THE Post.
This is it. The post I've been wanting to put up since November. This is The Mannitol Post. It's a long story.
Last summer I decided I would participate in two different clinical trials - one for inhaled powdered Cipro, and the other for inhaled powdered Mannitol. I did the Cipro study first. It was a month long and I had to show up for PFTs and check-ups every week, but it was only a month. No. Big. Deal. The next study was going to be more challenging and taxing. Remember, I had agreed to babysit more regularly starting in August, and I was loving the babysitting. I even did some babysitting where I had to take my afternoon IV dose with me. That was a rough week. Actually a rough two weeks. I did IVs for the first time all by myself - with no help from anyone. I did the IVs at the end of the Cipro study, so I had to wait to start the Mannitol study.
The Mannitol Study. Let me start off by explaining what Mannitol is. It is FDA approved for other uses. They use it IV to reduce brain swelling. Most chewing gum is coated in powdered Mannitol. It is not illegal to own Mannitol (I found food-grade Mannitol on the internet and they sell it by the pound). This study is to approve a different use for Mannitol. In this study, powdered Mannitol is inhaled into the lungs via capsules put into an inhaler. The study was a year-long commitment. In the first 6 months you would either have the drug or a placebo. The second 6 months is what they call "open label," meaning everyone has the drug.
I didn't think this would be a huge commitment. Inhale 10 capsules twice a day for a year. All for the sake of science and my health. Note the second part of that sentence. I participate in studies for the selfish reason of benefiting my own health in addition to doing it for science and to help other patients.
When I got into the study, I realized it was going to be a MUCH bigger commitment than I originally thought. Mainly because of the JOURNAL. This was going to be the JOURNAL FROM HELL. In all honesty, I was going to be lazy about it. They wanted you to record ALL symptoms - colds, sinus stuff, sprained ankles, etc. I really wanted to say, "Stubbing my toe at least once a week is in NO WAY related to your study." But I agreed. Then I was told to record all doctors visits, all nurse visits (remember I have a daily nurse who does manual chest PT for me), and every time you pick up medication at the pharmacy. I thought this was ridiculous. I try to limit my pharmacy trips to once a week - but it's sometimes more. I honestly thought I was going to spend most of my free time filling out that journal and I would never again blog or write in my personal journal. I wasn't enthusiastic about the JOURNAL FROM HELL, but I agreed.
For the study, they have you do a tolerance test to see if you can handle the drug. It involved lots of PFTs and taking the medication. One half hour after I took the medication my PFTs (lung function tests) had improved more than 10%. TEN PERCENT. I hadn't seen numbers that high in years. It was unbelievable. So I agreed to do the first 6 months not knowing whether or not I had the drug just so I could get to the second 6 months to have the drug!
A week after the tolerance test I was double-blinded and given my stuff. Again, PFTs were done with your substance, and then for the 30 minutes after the test I had to collect all the sputum I coughed up. Both times I did PFTs - with the tolerance test and the first dose of 'Mannitol' - I coughed really hard. I also coughed up tons of gunk. The second time I collected all this gunk and it filled a sputum cup half full. Completely gross. I wish I had taken photos so I could show you the complete gross-ness of this sputum cup. I knew I had the drug because of the way I coughed and because my lung functions again went up more than 10% in 30 minutes. I knew I was holding onto a miracle drug. I just didn't know how much trouble it would cause me.
I did exactly three doses of Mannitol as I was supposed to - 10 capsules twice a day. I woke at 6am on Saturday with a cough I couldn't get rid of. This was the hardest I had ever coughed (saying a lot for a CFer... I pretty much cough for a living!). My lungs ached and the muscles in my chest and abs were quivering from working so hard. I tried everything to sooth the cough because I wanted so badly to continue with the study. Cough drops. Eating. Drinking water. Sitting in a steamed bathroom. Doing all at the same time. And nothing worked. After six hours I finally gave in and took cough syrup with codeine in it, which finally soothed my cough. But I knew I couldn't take the Mannitol the way I had been instructed to.
