Post by Adina on Jun 5, 2008 13:31:08 GMT -5
I posted here before that I had participated in Phase II of the BLVR Clinical Trial sponsored by Aeris Therapeutics. I am now six months post-procedure and am reporting the results to date. I had some difficulties with the local doctor that are referred to below, but the main post on those difficulties is on CI. When I was pursuing treatment options, I looked for both “positive” and “negative” experiences simply because I felt I could make a more informed decision by seeing more than one side to a ‘story.’ It is in that spirit that I make this post. I hope it can at least help people in their own research and exploration of options.
I'd like to preface this story with the fact that I went into this procedure with a very positive and upbeat spirit and mindset.
I had a series of three PFTs leading up to the procedure on Dec. 19, 2007. All the numbers I will give you are POST-Bronch as that’s what Aeris is using for its statistics. For the three tests in the few weeks before the procedure, my FEV1 was 25%, 26% and 24%. My FVC was 57%, 57% and 49%. My DLCO was 20%, 21%, and 19%. My RV was 193%, 208%, and 194%. And my TLC was 120%, 124% and 119%. What they’re looking for primarily is a reduction in air trapping, but of course, they’re also looking for other improvements in FEV1, FVC, exercise capacity, etc.
Although I DID actually experience some real improvement in both how I felt and in my ‘numbers,’ at the six-week check up (Feb. 1), I began to get worse and needed a round of prednisone just ten days later. At the beginning of March I began getting more SOB again. I went for the 12-week testing (March 13). Twelve weeks is the target to see the improvement they’re looking for, which I mentioned above.
At six weeks my FEV1 was 28% (it was that high a year ago, too), my FVC was 54%; DLCO was 26%; RV 168%; and TLC 115%. You can see an improvement over the Pre-BLVR numbers, which reflect how I also felt.
At 12 weeks, my FEV1 was also 28%; FVC 59%; DLCO 24%; RV 212%; and TLC 127%. The RV and TLC are both higher than they were at six weeks. So again, how I felt and the numbers both 'matched.'
Since, as I said in a previous post, the doctor (Dr. T) who actually did the procedure refused to answer my questions and then forbid me to even ASK questions, I called Aeris Therapeutics and talked to the doctor (Dr. I) who actually founded the company. I asked to tape the calls, and he consented.
Here's what he told me about my own situation: At 12 weeks (the target time for initial results), I showed a "moderately good" response, which means that my improvement was a little over 10% from my baseline. (He said some patients have had a 50% improvement). He also said the BLVR doesn't collapse lung as effectively as surgery, but it's obviously less complicated than surgery. Since I was told (BEFORE the procedure) that the BLVR I had (the 20 ml) was supposed to - was intended to - reduce the actual amount of my lung by about the same 30% that LVRS does, I asked him how much MINE had ACtually been reduced, and he told me by about 15%.
He told me that if I had come to him and asked him how I should be doing, he would tell me that I "should be doing somewhat better. Your improvement is as good as one would expect with an inhaled medication, if not a little better." Now, THAT really didn't make me happy that I went thru a procedure that yielded not much better results than an inhaler.
He said my RV/TLC ratio is a little worse at 12 weeks than it was at the 6-week testing, but that my FEV1 is better - almost twice as good. (However, it was only a couple percent better, which as we know can happen from one day to the next withOUT any intervention. And looking at it, I have NO idea how he figured it’s TWICE as good). He said my Vital Capacity is also better.
Dr. I also told me that they're finding that the areas next to the areas they treat with the BLVR gel tend to get BIGGER... and that even the areas they treat, although they initially shrink, can then get bigger. They don't know why that's happening, but they have some "leads."
Later I looked at my reports of my x-rays and CT scans, one of them said that there were "significant bullous emphesematic changes since the last scan/x-ray." That would have been between the 6-week testing and the 12-week testing.
