Panelist Dr. Sharon Rounds, chief of pulmonary/critical care at Providence (R.I.) Veterans Affairs Medical Center, said that despite her concerns about the regional variability in the effectiveness results, she was impressed with the secondary end points and that “on balance, the risks are offset by the reasonably effective nature of the intervention.” A long-term study following patients for at least 5 years after treatment is needed to monitor treatment durability and potential long-term sequelae of “undoubted damage to the epithelium and other components of the airway wall, in addition to bronchial smooth muscle,” she added.
Another panel member, Dr. Polly Parsons, director of the pulmonary and critical care medicine unit at the University of Vermont, Burlington, agreed that the evidence provided “reasonable assurance” that the device was safe and effective, but added it would be a concern if it was used in patients “beyond those defined as eligible for the trial.”
The panelist who voted against approval, Dr. Sandra Willsie, a pulmonologist in Overland Park, Kan., said, “I believe there's promise here, but I have misgivings in view of the very impressive placebo effect that the data are robust enough.”
The FDA usually follows the recommendations of its advisory panels. If the agent is approved, the company plans further studies, including one that will follow patients in the pivotal trial through 5 years, and will provide didactic and interactive training for physicians.