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.

Kelly

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

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

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.

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

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.

Peter

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