Navigation Links
FDA Panel Appears Skeptical Over Key Avandia Data
Date:7/13/2010

By Amanda Gardner
HealthDay Reporter

TUESDAY, July 13 (HealthDay News) During hearings Tuesday into the safety of controversial diabetes drug Avandia, members of the government panel that could decide the drugs' fate seemed skeptical of much of the data presented.

A decision on whether to ban Avandia or not is expected Wednesday.

The hearing has coincided with news that the drug's maker, GlaxoSmithKline, may have buried or manipulated data crucial to Avandia's approval and continued sale.

"Can we trust the sponsor?" Dr. Ellis F. Unger, a U.S. Food and Drug Administration official, asked when referring to GlaxoSmithKline (GSK), The New York Times reported. "I think thats something the committee is going to need to think about here," he said.

Dr. Nancy L. Geller, a member of the FDA advisory committee and director of the Office of Biostatistics Research at the National Heart, Lung and Blood Institute, also made her doubts known, the Times reported. "I'm just concerned about data quality overall," she said.

When told that mortality estimates from clinical trials are generally reliable, Geller replied, "Not if you report the wrong follow-up date and not if you withdraw someone from a trial just before their death."

Things have looked increasingly grim for Avandia this week. In a report released early Tuesday, the Times said that GSK knew more than a decade ago that Avandia caused an increased risk of heart problems but covered up the information.

In a 1999 trial pitting Avandia against its competitor, Actos, the drug company, then known as SmithKline Beecham, found that Avandia posed a heart risk, the newspaper reported.

The Times report, based on internal company documents it obtained, said that the company did not post results of its drug trial findings on its Web site or submit them to federal regulators.

According to a March 29, 2001, e-mail
'/>"/>

Copyright©2010 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3 4

Related medicine news :

