> Harvey, > How are you doing? Do you think the med is kicking in? I think it has > been a few weeks hasn't it?
> Thinking of you.
> Kelly
Ohhh, I keep getting into so much trouble with the program but I do feel better. A person is not suppose to change anything or take any new medicine or change the amounts of medicine a person takes. They want to know what there medicine is doing with my body and nothing else.
Ok,,,,ok,,, I understand that but I have this catch 22 that I deal with,,,,, prednisone. A person can not take 10 mg or more and be in the program. At the very start I was living on pred. and Naprosyn while I lived through 30 days of getting Enbril out of my system. I was taking 10 mg at the very start....only my RD kept me in. Then,,,, when I was feeling better,,, I lowered the pred to 7.5 because the more pred I take the worse my shingles are. The lady got soooo mad at me that I was nearly washed out again because I changed an amount of anything I take. I can take being chewed out as well as the next guy but she went on and on and on. I finally put my hand up and said,,,, I fully understand your point and nothing I could say would change the fact that I changed the amount of something I take,,,, can we move on now? The shots I take are a pretty big shot,,,,,two of them. It seemed to me that she gave them to me a little fast which hurts like hell. I asked her when I was going to be able to give myself my shots or shot. Her eyebrows went up and I thought she was going to start in on me again....LOL I just smiled at her and she said,,,, soon. I know that they are building up the medicine in my system but what I have not told them,,,,,,,, is that I have started to itch in my lower back like I did with Remicade. I think it will be OK when I cut back to one shot every two weeks. So it goes. Harv
> > Harvey, > > How are you doing? Do you think the med is kicking in? I think it has > > been a few weeks hasn't it?
> > Thinking of you.
> > Kelly
> Ohhh, I keep getting into so much trouble with the program but I do feel > better. A person is not suppose to change anything or take any new medicine > or change the amounts of medicine a person takes. They want to know what > there medicine is doing with my body and nothing else.
> Ok,,,,ok,,, I understand that but I have this catch 22 that I deal > with,,,,, prednisone. A person can not take 10 mg or more and be in the > program. At the very start I was living on pred. and Naprosyn while I > lived through 30 days of getting Enbril out of my system. I was taking 10 > mg at the very start....only my RD kept me in. Then,,,, when I was feeling > better,,, I lowered the pred to 7.5 because the more pred I take the worse > my shingles are. The lady got soooo mad at me that I was nearly washed out > again because I changed an amount of anything I take. I can take being > chewed out as well as the next guy but she went on and on and on. I > finally put my hand up and said,,,, I fully understand your point and > nothing I could say would change the fact that I changed the amount of > something I take,,,, can we move on now? > The shots I take are a pretty big shot,,,,,two of them. It seemed to > me that she gave them to me a little fast which hurts like hell. I asked > her when I was going to be able to give myself my shots or shot. Her > eyebrows went up and I thought she was going to start in on me again....LOL > I just smiled at her and she said,,,, soon. > I know that they are building up the medicine in my system but what I > have not told them,,,,,,,, is that I have started to itch in my lower back > like I did with Remicade. I think it will be OK when I cut back to one > shot every two weeks. So it goes. > Harv
Harv.
I wish you all the best with your new medication. Don't let the medical terrorists get to you. Some of them seem to delight in running other people's lives.
I wish you all the best with your new medication. Don't let the medical terrorists get to you. Some of them seem to delight in running other people's lives.
Peter
Wellllll, I know what you mean but I do not think so in this case. My RD has already told them that I only take enough medicine to control what I have and we can not act that way when dealing with a drug test program. Most people take exactly what they are told to take and thats it. I would too if we were trying to cure something. I am sorry to say that they are not going to cure a dam thing. Not when Enbrel just passed 1.3 billion this year. I will say that I did not get the kick of well being with Enbrel. That may not be fair to say that but it is the way I feel. Maybe getting chewed out really well was all the kick I am going to get. LOLOL Harv
Peter wrote: > I wish you all the best with your new medication. > Don't let the medical terrorists get to you. Some of them seem to > delight in running other people's lives.
I don't think they are being medical terrorists. It's a drug trial. Changes can invalidate the data.
From one who knows drug trials very well, Harve. In a trial, you are volunteering your body to test their drug, and the FDA is watching their every move. It HAS to be a controlled trial so certain protocols are set up. If participants don't follow the protocol, to the letter, the results of the trial will be invalidated. That can be disastrous to all involved in the trial and to all the patients waiting for a new drug for their disease. Drug companies spend billions of dollars investigating new drugs and they have to trust he results of any clinical trials they run. You are not in this trial for yourself, as much as I understand your own personal reason for being in the trial, your body belongs to the drug company and their trial. Harve, think about what the outcome can be if you don't follow the protocol. They can and will bump you out if you continue to violate the rules of the trial, then where will you be? Just be good, dear friend, and play fair with them and something will be learned from this trial, perhaps something very good that will help you and many, many others.
> I wish you all the best with your new medication. > Don't let the medical terrorists get to you. Some of them seem to > delight in running other people's lives.
> Peter
> Wellllll, I know what you mean but I do not think so in this case. My RD > has already told them that I only take enough medicine to control what I > have and we can not act that way when dealing with a drug test program. > Most people take exactly what they are told to take and thats it. > I would too if we were trying to cure something. I am sorry to say that > they are not going to cure a dam thing. Not when Enbrel just passed 1.3 > billion this year. > I will say that I did not get the kick of well being with Enbrel. That > may not be fair to say that but it is the way I feel. Maybe getting > chewed out really well was all the kick I am going to get. > LOLOL > Harv
I was just going to say the same thing. Also that side effect needs to be told about. For all you know others might be having the same thing, or it might be a sign of toxicity or something. You need to tell them even if you can ride it out it may be others cannot safely ride it out.
Just because the itching appears doesn't mean that it won't go away. Look at Kineret - everyone got the rash at a certain point and it does go away. They do need to know that though.
By you not following the protocol they risk the FDA pulling the test trial results. Just think where our meds we have would be if test trial results were pulled and the meds didn't get approved.
Harv for your sake and theirs you need to be honest, ask about med changes before you do it and follow their protocol. If you think you can't do it then please go back to your rd and find other options.
When Gloria volunteered for Enbrel and I volunteered for my drug trials the results were closely watched. Gloria helped with enbrel and without her trials perhaps it would never have gotten off the ground. Mine worked so well but between the economic expenses of the trial and the fact that so many others were in the same ballpark the study was dropped. Then I was in a partially paid trial for rituxan. This is over now but again helped to make the province I am in agree to pay in part for the med. This is huge!
It isn't just for their sake but for yours. They need to know that the shingles was getting worse with the extra prednisone and that the rash has continued. Please don't hold back information.
I do care as well. I am glad to hear though that you think it is working a little. The results I have seen from other sources says it is one of the promising ones. We still need some promising ones. There are still people that the meds we have now don't work on or stop working for them. What you are doing is very important to them but also hopefully important to your choices. More important though I worry that a change from the protocol or a hidden side effect (that doesn't necessarily kick you off the program - they just need to monitor) could be dangerous to you,
Kelly
"Gloria" <gloriasfi...@gmail.com> wrote in message
> From one who knows drug trials very well, Harve. In a trial, you are > volunteering your body to test their drug, and the FDA is watching their > every move. It HAS to be a controlled trial so certain protocols are set > up. If participants don't follow the protocol, to the letter, the results > of the trial will be invalidated. That can be disastrous to all involved > in the trial and to all the patients waiting for a new drug for their > disease. Drug companies spend billions of dollars investigating new drugs > and they have to trust he results of any clinical trials they run. You > are not in this trial for yourself, as much as I understand your own > personal reason for being in the trial, your body belongs to the drug > company and their trial. Harve, think about what the outcome can be if > you don't follow the protocol. They can and will bump you out if you > continue to violate the rules of the trial, then where will you be? Just > be good, dear friend, and play fair with them and something will be > learned from this trial, perhaps something very good that will help you > and many, many others.
>> I wish you all the best with your new medication. >> Don't let the medical terrorists get to you. Some of them seem to >> delight in running other people's lives.
>> Peter
>> Wellllll, I know what you mean but I do not think so in this case. My >> RD has already told them that I only take enough medicine to control what >> I have and we can not act that way when dealing with a drug test program. >> Most people take exactly what they are told to take and thats it. >> I would too if we were trying to cure something. I am sorry to say >> that they are not going to cure a dam thing. Not when Enbrel just >> passed 1.3 billion this year. >> I will say that I did not get the kick of well being with Enbrel. That >> may not be fair to say that but it is the way I feel. Maybe getting >> chewed out really well was all the kick I am going to get. >> LOLOL >> Harv
> > Harvey, > > How are you doing? Do you think the med is kicking in? I think it has > > been a few weeks hasn't it?
> > Thinking of you.
> > Kelly
> Ohhh, I keep getting into so much trouble with the program but I do feel > better. A person is not suppose to change anything or take any new medicine > or change the amounts of medicine a person takes. They want to know what > there medicine is doing with my body and nothing else.
> Ok,,,,ok,,, I understand that but I have this catch 22 that I deal > with,,,,, prednisone. A person can not take 10 mg or more and be in the > program. At the very start I was living on pred. and Naprosyn while I > lived through 30 days of getting Enbril out of my system. I was taking 10 > mg at the very start....only my RD kept me in. Then,,,, when I was feeling > better,,, I lowered the pred to 7.5 because the more pred I take the worse > my shingles are. The lady got soooo mad at me that I was nearly washed out > again because I changed an amount of anything I take. I can take being > chewed out as well as the next guy but she went on and on and on. I > finally put my hand up and said,,,, I fully understand your point and > nothing I could say would change the fact that I changed the amount of > something I take,,,, can we move on now? > The shots I take are a pretty big shot,,,,,two of them. It seemed to > me that she gave them to me a little fast which hurts like hell. I asked > her when I was going to be able to give myself my shots or shot. Her > eyebrows went up and I thought she was going to start in on me again....LOL > I just smiled at her and she said,,,, soon. > I know that they are building up the medicine in my system but what I > have not told them,,,,,,,, is that I have started to itch in my lower back > like I did with Remicade. I think it will be OK when I cut back to one > shot every two weeks. So it goes. > Harv
Best of luck with the med and with the people who give you the med.
> From one who knows drug trials very well, Harve. In a trial, you are > volunteering your body to test their drug, and the FDA is watching their > every move. It HAS to be a controlled trial so certain protocols are set > up. If participants don't follow the protocol, to the letter, the results > of the trial will be invalidated. That can be disastrous to all involved > in the trial and to all the patients waiting for a new drug for their > disease. Drug companies spend billions of dollars investigating new drugs > and they have to trust he results of any clinical trials they run. You > are not in this trial for yourself, as much as I understand your own > personal reason for being in the trial, your body belongs to the drug > company and their trial. Harve, think about what the outcome can be if > you don't follow the protocol. They can and will bump you out if you > continue to violate the rules of the trial, then where will you be? Just > be good, dear friend, and play fair with them and something will be > learned from this trial, perhaps something very good that will help you > and many, many others.
> Because I care, > Gloria
Back when,,,, You were in the Enbrel trials and did help to make a difference for many, many people. You were in it when it had not been OKed by the Gov. All of us that used Enbrel for many years have you and people like you to thank for what took place. In short,,, you are my hero. This drug has already been OKed by the gov. I am not taking the chance that you did. I am helping with the information if it works for me with all the years that I took Enbrel in the back ground or history. I understand what is taking place in the trials and will have no other changes in medicine. thanks Harv
>I was just going to say the same thing. Also that side effect needs to be >told about. For all you know others might be having the same thing, or it >might be a sign of toxicity or something. You need to tell them even if >you can ride it out it may be others cannot safely ride it out.
> Just because the itching appears doesn't mean that it won't go away. Look > at Kineret - everyone got the rash at a certain point and it does go away. > They do need to know that though.
> By you not following the protocol they risk the FDA pulling the test trial > results. Just think where our meds we have would be if test trial results > were pulled and the meds didn't get approved.
> Harv for your sake and theirs you need to be honest, ask about med changes > before you do it and follow their protocol. If you think you can't do it > then please go back to your rd and find other options.
