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Correspondence  |   May 2005
Case Series or Uncontrolled Clinical Study?
Author Notes
  • Medical College of Wisconsin and Zablocki VA Medical Center, Milwaukee, Wisconsin.
Article Information
Correspondence
Correspondence   |   May 2005
Case Series or Uncontrolled Clinical Study?
Anesthesiology 5 2005, Vol.102, 1066-1067. doi:
Anesthesiology 5 2005, Vol.102, 1066-1067. doi:
In Reply:—
I believe Dr. Mychaskiw and Dr. Badr indicate four areas of concern in their Letter to the Editor. The first relates to the clinical choice of using extremely high doses of dexmedetomidine, the second refers to case management and oxygen therapy, the third is the perception that the Journal  endorses the technique of “off-label” use of dexmedetomidine, and the fourth has to do with my conflict of interest disclosure. I believe the first two concerns are questions about the editorial review process. Clearly, expert reviewers provided sufficient enthusiasm to have the case reports published. I was not involved in the review and cannot comment except on one area of concern; my personal belief is oxygen is generally good for patients, even during spontaneous ventilation.
I do wish to comment on the third issue of the Journal’  s perceived “endorsement” of the “off-label” use of dexmedetomidine in the clinical care of several difficult cases. Case reports are meant to “draw attention to important and novel clinical situations, treatments, and complications.” I commend the Journal  for asking for expert commentary on the described use of dexmedetomidine with a focus on further education and safety. Without the editorial by Dr. Maze and myself,1 the clinician might not have been aware of the “caveats” and “potential side effects of large concentrations of dexmedetomidine” described in detail in our editorial. The concerns we expressed were: 1) reports of apnea from bolus administration of dexmedetomidine in patients with a history of sleep apnea; 2) hypertension, both pulmonary and systemic; and 3) bradycardia. Clearly an endorsement of “off-label” use of dexmedetomidine was not intended or given. However, the off-label use of anesthesia-related drugs is extensive. Consider a careful read of the Food and Drug Administration labeling of drugs such as the use of the antiepileptic drug gabapentin for pain syndromes, dexamethasone for postoperative nausea and vomiting, intrathecal use of fentanyl, meperidine for shivering, and many drugs used in the pediatric population. The list of accepted drug usages that are not supported by Food and Drug Administration labeling is lengthy. With each unapproved use came case reports followed by controversy (e.g.  , letters to editors), followed by controlled studies and ultimately accepted practice when the risk:benefit ratio was proven despite package labeling. Finally, Drs. Mychaskiw and Badr express concern with my attestation that I maintain no financial interest or commercial activity in the topic of our editorial and further perceive that I have received “substantial financial support and honoraria” from Abbott Laboratories (Abbott Park, IL). Perhaps a careful review of my income statements would have eliminated their adjective “substantial.” Importantly, Hospira Inc. (Lake Forest, IL) owns and markets dexmedetomidine, and they claim no financial relationship to Abbott Laboratories and are listed as a separate company on the New York Stock Exchange. I have not received research funding from Hospira Inc. and do not speak on their behalf. Previously, Abbott Laboratories had marketed dexmedetomidine; my last support from them for a dexmedetomidine study was in 1999. The volunteer studies I refer to in our editorial were funded in the early 1990s. Based on the lack of support for studies with dexmedetomidine for 5 yr and the absence of speaking on this topic on behalf of Hospira Inc, I stand by the strict interpretation of my attestation at the time of the publication of our editorial.
Medical College of Wisconsin and Zablocki VA Medical Center, Milwaukee, Wisconsin.
Reference
Reference
Ebert T, Maze M: Dexmedetomidine: Another arrow for the clinician’s quiver. Anesthesiology 2004; 101:568–70Ebert, T Maze, M