I couldn't believe the cough. It's hard for me to put into words how horrible and how strong the coughing was. My upstairs neighbor came down several times and knocked on my door... and I was coughing too hard to answer. Finally I checked the door and there was a small blue Post-It that read, "Please turn down your sub woofers. It's shaking our walls." I had nothing playing because I was trying to calm my cough. My cough was shaking the walls in a concrete building. Lovely.
Since I couldn't tolerate the drug the way I was supposed to take it I had to drop out of the study - which means you need to return the un-used drug. But I read through the papers I had signed, and no where did it say I was required to return the medication. I bet they've revised study documents now, but nothing I signed said I had to give it back - so I didn't. Actually, I waited a month or two to even tell them I was dropping out of the study. Because I needed this drug. I needed to make it work for me. I couldn't give up the lung function percentage that it was giving me. My lungs will never be completely at full capacity because I have scarring, but I want them to be the best they can be.
Before I told them I was dropping out of the study I played around with dosing. First, fewer capsules twice a day. That was too much - the horrible cough continued. Then once a day, every other day, once a week, and finally I settled on 6-8 capsules once every two weeks. That's a big difference from 10 capsules twice a day. But my lung functions maintained. And even more importantly - I FELT AWESOME.
I told my study coordinator I was dropping out of the study and I refused to return the medication. She was furious with me. We had several long circular conversations where she tried to convince me I needed to return the medication, and I tried to convince her I needed to keep it. I told her I'm fighting for my health - for my life. It was time for another hospitalization, and I wasn't even close to needing IVs yet. At one point she said, "I understand..." and I interrupted with, "No. You. Don't. When was the last time you had to spend two weeks in the hospital for IV antibiotics that damage your kidneys, liver, and cause hearing loss? I am fighting for my life - the right to have a more normal life, and if this medication keeps me out of the hospital for even 6 months at a time, I am going to keep doing what I'm doing. Because 6 months without IVs is better than having to do them every 3 months."
After that, she stopped calling. They sent a certified letter, which I refused. I knew that was all the action they could take against me.
I knew I was on my own. I felt black-listed. I knew my research coordinator was talking about me to other research coordinators (I have a friend who works in the department and overheard these conversations). At one point she said, "Well, you know, her father is a psychiatrist and she's on a lot of psych meds." THAT pissed me off. I understand that I complicated her job and that I was a pain in the ass - but to call me crazy, and to bring my father into it is INSANE. The fact that my father is a psychiatrist has NOTHING to do with the fact that I have PTSD, Depression and Anxiety. See my little blogging profile - those aren't related to my CF. Anyways, that pretty much ended any desire I had to explain myself to her - or to have anything to do with that CF clinic. I just assume that the doctor who was in charge of the study (who is/was my CF doc in my town), isn't my biggest fan.
So now the months are flying by - I reach 6 months without IVs... 7, 8, 9... and I finally decide I need to see a CF doc and finally see if my lungs are maintaining number-wise. I was healthy - I AM healthy, but I wanted the numbers to prove it. So I make an appointment at a clinic 2 hours away, and yes, my numbers are maintaining.
The same week I went to the far away clinic, I went to a CF Adult Group meeting. There a couple people criticized me. I was told I could go to jail, I might as well have a ton of pot in my house, that I'm selfish to 'ruin' the study. And at first I cried. I even wrote about it here - why I'm scared to write about the Mannitol. And now none of that matters to me. The opinion of those CFers can't matter to me - because I am taking care of myself the best I know how.
I am living my life, I'm loving my life, and I don't care what I had to do to get here. I had to do what I had to do. I found something that works for me, and I'll be damned if I'm going to give it up because the FDA says I should.
It's 11 months since I started my last round of IVs. And now I feel it's safe to plan my One Year Sans IVs party. I'm celebrating my life, the people I love, and the amazing drug that helped me beyond my imagination.
Here's to Mannitol - my wonder drug.
