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@boomerexpert

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.

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Replies to "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'..."

@luvocean.....this is a long shot,,,,call main number of National Jewish Health at 1-8772255654 and ask for Pharmacy....tdrell

My medication (used for inhalation therapy) is called amikacin sulfate injection USP for intramuscular or intravenous use. If you cannot obtain it from a local pharmacy, you may want to try surgical supply facilities. I know that CIGNA home pharmacy carries it but you must connect with their medical, specialty pharmacy department. Terry

So I did the hour interview with the research company. Even though it was mostly comprised of questions requiring personal responses as to my MAC journey, I certainly did my very best to advocate for all of us.

I'm confident you did! Glad you let them know just how poorly treated this infection is and how many folks are getting it.

That I did!