Public-Private Partnership Launches Osteoarthritis Initiative

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 http://www.nih.gov/niams/news/oisg/index.htm.

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.

* 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.

Attachment: Questions & Answers About the Osteoarthritis Initiative

WHAT IS OSTEOARTHRITIS?

Osteoarthritis (OA), the most common form of arthritis, is a joint disease marked by the gradual loss of cartilage that cushions and protects the bones, abnormal bone growth around the joint, and other joint changes that cause pain and disability. More than 20 million people in the U.S. have this disease, which mostly occurs in older people but can affect younger men and women. The knee is among the most commonly affected joints. There are currently no treatments, other than surgical joint replacement, that change the course of the disease, and clinical trials for prospective therapies are long, difficult and expensive.

WHAT IS THE OSTEOARTHRITIS INITIATIVE?

The Osteoarthritis Initiative (OAI) is a collaboration between the federal National Institutes of Health (NIH) and pharmaceutical companies to pool funds and expertise for a public repository of OA patient data, radiological information and biological specimens. Scientists will be able to use this public resource to test much-needed biochemical and imaging markers of disease progression, to further the development of OA drugs, and to improve public health. Neither the federal nor private sector alone would be able to develop such a resource.

WHAT PROMPTED NIH TO DEVELOP THE INITIATIVE?

Scientists, health care providers and drug companies need biochemical and imaging markers of how OA progresses in order to diagnose, monitor, and develop and implement treatments for this condition. Current methods of evaluating disease progression, including x rays and blood tests, are not accurate enough to be used in clinical trials of potential treatments. The data and specimen repository will establish standards of disease progression against which potential biochemical and imaging markers can be evaluated and clinical trials of promising agents will be facilitated.

HOW WILL THE INITIATIVE BE IMPLEMENTED?

NIH will solicit and review applications and award research contracts for 4-6 clinical centers and 1 coordinating center to create the repository. Following participant recruitment, data and specimens will be collected over 5 to 7 years from approximately 5,000 people at high risk of having osteoarthritis and at high risk of progression to severe osteoarthritis during the course of the study. In addition to conducting a longitudinal natural history study, scientists will collect blood and carry out imaging studies of the hips, hands and knees throughout the study.

WHO IS INVOLVED?

The initiative is coordinated by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and the National Institute on Aging (NIA), with additional support from the National Institute of Dental and Craniofacial Research, the Office of Research on Women's Health, the National Center on Minority Health and Health Disparities, the National Center for Complementary and Alternative Medicine, the National Center for Research Resources, the Office of Technology Transfer, the Office of the General Counsel, and the Office of Science Policy, all parts of NIH. These NIH institutes and offices form the public part of the partnership. The private-sector partners are GlaxoSmithKline, Merck, Novartis Pharmaceuticals Corporation, and Pfizer. 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). Funding for the OAI is being managed by the Foundation for the National Institutes of Health, Inc.

HOW MUCH WILL IT COST?

The public-private partnership will provide approximately 8 million dollars a year to fund this effort.

WHEN WILL IT START?

NIH Requests for Proposals will be issued within the month. Research contracts for the clinical centers and coordinating center are expected to be in place by August 2002, with participant recruitment underway by May 2003.

WHO WILL PARTICIPATE IN THE INITIATIVE'S STUDIES?

The clinical centers will recruit people over the age of 50 at high risk of having OA and at high risk of progressing to more severe forms of the disease; that is, those with obesity, previous knee injury, low-grade knee pain, abnormal gait, etc.

HOW WILL THE RESULTS BE SHARED BY THE INITIATIVE'S PUBLIC AND PRIVATE PARTNERS?

All partners have agreed that biomarkers and all other research tools developed using the repository must be made widely available to gain the most benefit for public health. Thus, clinical data and x ray information will be freely accessible to qualified scientists everywhere. For other resources that are limited (such as biological specimens), priority will be given to researchers studying promising biomarkers that will be made widely available for research and commercial use.

WHERE CAN I GET MORE INFORMATION?

If you would like more information on the OAI, call the NIAMS at (301) 496-8190 or the NIA at (301) 496-1752. For additional information, visit the OAI Web site at http://www.nih.gov/niams/news/oisg/index.htm.