Buried Seroquel Study DetailedMar 19, 2009 | Parker Waichman LLP
A Seroquel study completed the same year the drug was approved was apparently buried by AstraZeneca because of its disappointing results. According to The Washington Post, Seroquel Study 15 found that patients gained 11 pounds a year on the drug, something that would have put them at an increased risk of diabetes.
Seroquel - which was introduced in 1997 - has long been linked to a risk of weight gain and diabetes. Information on this risk was originally included in the “Adverse Reactions” section of its label. In 2003, the Food & Drug Administration (FDA) required AstraZeneca to give the information added prominence by moving it to the label’s “Warnings” section. Earlier this year, the label was updated to include data on children and adolescents, including blood-glucose levels, cholesterol, weight gain and increased appetite.
AstaZeneca faces over 9,000 Seroquel lawsuits filed by people who claim the company withheld information about the antipsychotic drug’s diabetes risk. Several states that have also sued AstraZeneca have charged that the company illegally promoted Seroquel for unapproved uses.
The saga of Seroquel Study 15 was uncovered in the course of this litigation. According to The Washington Post, the weight gain seen in the study alarmed AstraZeneca. Company emails unsealed in Seroquel lawsuits indicate that AstraZeneca executives endorsed a company doctor's efforts to put a "positive spin" on Study 15. Company officials also discussed misleading doctors by "cherry-picking" data.
According to The Washington Post, Study 15 - which compared patients taking varying doses of Seroquel to those taking the older drug Haldol - also should have raised serious questions about Seroquel's effectiveness. The study showed that Seroquel failed to outperform Haldol in preventing psychotic relapses. The makers of atypical antipsychotics like Seroquel have long maintained they work better than older generation drugs.
In 1999, AstraZeneca touted different data at an American Psychiatric Association conference and at a European meeting. According to The Post, the company maintained that this data showed that Seroquel helped psychotic patients lose weight.
The company-funded study AstraZeneca used to back that claim was conducted by a Chicago psychiatrist. This doctor reviewed the records of 65 patients who switched their medication to Seroquel, the Post said. He concluded that patients lost an average of nine pounds over 10 months. But other internal documents reviewed by the Post indicate that AstraZeneca officials did not hold this doctor in high regard. They had concerns that he had modified study protocols and failed to get informed consent from patients. They also wrote that they did not trust him with anything more complicated than chart reviews, the Post said.
While the public never got to see Seroquel Study 15, the FDA did - yet it approved the drug anyway. According to the Post, the FDA claims it did not have the authority to make Study 15 public.
As a result, eight years later when a taxpayer-funded study on the effectiveness of Seroquel and other atypical antipsychotics reached conclusions similar to those in Study 15, patients who had been taking Seroquel, as well as doctors who prescribed it, were taken by surprise. One psychiatrist interviewed by the Post said that had doctors known about Seroquel Study 15 in 1997, "it would raise your eyebrows."