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:12/21/2014)... December 21, 2014 Over the past ... issues in hundreds of emergency departments across the nation, ... findings have been translated into an innovative suite of ... correct deficiencies and enhance the patient experience. , ... physician staffing and management services for hospitals, announced the ...
(Date:12/21/2014)... OH (PRWEB) December 21, 2014 As ... men alleging heart attacks, stroke and blood clots from ... to increase, a new study shows that the male ... colon cancer. In a study published in the Proceedings ... researcher, James Amos-Landgraf examined a group of male rats ...
(Date:12/21/2014)... 2014 Concept Plus, LLC. a SDB ... in Fairfax, VA., today announced it has been recognized ... list, which ranks the fastest growing government contracting small businesses ... 2013. , This is the first year that Concept Plus, ... 20 with a 95.92% compound annual growth rate. “For Concept ...
(Date:12/20/2014)... MissyDress, a distinguished special dress supplier, has ... business has drastically cut prices to all its prom ... Jan. 30, 2015. Many of the hottest styles are ... lace dresses, and more. , A spokesman for MissyDress ... Whether A-line princess prom dresses or sweetheart chiffon prom ...
(Date:12/20/2014)... 2014 Dress company LunaDress has recently announced ... its Christmas Sale, offering big discounts on all of its ... an idea to own a perfect wedding gown. If you ... dress, then come to LunaDress. Many different wedding dress styles ... our website now and enjoy the current special offer, up ...
Breaking Medicine News(10 mins):Health News:NES Health Launches Stipend Program for Emergency Physicians in Training to Financially Assist Emergency Department Doctors While They Learn 2Health News:New Low Testosterone Therapy Study Shows Male Hormone Testosterone May Contribute To Colon Cancer Reports Wright & Schulte LLC 2Health News:New Low Testosterone Therapy Study Shows Male Hormone Testosterone May Contribute To Colon Cancer Reports Wright & Schulte LLC 3Health News:New Low Testosterone Therapy Study Shows Male Hormone Testosterone May Contribute To Colon Cancer Reports Wright & Schulte LLC 4Health News:Concept Plus, LLC. Named One of Washington Technology’s Fast 50 2Health News:MissyDress: The Prices of Prom Dresses Just Reduced 2Health News:2015 Collection of Wedding Dresses from LunaDress Online on Sale Now 2
... a severe stroke generally improves the patients, lives and ... neurologists at the University of Rochester Medical Center. , ... perspective a decision that is nearly always painful and ... aggressive surgery after a catastrophic stroke is worth it. ...
... Improved patient-oriented research in Europe will benefit European citizens ... of scientific discoveries from the laboratory bench to the ... world this effort will be of great importance for ... of society as a whole. , To achieve ...
... will affect more than 78 million U.S. baby ... can resolve their vision needs to avoid readers.ROCHESTER, ... of the #1 multifocal lens design, has launched ... of raising U.S. awareness of presbyopia and multifocal ...
... Following a successful two-year campaign of support for the ... Cutlery has announced that it is extending its support ... donated more than $274,000 to Go Red For Women ... $74,000 raised through a 10 percent contribution from the ...
... been proclaimed as "World Glaucoma Day" by glaucoma specialists ... Organization, more than five million people, many of African ... lacked the opportunity to get tested for Earlier Glaucoma ... Dr. Robert Welsh, a Rotarian, a world-renowned Eye Surgeon ...
... insurance store in Mechanicsburg to hold grand opening on ... first pair of health insurance retail stores, Highmark Direct, ... Pennsylvania will celebrate its grand opening at the Silver ... Saturday, March 21. During the grand opening, individuals, families ...
