News Notes

Four pharmaceuticals have joined the National Institutes of Health to find early warning signs and potential drug targets for osteoarthritis. The Osteoarthritis Initiative (OAI) will provide approximately $8 million a year over the next five-to-seven years to support clinical data collection from 5,000 people at high-risk for osteoarthritis. GlaxoSmithKline, Merck, Novartis Pharmaceuticals, and Pfizer have each committed $800,000, and the majority of federal funding comes from the coffers of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and the National Institute on Aging. Most of the patient data, which will include X-ray and magnetic resonance images, will be made available to all members of the scientific community in hopes that biological markers for this disease can be discovered giving all drug researchers a foothold in developing treatments. Nonrenewable biosamples will be open to competitors under the condition that they make public what they find. Joan McGowan, chief, musculoskeletal diseases branch at NIAMS, explains that even though the four companies have no drugs involved, they will have restricted access to certain aspects of the project, such as peer reviewed selection of collection sites. "I think they're going out on a limb," she says, because besides good press and the ability to interact with the NIH, they are receiving no significant benefit. "I think that pharmaceutical companies have had success with other types of arthritis ... and they recognize that there's a bigger market with osteoarthritis," McGowan says.

A group of patient and social justice advocates plan to form an Alliance for Human Research Protection to provide oversight on clinical research from laypersons' point of view, says John H. Noble Jr., a founder and professor of social justice at the Catholic University of America. He lambastes internal review boards (IRBs) designed to protect human subjects as agents of institutions "who are hustling the bucks" from industry and other sources. Noble says IRBs need to be "severed from research institutions" and provided adequate resources as part of the accepted overhead costs of conducting clinical trials. Government commitment to patient protection "without the [funding] is just a sham," he says. Greg Koski, director of the federal Office of Human Research Protections (OHRP), which grants authority to the IRBs, acknowledges that concern over IRB members' financial ties to industry can be valid. "But I don't think it's fair to call [the system] a sham," he says. "While there are legitimate reasons to be concerned about conflicts, it's also fair to say institutions have an interest in making sure things are done right. We have to work toward ensuring that conflicts do not exist." Koski says he welcomes the creation of any group that broadens public participation in and understanding of research oversight. Comprising lay people, researchers, and ethicists, the alliance would have no regulatory authority, but its founders aim to use public censure to help enforce legal guidelines.

A new network, the Mutant Mouse Regional Resource Centers (MMRRCs), funded by the National Center for Research Resources (NCRR), will store and catalog new mutant mouse strains donated by researchers. The University of North Carolina at Chapel Hill; the University of California at Davis; Taconic Farms in New York; and a collaboration between Harlan Sprague Dawley Inc., the University of Missouri, and Indiana University make up the four regional nodes that will collect, store, and redistribute new mutant mouse strains. The resource centers will enhance the availability of mutant strains, defray the costs of storage, ensure healthier, more regulated strains, and work to improve items such as phenotyping and the methods of cryogenic preservation. The centers hope to acquire about 200 mouse strains a year, according to Franziska Grieder, director, laboratory animal sciences program, NCRR. But new strains may not be available from the Web site (www.mmrrc.org) for six to nine months, Grieder explains.