Re: A petition for BMS -, Cheryl, Shelley,

[Guest guest]

Hi ,

Thanks for clarifying the problem with the timing of trial openings. I guess I

had forgotten all the hoopla surrounding the creation of the new list and was

concerned that we needed someone to get word to all the lists to participate.

Thanks for clarifying that again. I'm certainly busy enough with my own life

but just wanted offer to help the process along if it was needed.

Of course someone will have to set a date to send letters, where to send them

and the pertinent information (what we want) clearly stated in each letter

together with the personal stories and pleas. We have to ask for exactly what

we want and it has to be clearly communicated.

Enjoy the weekend! It's sunny here. There's no real spring in Washington.

Lots of flowers but it stays cold and rainy then, boom(!) it's summer! Not

used to that abrupt season change yet.

L

Re: [ ] A petition for BMS -Cheryl from L

At 06:24 PM 5/28/05 -0400, you wrote:

>

>Do you have any idea when they plan to close Phase II? Is it imminent

>because that's what it sounds like. So we'll have to act soon.

Hi and list,

Here is a communication I got from OHSU just this last Tues:

The Phase II BMS trial for chronic stage is closing very soon, but some

new ones are in the works.

Carolyn Blasdel, RN, MA, OCN

Clinical Research Nurse for Dr. Druker

___________

OHSU never did even manage to get the Phase II BMS trial open (at least not

for chronic) because of delay getting the needed approval from their

Internal Review Board.

Of course, saying new trials are in the works does not say how long of a

delay until they would start. For the Phase II trials, the trial centers

had the protocols in about January (right after ASH) and it still took

months to get the trials opened up.

So, we are arguing for their not to be a 3 - 6 month or longer gap between

the closing of the Phase II tirals and new trials opening.

Some people who needed the BMS trial could not meet the patient criteria,

so we would also argue that the criteria be more open, so that those who

need a new drug would have access now.

Phase II is closing because they have the minimum 100 patients that they

needed for this trial....this will be the data that goes to the FDA.

As with Gleevec, if they expand the trials now, it is really to give more

people access to the drug (and it gives them a ready pool of consumers when

the drug is approved....because these trials dispand as soon as the drug is

approved).

, I personally don't think this is so complicated that there needs to

be a group to organize things..........it seems to me that all we need is a

person(s) to address our correspondence to, a mailing address and a week

identified to put the letters in the mail. Then this info can be shared

with all lists.

As far as some having chosen to leave other lists.....that is not exactly

the true situation. Rob banned 3 of us from posting to the cml list

(Zavie, Tracey and myself).....and put 2 others on moderated

status........when we argued with him that we did not get him banned as the

owner of the list........but that is all water under the

bridge......except to say that several of us cannot post on that list.

Cheryl....thanks for sharing your letter. Several others might choose to do

the same....it gives other folks some ideas of things to

include.........but I really do feel that a personal letter carries a lot

more weight than including your name on a petition......they will hear real

stories of why it is important to keep the trials open until the drug is

approved.

C.