Last summer I decided I would participate in two different clinical trials - one for inhaled powdered Cipro, and the other for inhaled powdered Mannitol. I did the Cipro study first. It was a month long and I had to show up for PFTs and check-ups every week, but it was only a month. No. Big. Deal. The next study was going to be more challenging and taxing. Remember, I had agreed to babysit more regularly starting in August, and I was loving the babysitting. I even did some babysitting where I had to take my afternoon IV dose with me. That was a rough week. Actually a rough two weeks. I did IVs for the first time all by myself - with no help from anyone. I did the IVs at the end of the Cipro study, so I had to wait to start the Mannitol study.
The Mannitol Study. Let me start off by explaining what Mannitol is. It is FDA approved for other uses. They use it IV to reduce brain swelling. Most chewing gum is coated in powdered Mannitol. It is not illegal to own Mannitol (I found food-grade Mannitol on the internet and they sell it by the pound). This study is to approve a different use for Mannitol. In this study, powdered Mannitol is inhaled into the lungs via capsules put into an inhaler. The study was a year-long commitment. In the first 6 months you would either have the drug or a placebo. The second 6 months is what they call "open label," meaning everyone has the drug.
I didn't think this would be a huge commitment. Inhale 10 capsules twice a day for a year. All for the sake of science and my health. Note the second part of that sentence. I participate in studies for the selfish reason of benefiting my own health in addition to doing it for science and to help other patients.
When I got into the study, I realized it was going to be a MUCH bigger commitment than I originally thought. Mainly because of the JOURNAL. This was going to be the JOURNAL FROM HELL. In all honesty, I was going to be lazy about it. They wanted you to record ALL symptoms - colds, sinus stuff, sprained ankles, etc. I really wanted to say, "Stubbing my toe at least once a week is in NO WAY related to your study." But I agreed. Then I was told to record all doctors visits, all nurse visits (remember I have a daily nurse who does manual chest PT for me), and every time you pick up medication at the pharmacy. I thought this was ridiculous. I try to limit my pharmacy trips to once a week - but it's sometimes more. I honestly thought I was going to spend most of my free time filling out that journal and I would never again blog or write in my personal journal. I wasn't enthusiastic about the JOURNAL FROM HELL, but I agreed.
For the study, they have you do a tolerance test to see if you can handle the drug. It involved lots of PFTs and taking the medication. One half hour after I took the medication my PFTs (lung function tests) had improved more than 10%. TEN PERCENT. I hadn't seen numbers that high in years. It was unbelievable. So I agreed to do the first 6 months not knowing whether or not I had the drug just so I could get to the second 6 months to have the drug!
A week after the tolerance test I was double-blinded and given my stuff. Again, PFTs were done with your substance, and then for the 30 minutes after the test I had to collect all the sputum I coughed up. Both times I did PFTs - with the tolerance test and the first dose of 'Mannitol' - I coughed really hard. I also coughed up tons of gunk. The second time I collected all this gunk and it filled a sputum cup half full. Completely gross. I wish I had taken photos so I could show you the complete gross-ness of this sputum cup. I knew I had the drug because of the way I coughed and because my lung functions again went up more than 10% in 30 minutes. I knew I was holding onto a miracle drug. I just didn't know how much trouble it would cause me.
I did exactly three doses of Mannitol as I was supposed to - 10 capsules twice a day. I woke at 6am on Saturday with a cough I couldn't get rid of. This was the hardest I had ever coughed (saying a lot for a CFer... I pretty much cough for a living!). My lungs ached and the muscles in my chest and abs were quivering from working so hard. I tried everything to sooth the cough because I wanted so badly to continue with the study. Cough drops. Eating. Drinking water. Sitting in a steamed bathroom. Doing all at the same time. And nothing worked. After six hours I finally gave in and took cough syrup with codeine in it, which finally soothed my cough. But I knew I couldn't take the Mannitol the way I had been instructed to.
I couldn't believe the cough. It's hard for me to put into words how horrible and how strong the coughing was. My upstairs neighbor came down several times and knocked on my door... and I was coughing too hard to answer. Finally I checked the door and there was a small blue Post-It that read, "Please turn down your sub woofers. It's shaking our walls." I had nothing playing because I was trying to calm my cough. My cough was shaking the walls in a concrete building. Lovely.
