The conventional wisdom in psychiatric circles is that newer antipsychotic drugs are far better than older drug. But a long-term trial of the antipsychotic drug Seroquel suggested otherwise.
Newly unearthed documents show that, as a result, “Study 15” suffered the same fate as many industry-sponsored trials that yield data drugmakers don't like -- it was buried. It took eight years before a taxpayer-funded study rediscovered what Study 15 had found, and raised serious concerns about an entire class of expensive drugs.
Study 15 was silenced in 1997, the same year Seroquel was approved by the FDA to treat schizophrenia. The drug went on to be prescribed to hundreds of thousands of patients around the world and has earned billions for AstraZeneca International.
The results of Study 15 were never published or shared with doctors, even as less rigorous studies that came up with positive results for Seroquel were published and used in marketing campaigns. The results of Study 15 were provided only to the FDA, and the agency has maintained that it does not have the authority to disclose such studies.
Study 15 has become a case study in how drug companies can control the publicly available research about their products. Details of the study emerged through lawsuits that are now playing out in courtrooms nationwide -- lawsuits alleging that Seroquel caused weight gain, hyperglycemia and diabetes in thousands of patients.