PHILADELPHIA, May 21 /PRNewswire-FirstCall/ -- The following is
GlaxoSmithKline's (NYSE: GSK) response to a press release issued by the US
Senate Committee on Finance about Avandia(R) (rosiglitazone maleate):
The suggestion that GlaxoSmithKline has placed patients at risk and
attempted to silence independent investigation of data is absolutely false.
Any fair examination of the company's record will show that GSK has been
fully transparent in its efforts to thoroughly study the safety and
effectiveness of Avandia, and to widely communicate that information to
governments, scientists, physicians, and the public in the best interests
of both patients and scientific debate.
The statistical analysis on which the Committee bases its concern is,
by the author's own admission, limited, while the editorial accompanying
the paper states: "the possibility that the findings were due to chance
cannot be excluded."
In contrast, GSK has initiated the most comprehensive and rigorous
program of scientific analysis for any oral anti-diabetic medicine on the
market today, with experience in over 52,000 patients. The company has
initiated:
* Extensive clinical trials, including long-term clinical trials in
diabetic patients;
* A prospective, long-term, clinical trial specifically designed to
address cardiovascular safety in diabetic patients;
* A proactive, integrated clinical trial analysis of the company's own
collected data; and
* Rigorous monitoring of spontaneously reported adverse events.
These data show that Avandia has a cardiovascular safety profile
comparable to other oral anti-diabetic medicines. In addition, independent
investigators performed a comprehensive analysis of patients in a US
managed care database of more than 33,000 people with diabetes, and showed
there was no difference in cardiovascular events among patients taking
Avandia- containing regimens versus other oral anti-diabetic medicines.
Over time, the company has actively shared new data on Avandia with the
FDA and with regulators worldwide as quickly as scientifically possible.
GSK has a strong commitment to providing timely access to its data, which
is why the company was one of the first to develop a Clinical Trials
Register, on which Avandia data has been posted, and where it is available
to any scientific investigator interested in doing their own analysis.
GSK stands firmly behind the safety of Avandia when used appropriately,
and will strongly defend its commitment to patient safety and to full
transparency of its scientific information. We welcome the opportunity to
meet with the Committee and its staff to correct misunderstandings and to
clarify the record.
GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. For company information, visit GlaxoSmithKline on the World Wide
Web at http://www.gsk.com.
SOURCE GlaxoSmithKline
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