NEJM report finds negative FDA reviews of antidepressants did not get published
WALTHAM, Mass. The New England Journal of Medicine published a report Thursday regarding a study involving reviews from the Food and Drug Administration for studies of 12 antidepressant agents and the published outcomes based on the FDA reviews.
The results showed that among 74 FDA-registered studies, 31 percent were not published. Whether and how the studies were published were associated with the study outcome. A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published.
“Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies),” the report stated.
According to the published literature, it appeared that 94 percent of the trials conducted were positive. By contrast, the FDA analysis showed that 51 percent were positive. The Journal did state that the results could have been due to any number of factors, but concluded its abstract saying, “selective reporting of clinical trial results may have adverse consequences for researchers, study participants, health care professionals, and patients.”
Study shows infrared thermometer helps cut down on diabetic foot ulcers
WASHINGTON A new study published last month in the American Journal of Medicine showed that a new infrared digital thermometer decreases the chance of a diabetic receiving a foot ulcer, according to published reports.
Foot ulcers each year strike 600,000 U.S. diabetics, who are slow to notice they even have a wound because diabetes has numbed their feet. Worse, foot ulcers are so slow healing and vulnerable to infection that they’re to blame for most of the roughly 80,000 amputations of toes, feet and lower legs that diabetics undergo each year.
Using the thermometer reduced the number of high-risk patients who got foot ulcers by nearly two-thirds, according to Armstrong who studied 225 diabetic veterans.
The thermometer works by measuring the difference in temperature around the foot, looking for hot spots that can signal inflammation, which correlates to tissue injury. Patients measure half a dozen spots on each foot. When the thermometer signals a hot spot, they put up their feet for a day or so until the temperature normalizes. Easing pressure before the skin cracks lets the body heal more easily than it can with a full-blown wound.
“Heat is one of the most sensitive things, one of the first things that happens when we begin to have tissue breakdown,” says Crystal Holmes, a University of Michigan podiatrist who has begun prescribing the thermometers.
The results of the study, which took place over 18 months, showed that 12.2 percent of patients who did standard foot checks got ulcers, compared to 4.7 percent of those who used the thermometers.
The thermometer, called the TempTouch and made by Xilas, is currently available by prescription only.
AstraZeneca to conduct comparison between Crestor and Lipitor
LONDON AstraZeneca announced that it will conduct a clinical trial comparing its cholesterol-fighting drug Crestor with Pfizer’s cholesterol drug Lipitor, the world’s best selling drug, according to Reuters.
The new trial, called SATURN, would compare the drugs’ ability to reduce the progression, or induce regression, of atherosclerosis, the main cause of cardiovascular disease, following two years of treatment in patients with coronary artery disease. Crestor was recently approved by the Food and Drug Administration to fight atherosclerosis.
AstraZeneca said the first of around 1,300 patients in the SATURN trial would be enrolled later this month and the study was expected to complete in 2011.
Lipitor had sales of $12.9 billion, compared to Crestor’s $2 billion in 2006.