Rebuttal Comments from Dr. Dunn and Dr. Wechsler

I ntroduction: In recent years a number of emerging new therapies have become available for the treatment of severe asthma among which bronchial ther-moplasty is the only nonpharmacologic intervention that has been approved by the United States Food and Drug Administration in 2010. 1 Although bronchial thermoplasty has great promise for the patient with severe asthma and is now within the therapeutic ar-mamentarium of the allergist-immunologist, the modality has paradoxically raised both excitement and curiosity but also questions as to when and how to recommend its use 2 as well as concerns relating to any potential harm that may be associated with the procedure. 3–5 In the interest of assisting the allergist-immu-nologist in the decision-making process for the use of this new treatment modality, two separate articles by Dunn and Wechsler ME 6 and Iyler and Lim 7 are presented in this issue of the Proceedings that offer opposing viewpoints on the role of bronchial thermo-plasty in a pro/con debate format. In addition, employing a novel publication format, each author was given an opportunity to make rebuttal comments to each other's presentation which are printed below in this editorial. It is our hope that this information will be useful and will assist the allergist-immunologist in making the best therapeutic decisions for the patient with severe asthma. 6 : " Facts are stubborn things; and whatever may be our wishes, our inclinations, or the dictates of our passion, they cannot alter the state of facts and evidence "-John Adams, 1770. Unfortunately, the 'pro' article on Bronchial thermo-plasty (BT) by Dunn and Wechsler skillfully avoids dealing with the facts and truth about bronchial ther-moplasty. The first (and most important) fact is that the primary end point in the AIR-2 trial was negative (posterior probability of superiority [PPS] of 96% rather than the prespecified value of 96.4% in the AIR-2 trial). The 2 nd most important fact is the lack of follow up in the sham controlled arm of the AIR-2 trial. These two facts alone would be a reason to pause and question any further claims regarding the efficacy of BT. We must accept only the highest and most robust standards for medical evidence before changing clinical practice. The available evidence for BT does not meet these standards. In fact, the very approval of BT by the FDA is both troubling and puzzling. We cannot think of a single approved device (or …