NIH Osteoarthritis Initiative
The Osteoarthritis Initiative, sponsored by the National Institutes of Health, last month released its first set of baseline data to researchers. The initiative is a multicenter, 4-year observational study of nearly 5,000 men and women with either early-stage and advanced knee osteoarthritis, as well as those at risk for developing the disease. The first data set includes baseline questionnaire and exam data for about 2,600 participants. In addition, baseline x-ray and MRI images for a 200-patient sample are available to researchers upon request. Study investigators are scheduled to release the second set of data later this year and a third set in early 2007. Other data set will be released about every six months, according to NIH. The data are available online at
Mixed Reviews for Merck
The most recent Vioxx court cases have produced mixed results for the drugmaker Merck & Co. In August, a Los Angeles jury ruled in the company's favor, finding that Vioxx (rofecoxib) was not responsible for the heart attack of Stewart Grossberg, who had been taking the drug intermittently. Merck argued successfully that Vioxx was not responsible for Mr. Grossberg's heart attack because he has high cholesterol levels, atherosclerosis, and a family history of cardiac problems. But about 2 weeks later, a federal jury in New Orleans found Merck liable for $51 million in damages in the 2002 heart attack of Gerald Barnett, a 62-year-old retired special agent of the FBI. The company is currently exploring grounds for appeal including insufficient evidence and the application of incorrect legal standards, according to Merck. The company was also dealt another blow in August, when a New Jersey judge decided to set aside a 2005 jury verdict that had been in Merck's favor. The judge ordered a new trial to take place early next year. The judge cited a December 2005 New England Journal of Medicine editorial expressing concerns about Vioxx-related study data as the basis for throwing out the jury verdict (N. Engl. J. Med. 2005;353:2813–4).
Focusing on Quality
A Michigan insurer aims to improve quality in low back care by providing special designation to health care facilities that have demonstrated better outcomes and fewer complications. The Blue Care Network of Michigan last month announced 61 Centers of Excellence facilities across the state for low back pain. These Centers of Excellence had to score at or above the 80th percentile overall for criteria that included having a multidisciplinary approach to treating low back pain, evidence-based treatments that have improved outcomes in low back pain, a medical director for the facility and physical therapists on-site, and access to a mental health professional. The designation will last for 2 years, after which the facility must reapply. Blue Care Network plans to promote the Centers for Excellence to its members, as well as to physicians involved in the treatment of low back pain. And Blue Care Network members who are seeking low back pain treatment are “strongly encouraged” to seek care at one of the 61 designated centers, according to the insurer. A list of the centers is available at
Senate Bill to Boost Drug Safety
After months of public discourse, Sen. Edward Kennedy (D-Mass.) and Sen. Mike Enzi (R-Wyo.) have introduced a bill that aims to increase assurances that drugs are safe before they reach the marketplace or at least have a plan in place to more closely monitor when they need to be withdrawn. The Enhancing Drug Safety and Innovation Act would require pharmaceutical manufacturers to be more proactive about safety problems. Companies would have to establish risk evaluation and management strategies that would be agreed upon by the manufacturer and the Food and Drug Administration before the product is approved. The companies would have to submit adverse event reports every 15 days, quarterly, and annually. If a company knowingly does not comply with the agreed-upon strategy, the FDA can impose monetary penalties. The senators also proposed that manufacturers make clinical trial results public. The bill also would overhaul the FDA's process for vetting outside advisory panel members, with a goal of minimizing conflicts of interest and then ensuring that they are fully disclosed.
Regulating Nanotechnology
The Food and Drug Administration has launched an internal nanotechnology task force aimed at figuring out new regulatory approaches for pharmaceutical products and devices that use nanotechnology materials. Nanotechnology materials are about 1–100 nm and often have different chemical and physical properties than larger materials do, such as altered magnetic properties and increased chemical and biologic activity, according to the FDA.