Guest guest Posted January 16, 2006 Report Share Posted January 16, 2006 A booklet given to me by my doctor and put out by Xolair manufacturers states that " In clinical studies, 0.5% of patients receiving XOLAIR developed cancer, compared with 0.2% of patients receiving placebo injections. Several different types were seen. Please discuss this information with your doctor. " That is 5 in 1,000 vs 2 in 1,000. Clinical trials are double-blind, so neither the patient nor the tester knows who is getting the medicine vs the placebo. You have to decide if the benefit of the medicine is worth the very small increased danger of getting cancer. Carol My doctor told me that cancer patients were used during the trials and that is why cancer came up as a side effect.... Sharon Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 17, 2006 Report Share Posted January 17, 2006 I've seen the same information you're describing, Carol. But I did do a search after someone else on this website said that the numerical differences seen during the initial study were not statistically significant and I found the statement from a Federal Drug Administration committee saying exactly that. The clinical study I'll be participating in is different from the clinical trials that are done to get new drugs approved. This study will not be double-blind, in fact will not have a blind arm at all, meaning all patients who want Xolair will receive Xolair only, never a placebo. The purpose as described to me is for the company that makes Xolair, Genentech, to see over a very long time (years) in a very large number of patients (much larger than the original cliical trials) whether there is any increase in number of cases of cancer compared to the general population. The numbers and time course in the study would make any differences seen more statistically valid than the original clinical trials. I don't know yet where the comparison group of people not on Xolair is coming from. I'm guessing Genentech wants to prove the safety of Xolair even more conclusively, to decrease the chance of a successful lawsuit by someone on Xolair who happens to develop cancer - sorry to be such a cynic, but that kind of stuff is what motivates some studies by pharmaceutical companies. Patients will not receive Xolair free - it still has to be paid for by Medicare or other insurance or the patient. Cancer patients would not have been used in the clinical trial but perhaps your doctor meant that the patients who were diagnosed with cancer during the study may have had unsuspected cancer (without symptoms) when the study started, with symptoms only appearing as the study progressed but not really because of Xolair itself. Thanks to everyone for your input. Fran > > A booklet given to me by my doctor and put out by Xolair manufacturers states that " In clinical studies, 0.5% of patients receiving XOLAIR developed cancer, compared with 0.2% of patients receiving placebo injections. Several different types were seen. Please discuss this information with your doctor. " That is 5 in 1,000 vs 2 in 1,000. > Clinical trials are double-blind, so neither the patient nor the tester knows who is getting the medicine vs the placebo. > You have to decide if the benefit of the medicine is worth the very small increased danger of getting cancer. > Carol > > My doctor told me that cancer patients were used during the trials and that > is why cancer came up as a side effect.... Sharon > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 17, 2006 Report Share Posted January 17, 2006 Fran, Glad to hear Genentech continues to practice responsible science. If you don't mind, please keep the group posted on anything you learn from the study that you're participating in. Take care, Addy Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 17, 2006 Report Share Posted January 17, 2006 Just a side note with regard to using cancer patients for the study. I was asked to participate in the long term study of the relationship between Xolair and cancer. One of the screening questions was if you have had ANY cancer ever diagnosed. I had a couple places of basel cell on my chest; therefore, I could not participate in the study. I guess a lot would depend on the honesty of the participant, and whether they know if they even had cancer prior to dtarting Xolair. Whether to take Xolair, or not, was a no brainer for me. I was able to reduce the number and dosage of other medications, and feel significantly better on Xolair. The cancer question came out after I had been on Xolair for quite awhile due to participating in approval studies. IMHO, the side effets of corticosteroids is more to worry about than the side effects of Xolair...at this point in time. JF > > I've seen the same information you're describing, Carol. But I did do > a search after someone else on this website said that the numerical > differences seen during the initial study were not statistically > significant and I found the statement from a Federal Drug > Administration committee saying exactly that. > > The clinical study I'll be participating in is different from the > clinical trials that are done to get new drugs approved. This study > will not be double-blind, in fact will not have a blind arm at all, > meaning all patients who want Xolair will receive Xolair only, never a > placebo. The purpose as described to me is for the company that makes > Xolair, Genentech, to see over a very long time (years) in a very > large number of patients (much larger than the original cliical > trials) whether there is any increase in number of cases of cancer > compared to the general population. The numbers and time course in the > study would make any differences seen more statistically valid than > the original clinical trials. I don't know yet where the comparison > group of people not on Xolair is coming from. I'm guessing Genentech > wants to prove the safety of Xolair even more conclusively, to > decrease the chance of a successful lawsuit by someone on Xolair who > happens to develop cancer - sorry to be such a cynic, but that kind of > stuff is what motivates some studies by pharmaceutical companies. > > Patients will not receive Xolair free - it still has to be paid for by > Medicare or other insurance or the patient. > > Cancer patients would not have been used in the clinical trial but > perhaps your doctor meant that the patients who were diagnosed with > cancer during the study may have had unsuspected cancer (without > symptoms) when the study started, with symptoms only appearing as the > study progressed but not really because of Xolair itself. > > Thanks to everyone for your input. > Fran > > > > > > --- In , " Carol Corley " <mybouvs@m...