1. NJIT professor heads panel studying sudden car acceleration
2. FDA Panel Votes Against Approval of Female Viagra
3. FDA Panel Weighs OK of Female Viagra
4. FDA Panel Backs New Morning After Pill
5. FDA Panel to Vote on New Morning After Pill
6. U.S. Panel Upholds Ban on Gay Men as Blood Donors
7. John Theurer Cancer Center and LLS host panel discussion with leading hematologists
8. DSPanel's New Mobile Analytics Server for Business Intelligence: Data Analysis, Monitoring and Planning When and Where You Need It
9. ANY LAB TEST NOW Launches New Infectious Disease Panels - Affordable Panels Test for H1N1, Staph, E. coli and Other Infectious Diseases
10. PSA-TEC to Present State of the Industry Panel Discussion
11. Panel recommends standardizing prescription container labeling
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Panel Appears Skeptical Over Key Avandia Data
(Date:11/28/2014)... 29, 2014 The report “Poxvirus ... on the therapeutic development for Poxvirus Infections, complete ... by drug target, mechanism of action (MoA), route ... latest updates, and featured news and press releases. ... therapeutic development for Poxvirus Infections and special features ...
(Date:11/28/2014)... Recently, PrettyTailor.com has developed and created its ... around the world in celebration of the coming holiday ... launched a special offer on all these outfits. ... pioneer in the garment industry, PrettyTailor.com brings together art ... and small. The business carries quite a few in ...
(Date:11/28/2014)... The holiday season is fast approaching. As a ... collection of fashionable party dresses. What’s more, the company is ... brand new outfits; the special offer is valid until Dec. ... supplier and it has received a lot of requests for ... designed to flatter various body shapes; they are available in ...
(Date:11/28/2014)... York, NY (PRWEB) November 28, 2014 ... Salvage ( http://www.rustysautosalvage.com ), one of the nation's leading ... junk and salvage vehicles to be more competitive and ... customer’s lives during this festive time of year. , ... many car owners across the US also deal with ...
(Date:11/28/2014)... York (PRWEB) November 28, 2014 ... to move forward in New Jersey’s Bergen County ... a consolidated litigation established there is quickly approaching ... updated on November 18th shows 1,293 lawsuits now ... for lawsuits that allege complications resulting from spontaneous ...
Breaking Medicine News(10 mins):Health News:Poxvirus Infections and Vestibular Diseases Pipeline Market Drugs and Companies Review H2 2014 2Health News:Poxvirus Infections and Vestibular Diseases Pipeline Market Drugs and Companies Review H2 2014 3Health News:Poxvirus Infections and Vestibular Diseases Pipeline Market Drugs and Companies Review H2 2014 4Health News:2015 Wedding Dresses from PrettyTailor.com Available Now 2Health News:Trendy Party Dresses For The Coming Holiday Season From Balfleet.com 2Health News:Rusty's Auto Salvage Increasing Their Cash Offers to Help Drivers Save Throughout the Busy Holiday Season 2Health News:Nearly 1,300 Mirena Lawsuits Now Filed in Consolidated New Jersey Litigation, Bernstein Liebhard LLP Reports 2Health News:Nearly 1,300 Mirena Lawsuits Now Filed in Consolidated New Jersey Litigation, Bernstein Liebhard LLP Reports 3
... site, Best Branded ... WEST CONSHOHOCKEN, Pa., March 10 Cadient Group, ... today it has received multiple nominations for the 2008,DTC ... the DTC,National Advertising Awards Dinner on April 17, 2008., ...
... 8 a.m. EDT, SHENZHEN, China, March 10 /Xinhua-PRNewswire-FirstCall/ ... ("Nepstar" or "the Company"), the,largest drugstore chain in China ... that it will report financial results for the,fourth quarter ... market,opens on March 19, 2008., The Company will ...
... and SUZHOU, China, March 10 ,Wyeth (NYSE: ... $280 million to,build a state-of-the-art nutritional manufacturing facility ... facility will primarily,produce infant formula milk powder and ... one of the world,s largest nutritional,manufacturing facilities., ...
... Conn., March 10 Therap Services announces,the appointment ... Services is a web-based service bureau offering an ... Therap has a,customer support team consisting of former ... "We are happy to have Anna in ...
... Scientists funded by the Biotechnology and Biological Sciences ... the journal Molecular Pharmacology identifying the structure of ... such as epilepsy and pre-menstrual tension. The same ... sensitive to alcohol. , The University of Cambridge ...
... after breathing, stretching program still evident 3 months ... -- Yoga helps ease hot flashes and other menopausal ... , Some of the 37 women who,d had early ... of Awareness" program, while others were assigned to a ...
Cached Medicine News:Health News:Cadient Group Receives Multiple Nominations for 2008 DTC National Advertising Awards 2Health News:China Nepstar Chain Drugstore to Announce Fourth Quarter 2007 Financial Results on March 19 2Health News:China Nepstar Chain Drugstore to Announce Fourth Quarter 2007 Financial Results on March 19 3Health News:Wyeth to Invest $280 Million to Build State-of-the-Art Nutritional Manufacturing Facility in China 2Health News:Wyeth to Invest $280 Million to Build State-of-the-Art Nutritional Manufacturing Facility in China 3Health News:Therap Services Welcomes Anna Keith to the US Customer Support Team 2Health News:Scientists determine structure of brain receptor implicated in epilepsy and PMT 2Health News:Yoga Eases Menopause Symptoms in Breast Cancer Survivors 2
(Date:11/26/2014)... , Nov. 26, 2014  Avanir Pharmaceuticals, ... the U.S. Food and Drug Administration (FDA) has ... Drug Application (NDA) for AVP-825. AVP-825 is an ... powder delivered intranasally utilizing a novel Breath Powered ... Response letter, and consistent with the preliminary feedback ...
(Date:11/26/2014)... -- BioScrip ® , Inc. (NASDAQ: BIOS ) announced today ... will present at the Bank of America Merrill Lynch 2014 Leveraged ... , , , Wednesday, December 3, 2014 , , , ... , , Location: , , , Boca Raton Resort and Club, ... BioScrip, Inc. is a leading national provider of ...
(Date:11/26/2014)... 26, 2014  Aridis Pharmaceuticals, Inc., a biopharmaceutical ... for infectious diseases, announced today the addition of ... key opinion leader in the areas of pneumonia ... Founder and Chief Executive Officer, ... Opal,s extensive experience investigating bacterial toxins and key ...
Breaking Medicine Technology:Avanir Pharmaceuticals Receives Complete Response Letter (CRL) from FDA on AVP-825 NDA 2Avanir Pharmaceuticals Receives Complete Response Letter (CRL) from FDA on AVP-825 NDA 3Avanir Pharmaceuticals Receives Complete Response Letter (CRL) from FDA on AVP-825 NDA 4Aridis Pharmaceuticals Appoints Dr. Steven Opal to Scientific Advisory Board 2Aridis Pharmaceuticals Appoints Dr. Steven Opal to Scientific Advisory Board 3
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: