(MAC/MAI) Mycobacterium Avium Complex Pulmonary Disease: Join us

Call for comments to the FDA! https://www.bronchiectasisandntminitiative.org/BronchandNTM360social/Community-Discussions/Blog/Article/64/The-FDA-NEEDS-to-Hear-from-You
Here's what I emailed to the bunch of em' listed (using the guidelines given at the site above):

"I have bronchiatisis and MAC (and RA…but who’s counting…). Current treatment for bronch (and MAC) is grueling, toxic to the system, and very old school (piling on more heavy antibiotics as what the medical community has currently doesn’t work well anymore…).

I understand you have refused to approve Linhaliq (I am not associated with Aradigm), an inhaled version of ciprofloxacin that has already undergone several clinical trials. Something that could work far better without toxically engaging the rest of my system in treatment (as is the case w/current oral treatments – nausea; extreme fatigue, significant weight loss), and I understand you won’t approve it for reasons such as:
• concern over antibiotic resistance over time (do you think that won’t happen with current treatment protocol?)
• the question wasn’t posed properly (you’d approve for reduction in frequency of exacerbations vs. prolonging initial onset)
• time to first exacerbation is not considered the most appropriate outcome for the bronchiectasis population as it may not adequately reflect whether patients truly do better and feel better on the new treatment (a treatment that extends the time before first exacerbation would be very welcome….we’ll be happy to partake in another clinical trial to prove that with it we can stay well longer).
This shows a significant lack of patient focus, since we need something better than the current treatment devised 25 years ago…and we don’t care in which way it works best, we care that it’s been shown to work.

I, as one of the millions of us w/bronch (many like me with MAC as well)…and the number is growing exponentially…have watched as little meaningful research is done to devise 21st century treatments (that we know can be easily created with just the will to do so) while losing lung function, and getting sicker rather than better (given the current treatment is as bad as the infection). I implore you to reconsider, and do whatever it takes to get us something – this year - that works better than a decades’ old treatment. As I’m sure you hear daily, our lives are literally counting on it.

Thank you.
Terri Benincasa"

Hope all will write...comment period closes Friday.

My name is Mariah and I have lived with myobacterium avian and bronchiectasis since 2011--and probably a number of years before then. As some have noted, it was a constant cough that took me to my internal medicine doctor who sent me for a lung x-ray. She thought it was pneumonia and so I started on 10 days of an antibiotic. The x-ray was repeated in 6 weeks--no change. So I had an MRI--I was afraid it might be lung cancer, but my internist assured me that the findings did not fit that of lung cancer. My pulmonologist reviewed the various treatments for MAC and I decided to wait. But, after a year and the symptoms becoming worse I started on the 15 month 3-drug regimen to which I was very faithful although I disliked some of the side effects.

I am now living with bronchiectasis and have seen lung function decline although the tests seem to reveal I am doing okay. Last summer we visited Yosemite and Sequoia. The elevation was very difficult for me--the first time that has occurred. I know my tolerance for exercise is much less, but I persist in walking daily, yoga, etc.

I am happy to be in touch with others who have MAC and know it occurs more in women than in men.

My name is Mariah and I have lived with myobacterium avian and bronchiectasis since 2011--and probably a number of years before then. As some have noted, it was a constant cough that took me to my internal medicine doctor who sent me for a lung x-ray. She thought it was pneumonia and so I started on 10 days of an antibiotic. The x-ray was repeated in 6 weeks--no change. So I had an MRI--I was afraid it might be lung cancer, but my internist assured me that the findings did not fit that of lung cancer. My pulmonologist reviewed the various treatments for MAC and I decided to wait. But, after a year and the symptoms becoming worse I started on the 15 month 3-drug regimen to which I was very faithful although I disliked some of the side effects.

I am now living with bronchiectasis and have seen lung function decline although the tests seem to reveal I am doing okay. Last summer we visited Yosemite and Sequoia. The elevation was very difficult for me--the first time that has occurred. I know my tolerance for exercise is much less, but I persist in walking daily, yoga, etc.

I am happy to be in touch with others who have MAC and know it occurs more in women than in men.

My name is Mariah and I have lived with myobacterium avian and bronchiectasis since 2011--and probably a number of years before then. As some have noted, it was a constant cough that took me to my internal medicine doctor who sent me for a lung x-ray. She thought it was pneumonia and so I started on 10 days of an antibiotic. The x-ray was repeated in 6 weeks--no change. So I had an MRI--I was afraid it might be lung cancer, but my internist assured me that the findings did not fit that of lung cancer. My pulmonologist reviewed the various treatments for MAC and I decided to wait. But, after a year and the symptoms becoming worse I started on the 15 month 3-drug regimen to which I was very faithful although I disliked some of the side effects.

