Doris Laird, a humanities professor at Florida A&M, believes RU-486, the controversial abortion pill that won government approval late last month, will be a lifesaver.
She should know. The 69-year-old Laird has been taking the drug for seven years, not to induce abortion but to control a slow-growing, benign brain tumor called meningioma that once threatened her vision and her life.
Though the medical community is divided on the effectiveness of RU-486 on meningioma, you can’t tell that to Laird. Since she’s been on it, “my brain tumor has not grown at all,” she said.
Lost in all the heated rhetoric and debate over RU-486, which the Food and Drug Administration OK’d after years of political wrangling, is the likelihood that the drug could be much more than just an abortion inducer.
Researchers around the country are already gearing up to study other potential uses of the drug in projects that had been impossible while RU-486 was not legally available in this country and research supplies were limited.
Research was stalled for years because there has been virtually no supply of the drug, said Eleanor Smeal, president of the Feminist Majority Foundation, a Virginia-based national women’s-rights group that helped provide Laird and the roughly 40 other Americans who have been using the drug for nonabortion purposes on a compassionate-use basis.
But now that the drug is approved, “researchers are beating on my door to test it for other uses,” said Dr. Richard Hausknecht, medical director at Danco Laboratories in New York City, the drug’s distributor. “We’re anxious to see this research go forward,” he added, noting Danco has plenty of the drug on hand to share with researchers.
Researchers are excited about RU-486 as a multipurpose drug because of its effectiveness at blocking the hormone progesterone. Because a woman’s uterus cannot maintain pregnancy without progesterone, blocking its production effectively ends gestation.
But progesterone also can drive a number of tumors – both benign tumors like meningioma and malignant ones such as breast, uterine and ovarian cancer. Thus, blocking progesterone in patients with these conditions should, in theory, slow tumor growth.
Progesterone also drives a number of non-cancerous conditions such as uterine fibroids, which affect more than 20 percent of women over 30 and contribute substantially to America’s 600,000 hysterectomies every year, and endometriosis, an abnormal growth of uterine tissue outside the uterus, which affects 5 to 15 percent of reproductive-age women.
Moreover, by lowering levels of the stress hormone, cortisol, RU-486 may also help people with Cushing’s disease, a disorder of the pituitary.
Even outside of research trials, some patients may soon be able to get access to RU-486, also known as mifepristone and Mifeprex, for nonabortion uses. Once the drug is on the market, which is expected within a month, any qualified doctor who sets up an account with Danco can legally provide
Mifeprex to patients both for abortion and “off-label,” or nonapproved, uses as well. The first off-label uses are likely to be other pregnancy-related conditions. In France, Hausknecht noted, the drug is already approved to soften the cervix before a surgical second trimester abortion and to induce labor in women whose fetuses have died in utero.
Mifeprex also may help women who have early ectopic pregnancy, in which the fertilized egg implants in a Fallopian tube rather than the uterus. Hausknecht, who is also an associate professor of obstetrics and gynecology at Mount Sinai School of Medicine in New York, hopes to start a multicenter trial of Mifeprex for this use soon. In Europe, he said, researchers have already shown that when RU486 is combined with another
drug, methotrexate, it boosts the success rate for early ectopic abortion from 75 to 90 percent.
Uterine fibroids, which, like the uterus itself, are sensitive to progesterone, also respond to Mifeprex, though they may start growing again when the drug is stopped. A small study by California researchers published in 1993 in the Journal of Clinical Endocrinology and Metabolism showed that RU-486, taken daily for three months at far smaller doses than those used for abortion, shrank fibroids significantly.
Another small California study, published in 1998 in the American Journal of Obstetrics and Gynecology, showed that RU-486, in tiny doses, reduced the pain of endometriosis, although it did not seem to slow the abnormal growth per se. More data are needed, said Dr. Johanna Perlmutter, an obstetrician-gynecologist at Beth Israel Deaconess Medical Center in Boston, but Mifeprex should be useful for endometriosis.
For cancer treatment, perhaps the most tantalizing findings were those published earlier this year in the Journal Gynecologic Oncology by researchers from the Robert Wood Johnson Medical School in New Jersey.
They studied 34 women whose ovarian tumors had not responded to standard chemotherapy drugs and found that Mifeprex seemed to slow the cancer in about a quarter of the women, resulting either in at least a temporary shrinkage of the tumor or a decrease in a tumor marker called CA-125 as shown by blood tests.
In uterine cancer, preliminary data suggest that RU-486 can stop tumor growth in the test tube. In breast cancer, early studies suggest that the drug may hold the disease in check in some women, according to a 1994 review of the data by Dutch researchers.
And what of those, like Doris Laird, who struggle with meningioma? Laird’s tumor seems not to have grown, though whether that’s due to RU-486 or the naturally-slow growth of this kind of tumor is unclear. Other people with meningioma, among them, Sheila, a 53-year old writer and editor who lives in a Boston suburb and did not want her last name used, have not been so lucky. Sheila took RU-486 as part of a study and believes “it bought me at least18 months or better of time.” She stopped taking the drug when brain scans showed her tumor was growing slowly. Unfortunately, the biggest study to date on RU-486 and meningioma seems to be yielding disappointing results.
Several years ago, a pilot study led by Dr. Steven Grunberg, a medical oncologist at the Vermont Cancer Center in Burlington, showed that the drug seemed to benefit about a half-dozen of the 28 people tested.
“You do not get dramatic shrinkage of the tumors but vision improved in two people who had been losing their sight,” he said. “It only takes a slight change in the right direction to see that they were delighted.”
At Beth Israel in Boston, Dr. Daniel Karp, director of cancer clinical research, also saw two of his meningioma patients stay stable for many months after stopping the drug.
But a number of researchers around the country, including Karp and Grunberg, have now pooled their data on 192 meningioma patients and the emerging picture is less rosy. In fact, patients taking RU-486 did not fare any better than those on placebo, Karp said.
“For the average patient, it did not look promising,” said Dr. Peter Ravdin, a medical oncologist at the Southwest Oncology Group in San Antonio, Texas, who is analyzing the study. “But we’re still looking to see if there is a subset of people who would benefit.”
Such hopes and disappointments, of course, are the essence of medical research. But even if RU-486 does not fulfill all of researchers’ hopes, that it can now be studied for many conditions other than abortion is welcome news.
Smeal, of the Feminist Majority, vows to continue fighting for the drug, this time for nonabortion uses: “Our next major campaign is to press the NIH [National Institutes of Health]for funding for these trials.”