Leber, Paul

Leber, Paul, Approvable Action on Forrest Laboratories, Inc. Nda 20-822 Celexa (Citalopram Hbr) for the Management of Depression , in Memorandum to the Department of Health and Human Services, Public Health Service, Pood and Drug Administration, Center for Drug Evaluation and Research, Washington, DC, 4 May 1998 Lee, Sandra, John R. Walker, Laura Jakul and Kathryn Sexton, Does Elimination of Placebo Responders in a Placebo Run-in Increase the... 

The author of the FDA memo revealing the decision to hide the existence of the clinical trials that had failed to find a difference between drug and placebo was Dr Paul Leber, Director of the FDA Division of Neuropharmacological Drug Products. Here is what he wrote about the labelling of Cipramil, which is referred to by its generic name, citalopram, in the document ... 

Sotsky, Stuart M., D. R. Glass, M. Tracie Shea, Paul A. Pilkonis, J. F. Collins, Irene Elkin, John T. Watkins, S. D. Imber, W. R. Leber and J. Moyer, Patient Predictors of Response to Psychotherapy and Pharmacotherapy Findings in the NIMH Treatment of Depression Collaborative Research Program , American Journal of Psychiatry 148 (1991) 997-1008... 

The final label change was negotiated and approved under the authority of Paul Leber, Director of the Division of Neuropharmacological Drug Products, the division responsible for Halcion s original approval. In several ways, the label seems to fall far short of conclusions generated by both the literature and the division responsible for postmarketing surveillance. 

Paul Leber (1992) also pointed out that the risks may be even greater than a statistical analysis indicates. Additional factors include the following ... 

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. 

Despite Kapit s function as the chief safety investigator for Prozac, the Division of Psychopharmacological Drug Products, under psychiatrist Paul Leber (see chapter 13), allowed none of Kapit s concerns to appear on the drug s label. The label does not indicate that Prozac is a potentially stimulant drug or that it can cause or worsen depression. 

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