One question that needs more attention is why are gay men and lesbians excluded from participating in certain medical studies? A little over a year ago a letter written by three scientists from the Fox Chase Cancer Center in Philadelphia appeared in The New England Journal of Medicine. The letter cited several dozen clinical trials [...]
In one of those situations when actual clinical practice precedes the normal drug development process a recent announcement from Janssen Research & Development, LLC (Johnson & Johnson) informs that they have un-blinded their Phase 3 study, COU-AA-302, which clearly demonstrates that Zytiga (abiraterone acetate), when taken with prednisone, is effective in treating both mildly symptomatic [...]
Men who inherit a mutation in the HOXB13 gene have a 10 to 20 times increased risk of developing prostate cancer, according to the study in the January 12, 2012 issue of the New England Journal of Medicine. Finally, the first major gene mutation associated with an increased risk for prostate cancer has been identified. [...]
Will the Centers for Medicare & Medicaid Services (CMS) be able to optimize patient care with regard to both on-label and off-label drugs? CMS', at this time, has not shown itself to be either in favor or against new technology or the introduction of new uses for drugs. They still seem interested in promoting access [...]
Historically, I have been critical of the FDA, especially around the delay of the approval of Provenge. Now, it is time to take a look at the FDA and what I believe the future will be for this agency. I do first need to make it clear that I do believe that the FDA plays [...]