> When Gloria volunteered for Enbrel and I volunteered for my drug trials > the results were closely watched. Gloria helped with enbrel and without > her trials perhaps it would never have gotten off the ground. Mine worked > so well but between the economic expenses of the trial and the fact that > so many others were in the same ballpark the study was dropped. Then I > was in a partially paid trial for rituxan. This is over now but again > helped to make the province I am in agree to pay in part for the med. > This is huge!
> It isn't just for their sake but for yours. They need to know that the > shingles was getting worse with the extra prednisone and that the rash has > continued. Please don't hold back information.
> I do care as well. I am glad to hear though that you think it is working > a little. The results I have seen from other sources says it is one of > the promising ones. We still need some promising ones. There are still > people that the meds we have now don't work on or stop working for them. > What you are doing is very important to them but also hopefully important > to your choices. More important though I worry that a change from the > protocol or a hidden side effect (that doesn't necessarily kick you off > the program - they just need to monitor) could be dangerous to you,
It has been okayed by the government but still can be of danger and side effects still need to be monitored - that is why the continued trials are needed. In phase 1, 2 and 3 there are still limited people taking the trial drugs and the interactions with other medications are understandably hard to tell. Once a drug is out in the public so to say there is a broader range of people, they are taking many different meds from those in the beginning trials. Therefore side effects that did not come out before initial approval by the government do come out.
For example my reaction with enbrel. neurological reactions and the tb reactions and the warnings as such were not released until way after after initial release as they didn't know about this. The arava problems were not discovered in huge amounts until after. Luckily arava was not pulled for this as it has been a valuable med that has helped others where other meds has not. What is taking place in your trials could make the fda still pull the med, could enable the drug company to say "do not take this med with....." or to get the drug company to put other valuable warnings such as the one for rituxan saying "pml has been associated with off label use for ......patients". Basically they are warnings - black box warnings.
Not saying any of this could happen but it could.
So yes you are taking chances with yourself and with others too. This is as important a med trial - the fda trials are not just to make work. They are there for a purpose.
> "Gloria" <gloriasfi...@gmail.com> wrote in message > news:h2l9sr$of8$1@news.eternal-september.org... >> From one who knows drug trials very well, Harve. In a trial, you are >> volunteering your body to test their drug, and the FDA is watching their >> every move. It HAS to be a controlled trial so certain protocols are set >> up. If participants don't follow the protocol, to the letter, the >> results of the trial will be invalidated. That can be disastrous to all >> involved in the trial and to all the patients waiting for a new drug for >> their disease. Drug companies spend billions of dollars investigating new >> drugs and they have to trust he results of any clinical trials they run. >> You are not in this trial for yourself, as much as I understand your own >> personal reason for being in the trial, your body belongs to the drug >> company and their trial. Harve, think about what the outcome can be if >> you don't follow the protocol. They can and will bump you out if you >> continue to violate the rules of the trial, then where will you be? Just >> be good, dear friend, and play fair with them and something will be >> learned from this trial, perhaps something very good that will help you >> and many, many others.
>> Because I care, >> Gloria
> Back when,,,, You were in the Enbrel trials and did help to make a > difference for many, many people. You were in it when it had not been > OKed by the Gov. All of us that used Enbrel for many years have you and > people like you to thank for what took place. In short,,, you are my > hero. > This drug has already been OKed by the gov. I am not taking the chance > that you did. I am helping with the information if it works for me with > all the years that I took Enbrel in the back ground or history. I > understand what is taking place in the trials and will have no other > changes in medicine. > thanks > Harv
Hooray for Harv. It certainly seems like old Fate wants to mess things up just when you get to feeling optimistic and that this time it's going to work! We're behind you, Harv.
