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Pseudo-Emergent Use of an Investigational Drug

Section Editor(s): Saidman, LawrenceShafer, Steven L. MD

doi: 10.1213/01.ane.0000268703.57114.b9
Letters to the Editor: Letters & Announcements

Editor-in-Chief; Anesthesia & Analgesia

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In Response:

Dr. Rosman raises serious and valid concerns (1) about the ethics of publishing a case report describing use of an investigational drug without prior informed consent (2). These concerns were preeminent in our editorial evaluation.

In working through the ethical issues posed by this case, our first question was the same as that posed by Dr. Rosman: was this a grave emergency? The claim is plausible. Severe residual neuromuscular blockade is an emergency. We decided it was not our place to determine if this was truly a “grave” emergency or a lesser emergency. That determination had been made by board-certified anesthesiologists during the care of the patient. Neither Dr. Rosman nor I were at the patient's bedside when the attending physicians believed their patient to be at grave risk. The second question was whether the investigators followed the correct protocol for emergency use of an investigational drug. We took the unusual step of asking the authors to forward to the Journal their institutional policy and the documents submitted to their IRB. These were reviewed, and are in order. The third question was whether the FDA had a policy permitting emergency use of an investigational drug. It was for this reason, we requested an editorial from the Agency (3). We did not consider the question of iatrogenic injury. Regardless of the cause, an emergency is an emergency and must be handled appropriately.

Dr. Rosman's concerns are valid. His thoughtful criticism has provided the Journal an opportunity to describe the process by which we vetted an ethical question for which we could find no precedent in the anesthesia literature.

Steven L. Shafer, MD


Anesthesia & Analgesia

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1. Rosman EJ. Pseudo-emergent use of an investigational drug. Anesth Analg 2007;105:876
2. Lenz A, Hill G, White PF. The emergency use of sugammadex after failure of standard reversal drugs. Anesth Analg 2007; 104:585–6
3. Schultheis LW, Rappaport BA. The Food and Drug Administration perspective: use of an investigational drug in a medical emergency. Anesth Analg 2007;104:479–80
© 2007 International Anesthesia Research Society