DOJ Launches Investigation of Astrazeneca’s Brilinta Clinical Trial

DOJ Launches Investigation of Astrazeneca’s Brilinta Clinical Trial

October 31st, 2013 // 3:46 pm @

Astrazeneca has a new headache to handle with its Brilinta blood thinner medication. The drug was picked by analysts in recent months as one of the biggest let downs. It was expected to sell more than two billion dollars per year, but now most analysts don’t think it will sell more than $1 billion.

Now, in its most recent quarterly earnings report, the firm stated that the DOJ is now probing its major clinical trial of Brilinta, called PLATO. The Department of Justice demanded information and documentation about the clinical trial. The company noted in its release that it would cooperate fully.

Astrazeneca has not stated what the DOJ is looking for, but the study has gotten some tough criticism from several researchers. James DiNicolantioni and Dr. Ales Tomek raised several questions about the clinical study results in 2012 in a report that they released in the International Journal of Cardiology.

There they talked about concerns that the results of the clinical study that were reviewed by a CRO showed a negative outcome for the drug ticagrelor , that was not as good as the clopidogrel arm. The Astrazeneca investigators reported more positive results.

The two researchers also noted that about 50% of the favorable results in the study were from Hungary and Poland. The reporting that was done on heart related events showed to favor Brilinta, and 23 possible heart related events on Brilinta were downgraded and not included in the study.

The FDA report highlighted what is shown to be serious problems with how the PLATO results were reported. Clinicians may want to reconsider how they prescribe ticagrelor.

However, the Astrazeneca CEO Pascal Soriot stated that he has a high degree of confidence in the clinical data that came from PLATO. He noted that a very strong group of academics oversaw that trial.

However, one of the PIs on the study, Lars Wallentin has fought the allegations that the PLATO trial was not done properly.

He noted that since the PLATO trial was published in 2009, DiNicolantonio has written 30 manuscripts for several hournals that criticized the PLATO clinical trial, as well as the investigators, sponsor and without providing data to support the allegations.


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