NYTimes' cherry-picking is misleading.

Today's inflammatory New York Times story, "Diabetes Drug Maker Hid Test Data on Risks, Files Indicate," is based on selected documents provided to plaintiffs' attorneys in litigation which were then also provided to the Senate Finance Committee.  Selectively making public a cherry-picked few documents from over 14 million pages in litigation presents an incomplete and misleading picture of the safety of Avandia and company conduct.

 

The New York Times focuses on one small study that did not involve Avandia.  GSK conducted this study on a competitor drug looking at its effects on LDL cholesterol and triglycerides; it was not a head-to-head study directly comparing Avandia and the competitor, pioglitazone, as reported by the New York Times.  GSK conducted the study to help inform a decision of whether or not to do a head-to-head trial between Avandia and the competitor.  The results of this competitor drug study were consistent with the FDA-approved drug label for pioglitazone, and therefore did not contribute any clinically significant new information.  Because the study offered no new clinically relevant information and did not involve a GSK drug, GSK did not publish the data. 

 

Two studies comparing Avandia and another drug, glyburide, are referenced by the New York Times; it's important to note that GSK submitted this data to the FDA in 1999 and made those data available publicly on the company's Clinical Study Register.

 

GSK has worked consistently--before and after Avandia was approved in 1999 by the FDA--to add to our understanding of the cardiovascular safety of the medicine.  As far back as late 2001, as part of the company's ongoing pharmacovigilance program, GSK conducted a review of Avandia and heart attack.  At that time, the data identified no signal of an increased risk for heart attacks associated with Avandia.  GSK informed the FDA of this internal review and described its results in a Periodic Safety Update Report. 

 

Subsequently and to date, over 200 studies and protocols on Avandia--including those that contain data on heart attack--have been made publicly available on the company's clinical trial register.  In fact, Avandia is the most widely studied oral anti-diabetic medicine for type 2 diabetes, which means we know more about both the safety and the efficacy of this medicine than any other oral drug for diabetes.  When you look at all of the clinical trial data available, we believe the data show that Avandia has an ischemic cardiovascular safety profile comparable to the most widely prescribed oral diabetes medicines.  GSK has been--and remains--committed to and diligent in providing its safety data on Avandia to the FDA, and in publishing its clinical trial data in peer-reviewed journals or on its clinical trial website.

 

Here is our statement on the Senate Finance Committee press release issued today.

 

And here is our legally required fair balance.

 

Important Safety Information

 

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.

 

Prescription AVANDIA, along with diet and exercise, helps improve blood sugar control in adults with type 2 diabetes.

 

For more information about AVANDIA, please see Medication Guide

(http://www.avandia.com/type-2-diabetes-medication-guide.html) and full Prescribing Information, including Boxed WARNING (http://us.gsk.com/products/assets/us_avandia.pdf).