This you’ve got to read!!
From the St. Petersburg Times:
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This month in Orlando, lawyers for the drugmaker will argue that unsealing company documents, including unpublished clinical trial data and letters from the FDA, could harm “a vulnerable patient population.”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.
In light of Seroquel’s popularity, the argument that hiding information protects patients has public health advocates throwing up their hands.
“They don’t want anybody to know about the side effects of their drug, and they’re keeping secret the results of studies from patients, their doctors and the FDA,” said Dr. David Egilman, clinical associate professor at Brown University’s Department of Community Health.
“Saying they’re protecting the patient is a self-serving, fraudulent argument.”…
…Plaintiffs say the company knew as early as 2000 that Seroquel caused diabetes, weight gain and other health problems, but failed to adequately warn patients and doctors…
…AstraZeneca denies the allegations and has spent more than $500 million defending itself against Seroquel claims. Key to the company’s strategy has been its insistence that millions of pages of documents produced in discovery should remain under seal, out of the public eye.
To Egilman, such blanket agreements in drug liability cases are outrageous. “Confidentiality agreements that prohibit disclosure of important information that may impact public health to state and federal authorities should be illegal,” he said. “The court should at least send all discovery in drug cases to the FDA and DOJ (Department of Justice) for review if they intend to seal them.” (read the rest)
This is outright criminality. When will it end? Dr. David Egilman, you may remember, was one of the heroes involved in busting Eli Lilly with the Zyprexa scandals. You go Egilman!!