that this number will triple to 13.8 million by 2050. These latest estimates,  published online  February 6 in Neurology , were devised by a team from the Rush Institute for Healthy Aging, Chicago, Illinois. "These are staggering numbers," coauthor Jennifer Weuve, MPH, ScD, commented to  Medscape Medical News . "The ramifications for society and family caregivers in particular are huge." "This is not really a surprise," she added. "It's a bit like climate change. We've known about it for years but we haven't done much to stop it. Our data drum home the message that research into the prevention and treatment of Alzheimer's must be a priority, as well as developing better ways of managing patients with the condition and helping caregivers." A Complicated Task Weuve explained th

President Barack Obama yesterday renominated Marilyn Tavenner, the acting administrator of the Centers for Medicare & Medicaid Services (CMS), to serve in that post without the caveat of "acting" attached to it. If the Senate approves her nomination, Tavenner will be the first confirmed, full-fledged CMS administrator since Mark McClellan, MD, PhD, stepped down from that position in October 2006, during the George W. Bush administration. Dr. McClellan's successors either were acting administrators or, in the case of Donald Berwick, MD, who was Tavenner's immediate predecessor, a recess appointment. As illustrated by Dr. Berwick's  CMS history , Senate confirmation can be tough to get when one party has enough votes to filibuster and otherwise stymie a nomination by an opposing party's president. That was the case when Obama nominated Dr. Berwick, whom Senate Republicans portrayed as an advocate of healthcare rationing, a characterization denied by t

The U.S. Food and Drug Administration today approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. Multiple myeloma is a form of blood cancer that primarily affects older adults and arises from plasma cells in the bone marrow. According to the National Cancer Institute, approximately 21,700 Americans are diagnosed with multiple myeloma and 10,710 die yearly from the disease. Pomalyst is a pill that modulates the body’s immune system to destroy cancerous cells and inhibit their growth. It is intended for patients who have received at least two prior therapies, including lenalidomide and bortezomib, and whose disease did not respond to treatment and progressed within 60 days of the last treatment (relapsed and refractory). For more information please visit:  Pomalyst

WASHINGTON (Reuters) Jan 03 - U.S. officials on Thursday gave four states currently governed by Republicans the green light to set up their own health insurance exchanges under President Barack Obama's healthcare reform law, an initiative largely opposed by Republicans. The U.S. Department of Health and Human Services said Idaho, Nevada, New Mexico and Utah joined a list totaling 17 states and the District of Columbia that have all won conditional approval to establish their own state exchanges, with operations set to begin on January 1, 2014. A fifth Republican-governed state, Mississippi, applied to operate a state exchange, but has not received approval because of a dispute about how much authority state officials should exercise over the operations of its prospective online marketplace, officials said. The U.S. administration also cleared an exchange that Arkansas plans to run in partnership with the federal government. Delaware received approval for a similar partners

By Genevra Pittman NEW YORK (Reuters Health) Jan 03 - One-third of people getting a CT scan didn't know the test exposed their body to radiation, in a new study from a single U.S. medical center. The majority of patients also underestimated the amount of radiation delivered by a CT scan, and just one in 20 believed the scan would increase their chance of ever getting cancer. The study's lead researcher, Janet Busey, said doctors need to do a better job of talking to patients about the risks and benefits of the tests, including about radiation exposure. One challenge is that there is still debate within the medical community about just how much long term cancer risk the scans carry, she said. That risk also depends on how many scans a patient gets and which organs are exposed to radiation. "There's no doubt, CT saves lives," Busey, from the University of Washington in Seattle, told Reuters Health. And their benefits usually outweigh their risks, she ad