Aa
Really need Info
Let me recap real quick, my study dose not alowe rescuse meds untill we stop vx at the end of week 12, Sunday is the end for me. Monday I go to study nurse for blood and more meds, I know I am not in group D which stops all meds at week 12, so I either have 12 more weeks of meds or 24 more weeks. My riba started at 1200mg cut in half at week 3 for low hbg, so I think I should start procrit so I can go back up on my riba for my remaining time. Who knows I may be on placebo!! and vx has no track record let! I need to do what is best for me and my health. Now my problem my DR will not give me procrit, told me I do not need it my hbg is 9.5, but I feel o.k. I showed Jim a paper (study) my DR wrote that said after you become und lowering riba will not hurt chances for svr, I hope you remember that paper Jim. Shoud I demaned procrit?? or should I just keep going like I am?? I KNOW vertex and all of our study nurse's read this site , My nurse, PDS nurse and MRE, Dr all got a letter about this site and the vx lab rats that post, I have been a good patinet, But should I put my foot down now?? I tried to get a pcr at week 4, was told no, so I had one done at week 11, I know that will not tell me placebo or soc BUT I did not want to go to week 20 and not know,sorry jen, I will find out my pcr today. What would you do. Thanks Pam
Thanks for that. Pam is going to be delighted that you found those references. She actually has met directly with him about this and, according to her, he flat out told her that he doesn't believe it's necessary to raise the ribavirin once a person has become undedected. According to protocol of the study, that makes no sense because he shouldn't know if she is undedected. Only the third party administrator, Dr. Andrew Muir, at Duke University should be privy to that information.
Dr. Shiffman, as well as her study nurse have been telling Pam all along that she would be unblinded at 12 weeks, which is incorrect information. The study only unblinds one group at 12 weeks, the 12 week group. The rest of us have to wait until 20 weeks. They were so insistant about that point that I speculated that perhaps Dr. Shiffman knew which group she was in. I thought perhaps he had requested an early unblinding before he dropped her riba at week 3. I thought the reason he was dead set against procrit is that he knew perhaps she was in the 12 week group and was coming off of all study drugs at week 12, therefore he didn't want to bother with all of the pre-authorization business that goes on to get Procrit through private insurance. None of this makes much sense and as it turns out, none of the speculations are true. They were just giving her misinformation as to the unblinding period and I have no idea why Dr. Shiffman won't prescribe Procrit. Pam puts me on the phone quite often when she calls her study nurse and I frankly am a little appalled by the unprofessionalism and misinformation that is being dispensed. And, I do know the correct info because I'm in the study, as well as others throughout the country. The whole thing is very odd, imo.
Dr. Shiffman, as well as her study nurse have been telling Pam all along that she would be unblinded at 12 weeks, which is incorrect information. The study only unblinds one group at 12 weeks, the 12 week group. The rest of us have to wait until 20 weeks. They were so insistant about that point that I speculated that perhaps Dr. Shiffman knew which group she was in. I thought perhaps he had requested an early unblinding before he dropped her riba at week 3. I thought the reason he was dead set against procrit is that he knew perhaps she was in the 12 week group and was coming off of all study drugs at week 12, therefore he didn't want to bother with all of the pre-authorization business that goes on to get Procrit through private insurance. None of this makes much sense and as it turns out, none of the speculations are true. They were just giving her misinformation as to the unblinding period and I have no idea why Dr. Shiffman won't prescribe Procrit. Pam puts me on the phone quite often when she calls her study nurse and I frankly am a little appalled by the unprofessionalism and misinformation that is being dispensed. And, I do know the correct info because I'm in the study, as well as others throughout the country. The whole thing is very odd, imo.
Found the paper from the link PLN posted on 10/2.
http://www.ccjm.org/PDFFILES/hepadshiffman.pdf
Page 3, reads in part:
DOSE REDUCTION: Reducing the dose of ribavirn especially during the first 12 to 24 weeks of tx impairs the abiity of patients with HCV genotype 1 to achieve SVR...In contrast, patients in whom the dowe of either of these meds was reduced after week 12 had a smaller decline in SVR rates.....In contrast, reducing the dose of ribavirin after HCV RNA levels already have become undetectible appears to have little effect on SVR rates.
--------------------------------------
So there it is, the last sentence. Assuming he's still referring to the first 12 weeks of treatment, I'd have a couple of questions. First, how does he know that PLN was non-detectible when the riba was reduced since this is a blinded study? And second, what exacttly is "appears" based on. Unlike many of his other statements, I could find no footnotes for this. Personally, I'd like to see study data supporting the statement and then see how the study data profile pares up to the PLN's profile.
It's quite obvious at this point that Shiffman is no neophyte in terms of riba/epo/SVR, etc, but for me more answers/explanations would be needed. Also, consider a quick second consult with someone else at his level like a Dieterich, Afdhal or Jacbosen.
Wish I could be more helpful.
-- Jim
http://www.ccjm.org/PDFFILES/hepadshiffman.pdf
Page 3, reads in part:
DOSE REDUCTION: Reducing the dose of ribavirn especially during the first 12 to 24 weeks of tx impairs the abiity of patients with HCV genotype 1 to achieve SVR...In contrast, patients in whom the dowe of either of these meds was reduced after week 12 had a smaller decline in SVR rates.....In contrast, reducing the dose of ribavirin after HCV RNA levels already have become undetectible appears to have little effect on SVR rates.
