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:7/24/2014)... University of Texas at Arlington professor who co-authored ... foundations engaged in community revitalization has been awarded ... 2014., Maria Martinez-Cosio, associate professor in the School ... award this week at the society,s national conference, ... lecturer and academic coordinator in the Urban Studies ...
(Date:7/24/2014)... of contents if you need to know precisely what substances ... to be a highly skilled chemist or to have genuine ... molecular structure of the various substances. Christian Grundahl Frankr, a ... has developed a method that allows him to use X-rays ... ,Fingerprints, of a Substance , The technique is called ,powder ...
(Date:7/24/2014)... 23, 2014 (HealthDay News) -- A growing number of ... to boost their muscles and athletic ability, a new ... admit to using hGH jumped to 11 percent in ... in 2012, the new survey from the Partnership for ... a need for tighter regulation and oversight of performance-enhancing ...
(Date:7/24/2014)... a professional supplier of wedding dresses and special occasion gowns, ... of cheap wedding dresses to its online catalog. ... discounts. According to the CEO of the company, Stwd.co.uk is ... They are available at low rates, up to 55% off. ... previously priced at $150, and it is offered at a ...
(Date:7/24/2014)... 2014 Hayes, Inc. ( http://www.hayesinc.com ), ... use of evidence, is pleased to announce that Dee ... guest speaker at the AHRMM14 Conference in ... expert in value analysis who also serves as the ... Professionals (AHVAP), will facilitate and participate in two preconference ...
Breaking Medicine News(10 mins):Health News:Strategy for community development partnerships earns award for UT Arlington professor 2Health News:Chemist develops X-ray vision for quality assurance 2Health News:Chemist develops X-ray vision for quality assurance 3Health News:Dangerous Use of Growth Hormone Surges Among U.S. Teens 2Health News:Dangerous Use of Growth Hormone Surges Among U.S. Teens 3Health News:Dangerous Use of Growth Hormone Surges Among U.S. Teens 4Health News:Dangerous Use of Growth Hormone Surges Among U.S. Teens 5Health News:Cheap Wedding Dresses Are Offered by Stwd.co.uk at Low Prices 2Health News:Hayes, Inc. Senior Vice President to Speak at AHRMM14 Conference 2Health News:Hayes, Inc. Senior Vice President to Speak at AHRMM14 Conference 3
... doctors' fail in recognizing cow's milk allergy in babies, which ... able to correctly diagnose the disease, wrongly recommending soy-based milk ... ,The survey of 500 doctors is being published ... by SHS International. The survey found out that most of ...
... practitioners need better resources and support to care for ... researchers. // ,In an editorial for ... general practice and family health specialists have outlined new ... in which partner violence is occurring. ...
... to treat bleeding disorders, like hemophilia, is being used to ... ,The drug Recombinant Activated Factor VIII has been proven ... can cause heart attacks, and strokes due to clot formation. ... to prescribe it to control life threatening blood loss. ...
... women boxers gathered here for the ongoing World Championships seem ... they stand a chance //of rupturing their womb muscles that ... simply after medals, for others, mostly foreign boxers, marriage is ... Indian pugilists - M.C. Mary Kom, 24, who is seeking ...
... eating reduces intake of food' – The general belief of ... of Rhode Island study confirms // that the concept of ... was bandied about for decades due to the lack of ... relation between slow eating and less calories intake. The study ...
... scientists at Dartmouth Medical School and Dartmouth College, have ... changing muscle metabolism and performance. // The researchers are ... of muscle diseases. , ,The researchers ... (or AMPK) is responsible for realizing the best muscle ...
Cached Medicine News:Health News:Majority Of Doctors Tend To Ignore Milk Allergy Cases In Babies 2Health News:Tackling Violence in Families 2Health News:As these women box on, do they risk becoming mothers? 2Health News:As these women box on, do they risk becoming mothers? 3Health News:Dartmouth researchers zero-in on a gene that heightens muscle performance 2
(Date:7/24/2014)... Zimmer Holdings, Inc. (NYSE and SIX: ZMH) today reported ... The Company reported second quarter net sales of $1.18 ... currency over the second quarter of 2013.  Diluted earnings ... $1.49 adjusted, an increase of 4.2% adjusted over the ... was marked by solid sales growth in a number ...
(Date:7/24/2014)... July 24, 2014   ndd Medical Technologies , ... employing precise ultrasound technology, announced that its EasyOne Pro ... measure Carbon Monoxide Diffusing Capacity (DLCO) for phase 2 ... study of Chronic Obstructive Pulmonary Disease (COPD) ever undertaken. ... in the U.S. and affects millions of people worldwide.  ...
(Date:7/23/2014)... 2014 Announced at the 20 th ... agreement seeks to increase access to a promising new HIV ... 2014 conference in Melbourne today, the ... Gilead Sciences for tenofovir alafenamide (TAF), a promising new medicine ... in India and China ...
Breaking Medicine Technology:Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 2Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 3Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 4Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 5Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 6Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 7Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 8Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 9Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 10Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 11Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 12Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 13Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 14Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 15Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 16Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 17Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 18Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 19Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 20Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 21Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 22Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 23Zimmer Holdings, Inc. Reports Second Quarter 2014 Financial Results 24EasyOne Pro from ndd Medical Technologies Chosen Again as the Exclusive PFT Testing Technology in Phase 2 of COPDGene Study 2The Medicines Patent Pool (MPP) Broadens Collaboration with Gilead Sciences: Signs Licence for Phase III Medicine Tenofovir Alafenamide (TAF) 2The Medicines Patent Pool (MPP) Broadens Collaboration with Gilead Sciences: Signs Licence for Phase III Medicine Tenofovir Alafenamide (TAF) 3
... 2011 Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA ) ... quarter ended September 30, 2011, on Monday, November 7, 2011, ... November 7, at 5:00 p.m. Eastern Time / 2:00 p.m. ... and live webcast to provide a company update, as well ...
... Techne Corporation (NASDAQ: TECH ) announced that its ... $0.28 per share for the quarter ended September 30, 2011. ... all common shareholders of record on November 7, 2011.  Future ... on a quarterly basis. Techne Corporation has two ...
Cached Medicine Technology:Alexza to Announce 2011 Third Quarter Financial Results on Monday, November 7, 2011 2Alexza to Announce 2011 Third Quarter Financial Results on Monday, November 7, 2011 3Alexza to Announce 2011 Third Quarter Financial Results on Monday, November 7, 2011 4
... 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 ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: