Sixteen years ago, Doris Laird, a humanities professor at Florida Agricultural and Mechanical University in Tallahassee, developed a benign brain tumor the size of an orange.
She had surgery — an operation that took 22 1/2 hours. It worked, or so she thought. But four years later, the tumor, a meningioma, was back. She had more surgery; 12 hours this time. Six years ago, it came back again, growing so much it threatened her vision — and her life. She had another 12-hour operation.
In 1994, Laird began taking RU486, the French abortion pill that is not approved for use in this country, on a “compassionate use” basis. There is preliminary evidence that the drug, which blocks the hormone progesterone, also slows the growth of meningioma. In Laird’s case, she says, it “stopped my tumor completely from growing.”
There’s also evidence that RU486 may be useful for a number of other medical problems, including fibroid tumors of the uterus; endometriosis (benign growths of tissue from the lining of the uterus; and Cushing’s Syndrome, a disorder of the pituitary gland.
To get RU486 on a compassionate use basis, Laird, like other patients in the same predicament, had to get an American doctor to prove to the US Food and Drug Administration that she had a serious disease that might respond to the drug. The doctor then arranged with the small French company that sells RU486 in Europe to send it free to her here.
Though cumbersome, this arrangement worked well enough for a while. But in a troubling example of the way politics can sometimes get in the way of legitimate medical needs, it all fell apart this summer when Exelgyn, the French company that in 1997 was given rights to RU486 by the original manufacturer, Roussel Uclaf, balked.
“We are ready to sell the tablets at cost, $5 a tablet,” says the company spokeswoman, Catherine Euvrard. “We are trying to find a US-based organization which is responsible enough to understand that it is up to a US organization to take care of US citizens, not to a tiny French company. I cannot tell you more.”
Laird would have been willing to pay, but like an estimated 25 to 30 other patients in similar straits, she has been caught in a web of red tape and abortion politics.
In 1996, RU486 was deemed “approvable” by the FDA as an abortion pill, but it has not been finally approved and cannot yet be marketed here. (Once approved, RU486, also known as mifepristone, could legally be used “off-label” for other medical purposes such as brain tumors.)
The New York-based Population Council, a nonprofit research group, has had the US rights to RU486 since 1994, but the company it licensed to actually produce and market the drug in the United States, the Danco Group in New York, is still in the process of arranging for manufacturing and distribution.
Danco, says spokeswoman Heather O’Neill, expects to make it available in the US “sometime next year.”
Jennifer Jackman, director of policy and research for the Feminist Majority Foundation, a Virginia-based national women’s rights group trying to bring RU486 to this country, says the “whole compassionate use thing has been a casualty of anti-abortion politics.” She adds that “plans are being worked out to provide it. I can’t be more specific.”
The National Right to Life Committee, prominent in the fight against abortion and RU486, did not return repeated calls.
Sandra Waldman, spokeswoman for the Population Council, echoes that. For two years, the council provided RU486 on a compassionate use basis to 24 patients from a supply it had obtained for research purposes, but that supply has been exhausted.
Waldman adds that the council is “very aware” of the supply problem. “Plans are being worked out for a strategy to handle current and new cases of compassionate use,” she says. “I can’t say more. An announcement will be made soon by the people involved. It isn’t all worked out.”
It certainly isn’t. In theory, patients like Laird could try to buy RU486 from doctors in Europe, where it is sold legally. But even in Europe, the drug is tightly controlled and is generally available only for abortions.
Even if they succeeded in buying RU486 in Europe, patients fear it would be confiscated if they tried to bring it into this country. The FDA allows importation of limited quantities of unapproved drugs for personal use in life-threatening situations. Recently, after consulting with its lawyer, the agency said it would “consider” allowing patients with meningioma to import a three-month supply. But patients worry because an “import alert” the FDA imposed in 1990 forbidding the import of RU486 for abortion purposes is still in effect.
For patients in whom RU486 does seem to slow brain tumor growth, there is great frustration that politics limits their options — even among those who once called themselves opposed to abortion.
Laird, who says her husband “lives on the Internet trying to solve this for me,” says she is “generally against” abortion. But she adds, “I can’t be against its being made legal. We’re talking about my sight and my life. It’s become very personal.”
It’s personal, too, for Anne McGinnis Breen, a Tucson woman who is 51 and had her first meningioma surgery at 39. She is a “practicing Catholic, married for 30 years, with three children. I don’t consider myself a feminist.”
But six years ago, her tumor recurred. “I am convinced,” she says, “that if I could have had this medication after that first craniotomy, I would not have had this recurrence.”
She has been on RU486 for two years — she has a small supply left — and according to the brain scans she gets every four months, her tumor has stopped growing. “Believe me,” she says, “I’m a radical now.”
Lyle R. Groshel of Virginia Beach, Va., echoes that. He won’t state his position on abortion.His wife’s meningioma has been treated with radiation, but if it grows back, “her only option is to find a drug that may stop the growth,” he wrote in an impassioned e-mail.
“I find it reprehensible that our government can prevent the importation or production of RU486 for use by people with meningioma.”
SIDEBAR
How RU486 does its job
RU486 works by blocking progesterone, a hormone needed for pregnancy. In combination with another drug, misoprostol, RU486 induces miscarriage. Taken alone within 72 hours of unprotected sex, it works as an emergency contraceptive.
The reason it may work on meningiomas — rare, noncancerous brain tumors that strike about 4,000 people a year — is that many of these tumors are also driven by progesterone, and blocking progesterone may slow the tumor. Surgery often works, but the tumors can regrow.
Because of its progesterone-blocking action, RU486 may also help control endometriosis (abnormal growth of uterine tissue outside the uterus) and fibroids, benign uterine tumors.
Through another mechanism, blocking of the hormone cortisol, RU486 may help treat Cushing’s syndrome, a hormonal abnormality.
So far, the data supporting the use of RU486 for brain tumors are preliminary. In 1991, California researchers reported in the Journal of Neurosurgery that they tried RU486 in 14 people with inoperable meningiomas, and five responded well.
That may sound unimpressive, but it’s “very encouraging,” says Dr. Daniel Karp, director of cancer clinical research at Beth Israel Deaconess Medical Center in Boston.
So encouraging, in fact, that the National Cancer Institute set up a placebo-controlled, multicenter study involving 200 meningioma patients. That study ended in July and results are not yet ready, says Karp, who was one of the investigators.
Even if RU486 is not a magic bullet for meningioma, “the results of the study need to be looked at — these patients are not surgically treatable,” adds Dr. John Erban, chief of hematology and oncology at New England Medical Center in Boston and another investigator in the meningioma study.