Word: fda
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...Administration for failing to identify the risks of the drug before it was approved. Now a study released by the New England Journal of Medicine has linked one of the most commonly prescribed diabetes drugs, Avandia, to a significant increase in the risk of heart attack. But both the FDA and Avandia's manufacturer, the British pharmaceutical giant GlaxoSmithKline, are moving quickly to try to avoid being engulfed in a similar debacle...
...because he was concerned by the data in two of the largest studies of patients taking the drug. "The cardiovascular events were all going the wrong direction," he says. Though the results weren't statistically significant, they pushed him to look at other data sets, including studies by the FDA and from the clinical-trials registry on GlaxoSmithKline's website. Nissen had gathered his data by April 24, and six days later submitted the paper to the Journal's editors...
...unpleasant sensations, I'm just a nervous foot-tapper, yet hearing the term on television, seeing the advertisement for treatment and searching on the term, I could be easily convinced I had the disease. According to search term data, searches on the condition reached their peak soon after the FDA approved requip in May of 2005, one of the first drugs targeted specifically at the condition...
...ubiquitous. Of the 120 strains isolated from humans - about 40 of which are in the mouth and genital tracts - Merck's recently FDA-approved vaccine, Gardasil, protects against four: HPV-6 and HPV-11, which cause warts; and HPV-16 and HPV-18, which cause about 70% of cervical cancers. Similarly, according to the study, HPV-16 was present in 72 of the 100 cancer patients enrolled in the study. Between 12,000 and 15,000 new cases of oropharyngeal cancer are diagnosed each year, and about 3,000 people die from it. "It is a significant health issue," says...
...mass-producing drugs) are able - or willing - to take on the work of producing a different vaccine for every patient. But with three Phase III clinical trials for idiotype vaccines under way in the U.S., and several other types of custom treatments in development (on March 29, an fda advisory committee found "substantial evidence" that a prostate cancer vaccine is effective, increasing the likelihood of its approval), hopes for cancer vaccines are running high...