NIH Lupus Research Plan
Government scientists recently outlined plans for future lupus research. The goals include laying the foundation for lupus prevention, identifying disease triggers, defining target organ damage mechanisms, understanding autoantibodies, discovering and validating biomarkers, and advancing therapy. These goals are part of a long-range planning document recently released by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, of the National Institutes of Health. The NIH document predicts lupus prevention could become an “attainable goal” in the next decade. Mandated by Congress, the plan was developed with input from lupus experts, according to NIH. “The ultimate goal of this plan is to identify needs and opportunities from both public and private organizations to continue to accelerate progress in lupus research to further improve quality of life of patients who have lupus,” Dr. Stephen Katz, director of NIAMS, wrote in the plan's introduction.
Vioxx Class Action Suit Denied
A ruling that gave nationwide class-action status to insurance companies seeking reimbursement for rofecoxib (Vioxx) expenditures was overturned Sept. 6 by the New Jersey Supreme Court. The Court agreed with Merck, maker of rofecoxib, that the claims of the insurance companies and HMOs were different and therefore not appropriate for a class action suit; however, the court did rule that plaintiffs may pursue individual suits against the company. “Although we respectfully disagree with the Court's conclusion, we are pleased that our client's substantive claims are preserved. Importantly, the Court's ruling gives us the green light to pursue these claims,” said Christopher A. Seeger, lead lawyer for the plaintiffs, said in a statement.
Grant Awarded in Oklahoma
The National Institutes of Health has awarded $2.66 million to the Oklahoma Medical Research Foundation to establish the Oklahoma Rheumatic Disease Research Cores Center. The center's first pilot projects will evaluate a new molecule to determine whether it is a candidate future lupus therapies and examine risk factors for autoimmune disease in children. The money also will support junior researchers as well as researchers from outside of rheumatology, said Dr. Judith James, the principal investigator on the grant, who holds the Lou C. Kerr Chair in Biomedical Research at OMRF.
WHI Results Still Confusing to MDs
Just 18% of physicians said they have “no confusion at all” about the results of the Women's Health Initiative study, according to an online survey of more than 400 physicians conducted on behalf of The Hormone Foundation. In addition, only 15% believe patients accurately understand the risks of hormone therapy. The results “underscore the importance of physicians' role in educating patients and [the public] on menopause management,” said foundation director Paula Correa. The survey, sponsored by Novogyne Pharmaceuticals, also found that 74% of physicians still consider hormone therapy first-line treatment for menopause symptoms. Novogyne manufactures the hormone therapy patches, Vivelle-Dot, Vivelle, and CombiPatch.
FDA Wins Reauthorization
The Food and Drug Administration Amendments Act of 2007 passed Congress and was signed into law by President Bush just days before its slated expiration date of Sept. 30. The Act contained within it provisions to collect “user fees” from pharmaceutical and medical device makers to review their products, monitor direct-to-consumer advertising, and track recalls of medical devices, among other things. The “user fees” fund 25% of the agency's operating budget, said FDA Commissioner Andrew C. von Eschenbach in a statement. The agency also was given authority to require drug and device makers to disclose clinical trial data publicly and to fine manufacturers who do not do so in a timely manner, and more power to order postmarketing clinical trials. Notably absent from the final version of the bill was the creation of a regulatory pathway to approve generic versions of complex biologic agents (see related story, p. 1).
Insurance Premium Increase Slows
Employer-sponsored health insurance premiums rose on average 6.1% in 2007, reflecting a continuing slowdown in premium increases. The 2007 increase is the smallest since 1999, according to a survey by the Kaiser Family Foundation and the Health Research and Educational Trust. But experts say the slowdown is temporary and isn't providing relief to individuals or employers. The 6.1% increase is higher than the average wage increase (3.7%) and the overall inflation rate (2.6%). In 2007, the average premium for family coverage in the U.S. is $12,106. Workers pay about $3,281. Preferred provider organizations insure about 57% of covered workers; consumer-driven plans account for about 5%. For details, visit