CML

You're right. I do have the wonderful people on this list. Including you.
Thank you for your wise words and for understanding how painful it's been.
Unfortunately the harassing harpy isn't gone yet but my writing muse has
returned and I hae so many ideas flowing in that I have to believe that it's
because I finally let my secret out and told my CML family.
Thank you for everything. All I can really think to say to everyone who has
written is "Back atcha!"
Lots of love,
Susan

Dear Susan,
I am so sorry for your troubles. Betrayal of trust is perhaps one of the
hardest and most painful things to endure. I could say that you're better off
without this guy and that someone who would do this is no real friend, but I'm
not sure that will make you feel any better. Just know that the world is at
your feet and this guy is only one small part of it. You are talented and
caring and have much to offer. Now that this guy has shown his true colors and
the harassing harpy is gone, you may find that in time your peace of mind and
writing muse will return. You haven't been abandoned and you are not alone. You
have all the good people on this list. You are in my thoughts and prayers.
Adrienne
loewen1 <loewen1@...
Hi All,
I just need to take a few moments to tell you that I'm struggling with the loss
of a friend. He abandoned me for a woman (beautiful and young) who has been
harrassing me in many different ways for the last five years. She makes tv
commercials too. I'm sure you've seen her. He chose her instead of a
friendship with me and I don't know why. Probably because she's young and
beautiful and rich. There have been some Caifornians in town and they let me
know about it.
I'm devastated.. He didn't even tell me. Obviously, he'd rather have a woman
with very questionalble ethics who has made my life a living hell than me. He
left town with no notice. No warning. he's nowhere to be found. Because of
this woman and her stage mother (LA, you know), I have ended up in a
psychiatrist's office on antidepressants plus lithium. For days I couldn't stop
crying. Now that's stopped but I feel a very deep sadness and I think it will
take a very long time for it to go away because of this unbelievable betrayal.
Thanks for listening.
Susan L

What a special person you are, Lisa. I wouldn't normally have posted what I did
except that I don't know that many people here so you guys are pretty much it!
And you're so loving and understanding when any of us hae CML problems. I'm
sorry you seem to have had a hard life. You obviously have a kind a goodhearted
soul.
Thank you for taking the time to tell me to foster hope and keep going. I'm
doing what I can for myself to bolster my self-esteem and foster hope for the
future which seems very shaky, still, but knowing that my wonderful cats have to
be fed and cared for everyday keeps me going -=-getting out of bed and doing
what needs to be done and then giving myself little treats--like ice cream and
blonde hair again.
Be good to yourself and hope others are good to you, too.
Love,
Susan

More options for the future!
Kosan Initiates Phase I Clinical Trial of Second-Generation Hsp90 Inhibitor
KOS-1022 in Hematologic Cancers
Monday June 6, 7:30 am ET
Company Also Announces Grant of U.S. Patent Covering KOS-1022
HAYWARD, Calif., June 6 /PRNewswire-FirstCall/ -- Kosan Biosciences

Hi Dana,
It's always interesting to me who takes the time to write and show they care and
who doesn't. Thank you so much. It's not so much what you say but that you
bothered to take the time to write and that you obviously care that I'm in pain.
It also means a lot that you write even though it's not direectly about my
leukemia. However, I am one who believes that constant stress over a long
period of time affects one's health--including leukemia.
You're very sweet.
Love,
Susan

Hey Zavie,
Thanks for the reading tip. I will buy the book as I enjoyed her
articles in Glamour magazine. It might also be good to mention here
that Erin will be in Ireland as part of the group attending from the
United States at the Novartis "New Horizons in Treating Cancer", the
Third International Conference for Organizations Representing People
with CML or GIST.
I think I will ask her to sign my copy of the book if she is up to it.
See you in Ireland!
Cheers,
Cheryl-Anne

Susan,
I just wanted to write to let you know that we are here for you. I
may not know exactly what to say, but I will be thinking of you and
sending you virtual positive good thoughts.
Hugs,
Dana

Hi Maggie,
Where does your husband get his medical care? do you know if he is seeing a
cml specialist?
The usual starting dose is 400mg......but when another problem is found
(and I think you said your husband has another mutation?? can you get more
information about that)............
it is typical to try to increase the dose, sometimes doubling it to
800mg......but not all patients
do OK with that dose, and sometimes they have to lower it to 600mg. You and
Sergio need to tell the doctor that he is having too many problems with
this dose.
And also.....maybe there are some remedies for his side effects.
For the diarrhea, most people try Imodium....it is available in the drug
store without a prescription.
Some people do need to take medication for bone pain. Fatigue is pretty
common with the higher dose and sometimes it gets less after a
while.............
but it sounds like you both need to discuss the problems he is having with
his doctor.
Also, some people find an anti-depressant helpful for a period of time.
The dose he is not taking is interfering with his qualify of life.....so
that is what you need to talk to the doctor about. Hope this helps some.
Nancy C.

The book "My (So-Called) Normal Life" by Erin Zammett is a must read for CML
patients.
Erin is an associate editor of Glamour magazine. She was diagnosed with CML
at age 23.
I read it in one day. For me, her trips to Portland to participate in the
Gleevec/Ara-C trial with Dr. Mauro relived my own experience with Dr. Mauro
in the 113 trials.
Zavie

I haven't had time to write to you individually but I will. Thank
you for your wonderful messages which really did help. Last night
suicide was a real potential option but today, when I escaped from
the source of harrassment, I had a decent (not great) day. Tonight
I've been scannin a novel I wrote years ago and hpe to get published
now. My HP all in one scanner, printer, copier, fax has given me
fits but hopefully with the help of 3 different techies it's going
to work now.
Thank you again for taking the time to write to me and especially
caring about what happened to me. MJ I'll write to you later. I'll
write to all of you actually for helping me get through yet another
day.
Time to call it a night. Sweetdreams.
Love,
Susan
And by the way, the friend (not lover) who abandoned me and may yet
come around and understand what I'm going through. Well, he's a cml
patient.
Talk to you tomorrow.

Thank you Amers!
You mom's name is on my jacket.. "kttweety"
- Gale

can some one please tell me the best time to sign on to to enteract
with others with cml and their caregiver?

Frist off I would like to say hi to eveyone and that I'm still
trying to figue out all of these site.But anyway here I go ,some
of
you already know of Sergio and me But for those of you who don't I
will make a long story short.Segio was dx Oct 13 2003 and was put
on
400 mg of gleevec and have blood test evey wk. and doing fine.In
fact one day about 6mo into the meds. his blood work came back and
the dr said that he was in remission we were so happy and at last
we could go back to living a some what normal life. Zavie gave him
a number and I kept on reading all the posting and tried to learn
what I could it all so greek to me and than one day I saw that a
lot you had had 2,3,4 bmb the frist year and Sergio only had the
frist one when they found the cml, so at the next dr. visit I asked
the dr why he had not order any follow up bmb and he look at the
chart and order one which has cause a lot of trouble.Frist he
couldn't get aneedle in as he said his bone were to to hard and
neede to send him to the hospital,there they did it and the test
came back saying that the blood was ok but the morrow wasn't and
there was a muntion 1in 25 or something like that ,so out toucla
and there was told he was under medicateand order him to have
another bmb for his number and to start to take 800 mg of gleevec
So now he is on 800mg sick weekly blood test and needs a bmb in a
month to compare the number .Now he has return to be mad sad and
not a happy person and basically just want to dead.I think I can
understand but I do'nt know what to do for him.I know the med. make
him sick and he go to the bathroom a lot and sleep alot and doesn't
get around alot because of alot of pain in his bone and he gained
about 30lbs. This illness has changed our life and goals so much
and our rows in life that one dosen,t kown if they are coming or
going or if its just a bad dream and we haven't woken up yet. Tank
you for listening it kinda help a little
maggie=wife
sergio dx10-2003

Hi Susan"
I am so sorry to hear about your loss of your companion, as well as
your problems with writing at present. As painful as it is now, it is
better to know these things as early as possible instead of having
years of betrayal and then finding out. I know how devastating
depression over these episodes must be. Perhaps it was guilt and shame
that made this man avoid the confrontation of talking with you. At any
rate, I have always found that when one door closes, God opens another,
so keep your faith and stay strong.
Fred

Hey Susan,
Sorry for your troubles. I was touched by your ability to be brave and
share your feelings about this situation with us. Take a little time to
grieve the loss of the friendship you had. Hopefully your feelings of loss
and sadness will clear up shortly. The one thing I know for sure (as Oprah
likes to say) is that since the diagnosis of CML I found I can no longer
afford the "luxury" of getting too hung up emotionally on anyone or
anything. I work on avoiding "toxic" friendships, or "toxic" environments.
However, it is still a "work in progress". It isn't easy learning how to
"let go", but the feeling of freedom that comes when you get it right is
amazing. If there was any lesson to be learned from your relationship with
this person, accept it, but then move on. Keep the good stuff, get rid of
the "toxic" stuff. Then "trust the emergence" of what can come into your
life now that the "space" taken up by the negativity of the situation has
been cleared away and ready for something new.
Go out to the jazz fest today and treat yourself right. In time and when
you are ready, practice being happy. Remember, you are basically a very
good person, a talented writer and a caring friend. J.K. Rowling was on
welfare, a single mom and living in a dire situation when she started to
write the Harry Potter books. And then of course, always remember -
"Success is the best revenge". Maybe you can write a novel about the entire
situation, maybe it will become a best seller - I promise to buy the first
book!
Love & Peace and all best wishes for good things to follow!
Cheryl

Thanks "Amers" for signing the petition.....and asking others for support
also.
I am sure that Gale, who will be sporting the jacket as she runs her 1/2
marathon will respond about getting your Mom's name on it.
Nancy C.

Hello to All:
I'm at my Mom's reading her Digests and I don't know whether she meets the
criteria to be on your jacket, I do know that my Mom's a 'survivor'. She's
surviving numerous Orthopedic Diseases, Orthopedic surgerys, Coronary Artery
Disease, COPD, and CML after being given only 2 - 5 months to live in 2003.
Should she meet the criteria, she's known to you guys as "KTTWEETY or I AIN'T
FINISHED YET".
I am going to sign your petition and get my brother and others to do so, my Mom
speaks of you guys all the time, I'm glad she has this group; only wish it had
been available to her earlier in her survival.
"Amers"
"K"
"I AIN'T FINISHED YET"!!!

There's one other thing. As you know the clinic where I was working
to suplement my disability until I found permanent work (which is
taking forever with no contaqcts(), I got offered an interview with
a hospice. I'm very conflicted. I have to have monwey coming in
but the last job I had -- where the harassnebt started from the
woman I told you about was at a hospice. I dont believe in
coincidence anymore. But I'll go for the interview. My wonderful
soaring dreams of being a writer have crashed because the harazsment
depressed me so much that I could not write. I'm hoping that
medication will give me to the point where I can dream and have hope
for h=the future again. Right now it seems totally hopeless in
every way. Young beautiful mean women can be poisonous. I want my
last years to be happoy and successful. I joined a writing group
last week and wil continue with that -- weekly writing and
critique. I write these messages because leukemia has actually
seemed a small thing given what I've been through. I hope to attend
a jazzfest tomorrow in Washington, enjoy myself and ready myself for
better people in my life who stand by me during difficult times and
don't take the first opportunity to betray a trust.
Thanks for listening. My next posts should be more hopeful.
Susan L.

Hi All,
I just need to take a few moments to tell you that I'm struggling with the loss
of a friend. He abandoned me for a woman (beautiful and young) who has been
harrassing me in many different ways for the last five years. She makes tv
commercials too. I'm sure you've seen her. He chose her instead of a
friendship with me and I don't know why. Probably because she's young and
beautiful and rich. There have been some Caifornians in town and they let me
know about it.
I'm devastated.. He didn't even tell me. Obviously, he'd rather have a woman
with very questionalble ethics who has made my life a living hell than me. He
left town with no notice. No warning. he's nowhere to be found. Because of
this woman and her stage mother (LA, you know), I have ended up in a
psychiatrist's office on antidepressants plus lithium. For days I couldn't stop
crying. Now that's stopped but I feel a very deep sadness and I think it will
take a very long time for it to go away because of this unbelievable betrayal.
Thanks for listening.
Susan L

Hi everyone,
I have something that has been going on with me lately. I've been
getting strange "breakouts" on the outside of my upper arms and on
the top of the forearm. The breakouts are like pimples but they
resemble goosebumps. My arms are also getting really blotchy with
reddish pigmenty dots. Plus, since I don't go in the sun anymore, I
am really fair, so it shows up more and now I'm very self conscious
wearing anything short sleeved.
I usually get these breakouts when I get the "Gleevec" run down,
fatigued feeling. I get this when I overdo it with my activities,
and I pay the price of it when I'm nearly horizontal the next day.
I realize that Gleevec blocks C-Kit but was just wondering if anyone
else in the group gets these breakouts?
I"ve been taking Gleevec 400 mg for 1 1/2 years now.
Any and all input would be greatly appreciated!
Lynn (Snickersunny)
Dx 12/10/03
PCRU
Zavie #692

Let's keep our eyes on this one!
New leukemia drug shows promise in overriding all Gleevec resistance
Temple University researchers have developed a new drug that could
potentially treat all forms of Gleevec-resistant chronic myelogenous
leukemia (CML). Their work is published in this week's early edition of
Proceedings of the National Academy of Sciences.
According to lead researcher, Prem Reddy, Ph.D., professor of biochemistry
and Director of the Fels Institute for Cancer Research at Temple University
School of Medicine, most patients with advanced CML, a rare but deadly form
of cancer, typically develop resistance to Gleevec, the most successful
treatment for CML to date, within a few years of starting the therapy.
CML is caused by the Philadelphia chromosome, an abnormality that produces a
cancer protein called BCR-ABL. Gleevec works by binding to BCR-ABL and
completely blocking its activity, thereby stopping cancer growth. When
Gleevec came to market about four years ago, it was widely hailed as a
miracle drug. For the first time, there was hope for this group of patients.
"Gleevec has been a remarkable success for the treatment of CML. However, a
significant number of patients eventually develop resistance to it because
their cancer cells are able to mutate and adapt," said Reddy.
Since discovering this phenomenon, scientists have sought new ways to
prevent or overcome this resistance. Recently, two experimental drugs were
found to be effective in circumventing some but not all forms of Gleevec
resistance. Both, for instance, failed to block the activity of a mutant
BCR-ABL, called T315I, which is one of the more predominant mutations seen
in Gleevec-resistant patients.
Reddy and his research team sought instead to develop a drug that would
circumvent all of the mutations and therefore all forms of resistance. They
focused on other possible avenues to inhibit the actions of BCR-ABL. To do
so, they targeted parts of the BCR-ABL protein that didn't appear to be
mutating and adapting to Gleevec.
"We developed ON012380, a compound that specifically inhibits BCR-ABL by
blocking a different site in the protein, which is essential for its
activity. As a result, ON012380 was found to induce cell death of all of the
known Gleevec-resistant mutants and cause regression of leukemias in human
tumor cells and in animal models," said Reddy, who is currently seeking FDA
approval to proceed with clinical trials. The drug is licensed to Onconova,
Inc.
"Our drug works just like Gleevec but by blocking another part of the
BCR-ABL protein. It can be combined with Gleevec to create synergy and when
patients become resistant to Gleevec, our drug kills 100 percent of the
cancer cells," said Reddy.

Yes, it's you!
You're very welcome...
- Gale

Hey everyone! I'll be in Houston from the 19th to the 21st for my
annual BMA at MDACC. If anyone will be down that at the same time let
me know. Possibly we could find a time to get together. I'll be
staying at the Rotary House as all the other hotels in the area are
FULL! Email me at aimesc31@....
Amy B.

Hello Everyone,
I wanted to let you all know about my husband's last visit to M.D. Anderson in
mid-May. By way of background, he was diagnosed with CML at the end of August
2003 in chronic phase. In November 2003 he started in a clinical trial at M.D.
Anderson which put him on 800 mg of Gleevec. The trial has two arms: one arm
keeps the patients on 800 for 3 to 5 years and the other one adds interferon to
800 mg of Gleevec after 6 months of being on just 800 of Gleevec. Jim's in the
first arm, so he's getting only Gleevec. Prior to joining the trial, he was on
hydrea. He's done well in the 18 months or so that he's been in the trial. His
initial PCR was 83. This was followed by 2.9, 0.17, 0.22, 0.09 and his latest
of 0.1. While his numbers dropped quickly in about the first 6 months, he's
been bumping around 0.2 and 0.1 for the past year. We don't have the
cytogenetics from his last visit yet, but there's no indication of disease
progression and we don't expect any. Nevertheless, his
doctor, Dr. Cortes, asked Jim to consider participating in another trial that
would keep him on 800 mg of Gleevec and then add a vaccine. He wasn't sure what
vaccine it would be because his staff was still writing the protocol for the
trial, but he was considering three possible vaccines, one of which was the heat
shock vaccine. He's hoping to find a combination of approaches that will get his
patients' PCR numbers lower when they seem to plateau, to an undetectable level,
if possible and ultimately, of course, to a point where the person can be said
to be cured. I'm pretty sure some of the people on the list participated in an
earlier trial using the heat shock protein with little or no success (my memory
could definitlely be failing me here). I also thought one or more people were
participating in a vaccine trial at Johns Hopkins. I'd appreciate any
information any of you might have on vaccine trials in general and these two in
particular. Please feel free to e-mail me
privately if you prefer. Many thanks in advance.
Adrienne

Hi Gale,
I saw a Michael H that was being added to your jacket. If it is me, I
would like to say that I am pleased and honored. Thank you!
If it is not me could you please add me to your jacket?
Thanks. I'm l;ooking forward to the picture of the jacket.
Michael Herring

I wanted to take the opportunity to thank you personally for moving forward
with the petition for all of us.
I was number 75 and immediately I forwarded it to a few of my dearest
friends who in turn have added 49 signatures so far!
I anticipate the e-mail I sent to be forwarded across the country to people
I don't even know in quit a few large originations.
As a Communications Consultant for National Accounts, I suspect I can get us
plenty of signatures.
Thanks again,
Lisa M

Thank you Gale,
I am absolutely overwhelmed emotionally!
Thank you so much for honoring Marque & the rest of us.
My prayers are with you as you enter into this journey!
Jennifer G. Congratulations & Thank you to you too for entering another
year. I have no doubt your tough enough to make it through!
Lisa M

Return Visit to MDACC and 100 day biopsy results.
Had a very frustrating trip to Houston today to discuss the results of my last
biopsy, because some of the information is missing and some of the test results
contradict other test results.
I will compare the results of my 60 day biopsy with my 100 day biopys.
60 Day biopsy:
Peripheral Blood PCR 5.6
Bone Marrow PCR 13.5
100% Donor Cells
100 Day Biopsy:
Peripheral Blood PCR 1.8 (good decline)
Bone Marrow PCR: info missing, test was never completed.
Bone Marrow shows 100% donor cells, but the peripheral blood shows only 79%
donor cells. (very bad)
My onc thinks this is donor cell discrepancy is an anomally and spoke with the
head of the lab, who agrees. They are running the test again on the same sample
they took two weeks ago. Hopefully, it will confirm that I am still 100% donor
cells, and that the peripheral blood reading was an error. As it stands right
now, the onc does not no for sure if I am getting better (the drop in Peripheral
Blood PCR value indicates that, my blood counts indicate that), or if I am
getting worse (he has to clear up this donor discrepancy first)
Talk about a rock and a hard place!
Good news is the central line was yanked out today! Yay....that thing gets to be
a real ball and chain after a while.
We decided to reduce the tacrolimus as planned even though the discrepancy
exists...so now I am on 1mg every other day. Half of what I was originally
taking in the beginning. I also remain on 600mgs of Gleevec.
So, although the signs are good that things are improving, we have to wait for
retesting results to disprove the anomally.
I go back down in two weeks for another test (just peripheral blood)
We drove all the way down there, spent a night at the Rotary, spent the whole
day at the hospital, and came back with questionable and partial information.
Frustrating.
That's all the info I have now...will update again when I know more.
Regards and Prayers, DT

Gale,
Thank you for honoring me and the others in this group. I'm grateful to be
running with you in spirit.
Best of everything to you. Hope we get to see some photos with you in the
jacket.
Love,
Susan L

Hey Gale,
This is a really cool idea, please take a picture so that we can see
what your jacket looks like.
Congratulations!
Cheers,
Cheryl-Anne

Hello All!
I'm decorating a 'purple' jacket for my upcoming Anchorage marathon
with the Leukemia Society's Team in Training. I can't believe I'll
be in Alaska within two weeks...
On the back of the jacket, at the top, will be: 'In memory of Marque
Leseur'. Underneath that, 'In honor of' followed by ALL of your names
(inside decorated white felt squares pinned onto the jacket). Each
square will have your name, like 'Zavie M.', 'Margot M.', 'Dane
T.', 'Cheryl-Anne' and so on. (No last names, just last initials.)
My goal is NOT to leave anyone out and to fill this jacket up!
Here are the names I have so far. Please email me off list if you'd
like your name on my jacket (soon, as I have to finish it by next
weekend!). Forgive me if I've forgotten you on this list:
Hunter, Zavie M., Margot M., Jennifer G., Cheryl-Anne, Giora, Jerry
M., Tracey, Stephanie, Christine, Kay, Gina D., Jeanie, Kristy, Dane
T., Barbara, Mike B., Michael H., Bob, Jonathan, Dave G., Sharon,
Bruce, Richard R, Richard T, Terry D, Anjana, Barb S., Brenda, Judy,
Nancy C, Shelley, Susan L., Cheryl, Lisa M., Lisa M., Joan P.,
Gloria, Shari
To your good blood,
Gale Bacon
dx'd 3/00
Gleevec 400mg

Hi,
Absolutely do not worry about it. I am interested about checking out all
kinds of transplants anyway since nothing has yet been ruled out for my husband
Karl. Hope everything works out for you and you find an new job.We'll add you to
our prayer list.
God bless,
Stephanie
loewens1 <loewen1@...
Hi,
I wanted to apologize for passing along misleading information to you
Stephanie. I hope someone has furnished you with more info or a place
you can find info about MUD BMTs.
Yesterday they closed the HIV/AIDS clinic where I've been working to
supplement my social security disability. It isn't just a personal
loss but also one for the Metro Washington area where this clinic has
been a wel-known and well-regarded place for HIV patients to go for
testing, medical and mental health treatment as well as support groups
and links to solve other situations like groceries and housing. It's
a real loss.
Anyway, I've been somewhat distracted lately and consumed with looking
for a new position.
Susan L

I first sent this message to the old group which is now CML Hope. I never heard
much from anyone But, Zavie told me about the new group. I knew there was one, I
just didn't know "where".
I hope the petition I am hearing so much about helps us all.
I don't see how BMS can play God with us. Are we all "pawns"?

Hi Sharman,
I am glad that you found us here.
You are JUST the kind of person that the petition is written for. I
remember how long you have been waiting for access to a BMS trial closer to
home so that you could participate....and you do need a new drug. You are a
real cml warrior-ess!
Please have your family and friends sign the petition also. There is
strength in numbers and the FDA and BMS have to know how many people care
about this issue.
I can also tell you, which might be hopeful, that I had a message from Dr.
Druker's research nurse....and OHSU never did get a chronic phase trial
open......that they are working on getting approval for the new
trials........but just the same, we want to keep the pressure on.
Nancy C.

Thanks, Christine!
I was number 187.
Love,
Susan

Hi,
I wanted to apologize for passing along misleading information to you
Stephanie. I hope someone has furnished you with more info or a place
you can find info about MUD BMTs.
Yesterday they closed the HIV/AIDS clinic where I've been working to
supplement my social security disability. It isn't just a personal
loss but also one for the Metro Washington area where this clinic has
been a wel-known and well-regarded place for HIV patients to go for
testing, medical and mental health treatment as well as support groups
and links to solve other situations like groceries and housing. It's
a real loss.
Anyway, I've been somewhat distracted lately and consumed with looking
for a new position.
Susan L

Dear Mr.Zavie Miller
I hope you are doing fine.
Its sad to inform you that my father passed away on 25th of May in his sleep.He
had shown resistance to Gleevac as he was about to get registered for BMS drug
trials in Singapore,But unfortunately he passed away all of a sudden without any
suffering and pain.
I must tell you that he had all his bleesings for you and we all are thankful to
you for the kind support you had shown to us.
God Bless You
Thanks and Brgds
Daman Batra
India
Zavie Miller <zmiller@...
Thank you for the post Louis
THE WALL STREET JOURNAL, 05/03/2005
By Amy Dockser Marcus
In a debate that has far-ranging implications for the most promising
new "smart drugs" in treating cancer, some doctors are now starting
to ask: Can patients ever stop taking them?
This is a question that rarely came up with standard chemotherapy
treatments, which often were so toxic that they either killed the
cancer or were stopped because of the potential harm to the patients.
The newer "smart drugs," such as Avastin, Gleevec and Tarceva, which
target only cancerous cells and leave normal ones unharmed, have
milder side effects. They often keep a tumor from growing but don't
completely eradicate it, raising the possibility that they may be
taken for years, possibly for the rest of someone's life,
transforming cancer into a chronic illness.
Many patients who have been on the drugs for years are starting to
ask their doctors when, if ever, they can stop. Some complain that
even the so-called mild side effects, such as fatigue, nausea,
swollen eyes and legs, among other issues, are difficult to endure on
a chronic basis. The drugs often are expensive. Novartis's Gleevec,
for leukemia and gastro-intestinal stromal tumors (GIST), and OSI
Pharmaceuticals Inc. and Genentech Inc.'s Tarceva, approved to treat
nonsmall-cell lung cancer, cost around $2,400 and $2,100 a month,
respectively, at wholesale prices. Genentech's Avastin, which is
approved for colo-rectal cancer, runs around $4,400 a month. Even
people with insurance can end up with large monthly co-payments.
Also, there is only scant data on the potential effects on a fetus,
so both women and men taking the drugs are advised not to have
children, a challenging issue for patients in their reproductive
years.
Now, academic centers such as M.D. Anderson Cancer Center in Houston;
the French Sarcoma Group, an organization of 36 cancer institutions
in France and Switzerland; and the Australasian Leukaemia & Lymphoma
Group, a consortium of centers in Australia and New Zealand, are
launching clinical trials that will do something that once was
unthinkable. They will enroll patients with chronic myelogenous
leukemia (CML) or GIST whose cancer is either undetectable by blood
tests or hasn't grown for the past two to three years and see what
happens when some of them stop taking Gleevec.
The current trials involve Gleevec in part because it was one of the
first smart drugs to win Food and Drug Administration approval, in
2001, and has a group of patients who have taken it for more than
three years. The questions raised in the trials go far beyond Gleevec
users and have implications for all such drugs. Many patients
eventually become "resistant" to cancer drugs -- GIST patients on
Gleevec have a particularly high rate but it's an issue for other
targeted therapies, too. One notion that researchers are exploring is
whether taking patients off a drug for a time will extend the life of
the drug's efficacy and perhaps delay resistance. Doctors who treat
patients with breast cancer also are looking into whether longer or
shorter durations of drugs such as Herceptin or Femara help prevent
the cancer from coming back.
"Every targeted therapy is facing the same key issue: How long do we
treat patients? Two years, five years, indefinitely?" says Brian
Druker, professor of medicine at Oregon Health & Science University
Cancer Institute in Portland and one of the developers of Gleevec.
The trials raise ethical concerns because of data that have emerged
recently involving small numbers of patients from Oregon Health &
Science University in Portland, the French Sarcoma Group's
institutions and M.D. Anderson that indicated the vast majority of
those who stopped taking the drug quickly relapsed. All of these
patients restarted the drug and doctors say there is no evidence that
their overall survival odds are any worse than someone who never
stopped taking the drug. But two GIST patients in one study weren't
able to get their cancer back in control after restarting the drug
and saw their disease worsen; one has died.
Two years ago, Andreas Hochhaus of the University of Heidelberg in
Manheim started collecting cases of patients who, for various
reasons, had stopped taking Gleevec. The Registry on Patients Who
Stop Gleevec After Remission now contains 20 patients in the U.S. and
in Europe. "Almost all" relapsed, Dr. Hochhaus said. "I do not think
people can stop taking Gleevec at any point."
Diane Young, vice president of clinical development at Novartis
Oncology, says the company's position is that "right now we don't
really feel there is sufficient data to support that the drug can be
stopped safely in patients" who are doing well on it. Dr. Young said
the limited evidence that exists suggests that even patients whose
disease is undetectable using current tests may still have some
residual disease that can grow if the drug is stopped.
The doctors setting up the current trials are being driven by the
small yet intriguing reports being published that showed some
patients were able to go off the drug and not relapse for extended
periods of time. Jean-Yves Blay, president of the French Sarcoma
Group, presented data at the American Society of Clinical Oncology
annual meeting last year involving 259 patients with GIST who were
taking Gleevec. In an interim report, Dr. Blay said 32 patients were
taken off Gleevec to see how they responded, and 24 of them saw their
tumors start to grow again. The median time to relapse was six
months. Dr. Blay said he and the other doctors recommended that
everyone go back on the drug, but as of February 2005, four patients
refused to do so and still hadn't relapsed after having been off for
12 to 14 months. Eventually, they all started taking Gleevec again,
because of encouragement from their families. The group's doctors are
studying the patients' tumors to see if there is some kind of
mutation in the proteins targeted by the tumor that can be tied to
the likelihood of relapse after stopping the drug.
Dr. Blay said one question that remains is whether the patients would
have fared better if they had stopped after being on the drug for a
longer period of time. The patients in the first trial had been in
remission only for a median of two years. Later this year, he said
the French Sarcoma Group will start a new trial involving GIST
patients who have been taking Gleevec for three years with no sign of
cancer progression, to see if some of these patients no longer need
the drug.
At M.D. Anderson, Jorge Cortes, deputy chairman of the department of
leukemia, is enrolling patients in a trial where they receive Gleevec
and interferon, rather than Gleevec alone. If the levels of leukemia
cells in their blood remain undetectable for two to three years, they
then will stop taking the drugs. The idea is "if we add other drugs
to the Gleevec, maybe it will improve their chances of staying in
remission once they stop taking Gleevec," Dr. Cortes said.
In a paper published in the journal Leukemia Research, a group of
doctors at Oregon Health & Science wrote about two patients who
stopped taking Gleevec. One of them asked to discontinue because of
worsening fatigue. She relapsed two months later. The second patient,
a 36-year-old woman diagnosed with leukemia in 2000, stopped taking
the drug after 17 months because she found out she was pregnant. One
year later, after delivering a normal child, the levels of leukemia
cells in her blood still were undetectable, according to the paper.
One month later, despite the fact that she still remained in
remission, she decided to go back on the drug after speaking with her
doctor.
Dr. Druker says her case and others show that "there is a potential
for differing outcomes when the drug is stopped."
This potential is what convinced Jennie Tilley to enroll in a 25-
person trial expected to start this fall being run by the
Australasian Leukaemia and Lymphoma Group. Ms. Tilley, 63, was
diagnosed in 1995 with leukemia. She was initially treated with
interferon but had terrible mood swings and lost weight. She had a
bone-marrow transplant but her leukemia counts kept rising. In 2001,
she went on Gleevec. Her disease has been undetectable since 2003.
Ms. Tilley, who lives in Port MacDonnell in the southern part of
Australia, said she has suffered side effects from the Gleevec. She
gets constant subcutaneous eye hemorrhages, which she says are very
painful and feel "like a hot needle is going through your eye." Her
hair "pulls out in chunks," she said. But she said she was most
concerned by a recent study done by Novartis showing an increased
frequency of genitourinary tumors in rats treated with Gleevec daily
for 24 months. Ms. Tilley said the report reminded her that "they
don't know the long-term effects of taking this drug because it is so
new."
Novartis's Dr. Young says the rat study is continuing, but that in
safety data from more than 9,000 patients, there hasn't been findings
of increased incidence of any kind of tumor. She added that the
company did send out a letter to physicians in November 2004 about
the rat data and updated the Gleevec label to reflect the findings.
Ms. Tilley said the knowledge she can go back on the drug if her
counts go up, and that others who have done this have been able to
get the cancer back into control, made her feel that, "I've got a
parachute."
Reasons To Stop
Why some cancer patients quit taking so-called smart drugs:
-- Side effects -- The drugs can cause fatigue, swollen eyes and
legs, nausea and vomiting.
-- Fertility issues -- Both women and men often are advised to
refrain from having children while taking these drugs.
-- Cost -- Even patients with insurance can have significant co-
payments, which add up.
-- Drug resistance -- Some tumors develop mutations that become
resistant to the drug and require new therapy.
Stopping Cancer Drugs
Clinical trials starting this year where some patients will stop
taking their medication to test whether the cancer will progress:
SPONSOR: M.D.Anderson, Houston TRIAL: Leukemia patients will take
Gleevec and interferon. If they remain without detectable levels of
cancer in their blood for two to three years, the drugs will be
stopped.
CONTACT: Jorge Cortes, 713-794-5783
SPONSOR: French Sarcoma Group, 36 institutions in France and
Switzerland * TRIAL: GIST patients whose cancer hasn t progressed for
at least three years will be eligible for a trial where some people
will stop taking Gleevec.
CONTACT: Jean-Yves Blay, Blay@...
SPONSOR: Australasian Leukaemia and Lymphoma Group, Australia **
TRIAL: Leukemia patients with undetectable levels of cancer in their
blood for at least two years will be eligible for a trial where some
people will stop taking Gleevec.
CONTACT:
www.petermac.unimelb.edu.au/allg
*Accredited oncology centers in the U.S. are eligible to participate
**Available only to patients in Australia
Copyright (c) 2005 Dow Jones Reuters Business Interactive LLC
(Factiva)
Louis Nault
Montreal, Quebec, Canada

Just curious Cheryl,
Since my Son and Daughter in-law are expected to deliver my 3rd grandchild
in September, how could we go about donating the umbilical cord?
Lisa
Tampa Fl
Message: 6
Date: Wed, 1 Jun 2005 07:40:59 -0400
From: "Cheryl-Anne Simoneau" <cheryl.simoneau@...
Subject: Another issue we could all work on!
Schumer proposes centers to store umbilical blood
By JANE LERNER
THE JOURNAL NEWS
(Original publication: June 1, 2005)
NYACK - Rockland obstetrician Nicholas Klein delivers close to 1,000 babies
every year, and the umbilical cords he cuts are discarded in all but a
handful of cases.
But under a plan proposed yesterday by U.S. Sen. Charles Schumer, those
umbilical cords and the potentially life-saving blood they contain could
become part of a national donor network for people sick with cancer,
leukemia and other diseases.
"We can turn medical waste into medical miracles," Schumer said as he
announced his support for the Cord Blood Stem Cell Act, legislation he is
sponsoring in the Senate to create a network of cord-blood bank centers to
store and distribute umbilical-cord blood for treatment and research.
"Cord blood is not being used to its fullest potential," he said during a
stop at Nyack Hospital, one of several he made to announce the plan. "We
have to change that."
Cord blood is blood that remains in the umbilical cord and placenta at the
time of birth. The blood, which usually is discarded after delivery, is rich
in stem cells.
Those cells can be a better alternative for patients with cancer, leukemia
and other diseases whose only treatment option now is a bone-marrow
transplant.
Schumer estimated that 3,000 people in Westchester, Rockland and Putnam are
diagnosed each year with blood diseases that could be treated with
transplants of cord blood.
Because immune-system cells contained in cord blood are less mature, they
have not yet "learned" to attack foreign substances, and so would be less
likely to attack the recipient's immune system, according to the National
Marrow Donor Program, an organization that tries to match bone marrow donors
and recipients.
Doctors performed the first successful transplant of umbilical-cord blood 17
years ago in a 5-year-old boy suffering from a rare blood disorder.
Many patients could benefit from such treatment, said Dr. Michael Rader,
head of the cancer center at Nyack Hospital, who joined Schumer in
announcing the plan.
"But," he said, "the supply just isn't there."
Private companies now offer women the option of collecting and storing
umbilical-cord blood after they deliver their babies, potentially for their
children or other family members to use.
It's an option few women choose, Klein said. He estimated that the cord was
saved in half a dozen cases of the 1,000 births he attended last year.
"It's very rare that someone wants to do it," he said.
The top reason is cost: The initial fee for a kit to collect the blood is
about $1,800, plus a yearly storage fee of $150 or $200.
New City resident Christie Aguas briefly considered saving the cord blood
when she gave birth to her daughter, Vienna, in April at Lawrence Hospital
Center in Bronxville.
"But it was a lot of money, and I wasn't really sure that there was a need
for it," she said.
Aguas said she would be in favor of a proposal like the one Schumer
suggested, which wouldn't require families to pay to donate or store the
blood.
"It's a good idea as long as I would still have the option of using the
blood for my own daughter," she said.
Donated cord blood could have helped Dr. Bob Morris, 65, a former Pound
Ridge resident who developed chronic myeloid leukemia several years ago.
Morris, a retired obstetrician, was told that a bone-marrow transplant was
his best chance for recovery. But the risky procedure was not recommended
for people his age. "A cord-blood transplant would have been an excellent
option," he said.
Through a friend, Morris learned of a clinical trial of Gleevec, then an
experimental drug. The medication became widely available in 2001. Morris,
who lives in Fort Lee, N.J., credited the drug with putting him in
remission.
Morris has been lobbying for the creation of a national cord-blood donor
program, and he joined Schumer at several hospitals yesterday.
Schumer said the program would cost "a couple of hundred million" and would
be paid for out of the federal government's $200 billion budget for health
care.
"It would save money because the cost of a cord-blood transplant is less
than the cost of a bone-marrow transplant," he said. As part of the
proposal, he would ask federally funded insurance programs to pay for
cord-blood transplants.
Schumer said he had been touched by the plight of people sick with cancer
who desperately needed bone-marrow donors, but couldn't find matches.
"They wait and they wait and they wait," he said. "Here's a way we could
save their lives."

Dear All,
Here is the link to the petition I have started to facilitate access
to
the BMS trials.
The information is based on my current understanding of the issues
after discussion with my trial team and fellow BMS trial
participants.
Please sign and forward on to as many folks as you can. Let's see how
fast we can get over 4,000 signatures.
http://www.petitiononline.com/BMStrial/petition.html
I have not yet determined the closing date for the petition and will
let you all know when I do. At that time we can coordinate personal
letters to be submitted at the same time as the petition.
I know we can be effective if we work together.
Peace,love and everything good,
Christine
dx 11/98
BMS Trial 013

Stephanie,
I'm not going to blame my bad memory on Gleevec but I do apologize for
incorrectinformation. Someone should direct you to information on more common
transplants instead of just correcting me, though. I hope somene does.
Susan

Thanks for your responses to my question about an autologous
transplant.I'll check out the web sites suggested. We have another
appt. at Vanderbilt June20. If I learn anything helpfull i'll be sure
to let you all know.
Thanks again and God Bless,
Stephanie

Thanks Tracey. Sandy also used her own cells even though it's a "mini"
transplant. Another option that may not be a cure but it's out there.\
Stephanie, on the same website www.cmlsupport.org/ you can click on Elizabeth's
diary and get connected to her Caringbridge site. She's on Day 15 of a
transplant in which they used her mother's marrow. That's not the usual sibling
transplant. She had complications even before the transplant so it's not
strictly a CML transplant. Turns out her CML became MDS and AML before they got
to the transplant. You could also check the archives of this website for Dane's
diary of his transplant which was from an unrelated donor.
Hope this gives you a start on your search for information.
Susan L

Hi Stephanie and Susan,
Autologous transplants are when they use the patient's own cells to do
the transplant as opposed to using a donor's cells. In some lymphomas
this has been successful but as far as I know, in CML, it has never
been a cure. It can however buy a person some time while they wait
for other treatments or donors to become available if they have run
out of options.
Take care,
Tracey

Isn't there a website where you can set up a petition
and you just go in and sign it? I have no idea where
it is or even if it exists anymore, but that would be
a good way to get a large number of people involved in
the BMS petition process. Just a thought.
Bob Stewart, Granger, Indiana

Science Fighting Cancer On Multiple Fronts
By Amanda Gardner
WEDNESDAY, June 1 (HealthDay News) -- One of the most exciting
developments to come out of the recent meeting of the American Society
of Clinical Oncologists was the news that Avastin, a colorectal cancer
drug, also prolonged progression-free survival in breast cancer and
advanced non-small cell lung cancer patients.
Many experts hailed the accomplishment as a proof-of-concept for
anti-angiogenesis drugs specifically and targeted therapies more
generally, which have been in the works for years but only recently
have started to pay off in terms of effective medications.
In contrast, research into cancer vaccines -- the focus of researchers
for more than a century -- has yet failed to deliver any meaningful
results. Several vaccine studies were presented at the ASCO
conference, but none of the compounds studied are anywhere near the
marketplace, experts say.
Right now in the world of cancer research, vaccines seem to have ceded
their top spot to angiogenesis.
"The winds move back and forth," confirmed Dr. Joseph P. Eder,
clinical director of translational pharmacology and early clinical
drugs at the Dana Farber/Harvard Cancer Center in Boston.
The parallel paths of these two avenues of research have one thing in
common, however: They each highlight the challenges and promise of the
ongoing quest for new, more effective cancer treatments.
Anti-angiogenesis drugs such as Avastin (bevacizumab) work by
inhibiting the formation of new blood vessels that feed tumors.
The idea was promising when it was first put forth, but solid results
proved elusive and skeptics soon stepped forward. Some experts worried
the approach might stimulate excessive patient bleeding or interfere
with wound healing. This has not turned out to be the case, however,
largely because existing drugs target very specific cell receptors.
On the other hand, anti-cancer vaccine initiatives continue to bear
little fruit in terms of promising treatments, mainly because the
biology behind them is so complex.
"The immune system itself, and all the controls and counter-controls
and back-up controls are much more complicated than we still fully
understand," said William C. Phelps, scientific program director of
the research department at the
American Cancer Society in Atlanta.
"By comparison, angiogenesis is much better understood," he said. "Not
to say that it's not complicated, but by comparison it's dramatically
less complicated."
Vaccines do have several potential advantages over more traditional
drugs, which keeps scientific interest in them alive. "One of the most
attractive parts of the vaccine approach is trying to stimulate the
body's natural responses, something we would believe is always
operative and is successful at eliminating tumor cells as they arise,"
Phelps explained. Immunization also has the advantage of being
non-toxic, because doctors are not introducing a foreign substance to
the body.
The most promising vaccine trials have been in the areas of melanoma
and renal cell cancers, Phelps said, and in these areas there have
been enough "limited glimpses at success" to keep vaccines on the
research radar.
Eder agreed that vaccine research isn't likely to subside any time
soon.
"I certainly wouldn't count vaccines out. It's still a valid theory,"
added Dr. Len Lichtenfeld, deputy chief medical officer of the
American Cancer Society in Atlanta.
And, Lichtenfeld pointed out, "When we have success, we tend to forget
the problems."
"Although we're now seeing the fruits of our labor in angiogenesis and
other targeted therapies, five and 10 years ago there were significant
questions about whether this science would translate from test tubes
into clinical practice," he said.
Perhaps the key to successful cancer therapy lies not in a "one/or"
approach, but rather in "both/and" combination strategies, Phelps
said.
"We imagine that treatment is always going to be multi-modal," Phelps
said. "The best combinations are probably going to be approaches that
are quite different, so if we can apply a vaccination protocol to
stimulate the immune system and a [second] protocol to inhibit growth
of new blood cells, that can have a tumor de-bulking kind of
approach."
"The more different the approaches are in combination, probably the
better," he added. "Immune approaches, as well as anti-angiogenesis,
are both going to be useful."
More information
The Angiogenesis Foundation has more on angiogenesis therapies.

Schumer proposes centers to store umbilical blood
By JANE LERNER
THE JOURNAL NEWS
(Original publication: June 1, 2005)
NYACK - Rockland obstetrician Nicholas Klein delivers close to 1,000 babies
every year, and the umbilical cords he cuts are discarded in all but a
handful of cases.
But under a plan proposed yesterday by U.S. Sen. Charles Schumer, those
umbilical cords and the potentially life-saving blood they contain could
become part of a national donor network for people sick with cancer,
leukemia and other diseases.
"We can turn medical waste into medical miracles," Schumer said as he
announced his support for the Cord Blood Stem Cell Act, legislation he is
sponsoring in the Senate to create a network of cord-blood bank centers to
store and distribute umbilical-cord blood for treatment and research.
"Cord blood is not being used to its fullest potential," he said during a
stop at Nyack Hospital, one of several he made to announce the plan. "We
have to change that."
Cord blood is blood that remains in the umbilical cord and placenta at the
time of birth. The blood, which usually is discarded after delivery, is rich
in stem cells.
Those cells can be a better alternative for patients with cancer, leukemia
and other diseases whose only treatment option now is a bone-marrow
transplant.
Schumer estimated that 3,000 people in Westchester, Rockland and Putnam are
diagnosed each year with blood diseases that could be treated with
transplants of cord blood.
Because immune-system cells contained in cord blood are less mature, they
have not yet "learned" to attack foreign substances, and so would be less
likely to attack the recipient's immune system, according to the National
Marrow Donor Program, an organization that tries to match bone marrow donors
and recipients.
Doctors performed the first successful transplant of umbilical-cord blood 17
years ago in a 5-year-old boy suffering from a rare blood disorder.
Many patients could benefit from such treatment, said Dr. Michael Rader,
head of the cancer center at Nyack Hospital, who joined Schumer in
announcing the plan.
"But," he said, "the supply just isn't there."
Private companies now offer women the option of collecting and storing
umbilical-cord blood after they deliver their babies, potentially for their
children or other family members to use.
It's an option few women choose, Klein said. He estimated that the cord was
saved in half a dozen cases of the 1,000 births he attended last year.
"It's very rare that someone wants to do it," he said.
The top reason is cost: The initial fee for a kit to collect the blood is
about $1,800, plus a yearly storage fee of $150 or $200.
New City resident Christie Aguas briefly considered saving the cord blood
when she gave birth to her daughter, Vienna, in April at Lawrence Hospital
Center in Bronxville.
"But it was a lot of money, and I wasn't really sure that there was a need
for it," she said.
Aguas said she would be in favor of a proposal like the one Schumer
suggested, which wouldn't require families to pay to donate or store the
blood.
"It's a good idea as long as I would still have the option of using the
blood for my own daughter," she said.
Donated cord blood could have helped Dr. Bob Morris, 65, a former Pound
Ridge resident who developed chronic myeloid leukemia several years ago.
Morris, a retired obstetrician, was told that a bone-marrow transplant was
his best chance for recovery. But the risky procedure was not recommended
for people his age. "A cord-blood transplant would have been an excellent
option," he said.
Through a friend, Morris learned of a clinical trial of Gleevec, then an
experimental drug. The medication became widely available in 2001. Morris,
who lives in Fort Lee, N.J., credited the drug with putting him in
remission.
Morris has been lobbying for the creation of a national cord-blood donor
program, and he joined Schumer at several hospitals yesterday.
Schumer said the program would cost "a couple of hundred million" and would
be paid for out of the federal government's $200 billion budget for health
care.
"It would save money because the cost of a cord-blood transplant is less
than the cost of a bone-marrow transplant," he said. As part of the
proposal, he would ask federally funded insurance programs to pay for
cord-blood transplants.
Schumer said he had been touched by the plight of people sick with cancer
who desperately needed bone-marrow donors, but couldn't find matches.
"They wait and they wait and they wait," he said. "Here's a way we could
save their lives."

I'll be mmost happy to sign a petition with regard to BMS.
Well, my dental work started to hemorrhage again. What fun! I'm going
to work with the hematologist to try to find out why all of this
happens. This is the fourth hemorrhaging episode in less than a year.
Not good. Thanks, MJH

Medicine & Markets
FDA Unravels The Cancer Miracle
Scott Gottlieb, M.D., 05.31.05, 2:45 PM ET
NEW YORK - Cancer survival rates are climbing. Earlier detection is
one reason. Another is the new medicines that created through recent
innovations in biotechnology. Drugs today are more targeted to tumors,
so patients are seeing their lives prolonged with fewer of the side
effects that came with traditional cancer drugs.
The hope for the future is even better. More than 400 new cancer drugs
are in development. One of the clearest beneficiaries of recent
innovations has been the field of breast cancer, where 15-year
survival rates for early stage breast cancer patients have gone from
one in ten to one in five in just the past decade.
With a series of new breast cancer drugs such as Bristol-Myers
Squibb's (nyse: BMY - news - people ) Taxol, the aromatase inhibitors,
Genentech's (nyse: DNA - news - people ) Herceptin and now Avastin
(developed for colon cancer, it was recently shown to almost double
the length of time women in late stages of breast cancer survive after
chemotherapy), doctors are finally piecing together all of the new
drugs they have into cocktails that are saving many more lives.
Some experts now say that recent product launches for colon cancer,
including ImClone's (nasdaq: IMCL - news - people ) drug Erbitux, a
similar drug made by Abgenix (nasdaq: ABGX - news - people ), another
from Amgen (nasdaq: AMGN - news - people ) and Genentech's Avastin,
will mean similar gains for that cancer.
The bottom line is clear: There's still far too much death and
suffering from cancer, but investments in research are paying off.
Relaxed regulatory standards at the Food and Drug Administration when
it came to drugs that treated unmet medical needs (like advanced
cancer) have also contributed to these gains. Lower regulatory hurdles
allowed poorly funded biotech firms with good ideas to get new drugs
to market sooner and made it easier for doctors to make quick use of
the best new medicines.
But now the FDA is raising the bar when it comes to approving new
cancer drugs at the very moment when cancer seems more beatable. In
recent months, the FDA's cancer division has issued a number of new
policies that, taken together, will make it harder for new cancer
drugs to reach patients. As I noted in my recent issue of the
Forbes/Gottlieb Biotech Investor, this higher bar is already weighing
on the approval of some drugs in development right now.
While more rigid standards might make sense for routine medicines like
blood pressure pills and antihistamines, since medical options already
exist for these conditions, the same is not true of cancer. Despite
recent success, many cancers still have few effective treatments, and
even breast cancer and colon cancer, which have benefited from recent
innovations, still claim too many victims, especially when these
diseases reach advanced stages.
One big change is in the way the FDA evaluates new cancer medicines
for what is called "accelerated approval," where the agency rapidly
approves promising drugs for advanced diseases that are poorly treated
with existing medicines.
Previously, if no other drugs were approved for a particular kind of
cancer, then a new medicine would be considered for this accelerated
approval process. Now the FDA will consider all of the off-label
medicines that doctors might be experimenting with before it decides
if a new cancer drug should be eligible for the rapid approval
process. Since information on off-label uses of drugs is usually
preliminary and sometimes scant, comparing new drugs to off-label
medicines is going to give biotech companies a very hard and hazy
hurdle to beat.
The FDA's cancer division also said it is no longer going to consider
drugs for accelerated approval based solely on findings such as a new
drug's ability to shrink cancer tumors or stall their growth.
The FDA's cancer division is comprised of well-intentioned cancer
specialists, many of whom used to practice medicine but have since
left patient care behind. Having lost touch with the realities of
everyday medical practice over time, it has become too easy for these
former physicians to be absorbed by the statistical work of drug
review rather than the practical need to get new options to sick
patients as soon as possible.
For example, the FDA's medical reviewers focus only on a new
treatment's effectiveness relative to existing drugs. But they usually
ignore the fact that some new treatments have fewer side effects than
existing medicines, even though the newer medicine may not be as
effective at shrinking tumors. In the real world, the patients I see
on hospital rounds make tradeoffs like these every day, opting for
slightly less effective medical regimens if they come with fewer side
effects.
The FDA's cancer specialists, in some recent public meetings, have
also openly bemoaned what they call a "race to the bottom," where
biotech companies opt for the shortest possible clinical trials in
order to get their drugs to market as quickly as possible. The FDA
wants cancer companies to spend more time on trials and generate more
data about the ultimate effectiveness of their new drugs.
Delaying new treatments for the sake of generating more rigorous and
complete medical evidence helps patients--to a point. But in the field
of cancer, where practicing oncologists already do a very good job of
developing their own medical evidence and prescribe new medicines
based on the results of these scientific studies, the FDA's strict
posture is probably overkill.
Delays make drug development more expensive bye closing the market to
small biotech firms with good ideas and delaying new drugs from
getting to dying patients. The FDA is trying to save patients from the
harmful effects of new medicines that have not fully proved their
mettle, but in the process, many more patients will die from the
extended wait for the good medicines, than from using bad ones.
Scott Gottlieb is a physician and editor of the Forbes/Gottlieb
Biotech Investor. He is a fellow at the American Enterprise Institute
and is a former senior official at the Food and Drug Administration
and Medicare program. Dr. Gottlieb may own stock in the companies
mentioned in this article or consult with firms that advise them. His
FDA policy blog can be found at www.fdainsider.com.
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Send comments and questions to newsletters@....

Zavie,
I have provided our new group address to Stavos and promised to post his
message for you to see...
Lisa
Subject: HELLO FROM GREECE
My name is Stavros and i live in ATHENS of Greece.I have cml from
july
1996.First i had taken hydrea for 6 months,after i had taken
interferon
until May 2001 when Glivec comes in Greece.Today i am in 400mg i
have
ccr but last BMA test was two years ago.
I want to say hello to everybody.I read yours messages frequently.I
no
have any news from Zavie
and others old members.THANKS A LOT.
STAVROS
DXD 7/1996
#559 IN LIST

To all who have replied to my 5 year anniversary post.
Thank you!
And I look forward to seeing all of yours!
Lisa

Cheryl, Can we part of this petiotion?If so to what address and when should we
send the petition letter for BMS?
Teresa T

Hi Richard,
I think you have the right idea about addressing this to the BMS CEO,
that is what Suzan McNamara did with the Novartis petition. As for
the publicity, I can get something started here in Montreal and we
can certainly coordinate it with some PR activity in the states.
As you know Christine has volunteered to start up the petition and I
know she will be working on that today.
Cheers,
Cheryl-Anne

Hi Cheryl,
Since you seem to be computer savvy, I'm turning to you for help. I tried to
sign in to the cml2 home page last night and had forgotten my id and password
which started a long string of mishaps. I now have a new id and password but

Hi All,
I've been off-air the whole Memorial Day weekend, only now catching up on
emails and planning my work week. I'll start working on reaching my BMS
contact tomorrow, but I agree with what someone said, that a letter campaign
should proceed in parallel, and will probably be more productive in the long
run anyway.
Any letters we send should probably be short because otherwise they won't
get read. The more varied they are the better - though I know it's a
nuisance writing so many different letters. Mention of these listservs role
in moving Novartis to action a few years ago might also be worthwhile - to
give our recipient a sense of our potential clout. I don't know whether or
not we'd ever want to go to the media with this little campaign, but mention
of such a possibility would only help in getting BMS's attention.
We need to think about whom to address the letters to. BMS's CEO?
More tomorrow.
Cheers,
Richard R

Dear Dane,
It is always so good to hear from you and how well you are doing.
You are in my meditations and prayers on a daily basis.
Here's continued good wishes for your continued good recovery!
Namasté
Cheryl

Hi.
Please go to www.newcmldrug.com and scroll down to Shelley's post that
she posted with us and then read the response from Christine Sao
Miguel. It seems there's already something in the works and there
could be more important information tomorrow, June l.
Susan L

Congratulations for the intial peripheral blood PCR results. Go Dane Go
Teresa T

-Hi Margot, congratulations on your continued great test results. I
hope I can do as well as you are.
Shari from Kansas

Hi Nancy,
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.
Susan L

BMT +110
Been back home now for over a week and settling back into it nicely. We've had
a real heat wave down here so I have been laying low and trying not to get my
CVC dressing all sweaty.
I did get some initial test results back from the biopsy and blood tests I took
before leaving Houston on the 19th.
My peripheral blood pcr came back to 1.2 from a 5.6! This is a good sign that
either the Gleevec, my immune system or both are fighting the residual levels of
cancer cells.
I will be back in Houston on June 2 for the other test results and to receive
any change in meds. I imagine they will reduce my tacrolimus and start slowly
weaning me off it. I also hope to have this CVC yanked out then too!
I am very encouraged by these intial peripheral blood PCR results.
Health wise, I feel great. Lot's of energy and no outward sign of GVHD. My gut
is a mess...probably the massive doses of Magnesium, though.
Full report will be forthwith upon my return from Houston.
Regards and Prayers.
dt

IAintFinishedYet <kttweety@...
-0700 (PDT)
From: IAintFinishedYet <kttweety@...
Subject: Re: [cml 2] Digest Number 81

Hey Dave & Group:
My PCP diagnosed Conjunctivitis in '04 post our bug and my Optometrist has ran
tests each year due to the symptoms you are having at this time. To date, it is
a side effect of the gleevec and it comes and goes with the weather changes. I
would like to know what your doctor says about it though. As a Midwesterner, who
spent many years in Arizona, you have made the right decision with your move.
Could someone please email me offlist with the information to write concerning
the trials. I don't read the digests everyday. I will participate and get family
and friends involved in this when the time comes by letters or petition.
"K"
"I AIN'T FINISHED YET"!!!

