Anti-Abortion Politics Jeopardize Clinical
Trials
Despite mifepristone's very exciting medical
promise, anti-abortion politics has interfered with the
development of the drug's full potential. In the 1990s
mifepristone research came to a virtual standstill because
the controversy anti-abortion forces created around its
abortion use prevented most U.S. researchers from obtaining
supplies of the medication. FDA approval of mifepristone
on September 28, 2000 means that not only is the drug
now available for early abortion, but also that U.S. mifepristone
supplies will enable trials on the medication's other
non-abortion uses to move forward at last.
Millions of women have used mifepristone
for a safe, effective and early medical abortion. Nonetheless,
the Bush administration, in perhaps an attempt to restrict
mifepristone or take it off the market, has indicated
it may review mifepristone's already proven safety record.
Unless Mifepristone remains on the market, there will
be no supplies available for U.S. clinical trials.
History of the Compassionate
Use Program
Despite the dearth of clinical trials, a
few patients have been able to receive mifepristone treatment.
Until late 1998, the French firms Roussel Uclaf and then
Exelgyn provided mifepristone to seriously ill patients
to treat meningioma and other life-threatening illnesses
for what is called "compassionate use." Patients could
obtain the medication after their physicians received
single-patient Investigational New Drug (IND) approval
from the FDA when other methods of treatment were not
working and mifepristone has shown some clinical efficacy
in ameliorating the disease or condition. In late1998,
Exelgyn decided that they could no longer administer the
compassionate use program for U.S. patients. Neither the
Population Council, which holds the U.S. patent rights
to mifepristone and the Danco Group, the American company
that has been licensed by the Population Council to produce
mifepristone for the U.S., also were unable to take on
the program. In January 1999, the Feminist Majority Foundation,
with two respected physicians serving as co-medical directors,
assumed sole responsibility for administering the mifepristone
compassionate use program for seriously ill patients in
the U.S. Without our intervention, these patients would
have no other avenue for obtaining the drug.
FDA Approval and Compassionate Use
The Feminist Majority Foundation expected that after
FDA approval of mifepristone physicians would be able
to obtain the medication directly through Danco's distribution
system and to use it off-label to treat non-abortion indications.
However, the conditions of final FDA approval require
that physicians intending to administer mifepristone for
any use other than early abortion must obtain an IND,
even for single-patient treatment. As a result of this
unusual requirement, our compassionate use program remains
in place as the only way patients can obtain the medication.
How the Compassionate Use Program
Works
Physicians apply to the Feminist Majority Foundation
for supplies of mifepristone for each patient. They also
file an IND application to obtain permission for single
patient use of mifepristone from the FDA. Our medical
directors review each case and secure physician and patient
agreements. The FDA issues an IND number in those cases
where patients have exhausted other treatment options
and suffer from serious diseases for which mifepristone
shows some research promise as a treatment. The Feminist
Majority Foundation purchases mifepristone at cost. We
then distribute mifepristone at cost to physicians.
How Mifepristone Is Affecting Patient's
Lives
Over the past two years, the Feminist Majority Foundation
has provided mifepristone to a total of 71patients - 53
women and 18 men. These patients have received mifepristone
treatment for meningioma, leiomysarcoma, endometrial cancer,
breast cancer, and Cushing's Syndrome. Many of the patients
have told us that mifepristone is literally saving their
lives and improving their capacity to maintain a good
quality of life. Said a college professor whose meningioma
has been treated with mifepristone for eight years, "I
see this as a matter of life and death. Mifepristone is
saving my life and sight. Discontinuing its use can ultimately
result in death or blindness. It is enabling me to continue
my career as a professor."
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In a recent study of 34 ovarian cancer patients
whose tumors were resistant to other treatments, 26.5%
responded to mifepristone treatment - 3 patients had
a complete response and 6 had a partial response.
Studies have found that mifepristone can cause a
50% reduction in the size of uterine fibroid tumors,
which are one of the leading causes of the some 600,000
hysterectomies that are performed each year and the most
frequent cause of hysterectomies for women between the
ages of 35-54.
Other studies have found that mifepristone may be effective
in treating endometriosis, endometrial cancer, meningioma
(a type of brain tumor), and some types of breast cancer,
and in assisting labor induction. New research
shows that mifepristone in very low doses is an effective
form of emergency contraceptive.
And mifepristone's anti-glucocorticoid action may have
profound implications for the treatment of depression,
HIV virus, Alzheimer's disease, and other conditions
related to elevated levels of cortisol. It is an effective
treatment for Cushing's Syndrome, an adrenal disorder.
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