FDA Withholds Studies From the Public
A recent observational study perfomed with data from a UK general practice database found a similiar increase in risk of heart attack between Vioxx, Celebrex, and naproxen. The study is found in the most recent addition of the British Medical Journal. While this came as no suprise, an editorial written by Dr. Peter Juni revealed some disturbing information about attempts to acquire information from the FDA.
[O]nly about 16 out of at least 27 trials of Celecoxib that were performed up to 2002 in patients with musculoskeletal pain were included in the relevant reports. In any event, reporting on study charactieristics nd adverse events was not always transparent, and cmplete data on cardiovascular safety were available for only three trials...
In fact, when seeking information about the withdrawn drug Bextra, there were 28 pages removed from the FDA's statistical review of Bextra. An image taken directly from the FDA's report is found below.
Not only should we be asking what is the FDA trying to hide, but more importantly why they are trying to hide it? Is the FDA stuck so deep in the pockets of big pharma that they cannot release studies that could protect public health?
