Tuned down for receiving dex.

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Sequoia

Senior member
Joined
Sep 19, 2010
Messages
841
Reason
PALS
Diagnosis
08/2010
Country
US
State
Washington
City
Seattle
I AM SO ANGRY! i RECEIVED THIS LETTER FROM THE DEX TRIAL COORDINATOR:

Hi Sharon,
Hope all is well with you. I believe the home nurse will be visiting you this Saturday, Sept 22nd for the end of study visit for the Biogen study. Unfortunately this will be your final visit for the study. I know that you were very much interested in participating in the Extension study, wherein you would have received the dexapramipexole study drug, but we cannot enroll you into this new study for 2 reasons.

The first reason is that our IRB (which is the board that is designed to protect the rights and welfare of research subjects) were not in favor of letting our site enroll a subject into an investigational drug study who is no longer able to travel to our site. They discussed your case at great lengths at their last board meeting and the chairman just recently made the decision that we could not enroll you into the extension study.

The second reason is that the sponsor, Biogen, recently indicated that we can no longer obtain the ALSFRS-R QUESTIONNAIRE via email. Since they no longer allow us to complete the questionnaire via email (as we have been doing so), we wouldn’t be able to collect any data from you.

I am SO sorry that you cannot enroll into the Extension study. I know that you were really interested in receiving the study drug. I wish there was a site in Seattle that you could be seen at.

Once you complete your End of Study Visit on Saturday, I will need you to send back the study drug to me. I will send you a FedEx pack and label to return it back to me. Please confirm that you received the End of Study Lab Kit. The nurse will need this to complete the visit.

Best of wishes to you Sharon.



THEY HAVE TAKEN AWAY MY LAST HOPE FOR SLOWING PROGRESSION DOWN!
 
I am so sorry and disappointed for you. Hugs
 
I'm so sorry my Sharon. It's not fair! But fairness has never been at the top of their list of priorities, has it.
Love you!
 
I am very sorry Sharon. It must feel like such a crushing blow and such a disappointment having gone as far as you have with the study thus far. My thoughts are with you.
 
Sharon,

I am so sorry. I know how much you were counting on getting the dru g. I agree with Marta, and I wonder how many others were sent a letter similar to yours, or for other reasons excluded also.

Prayers to you dear one,
 
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Sharon, how much of the "study d rug" do you have left that they want you to send back? I don't think anyone would hold it against you if you told them you gave it to your helper to mail back and that was the last you saw of it.
 
Kiwi,

I believe Sharon was on the pla ce bo. That is why she worked so hard to stay in the program. She knew she would be getting the real deal.
 
Thank you, KiwiSally! Seriously, there is no way in Heaven that they would have received one bit of the drug back if I were in charge of returning it. I wish you well, and I'm so sorry this is happening to you.
 
Thanks Mom, I didn't realize Sharon knew she was on the placebo. So very unfair.
 
Oh Sharon, so many things make no sense! This is one of those! I am disappointed with you. I am so sorry. Sending hugs and prayers!
 
Kiwi,

I'm not 100 percent sure, but I do believe I read it was so. I may be mistaken. And yes, I would NOT send them anything back. Like I said before, I wonder how many others, who put their health on the line, to be treated this way in the end. It infuriates me.
 
Aagh, I got modded! And then lost the signal!

Kiwi, I believe I read it but memory is poor. Could be wrong.
 
Sweet Sharon, I am truly sorry this has happened, what a blow! Still in my prayers, and sending Hugs and Kisses!
 
That is just plain wrong. They can use you as long as they like then drop you like that. I'm so sorry Sharon. It is really not fair.
 
Sharon,

You have been disqualified due to travel arrangements, correct? Was the clinic in San Francisco? And how often would you need to be seen there in a year's time?

How, if possible, would we be able to get you there? Are you still capable of flying? If not by plane, by train?

Praying for answers,
 
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