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National Institute of General Medical Sciences Reorganizes

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The National Institute of General Medical Sciences (NIGMS), a part of the National Institutes of Health that supports basic research and research training, has established two new divisions. Each will administer existing NIGMS programs along with programs transferred to NIGMS from the former NIH National Center for Research Resources (NCRR).

“This reorganization will synergize and strengthen our activities in several critical mission areas,” said NIGMS Acting Director Judith H. Greenberg, Ph.D. “We also look forward to working with the staff, investigators, institutions and other groups associated with the highly regarded NCRR programs we are receiving,” she added.

The new Division of Training, Workforce Development, and Diversity merges NIGMS research training programs with activities that were previously in the institute’s Division of Minority Opportunities in Research (MORE). The division also houses the Institutional Development Award program from NCRR. It is led by former MORE Director Clifton A. Poodry, Ph.D.

“We created the new division because we recognize that training and the development of an outstanding and diverse biomedical workforce are intimately connected. The reorganization is consistent with key elements of our strategic plans and reflects input we received from many stakeholders,” said Greenberg.

The new Division of Biomedical Technology, Bioinformatics, and Computational Biology administers research and research training in areas that join biology with the computer sciences, engineering, mathematics and physics. It includes programs of the former NIGMS Center for Bioinformatics and Computational Biology (CBCB) along with NCRR biomedical technology programs. Former CBCB Director Karin Remington, Ph.D., is the division director.

“Great progress is often made at the intersections of scientific fields, and the Division of Biomedical Technology, Bioinformatics, and Computational Biology is well-positioned to facilitate just such advances,” Greenberg noted.

The amount of money allocated to programs in the new divisions will not change as a result of the reorganization or transfer of NCRR programs. Most grants in the new divisions will continue to be managed by the same staff members.

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FDA Expands use of Prevnar 13 Vaccine for People Ages 50 and Older

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Prevnar 13, a pneumococcal 13-valent conjugate vaccine, was approved today by the U.S. Food and Drug Administration for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae.

Pneumococcal pneumonia, caused when the bacterium Streptococcus pneumoniae infects the lungs, is the most common disease caused by this bacterium in adults. When the bacterium invades parts of the body that are normally free from germs, such as the blood or spinal fluid, the disease is considered “invasive.”

“According to recent information for the United States, it is estimated that approximately 300,000 adults 50 years of age and older are hospitalized yearly because of pneumococcal pneumonia,” said Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research. “Pneumococcal disease is a substantial cause of illness and death. Today’s approval provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group.”

The new use for Prevnar 13 was approved under the agency’s accelerated approval pathway, which allows for earlier approval of treatments for serious and life-threatening illnesses. The pathway allows for the demonstration of effectiveness of a vaccine using an immune marker that is reasonably likely to predict clinical benefit.

In randomized, multi-center studies in the United States and Europe, people 50 and older received either Prevnar 13 or Pneumovax 23, a licensed pneumococcal vaccine also approved for use in this age group. The studies showed that for the 12 common serotypes, Prevnar 13 induced antibody levels that were either comparable to or higher than the levels induced by Pneumovax 23.

The safety of Prevnar 13 was evaluated in about 6,000 people ages 50 and older who received Prevnar 13 and who had and had not previously received Pneumovax 23. Common adverse reactions reported with Prevnar 13 were pain, redness, and swelling at the injection site, limitation of movement of the injected arm, fatigue, headache, chills, decreased appetite, generalized muscle pain, and joint pain. Similar reactions were observed in those who received Pneumovax 23.

Accelerated approval is granted on the condition that a clinical trial is conducted during the post-approval marketing of the vaccine to verify the anticipated clinical benefit. An additional trial in 85,000 people ages 65 and older, with no previous history of receiving Pneumovax 23, is underway to confirm the clinical benefit of Prevnar 13 in the prevention of pneumococcal pneumonia.

Prevnar 13 is already approved for use in children ages 6 weeks through 5 years for the prevention of invasive disease caused by 13 different serotypes of the bacterium Streptococcus pneumoniae and for the prevention of otitis media caused by seven of the serotypes of the bacterium.

