RU-486’s Other Medical Benefits Resurface in Post-Approval Era
Between 1982 and 1993, Doris Laird underwent three major surgeries--one of them lasting 23 hours--to try to remove a fast-growing meningioma, a life-threatening brain tumor the size of an orange that was wrapped around her optic nerve.
Since 1993, however, she has been swallowing a single white pill every morning that looks a lot like an aspirin--and what’s left of her tumor has quit growing.
The medicine is mifepristone, or RU-486, the so-called abortion pill, and Laird, 69, a college professor from Tallahassee, Fla., is convinced it saved her sight and is saving her life. “There’s no question about it,” she said.
Scientists believe that there are numerous other medical benefits to the drug that have been lost or overshadowed by the years-long volatile political debate about its use as an early method of ending pregnancy, and that its approval in this country will generate new interest into these other areas.
The drug has shown promise against meningiomas like Laird’s; certain breast, ovarian and prostate cancers; fibroid tumors--a leading cause of hysterectomies in this country; and Cushing’s syndrome, a disease that results from the body’s overproduction of the hormone cortisol.
“It has tremendous potential,” said Dr. Eric Schaff, professor of family medicine at the University of Rochester, who has studied the drug’s effect against fibroids, believed to afflict 30% of all women older than 40.
The drug blocks the hormone progesterone and seems to have an impact against conditions influenced by it.
Until now, however, it has been difficult for researchers to get the drug for anything but abortion clinical trials, although some small studies have been conducted. And 37 patients, Laird among them, currently are receiving it under the Food and Drug Administration’s “compassionate use” program.
Now that the FDA finally has licensed the drug, and U.S. supplies will become more plentiful as a result, many believe research into non-abortion-related conditions, and even “off label” private use for these conditions, may increase.
“Once the manufacturer gets up and running, they will have a bigger supply, and scientists who want to do clinical trials will find it easier to obtain the drug,” said Eleanor Smeal, president of the Feminist Majority Foundation, a women’s rights advocacy organization that received FDA permission to distribute the drug to certain individual patients for “compassionate use.”
“We hope then that the work will increase because the promise is so significant,” she added.
Scientists have recognized the drug’s potential for treating numerous conditions for more than a decade. Back in 1990, for example, a French study found that the drug produced tumor regression in 18% of advanced breast cancer patients for whom other treatments had failed. In 1993, a National Academy of Science panel said the pill should be studied extensively for its potential therapeutic benefits.
More recent studies have been encouraging, although they have been conducted on only a small number of patients.
For example, a study released last year of 34 ovarian cancer patients indicated that the drug has an impact on ovarian cancers resistant to other chemotherapy.
Ovarian cancer is the deadliest of reproductive cancers, with few treatment options when diagnosed at a late stage--which is frequently the case because its early symptoms are often vague or “silent.”
Nine of the patients in the study responded to the drug--six of them showed a “partial” response, i.e., a decrease in tumor size, and three a showed “complete,” response, according to a report published last year in the journal Gynecologic Oncology.
The study was conducted by researchers at Cooper Hospital/University Medical Center and the Robert Wood Johnson Medical School, both in Camden, N.J. The researchers, writing in the journal, urged that further studies be performed “when the drug becomes more widely available in the United States.”
Schaff believes that an increased use of the drug to control fibroid tumors--a very common growth that occurs in the muscle of the uterus--will result in a decrease in the large number of hysterectomies performed in this country every year.
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“Progesterone causes the tumor to grow, and if you block it with mifepristone, it shrinks,” he said. “This is also true for certain cancers--breast, ovarian, prostate--that are progesterone-sensitive. It would also be effective against those.”
The FDA, on a case-by-case basis, often allows individual patients to receive experimental drugs if there are no clinical trials available, or if the patients are unable--for geographic or other reasons--to participate in a clinical trial.
These numbers are likely to grow as the drug becomes more available, and if doctors are reluctant to give it to patients on an “off-label” basis.
Traditionally, once a drug is licensed, doctors are free to prescribe it for any reason, and the agency maintains a “hands off” attitude, maintaining that it does not regulate the practice of medicine.
But in the case of RU-486, physicians will be required to sign an agreement promising to use it only for its stated purpose--abortion--as a condition of receiving it from the manufacturer.
Paradoxically, its use for cancer and other conditions is supported by abortion foes, many of whom believe that abortion advocates have pushed the non-abortion medical angle as a way of pursuing its abortion agenda.
“We’ve never opposed its use for these other areas,” said Laura Echevarria, a spokeswoman for the National Right to Life Committee. “It does sound good to present it as something that might possibly benefit women with breast cancer--but why wasn’t it pursued for this five years ago?”