--------------------------------------
So there it is, the last sentence. Assuming he's still referring to the first 12 weeks of treatment, I'd have a couple of questions. First, how does he know that PLN was non-detectible when the riba was reduced since this is a blinded study? And second, what exacttly is "appears" based on. Unlike many of his other statements, I could find no footnotes for this. Personally, I'd like to see study data supporting the statement and then see how the study data profile pares up to the PLN's profile.
It's quite obvious at this point that Shiffman is no neophyte in terms of riba/epo/SVR, etc, but for me more answers/explanations would be needed. Also, consider a quick second consult with someone else at his level like a Dieterich, Afdhal or Jacbosen.
Wish I could be more helpful.
-- Jim
Of course the doctors are right that Procrit carries its own risks. All drugs do. The most important thing (to me) if Procrit is prescribed is weekly CBCs (I posted mine below on the thread started by pds, I think, a few below this one).
They don't want the hemoglobin to rise more than 2 points in a week. It could endanger the heart. Thickens the blood. I would have to read the insert with the rx to really discuss this intelligently and I don't have it here.
Still, under the proper care, it is the best thing round to allow us on full dose medications to increase our chance at SVR.
They don't want the hemoglobin to rise more than 2 points in a week. It could endanger the heart. Thickens the blood. I would have to read the insert with the rx to really discuss this intelligently and I don't have it here.
Still, under the proper care, it is the best thing round to allow us on full dose medications to increase our chance at SVR.
Yes, it does get odder and odder. Like you say, how do we know she is non-detected or even in the VX-950 group? The other thing, Shiffman's point of view -- which we haven't seen the source -- wasn't based on being non-detectible with VX-950 -- so this could cloud the picture as well.
If it were me, I'd first try and find out how Shiffman knows that I was non-detectible as the study is supposedly blinded-- second, ask for the study that backs up his position (plus querry him on the VX950 angle above)-- and, third, get on a plane or train and bounce the whole thing off someone else in his league like the doctors previously mentioned. Alternatively, she could do what most folks do and that is simply listen to their doctors and cross their fingers. A lot easier, but not a path chosen by all here :)
-- Jim
If it were me, I'd first try and find out how Shiffman knows that I was non-detectible as the study is supposedly blinded-- second, ask for the study that backs up his position (plus querry him on the VX950 angle above)-- and, third, get on a plane or train and bounce the whole thing off someone else in his league like the doctors previously mentioned. Alternatively, she could do what most folks do and that is simply listen to their doctors and cross their fingers. A lot easier, but not a path chosen by all here :)
-- Jim
Wow what a headache. I mean as if all this hoo ha we've all had to go through isn't enough, you gotta put up with this nonsense. The criteria as spelled out to me prior to enrolling in the trial is simply that (1) rescue drugs are precluded for the first 12 weeks only and (2) they ARE available after that as needed - PERIOD! They are definitely NOT absolutely precluded in the trial protocol guidelines. And there's no way they have a "moving standard" from study group to study group either. The standard and rules are the same for all groups, obviously. I'm sure Dr Schiffman, as all of the study doctors, have their own powers of discretion concerning the individualized management of the care of their patients based on each paitent's specific criteria. And of course that's appropriate and even necessary. But I absolutely do NOT believe he can flatly dictate to you that you cannot have procrit which effectively enforces an ongoing half dosing of riba. The only way he could do that is if there was some outstanding condition that indicated the procrit would be a danger to your health or was in some way contraindicated. But that's not the case, right?? You don't have any special health concerns that preclude the use of procrit, right? He hasn't stated that right? If not, then I would simply sit down with Dr Schiffman, tell him you are going to get the procrit outside of the study and that you wish to increase your riba once the hemo elevates. You want him to work with you on your decision and ensure he's onboard with it and that he isn't going to attempt to have you dropped from the study for doing so. Legally and ethically he cannot drop you from the study for doing so. That would be in violation of the agreed upon contract, so I'm sure he'll understand and concede to your wishes if push comes to shove. Just because we are enrolled in this study we are not precluded from seeking medical care elsewhere, that's just a simple fact. And you receiving the procrit after the initial 12 weeks is NOT in violation of the study protocol. Therefore, he cannot terminate you from the study for doing so, end of story.
Pam, be assertive and firm. Communicate to him what you want to do, and get his assurance he will work with you on your decision. Get him to openly commit to you that he will not attempt to discontinue you for doing so. If he refuses and/or implies he will attempt to discontinue...well, that's when the next level has to be taken. No need to discuss that option unless it comes to that, which I seriously doubt it would. Good luck, hang in there it'll all work out.
Pam, be assertive and firm. Communicate to him what you want to do, and get his assurance he will work with you on your decision. Get him to openly commit to you that he will not attempt to discontinue you for doing so. If he refuses and/or implies he will attempt to discontinue...well, that's when the next level has to be taken. No need to discuss that option unless it comes to that, which I seriously doubt it would. Good luck, hang in there it'll all work out.
I think adding "Shiffman" changes the equation somewhat. The problem doesn't seem to be the protocol's but Shiffman's own take on Epo intervention as discussed earlier. It sounds like PLN will either have have to get Shiffman to re-evaluate his opinion based on things previously discussed; accede to patients wishes regardless of his opinion; or switch doctors. What Shiffman appears to be saying is that full-dose riba isn't necessary after someone is non-detectible and for some reason he's assuming that PLN is/was non-detectible even though the study is blinded.
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