In addition to a study of 13, 000 patients that will be used to convince the FDA to approve the drug, Novartis is conducting an 18, 000-patient outcome study to try and demonstrate that its drug does not cause an increased risk, however rare, of heart attack.
Eric Topol of Scripps Health says his concerns would be the same whatever the outcome of the study.
Lieberman is adamant that Vibram sponsorship had nothing to do with the outcome of the study, which was also funded by the American School of Prehistoric Research, the Goelet Fund and Harvard University.
The announcement today is the outcome of a detailed study on the structure of the company, comparing what we need for the future with what we have today.
Merck also plans to seek FDA approval for its investigational cardiovascular drugs Tredaptive and Vorapaxar by early next year (Read Merck Updates: Outcome of Large Clinical Study On Tredaptive Soon).
But the results were very odd: first, they saw a drop in plasma thiol levels (a drop is a bad outcome, for this study) in patients treated for 2-12 months, from 124 down to 105.
These individuals together have extensive experience conducting large trials, are widely respected clinical scientists, had overcome considerable challenges in the implementation of the study, and had no stake in the outcome.
FORBES: Researchers Who Ran Controversial Chelation Trial Respond to Questions
The Los Angeles City Council recently decided to study the issue of transferring the airport back to Ontario, though the outcome remains unclear.
Overall, says Boston Medical Center's Dr. Fernando, a co-author of the study, 70% to 80% of patients are satisfied with the outcome a year or two after the procedure.
Study designed to determine whether the dose (amount) or type of treatment impacts outcome.
In one National Cancer Institute-sponsored study, weight loss of greater than 5 percent from baseline was a predictor of poor outcome, independent of cancer stage, type of cancer, and patient performance status.
However, the latest study, from the University of Santiago de Compostella, found a huge difference in the outcome for patients who were allowed to carry on taking their statins when they reached hospital after a stroke.
That is why the best outcome from Kyoto would have been a modest, politically workable agreement to curb emissions of greenhouse gases pending further study.
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