 |
|
|
|
|
Diabetes Drug Should Stay Despite Heart Risks, U.S. Advisers Say
|
| | | | Related Healthscout Videos | |
|
Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >> Dr. David Graham, associate director for science and medicine in the FDA's Office of Surveillance and Epidemiology and an Avandia critic, disagreed with Glaxo's interpretation of the RECORD study. In a report submitted by the FDA to the advisory panel before the hearing, Graham concluded:
"RECORD does not now, nor will it at completion, provide meaningful evidence to demonstrate with any degree of certainty that RSG [Avandia] does not increase the risk of acute myocardial infarction [heart attack] or sudden death, or the APTC outcome. The biased design of RECORD renders it useless as an objective measure of Avandia's cardiovascular safety."
Zambanini countered by saying that the RECORD study has seen very few cardiac deaths. "To say that this study is of no value isn't true," he said.
Text Continues Below
During Monday's testimony, Graham was supported by his boss, Dal Pan, who said the risks posed by Avandia outweighed the benefits.
But another agency official, Dr. Robert Meyer, head of the FDA office that reviews new diabetes drugs, urged panel members to keep an open mind about Avandia, the AP reported.
"It is important that the committee understand there is a fundamental disagreement within (the FDA's drugs office) on the scientific conclusions that should be drawn," Meyer said.
That rift revealed a division between FDA officials responsible for approving new medicines and those who monitor their safety once on the market, the AP said.
More than 2 million people worldwide take Avandia for type 2 diabetes, the most common form of diabetes in which the body doesn't produce enough of the hormone insulin or cells ignore the insulin, leading to a buildup of blood sugar that can pose a range of health risks. Obesity is often a cause of type 2 diabetes. The drug generates $3.2 billion in annual sales for GlaxoSmithKline.
Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
|
Copyright © 2007 ScoutNews, LLC. All rights reserved.
Last updated 7/31/2007
|
|
SOURCES: July 30, 2007, U.S. Food and Drug Administration teleconference with Robert Meyer, M.D., director, FDA's Office of Evaluation II, Center for Drug Evaluation and Research; and
Clifford Rosen, M.D., acting committee chairman, Maine Center for Osteoporosis, St. Joseph Hospital, Bangor, Maine; and Gerald Dal Pan, M.D., director of the FDA's Office of Surveillance and Epidemiology;
Larry Deeb, M.D., president, medicine and science, American Diabetes Association, Alexandria, Va.; Andy Zambanini, M.D., director, clinical development, GlaxoSmithKline; July 30, 2007, prepared statement, Sidney Wolfe, M.D., director of Public Citizen's Health Research Group, Washington, D.C.; July 30, 2007, prepared statement, GlaxoSmithKline
|
.gif)
