VA Accepts POWs' Osteoporosis
Officials at the Department of Veterans Affairs are proposing to extend benefits to former prisoners of war who suffer from disabling osteoporosis. In a proposed rule, the VA seeks to establish a presumption of service connection for osteoporosis that's at least 10% disabling in veterans held at least 30 days as POWs. Several studies have shown that POWs suffered serious bone loss following captivity because of dietary deficiencies during their imprisonment.
New Site for Arthritis Patients
The Arthritis Foundation has launched a new online resource to inspire people with arthritis to engage in physical activity. The “Let's Move Together” Web site (
OA Initiative Biospecimens Available
Researchers can now obtain serum, plasma, DNA, and other biospecimens collected as part of the Osteoarthritis Initiative. The Osteoarthritis Initiative is a research partnership between the National Institutes of Health and private industry that aims to improve the diagnosis and monitoring of osteoarthritis. The study, which began enrolling participants in 2004, includes men and women age 45 and older who are at risk for developing osteroarthritis and those who early disease. Biospecimens are available for the entire cohort (4,796 participants) for the baseline, 12-month, and 24-month follow-up visits. A committee appointed by NIH will review researcher requests for biospecimens based on significance, approach, innovation, investigator qualifications, plans for data sharing, and research environment. The committee will also take into account the potential for the proposed research to advance the understanding or treatment of osteoarthritis.
FDA Posts Guidance on Handouts
The FDA has issued updated guidance for manufacturers that distribute journal articles or other scientific publications concerning off-label uses for their FDA-approved drugs, devices, or biologics. On its Web site, the agency suggests that distributed journal articles be only from organizations using editorial boards with “demonstrated expertise in the subject of the article,” independence to review articles, and fully disclosed conflicts of interest. Authors and editors should also disclose conflicts. Acceptable articles can't be from special supplements funded even partially by a manufacturer. In its presentation to practitioners, an article shouldn't be highlighted, otherwise marked up, or attached to promotional materials.
PhRMA Revises Ad Guidelines
The Pharmaceutical Research and Manufacturers of America recently advised drug makers to state when actors portray medical professionals in direct-to-consumer drug advertisements and to acknowledge any compensation given to real medical professionals in ads. In addition, the new, nonbinding guidelines support the inclusion of “black box” warnings in the ads, and reinforce that companies shouldn't promote off-label uses. Rep. John Dingell (D-Mich.), who has led investigations into direct-to-consumer ads, commended PhRMA for the new guidelines but noted that the organization hasn't endorsed a 2-year prohibition on such ads for newly approved drugs, as recommended by the Institute of Medicine.
New EHR Certification Options
The Certification Commission for Healthcare Information Technology plans to endorse ambulatory electronic health record (EHR) products that offer advanced capabilities in four new areas: clinical research, dermatology, advanced interoperability, and advanced quality. The CCHIT currently offers voluntary certification in both the ambulatory and inpatient settings to vendors of EHRs that support basic clinical tasks, are able to send and receive information, and provide security for medical information. The new options for product certification would be added in 2010. The CCHIT is recognized by the federal government as the official reviewer of products in health information technology. CCHIT chair Dr. Mark Leavitt said in a statement that in the next few years, the commission may develop optional add-on certifications.