At least he explained HOW they measure things, e.g., the RV/TLC ratio, and the actual reduction, etc., which was all I was asking the doc HERE to do, and he refused. When I told Dr. I that's all I was asking for, just to have things explained to me and that the doc here refused, he said, "Well, you have to realize that Dr. T is a clinician, not a researcher, and that he may not have that level of sophistication where he can address some of the complex questions that you have."
Dr. I indicated said if I still don't show much improvement at six months (which is where I am now) then my options still include LVRS, or TX, or another BLVR treatment, etc. I am NOT going back to the doc here, tho, for the reasons I mentioned in the other post, as well as some other issues that arose after my last post, so I will need to get another PFT somewhere else.
I suggest that if you’re interested in this procedure you also look at the presentation by Aeris President and CEO David Dove at the Omrix Biopharmaceuticals Analyst & Investor Day held on March 27, 2008. Aeris and Omrix have a manufacturing and supply agreement. You can find the presentation – “Perspectives in Biosurgery” in the information at this URL: library.corporate-ir.net/library/19/197/197979/items/286778/Dove_Aeris.pdf Once you do that, you will understand that we are a MARKET SEGMENT and MARKET SHARE, no more.
Although I knew that I might not benefit by the procedure, what I did not know but learned as I went along – both from my own experiences and those of a couple of other local people – that the coordinator here will fudge how tests are conducted in order to help people qualify. Sadly, I have learned that this is not uncommon for clinical trials. So the next step is to read Overdosed America by John Abramson, M.D. of the Harvard Medical School. He has extensive information about the conduct of clinical trials and the manipulation and presentation of data from trials. I did not have this book until after the procedure, or I never would have gone thru it.
Also, knowing what I do now about this trial, as well as clinical trials overall and in general, I simply would not participate in one ever again, especially not in a Phase II trial. It's just TOO experimental.
Much of my own experience is due to the local doctor, so if someone is still interested in getting this done in Ohio, I would recommend going to the Cleveland Clinic instead. They were not part of the trial yet when I had mine done, but they are doing it now.
My PFTs are obviously in the low "very severe" range. Perhaps some of those who saw more improvment had better numbers to start with, but so far that information is not publicly available. Aeris won't even share it with the doctors doing the procedure, what they call the "Principal Investigator."
If anyone has questions, I'll try to answer as best as I can.
And I want to add a very special and HUGE thanks to roadtrip, who coached me thru how to handle these idiots! Let's hear it for roadtrip!
I'd like to preface this story with the fact that I went into this procedure with a very positive and upbeat spirit and mindset.
I had a series of three PFTs leading up to the procedure on Dec. 19, 2007. All the numbers I will give you are POST-Bronch as that’s what Aeris is using for its statistics. For the three tests in the few weeks before the procedure, my FEV1 was 25%, 26% and 24%. My FVC was 57%, 57% and 49%. My DLCO was 20%, 21%, and 19%. My RV was 193%, 208%, and 194%. And my TLC was 120%, 124% and 119%. What they’re looking for primarily is a reduction in air trapping, but of course, they’re also looking for other improvements in FEV1, FVC, exercise capacity, etc.
Although I DID actually experience some real improvement in both how I felt and in my ‘numbers,’ at the six-week check up (Feb. 1), I began to get worse and needed a round of prednisone just ten days later. At the beginning of March I began getting more SOB again. I went for the 12-week testing (March 13). Twelve weeks is the target to see the improvement they’re looking for, which I mentioned above.
At six weeks my FEV1 was 28% (it was that high a year ago, too), my FVC was 54%; DLCO was 26%; RV 168%; and TLC 115%. You can see an improvement over the Pre-BLVR numbers, which reflect how I also felt.
At 12 weeks, my FEV1 was also 28%; FVC 59%; DLCO 24%; RV 212%; and TLC 127%. The RV and TLC are both higher than they were at six weeks. So again, how I felt and the numbers both 'matched.'
Since, as I said in a previous post, the doctor (Dr. T) who actually did the procedure refused to answer my questions and then forbid me to even ASK questions, I called Aeris Therapeutics and talked to the doctor (Dr. I) who actually founded the company. I asked to tape the calls, and he consented.
