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.

Take care,
Gloria

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

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