Posted by James
Given the failure of Congress to appropriate adequate funds for drug safety, no one expects future FDA appropriations to add congressional money to the user fees that will be available for the database. That is why the agency hopes to also supplement user fees with funding provided by the Reagan-Udall Foundation, also being established by the FDAAA. The fund has a much broader purpose, however. It is a private foundation, modeled on the ones already used by the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH). The fund will raise its own operating budget. That money will be spent on collaborative research in which drug companies, academic centers, and others join together for research that would be dispersed broadly and whose results generally would not be patented. The kinds of research projects to be undertaken would be those on the FDA’s Critical Path Initiative (CPI) list.
The FDA established the CPI in March 2004. The CPI list includes 76 projects, but the FDA has funded only half a dozen or so. These projects cover biomarkers, animal models, inter-individual variability in drug response, data analysis technology and methodology in drug development, and improvements in designing and conducting clinical trials.
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Posted by James
Dolly A. Judge, Pfizer Vice President of Federal Government Relations, says:
I think more interactions are better for drug safety management purposes. But I know the optics of the industry and agency meeting more frequently is not necessarily better politically. Senator Grassley and others have been critical of the relationship between industry and FDA, so more meetings could further enhance a false perception that the relationship is too close or somehow it is unholy, so to speak.
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Posted by James
Avandia drug, the type-2 diabetes drug manufactured by Glaxo-SmithKline, is the most recent poster child for drug safety hysteria. A meta-analysis published last May by a noted cardiologist fueled concern and headlines over possible cardiovascular side effects from the drug (rosiglitazone maleate), forcing the FDA to revisit Avandia’s labeling in the absence of any new, convincing clinical trials. The result: GSK’s agreement in mid-November to expand Avandia’s existing black-box warning with confusing language saying “a risk of an increase in myocardial ischemic events was not confirmed or excluded in three long-term clinical trials.”
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Posted by James
The major aim of this study was to assess the outcome of severe hyponatremia and characterize factors influencing outcome in hospitalized patients with this disorder. This study suggests that severe hyponatremia is associated with high mortality. It is unclear if this association derives from hyponatremia per se, or the associated comorbidity in these subjects.
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Posted by James
Demographic and Clinical Characteristics of Study Patients
We found severe hyponatremia in 168 patients out of a total of 5994 patients with a diagnosis of hyponatremia at our facility over the study period, yielding an incidence of approximately 2.8%. Tables 1 and 2 summarize the demographic and clinical features of these patients.
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Posted by James
Study Setting
This study was done at Grady Memorial Hospital, a large tertiary teaching hospital , that serves a mostly urban population of city of Atlanta and the surrounding counties of Dekalb and Fulton.
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Posted by James
Hyponatremia is the most common electrolyte disorder in clinical medicine. Severe hyponatremia, defined as a serum sodium concentration of less than 115 mmol/L, may be associated with substantial morbidity and increased mortality. However, considerable controversy surrounds the optimal therapy for severe hyponatremia, as both an overly rapid correction rate and slow correction may be associated with neurologic injury and death. Ayus et al. proposed an hourly correction rate of 1.3mmol/L, using 5% saline with generic furosemide, while avoiding correction to normonatremic or hyperna-tremic levels at 48 hours, or a correction of no greater than 25mmol/L in the first 48 hours. Sterns and his coworkers, on the other hand, suggest that patients with severe chronic hyponatremia are more likely to avoid neurologic complications when hyponatremia was corrected slowly. Furthermore, it appears that chronic hyponatremia is not an entirely benign condition, as a recent report has shown that chronic symptomatic hyponatremia in post-menopausal women can be associated with major morbidity and mortality.
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