Since I couldn't tolerate the drug the way I was supposed to take it I had to drop out of the study - which means you need to return the un-used drug. But I read through the papers I had signed, and no where did it say I was required to return the medication. I bet they've revised study documents now, but nothing I signed said I had to give it back - so I didn't. Actually, I waited a month or two to even tell them I was dropping out of the study. Because I needed this drug. I needed to make it work for me. I couldn't give up the lung function percentage that it was giving me. My lungs will never be completely at full capacity because I have scarring, but I want them to be the best they can be.
Before I told them I was dropping out of the study I played around with dosing. First, fewer capsules twice a day. That was too much - the horrible cough continued. Then once a day, every other day, once a week, and finally I settled on 6-8 capsules once every two weeks. That's a big difference from 10 capsules twice a day. But my lung functions maintained. And even more importantly - I FELT AWESOME.
I told my study coordinator I was dropping out of the study and I refused to return the medication. She was furious with me. We had several long circular conversations where she tried to convince me I needed to return the medication, and I tried to convince her I needed to keep it. I told her I'm fighting for my health - for my life. It was time for another hospitalization, and I wasn't even close to needing IVs yet. At one point she said, "I understand..." and I interrupted with, "No. You. Don't. When was the last time you had to spend two weeks in the hospital for IV antibiotics that damage your kidneys, liver, and cause hearing loss? I am fighting for my life - the right to have a more normal life, and if this medication keeps me out of the hospital for even 6 months at a time, I am going to keep doing what I'm doing. Because 6 months without IVs is better than having to do them every 3 months."
After that, she stopped calling. They sent a certified letter, which I refused. I knew that was all the action they could take against me.
I knew I was on my own. I felt black-listed. I knew my research coordinator was talking about me to other research coordinators (I have a friend who works in the department and overheard these conversations). At one point she said, "Well, you know, her father is a psychiatrist and she's on a lot of psych meds." THAT pissed me off. I understand that I complicated her job and that I was a pain in the ass - but to call me crazy, and to bring my father into it is INSANE. The fact that my father is a psychiatrist has NOTHING to do with the fact that I have PTSD, Depression and Anxiety. See my little blogging profile - those aren't related to my CF. Anyways, that pretty much ended any desire I had to explain myself to her - or to have anything to do with that CF clinic. I just assume that the doctor who was in charge of the study (who is/was my CF doc in my town), isn't my biggest fan.
So now the months are flying by - I reach 6 months without IVs... 7, 8, 9... and I finally decide I need to see a CF doc and finally see if my lungs are maintaining number-wise. I was healthy - I AM healthy, but I wanted the numbers to prove it. So I make an appointment at a clinic 2 hours away, and yes, my numbers are maintaining.
The same week I went to the far away clinic, I went to a CF Adult Group meeting. There a couple people criticized me. I was told I could go to jail, I might as well have a ton of pot in my house, that I'm selfish to 'ruin' the study. And at first I cried. I even wrote about it here - why I'm scared to write about the Mannitol. And now none of that matters to me. The opinion of those CFers can't matter to me - because I am taking care of myself the best I know how.
I am living my life, I'm loving my life, and I don't care what I had to do to get here. I had to do what I had to do. I found something that works for me, and I'll be damned if I'm going to give it up because the FDA says I should.
It's 11 months since I started my last round of IVs. And now I feel it's safe to plan my One Year Sans IVs party. I'm celebrating my life, the people I love, and the amazing drug that helped me beyond my imagination.
Here's to Mannitol - my wonder drug.
Comments
I think the researchers acted very poorly. To talk about you like that is extremely unprofessional. Honestly, I wouldn't fund such researchers.
These studies should always provide the drug to everyone, as they had it set up. If you needed to drop out, it should suffice to just call in and say you're done. You were going to get a buttload of the drug for the second part anyway, so why should they care?
There's a greater moral part of this story - what do you do when you're life is on the line? I would have done the same thing. No one was harmed by what you did, other than some numbers in a study and some researchers getting their nickers in a bind. I'm all for research, but you have to make some exceptions when the experiment is helping to save someone's life.
It sounds like you're doing well though. 11 months since IV's is great! I hope you can keep going longer. Good luck!