Steven Nissen: The Hidden Agenda Behind The FDA's New Avandia Hearings
Is the FDA holding a two-day panel with the goal of making its leadership look better with regard to the withdrawn diabetes drug? The cardiologist who blew the whistle on Avandia wants to know. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - May 23, 2013 Category: Pharmaceuticals Authors: Matthew Herper Source Type: news
Does pharmaceutical-funded research produce biased reports in medical journals?
In 2003, when diabetes drug Avandia was released, The New England Journal of Medicine published an article about how the drug outperformed two leading competitors in a clinical trial. The study was funded by GlaxoSmithKline, the makers of Avandia; four of the authors were GSK employees, and the others had received support as consultants. The article failed to mention that Avandia showed early warn.... (Source: Sound Medicine)
Source: Sound Medicine - May 12, 2013 Category: Global & Universal Authors: Sound Medicine Source Type: news
Avandia and Actos: Safe for you?
Avandia and Actos: What does the controversy over these diabetes drugs mean for you? (Source: MayoClinic.com Full Feed)
Source: MayoClinic.com Full Feed - May 8, 2013 Category: Consumer Health News Source Type: news
Avandia and Actos: Safe for you?
Avandia and Actos: What does the controversy over these diabetes drugs mean for you? (Source: MayoClinic.com - Ask a Specialist)
Source: MayoClinic.com - Ask a Specialist - May 8, 2013 Category: Consumer Health News Source Type: news
Epoxide Hydrolase Inhibition And Thiazolidinediones
Scientists at the Medical College of Wisconsin and the University of California at Davis, led by Dr. John Imig and Dr. Bruce Hammock have determined the synergistic actions of inhibiting soluble epoxide hydrolase (sEH) with tAUCB (trans-4-(4-[3-adamantan-1-yl-ureid]-cyclohexyloxy)-benzoic acid) and activating peroxisome proliferator-activator receptorγ (PPARγ) with the thiazolidinedione rosiglitazone on the pathological progression of cardiometabolic syndrome... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - April 25, 2013 Category: Consumer Health News Tags: Heart Disease Source Type: news
Epoxide hydrolase inhibition and Thiazolidinediones: A therapy for cardiometabolic syndrome
(Society for Experimental Biology and Medicine) Scientists at the Medical College of Wisconsin and the University of California at Davis, led by Dr. John Imig and Dr. Bruce Hammock determined the synergistic actions of inhibiting soluble epoxide hydrolase with tAUCB and activating peroxisome proliferator-activator receptorγ with the thiazolidinedione rosiglitazone on the pathological progression of cardiometabolic syndrome. Cardiometabolic syndrome occurs with obesity and hypertension increasing risks for cardiovascular disease and causing significant, rapidly progressive kidney disease. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - April 23, 2013 Category: Global & Universal Source Type: news
The FDA, Surrogate Endpoints, And Blood Pressure Drugs
(Updated) In recent years the FDA has come under increasing fire for approving drugs on the basis of surrogate endpoints without any evidence of greater clinical benefit. The most famous example of this is the diabetes drug rosiglitazone. Despite strong evidence demonstrating that it was effective at lower blood glucose levels-- the surrogate endpoint-- serious questions emerged about the cardiovascular safety of the drug, eventually leading to its near withdrawal from the market in the US (and full withdrawal in Europe). Questions have also been raised about the long term health effects of drugs targeting a specific endpo...
Source: Forbes.com Healthcare News - April 22, 2013 Category: Pharmaceuticals Authors: Larry Husten Source Type: news
High Court Rejects Glaxo Appeal
The U.S. Supreme Court cleared the way for health insurer Humana to sue GlaxoSmithKline for the recovery of health-care expenses on some patients who were allegedly harmed by diabetes drug Avandia. (Source: WSJ.com: Health)
Source: WSJ.com: Health - April 15, 2013 Category: Pharmaceuticals Tags: PAID Source Type: news
Will new FDA meeting on Avandia prompt withdrawal of drug?
The FDA has announced that two of its panels will discuss the reanalysis of the controversial RECORD trial with the much-maligned diabetes drug rosiglitazone in June. (Source: theHeart.org)
Source: theHeart.org - April 15, 2013 Category: Cardiology Source Type: news
Will New FDA Meeting on Avandia Prompt Withdrawal of Drug?Will New FDA Meeting on Avandia Prompt Withdrawal of Drug?
The FDA has announced that 2 of its panels will discuss the reanalysis of the controversial RECORD trial with the much-maligned diabetes drug rosiglitazone in June. Medscape Medical News (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 15, 2013 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news
Avandia Safety Being Reconsidered By FDA Panel
Despite GlaxoSmithKline saying it does not plan to make almost-discontinued diabetes drug Avandia available in the USA, the FDA's Endocrinologic and Metabolic advisory panel along with the FDA's Drug Safety and Risk Management Advisory committee will consider the medication's safety in June 2013. In September 2010, the FDA (Food and Drug Administration) severely restricted Avandia usage, and ordered GlaxoSmithKline to convene an independent group of scientists to re-check data on the drug's clinical trials... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - April 15, 2013 Category: Consumer Health News Tags: Diabetes Source Type: news
Avandia Again Focus of FDA Review
WASHINGTON (MedPage Today) -- The FDA will review results of the latest "independent readjudication” of the study that formed the basis for its original approval of rosiglitazone (Avandia). (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - April 13, 2013 Category: Cardiology Source Type: news
FDA to Reassess Safety Risk for Avandia
The onetime blockbuster diabetes drug Avandia is getting an unusual safety reassessment by federal regulators three years after they curbed its sales over cardiovascular risks. (Source: WSJ.com: Health)
Source: WSJ.com: Health - April 12, 2013 Category: Pharmaceuticals Tags: PAID Source Type: news
FDA Schedules Another 2 Day Avandia Advisory Panel
Once again the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) will be the subject of a 2 day FDA hearing. According to a meeting announcement scheduled to be published in the Federal Register on Monday, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet on June 5 and June 6 to "discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial." (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - April 12, 2013 Category: Pharmaceuticals Authors: Larry Husten Source Type: news
FDA advisory panel to reconsider Avandia safety
(Reuters) - A federal health advisory panel in June will reconsider safety data on GlaxoSmithKline Plc's Avandia diabetes drug, although the British drugmaker on Friday said it has not sought permission to make the nearly discontinued drug widely available again in the United States. (Source: Reuters: Health)
Source: Reuters: Health - April 12, 2013 Category: Consumer Health News Tags: healthNews Source Type: news
