Joanna Le Noury research psychologist, John M Nardo retired clinical assistant professor, David Healy professor, Jon Jureidini clinical professor, Melissa Raven postdoctoral fellow, Catalin Tufanaru research associate et al
Le Noury J, Nardo J M, Healy D, Jureidini J, Raven M, Tufanaru C et al.
Authors’ reply to Sasich and Linden
BMJ 2015; 351 :h5412
doi:10.1136/bmj.h5412
Re: Authors’ reply to Sasich and Linden
The meaning of an FDA approvable letter has often been misunderstood. An approvable letter means that there are unresolved issues between the agency and the sponsor. Resolution of approvable letters can take years. Clearly, the FDA did not approve the drug for depression in pediatric population.
The Pediatric Use section of the current professional product label for paroxetine, does refer to negative trials:
“Three placebo-controlled trials in 752 pediatric patients with MDD have been conducted with immediate-release PAXIL, and the data were not sufficient to support a claim for use in pediatric patients.”
The statement; “The knowledge that there was a problem with this trial did not come from the FDA.” cites my rapid response as the source for this statement. I did not make this statement. A correction would be appreciated.
The FDA epidemiologist who reviewed the paroxetine depression trials in children and adolescents in 2002 noted Study 329 was a failed trial, failing to demonstrate assay sensitivity, as paroxetine and imipramine could not be differentiated from placebo.
FDA documents would make a difference if guideline authors had accessed them. Failure to use this information may stem from unfamiliarity with the FDA drug approval process.
Safety and efficacy cannot be separated. If there is no demonstrated benefit for paroxetine, then even one suicide can only lead to the conclusion that the risks out weight benefits.
The Study 329 re-analysis confirmed what was already available in public FDA summary documents since at least 1998. This argues for ensuring that this information should be available in consumer friendly language to patients and their parents.
Competing interests: No competing interests