mifepristone

[Guest guest]

Hello, this is my first posting on the site and I have an important question.

Why is there not an uproar about the witholding of Mifepristone for fibroid

treatment????The studies have all shown high percentage of shrinkage all symtoms

aleviated and very few side effects. We are being forced to have unneccesary

surgeries for some stupid political reasons. I think we need to insist that our

doctors find a way to get us this medicine and NOW.

[Guest guest]

Hi Diane:

Actually, the research study using asoprisnil has even better results than with

the mifepristone. The mifepristone can cause hyperplasia, which is a

pre-cancerous condition of the uterine lining. The asoprisnil, so far, does

not. For more information, go to:

http://www.luhs.org/templates/luhs/clinical_trials/index.cfm?id_col=22

Good luck - feel free to keep in touch,

Edie

[Guest guest]

> Actually, the research study using asoprisnil has even better

results than with the mifepristone. The mifepristone can cause

hyperplasia, which is a pre-cancerous condition of the uterine lining.

The asoprisnil, so far, does not.

> Edie

***************************

Um, based on " what " are you making this claim regarding asoprisnil?

The clinical investigators have published NOTHING (related to human

use) on their drug, to date. NOTHING. The clinical work is still in

progress and all we have is heresay info from a variety of docs

participating in the clinical trials and still attempting to recruit

patients for the trial. I've specifically asked researchers involved

in asoprisnil WHEN they intend to publish their results....and have

got nothing but the run around....I've also heard there may be " other "

problems associated with asoprisnil...but no one seems to want to

clarify what this means....ly, I'm still waiting for the

explanation that clarifies what happened to the asoprisnil precursor...

We do have a recently published ANIMAL study on this drug ...seems to

me that this should have been published well before taking on human

subjects...but, then again, that's probably just my " patient advocate "

side showing overt protectionism....

Asoprisnil (J867): a selective progesterone receptor modulator for

gynecological therapy.

DeManno D, Elger W, Garg R, Lee R, Schneider B, Hess-Stumpp H,

Schubert G, Chwalisz K.

Steroids. 2003 Nov;68(10-13):1019-32.

TAP Pharmaceutical Products Inc., 675 N. Field Drive, 600452, Lake

Forest, IL, USA

read the abstract (or order full text) here:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=1\

4667995 & dopt=Abstract

At AAGL, I learned that Dr. Francis Hutchins -- a leading fibroid gyn

who was recruited just last year by TAP to lead the research on this

-- is no longer employed by TAP. His departure was seemingly NOT

amicable...but explanations on this were sparse.

Sorry, but at this point I would have to entirely disagree with your

conclusion re: asoprisnil vs. mifepristone. Until data is publicly

shared via the peer review publishing process, we can't say we really

know much of anything about asoprisnil and fibroids.

Carla Dionne

Executive Director

National Uterine Fibroids Foundation

http://www.nuff.org

[Guest guest]

Hi Carla:

Thanks for the clarification - mine was only my personal comments from all the

reading I have done, thus far, on mifepristone and asoprisnil. That is why it

is good you are monitoring these posts because of course you will always

(hopefully) have up-to-date info for all of us.

Thanks again, Edie

[Guest guest]

Thanks...I called to enroll. But I don't think that this drug has been through

as many trials with as good results as mifepristone., and there are a few more

side effects with it.

[Guest guest]

Great news today...I contacted the Feminist Majority and discovered that they

have a program called Compassionate Use.

This allows Drs to request certain drugs for patient who have no other options

for quality of life improvement. check it out. I called my dr and she is looking

into it for me

[Guest guest]

> Great news today...I contacted the Feminist Majority and discovered

that they have a program called Compassionate Use.

>

> This allows Drs to request certain drugs for patient who have no

other options for quality of life improvement. check it out. I called

my dr and she is looking into it for me

**************************

Well, I'm not sure who you spoke to at the Feminist Majority

Foundation but....while they do indeed work under FDA guidelines for

Compassionate Use of mifepristone....fibroids does NOT quality.

The FDA reviews and approves all applications for Compassionate Use of

this drug. You wrote " ...who have no other options for quality of

life improvement. " The hysterectomy IS an option. As is myomectomy

and embolization. I know of only one case of fibroids where a woman

applied for this due to other severe medical conditions which

prohibited her from safely undergoing surgery or embolization...and to

my knowledge her application was NOT approved. I'll double-check on

this though because I do know her case was severe and things may have

changed from the last I heard of it.

What, for example, qualifies for Compassionate Use under FDA

guidelines? A medical case along the lines of an inoperable brain

tumor which has progesterone receptors -- a meningioma.

Sorry. Wish fibroids did qualify. Don't know of a single case where

they have.

Carla Dionne

[Guest guest]

http://www.acog.org/from_home/publications/green_journal/wrapper.cfm?document=20\

03/ong13884fla.htm

[Guest guest]

Carla,

Needlesss to say how dissappointed I am...surgery isn't a possibility for me due

to psychological reasons ( for which there is a lot of documentation) but that's

not the part that feels so bad. What about all the other women that are being

subjected to expensive and dangerous procedures that could be totally

unnecessary? I am assuming that you are involved in the Feminist Majority in

some way. What can we as women collectively do to change this ?

Re: mifepristone

> Great news today...I contacted the Feminist Majority and discovered

that they have a program called Compassionate Use.

>

> This allows Drs to request certain drugs for patient who have no

other options for quality of life improvement. check it out. I called

my dr and she is looking into it for me

**************************

Well, I'm not sure who you spoke to at the Feminist Majority

Foundation but....while they do indeed work under FDA guidelines for

Compassionate Use of mifepristone....fibroids does NOT quality.

The FDA reviews and approves all applications for Compassionate Use of

this drug. You wrote " ...who have no other options for quality of

life improvement. " The hysterectomy IS an option. As is myomectomy

and embolization. I know of only one case of fibroids where a woman

applied for this due to other severe medical conditions which

prohibited her from safely undergoing surgery or embolization...and to

my knowledge her application was NOT approved. I'll double-check on

this though because I do know her case was severe and things may have

changed from the last I heard of it.

What, for example, qualifies for Compassionate Use under FDA

guidelines? A medical case along the lines of an inoperable brain

tumor which has progesterone receptors -- a meningioma.

Sorry. Wish fibroids did qualify. Don't know of a single case where

they have.

Carla Dionne

[Guest guest]

Hey,

In my research into progesterone over the past few weeks I did come

across a couple interesting links which talked about how RU486 worked

from a hormonal standpoint. These articles talk about it in

relationship to endometriosis and depression, not really in the

context of it an an emergency contraceptive. It's pretty interesting.

RU-486 may dramatically relieve psychotic depression

http://news-service.stanford.edu/news/november8/ru486-1108.html

RU-486 Explained

http://www.endocenter.org/ru486explained.htm

--Ann

[Guest guest]

> Carla,

> Needless to say how disappointed I am...surgery isn't a possibility

for me due to psychological reasons (for which there is a lot of

documentation) but that's not the part that feels so bad. What about

all the other women that are being subjected to expensive and

dangerous procedures that could be totally unnecessary? I am assuming

that you are involved in the Feminist Majority in some way. What can

we as women collectively do to change this?

*******************************

Dear Diane and all the members of this group,

The #1 thing you and everyone concerned about this can do: lobby like

crazy to get your Senators and Representatives to support the Uterine

Fibroids Research and Education Act. Talk it up to EVERYONE you know

and even those you don't know at all.

- Getting your hair cut? Talk about it LOUDLY to your beautician.

- Out shopping with friends and find yourself in a " captured " line at

the register? Don't be shy...talk LOUDLY and use that opportunity to

educate the unsuspecting eavesdroppers all around you. What better

time to do this than during the month of December when nearly every

store in the nation is packed with shoppers waiting in line?

- Attend religious services? Make an appointment with whoever gives

the weekly services at your place of worship and talk about how

devastating this disease is and how women you care about within your

own congregation can find help and give help to one another. It has

always amazed me to find overwhelming support among pastors, priests,

and rabbi...religious representatives who service their members

individually through all the trials and tribulations of their lives --

including disease, infertility, surgery, and subsequent outcomes. Oh,

the conversations I've had with clergy...the changes in women they

witness post-hysterectomy...the marriages they counsel struck by this

disease and/or fallout from treatment. Clergy are incredible allies

-- if we only seek them out and open the door for discussion.

(Footnote on clergy: Mifepristone is too often perceived as ONLY an

abortion pill. We need to share our knowledge of mifepristone as a

fibroid treatment with these people -- even if it means printing off

that published study and hand delivering it to them. We also need to

share that mifepristone in a 5-10 mg dose -- a fraction of the dose

used for abortion -- is SAVING LIVES DAILY and has been for about a

decade in this country. How? By shrinking brain tumors. Why are we

still in FDA approved " Compassionate Use " mode for a drug that has

clearly demonstrated it's life saving potential with brain tumors?

Why is any meningioma patient in this nation still subjected to major

brain surgery -- a horrific surgery that I wouldn't wish on anyone,

having simply witnessed it twice with my very own sister -- when there

is a drug available that would mitigate this need? Why? Your clergy

desperately needs to hear this question and learn of your perspective

on this issue.)

There are many, many public opportunities for expression, if we only

seek them out. Radio, TV, and newspapers are in abundance in this

nation...and looking for YOUR story ideas. Call them. Again and

again and again. Identify the health reporters and/or health editors

working in YOUR community and target them with an information blitz

and queries as to why they aren't covering this story. Don't take no

for an answer...you just KNOW the women in your community need this

information in order to truly make an informed decision regarding

their health. Clip stories you've seen elsewhere and ask them why

THEY aren't doing a story too!

Are the women of Mississippi, Alabama, Arkansas, Louisiana, (pick your

southern or midwestern state!) any less deserving of appropriate

information on treatment alternatives than the women of Illinois, New

York, California, or Massachusetts? Apparently they are...because

I've NEVER seen a story on fibroid treatment alternatives run in a

Mississippi paper yet that was actually instigated/written by a

reporter living there! No wonder their hysterectomy stats pop off the

CDC charts! No wonder gynecologists get away with joking about women

who still have a uterus in the state of Mississippi by labeling them

" escapees " ! That's right – " escapees " from the hysterectomy are a

rare breed in the fine state of Mississippi. If women living there

only knew about the alternatives…if women living there only knew how

they were being talked about in the gynecological community…if women

living there only knew what mindless lemmings they are perceived as by

joking physicians who have forgotten entirely the concept of medical

ethics in informed consent…if women living there only knew…

And if you're thinking Mississippi sounds pretty bad right about

now…don't even get me started on Native Americans and the embarrassing

state of Indian Health Services in this nation. Budget cut after

budget cut has decimated the funding desperately needed to equip and

appropriately run IHS hospitals. Reliant on volunteer physicians to

give of their time…volunteer physicians who firmly and quite

ignorantly believe poverty on the reservations could be avoided if the

women there simply stopped having children. In the 70's there was a

Congressional investigation and hearing on this. Sadly, unbeknownst

to many, not a lot has changed since then. Well, except for one

thing…these days Native American women avoid the IHS hospitals and

volunteer physicians like they would avoid blankets tainted with small

pox…at least, if they have any kind of choice at all, they definitely

go elsewhere for health care related to their reproductive organs…

Congress will be entering into the second half of this session in

January and as soon as the holidays are behind us it will be critical

to take charge and begin activism like you've never thought you could

previously! Currently, only 4 Senators are listed as co-sponsors of

this bill. That's an appallingly far cry from the number who

supported the previous version of this bill during the last

Congressional Session. Also, less than 100 Representatives in the

House currently support this bill. This is truly a very sad state and

can only be turned around by women choosing to get involved who won't

take " no " for an answer and can rally their own contingency of

supporters online and off to make those calls, emails, and letters

shouting from the rooftops that we want support for this bill.

We'd also like a wee bit of accountability on prior NIH " fibroid

research " funding which has been primarily pharmaceutically co-opted

(e.g., Lupron) or directed towards the hysterectomy. Little to none

of this " fibroid research " has served women with uterine fibroids well

nor has it resulted in a single change in the status quo of

hysterectomy in this nation. Congress needs to know what our NIH

dollars have/have not done for women with uterine fibroids and

precisely how ANGRY all of the lackadaisical, wasteful,

pharmaceutically co-opted, gynecological-financially-motivated

attitudes of those in charge of soliciting/approving research

proposals towards this condition, and the utter lack of even looking

at funding/finding potential solutions beyond the hysterectomy makes

all of us. ANGRY!!!

Actually, from the movie script of " Network':

" … " I'm as mad as Hell, and I'm not going to take this anymore! "

and

" All I know is, first, you've got to get mad. You've got to say, " I'm

a human being, God damnit! My life has value! "

Yep. Angry. And I'm not going away any time soon. I want NIH

accountability for their lack of funding for appropriate uterine

fibroids research during the last three decades and I have every

intention of going after that accountability in any/every way possible

in the coming year. I need YOUR anger and activism on this too.

Stand up and DEMAND accountability and let your Congressional

Representatives know just how angry YOU are about the maintenance of

the " hysterectomy status quo " in this nation. Point fingers. Request

a Congressional investigation. Demand accountability. Make your

passion stand up and be noticed in the strongest proactive manner you

can muster.

Uterine fibroids is possibly the most prevalent disease women in the

United States face today. While mortality from this disease isn't on

the scale of cancer, it DOES exist. We've seen it first hand from the

membership base of this group. I've also felt the impact of mortality

in my position offline as the director of NUFF -- as we've provided

educational materials for distribution at more than one funeral in the

past year in this country. Thanks to fibroids. But you won't read

about those cases in the medical literature. It's simply not in the

best interest of physicians to publicly expose their own negligence in

the medical care of patients. If a woman dies of cancer, vital

statistics picks up on the data. If a woman dies from complications

related to hysterectomy, myomectomy, or embolization, or any

mitigating factors related to fibroids, such as embolism or simply

bleeding to death -- well, you won't see those numbers collected by

anyone in a manner that is useful to identifying its association to

fibroids. Nice bubble of silence that leaves no one truly knowing or

understanding the extent of potential harm from fibroids.

In the coming year, I have every intention of putting a face -- a very

real face -- to mortality reality of this disease. Courtesy of

uterine fibroids, " Cheryl " bled to death in the arms of her husband as

they were waiting for an ambulance. " Cheryl " had a Master's Degree

and was recognized as one of the top 100 educators in this nation. As

a widely loved and well respected African American role model, the

work she did with misguided/misdirected youth in her community to get

them back on track and contributing members of society was an

incredible testament to the loss this nation experienced when she

died. Highly educated, state and nationally recognized for her

educational and societal contributions, she did NOT neglect her health

or her specific fibroid-related bleeding condition. In fact, she was

under a gynecologist's care at the time of her death. Unfortunately,

her gynecologist told her that hysterectomy was her ONLY choice and

embolization wasn't an option because there were purportedly no

interventional radiologists in their state who performed the

procedure. So, believing and trusting her gynecologist, " Cheryl " made

plans to travel to another state to receive fibroid embolization

treatment. She never made that appointment.

" Cheryl's " death certificate clearly identifies " fibroids " as her

cause of death.

Neither " Cheryl " nor her spouse knew there was, in fact, an

interventional radiologist on staff at a hospital less than an hour

from her home who would have gladly performed fibroid embolization for

her.

Death may be rare, but it DOES occur. Sometimes, entirely without an

ounce of justification.

While death is the ultimate devastation, fertility and the future of

our reproductive capabilities are also seriously at stake with this

disease -- and for African American women it may represent an

ever-increasing certainty of infertility. That may sound a wee bit

dramatic...but environmental endocrine disruption is at an all time

high and one only has to look towards the research done by the World

Wildlife Federation to know that what we are seeing in animal

populations in the U.S. and around the world will indeed trickle down

to humans, given time and lack of intervention. It is NOT a pretty

thought ladies. Ambivalent sexuality/genitalia is already a reality

in some species...as is simply the extinction of some species.

How ludicrous is it for the human race to bow down to the almighty

hysterectomy politics and financial war of physicians and

pharmaceuticals when the reproductive future of generations to come

may be on the line here? The BIG PICTURE goes beyond the war on

hysterectomy, folks. The BIG PICTURE has to do with pinpointing

cause, cure, and prevention. We'll never find solutions if we

continue to be mired in the hysterectomy status quo that seems so near

and dear to powerful lobbying groups, such as that put forth by ACOG

and the pharmaceutical industry. Let's not kid ourselves here – our

uteri is their business. BUSINESS. What is, exactly, a

gynecologist's return on investment (ROI) in you if you choose an

alternative treatment s/he doesn't perform? What's his/her ROI if

there's a cure or prevention? What is the bread and butter of a

gynecologist who no longer delivers babies? The ugly truth? The

annual hysterectomy statistics in this nation aren't as high as they

are because gynecologists are taking the time to actually discuss with

their patients the alternative treatments currently available. No

way. What's the ROI on that nonsense?

As you can read…I could go on and on and on about this…there is SO

much to share…SO much to learn…SO much to inform the public on…but I

can't do this crusade alone.

We need to take a stand on all of this and more – collectively and

with all the passion we have buried deep inside of each and every one

of us. We need to simply draw a line in the sand and embark upon an

all out war against research funding ambivalence and complacency

regarding the hysterectomy status quo. Breast cancer folks didn't

find themselves with $1 billion/year funding by sitting around and

waiting for Congress to do the right thing. They became organized and

vocal. Extremely. Now that their teeth are firmly planted in the

hineys of everyone in Congress and most of Corporate America.... we

need to take a close look at how to sink OUR teeth into the other

" cheek " and demand some research/funding for uterine fibroids.

Whether you're a pit bull or a pug, a Labrador or a poodle…it's time

to choose your targets and take a bite out of this problem. Nothing

will change if you don't begin barking, and barking loudly. In every

way imaginable – as well as a few ways that, perhaps, you would never

have imagined! Throw your party line into gear and pick up that phone

to dial in everyone you know.

It is, after all, a numbers game. Without great numbers of women

speaking up, the problem will continue to have the door slammed in its

face. The bill currently sitting in Congress will be swept under the

rug yet another year….

Okay, stepping down from the soapbox now. There's so much more I'd

like to share. But 2,000+ words are enough for any single rant….

Carla Dionne

Executive Director

National Uterine Fibroids Foundation

p.s. As the year comes to an end, please don't forget the National

Uterine Fibroids Foundation in your list of tax exempt charities. We

desperately need your dollars to keep the phone lines up and brochures

printed for distribution….and so much more. Currently, I'm posting

this email online via a public computer because the main NUFF computer

has maxxed out its memory, as well as its ability to withstand viruses

and hackers. It's been sitting in a computer service shop for most

of this week, as the techs help me to retrieve data files and archived

email so that I can migrate it all to a new computer – a computer than

NUFF can't really afford right now but has to have. We need your help

in many, many ways. Please give whenever and whatever you can. If

not dollars, then time. Time calling every single member of Congress

and letting them know just how you feel about all of this and more….

p.s.s. Happy Holidays to all of you. Please forgive me, as I'm not

always this verbose – but the tipping point has been reached for me

and you need to know just what this may mean in the coming year for

NUFF as our cries for your support both financially and in public

displays of activism escalate.

p.s.s. You have my express permission to forward this email to anyone

you deem appropriate.

[Guest guest]

Dear CArla, Thank you for your reply and all the amazing work you've done to

date on tnis issue. I am new to all of this, having been suffering with heavy

bleeding for years, but only recently diagnosed with fibroids as the cause. In

the few weeks that I've been looking into this , I have seen so little about

mifepristone and the other trial drugs available, and on the message boards they

are never even mentioned. I have already contacted my congressman Sen

Jeffords and have a meeting with someone in his office next week. Don't you

think that as patients every woman should be hounding her physician to get these

medications for her? Don't doctors have any clout in all of this? I know my gyn

was thrilled to see the studies from Rochester and Santa Barbera...and will go

to b at for me with the Feminist Majority for compassionate use....if many

doctors did this would it help?

What I don't understand is they ALREADY use the drug daily for the controversial

purpose....how can using it for sick people make any difference politically? and

women who want abortions have alternatives...regular abortions so why would they

expect someone to have a hysterectomy instead of trying a daily inexpensive

pill?

so many questions

d