For the first time, a public-private partnership will bring together new resources and commitment to help find biological markers for the progression of osteoarthritis, a degenerative joint disease that is a major cause of disability in people 65 and older. Over 5-7 years, the Osteoarthritis Initiative (OAI) will collect information and define disease standards on 5,000 people at high risk of having osteoarthritis and at high risk of progressing to severe osteoarthritis during the course of the study. Currently, new drug development for OA is hindered by the lack of objective and measurable standards for disease progression by which new drugs can be evaluated.
"The Osteoarthritis Initiative is an excellent example of what the Federal Government and private industry can accomplish when they join hands to share their knowledge and resources," said Secretary of Health and Human Services Tommy G. Thompson. "This initiative can speed progress toward better drugs, quicker treatment, and a less painful outcome for vast numbers of people who will develop osteoarthritis."
The OAI consortium includes public funding from the National Institutes of Health (NIH) and private funding from several pharmaceutical companies: GlaxoSmithKline, Merck, Novartis Pharmaceuticals Corporation, and Pfizer. The consortium is being facilitated by the Foundation for the National Institutes of Health, Inc. The OAI will provide approximately $8 million yearly for as many as six clinical research centers to establish and maintain a natural history database for osteoarthritis that will include clinical evaluation data and radiological images, and a biospecimen repository. All data and images collected will be available to researchers worldwide to help quicken the pace of scientific studies and biomarker identification.
"Despite an existing pool of data and research specimens on osteoarthritis, the challenge is to establish a stringently collected archive of information that will drive scientific development in this area. The strength of this initiative is the partnership's breadth—government and the private sector working together to accomplish what neither could do alone," said Dr. Stephen I. Katz, director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), one of the principal sponsors.
According to Dr. Richard J. Hodes, director of the National Institute on Aging (NIA), "Our efforts to help people with osteoarthritis, a disease that affects large numbers of older women and men, have been frustrated by our inability to correlate the results of physical examination, radiological evidence, and biospecimens." The NIA is the other principal federal sponsor of the OAI.*
While recent advances have yielded highly effective therapies for rheumatoid arthritis, no such therapies exist for osteoarthritis, and most current treatments are designed only to relieve the pain and stall the disability caused by bone and joint degeneration. OA is a chronic disease that is different in each person, which complicates clinical trials for new therapies.
As the U.S. population swells with graying baby boomers, vast numbers of people will suffer from degenerative joint diseases. Today, 35 million people—13 percent of the U.S. population—are 65 and older, and more than half of them have evidence of osteoarthritis in at least one joint. By 2030, 20 percent of Americans—about 70 million—will have passed their 65th birthday, and will be at risk for OA. For more information on the OAI, visit www.nih.gov/niams/news/oisg/index.htm.
* In addition to the NIA and NIAMS, other public partners in the Osteoarthritis Initiative at NIH include the Office of Research on Women's Health (ORWH), National Institute of Dental and Craniofacial Research (NIDCR), National Center on Minority Health and Health Disparities (NCMHD), and the National Center for Complementary and Alternative Medicine (NCCAM). The National Center for Research Resources (NCRR), the Office of Technology Transfer, the Office of the General Counsel, and the Office of Science Policy have also played pivotal roles in the establishment of this initiative. Another Department of Health and Human Services (DHHS) component involved is the Center for Drug Evaluation and Research of the Food and Drug Administration (FDA). Private-sector funding for the OAI is being managed by the Foundation for the National Institutes of Health, Inc.
The NIH mission is to uncover new knowledge that will lead to better health for everyone. NIH works toward that mission by conducting research in its own laboratories; supporting the research of nonfederal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad; helping in the training of research investigators; and fostering communication of medical information.