The approval of Prevnar 13 for adults 50 years and older supports the Department of Health and Human Services’ Healthy People 2020 objectives.

Prevnar 13 is manufactured by Collegeville, Pa.-based Wyeth Pharmaceuticals.

For more information:

PREVNAR 13

Healthy People 2020

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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John Buse to Chair Federal Diabetes Education Program

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John Buse, M.D., Ph.D., of the University of North Carolina at Chapel Hill School of Medicine, has been named the new chair of the National Diabetes Education Program (NDEP), a joint program of the National Institutes of Health and the Centers for Disease Control and Prevention, NDEP announced today. The appointment, for a two-year term, is effective Jan. 1, 2012.

Since 1997, the NDEP has engaged public and private partnerships to improve diabetes management and outcomes, to promote early diagnosis, and to prevent or delay the onset of type 2 diabetes in the United States and its territories. Nearly 26 million Americans have diabetes, and 79 million have prediabetes, a condition that places them at increased risk for developing type 2 diabetes and heart disease.

“Our nation is facing a diabetes crisis.  The disease is affecting more people and at younger ages.  The NDEP plays a unique role in bringing together diverse stakeholders to foster cooperation and collaboration to translate research-proven approaches to prevention and therapy into action by patients, providers and communities,” said Buse.

Buse will guide the NDEP in its efforts to reduce the burden of diabetes. NDEP facilitates the adoption of proven approaches to improve the health of people with diabetes and to prevent or delay the onset of type 2 diabetes.  Buse is charged with strengthening the program’s outreach and engagement with partners and leading activities to support NDEP’s mission to empower patients, health care providers and communities to improve diabetes-related health care and prevention efforts.

“Dr. Buse is a proven leader in the diabetes community whose expertise and insight will be invaluable to the NDEP,” said Judith Fradkin, M.D., director of the Division of Diabetes, Endocrinology, and Metabolic Diseases for NIH’s National Institute of Diabetes and Digestive and Kidney Diseases.  “As NDEP prepares to recognize its 15-year anniversary in 2012, Dr. Buse’s leadership will ensure that the program continues to play an important role in supporting improved diabetes prevention and care through its work to translate new research findings to patients, their families, health care professionals, and communities.”

Buse’s leadership role with the NDEP builds on notable accomplishments spanning more than 25 years.  Currently a medical professor at UNC-Chapel Hill, he serves as the director of the Diabetes Care Center, chief of the Division of Endocrinology and executive associate dean for clinical research, and works within the leadership of the North Carolina Translational and Clinical Sciences Institute, home of the UNC NIH Clinical and Translational Science Awards.  He has played key roles in numerous multicenter clinical trials, including two major NIH-sponsored trials:  ACCORD (Action to Control Cardiovascular Risk in Diabetes), for which he serves as study vice-chair, and STOPP-T2D (Studies to Treat Or Prevent Pediatric Type 2 Diabetes). Buse served as 2008 president, medicine and science, of the American Diabetes Association (ADA), for which he has also chaired many committees and task forces.  He was also on the board of the Carolinas affiliate of the American Association of Clinical Endocrinologists.  He is a former associate editor of the ADA journals Clinical Diabetes and Diabetes Care.

Buse succeeds Martha (Marti) Funnell, M.S., R.N., as chair of the NDEP.  Funnell is a researcher at the University of Michigan Medical School, Ann Arbor, and co-director of the Behavioral, Clinical, and Health Systems Intervention Research Core at the Michigan Diabetes Research and Training Center.

“During Ms. Funnell’s leadership, the NDEP has taken major strides in its efforts to raise awareness about diabetes and to address the psychosocial and lifestyle-change challenges associated with diabetes self-management.  This has resulted in the development of NDEP’s new behavior change tool, DiabetesHealthSense (www.YourDiabetesInfo.org/HealthSense), which provides resources and tools to support health care professionals and their patients when it comes to achieving and sustaining health goals,” said Ann Albright, Ph.D., director of the Division of Diabetes Translation at CDC.  “We are extremely grateful to Ms. Funnell and look forward to her continued involvement with the NDEP as a member of its Support for Behavior Change Task Group.”

