Re: A petition for BMS -

[Guest guest]

Cheryl, Can we part of this petiotion?If so to what address and when should we

send the petition letter for BMS?

T

>

> 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

>

>

>

>