Over the weekend, media stories citing a Senate Finance Committee report distributed to reporters on a GSK diabetes medicine, Avandia ® (rosiglitazone), have challenged GSK's commitment to transparency, and have inaccurately stated or implied that the FDA has issued a call for withdrawal of Avandia. The Committee report, and subsequent media reports, unfairly cherry-pick information which mischaracterizes GlaxoSmithKline's comprehensive efforts to research Avandia and communicate scientific data to regulators, physicians and patients in a timely and transparent way. Importantly for patients on Avandia, the FDA is not calling for the withdrawal of the medicine.
We issued a statement strongly challenging the characterization of our medicine and our company. And while it remains our pledge not to promote GSK products on this blog, we do want to address the accusation that our company has somehow acted inappropriately, and worse, endangered patients' health. We also want to provide some important information that media reports do not include.
First, let's address this idea that the FDA is calling for withdrawal of Avandia.
The FDA itself has not issued new data or called for withdrawal. Instead, the document referenced in the media is a report from 2008 by two doctors who work at the FDA, resurrecting a call they made the year before--employing statistics they used at that time (e.g. 83,000 excess heart attacks between 1999 and 2007)--to say that Avandia has harmed patients. But importantly, these same claims and the call for withdrawal were considered--with all the scientific data available at that time--by an independent panel of scientific experts in 2007. That independent panel voted 22-1 to recommend that Avandia remain available to patients for the treatment of Type 2 diabetes. The FDA considered this recommendation and also decided, based on its own review of the science, that Avandia remain available to patients for the treatment of Type 2 diabetes. In the years since the FDA made its decision to keep Avandia on the market, seven clinical studies do not show an increased risk.
If we talk numbers, we need to talk about those clinical trials. Those seven large, prospective, randomized, clinical trials have completed and reported data on the cardiovascular safety of Avandia. These types of scientific trials are the gold standard for gathering and evaluating scientific data. None of these randomized clinical trials showed a statistically significant association between Avandia and heart attack or other ischemic cardiovascular events, like angina.
Second, let's address the idea that GSK did not share information the company had about the medicine's safety.
Again, we disagree with that assertion. Any fair examination of the company's record will show that GSK has been transparent 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.
At the time Avandia was approved by the FDA to be used along with diet and exercise by type 2 diabetes patients, GSK and regulatory agencies agreed it was important to develop the highest level of scientific evidence to assess the medicine's benefit-to-risk profile for type 2 diabetes, a chronic disease. Accordingly, GSK has followed a rigorous program of scientific analysis to research both the safety and benefits of Avandia. GSK promptly started the clinical studies it promised the FDA it would do.
GSK has reported its study findings to regulatory agencies, including the FDA, based on emerging clinical trial results and other data regarding the safety profile of Avandia. GSK gave its meta-analyses to the FDA and posted them on its web. Dr. Nissen, however, told Congress at the June 6, 2007 hearing that he gave his analysis to members of Congress rather than the FDA.
GSK also made studies and other data regarding Avandia available to scientists in the public domain in a variety of ways, including publication and posting data on the company's Clinical Trial Register. Dr. Nissen gathered data for his analysis from GSK's Clinical Trial Register, so the GSK data was obviously available publicly.
In addition, GSK has updated the product information for Avandia over the years to add cardiovascular and other safety information as new data has become available.
Third, let's address the idea that GSK intimidates scientists to squelch scientific debate.
GSK welcomes and supports open and independent scientific debate about its medicines. GSK does not condone any effort to silence such debate. As part of the process of scientific debate about medicines, we engage with scientists and physicians around the world in many forums, including academic journals, scientific and medical conventions, and other meetings.
Occasionally, GSK believes that statements made by others are not fully accurate or don't correctly present information on our medicines. For example, one Continuing Medical Education presentation contained inaccuracies about data on Avandia soon after the medicine became available to patients. GSK believed it was very important to seek a correction to ensure that the data on Avandia were accurately presented to physicians. In such situations, it's appropriate for the company to address and try to correct such inaccuracies or misstatements--in fact, we have a responsibility to do that so physicians have the most accurate information available to make the best choice of medicine for their patients.
The health and safety of patients who rely on our medicines is our priority. Our concern is that inaccuracies in the media will fuel fear and scare diabetic patients into stopping their medicines, with potentially serious health consequences. GSK stands by the safety and efficacy of Avandia when used appropriately according to its labeling and maintains this is an important medicine for the treatment of Type 2 diabetes.
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.