Earlier this week I participated in an asthma focus group , put on by the AAFA and sponsored by the company who makes the new Bronchial Thermoplasty equipment. I think there were 11 of us in the group, plus 3 silent observers. The severity of disease among the participants ran the gamut from people who had such severe steroid dependent asthma that they could barely speak or move , to those who had only used their inhaler once a month. The age range was 26 to 60. Oddly there were no female participants ( though they tried to get one on the phone during the conference). The entire thing was teleconferenced and lasted about 2 hours.
The first half of the discussion was introductions followed by the usual opener questions like..” How does asthma impact your life? How does it impact your family? How does it make you feel as a person ?”, ” Do feel that current the currently available therapies are adequate?”..”How do you feel about all the medication you have to take and their side effects?”
Though the views expressed by the participants were supposedly unbiased , the outcome of the conference was pretty predictable. You could tell that the moderator was gradually guiding the discussion in the direction of the newly touted breakthrough treatment , called “Bronchial Thermoplasty”.
Three of the group’s participants had actually undergone the Thermoplasty procedure during the phase II and phase III clinical trials. During the last 15 minutes of the conference they were allowed to speak. As predicted, they had nothing but good things to say about the treatment.
Comments like… ” It changed my life”….. “It’s a miracle”…. “The best thing that ever happened to me”… “I can play sports again”……that sort of thing. I must say, that after hearing those 1st hand accounts of how this new procedure changed their lives, I was really jazzed up. It made me feel like maybe there was hope for people like me. It was also great to hear that the anticipated FDA target date for approval is for December of this year.
Now back to clearer thinking. If I remember correctly, none of the people in this focus group who had undergone the treatment, had what I would consider, severe asthma. Prior to their Thermoplasty treatments, they were describing mild to moderate symptoms at best. The other thing that kind of puzzled me, is that the clinical trials were blind studies. The research participants were not suppose to know if they received the real thing or placebo,so I’m assuming that they were told of the results once the research was complete.
It would have been nice to hear from other people who had less than miraculous results from the procedure. However, it was good to hear that the side effects of the procedure itself ( which is done via bronchoscopy), were relatively minor for most of the participants.
My general sense is that the purpose for this focus group, was to develop a marketing plan for the device and at the same time, obtain the AAFAs stamp of approval for it.
So while I’m still very excited about this new procedure and how it will help thousands of asthma sufferers, I’m not convinced that it will produce the same miraculous effects for someone like me . In fact, I’m not even sure I will be a candidate for the procedure. If you remember , I was turned down for the clinical trials for this procedure because my asthma was considered too severe. Anyone with an FEV1 of less than 65% was excluded from participating . My FEV1 is only 36% now and it doesn’t reverse very much after bronchodialators. I have what they call “fixed asthma”, which basically means that my airways have become stiff and permanently narrowed . It’s questionable whether Thermoplasty, which targets the bronchial smooth muscle responsible for bronchoconstriction, would be of much benefit.
Then there’s the issue of cost and whether or not the insurance companies will pay for it. I would say, probably not, at least for the first few years. Though if you look at how much the insurance companies currently fork out every time I’m hospitalized, even if this new procedure helped prevent just one hospital stay per year, it would surely be in their best interest to approve it.
If I thought there was even the slightest chance that Thermoplasty could help me breath easier, Id travel to the far reaches of the planet and pay any amount to have it done. I guess we’ll just have to see how it goes after this new treatment option gets into full swing next year.