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AstraZeneca Probe Closed by the US Department of Justice
- Updated: August 20, 2014
Throughout the years, numerous medications have been developed to treat patients with certain types of heart problems, a critical endeavor considering that heart disease is the number one killer in the United States. However, there was new optimism after a particular drug called Brilinta surfaced. Developed by AstraZeneca and available in tablet form, this medication thins blood, thereby reducing risk of specific types of heart attacks and stroke.
Once granted approval by the Food and Drug Administration (FDA) in 2011, Brilinta quickly became one of the most widely prescribed medications of its kind throughout developed countries. Although currently used only for patients with severe heart problems, its maker has high hopes that in the near future, Brilinta will be used to treat an array of additional health problems.
Key Information Identified in Controlled Studies
After completing all the necessary studies and trials, and getting FDA approval, AstraZeneca was able to offer Brilinta as a viable treatment option and although the drug was pitched hard, two problems arose. First, sales fell well below expectations and second, the United States Department of Justice (DOJ) decided last fall to conduct an investigation on a clinical trial whereby the benefits of Brilinta over its top competitor were demonstrated.
The probe into Brilinta began after a medical professor submitted a complaint to the DOJ claiming some of the clinical trial numbers were manipulated. This professor also questioned the high number of deaths associated with the study’s control group, all participants who had taken Brilinta.
The study in question, Plato, involved comparisons between Brilinta and Plavix (clopidrogel), which was at one time the most lucrative medicine in the world prior to its patent ending in 2012. Plato involved 18,500 patients from 43 countries who were taking both Brilinta and aspirin. According to data, these patients suffered fewer heart attacks and strokes, but also, the number of deaths associated with vascular causes when compared to the rival Plavix and aspirin decreased.
During the investigation, one of the greatest fears was that Bilinta would need to carry new warning labels or perhaps be taken off the US market completely. This fear stemmed from a trial conducted in the United States whereby Plavix outperformed Brilinta although concerns were dismissed by the FDA, citing it could be due to the use of high-dose aspirin, thereby reducing the effectiveness of Brilinta.
Fortunately for AstraZeneca, the black cloud of speculation was lifted on August 18, 2014 when the DOJ confirmed its investigation was being formally closed and that no additional action was expected. Brilinta has been approved for use in over 100 countries and with troubles behind them AstraZeneca will once again push the benefits associated with this drug specific to people who suffer from certain kinds of heart disease.