Some Other Beneficial Medical Uses of Mifepristone from the FMFoundation website
In addition to its use in terminating unwanted pregnancies, MIFEPRISTONE (formerly known as RU-486) also may be effective in treating a range of serious diseases and medical conditions, many of which particularly affect women. Yet U.S. clinical trials for most of these uses have come to a standstill due to anti-abortion politics.
A B O R T I O N & F E R T I L I T Y C O N T R O L
Available to women in many countries, mifepristone was the first in a new generation of fertility control agents that can terminate an early pregnancy. Mifepristone works by blocking the action of progesterone, which is necessary to sustain a pregnancy.
Mifepristone, taken along with a prostaglandin, has been used by millions of women worldwide and has found to be safe and effective as an early abortion method during the first nine weeks of a pregnancy.
A woman can take mifepristone as soon as she knows she is pregnant. Mifepristone is administered orally, is non-invasive, requires no anesthesia, and bears little risk of infection. Many women prefer mifepristone because the procedure is more private and allows them greater psychological control in ending a pregnancy. Administered with a single dose of a misoprostol (a prostaglandin given either orally or as a vaginal suppository), mifepristone has been proven to be highly effective in successfully terminating pregnancy. [1]
Studies also show that mifepristone is a safe, effective form of emergency contraception. [2] [3] Preliminary studies show, as well, that mifepristone can act as both a male and female contraceptive.
M E N I N G I O M A S
Solid tumors of the lining of the brain called the meninges, account for 29% of all primary brain tumors and 12% of all spinal cord tumors. (CBTRUS 2004, pg 17,18 Figure 6.) Meningiomas occur two times more frequently in women than men. [4]
Meningiomas may enlarge or become symptomatic during the menstrual cycle or pregnancy, and are also associated with breast cancer. These indications suggest that the hormones estrogen and progesterone influence tumor growth. By binding with progesterone receptors, mifepristone may inhibit the growth of, or actually reduce meningiomas size.
In one study, mifepristone was found to have some efficacy in the treatment of patients with inoperable meningioma. [5] Another study showed that mifepristone interfered with the steroid action that influences the growth of meningiomas, further demonstrating mifepristone's treatment potential with this type of tumor. [6] Meningioma patients have testified before Congress that mifepristone has helped them battle their disease. The Feminist Majority Foundation currently operates a Compassionate Use Program in which 33 meningioma patients, with special FDA approval, are being treated with mifepristone under their physician's care. Many of these patients report that mifepristone has eased their pain and suffering. Some have said the drug is saving their lives.
E N D O M E T R I O S I S & F I B R O I D T U M O R S
Ten to twenty percent of American women of childbearing age have endometriosis. [7] Mifepristone shows promise as a treatment for endometriosis, which is a chronic, painful, long-term disease that can affect women throughout their entire reproductive years.
In addition to its anti-progestin and anti-glucocorticoid properties, mifepristone is a non-competitive anti-estrogen. As such, mifepristone blocks the capacity of the endometrial tissue to grow in response to estrogen, making mifepristone a possible hormonal treatment for endometriosis. [8]
Similarly, researchers believe mifepristone is a promising treatment option for uterine fibroid tumors. [9] Fibroid tumors, which are present in approximately 70% of women and cause symptoms in 25% , are a leading cause of the more than 600,000 hysterectomies performed annually in the U.S. [10]In one recent clinical study, researchers found that mifepristone reduced the average size of uterine fibroid tumors by 50% within six months of low-dose mifepristone therapy and that the drug was well tolerated by the women who participated in the study. [11]
B R E A S T & O V A R I A N C A N C E R S
The American Cancer Society estimates 211,240 cases of breast cancer will be diagnosed in 2005, with 40,410 deaths expected. Since 1990, the death rate has declined steadily, the result of improved treatment and early detection . However, since 1987, breast cancer incidence has increased by 0.3% per year. Breast cancer continues to be the second leading cause of cancer death among women of all ages, and 2.3 million women living in the US have been diagnosed with breast cancer. [12]
Mifepristone is an anti-progestin, which blocks the action of progesterone, and may be effective in treating progesterone-dependent forms of breast cancer. [13] [14] Experts estimate that mifepristone may be an effective treatment in 60% of breast cancer tumors, according to the National Surgical Adjuvant Breast and Bowel Project.
In animal studies in the Netherlands, mifepristone reduced breast cancer tumors as effectively as Tamoxifen, one of the most common and effective breast cancer treatments drugs. In that research, the administration of both Tamoxifen and mifepristone reduced tumors size more than each drug alone. [15]
A French clinical trial found that mifepristone might also be a treatment for tumors that have become resistant to Tamoxifen. In addition, this study reported that mifepristone reduced the pain caused by the metastasis of cancer cells to the bones. Trials have also been conducted in Canada and California to assess mifepristone as a treatment option for women who have breast cancer recurrences.
In 2000, ovarian cancer was diagnosed in approximately 23,000, and caused the death of more than 14,000 women. Ovarian cancer causes the most deaths of all gynecologic cancers and is responsible for five percent of all cancers in women. [16] A U.S. study reported in 2000 that for women with persistent ovarian cancer despite standard chemotherapy and radiation, treatment with mifepristone showed benefits in halting the disease in 26% of patients studied. [17]
C U S H I N G ' S S Y N D R O M E, P S YC H O T I C D E P R E S S I O N, & T H E H I V V I R U S
Cushing's Syndrome results from an over-production of the cortisol hormone. Too much cortisol can be fatal. The vast majority of Cushing's Syndrome victims are women, primarily in their 20s to 40s. [18]
Some forms of the deadly Cushing's Syndrome can be treated with mifepristone.(Brand name Corlux) The mifepristone compound is an anti-glucocorticoid: it binds to glucocorticoid receptors in the body and prevents the cortisol from binding. One important National Institutes of Health (NIH) study has shown that when persons gravely ill with inoperable Cushing's Syndrome tumors, more than 50% experienced reversal and control of the disease as well as complete regression of the Syndrome's physical features. [19]
Mifepristone has already helped patients suffering from advanced Cushing's Syndrome. Two of those survivors testified before Congress in 1990 that mifepristone saved their lives. [20]
Some studies indicate that the cortisol hormone plays a key role in the replication of the HIV virus. Elevated serum cortisol has been found at all stages of HIV-infection, particularly in late-stage HIV (AIDS) patients.
The anti-glucocorticoid properties of mifepristone make it a possible treatment for HIV and other cortisol related conditions and diseases. One in vitro study showed that by blocking cortisol, mifepristone lessened the infectivity of HIV and reduced the production of HIV by the already infected cells by 70%. [21]
As an anti-glucocorticoid, mifepristone is proving to be effective in treating several additional conditions and diseases that are caused by elevated levels of cortisol. These health problems include depression [22] , alcoholism, substance abuse, anorexia nervosa, ulcers, diabetes, Parkinson's, multiple sclerosis, and Alzheimer's. [23] Acute Psychotic Depression, which is manifest in 15% of patients with severe generalized depression causes symptoms such as hallucinations and paranoia. It is a disease for which no easy or readily effective treatment presently exists or is FDA approved. Patients are typically treated with either electric shock therapy (which carries considerable stigmatization), or dual drug therapy with anti-psychotic and anti-depressant medications. Unfortunately, both treatments can take weeks to months to have any significant effect. Because mifepristone can rapidly bring down the elevated cortisol levels associated with this form of depression, researchers at Stanford have been conducting clinical trials treating acute psychotic depression patients with mifepristone and the results have been very successful. Alan Schatzberg, MD, Chair of Stanford's psychiatry department likens mifepristone to "the equivalent to shock therapy in a pill" because in more than two-thirds of patients who took medium or high doses showed significant reductions in psychotic symptoms within seven days. [24] Because of these results, the U.S. Food and Drug Administration has put mifepristone on fast-track approval as a treatment for psychotic depression-it is the first drug for a psychiatric condition to be fast-tracked. [25]
You can find more overseas current research studies on mifepristone and cancer, chlamydia pneumonia, Epstein-Barr virus-immortalized B lymphocytes, and Hepatitsis C at PUB MED
Click Here to View a Brief Chronology of the Fight to Get Mifepristone Approved in the US.
[1] Spitz IM, et al. Early pregnancy termination with mifepristone and misoprostol in the United States. New England J of Medicine, 4/30/98.
[2] Baird DT, Dewar M, Glasier A et al. Mifepristone (RU486) compared with high-dose estrogen and progestogen for emergency postcoital contraception. New England J of Medicine, 10/8/92.
[3] Bygdeman M, Danielsson KG, et al. Contraceptive use of antiprogestin. European J of Contraception and Reproductive Health Care, 6/99.
[4] Association for Brain Tumor Research.
[5] Grunberg SM, et al. Role of antiprogestational therapy for meningiomas. Human Reproduction, 1994.
[6] De-Motta LA, de-Motta LD. Endocrine treatment of meningiomas: a review. Arq-Neuropsiquiatr. 6/95.
[7] Endometriosis Alliance.
[8] Kettel M, Murphy AA, et al. Clinical efficacy of the antiprogesterone RU-486 in the treatment of endometriosis and uterine fibroids. Human Reproduction, 1994.
[9] Eldar-Geva T; Healy DL . Other medical management of uterine fibroids. Baillieres Clin Obstet Gynaecol, 6/12/98.
[10] American College of Obstetricians and Gynecologists.
[11] Eisinger, Meldrum, et al. Low-Dose Mifepristone for Uterine Leiomyomata, Journal of the American College of Obstetricians and Gynecologists, February 2003.
[12] American Cancer Society. Breast Cancer Facts and Figures 2005-2006, 9/22/05.
[13] Martin JH, et al. Reduced expression of endothelial and inducible nitric oxide synthase in a human breast cancer cell line which has acquired estrogen independence. Cancer Letters, 9/20/99.
[14] Norris JD, Paige LA et al. Peptide antagonists of the human estrogen receptor. Science, 7/30/99.
[15] Klijn JGM, et al. Pre-clinical and clinical treatment of breast cancer with antiprogestins. Human Reproduction, 1994.
[16] Centers for Disease Control and Prevention.
[17] Rocereto, T. et al. Phase II study of Mifepristone in Refractory Ovarian Cancer. Gynecologic Oncology, 2000.
[18] Cushing's Syndrome Association.
[19] Nieman LK et al. Successful treatment of Cushing's Syndrome with the glucocorticoid antagonist RU-486. J of Endocrinology and Metabolism. 1985.
[20] U.S. 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. 11/19/90.
[21] Weiner et al. The glucocorticoid receptor type II complex is a target of the HIV-1 vpr gene product. Proc. Natl. Acad. Science, USA, 4/95.
[22] Wolkowitz OM, Reus VI. Treatment of Depression with antiglucocorticoid drugs. Psychosomatic Medicine, 9/99.
[23] Wolkowitz OM, Reus VI. Treatment of Depression with antiglucocorticoid drugs. Psychosomatic Medicine, 9/99.
[24] Wolkowitz OM, Reus VI. Treatment of Depression with antiglucocorticoid drugs. Psychosomatic Medicine, 9/99.
[25] Wolkowitz OM, Reus VI. Treatment of Depression with antiglucocorticoid drugs. Psychosomatic Medicine, 9/99.
