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Mifepristone

Campaign to Move Forward Women's Cancer Research

For more than a decade, the Feminist Majority Foundation has been encouraging and advocating for clinical trials using mifepristone, anti-progesterone compound medication formerly known as RU 486 (the abortion pill), for progesterone-receptor positive cancers primarily affecting women.

This type of cancer accounts for 60 percent of breast cancers, 85 percent of uterine cancers and 40 percent of ovarian cancers.

An Historic Opportunity to Move Forward

Scientists throughout the United States - many at the country's most prestigious research institutions - have long wanted to explore mifepristone as a treatment for types of cancers. Until recently, their research interests were usually met by numerous and unusual obstacles stemming from both anti-abortion politics and difficulties in securing a steady supply of the medication.

Now, the Feminist Majority Foundation has put together a team of prestigious clinical researchers, attorneys, and FDA specialists, and is moving ahead with Phase II clinical trials for women with progesterone-dependent uterine and ovarian cancers.

Feminist Majority Foundation's Unique Role

The Feminist Majority Foundation is well-positioned to take the requisite leadership to usher in the next phase of mifepristone clinical trials. Since 1989, the Feminist Majority Foundation has been leading the drive to first bring mifepristone to the US and then to win FDA approval for mifepristone as a method of early medical (pill-form) abortion.

  • We gathered over 700,000 petitions from Americans, including over 3,000 scientists and 12 Nobel Laureates, to urge the European pharmaceutical company that developed mifepristone to release it to American women.
  • We built a coalition of over 4,000 groups, including leading national medical and scientific associations, supporting FDA approval of mifepristone.
  • We worked extensively to shape mifepristone-related policy.
  • We conduct the only compassionate use program in the United States to provide mifepristone to physicians for critically ill patients, which remains the only way in which patients with life-threatening illnesses can obtain mifepristone.

FMF Compassionate Use Program

Through an agreement with the Population Council (the non-profit institution which initially held mifepristone patent rights), Exelgyn (the French company holding international patent rights for mifepristone), and Danco (the US firm licensed to supply mifepristone in the United States), FMF in 1998 took on the unique responsibility of conducting the Mifepristone Compassionate Use Program. Today FMF is the sole supplier of mifepristone to cancer patients and others suffering from life-threatening diseases for whom standard therapies no longer work.

We took on this responsibility because patients were in desperate need of the drug and no other organization would provide the service. In fact, a cutoff of the supply of mifepristone was imminent when FMF stepped forward. We provide the drug at cost or for free depending on financial need.

Since the Mifepristone Compassionate Use Program began, we have provided mifepristone to 123 patients - many suffering from breast cancer, ovarian cancer and uterine cancer. For patients with progesterone-receptor positive, life-threatening diseases, our compassionate use program is the onlyway their physicians can secure this progesterone-receptor antagonist medication. Presently, we must obtain a separate Investigative New Drug (IND) application for each patient in the program. Our work in getting these patients this medication is their lifeline - literally.

We know from our experience in adminstering this program that the side effects of mifepristone are minimal and that it can be taken safely for long periods of time.

The Promise of Mifepristone

Mifepristone is the first anti-progesterone drug to be synthesized and is the only anti-progestin that has been approved for any use. It was originally developed in France in the early 1980s for safe and very early medical (pill-form) abortion. Researchers have suspected for decades, however, that because of its unique mechanism of action (at the level of progesterone receptors), mifepristone could be effective in treating certain cancers that depend on progesterone for their growth.

Progesterone, in addition to estrogen and testosterone, is one of the body's most important steroid hormones. It is involved in many critical and familiar processes - such as sustaining the lining of the uterus during pregnancy.

Progesterone receptors are found in almost all areas of the body - form the brain to the breast to the reproductive organs - and these may be important in many hormonally-mediated disease processes including meningiomas (brain tumors), certain types of breast cancers, ovarian cancers and uterine cancers, as well as uterine fibroid tumors.

The development of mifepristone may represent a cutting-edge scientific breakthrough in treating progesterone-dependent conditions. Horomone-targeted therapy is critical in treating various cancers. Tamoxifen, an estrogen-receptor blocker, is the most commonly used drug in the treatment of estrogen-receptor positive breast cancer, which comprises 40 percent of all breast cancers. Yet, 60 percent of all breast cancers are progesterone-receptor positive. Until now, however, mifepristone - the only anti-progesterone drug that has been fully developed - has not been sufficiently explored as a treatment for any women's reproductive cancers or for breast cancer.

What You Can Do to Help

The Feminist Majority Foundation has left no stone unturned. And now we are on the brink of Phase II clinical trials that may provide vitally needed data for the treatment of all too often fatal forms of ovarian and uterine cancer. Next, we are determined to start breast cancer trials.

Your help is crucial in moving the ground-breaking research forward. We need you to make as large a contribution as you possibly can afford. We want you to participate.

These trials belong to all women. We can and we must move forward. We can do no less.

If this was a treatment for men's cancers, we believe that a non-profit organization like ours would not be necessary to raise funds for such research. But this is about women's cancer and we must break the logjam for this crucial research which has been stalled for over two decades. We have an amazing opportunity to move forward and the price is relatively small. The reward may be to truly revolutionize the treatment of progesterone-dependent female cancers.

When all else fails, feminists will and can make women's health research move forward.