With the advances in diabetes treatment and diagnosis, diabetics can live full lives with little interference from their affliction. New diabetes medicines are being researched everyday with the hopes that one day a perfect treatment will be discovered. It is possible that GlaxoSmithKline may have felt that their diabetes drug Avandia was that treatment. However soon after Avandia came to market, rumors of corruption, cover-ups and health hazards began to surface.
GlaxoSmithKline and Avandia
An article in the New York Times discussed allegations that Glaxo had worked to cover up Avandia’s heart risks since 1999. According to the article, GlaxoSmithKline completed a study in 1999 comparing Avandia to Actos. Actos was a diabetes drug manufactured by one of Glaxo’s competitors. Not only did the study find Avandia held no benefit over Actos, it also found Avandia could be more dangerous to the heart. According to the article, GlaxoSmithKline did not submit the study’s results to the FDA, as is required for all new drug applications. A GlaxoSmithKline executive, Dr. Martin I. Freed wrote in an e-mail message dated March 29, 2001, that the data should not see the light of day to anyone outside of GSK.
Since November 2007, the FDA has required that Avandia’s label include a black box warning. A black box warning is the strongest consumer safety alert. Avandia’s black box warning details its association with heart attacks. Since the addition of the black box, evidence linking Avandia to an increased risk of heart attacks has continued to accumulate. In September 2010, the Food and Drug Administration (FDA) placed severe restrictions on Avandia, citing its heart risks. As Avandia’s active ingredient, rosiglitazone, is also available in combination with other diabetes medications the newly-imposed restrictions will also apply to those drugs.
Dr. David Graham of the FDA Center for Drug Evaluation and Research Study:
- Involved 227,500 patients, making it the largest to date
- Found that patients who took Avandia were:
- 27 percent more likely to suffer a stroke,
- 25 percent more likely to develop heart failure and
- 14 percent more likely to die compared with those who took another drug called Actos.
- Patients in the U .S. Medicare system who took the drug may have suffered as many as 48,000 heart attacks, strokes and other problems between 1999 and 2009.
The RECORD Trial:
- Paid for by GlaxoSmithKline.
- Involved 4,500 patients
- Compared Avandia to patients receiving other diabetes drugs, for an average of 5.5 years
- RECORD did not show an increased heart attack risk that has been seen in some other Avandia studies, and has been used by Glaxo to tout its safety.
However, the RECORD trial was widely criticized on many fronts. The FDA review of the RECORD trial found at least a dozen instances in which patients taking Avandia suffered serious heart problems that were not counted in the trial tally of adverse events.
GlaxoSmithKline is unwilling to tell the truth about Avandia. Unfortunately, diabetic people are paying the price with their lives. If you have suffered a heart attack while taking Avandia be aware that the law limits the time when you may file a lawsuit. If you miss this deadline, you may be denied the right to file suit.