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Female, 56, Lebanon - OR, member since May 2006
"I never met a doctor I didn't love to hate." "Don't tell me I'm too old for rock and roll." The only thing I have left to do before I die happy is jeep-hike in New Zealand."...
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Tilting at windmills.....ones I paid for.
Mar 17, 2008 03:45PM
- 2 comments
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I submitted a document/petition to FDA today. Talk about a big hassle....I didn't even get to send it directly to the FDA. I had to go thru a web site called regulations.gov, which to me seems like a government way of creating another department, more pork, aaaggghh!
Okay, got that out of my system. I did get an official comment tracking number so I have something to reference when my comment/document gets lost. "Here's a number, now feel better while we act incompetent and lose it."
I ask in a nice way if the FDA would consider approval of Telaprevir for non-responders next year...the phase II data is good enough for them to do that. Telaprevir cannot be any worse than interferon and ribavarin and the FDA sure did approve those two quick enough. I shared with the FDA the incredible frustration of knowing, every minute of every day, that the virus was taking my liver from me and all the good docs in the universe can't stop it. One more good drug in the fight can only help...if only to get rid of that helpless look that doctors give me while they are telling me..."not much we can do right now, wait for new drugs". Man, I can't believe how much that pisses me off.
Anyway, I should feel better, but I don't think I do. I think I'm gonna think about this "communicating" thing with the FDA and maybe do it on a regular basis. Squeeky wheel.....
Willow
Okay, got that out of my system. I did get an official comment tracking number so I have something to reference when my comment/document gets lost. "Here's a number, now feel better while we act incompetent and lose it."
I ask in a nice way if the FDA would consider approval of Telaprevir for non-responders next year...the phase II data is good enough for them to do that. Telaprevir cannot be any worse than interferon and ribavarin and the FDA sure did approve those two quick enough. I shared with the FDA the incredible frustration of knowing, every minute of every day, that the virus was taking my liver from me and all the good docs in the universe can't stop it. One more good drug in the fight can only help...if only to get rid of that helpless look that doctors give me while they are telling me..."not much we can do right now, wait for new drugs". Man, I can't believe how much that pisses me off.
Anyway, I should feel better, but I don't think I do. I think I'm gonna think about this "communicating" thing with the FDA and maybe do it on a regular basis. Squeeky wheel.....
Willow
Willows, this is frijole (Kathy). I read your recent post on Telaprevir and linked back to your page and read this. I hope you have some success with this. I am going to request you be on my friend list. I like to keep in touch with fellow relapsers.
I am still in a position to wait. Had a biopsy in December and it was 1/1 still. Not any better than pre treatment, but not much worse, if any. Do you have time to wait? If I recall correctly you do not. I would like to know what your game plan is.
Kathy
I am still in a position to wait. Had a biopsy in December and it was 1/1 still. Not any better than pre treatment, but not much worse, if any. Do you have time to wait? If I recall correctly you do not. I would like to know what your game plan is.
Kathy
Kathy,
Well, my doctor figures I have time to wait, but not alot. I am stage 2/3, which is to say that there is cirhossis happening but the damage has to be more than 20% to be stage 3. But the decline is speeding up, so I'm on virtual pins and needles.....
You must know the feeling of waiting and waiting, even at stage 1....it gets pretty old sometimes. I get really frustrated...in my case, the damage isn't going to go away and I'm getting older! Now that I am on the down side of 50 (56), I'm beginning to fit about the worst profile one can have for re-treating. So I'm in a hurry for Telaprevir to be approved. Plus, I am so totally looking forward to the idea of only 24 weeks of interferon and ribavarin....I did okay for the first 24 weeks of SOC, but the last 24 weeks kicked my butt.
I went to my doctor last year after another biopsy with a great game plan, but he shot it down. He said I would only have about a 10% chance of success with retreating right now and he wanted me to stay rested, keep exercising and at the end of 2009, he and I would talk again about retreating either with Telaprevir or something like Alinia. So I'm in the waiting mode.
Sounds like you are too. Hope you can stay positive....I usually do, but when it comes to the FDA, I get a little cranky and begin to sound bitter. In general, I try to keep hope alive, stay up on the most current info about the new drugs and take care of myself. Hope you are having some luck doing the same. Enjoy your 1/1 status, good living and a good attitude, plus removing stress will keep you pretty healthy. Easier said than done for me tho!
Take care
Willows (Jackie)
Well, my doctor figures I have time to wait, but not alot. I am stage 2/3, which is to say that there is cirhossis happening but the damage has to be more than 20% to be stage 3. But the decline is speeding up, so I'm on virtual pins and needles.....
You must know the feeling of waiting and waiting, even at stage 1....it gets pretty old sometimes. I get really frustrated...in my case, the damage isn't going to go away and I'm getting older! Now that I am on the down side of 50 (56), I'm beginning to fit about the worst profile one can have for re-treating. So I'm in a hurry for Telaprevir to be approved. Plus, I am so totally looking forward to the idea of only 24 weeks of interferon and ribavarin....I did okay for the first 24 weeks of SOC, but the last 24 weeks kicked my butt.
I went to my doctor last year after another biopsy with a great game plan, but he shot it down. He said I would only have about a 10% chance of success with retreating right now and he wanted me to stay rested, keep exercising and at the end of 2009, he and I would talk again about retreating either with Telaprevir or something like Alinia. So I'm in the waiting mode.
Sounds like you are too. Hope you can stay positive....I usually do, but when it comes to the FDA, I get a little cranky and begin to sound bitter. In general, I try to keep hope alive, stay up on the most current info about the new drugs and take care of myself. Hope you are having some luck doing the same. Enjoy your 1/1 status, good living and a good attitude, plus removing stress will keep you pretty healthy. Easier said than done for me tho!
Take care
Willows (Jackie)
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