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.
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Thanks for the report. I always thought it would be cool to have a group of people do studies completely independent of government and companies so we could truly get an unbiased study. I think you have legit concerns about this procedure. However, it would be awesome if it really was as great as it sounds — and
Hello. I am an asthma specialist (Allergist). I have analyzed the published reports on Thermoplasty and have found too many problems with the procedure. My main concerns are listed below.
1. There is not even one, independent study showing that it works. All the studies were done by the company that makes the device. There is obvious conflict of interest.
2. The largest and the best study was AIR trial. It was on the basis of this study the FDA granted approval of the device. The AIR study showed that thermoplasty and placebo treatment were equally effective. There was no clinically significant difference between the two.
3. The AIR study had one patient in the placebo group who became very sick after the placebo procedure. He/She required nine admissions in the year after the treatment. If we remove this patient from the calculations, the thermoplasty group had worse outcome than the placebo group.
4. There is no theoretical basis to believe that reducing smooth muscle mass should help asthma. We do not know if increase smooth muscle mass in the result or the cause of asthma.
5. The animal studies with thermoplasty were not at all in concerrence with the clinical studies.
Hello Dr Gupta and thanks for leaving a comment on my blog re: bronchial thermoplasty. I’m not a physician, but I totally agree with you! In addition, thermoplasty does nothing to reduce the inflammatory component of asthma. I wrote this particular post while thermoplasty was still in trials and very little was known about it. ( I was actually excluded in participating in the clinical trials because my asthma was too severe. )
Here’s a more recent post I wrote about Thermoplasty.
By the way , to you know Dr Sally Wenzel over at the University of Pittsburgh? She’s one of the SARP investigators and is my personal physician. She’s a great person and feels the someway about thermoplasty as you do.
Thanks again for taking the time to comment.
Why be a d bag?. Give us asthmatics hope… I have had my dreams crushed by being told I can not join the military at least let them continue to work on this and perfect it.
No one is stopping you from having it done.
I have severe asthma and have tested as allergic to literally everything. I take Xolair monthly, use Advair 500/50, Singulair, Zyrtec, and Flonase daily. I also have three allergy shots each week.
My life has become smaller and smaller with each passing year and is extremely limited (work, home, work, home, work, home, etc…) due to asthma. Please know that I have high-quality, expensive air cleaners in both locations as well as in my car that enable me at least this activity.
I almost died with a viral-induced exacerabation this February. My very worried allergist recommended BT for me as my last resort treatment. I checked with my insurance company, and they would not cover the treatment. I did some research and found the clinical trial online.
After much paperwork, testing, etc…, I consider myself very lucky to have been selected for the Post-Approval Clinical Trial at HealthPartners in St. Paul, MN. I just had the second treatment at Regions Hospital and am recovering nicely though this recovery has been tougher than the first. I expect to have the third and final treatment before the end of this month (July 2012).
I am surprised and excited to report that I have already experienced an amazingly positive and significant difference in my asthma symptoms. I actually hope to live a semi-normal life again, and I cannot wait. I can already take walks and not wheeze. I have driven my husband’s convertible for an hour with the top down and did not wheeze. These seeming normal events are not normal for me.
BT has been a true blessing for me. Even if it the effect does not last over time, it was worth it to have freedom from struggling for a breath of air even for just a few days. I am so very thankful to my incredible doctors: Dr. Charlene McEvoy and Dr. Kristy Hamm. Natalie Woodruff is the coordinator for the program and she is committed, kind and so helpful.
The keys to success with this treatment are: being deemed sick enough with asthma but not too severe; having excellent doctors who are experienced in the procedure; following the pre-treatment and recovery protocols; and, most importantly being able to find a way to afford it.
I am a lifelong asthmatic, have ABPA, and am 70 years old. I had Thermoplasty done last fall. I was not guaranteed any improvement, however, my symptoms make my quality of life pretty limited. My Dr. said that I am the sickest patient he has..I told the Dr. that if it helped me only 10%, I wanted the opportunity. I would say my improvement is 40%!!
With the exception of the last 3 weeks, I haven’t felt better in a very long time. It is my “allergic time” in DFW area, but I look forward to the end of this allergy period.
I would do it again, in a heartbeat.
Glad it helped you 🙂