If you or someone you love has been injured as a result of Avandia® use, contact Phillips & Associates to schedule a free consultation.
On May 25, 1999, the FDA approved the diabetes drug Avandia® to be used in conjunction with diet and exercise to improve glycemic control. Dr. Robert Misbin, the FDA official who examined the data on Avandia® at the time of the drug’s approval, found that there was a noticeable increase in the rate of a condition known as congestive heart failure (CHF) in the study participants. Dr. Misbin advised GlaxoSmithKline, the manufacturer of the drug, to immediately begin studies to examine the cardiac effects of Avandia®.
Those studies, which date back as far as 2001, were reviewed in May 2007 by world-renowned cardiologist Dr. Stephen Nissen of the Cleveland Clinic. Dr. Nissen wrote an article in the New England Journal of Medicine, the most influential medical review magazine in the world, stating that the use of Avandia® showed a disturbing trend toward increasing not only CHF, but heart attack and stroke.The studies examined showed the increased risk of CHF to be about 700 percent, and about 50 percent for heart attack and stroke.
In response to Dr. Nissen’s article – published May 21, 2007, on the New England Journal of Medicine website – the FDA began its own studies, which are still being conducted. In addition, the agency ordered Glaxo to issue a public warning about the potential heart-related risks associated with Avandia®. Apparently, the weight of this evidence caused Glaxo to send a warning letter to doctors regarding the cardiovascular risks discovered by Dr. Nissen. At the same time, Glaxo began an intense public advertising blitz saying that Avandia® was safe.
In June 2007, Congress held a hearing on the FDA's safety assessment of Avandia®. During the proceeding, both FDA officials and Glaxo representatives were asked to explain why the Nissen findings were not reported sooner. The response was that they were waiting for additional studies. This angered many Congressmen, including Senator Charles Grassley, who accused Glaxo and the FDA of dragging their heels while thousands may have needlessly suffered heart-related injuries.
In fairness to the FDA, it is charged with examining thousands of drugs every year. The agency has a limited budget and must rely on study data provided by drug manufacturers. Sadly, Glaxo is aware of this and can “dump” information at the FDA’s front door, knowing the agency will not have enough time or manpower to thoroughly review it. Glaxo says simply that it gave the FDA the information, so it’s not the company's fault if it was improperly analyzed. However, as Dr. Psaty and other well-respected medical professionals have said, it is Glaxo’s fault. Glaxo cannot hide information that is damaging to its profits when doing so endangers the health of those who use the company's products.
The following is a detailed report on the congressional hearing that took place June 6, 2007, to evaluate the FDA's safety assessment of Avandia®.
On June 6, 2007, the U.S. House of Representatives Committee on Oversight and Reform met to consider the process by which Avandia® received FDA approval. The chairman of the committee, Rep. Henry Waxman (D-Calif.), called the hearing after a May 2007 article published in the New England Journal of Medicine said that Avandia® may increase the risk of heart attack.
Both FDA and Glaxo representatives testified during the proceeding, as did three of the most prominent physicians in the nation: Drs. John Buse, Stephen Nissen, and Bruce Psaty.
In May, the FDA issued a safety warning about Avandia®. The agency, however, had not previously mentioned the black box warning, which it asked for just days after the initial safety warning.
Dr. Andrew Von Eschenbach, the head of the FDA said, “Although this issue is already prominent in the warnings section for both drugs, FDA decided to make this request because, despite the existing warnings, these drugs were being prescribed to patients with significant heart failure,” He also said, “FDA will work diligently with both companies to accomplish these revisions.”
As to the agency's reaction to the drug's safety, von Eschenbach said that Glaxo gave the FDA two studies about Avandia® in August 2006. The results were inconsistent, he said, so the agency did not make them public. The FDA instead began a comprehensive internal re-analysis of the data.
Von Eschenbach said numerous times that the agency is still examining studies about Avandia® and assessing the drug's risk. He added that the FDA is committed to early communication of new information about the safety of medical products, but that any communication must be “responsible and measured, taking into account the impact that the message will have on patients and practitioners alike.”
But Rep. Waxman, in his opening statements, said that he called the hearing because the public still doesn't know the effects the drug may have, even though the drug was approved by the FDA in1999 for type 2 diabetes.
“Although Avandia®has been on the market for eight years and has been used by millions of Americans, the post-market studies have not been done to say conclusively whether Avandia®increases or decreases the risk of heart attacks,” Waxman said. “That's a major failure of our system. And it is what is causing so much confusion and worry among the patients who are taking Avandia®today.”
Dr. Moncef Slaoui, chairman of Glaxo's research and development division, said that the company believed the overall safety of Avandia® was comparable to that of other available anti-diabetes medications. He said the company had already initiated testing of more than 52,000 patients, meaning it had already done what Congress wants pharmaceutical companies to do – rigorous scientific analysis of a medicine's safety and benefit after it is approved for wider use among patients.
Slaoui defended Glaxo's actions by saying the company warned of congestive heart failure problems associated with Avandia® when the drug went onto the market. Slaoui’s claim is rather interesting, however, in light of the fact that in 2002, an FDA memo stated that Glaxo had failed to adequately warn of these problems, and demanded new and stronger warnings.
If you or someone you love may have been injured as a result of using Avandia®, contact the attorneys at Phillips & Associates for a free case evaluation.