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:7/28/2015)... ... ... Morristown Medical Center, part of Atlantic Health System, today announced it was ... the nation, to implant the newly approved CoreValve® Evolut® R System from Medtronic. The ... condition. , The CoreValve® Evolut® R System was approved by the U.S. Food and ...
(Date:7/28/2015)... Costa Mesa, Calif (PRWEB) , ... July 28, ... ... disability in the United States with 1 in 68 children currently affected with ... to get their child on the road to recovery is extremely daunting. That’s ...
(Date:7/28/2015)... ... July 28, 2015 , ... DuPont ... visit to Ethiopia to learn more about the impact of U.S. collaborations with ... initiative focuses on accelerating agricultural development as an engine of broad-based economic growth ...
(Date:7/28/2015)... ... 2015 (PRWEB) July 28, 2015 , ... Nations Insurance Solutions, ... quotes to its clients, recently announced the launch of Commercial, Auto and Motorcycle ... specific needs. , Liability automobile insurance policies are one popular type of ...
(Date:7/28/2015)... ... ... Women in Technology (WIT), the premier organization contributing to the success of professional ... Dezzutti, CEO and president at Market Connections, Inc. as the organization’s president of the ... empowers women to thrive and excel in the technology field. In order to do ...
Breaking Medicine News(10 mins):Health News:Morristown Medical Center First Hospital in New Jersey to Implant Newly Approved Heart Valve 2Health News:Morristown Medical Center First Hospital in New Jersey to Implant Newly Approved Heart Valve 3Health News:National TACA Autism Conference Offers Hope and Help to Families Affected by Autism 2Health News:US President learns from DuPont Innovations in Food and Agriculture in Ethiopia 2Health News:US President learns from DuPont Innovations in Food and Agriculture in Ethiopia 3Health News:US President learns from DuPont Innovations in Food and Agriculture in Ethiopia 4Health News:Nations Insurance Solutions Announces Auto, Motorcycle, and Commercial Business Insurance Quotes. 2Health News:Lisa Dezzutti Named President of Women in Technology (WIT) Board of Directors 2
... FRANCISCO, Jan. 12 Hiemstra Product Development, a,premier ... debut of,hiQual, its proprietary electronic quality management system ... integration of hiQual, Hiemstra,s development team can reduce,risk ... necessary documentation,required under ISO 13485:2003 and FDA 21 ...
... for more than 500,000 crashes a year, National Safety Council ... leading consumer safety organization is calling for a nationwide ... devices. , While there are a few state and local ... Safety Council (NSC) believes it,s time to make it unanimous. ...
... used with caution, experts say , , SUNDAY, Jan. 11 ... thinner" -- that,s frequently prescribed for people with atrial ... cardiac condition, which causes the heart,s two upper chambers ... vulnerable to a blood clot in the brain that ...
... of a scientific study in which victims of a brain injury ... that feelings of spirituality might actually be caused by brain damage ... , ... Denver, CO (PRWEB) January 11, 2009 -- LegalView, ...
... giving guests a reason to be cheerful by announcing a winter sale ... ... (PRWEB) January 11, 2009 -- The Linwood Group has revealed that it ... can access its first rate facilities., , ,From Christmas through to the ...
... more than a decade needed to achieve goals ... number of board-certified emergency doctors in the United ... department staffing needs in the future, say Massachusetts ... that alternative strategies for staffing emergency departments are ...
Cached Medicine News:Health News:Reduce Risk, Achieve Compliance and Accelerate Time to Market with hiQual and Hiemstra Product Development 2Health News:Nationwide Cell Phone Ban for Drivers Urged 2Health News:Nationwide Cell Phone Ban for Drivers Urged 3Health News:Nationwide Cell Phone Ban for Drivers Urged 4Health News:Doctors Re-Examine Blood Thinners to Prevent Strokes 2Health News:LegalView Reports Traumatic Brain Injury Study Concluding Spirituality Increases Following Brain Damage 2Health News:LegalView Reports Traumatic Brain Injury Study Concluding Spirituality Increases Following Brain Damage 3Health News:LegalView Reports Traumatic Brain Injury Study Concluding Spirituality Increases Following Brain Damage 4Health News:Linwood Group Setting Price Benchmark for Alcohol Rehab 2Health News:Certified ER Docs in Short Supply to Meet Future Needs 2
(Date:7/28/2015)... , July 28, 2015 Cumberland Pharmaceuticals Inc. ... release second quarter 2015 financial results after the market ... and live Internet webcast will be held on Tuesday, ... discuss the results. To participate in the ... (for international callers).  A rebroadcast of the teleconference will ...
(Date:7/28/2015)... Research and Markets ( http://www.researchandmarkets.com/research/cng4gn/refurbished ) has announced the ... Global Forecasts to 2019" report to their offering. ... estimated to grow expected to reach $9.37 billion by ... 2019. Factors such as growing ... increasing privatization in the healthcare sector, and rising adoption ...
(Date:7/28/2015)... CITY , July 28, 2015  PD-Rx ... today announced that it has partnered with Dobson ... Infrastructure as a Service (IaaS) product. ... medical practices across the United States.  Using Dobson ... disaster recovery and business continuity, ensure regulatory compliance, ...
Breaking Medicine Technology:Cumberland Pharmaceuticals To Announce Second Quarter 2015 Financial Results 2Refurbished Medical Equipment Market 2015 - Global Forecasts to 2019 2PD-Rx Partners With Dobson Technologies 2
... patients can drive safely six weeks following surgical,treatment, ... most patients, pain levels are so low that they ... car again. A study published in the August,2008 issue ... http://www.jbjs.org/ ),also found that emergency brake time response in ...
... Calif., Aug. 26 XTENT, Inc.,(Nasdaq: XTNT ) ... CUSTOM II trial was published in the most recent ... the article was,Dr. Pieter R. Stella, M.D., of University ... CUSTOM II Investigators from 13 clinical,sites across Europe., ...
Cached Medicine Technology:Braking After Bunion Surgery 2Braking After Bunion Surgery 3XTENT Announces CUSTOM II Data Selected for Publication in EuroIntervention 2XTENT Announces CUSTOM II Data Selected for Publication in EuroIntervention 3XTENT Announces CUSTOM II Data Selected for Publication in EuroIntervention 4
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... 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 ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... 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 ...
Medicine Products: