A petition for BMS - Shelley, Judy, R., L. and C.

[Guest guest]

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