Response to Dunn and Wechsler6:
“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 thermoplasty (BT) by Dunn and Wechsler skillfully avoids dealing with the facts and truth about bronchial thermoplasty.
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 2nd 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 drug) that failed to meet any of its primary or secondary end points in a pivotal trial.
We wish to sincerely thank the editors of Allergy and Asthma Proceedings for putting together this very thoughtful and timely pro-con debate regarding BT. Clever marketing and glossy brochures should not distract us from the shaky evidence underpinning BT. We urge patients, providers and others to carefully review every point in our article and then decide whether BT would still be something they would consider for themselves or their loved ones. Dr. William. J. Mayo's timeless words at the 1910 Rush Medical College commencement address in Chicago sums up our argument; “the best interest of the patient is the only interest to be considered”.