Here's what he told me about my own situation: At 12 weeks (the target time for initial results), I showed a "moderately good" response, which means that my improvement was a little over 10% from my baseline. (He said some patients have had a 50% improvement). He also said the BLVR doesn't collapse lung as effectively as surgery, but it's obviously less complicated than surgery. Since I was told (BEFORE the procedure) that the BLVR I had (the 20 ml) was supposed to - was intended to - reduce the actual amount of my lung by about the same 30% that LVRS does, I asked him how much MINE had ACtually been reduced, and he told me by about 15%.
He told me that if I had come to him and asked him how I should be doing, he would tell me that I "should be doing somewhat better. Your improvement is as good as one would expect with an inhaled medication, if not a little better." Now, THAT really didn't make me happy that I went thru a procedure that yielded not much better results than an inhaler.
He said my RV/TLC ratio is a little worse at 12 weeks than it was at the 6-week testing, but that my FEV1 is better - almost twice as good. (However, it was only a couple percent better, which as we know can happen from one day to the next withOUT any intervention. And looking at it, I have NO idea how he figured it’s TWICE as good). He said my Vital Capacity is also better.
Dr. I also told me that they're finding that the areas next to the areas they treat with the BLVR gel tend to get BIGGER... and that even the areas they treat, although they initially shrink, can then get bigger. They don't know why that's happening, but they have some "leads."
Later I looked at my reports of my x-rays and CT scans, one of them said that there were "significant bullous emphesematic changes since the last scan/x-ray." That would have been between the 6-week testing and the 12-week testing.
At least he explained HOW they measure things, e.g., the RV/TLC ratio, and the actual reduction, etc., which was all I was asking the doc HERE to do, and he refused. When I told Dr. I that's all I was asking for, just to have things explained to me and that the doc here refused, he said, "Well, you have to realize that Dr. T is a clinician, not a researcher, and that he may not have that level of sophistication where he can address some of the complex questions that you have."
Dr. I indicated said if I still don't show much improvement at six months (which is where I am now) then my options still include LVRS, or TX, or another BLVR treatment, etc. I am NOT going back to the doc here, tho, for the reasons I mentioned in the other post, as well as some other issues that arose after my last post, so I will need to get another PFT somewhere else.
I suggest that if you’re interested in this procedure you also look at the presentation by Aeris President and CEO David Dove at the Omrix Biopharmaceuticals Analyst & Investor Day held on March 27, 2008. Aeris and Omrix have a manufacturing and supply agreement. You can find the presentation – “Perspectives in Biosurgery” in the information at this URL: library.corporate-ir.net/library/19/197/197979/items/286778/Dove_Aeris.pdf Once you do that, you will understand that we are a MARKET SEGMENT and MARKET SHARE, no more.
Although I knew that I might not benefit by the procedure, what I did not know but learned as I went along – both from my own experiences and those of a couple of other local people – that the coordinator here will fudge how tests are conducted in order to help people qualify. Sadly, I have learned that this is not uncommon for clinical trials. So the next step is to read Overdosed America by John Abramson, M.D. of the Harvard Medical School. He has extensive information about the conduct of clinical trials and the manipulation and presentation of data from trials. I did not have this book until after the procedure, or I never would have gone thru it.
Also, knowing what I do now about this trial, as well as clinical trials overall and in general, I simply would not participate in one ever again, especially not in a Phase II trial. It's just TOO experimental.
Much of my own experience is due to the local doctor, so if someone is still interested in getting this done in Ohio, I would recommend going to the Cleveland Clinic instead. They were not part of the trial yet when I had mine done, but they are doing it now.
My PFTs are obviously in the low "very severe" range. Perhaps some of those who saw more improvment had better numbers to start with, but so far that information is not publicly available. Aeris won't even share it with the doctors doing the procedure, what they call the "Principal Investigator."
If anyone has questions, I'll try to answer as best as I can.
And I want to add a very special and HUGE thanks to roadtrip, who coached me thru how to handle these idiots! Let's hear it for roadtrip!