Panelists wondered about the clinical effect of lowering LDL cholesterol from 400 to 300.
FORBES: FDA Panel Recommends Approval Of Mipomersen For Familial Hypercholesterolemia
Unlike antidepressants, which take days to weeks to turn down brain anxiety centers (and to show clinical effect), Xanax and other benzodiazepines produce immediate relief.
When Merck and Schering-Plough revealed Monday that the active ingredient in their top-selling cholesterol meds Zetia and Vytorin had flunked a clinical trial measuring its effect on artery plaque, they opened themselves up to a barrage of attacks.
Much of the placebo effect seen in clinical trials is the combination of the natural tendency of patients to get better and measurement error.
So far, safety studies have suggested it is not toxic, but the latest research, published in the Journal of Allergy and Clinical Immunology, studied the effect on the lungs and breathing.
Billie Piper is nominated for her role in clinical drugs trial drama The Effect, while the best actress category is completed by Hattie Morahan for A Doll's House and Kristin Scott Thomas for Old Times.
There have been no clinical trials to assess the effect of higher doses, although two other studies done on less-sick patients might suggest the higher doses are problematic--one in 1998 for patients with cardiac disease and one last year for chronic kidney disease patients.
Merck's (nyse: MRK - news - people ) decision is based on new three-year data from a clinical trial designed to test the effect of Vioxx on preventing colorectal polyps.
When I was a medical reviewer at the FDA in the 1980s, a completely unexpected side effect occurred in the clinical testing of a new formulation of human growth hormone synthesized in bacteria.
It was her husband's doctor, Bart Barlogie of the University of Arkansas Medical Center, who ran the first clinical trial to show Thalomid's effect in multiple myeloma.
In CIC clinical trials, the most common side effect were diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal distension (3% vs 2%).
FORBES: FDA Approves New Drug For Irritable Bowel Disorder (Update)
Researchers are now considering whether to push ahead towards clinical trials to find if the substance has a similar effect in humans.
The debacles of Avandia and Vioxx suggest that greater transparency throughout the clinical trials process and designing trials that actually address side effect concerns might help keep drugs off the market whose costs outweigh their benefits.
Christie Ballantyne, a cardiologist at the Baylor College of Medicine, led a clinical trial that indicated Vytorin may have a potent anti-inflammatory effect.
"In clinical trials, 20 milligrams of Mevacor has shown roughly the same side effect profile as placebo, " he says.
Is the magnitude of effect, if any, associated with acupuncture for a given clinical indication 'worth it' from the perspective of patients, payers, or policymakers?
应用推荐