> "Gloria" <gloriasfi...@gmail.com> wrote in message > news:h2l9sr$of8$1@news.eternal-september.org... >> From one who knows drug trials very well, Harve. In a trial, you are >> volunteering your body to test their drug, and the FDA is watching their >> every move. It HAS to be a controlled trial so certain protocols are set >> up. If participants don't follow the protocol, to the letter, the >> results of the trial will be invalidated. That can be disastrous to all >> involved in the trial and to all the patients waiting for a new drug for >> their disease. Drug companies spend billions of dollars investigating new >> drugs and they have to trust he results of any clinical trials they run. >> You are not in this trial for yourself, as much as I understand your own >> personal reason for being in the trial, your body belongs to the drug >> company and their trial. Harve, think about what the outcome can be if >> you don't follow the protocol. They can and will bump you out if you >> continue to violate the rules of the trial, then where will you be? Just >> be good, dear friend, and play fair with them and something will be >> learned from this trial, perhaps something very good that will help you >> and many, many others.
>> Because I care, >> Gloria
> Back when,,,, You were in the Enbrel trials and did help to make a > difference for many, many people. You were in it when it had not been > OKed by the Gov. All of us that used Enbrel for many years have you and > people like you to thank for what took place. In short,,, you are my > hero. > This drug has already been OKed by the gov. I am not taking the chance > that you did. I am helping with the information if it works for me with > all the years that I took Enbrel in the back ground or history. I > understand what is taking place in the trials and will have no other > changes in medicine. > thanks > Harv
I am glad to hear that you are feeling better. I know you still have a way to go but that is a plus to hear something is working for now to help out. I would think they would be happy that you lowered the dose so that they can see if the med they are giving you is doing any good.
> Ohhh, I keep getting into so much trouble with the program but I do feel > better. A person is not suppose to change anything or take any new > medicine or change the amounts of medicine a person takes. They want to > know what there medicine is doing with my body and nothing else.
> Ok,,,,ok,,, I understand that but I have this catch 22 that I deal > with,,,,, prednisone. A person can not take 10 mg or more and be in the > program. At the very start I was living on pred. and Naprosyn while I > lived through 30 days of getting Enbril out of my system. I was taking 10 > mg at the very start....only my RD kept me in. Then,,,, when I was > feeling better,,, I lowered the pred to 7.5 because the more pred I take > the worse my shingles are. The lady got soooo mad at me that I was > nearly washed out again because I changed an amount of anything I take. > I can take being chewed out as well as the next guy but she went on and on > and on. I finally put my hand up and said,,,, I fully understand your > point and nothing I could say would change the fact that I changed the > amount of something I take,,,, can we move on now? > The shots I take are a pretty big shot,,,,,two of them. It seemed to > me that she gave them to me a little fast which hurts like hell. I asked > her when I was going to be able to give myself my shots or shot. Her > eyebrows went up and I thought she was going to start in on me > again....LOL I just smiled at her and she said,,,, soon. > I know that they are building up the medicine in my system but what I > have not told them,,,,,,,, is that I have started to itch in my lower back > like I did with Remicade. I think it will be OK when I cut back to one > shot every two weeks. So it goes. > Harv
Harve, you've been a hero to me many times over. Thank you for your kind words and I admire your determination to keep 'doing what you gotta do' to fight this damned disease. You're a good man, dear friend.
> "Gloria" <gloriasfi...@gmail.com> wrote in message > news:h2l9sr$of8$1@news.eternal-september.org... >> From one who knows drug trials very well, Harve. In a trial, you are >> volunteering your body to test their drug, and the FDA is watching their >> every move. It HAS to be a controlled trial so certain protocols are set >> up. If participants don't follow the protocol, to the letter, the >> results of the trial will be invalidated. That can be disastrous to all >> involved in the trial and to all the patients waiting for a new drug for >> their disease. Drug companies spend billions of dollars investigating new >> drugs and they have to trust he results of any clinical trials they run. >> You are not in this trial for yourself, as much as I understand your own >> personal reason for being in the trial, your body belongs to the drug >> company and their trial. Harve, think about what the outcome can be if >> you don't follow the protocol. They can and will bump you out if you >> continue to violate the rules of the trial, then where will you be? Just >> be good, dear friend, and play fair with them and something will be >> learned from this trial, perhaps something very good that will help you >> and many, many others.