I am now living with bronchiectasis and have seen lung function decline although the tests seem to reveal I am doing okay. Last summer we visited Yosemite and Sequoia. The elevation was very difficult for me--the first time that has occurred. I know my tolerance for exercise is much less, but I persist in walking daily, yoga, etc.

I am happy to be in touch with others who have MAC and know it occurs more in women than in men.

My name is Mariah and I have lived with myobacterium avian and bronchiectasis since 2011--and probably a number of years before then. As some have noted, it was a constant cough that took me to my internal medicine doctor who sent me for a lung x-ray. She thought it was pneumonia and so I started on 10 days of an antibiotic. The x-ray was repeated in 6 weeks--no change. So I had an MRI--I was afraid it might be lung cancer, but my internist assured me that the findings did not fit that of lung cancer. My pulmonologist reviewed the various treatments for MAC and I decided to wait. But, after a year and the symptoms becoming worse I started on the 15 month 3-drug regimen to which I was very faithful although I disliked some of the side effects.

I am now living with bronchiectasis and have seen lung function decline although the tests seem to reveal I am doing okay. Last summer we visited Yosemite and Sequoia. The elevation was very difficult for me--the first time that has occurred. I know my tolerance for exercise is much less, but I persist in walking daily, yoga, etc.

I am happy to be in touch with others who have MAC and know it occurs more in women than in men.

My name is Mariah and I have lived with myobacterium avian and bronchiectasis since 2011--and probably a number of years before then. As some have noted, it was a constant cough that took me to my internal medicine doctor who sent me for a lung x-ray. She thought it was pneumonia and so I started on 10 days of an antibiotic. The x-ray was repeated in 6 weeks--no change. So I had an MRI--I was afraid it might be lung cancer, but my internist assured me that the findings did not fit that of lung cancer. My pulmonologist reviewed the various treatments for MAC and I decided to wait. But, after a year and the symptoms becoming worse I started on the 15 month 3-drug regimen to which I was very faithful although I disliked some of the side effects.

I am now living with bronchiectasis and have seen lung function decline although the tests seem to reveal I am doing okay. Last summer we visited Yosemite and Sequoia. The elevation was very difficult for me--the first time that has occurred. I know my tolerance for exercise is much less, but I persist in walking daily, yoga, etc.

I am happy to be in touch with others who have MAC and know it occurs more in women than in men.

Call for comments to the FDA! https://www.bronchiectasisandntminitiative.org/BronchandNTM360social/Community-Discussions/Blog/Article/64/The-FDA-NEEDS-to-Hear-from-You
Here's what I emailed to the bunch of em' listed (using the guidelines given at the site above):

"I have bronchiatisis and MAC (and RA…but who’s counting…). Current treatment for bronch (and MAC) is grueling, toxic to the system, and very old school (piling on more heavy antibiotics as what the medical community has currently doesn’t work well anymore…).

I understand you have refused to approve Linhaliq (I am not associated with Aradigm), an inhaled version of ciprofloxacin that has already undergone several clinical trials. Something that could work far better without toxically engaging the rest of my system in treatment (as is the case w/current oral treatments – nausea; extreme fatigue, significant weight loss), and I understand you won’t approve it for reasons such as:
• concern over antibiotic resistance over time (do you think that won’t happen with current treatment protocol?)
• the question wasn’t posed properly (you’d approve for reduction in frequency of exacerbations vs. prolonging initial onset)
• time to first exacerbation is not considered the most appropriate outcome for the bronchiectasis population as it may not adequately reflect whether patients truly do better and feel better on the new treatment (a treatment that extends the time before first exacerbation would be very welcome….we’ll be happy to partake in another clinical trial to prove that with it we can stay well longer).
This shows a significant lack of patient focus, since we need something better than the current treatment devised 25 years ago…and we don’t care in which way it works best, we care that it’s been shown to work.

I, as one of the millions of us w/bronch (many like me with MAC as well)…and the number is growing exponentially…have watched as little meaningful research is done to devise 21st century treatments (that we know can be easily created with just the will to do so) while losing lung function, and getting sicker rather than better (given the current treatment is as bad as the infection). I implore you to reconsider, and do whatever it takes to get us something – this year - that works better than a decades’ old treatment. As I’m sure you hear daily, our lives are literally counting on it.

Thank you.
Terri Benincasa"

Hope all will write...comment period closes Friday.