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GlaxoSmithKline responds to US Senate Committee on Finance report on Avandia

Research Triangle Park, NC (February 24, 2010) - Today, GlaxoSmithKline [NYSE:GSK] responded to the recently released Senate Committee on Finance’s January 2010 “Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia” (the “Staff Report”). Read GSK’s response (PDF).

In its response, GSK states that the Staff Report fails to present an accurate, balanced, or complete view of the currently available information on Avandia.  The company rejects any allegations of concealing safety information or acting inappropriately on behalf of patients.  GSK respectfully disagrees with the Committee’s decision to publish a Staff Report with the errors of fact, omission, and inference detailed in this White Paper.

A fair examination of the company's record will show that GSK has been diligent in its efforts to thoroughly study the safety and effectiveness of Avandia, and to widely communicate that information to governments, regulatory authorities, scientific peers, physicians and others in a variety of ways. 

The following is a summary of GSK’s response:

  • Among its most glaring omissions, the Staff Report does not include discussion of the final results of either the ADOPT, DREAM, or RECORD studies. ADOPT, DREAM and the interim data for RECORD were evaluated by an independent FDA advisory board in 2007 along with all the information available at that time on Avandia. That FDA advisory board voted 22-1 in favor of keeping Avandia available for patients. RECORD provides the best, most reliable assessment of Avandia’s cardiovascular safety. RECORD was initiated in 2001 and, in consultation with European regulators, was designed to compare cardiovascular outcomes of patients on Avandia added to metformin or sulfonylurea to those on metformin and sulfonylurea.  The study was sufficiently powered to confirm its primary hypothesis.  It showed that cardiovascular hospitalization or cardiovascular death (which includes heart attack, congestive heart failure, and stroke) was not statistically different between the two groups after an average of 5.5 years of therapy.
  • The report also fails to mention multiple other studies (APPROACH, VICTORY, STARR, VADT, ACCORD, BARI 2D) that all corroborate the ischemic cardiovascular safety of Avandia.  None of these studies show a statistically significant association between Avandia and heart attack or other ischemic cardiovascular events.The absence in the Staff Report of any reference to the final results of the ADOPT, DREAM and RECORD studies, as well as other important studies on the ischemic cardiovascular safety of Avandia, leaves the record incomplete and does not serve the interests of physicians or patients who rely on this medicine to help them treat and deal with diabetes.
  • Instead of reviewing the most recent and scientifically sound information, the Staff Report relies on a meta-analysis prepared by Dr. Nissen in 2007, an analysis which has been criticized widely, and contradicted by larger, more recent meta-analyses.
  • In addition, the Staff Report suggests that GSK did not work to actively monitor the safety of Avandia or inform the FDA of its investigations.  That suggestion is fundamentally flawed and contradicted by a record of extensive, on-going interactions between GSK and the FDA, and the FDA’s on-going review of Avandia in light of all the information available to the agency.  The Timeline included in the Staff Report omits key dates (included in the GSK White Paper) that demonstrate the on-going and open exchange of information that has characterized the FDA’s active review of this medicine and GSK’s efforts to provide data and respond to the agency’s inquiries.
  • The report does not give full consideration of the extensive measures GSK undertook to study Avandia prior to marketing approval; GSK’s continued efforts to study its safety and efficacy; and FDA’s determination that the risk-benefit profile of Avandia is favorable, which demonstrates that Avandia is an important option for physicians choosing a treatment for appropriate patients with type 2 diabetes.  Since approval by the FDA in 1999 and beyond, GSK has rigorously maintained an extensive and long-term program of scientific study for Avandia, which is the most comprehensive program of scientific analysis for any oral anti-diabetes medicine available to patients today, with experience in well over 52,000 patients. 
  • The company’s response also provides context for incidents cited in the Committee report which mischaracterized efforts to ensure that information about the company’s medicine was accurately presented by others. GSK does not condone the silencing of critics, nor did it attempt to subvert the independence of scientific debate around Avandia.  However, GSK will seek to correct inaccuracies and misstatements to ensure that physicians have the most accurate information available about its medicines when making prescribing choices for patients.

 

GSK stands behind the safety of Avandia. Contrary to recent media reports, the FDA has not called for withdrawal of Avandia, and in a recent statement, has advised that “Patients should continue taking rosiglitazone unless told by their healthcare professional to stop.”  GSK welcomes the opportunity for an independent and scientific evaluation of the collective safety of rosiglitazone at the upcoming FDA advisory committee in July.  In agreement with statements made recently by the Endocrine Society and the FDA, the safety of Avandia should be judged in light of all available scientific data with emphasis on long-term prospective studies.

The assessment of the safety of Avandia is continuing now with a clinical trial called TIDE, which was undertaken at the direction of the FDA, to include a randomized comparison of Avandia and Actos in addition to the comparison of Avandia to placebo.  The protocol for conducting the study was developed with and approved by FDA, and will provide the only large-scale, head-to-head comparison of the two medicines. TIDE also has been approved by an independent review board and appropriate safety boards that are responsible for monitoring and assessing the safety of the trial in Type 2 diabetes patients.

GSK is committed to transparency and has been diligent in reporting the results of clinical trials, observational studies and meta-analyses on the company’s website, as well as reporting them to regulatory agencies in a timely fashion.

Important Safety Information about AVANDIA® (rosiglitazone maleate)

Prescription AVANDIA, along with diet and exercise, helps improve blood sugar control in adults with type 2 diabetes. Taking AVANDIA with insulin or nitrates is not recommended.

AVANDIA can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart) you cannot be started on AVANDIA. AVANDIA is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling) even if these symptoms are not severe.

AVANDIA may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin.

If you have chest pain or a feeling of chest pressure, you should seek immediate medical attention, regardless of what diabetes medicines you are taking. If you take AVANDIA, tell your doctor right away if you have swollen legs or ankles, a rapid increase in weight or difficulty breathing, or unusual tiredness; experience changes in vision; become pregnant.

Before taking AVANDIA, review your medical history and tell your doctor if you:

  • Have heart failure or other heart problems, or are on any medicines for high blood pressure, high cholesterol or heart failure, or for prevention of heart disease or stroke.
  • Take insulin or nitrate medicines.
  • Have a type of diabetic eye disease called macular edema.
  • Have liver problems or had liver problems while taking REZULIN® (troglitazone).
  • Are pregnant or planning to become pregnant.
  • Are breastfeeding or planning to breastfeed.

 

Women taking AVANDIA should know that AVANDIA may increase the risk of pregnancy. More fractures have been observed in women taking AVANDIA. Other possible side effects of AVANDIA include anemia and hypoglycemia. Your doctor should do blood tests to check your liver before you start AVANDIA and during treatment as needed.

For more information about AVANDIA, please see Medication Guide. For further information on AVANDIA, please see full Prescribing Information (PDF).

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 further information please visit us.gsk.com.

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Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2008.