Navigation Links
Avandia Heart Risks Buried by Drug Company: Report

By Amanda Gardner
HealthDay Reporter

TUESDAY, July 13 (HealthDay News) -- The pharmacy company that makes Avandia knew more than a decade ago that the blockbuster diabetes drug caused an increased risk of heart problems but covered up the information, according to a report published Tuesday in The New York Times.

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 message the Times obtained, Dr. Martin I. Freed, a company executive, wrote about the study results: "This was done for the U.S. business, way under the radar. Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK." GlaxoSmith Kline is the corporate successor to SmithKline.

The safety of Avandia (rosiglitazone) comes under U.S. government scrutiny starting Tuesday, as an advisory panel of experts begins two days of hearings.

The new information released by the Times comes after new doubts surfaced last week on a key trial that helped keep Avandia on the market.

Last Friday, a medical reviewer for the U.S. Food and Drug Administration posted remarks on the agency's Web site suggesting that GlaxoSmithKline's "mishandling" of trial results may have masked some cardiovascular effects of Avandia.

The official's posting was part of a safety reassessment package prepared for the FDA's advisory panel meeting.

At issue in the review posting were the results of the landmark RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) trial, which was done by Glaxo at the FDA's request. The results, announced in June of 2009, found that Avandia raised the risk of heart failure but not to a level of statistical significance. The study also concluded that the drug did not increase the risk of cardiovascular disease or overall death.

In his posting, Thomas A. Marciniak, medical team leader of the division of cardiovascular and renal products at the FDA's Center for Drug Control and Evaluation, said that "RECORD was inadequately designed and conducted to provide any reassurance about the [cardiovascular] safety of rosiglitazone" and that "RECORD suggests the (sic) rosiglitazone increases the risk for [heart attacks]."

Last June, Glaxo used the trial results to tout the drug's safety.

"RECORD provides important and reassuring information about Avandia for physicians fighting diabetes," said Dr. Ellen Strahlman, Glaxo's chief medical officer, in a statement released at the time. "We believe that the results showed that Avandia is safe."

On Friday, the company, in a prepared statement, said, "The RECORD study was conducted according to good clinical practices and the data are reliable. . . RECORD demonstrated that Avandia was not associated with an overall increase in cardiovascular hospitalization or cardiovascular death compared to metformin and sulfonylureas."

But Dr. Kirk Garratt, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City, said Friday, "If the data from RECORD had truly been mishandled in some way, not only is it going to pretty well be the end of Avandia in the clinical world, but it's going to put GlaxoSmithKline under the magnifying glass in an important way for clinicians going forward. They'll lose credibility, and that's tough to get back."

"There is an alternative drug out there," Garratt added. "From the clinical side, it's a fortunate circumstance that we find ourselves in, since we have an alternative product that seems to have [little] risk associated with it."

Actos (pioglitazone), made by Takeda, is in the same pharmaceutical class as Avandia. Both are medications known as thiazolidinediones (TZDs), which are blood sugar-lowering drugs. Both are used by type 2 diabetics.

On Tuesday, groups including the American Diabetes Association, the American Association of Clinical Endocrinologists and The Endocrine Society issued a joint statement advising patients who are using Avandia to hold steady for now.

"Patients should continue taking all currently prescribed medications unless instructed otherwise by their health care provider," the experts said. "Stopping diabetes medications can result in higher levels of blood glucose that may cause serious short-term health problems and could increase the risk of diabetes-related complications in the long term."

They added that "until further clarification is provided by the FDA, the decision whether or not to use any medication must remain that of the treating provider in direct discussion with the individual patient."

More information

The U.S. National Library of Medicine has more on Avandia and Actos.

SOURCES: Kirk Garratt, M.D., clinical director of interventional cardiovascular research, Lenox Hill Hospital, New York City; New York Times, July 13, 2010, joint statement, American Association of Clinical Endocrinologists, American Diabetes Association and The Endocrine Society

Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Diabetes Drugs Avandia, Actos Tied to Fractures in Women
2. Remove Diabetes Drug Avandia From Market: FDA Reports
3. Remove Diabetes Drug Avandia From Market: FDA Documents
4. FDA Says It Hasnt Decided Whether to Pull Diabetes Drug Avandia Off the Market
5. FDA: No Decision on Whether to Pull Diabetes Drug Avandia Off the Market
6. Maher Law Firm Warns Avandia Users - NY Times Reports - FDA Recommends Recall of Avandia
7. Diabetes Drug Avandia Ups Heart Risk, Reviews Conclude
8. Latest Study on Diabetes Drug Avandia Finds No Heart Risks
9. FDA Reviewer Questions Results of Key Avandia Trial
10. ICU Patients at Risk for Rare Heart Rhythm Problem
11. Cook With Love This Valentines Day With Heart-Smart Recipes
Post Your Comments:
Related Image:
Avandia Heart Risks Buried by Drug Company: Report
(Date:11/29/2015)... ... November 29, 2015 , ... Key Housing, a top-rated corporate housing ... December, 2015, featured apartment community: Epic. In showcasing this featured apartment community in San ... Bay Area rental market to efficiently find housing suitable to their needs by showcasing ...
(Date:11/28/2015)... ... November 28, 2015 , ... Pixel Film Studios is back ... to choose from, the possibilities are endless. Users have full control over angle of ... Pulse masking effects, users are sure to get heads to turn. , ProPanel: Pulse ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... health care in America. As people age, more care is needed, especially with ... rising, and medical professionals are being overworked. The forgotten part of this equation: ...
(Date:11/27/2015)... ... ... The print component of “Supporting Our Caregivers” is distributed ... Minneapolis, South Florida, with a circulation of approximately 250,000 copies and an estimated ... media strategy and across a network of top news sites and partner media ...
(Date:11/27/2015)... ... November 27, 2015 , ... A simply groundbreaking television series, ... interesting show that delves into an array of issues that are presently affecting Americans. ... from open dialogue, this show is changing the subjects consumers focus on, one episode ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... SAN FRANCISCO , November 26, 2015 ... 1.82 billion by 2022, according to a new report by ... as Chronic Kidney Disease (CKD) which demands kidney transplantation is ... convenient and cost effective substitute for organ transplantation. --> ... 1.82 billion by 2022, according to a new report by ...
(Date:11/26/2015)... ) has ... Future Horizons and Growth Strategies in the ... Shares, Country Segment Forecasts, Competitive Intelligence, Emerging ... --> ) has announced the ... and Growth Strategies in the German Drugs ...
(Date:11/26/2015)... 26, 2015 ... adds "Global Repaglinide Industry 2015 ... on China Repaglinide Market, 2010-2019" reports ... and information to its online business ... . --> ...
Breaking Medicine Technology: