NIH and FDA Announce Collaborative Initiative to Fast-track Innovations to the Public

The U.S. Food and Drug Administration and the National Institutes of Health today unveiled an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients.

The initiative involves two interrelated scientific disciplines: translational science, the shaping of basic scientific discoveries into treatments; and regulatory science, the development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality. Both disciplines are needed to turn biomedical discoveries into products that benefit people.

Information on Life after Cancer Now Available on NIHSeniorHealth.gov

Older adults who have survived cancer can find out what to expect once treatment ends in Life after Cancer, the newest topic on NIHSenior Health.

Visitors to the site will learn about managing follow-up care, physical and emotional changes, and relationships with family and friends. The topic also addresses how a person’s age and health status can affect recovery and survival. This is important information for older adults who make up about 60 percent of cancer survivors and whose cancer treatments may have been complicated by other aging-related health conditions.

NIHSeniorHealth is a health and wellness Web site geared to the needs of older adults. It was developed by the National Institute on Aging (NIA) and the National Library of Medicine (NLM), both part of the National Institutes of Health.

Scientists Map Genetic Regulatory Elements for the Heart

Scientists have devised a new computational model that can be used to reveal genetic regulatory elements responsible for development of the human heart and maintenance of its function.

Although the teams focused on the heart, the computational method they developed is broadly applicable to other tissues, and was successfully used to identify regulatory elements for cells of the limbs and brain. Cataloging these regulatory sequences may improve understanding of diseases and lays the groundwork for improved medical treatments.

The research, conducted by scientists at the National Institutes of Health’s National Center for Biotechnology Information (NCBI) and the University of Chicago, is published in the March 2010 issue of Genome Research and is available online.

WHI Study Data Confirm Short-Term Heart Disease Risks of Combination Hormone Therapy for Postmenopausal Women

New analyses from the Women’s Health Initiative (WHI) confirm that combination hormone therapy increases the risk of heart disease in healthy postmenopausal women. Researchers report a trend toward an increased risk of heart disease during the first two years of hormone therapy among women who began therapy within 10 years of menopause, and a more marked elevation of risk among women who began hormone therapy more than 10 years after menopause. Analyses indicate that overall a woman’s risk of heart disease more than doubles within the first two years of taking combination HT.

The difference in the initial level of risk does not appear related to age, based on findings that the increased risk of heart disease was similar between women in their 50s on combination hormone therapy and women in their 60s.

The study is in the Feb. 16, 2010, Annals of Internal Medicine. The WHI is sponsored by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH).

Panel Calls for Reducing Colorectal Cancer Deaths by Striking Down Barriers to Screening

Colorectal cancer is the second leading cause of cancer-related deaths in the United States. Despite evidence and guidelines supporting the value of screening for this disease, rates of screening for colorectal cancer are consistently lower than those for other types of cancer, particularly breast and cervical. Although the screening rates in the target population of adults over age 50, have increased from 20-30 percent in 1997 to nearly 55 percent in 2008 – the rates are still too low. An NIH state-of-the-science panel was convened this week to identify ways to further increase the use and quality of colorectal cancer screening in the United States.

“We recognize that some may find colorectal cancer screening tests to be unpleasant and time-consuming. However, we also know that recommended screening strategies reduce colorectal cancer deaths,” said Dr. Donald Steinwachs, panel chair, and professor and director of the Health Services Research and Development Center at the Johns Hopkins University. “We need to find ways to encourage more people to get these important tests.”

The panel found that the most important factors associated with being screened are having insurance coverage and access to a regular health care provider. Their recommendations highlighted the need to remove out-of-pocket costs for screening tests.