>> Because I care, >> Gloria
> Back when,,,, You were in the Enbrel trials and did help to make a > difference for many, many people. You were in it when it had not been > OKed by the Gov. All of us that used Enbrel for many years have you and > people like you to thank for what took place. In short,,, you are my > hero. > This drug has already been OKed by the gov. I am not taking the chance > that you did. I am helping with the information if it works for me with > all the years that I took Enbrel in the back ground or history. I > understand what is taking place in the trials and will have no other > changes in medicine. > thanks > Harv
> I am glad to hear that you are feeling better. I know you still have a way > to go but that is a plus to hear something is working for now to help out. > I would think they would be happy that you lowered the dose so that they > can see if the med they are giving you is doing any good.
> -- > Love and hugs to all > Love Squirrely Jo
Hi Squirrely Jo,
Changing the dose of something like pred preceding the actual start of the trial and especially during the trial, can give false results of what the trial drug is doing. For instance, if a participant starts a drug like pred just prior to the trial and has good results in his RA condition in the trial, it is the pred and not the study drug that caused the improvement, but the improvement would be credited to the study drug. Same thing if one is on pred and lowers the dose during the trial, and they worsen, then the result would be falsely reported as to the study drug not working as well. When I started in the Enbrel trial, I had to keep my current dose of pred, that I was already on, the exact same all through the trial. I was trying to come off the 10 mg of pred that I had been sustained on for 2 years prior to the study coming along, due to side effects. I was down to 3 mg. when I was given the opportunity to participate in the Enbrel trial. That dose had to remain the same throughout all the qualifying questions and exams by the study coordinators and during the complete time period of the trial. Everything has to be controlled like that in order to get clear results. The drug companies are ticky, ticky, ticky, but they HAVE to be or else we would have drugs being approved that weren't investigated as thoroughly as they should be and the FDA would come down very hard on any company that did not show a stellar, fully participant compliant trial result. What Harve is doing is extremely important and I admire him for doing this. Harve is a good man and one of our best! I wish him all the best in this important trial.
On 7/4/2009 10:39 AM, gloriasfi...@gmail.com wrote to All:
I agree with your comments, Gloria. A good man. Gloria Nanny
-> Harve, you've been a hero to me many times over. Thank you for your kind -> words and I admire your determination to keep 'doing what you gotta do' to -> fight this damned disease. You're a good man, dear friend. -> -> Take care, -> Gloria -> -> "Harvey R. Stone" <hrst...@swbell.net> wrote in message -> news:NLr3m.3644$Jb1.909@flpi144.ffdc.sbc.com... -> > -> > "Gloria" <gloriasfi...@gmail.com> wrote in message -> > news:h2l9sr$of8$1@news.eternal-september.org... -> >> From one who knows drug trials very well, Harve. In a trial, you are -> >> volunteering your body to test their drug, and the FDA is watching their -> >> every move. It HAS to be a controlled trial so certain protocols are set -> >> up. If participants don't follow the protocol, to the letter, the -> >> results of the trial will be invalidated. That can be disastrous to all -> >> involved in the trial and to all the patients waiting for a new drug for -> >> their disease. Drug companies spend billions of dollars investigating new -> >> drugs and they have to trust he results of any clinical trials they run. -> >> You are not in this trial for yourself, as much as I understand your own -> >> personal reason for being in the trial, your body belongs to the drug -> >> company and their trial. Harve, think about what the outcome can be if -> >> you don't follow the protocol. They can and will bump you out if you -> >> continue to violate the rules of the trial, then where will you be? Just -> >> be good, dear friend, and play fair with them and something will be -> >> learned from this trial, perhaps something very good that will help you -> >> and many, many others. -> >> -> >> Because I care, -> >> Gloria -> > -> > Back when,,,, You were in the Enbrel trials and did help to make a -> > difference for many, many people. You were in it when it had not been -> > OKed by the Gov. All of us that used Enbrel for many years have you and -> > people like you to thank for what took place. In short,,, you are my -> > hero. -> > This drug has already been OKed by the gov. I am not taking the chance -> > that you did. I am helping with the information if it works for me with -> > all the years that I took Enbrel in the back ground or history. I -> > understand what is taking place in the trials and will have no other -> > changes in medicine. -> > thanks -> > Harv -> > -> ->
|
