Falling Behind European Standards Zoloft

Spurred on by Laughren s (1991) critique, an exchange of memos occurred between Paul Leber and his boss, Robert Temple, Director, Office of Drug Evaluation 1. The continuing subject was the approval of Zoloft, whose efficacy as an antidepressant remained in doubt up to the last minute. Temple noted that Zoloft was not being approved in some European countries because of its lack of robustness in the efficacy trials. Zoloft often failed to do any better than placebo in studies in the United States and never did as well as the older antidepressant amitriptyline. Despite these pervasive failures, one positive study and two supportive studies were found sufficient to earn approval. 

On December 24—a mere 6 days before the official approval letter was written for Zoloft—Leber (1991) responded to Temple s concerns about approving the drug. About the tougher standards in the European countries, Leber wrote  

Having outlined these standards, Leber acknowledged their merit but stated that they could not be implemented in America s current political climate  

Leber (1991) believed that Zoloft, despite its relative ineffectiveness, had met the FDA s official requirements for approval. He then concluded his memo with the following warning  

Approval [of Zoloft] may, however, for the reasons enumerated above, come under attack by constituencies that do not believe the agency is as demanding as it ought to be in regard to its standard for establishing the efficacy of antidepressant drug products. 

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