*I took this drug for nearly a year…I had bad experiences from it. They really need to look into whether Seroquel is truly therapeutic or not.*
ORLANDO, Feb. 27 — Newly unsealed court documents suggest that AstraZeneca tried to minimize the risk of diabetes and weight gain associated with its antipsychotic drug quetiapine (Seroquel), in part by “cherry-picking” data for publication.
The documents emerged during a trial consolidating lawsuits filed against AstraZeneca by some 9,000 people who claim to have developed diabetes while taking the drug. In the case, being heard here in federal court, the plaintiffs claim they were not adequately informed of the drug’s risk.
One of the most damning of the documents was a 1999 e-mail written by the company’s publications manager, John Tumas, indicating that the company had “buried” three clinical trials and was considering doing so with a fourth named COSTAR.
An e-mail written two years earlier by another AstraZeneca employee discussed ways to “minimize” and “put a positive spin” on safety data from a “cursed” quetiapine study — one of those Tumas later described as “buried.”
More recently, a 2005 telephone message to the company’s salespeople instructed them to “refocus” discussions with physicians away from questions about weight gain and diabetes.
“Our objective is to neutralize customer objections to Seroquel’s weight and diabetes profile.”
An AstraZeneca spokesman said the unpublished trial data had been submitted to the FDA as part of the approval process.
He also emphasized that weight gain, glucose dysregulation, and other safety risks are described in detail in the drug’s FDA-approved prescribing information.
The label includes specific trial data on the incidence of treatment-emergent weight gain, hyperglycemia, and diabetes.
However, it also suggests that these are class effects of atypical antipsychotic drugs rather than being specific to quetiapine.
In 2004, the FDA required that atypical antipsychotics carry a warning on weight gain and diabetes. It called for clinicians to perform regular blood glucose monitoring of patients given these agents.
But studies last year indicated that the warning has had little effect on rates of screening and monitoring.
For example, researchers analyzing a large insurance claims database found that the rate of glucose monitoring in patients given atypicals increased only four percentage points after the warning appeared, and remained less than 25%. (See ADA: Metabolic Monitoring Guidelines for Antipsychotics Largely Unheeded)
Promotional literature distributed in 1999 by AstraZeneca included a case study describing a diabetic patient who lost weight and stopped diabetic medications after switching to quetiapine from another antipsychotic drug.
Quetiapine is currently approved for treatment of schizophrenia, acute bipolar depression and mania, and for maintenance therapy of bipolar I disorder as an adjunct to lithium or divalproex.
AstraZeneca is currently seeking approval, as well, for an extended release form of the drug as treatment for generalized anxiety disorder and major depression.
This week, the FDA requested additional information from the company about the anxiety indication. An advisory committee meeting has been scheduled for April 8 on both new indications.
The quetiapine litigation has also taken a risque turn, with plaintiffs’ lawyers seeking to introduce evidence of alleged sexual relationships involving the company’s former U.S. medical director.
According to the attorney’s filing in the case, the executive had sexual contacts with a British researcher who worked on two quetiapine studies in bipolar depression, and also with a medical writer who helped produce journal articles describing the studies.
The attorneys argued that these contacts were improper because the studies and resulting journal articles were supposed to have been independent of AstraZeneca influence.
The executive, Wayne Macfadden, M.D., who left AstraZeneca in 2006, admitted the relationships under questioning by a plaintiff’s lawyer, the motion said.
“The mere existence of these relationships calls into question the integrity of the scientific work product of those involved,” according to the motion.
AstraZeneca has asked the court to exclude Dr. Macfadden’s relationships as irrelevant. The judge has yet to make a ruling.
Additional documents in the case remain sealed. Plaintiffs’ lawyers as well as the Bloomberg news organization have requested that they be made public as well.