Seroquel Documents: Study 15 Shows Seroquel Not Efficacious

As noted elsewhere today, I've obtained a copy of Seroquel Study 15 which was conducted in the mid-1990s and which AstraZeneca suppressed and did not submit anywhere for publication, as the Washington Post and others have reported. The study was before Seroquel was approved by the FDA, was completed in 1996, and sought to measure Seroquel's efficacy at treating psychosis versus Haldol.

After reading a portion of the very lengthy study, it's obvious why AZ didn't want this study published. It established that Seroquel wasn't a very efficacious antipsychotic at all with anywhere from 53 percent to 65 percent of patients in different Seroquel study groups withdrawing from the clinical trial due to psychotic relapse. That compares with 30 percent of Haldol patients who relapsed during the trial. Study 15 was submitted to the FDA as part of the company's application for the drug, which was approved by the FDA in 1997.

I've made the relevant withdrawals portion of the study available here, including Study 15's cover pages. It's three pages, but a slice of Study 15's 3,459 pages.

Drugs are approved if a company can provide two positive clinical trials of a new drug demonstrating its efficacy and safety over placebo and/or another drug of known efficacy. The FDA obviously had possession of Study 15 and with its feeble results, you have to wonder how the hell this drug ever got approved. Obviously, AZ had some positive studies for the drug, but you have to wonder how it could be so lousy with the Study 15 group and turn out to be positive-enough-for-approval later.

Later independent studies such as CATIE showed that the drug didn't work for 84 percent of patients.