The Suspension of Treatments in ADAPT: Concerns beyond the Cardiovascular Safety of Celecoxib or Naproxen

John C S Breitner,Curtis L Meinert,Barbara K Martin

doi:10.1371/journal.pctr.0010041

Abstract

The Suspension of Treatments in ADAPT: Concerns beyond the Cardiovascular Safety of Celecoxib or Naproxen

Highlights

Dr Nissen’s comments [1] on our paper [2] reveal a fundamental difference in his and our perspectives on the ethical conduct of clinical trials
As we told the Food and Drug Administration (FDA) Advisory Committee [4], the safety data ‘‘. . .. would not in themselves have led to a decision to suspend either treatment. . .[because of any] conclusion that this signal [with naproxen] was. . .sufficiently compelling or definitive to warrant a recommendation to suspend the treatment.’’ Yet, several operational issues would have made continuation of the naproxen arm difficult
The procedures required for reinstatement of the Alzheimer’s Disease Anti-inammatory Prevention Trial (ADAPT) investigational new drug (IND) application would have taken months, and in the interim all treatments would have been suspended regardless of our earlier decision

Summary

Introduction

Dr Nissen’s comments [1] on our paper [2] reveal a fundamental difference in his and our perspectives on the ethical conduct of clinical trials. Safety data in ADAPT, as in most trials, were not collected to test hypotheses. This principle—a direct reflection of the trial investigator’s ethical obligations to study participants—was especially important for ADAPT, a primary prevention trial with 7–10 years of planned interventions and no anticipated short-term benefits.

Results

Conclusion