My name is Eleanor Smeal. I am President of the Feminist
Majority Foundation.
For the past eight years, French women and women in Great Britain,
Sweden and China have had available to them the option of medical
abortion. For eight long years, American women have fought to
have this choice available to them.
Every step of the way, rather than decisions being based on
pure science and medicine, politics instead have blocked or slowed
the distribution of mifepristone. If only the medical well-being
of women were the issue, mifepristone would have been approved
eight years ago.
The Feminist Majority Foundation has led the nation's largest
public education campaign to make mifepristone available in the
U.S. The Feminist Majority Foundation began our Campaign for RU
486 and Contraceptive Research in 1988 after an exhaustive review
of scientific data on mifepristone, extensive consultations with
leading scientists and health care providers in the U.S. and abroad,
and visits to clinics in France where we spoke with women who
had undergone medical abortions with mifepristone. As women's
health advocates, we wanted to make sure mifepristone was as safe,
effective, and acceptable to women as it appeared from news reports.
Our conclusion: Mifepristone as a method of early abortion
and as a potential treatment for diseases and conditions ranging
from some forms of breast cancer to endometriosis is major medical
breakthrough in women's health care that must be made available
to women in the United States.
The feminist and scientific communities in the U.S. share this
very positive assessment of mifepristone. Over the past seven
years, we have delivered over 700,000 petitions from women and
men in this country urging the French company that developed RU
486 and its German parent company to license the compound in the
U.S. We also presented petitions from 3,000 scientists and academicians
who were outraged at the medical McCarthyism of allowing politics
to prevail over scientific research. All major feminist and women's
organizations and medical and scientific associations in this
country have passed resolutions asking for introduction of mifepristone
to the United States and for an expansion of trials on the compound's
many promising indications. These associations include the American
Public Health Association, National Organization for Women, American
Psychological Association, American Association for the Advancement
of Science, National Abortion Rights Action League, Association
of Reproductive Health Professionals, National Women's Health
Network, Endocrine Society, and American Institute of Biological
Sciences to name a few.
And the public supports mifepristone. Last year, Lou Harris,
the dean of pollsters, asked a nationwide, cross-section of Americans
whether or not they thought RU 486 should be made available to
women in the U.S. An overwhelming 66% said yes, which is especially
significant since mifepristone is not yet on the market here.
Legislatures in states such as New Hampshire, California, Hawaii,
Colorado and Maine have passed resolutions in support of mifepristone.
Physicians also are ready to incorporate mifepristone into their
practice of medicine. The Kaiser Foundation found that one-third
of obstetricians and gynecologists who currently do not perform
abortions are interested in administering mifepristone.
Why has mifepristone inspired such enthusiasm among women and
health care providers? Used in France up to 49 days and in Great
Britain and Sweden up to 63 days, mifepristone is a safe, effective
method of early abortion. Since physicians generally do not perform
vacuum aspiration abortions until the seventh week of pregnancy
or later, mifepristone is the only method of early abortion a
women can seek as soon as she knows that she is pregnant. Mifepristone
gives women greater control over their termination of pregnancies.
The mifepristone procedure is non-invasive, does not require anaethesia,
and has no risk of infection.
A leading mifepristone researcher, Dr. Gary Hodgen, who is President
of the Jones Institute Foundation and Professor of Reproductive
Medicine at the Eastern Virginia Medical School, had planned to
testify today. Dr. Hodgen was called away for a family emergency,
but he wanted me to convey to you his conclusions about the compound's
safety. Dr. Hodgen brought the first RU 486 into the USA in 1982.
He has studied mifepristone extensively in both pre-clinical and
clinical trials, some up tone year of therapy. He has published
over 30 peer-reviewed articles on RU 486. In all of his research
experience, Dr. Hodgen has found no scientific evidence of safety
problems from mifepristone. Even embryonic and fetal development
progressed normally, despite earl exposure to RU 486 either in
vitro or in utero. Dr. Hodgen concludes, "I believe
that this drug is safe for women!"
The Feminist Majority Foundation receives calls almost daily
from women wanting to know where they can go to obtain RU 486.
Some of these women so want access to this medication that they
are willing to travel to Great Britain to the Marie Stopes Clinic
which accepts American patients. Women who have had access to
mifepristone greet the new procedure very positively. In France,
approximately 80% of women seeking abortion during the early stage
of pregnancy for which mifepristone is appropriate choose the
medical procedure over surgical abortion. In the United States,
where almost 50% of abortions now take place in the first nine
weeks of pregnancy, and 90% are performed in the first trimester.
