Merck Loses First Vioxx Lawsuit
A jury in Texas last month awarded $253 million to the widow of a man who died after taking Vioxx (rofecoxib). The plaintiff charged that the drug maker Merck & Co. failed to warn physicians about the danger posed by Vioxx, that the drug was improperly designed, and that the company's negligence caused the death of the plaintiff's husband, Robert Ernst. Merck executives plan to appeal the verdict on the grounds that the jury was allowed to hear testimony that was both irrelevant and not based on reliable science, the company said. “While we are disappointed with the verdict, this decision should be put in its appropriate context,” Kenneth C. Frazier, Merck's senior vice president and general counsel, said in a statement. “This is the first of many trials. Each case has a different set of facts. Regardless of the outcome in this single case, the fact remains that plaintiffs have a significant legal burden in proving causation.” The award included $24 million in actual damages and $229 million in punitive damages. But the punitive damages could be reduced to about $2 million, according to Merck, since punitive damages are limited under Texas law.
Drug Acquisition Program Delay
Physicians who plan to participate in the Medicare Competitive Acquisition Program (CAP) for Part B Drugs and Biologicals will have to wait an extra 6 months for the launch of the program. Under CAP, as currently envisioned by Medicare, physicians would obtain drugs from a vendor and the vendor would be responsible for billing Medicare and collecting coinsurance or deductibles from patients. Officials at the Centers for Medicare and Medicaid Services announced last month that the agency is suspending the current CAP vendor bidding process. The bids had been scheduled to be due Aug. 5, but CMS officials are putting that process on hold to “more fully review public comments” and make clarifications to the bidding process. CMS officials expect to publish a final rule on CAP in late 2005, and bidding will open for all vendors again after the rule is published. If everything proceeds on schedule, drugs could be first delivered under the program by July 2006.
SEGRA Development Partnership
AstraZeneca and Schering AG are partnering for research and development in the area of Selective Glucocorticoid Receptor Agonists (SEGRAs). The two companies are planning to collaborate until the end of phase I clinical trials aimed at identifying novel SEGRAs. The 3-year agreement gives AstraZeneca an exclusive, worldwide license to develop and market compounds for rheumatoid and respiratory diseases. Schering AG, which has an advanced collection of identified SEGRAs, will have the exclusive, worldwide license for all other indications. Schering will also receive upfront fees, with both companies retaining rights to future payments and royalties. The full financial terms of the agreement were not made public.
Bones 101
The U.S. Bone and Joint Decade, an organization aimed at increasing awareness of musculoskeletal conditions, is launching a pilot project this fall on bone health and osteoporosis education. The program will include 1-hour educational sessions aimed at men and women in their mid-50s and 60s, to be held at public libraries and health clubs in at least six locations around the United States. Appropriately, the program's working title is “Fit to a T,” as in the T scores commonly used to gauge a person's bone density and susceptibility to fragility fracture. Participants will learn how to discuss their bone health with their physician and also how to assess their living environment for falling risk.
Spine Care Recognition
The National Committee for Quality Assurance (NCQA) is planning to launch a new physician recognition program late next year that will focus on quality care for patients with chronic back pain. The diagnosis and treatment of back pain are highly variable in the United States. While some patients never receive standard interventions, others undergo unnecessary diagnostic imaging and surgery, according to the NCQA. The organization has already convened a 15-member spine care advisory committee charged with providing advice on appropriate, evidence-based performance measures. The committee is made up of clinical researchers from different specialty areas, employers, health plans, and disability insurers. “In many cases, back pain is treated with unnecessary surgery that still leaves the patient in pain,” NCQA President Margaret E. O'Kane said in a statement. “This program will steer people to doctors who not only know how to diagnose back problems, but who also explain the pros and cons of treatment options, help them manage their condition and get well again.”