Re: A petition for BMS -Cheryl from L

[Guest guest]

Hi Cheryl,

I like your letter a lot because it is personal and also includes another

patient besides yourself. You're right that we all have a stake in this because

none of us knows when IM may fail us. I also agre with that we should

all send our communications to the same place during the same week so that the

sheer numbers has an impact that would be lost if they dribbled in a few at a

time.

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. I haven't been very

active at all on any of the lists for awhile because of the time element and so

I just keep up with a few friends and take a quick scroll through the various

sites to see if there's anything in particular I can add to or that would be

helpful to read. I haven't left any of the lists as some did, which I

understand. However, now that there are so many groups, I think there needs to

be a coordinator who posts the same message and request for letters on all the

lists at the same time.

I'm sure has access to important people at BMS or he wouldn't have made

the offer that he did and it is greatly appreciated. But it might not hurt to

work through a network of people that have come to know people who have gone

through the trial and others like you who work with Big Pharma. Maybe you all

can hash that out.

For my part, I vote for letters instead of a petition. It's harder to get

people to do it but they mean more. Petitions can be questionable to those who

receive them and can't verify the signatures. At least that's true in politics.

Dealing with big pharma probably isn't much different. Is there anyone who can

make the argument that keeping Phase II open will somehow work in favor of BMS?

It would be great if we could show them that this would benefit their program,

too. Saving lives is the goal, in addition to fast-tracking a drug that has put

and kept people in CCR without side effects for quite awhile now. But it would

still be effective to illustrate how this would be favorable to BMS.

I stand ready to write, and if needed, to help coordinate the effort iwth others

committed to the cause.

Best wishes,

L

[ ] A petition for BMS - , Judy, R., L. and

C.

Because of the work I do, and recently organizing the cancer conference here

in Montreal, I have been in touch with all the major Big Pharma companies,

BMS included.

From what I have heard, the intention is to collapse the Phase II trials and

get the data together quickly to start phase III trials with the idea to

" fast-track " the approval process. However, that doesn't mean that the

Phase II trials shouldn't be expanded. I spoke with my contacts recently on

this matter, and a petition along with personal letters, as suggested by

R and , would be a very good thing. It would certainly help

them by giving more information to add to the file for the FDA.

R, it will be good to hear what your contacts might have to say

about this.

I'd like to add that we are all stake-holders in this situation regardless

of the drug we take. The more data we have and the quicker this drug gets

fast-tracked to market the quicker the access we will all have to either

rely on it for a first line therapy, or in combination with IM to go after

minimal residual disease.

Here is a sample letter to help anyone suffering from writer's block. Fill

in your own information and scenario as needed.

Hope this helps!

To whom it may concern,

I am writing as a patient with Chronic Myelogenous Leukemia, a disease I

was diagnosed with when I was just 43 years old in November 2000. The date

of my diagnosis will forever be etched in my memory. It is the day that I

had to face the hard reality that I may not be here long enough to see my

daughter graduate from university, marry and hopefully one day have

children. Not long after being diagnosed my hopes for a better chance at

beating this disease increased dramatically, all because of a miraculous

breakthrough in CML treatment called Gleevec. After 18 months of interferon

therapy and reaching PCRU, I started to relapse, thankfully I had another

drug to switch to. Since starting on IM therapy I have regained my PCRU

status and it has been stable for the past two years. For the most part, my

life is pretty good and I am working full time, investing in my pension

plan, because I am pretty sure now that I will get to enjoy it. I know I am

one of the lucky ones.

However, for many CML patients the story is quite different. Through the

wonderful on line CML community I have made friends with many people, but

one in particular stands out. Her name is and for her and her

family her diagnosis with CML has presented many enormous challenges, which

she has faced with absolute grace and dignity. has bravely faced

rigorous treatments such as high dose Interferon with Ara-C, Gleevec, Heat

shock vaccines and lots of prayers, without ever achieving a viable

cytogenetic response. Her quality of life on these treatments was greatly

diminished. Recently she came to live with me part-time in Montreal while

she entered the Phase II trial of Dasatinib (formerly, BMS 354825). While

it is still too early to tell, she says she has never felt better on any

other drug treatment. My fingers are crossed that it is doing for her what

no other drug has been able to do yet-achieve a cytogenetic response.

We are all so grateful that there is another drug to turn to when the

treatment we are trying fails. The sad reality is that not everyone who

needs to be part of this trial is getting access to it.

Lately we have heard that the Phase II trials will be ending, which closes

the door on the many patients who need access to your drug now. This

disease doesn't wait for FDA approval to wreak havoc on the lives of those

it affects. I was lucky to have a second chance at this disease with

Gleevec. For many of my CML friends your drug is their second, third or

even fourth chance, and for some it just might be their only chance. Please

do whatever you can to keep these trials open and provide better access for

those of us who need it.

Thank you for your careful consideration.

Best Regards,

Cheryl-Anne Simoneau

[Guest guest]

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.

[Guest guest]

Hi ,

Thanks for your kind words. has given you a good reply on the

BMS trials, I have heard that they will close as early as the end of

June. I wish I knew exactly why some of the centres were never able

to get up and running, but I sure hope the situation improves if

these trials expand and certainly when Phase III starts.

My letter was really just something that someone can use to help

them think about what they would write about. But I will send it

off to BMS when we all decide on the time to do so.

Whatever we plan to do, I am sure we will make sure everyuone will

be able to participate regardless of which list they choose to

participate in. It is at times like these when we can all pull

together for everyone's good benefit;>)!

Glad we can count on you!

Cheers,

Cheryl-Anne

> For my part, I vote for letters instead of a petition. It's

harder to get people to do it but they mean more. Petitions can be

questionable to those who receive them and can't verify the

signatures. At least that's true in politics. Dealing with big

pharma probably isn't much different. Is there anyone who can make

the argument that keeping Phase II open will somehow work in favor

of BMS? It would be great if we could show them that this would

benefit their program, too. Saving lives is the goal, in addition

to fast-tracking a drug that has put and kept people in CCR without

side effects for quite awhile now. But it would still be effective

to illustrate how this would be favorable to BMS.

>

> I stand ready to write, and if needed, to help coordinate the

effort iwth others committed to the cause.

>

> Best wishes,

>

> L

[Guest guest]

Hi ,

Thanks for your input. I think personal letters are good, but as

you will have received an e-mail from late last night, you

will see that a petition with personal letters just might be the way

to go. Additionally, some times letter writing can be intimidating,

this way people can sign the petition and those who wish to write

can send a personal letter. The combination approach will have a

very good over all impact!

Best to you,

Cheryl-Anne

> 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.

>

>

>

>

[Guest guest]

At 02:15 PM 5/30/05 +0000, you wrote:

>Hi ,

>

>Thanks for your input. I think personal letters are good, but as

>you will have received an e-mail from late last night, you

>will see that a petition with personal letters just might be the way

>to go. Additionally, some times letter writing can be intimidating,

>this way people can sign the petition and those who wish to write

>can send a personal letter. The combination approach will have a

>very good over all impact!

Yes I do agree Cheryl..........

the petition will have the larger number of folks responding......

but I would love to see the office that receives maybe 500 personal

letters making an appeal!! I would request my family members to write and

would provide them the stamped and addressed envelop.

C.