Some of the documents they request to remain sealed are unpublished results of several drug studies and sales reps' notes on Seroquel's marketing strategies. In the world of transparency we live in today, it will be interesting to see if the files are kept sealed.
What is also interesting in the notes below is their own paid consultant who blatantly admits his patients who were taking the medication kept getting bigger and bigger and developed diabetes. More and more lawsuits are being filed and the drug accounted for around 14% of the total sales for AstraZeneca. There is also some mention of the U.S. Attorney's Office in Philadelphia investigating some whistle blower issues as relates to marketing of the drug.
The big issue here is the the alleged failure to provide adequate warnings on the side effects of developing diabetes with the drug. BD
AstraZeneca, maker of the blockbuster antipsychotic Seroquel, is battling to keep information about the drug out of the public's view … for the public's own good.
This month in Orlando, lawyers for the drugmaker will argue that unsealing company documents, including unpublished clinical trial data and letters from the FDA, could harm "a vulnerable patient population."
"This (disclosure) could jeopardize public safety by causing confusion and alarm in patients, who may then discontinue their medication without seeking the guidance of a medical professional,'' lawyers for the drugmaker said in a recent filing in federal court.
Seroquel is approved only for schizophrenia and bipolar disorder, but its use for everything from depression to insomnia to ADHD in kids is so widespread that the drug has been prescribed for more than 22 million patients. Its $4.5 billion in sales last year put it among the top-selling drugs in the world.
Dr. William C. Wirshing, a California psychiatrist, has lectured doctors on AstraZeneca's behalf and has prescribed Seroquel to as many as 5,000 patients. Though he has been a paid consultant for the drugmaker, in a pretrial deposition he left no question about the links he sees between the drug, weight gain and diabetes.
"You literally just got to watch them get bigger … it was riveting to me," said Wirshing who estimated that several hundred of his patients developed diabetes.