Mifepristone will replace at least 50% of surgical abortions.
The Feminist Majority Foundation has fought long and hard to
protect women's access to abortion and other medical services.
In addition to our work to bring mifepristone to this country,
we lead a nationwide National Clinic Access Project to protect
clinics from anti-abortion violence. We work closely with non-profit
clinics, for-profit clinics and individual doctors that perform
abortions. Our annual National Clinic Violence Survey found that
in 1995 violence at clinics experienced an decline overall, but
38.7% of clinics still faced one or more of the most severe forms
of violence, including death threats, stalking, bomb threats and
bombings, chemical attacks, blockades, invasions, arson and arson
threats. Availability of mifepristone could significantly curb
anti-abortion violence. As more physicians begin to administer
mifepristone, abortion services will become more decentralized
significantly undermining anti-abortion violence at clinics.
The time for approval of mifepristone is now -- and long overdue.
Every day that mifepristone is not available to American women
is another day that some woman will suffer needlessly. And, equally
important, every day mifepristone is not available is another
day that scientific development of anti-progestins for a number
of serious diseases and conditions primarily affecting women will
be delayed.
Today's hearing is on the safety and efficacy of mifepristone
as a method of pregnancy termination. But your actions today and
the FDA's ongoing review process of the Population Council's New
Drug Application for mifepristone as an abortifacient have great
bearing on future research and development of mifepristone as
a treatment for a whole host of diseases and conditions that affect
both women and men.
In 1989, under the Bush Administration, the FDA issued an "import
alert" on RU 486 sending the message that the United States was
hostile towards the research and development of mifepristone.
The import alert, as scientific researchers testified before Congress,
effectively brought to a halt even non-abortion research on mifepristone.
It is time for the FDA to reverse this negative symbolism. With
its approval of mifepristone, the FDA will signal scientists and
manufacturers that research on the compound's many indications
for improving women's health can move forward at long last.
Here are just some of the promising uses of mifepristone that
result from the compounds properties as both an anti-progestin
and an anti-glucocorticoid:
- Mifepristone shows promise as a treatment for progesterone-dependent
breast cancers, which account for some forty percent of all
breast cancer tumors. (Add footnotes) New research has found
mifepristone may inhibit the proliferation of ovarian cancer
cells.
- Other trials have found that mifepristone may be used to treat
endometriosis and fibroid tumors. (Add footnotes)
- Meningiomas, brain tumors which can be fatal if inoperable,
have shown some response to mifepristone in clinical trials.
Meningiomas occur two times more frequently in women than men.
(Add footnotes)
- Some forms of Cushing's Syndrome, an adrenal disorder that
results from the over-production of cortisol and that primarily
affects women in their 20s-40s, can be treated with mifepristone.
(Add footnotes) Two survivors of Cushing's Syndrome testified
before Congress in 1990 that mifepristone saved their lives.
(Add footnotes)
- Labor induction to facilitate birth and emergency contraception
are two of the many other serious conditions for which mifepristone
may be an effective treatment. (Add footnotes.)
- Mifepristone's anti-glucocorticoid action may have profound
indications for the treatment of HIV virus, Alzheimer's, depression
and other diseases and conditions related to elevated levels
of cortisol.
And scientists want to do this research. Two prominent researchers
who have studied mifepristone asked me to submit their testimony
today and to convey to this Committee how much your recommendation
and FDA approval of mifepristone will mean to women's health research.
Dr. Kathryn Horowitz, a breast cancer researcher at the University
of Colorado, who testified before Congress that the FDA's import
alert had impeded her ability to secure supplies of RU 486, now
is using the Chinese version of mifepristone in trials. Dr. Ana
Murphy conducted some of the pioneering research on the use of
mifepristone as a treatment for endometriosis and fibroid tumors.
This research has been stalled by limits on the supply of mifepristone
available for U.S. trials in the absence of an American distributor
for the compound. Approval of mifepristone by the FDA will finally
open the doors to much-needed medical research.
The women of this nation already waited far too long to have
access to the same medical treatment available to women in Europe.
Over 200,000 women from around the world have used mifepristone
as a method of early abortion. It is safe. It is effective. Mifepristone
has met and exceeded all FDA requirements for licensing. The Population
Council has submitted 163 volumes of data to the FDA. We urge
this Advisory Committee and the FDA to act expeditiously to allow
this medical advance to finally be brought to American women.
Thank you.
Fact Sheets on Mifepristone
The Chronology of The Fight
to Bring RU 486 to American Women