> wrote: > > > > A booklet given to me by my doctor and put out by Xolair > manufacturers states that " In clinical studies, 0.5% of patients > receiving XOLAIR developed cancer, compared with 0.2% of patients > receiving placebo injections. Several different types were seen. > Please discuss this information with your doctor. " That is 5 in 1,000 > vs 2 in 1,000. > > Clinical trials are double-blind, so neither the patient nor the > tester knows who is getting the medicine vs the placebo. > > You have to decide if the benefit of the medicine is worth the very > small increased danger of getting cancer. > > Carol > > > > My doctor told me that cancer patients were used during the trials > and that > > is why cancer came up as a side effect.... Sharon > > > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 17, 2006 Report Share Posted January 17, 2006 I hope they're also excluding people in the control group who've had a few basal cells. Meryl Just a side note with regard to using cancer patients for the study. I was asked to participate in the long term study of the relationship between Xolair and cancer. One of the screening questions was if you have had ANY cancer ever diagnosed. I had a couple places of basel cell on my chest; therefore, I could not participate in the study. I guess a lot would depend on the honesty of the participant, and whether they know if they even had cancer prior to dtarting Xolair. Whether to take Xolair, or not, was a no brainer for me. I was able to reduce the number and dosage of other medications, and feel significantly better on Xolair. The cancer question came out after I had been on Xolair for quite awhile due to participating in approval studies. IMHO, the side effets of corticosteroids is more to worry about than the side effects of Xolair...at this point in time. JF > > I've seen the same information you're describing, Carol. But I did do > a search after someone else on this website said that the numerical > differences seen during the initial study were not statistically > significant and I found the statement from a Federal Drug > Administration committee saying exactly that. > > The clinical study I'll be participating in is different from the > clinical trials that are done to get new drugs approved. This study > will not be double-blind, in fact will not have a blind arm at all, > meaning all patients who want Xolair will receive Xolair only, never a > placebo. The purpose as described to me is for the company that makes > Xolair, Genentech, to see over a very long time (years) in a very > large number of patients (much larger than the original cliical > trials) whether there is any increase in number of cases of cancer > compared to the general population. The numbers and time course in the > study would make any differences seen more statistically valid than > the original clinical trials. I don't know yet where the comparison > group of people not on Xolair is coming from. I'm guessing Genentech > wants to prove the safety of Xolair even more conclusively, to > decrease the chance of a successful lawsuit by someone on Xolair who > happens to develop cancer - sorry to be such a cynic, but that kind of > stuff is what motivates some studies by pharmaceutical companies. > > Patients will not receive Xolair free - it still has to be paid for by > Medicare or other insurance or the patient. > > Cancer patients would not have been used in the clinical trial but > perhaps your doctor meant that the patients who were diagnosed with > cancer during the study may have had unsuspected cancer (without > symptoms) when the study started, with symptoms only appearing as the > study progressed but not really because of Xolair itself. > > Thanks to everyone for your input. > Fran > > > > > > --- In , " Carol Corley " <mybouvs@m...> wrote: > > > > A booklet given to me by my doctor and put out by Xolair > manufacturers states that " In clinical studies, 0.5% of patients > receiving XOLAIR developed cancer, compared with 0.2% of patients > receiving placebo injections. Several different types were seen. > Please discuss this information with your doctor. " That is 5 in 1,000 > vs 2 in 1,000. > > Clinical trials are double-blind, so neither the patient nor the > tester knows who is getting the medicine vs the placebo. > > You have to decide if the benefit of the medicine is worth the very > small increased danger of getting cancer. > > Carol > > > > My doctor told me that cancer patients were used during the trials > and that > > is why cancer came up as a side effect.... Sharon > > > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 18, 2006 Report Share Posted January 18, 2006 Will do - Fran -- In , " pyle456 " <coachmac@w...> wrote: > > Fran, > > Glad to hear Genentech continues to practice responsible science. If > you don't mind, please keep the group posted on anything you learn > from the study that you're participating in. > > Take care, > > Addy > Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.