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 Richard 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 Richard 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,
Susan L

Hi:
Just thought I'd report that I just got my latest PCR results back
from MDACC. When I found out that the results just were for a qRT
PCR with a sensitivity of 100,000 cells, I was taken aback because
they had always done nested if the quantitative PCR was negative.
So I quickly e-mailed Dr. Koller to ask if nested had been done and
asked if possibly the nested wasn't completed yet. Here is the
answer I got back:
"The lab has found that with improvements in realtime PCR that the
nested PCR will not add sensitivity unless there is a problem with
amplifying abl, which in your case there was not. Also, there was
no discrepancy with the genescan. They will stick by their results
with a sensitivity of 1:100000.
Your reward for such an excellent test: stay on your Gleevec."
Of course, I am very happy with these results--who wouldn't be.
But I still I could use some explanation of exactly what "amplification"
means in this case as I always thought that the amplification
happens with the nested PCR, also what "genescan" stands for.
Anyone up to this explanation?
Margot

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
Richard R and Nancy, would be a very good thing. It would certainly help
them by giving more information to add to the file for the FDA.
Richard 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 Christine and for her and her
family her diagnosis with CML has presented many enormous challenges, which
she has faced with absolute grace and dignity. Christine 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

Dear Gloria:
Welcome back! It's good to hear from you. I remember vividly your pre BMT
posts. You sounded so worried and now look! Hope all continues to be well with
you.
Kathie in Florida/Kentucky
--

HELLO TO EVERYONE!
THIS IS GLORIA, I'M 2 DAYS AWAY FROM BEING 8 MONTHS POST BONE MARROW
TRANSPLANT. I'VE BEEN SO OUT OF THE GROUP LOOP, WHAT HAPPENED TO THE
OLD ONE? ANYHOW...IF THERE ARE MEMBERS WHO DON'T KNOW ME YOU CAN
VISIT MY CARINGBRIDGE SITE AT...
WWW.CARINGBRIDGE.ORG/MI/GLORIADUNFORD
GLAD TO HAVE FOUND YOU ALL AGAIN!
LOVE GLORIA

Hi Shelley,
After I wrote to you I realized that it seemed like I was sloughing off
responsibiilty to those in the BMS trial and I really didn't mean to do that. I
just read Richard's note and will certainly participate and ask friends and
family to do so, too. I do think it's a good idea to post on Jerry's site
though and I'm glad you did.
Keep us informed, please.
Best of everything,
Susan L

Hi Dave,
I have had the same itching, watering some pain in my eyes. Mostly my
left eye. I found some drops named Similasan. I found them at
Alberson's pharmacy. They along with artifical tears have helped me
tremendously. Hope this helps.
Joan P.
dxd 8/2003
CCr 3/2004
Gleevec 400mg.
#662

Well the gum surgery and grafts started to bleed a lot, so I had to
return to the periodontist and the hematologist. What fun! I'm to be
resting all weekend, and really resting. The graft is okay, however,
although I had more sutures and more numbing. This is the third bleed
in less than a year. The doctor's PA and I were 'laughing' about these
periodic things. It happens even with good care and caution and
prevention.
Thanks for listening, MJ

Yes, I had a similar side effect with one eye bleed. I used artificial tears
drop to calm it down. It last two weeks and start to be normal now. I believe
that this is gleevec side effect because my eye doctor said there was nothing
wrong with my eye.
Teresa T
dxd 1/03
CCR 7/03
PCRU 3/05
400 mg gleevec

Hi fellow CML'ers
For the last 3 days I have a pain in my left eye. It was itching and I
think I rubbed it to hard. It's turned red and yellow and quite
painfull. This is the second time in 2 months that I've had the
problem. I made a appointment with my eye doctor for this afternoon,
will see what he can come up with. Has anyone else have the same
problem? Otherwise all is well. Moving from Crown Point, IN. to
Venice, Fl. in a few months, I CAN NOT TAKE ANY MORE COLD WEATHER.
You all take care.
Dave Greenberg
Crown Point,IN.

Hi Shelley and Judy,
Great idea. I know someone high up in BMS and will write him about this.
I'll think about what else I can do as well. A letter blitz from everyone on
all the CML lists (which are MUCH larger than they were before because we
live so long now, and because we're such a gregarious group of "patients"
;-)), along with their family and friend ought to do it. If we do this, we
should aim to send all the letters in the same week.
Cheers,
Richard R

I was sleeping when I awakened to find the blood. However, it has
stopped. I'm calling the periodontist just to check to make sure I
don't have to go in or anything. I'm happy I didn't call him at home
at 3 am. Thanks so much, MJH

Hey Lisa,
Congratulations and thanks for the wonderful post sharing your feelings of
enthusiasm and grace.
Here's to many, many more years of success with this disease for you and all
of us.
Cheers,
Cheryl-Anne

Hi Barbara:
I stayed up for a couple of hours, and the bleedig has stopped. I put
ice on jaw and cheek. I think I'll sleep now, and call the
periodontist in a couple of hours. Glad I didn't panic - just tried to
relax by watching a film. When I saw blood when I awakened, it was
quite frightening.
My platelets are 80000, and I took Amicar. I still had leftover
solution in the refrigerator though I don't know if it was very useful,
but I used it.
Thanks for writing so early, and I sure hope there are no further
complications.
MJ

MJ,
My son Tom had gum graft surgery just before being diagnosed (7/04).
The periodontist told us to put damp gauze on the wound and apply
pressure to it for five minutes. The gauze should be damp so that it
doesn't stick to the wound and then pull off skin. He also told us to
place a wet tea bag over the wound and apply pressure for five minutes.
Tom's bleeding was extreme - he blew out his stitches three times. The
periodontist said, "Are there any bleeding or clotting disorders that
run in your family?" I said, "No, nothing like that." His concern
eventually led us to the clinic and a CML diagnosis. Thank goodness Tom
had the gum graft. Anyway, I would call the periodontist. Tom also
wound up having a spot in the roof of his mouth cauterized to stop the
bleeding. I hope this helps and that your bleeding stops. Are your
platelets low?
Barb

I awakened to find the gum surgery and graft I had bleeding. Trying to
stay calm. Should I call periodontist, dentist? Is it natural--this
is the third day after. Anyone up? Suggestions? I put ice on my
face.
thanks, MJ

Hi Shelley,
Thanks for the news, even though it isn't good. I highly recommend that you go
to Jerry Mayfield's website www.newcmldrug.com , then find BMS Discussion and
post your message there. There are a lot of people in the BMS posting there and
they have access to the BMS people all the time.
Susan L

Hi all!
My computor has been down for more than a week. I finally had to break dopwn
and get a new one. I received this letter from Judy Orem, and am passing it on
to you. I hope that you can help.
Shelley
Yesteray I was up at OHSU with a couple friends who were seeing Dr Druker. He
told both of them that they need to get on the BMS trials NOW. Both are
chronic but having difficulty controlling their counts with 800 Gleevec.
OHSU won't have the phase II trial before July at the earliest due to feet
dragging from the board that oversees new trial requirements at OHSU. Admin
type people and not doctors.
There are five different protocols that are involved with Phase II so that hope
is that Ray and Ginny can get into one. The problem that needs help is that BMS
is considering closeing phase II now and waiting for six months to go to phase
III. Novartis wanted to do a similar thing but the petition convinced them that
the need and interest was there to enlarge the phase II trial. Those new folks
got on the drug but were not officially part of phase II. That meant that when
Gleevec was approved they no longer continued to get their drug like the real
phase II folks are doing. Rather they were a ready market for purchasing
Gleevec and were advocates to their health insurance companies to get them to
add Gleevec to their prescription list.
What I think we need now is another gound swell from the cml community to go
after BMS to get them to expand rather than close the phase II trials. That's
where you come in. We need someone who is part of that community to shake,
rattel and roll the group into doing another petition or some such to get this
done. Can you see if there might be some interest in pushing BMS (CO.) to
increase rather than shut down phase II? Please see if you can get some
interest out there to help the folks that Gleevec isn't enough for and who need
the new BMS drug now.
I talked with Gina, on the LA phase I trial, and she feels great. Since she was
more advanced she is slower to get cytogenetic results but her counts are under
control and PCR shows improvement. The best part is she feels alive again. She
said they are getting really good results at LA and the side effects are
un-noticeable for her or her friends on the drug.
Any help is appreciated.
Shelley