California Avandia Lawsuit Lawyer
A Look at the History of Problems with Avandia
Avandia is a drug that's been used to help patients with type 2 diabetes, and it's manufactured by the pharmaceutical giant GlaxoSmithKline. Avandia hit the market with a high degree of promise, and its primary role was to work within an overall treatment protocol designed to keep patients' blood sugar levels under control.
Generally, Avandia was prescribed by doctors and used in conjunction with a strict program of exercise and a healthy diet, all of which combined to maintain a proper blood sugar level and to ease the discomfort and ancillary health risks that were often associated with type 2 diabetes. Type 2 diabetes, if managed properly, will generally not prevent patients from living long and productive lives. Hundreds of thousands still take the medicine, although some top endocrinologists say they have sworn off the drug.
However, recent events have led to a high degree of scrutiny being focused on Avandia, and doctors and Avandia lawyers across the country are beginning to take notice as more patients who have suffered as a result of taking this medication emerge. Below is a look at the history of problems Avandia has encountered and that have been reported by the FDA.
February 20, 2007
On this date, the FDA reported on its Web site that GlaxoSmithKline had issued a communication to healthcare professionals the results of a randomized statistical study of Avandia and those who were using it. Specifically, the FDA's Web site stated that, "Significantly more female patients who received rosiglitazone experienced fractures of the upper arm, hand, or foot, than did female patients who received either metformin or glyburide." As a result, GlaxoSmithKline warned healthcare providers to consider the risks of Avandia before prescribing it.
May 21, 2007
The FDA issued a safety alert regarding Avandia, and the letter published on its Web site stated that, "safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia." However, the FDA also stated that other ongoing and unpublished studies showed a preliminary contradiction with the initial data.
Regardless, the risk of cardiovascular events and the serious consequences that result from any heart problem led the FDA to report this problem and to issue this warning. Statistically, studies showed an increase of risk of heart problems by a factor of 30 - 40% for those patients who were taking Avandia to suffer from heart problems. A meta-analysis of data from 42 clinical trials found a 43% increase in relative risk of myocardial infarction among type 2 diabetics treated with rosiglitazone (Avandia). The odds ratio for MI was 1.43 (95% confidence interval 1.03-1.98, P=0.03), said Steven E. Nissen, M.D., of the Cleveland Clinic, lead author of the meta-analysis, which was released by the New England Journal of Medicine. Dr. Nissen and co-author Kathy Wolski, M.P. H., also of the Cleveland Clinic, analyzed data from randomized clinical trials published on the FDA web site and on a clinical-trials registry maintained by GlaxoSmithKline, manufacturer of rosiglitazone. All trials had a duration of more than 24 weeks. The data were combined by fixed-effects model.
The mean age of those in the trials was 56 and the mean glycated hemoglobin level was approximately 8.2%.
Thirty-five of the trials included in the analysis were included in the GlaxoSmithKline clinical-trial registry. Those trials randomized 9,502 patients to rosiglitazone and 5,961 to active control arms. Five of the trials were included in the registration data submitted to the FDA. Those trials randomized 1,967 patients to rosiglitazone and 793 to various comparator arms.
April 30, 2009
The FDA issued a Safety Alert on Avandia, stating," Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia."
December 2009
In a December 2009 internal memorandum, Dr. Janet Woodcock, director of the F.D.A.'s drug center, wrote that "there are multiple conflicting opinions" about Avandia within the agency, and she ordered officials to assemble another advisory committee, expected this summer, to reconsider whether the drug should be sold.
February 20, 2010
United States Senate Report Exposes Misconduct by GlaxoSmithKline (GSK), Avandia's manufacturers
In an exhaustive two year study of GSK and the devastation caused by Avandia released on February 20,2010, the United States Senate Staff Committee report exposed a planned campaign to discredit legitimate studies exposing the risks of Avandia designed to stifle legitimate scientific research critical of the drug. The committee reviewed over 250,000 pages of documents and conducted numerous interviews and research. The following are excerpts from the report important to AVANDIA users who suffered AVANDIA related heart attacks, and Avandia related strokes; "Committee staff began this investigation in May 2007 after a study was published in the New England Journal of Medicine, showing a link between the diabetes drug Avandia (rosiglitazone) and heart attacks. However, the reviewed evidence suggests that GSK knew for several years prior to this study that there were possible cardiac risks associated with Avandia. As a result, it can be argued that GSK had a duty to warn patients and the FDA of the Company's concerns. Instead, GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk."
GSK Attacks Legitimate scientific critics
"When an independent scientist sought to publish a study in 2007 pointing out the cardiovascular risk of Avandia, GSK acquired a leaked copy of that study from one of its consultants prior to the study being published. The company's own experts analyzed the study, found it to be statistically reliable, and then attacked the soundness of that study in press releases and public comments. GSK also sought to counter the study's findings by quickly releasing preliminary results from its own study on Avandia, even though the company's internal communications established that its study was not primarily designed to answer questions about cardiovascular risk."
GSK CONCEALED CRUCIAL AVANDIA SIDE EFFECTS
"Committee investigators also learned that GSK was aware since at least 2004 that the RECORD trial was statistically inadequate, or ''underpowered''to answer questions regarding cardiovascular safety. Such ''inconclusive'' results could be favorable to GSK and the marketing strategy for Avandia. Further, experts were advising GSK since 2004 about the possible biological mechanisms related to why Avandia may cause an increased risk for heart attacks. However, GSK appeared eager to design studies to prove that Avandia was safer than its competitor ACTOS (pioglitazone), which is manufactured by Takeda. At a July 30, 2007, safety panel on Avandia, Food and Drug Administration (FDA) scientists presented an analysis estimating that Avandia use was associated with approximately 83,000 excess heart attacks since the drug came on the market.15 Had GSK considered Avandia's potential increased cardiovascular risk more seriously when the issue was first raised in 1999 by Dr. Buse, as well as by some of their own consultants in later years, some of these heart attacks may have been avoided."
The US Senate report concluded:
"The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public. Several years prior to Nissen's study, it can be argued that GSK was on notice that Avandia may have problems. Based on this knowledge, GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner. Instead, GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk."
Contact the BRANDI LAW FIRM Today to learn more.
The negative effects of Avandia can be life threatening and even fatal. If you or a loved one suffered an injury or medical condition while taking Avandia, you may have a claim for financial recovery. Contact our San Francisco law firm to personally consult with our experienced drug litigation lawyers.
