AstraZeneca PLC, PTSD and a Buried Seroquel Study

File this under ‘hidden clinical trial disorder.’ For a decade, the US military regularly prescribed its service members atypical antipsychotics, which are approved to treat schizophrenia and bipolar disorder, for various off-label uses, notably insomnia and post-traumatic stress disorder. And the antipsychotic that was most widely prescribed has been the Seroquel pill, which is sold by AstraZeneca. For instance, a 2009 review of off-label use in the Veterans Affairs health care system found that 60 percent of patients who received an antipsychotic had no record of a diagnosis for which these drugs are approved. The largest proportion of prescriptions for off-label use were written for PTSD and Seroquel had the greatest off-label use. Last year, the armed services issued more than 54,500 prescriptions for Seroquel alone, which was, by far, the most for any antipsychotic. And by 2009, Seroquel became the VA’s second-biggest pharmaceutical expenditure, reaching $125.4 million, up from $14.4 million in 2001. This off-label use occurred even though VA clinical guidelines issued in 2004 stated that “there is insufficient evidence to recommend atypical antipsychotics for the treatment of PTSD.”