The Blue sheet最新文献

Gonococcal pilus vaccine development project by Bactex includes a recently completed clinical trial involving approximately 3500 US army volunteers in Korea. Results of the double-blind, placebo controlled study, conducted during the 1st 8 weeks of 1983, are currently being analyzed. The findings will be confirmed by further testing and if the vaccine proves effective, Bactex plans to apply for a biological license. Bactex was founded in 1974 with the assistance of loans from the Center for Entrepreneurial Development at Carnegie Mellon University. The center at Carnegie, set up and funded by the National Science Foundation, serves to stimulate the transfer of technology from the academic community to industry. Similar centers have been established at MIT and the University of Washington, Bactex President and University of Pittsburgh microbiologist Charles Brinton told "The Blue Sheet" the company is developing additional human vaccines based on pilus technology. He noted that the firm also has a joint agreement with Schering's Animal Health Division for the production of animal vaccines. Under this agreement, Bactex developed a vaccine for neonatal diarrhea in piglets, which Schering began marketing about a month ago. In addition to the study in Korea, Brinton has tested the gonorrhea vaccine in approximately 230 volunteers at the University of Pittsburgh. The Korean trial was partially funded by the US Army Medical Research and Development Command.

Oral contraceptive (OC) labeling disclosure of possible benefits from use of the products, was recommended by the U.S. Food and Drug Administration's (FDA) Fertility and Maternal Health Drugs Advisory Committee at its February 11 meeting. Committee member Howard Orr, Centers for Disease Control, noting the emphasis on cautionary and warning statements contained in current OC labeling maintained: "Women should make informed decisions and this is the other half. The package insert must include the benefits information." The recommendation by the committee represents a shift in the approach to what constitutes proper labeling for OC products. Since first approved, the drugs have never carried a discussion of benefits on their labels. "A number of additional benefits from OCs--other than contraception--have emerged from the large number of studies recorded in the literature on OC use," Ron Nelson, White Memorial Medical Center, stated. "Studies cited a more regular and lighter menstrual flow, resulting in less blood loss and lower iron deficiency and anemia in contraceptive pill users, and dysmenorrhea and premenstrual tension have been sifnificantly reduced." "Ovarian cysts and pelvic inflammatory disease occurred less frequently in pill users than in controls," Nelson continued, "and the incidence of fibrocystic disease of the breast were less. There are some instances where OCs may incur protection against the development of ovarian cancer, endometrial cancer, and rheumatoid arthritis." Orr added: "I think there are 2 good studies that show almost a total elimination of ectopic pregnancy with women who took the pill. Given that now there's an epidemic of the disease going around, I think it's worth adding." The committee was asked by FDA last November to recommend changes in the current physician and patient OC labeling. FDA's Solomon Sobel, MD, Endocrine and Metabolic Drugs Division, told the committee that an agency subcommittee would review the recommendations, present them to the committee in May for final comment, then publish them in the Federal Register.