Cached Medicine News:Health News:Weighing the options after life-altering stroke 2Health News:Weighing the options after life-altering stroke 3Health News:Weighing the options after life-altering stroke 4Health News:Better health and prosperity in Europe via improved clinical research 2Health News:Bausch & Lomb Launches Multi-Tiered U.S. Consumer Education Initiative to Raise Awareness of Presbyopia 2Health News:Bausch & Lomb Launches Multi-Tiered U.S. Consumer Education Initiative to Raise Awareness of Presbyopia 3Health News:CUTCO Cutlery Extends Its Support of Go Red For Women 2Health News:Welsh 'Self-Test' to Help Cure Glaucoma on World Glaucoma Day 2Health News:Highmark Retail Store to Celebrate Grand Opening 2
(Date:12/19/2014)... YORK , Dec. 18, 2014 Somewhere ... addressing hearing health was forgotten. But Audicus , ... to hear better this new year. Hearing ... facing the aging population, though it is often unaddressed. ... in four has a hearing aid, mainly due to ...
(Date:12/19/2014)... REDWOOD CITY, Calif., Dec. 18, 2014 ... on the development of medical diagnostics based on ... of gas flow, today announced financial results for ... 30, 2014. "Following the completion of ... well positioned to maximize the recently initiated CoSense® ...
(Date:12/19/2014)... , Dec. 18, 2014   Aratana ... a biopharmaceutical company focused on the licensing, development ... today announced positive results from its pivotal field ... for treating pain in dogs with osteoarthritis.  In ... pain assessment scores that were statistically significant compared ...
Breaking Medicine Technology:Audicus Will Help People Resolve to Hear Better in 2015 2Capnia Reports Third Quarter 2014 Financial Results 2Capnia Reports Third Quarter 2014 Financial Results 3Capnia Reports Third Quarter 2014 Financial Results 4Capnia Reports Third Quarter 2014 Financial Results 5Capnia Reports Third Quarter 2014 Financial Results 6Capnia Reports Third Quarter 2014 Financial Results 7Capnia Reports Third Quarter 2014 Financial Results 8Aratana Therapeutics Announces Positive Top-Line Results from AT-001 Pivotal Field Study in Client-Owned Dogs with Osteoarthritis 2Aratana Therapeutics Announces Positive Top-Line Results from AT-001 Pivotal Field Study in Client-Owned Dogs with Osteoarthritis 3Aratana Therapeutics Announces Positive Top-Line Results from AT-001 Pivotal Field Study in Client-Owned Dogs with Osteoarthritis 4Aratana Therapeutics Announces Positive Top-Line Results from AT-001 Pivotal Field Study in Client-Owned Dogs with Osteoarthritis 5
... Nov. 2, 2010 Cambrex Corporation (NYSE: CBM ... Zenara Pharma, a Hyderabad, India based pharmaceutical company focused on ... Highlights To be named ... global suppliers to the large and growing Nicotine Replacement Therapy ...
... Charleston Laboratories, Inc., an emerging specialty pharmaceutical ... (OINV) in opioid pharmaceuticals, announced today that it ... government under the Qualifying Therapeutic Discovery Project (QTDP) ... award to advance the development of its lead ...
Cached Medicine Technology:Cambrex Acquires Stake in Zenara Pharma 2Cambrex Acquires Stake in Zenara Pharma 3Cambrex Acquires Stake in Zenara Pharma 4Charleston Laboratories, Inc. Awarded a Qualifying Therapeutic Discovery Project (QTDP) Grant Under the U.S. Patient Protection and Affordable Care Act of 2010 2
... Implant (KGTI) system offers the latest technology ... MPJ. The implant system is anatomically designed ... ,The KGTI is the most advanced reconstructive ... on the market today. The system consists ...
... Nerve Electrodes provide direct cranial nerve ... patented circumferential design provides sensitive contact ... stable real-time recordings. This unique approach ... the removal of acoustic neuromas, microvascular ...
... Ad-Techs Model CMU Cortical Mapping Unit ... of recording EEGs from exposed cortex during ... each electrode plate can be positioned independently ... clamp provides two alternative mounting locations and ...
An ambulatory recorder can help the patient be more comfortable and at ease as well as increasing an EEG laboratory's recording capacity....
Medicine Products: