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Dr. Jerry Avorn, professor of medicine at Harvard Medical School and author of an accompanying journal editorial, agreed with the article's authors that, until recently the part of FDA that approves devices has been run in a much more loose manner than the part of FDA that approves drugs. Hormone therapy has traditionally been the most common treatment offered to women experiencing hot flashes as part of the menopausal transition. However, when the Women's Health Initiative study reported in 2002 that hormonal therapy had potentially serious risks, many women decided the benefits didn't outweigh the potential hazards. Since that finding, experts have been able to better identify which women might have a greater risk from hormone therapy, and those for whom hormones are a possible option. We're looking at changes in a disease that has a long asymptomatic period ... that probably goes on for a couple of decades before showing symptoms. We probably do want to go to a point where we can pick out people before symptoms show, but we have nothing to treat them [with], said Dr. Raj C. Shah, medical director of the Rush Memory Clinic in Chicago. It's a little bit of chicken and egg, but we have to start somewhere -- and an advance in one area helps advance another. The study was initially funded by Aspreva Pharmaceuticals, in collaboration with Roche Pharmaceuticals. Roche produces CellCept, which is U.S. Food and Drug Administration-approved for people who've had an organ transplant. Aspreva's agreement with Roche allowed them to seek approval of CellCept specifically for the treatment of lupus nephritis, according to Dooley. During the course of the study, Aspreva went out of business and was acquired by Vifor Pharmaceuticals. Vifor continued funding the study.

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