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Mifepristone shows promise as a treatment for a wide range of serious diseases and conditions. Yet clinical trials on most of these uses in the U.S. have come to a standstill because of anti-abortion politics. In the absence of clinical trials, several dozen people with Cushing's Syndrome, meningioma, and breast cancer are currently being treated with mifepristone under compassionate use protocols.
FERTILITY CONTROL Available to women in France, Sweden, and Great Britain, Mifepristone (formerly known as RU 486) is the first in a new generation of fertility control agents that can cause the interruption of early pregnancy. Mifepristone blocks the action of progesterone, which is necessary to sustain a pregnancy.
Mifepristone, taken in pill form in conjunction with a prostaglandin, has been used by over 200,000 women worldwide and has been found to be safe and effective as a method of early abortion during the first nine weeks of pregnancy.
A woman can take mifepristone as soon as she knows that she is pregnant. The administration of mifepristone is non-invasive, has less risk of infection, and does not require anesthesia. Many women prefer mifepristone because the procedure is more private and allows them greater psychological control over the termination of pregnancy. Due to its popularity, RU 486 eventually could replace 50% of vacuum aspiration abortions. Administered with a single dose of misoprostol, a prostaglandin used in pill or vaginal suppository, Mifepristone has been proven to be 96.9% effective in terminating pregnancy.
Studies show mifepristone is a safe, effective post-coital contraceptive,1 and has fewer side effects and is easier to use than the current "morning-after" pill. Preliminary studies show RU 486 potentially can act as both a male and female contraceptive.
BREAST AND OVARIAN CANCER Breast cancer is an epidemic. In 1997, 180,200 women were diagnosed with breast cancer in this country alone. In 1997, 43,900 women will die of breast cancer in the United States.2
As an anti-progestin, mifepristone blocks the action of progesterone, and therefore may be effective in treating progesterone-dependent breast cancers. Experts estimate that mifepristone may be a treatment for 40% of breast cancer tumors.
In animal studies in the Netherlands, mifepristone reduced breast cancer tumors as well as tamoxifen. In the trials, the administration of both tamoxifen and mifepristone reduced tumor size more than each drug alone.3
A French clinical trial found that mifepristone also may be a second-line treatment for tumors that have become resistant to tamoxifen. In addition, this study reported that mifepristone reduced the pain from the metastasis of cancer cells to the bones. Trials have been conducted recently in Canada and in California to test mifepristone as a treatment for women who have breast cancer recurrences.
Laboratory trials conducted by Dr. Faina Rose of the University of Medicine and Dentistry in New Jersey suggest that mifepristone also may inhibit the proliferation of ovarian cancer cells.4
MENINGIOMA Meningiomas account for between 15% of all primary brain tumors, and 12% of all spinal cord tumors. Meningiomas occur two times more frequently in women than in men.5
Meningiomas may enlarge or become symptomatic during pregnancy or the menstrual cycle, and are positively associated with breast cancer. These indications suggest that the hormones estrogen and progesterone influence tumor growth. By binding with progesterone receptors, RU 486 may inhibit the growth of, or actually reduce meningioma.
In a study by Dr. Grunberg et al. at the University of Southern California School of Medicine, RU 486 was found to have some efficacy in the treatment of patients with inoperable meningioma.6 A 1995 study conducted in Portugal showed that mifepristone interferes with the steroid action that influences the growth of meningiomas, further indicating mifepristone's potential as a treatment for this type of cancer.7
Meningioma patients have testified before Congress that mifepristone has helped treat their disease.
ENDOMETRIOSIS AND FIBROID TUMORS Ten to twenty percent of American women of child bearing age have endometriosis.8
The new French pill RU 486 shows promise as a treatment for endometriosis, a chronic, long-term, painful disease that can affect women for their entire reproductive lives.
In addition to being an anti-progestin and an anti-glucocorticoid, RU 486 is a non-competitive anti-estrogen. RU 486 blocks the capacity of the endometrial tissue to grow in response to estrogen. As such, RU 486 is a possible new hormonal treatment for endometriosis.9
Through a similar mechanism, RU 486 may be a treatment for uterine fibroid tumors.
Fibroid tumors, which affect about 30% of women, are a leading cause of hysterectomies.10
Clinical trials at the University of California-San Diego found that RU 486 reduced the mean size of uterine fibroid tumors and that RU 486 was well-tolerated by the women in the study.11
CUSHING'S SYNDROME Cushing's Syndrome results from an over-production of cortisol. Too much cortisol can be fatal. The vast majority of Cushing's Syndrome victims are women, primarily in their 20's - 40's.12
Some forms of Cushing's Syndrome, a deadly disease, can be treated with the new French pill RU 486.
The RU486 compound is an anti-glucocorticoid; it binds to glucocorticoid receptors in the body and thus prevents the hormone cortisol from binding. One important National Institutes of Health (NIH) study has shown that when people gravely ill with inoperable tumors were given RU 486, over half experienced actual reversal and control of the disease as well as complete regression of the Syndrome's features.13
RU 486 already has helped patients with advanced Cushing's Syndrome symptoms. Two such survivors testified before Congress in 1990 that RU 486 saved their lives.14
THE HIV VIRUS Recent studies indicate that cortisol plays a key role in the replication of the HIV virus. Serum cortisol has been found to be elevated at all stages of HIV-infection, particularly in AIDS patients (late stages of HIV).
Mifepristone's anti-glucocorticoid properties make it a possible treatment for HIV and other cortisol related conditions and diseases. In vitro studies conducted by Dr. David Weiner show that by blocking cortisol, mifepristone blunts the infectivity of HIV and reduces the production of HIV by the already infected cells by 70%.15
As an anti-glucocorticoid, mifepristone may prove effective in treating several additional conditions and diseases that are caused by elevated levels of cortisol. These health problems include depression, alcoholism, substance abuse, anorexia nervosa, ulcers, diabetes, Parkinson's, Multiple Sclerosis, and Alzheimer's.16
ENDNOTES:
1 Baird DT, Dewar M, Glasier A et al. Mifepristone (RU 486) Compared with High-Dose Estrogen and Progestogen for Emergency Postcoital Contraception. New England Journal of Medicine. Vol 327 N15, October 8, 1992; 1041-1044.
2 American Cancer Society
3 Klijn JGM, et. al. Pre-clinical and Clinical Treatment of Breast Cancer with Antiprogestins. Human Reproduction. Vol 9 Supp 1, 1994.
4 The Reuter Business Report. RU 486 May Treat Ovarian Cancer, Researchers Say. February 19, 1995.
5 Association For Brain Tumor Research
6 Grunberg SM, et al. Role of Antiprogestational Therapy for Meningiomas. Human Reproduction. Vol 9 Supp 1, 1994.
7 da-Motta LA, de-Motta LD. Endocrine Treatment of Meningiomas: a Review. Arq-Neuropsiquiatr. Vol 53 (2), June 1995; 324-32.
8 Endometriosis Alliance.
9 Kettel M, Murphy AA, et al. Clinical Efficacy of the Antiprogesterone RU 486 in the Treatment of Endometriosis and Uterine Fibroids. Human Reproduction. Vol 9 Supp 1, 1994.
10 American Cancer Society
11 Murphy et al. Regression of Uterine Leiomyomata in Response to the antioprogesterone RU 486. Journal of Clinical Endocrinology and Metabolism, 76(2), 513-17: 1993.
12 Cushing's Syndrome Association.
13 Nieman LK et al. Successful Treatment of Cushing's Syndrome with the Glucocorticoid Antagonist RU 486. Journal of Endocrinology and Metabolism. Vol 61(3), 1985; 536-40.
14 House of Representatives, Subcommittee on Regulation, Business Opportunities, and Energy, Committee on Small Business, RU 486: The Import Ban and its Effects on Medical Research, serial no. 1101-85, November 19, 1990.
15 Weiner et al. The glucocorticoid receptor type II complex is a target of the HIV-1 vpr gene product. Proc. Natl. Acad. Science, USA, 92, 3621-3625: (Apr) 1995.
16 New International Association Provides Evidence of Cortisol's Major Role in AIDS and Other Diseases. PR Newswire, Financial News. June 21, 1996.
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