(WOMENSENEWS)–With more research, it could offer new treatments for breast cancer, fibroids and endometriosis.
But since it’s an abortion drug, since it weathered a congressional investigation two years ago–and since it’s in short supply–researchers have yet to test its full potential.
That, says Amy Allina, program director of the Washington-based National Women’s Health Network, is the story on mifepristone. "This drug has the potential to make women healthier in many ways," says Allina. "But the politics surrounding it have made it difficult to secure funding for more research, and scientists are shying away from studying the drug because they fear getting research protocols approved will be difficult."
A 2006 paper in the medical journal Gynecological Endocrinology agreed, saying "association with abortion limits the clinical applications of mifepristone."
Susan Wood, former director of the U.S. Food and Drug Administration’s Office on Women’s Health and now a research professor at the George Washington University School of Public Health and Health Services in Washington, D.C., says Election Day might make a big difference.
"A new presidential administration could change the atmosphere at the National Institutes of Health, which funds medical research, and the FDA, which oversees it," says Wood, who resigned from the FDA in 2005 to protest delays in granting emergency contraceptives over-the-counter status. "A new administration has the potential to reduce the hesitancy that government and private funders might have about mifepristone."
Kevin Fiscella, an associate professor at New York’s University of Rochester Medical Center, says studies on mifepristone’s applications beyond abortion have been limited by a shortage of the drug.
"For more than a decade, it was difficult for American researchers to get their hands on mifepristone because there wasn’t a U.S. supplier," says Fiscella. "Now it’s available through Danco Laboratories, a relatively small supplier that may not be able to produce quantities needed for larger studies."
Mifespristone was the subject of congressional hearings in 2006 that followed the deaths of six U.S. women and one Canadian who took it to terminate unwanted pregnancies.
All the women died of bacterial infections, and the FDA strengthened the drug’s warning label to stress the risk, though it was never withdrawn for use in medical abortion.
In the two years since the hearing, authorities have not established a definitive link between those fatalities and the use of mifepristone to induce abortions, but widespread research into the drug remains sidelined by an anti-choice federal government.
More than 900,000 U.S. women and more than 2 million women in 37 other countries have used mifepristone in medical abortions, according to its New York-based manufacturer, Danco.
More than 97 percent of users surveyed would recommend the method to a friend, according to the New York-based Planned Parenthood Federation of America.
Even so, the FDA has received reports of more than 950 problems (mostly hemorrhaging and infection) associated with mifepristone’s use for abortions.
Higher Risk for Medical Abortion
Though only 0.016 percent of users experience these side effects, medical abortion still carries 10 times the risk of death associated with surgical abortion, according to Planned Parenthood.
Mifepristone is offered by 60 percent of U.S. abortion providers and accounts for 13 percent of all abortions and 22 percent of those before nine weeks’ gestation, according to the New York-based Guttmacher Institute.
In 2006, Ohio legislators passed a measure that would restrict the drug’s use for abortions and as a research subject in the state but the law was struck down by a federal court.
In 2007, two mifepristone researchers in Canada reportedly received death threats from anti-choice activists, but nevertheless moved forward with their research.
Mifepristone was in various stages of research investigation before the scare in 2006.
Fiscella, at the University of Rochester Medical Center, is investigating the drug’s potential to treat fibroids. His research shows taking mifepristone can lead to a 40 percent reduction in the size of fibroids, noncancerous uterine growths that can impair fertility and cause pelvic pain and anemia.
"In small doses, mifepristone blocks the reproductive hormone progesterone, which is why it may help with progesterone-affected conditions such as fibroids, endometriosis, breast cancer and ovarian cancers," says Fiscella. "In larger doses, mifepristone blocks glucocorticoid hormones released during stress, which is why it may help treat conditions affected by these hormones, such as depression and Cushing’s syndrome."
Studies Showed Promise
Mifepristone studies underway before the 2006 congressional hearings include ones related to breast cancer (the University of California); depression (Stanford University); ovarian cancer (the University of South Dakota); and endometriosis, or the growth of uterine tissue outside the uterus (the Colorado Center for Reproductive Medicine). All these studies showed positive outcomes before 2006.
Although rarely prescribed this way, mifepristone can work as an emergency contraceptive if taken within five days of unprotected sex, though it is a different drug from Plan B, also called the "morning-after" pill.
"Mifepristone can serve as emergency contraception as safely and effectively as it terminates early pregnancy," says Beverly Winikoff, president of the New York-based Gynuity Health Projects.
Other studies have found possible applications of the drug for Alzheimer’s disease, glaucoma, ulcers, meningiomas (tumors that arise from the membranes lining the brain and spinal cord) and Cushing’s syndrome (a condition in which prolonged exposure to stress hormones causes stretch marks, high blood pressure and other health problems).
If patients want to try mifepristone for other applications besides its FDA-approved use to induce abortion, doctors may prescribe it "off label," a common practice in which physicians can write prescriptions for a drug approved for one purpose for that drug’s use in a second purpose.
Off-label use is considered safe if it is supported by research. In fact, many drugs prescribed to women for pregnancy-related conditions are prescribed off-label. Drugs developed specifically to treat pregnant women are rarely developed by pharmaceutical companies and no new classes of drugs for pregnancy-related treatments have been developed in the past two decades, according to a study published in January.
However, health advocates say mifepristone’s widespread use for emergency contraception and for the treatment of endometriosis, fibroids, cancer and other illnesses will only come with more study and with official FDA approval for these uses. Off-label prescriptions are not encouraged until research on a drug is definitive.
"The Bush administration has been staunchly opposed to reproductive choice in general and to the use of mifepristone in particular," Allina says. "But having a new administration after the 2008 election could result in less stigma, more federal and private funding and eventual FDA approval for more uses."
Molly M. Ginty is a freelance writer based in New York City.