With its more than 200 partner organizations, the NDEP identifies, disseminates, and supports the adoption of evidence-based, culturally and linguistically appropriate tools and resources that support behavior change, improved quality of life, and better diabetes outcomes.   NDEP resources are available at www.YourDiabetesInfo.org or by calling toll-free 1-888-693-NDEP (1-888-693-6337).

The NIDDK, a component of the National Institutes of Health (NIH), conducts and supports research on diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition and obesity; and kidney, urologic and hematologic diseases. Spanning the full spectrum of medicine and afflicting people of all ages and ethnic groups, these diseases encompass some of the most common, severe, and disabling conditions affecting Americans. For more information about the NIDDK and its programs, see www.niddk.nih.gov.

CDC’s Division of Diabetes Translation works to reduce the preventable burden of diabetes through public health leadership, partnership, research, programs, and policies that translate science into practice. For more information, see www.cdc.gov/diabetes.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers  and is a component of the U.S. Department of Health and Human Services. NIH  is the primary federal agency conducting and supporting basic, clinical, and  translational medical research, and is investigating the causes, treatments,  and cures for both common and rare diseases. For more information about NIH  and its programs, visit www.nih.gov.

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Regeneration after a Stroke Requires Intact Communication Channels Between the two Halves of the Brain

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The structure of the corpus callosum, a thick band of nerve fibres that connects the two halves of the brain with each other and in this way enables the rapid exchange of information between the left and right hemispheres, plays an important role in the regaining of motor skills following a stroke. A study currently published in the journal Human Brain Mapping has shown that in stroke patients with particularly severely impaired hand movement, this communication channel between the two brain hemispheres in particular was badly damaged.

In order to relate brain function and anatomical structure with each other, in this study the scientists from the Max Planck Institute for Neurological Research and the Department of Neurology at the University Hospital of Cologne combined two imaging methods. They asked stroke patients to make a simple tapping movement using the hand affected by the stroke and recorded their brain activity using functional magnetic resonance imaging. The data obtained in this way were then compared with data from healthy subjects. As expected from previous test results, compared with the control group, the stroke patients recorded a lower tapping speed and increased brain activity on both sides of the brain. “The increased activity in the healthy brain hemisphere, in particular, points to the impaired processing of motor programs between the two brain hemispheres,” explains Christian Grefkes, head of the research study.

In order to demonstrate the structural connection between brain areas, the Cologne researchers used diffusion-based magnetic resonance imaging (dMRI), which can be used to reconstruct longer stretches of nerve fibres. dMRI is based on the principle that cell elements, such as the membrane or extensions, inhibit the spread of water molecules thereby preventing them from diffusing randomly in all directions. Consequently, parallel nerve fibres can be clearly identified using dMRI. Compared to the healthy control group, the stroke patients had lower diffusion values in the corpus callosum region. This would indicate that this interhemispheric communications connection was damaged by the stroke. The most significant deviations from the values of the control group were observed in patients with more severe motor defects and increased activity in the healthy brain hemisphere.

Therefore, in addition to cell death in the actual stroke area, damage to a very distant connection structure plays a crucial role in the inability of stroke patients to fully regain their original motor capacities. “This is why, we are currently examining whether we can regenerate the communication between the brain hemispheres through early and regular stimulation treatment. Our long-term aim is to improve motor deficits in stroke patients,” says Grefkes.

 

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The above story is reprinted from materials provided by Max Planck Gesellschaft.

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Journal Reference:

Ling E. Wang, Marc Tittgemeyer, Davide Imperati, Svenja Diekhoff, Mitra Ameli, Gereon R. Fink und Christian Grefkes. Degeneration of corpus callosum and recovery of motor function after stroke: A multimodal magnetic resonance imaging study. Human Brain Mapping, online publication, 22, Oct. 2011 | DOI: 10.1002/hbm.21417

Disclaimer: Views expressed in this article do not necessarily reflect those of PreventiveMedicineDaily or its staff.

 

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