Jagged Little Pill
FDA delays abortion drug with pregnancy politics-as-usual
By Rhonda Reeves

what a jagged little pill...

wait until the dust settles

-Alanis Morrisette

When Loretta Lynn sang "Daddy don't you worry none 'cause Mama's got the pill," she was celebrating a brave new world for women - an era where women could now make choices about when or if they would reproduce. She could hardly have foreseen the sexual revolution to come, followed by nearly three decades of abortion wars, and the complete polarization of reproductive politics.

Now there's a new pill in town. Mifepristone (commonly known as the French abortion pill, RU-486) has been poised for entry into the U.S. market since 1996. But political and religious battles have steadily blocked its release.

On June 7, the FDA announced a new array of possible restrictions that will further delay or derail the process. (They have until September 30 to act on passage of the drug. By that date, they may approve, reject, or ask more questions. Again.)

Dr. Donald Edger, medical director for Lexington's Planned Parenthood, is candid in his assessment of the list of restrictions, and the continual delays which have besieged this drug. "It sounds like the FDA's doing like some people do. When they have a tough job ahead of them, they put it off."

The line in the sand is clearly drawn over mifepristone.

Advocates for the drug see it as a safe medical alternative to surgery, which will put decisions about a pregnancy where they think it belongs: in the hands of a pregnant woman. The decision could be made in relative privacy, free from the fear of intimidation, harassment, or even violence that plagues abortion clinics.

Anti-abortion activists call mifepristone, "government-approved human pesticide." They fear that abortion rates will increase, though advocates for the drug don't expect increased numbers overall. There is some speculation that women may elect for termination earlier in the pregnancy, as mifepristone is only an option through seven weeks.

In materials opposing the drug, Focus on the Family paints gruesome pictures of women who are ill-prepared to "deliver" a "fetus" at home, unprepared to see "their child."

Edger frankly disputes this as misinformation, saying, "up to 2 millimeters" would be more accurate, up to seven weeks in a pregnancy - which is the cut-off point for administering mifepristone. He says language like "fetus" or "child" is used, because it supports the political/religious agenda that all life begins at conception.

Another position advanced by anti-abortion advocates, is that women will now be free to practice "prescription pad" abortions. In fact, there are no plans for mifepristone to be distributed by pharmacies. The drug could be administered by a woman's doctor, in the privacy of a physician's office - with followup monitored for several hours, and aftercare scheduled to ensure the safety and success of the procedure.

Scarlet Letters

The proposed restrictions have included:

·doctors must have admitting privileges at a hospital within an hour's drive of their office;

·doctors who prescribe the drug must be trained in providing surgical abortions;

·a national registry of all doctors who prescribe the drug; and

·long-term follow-up studies on all patients.

By June 8, reports suggested that the FDA might have dropped, or was considering dropping, the last two provisions.

The proposed national registry was considered by many pro-choice advocates to serve as nothing more than ammo for a witch hunt - a scarlet letter which would brand doctors, and assist anti-abortion activists in their campaigns of harassment and intimidation.

Even if the registry and follow-up studies are dropped, however, the first two conditions may be enough to render the drug virtually obsolete before it is ever introduced in this country.

The Ghetto of

Abortion Services

The demand that doctors who prescribe the drug must be trained to provide surgical abortions severely limits mifepristone's scope (since abortion training has dwindled to almost nonexistent at many major medical centers); advocates insist that it is a ridiculous restriction - and one that has nothing to do with safety.

Paul Blumenthal (medical director for Planned Parenthood of Maryland), protested to the Washington Post, "What they have recommended [for] providers is beyond what they do with any other drug. Midwives deliver babies, but they don't do Caesarean sections - they refer that to someone trained to do them. Why must a doctor providing mifepristone know how to perform a surgical abortion?"

Pro-choice advocates assert that if this restriction is allowed to stand, it may make distribution of the drug almost impossible.

Many medical schools, including the University of Kentucky, want no part of surgical abortion training.

Dr. Edger, who provided abortion services in his ob-gyn practice (from which he retired in 1996) before joining Planned Parenthood, said he proposed that UK residents could visit his practice "to learn to terminate a pregnancy" several years ago. The University declined. Emphatically.

Still, Edger believes that requiring doctors to be trained in surgical abortions to administer this drug is just another smokescreen - one designed to narrow the field of providers and limit access.

He thinks it's implausible to suggest that gynecologists will not know how to handle possible complications that might result from the drug, since they are trained to deal with the aftermath of spontaneous abortions (referred to by many as miscarriages) all the time. "They know how to empty a uterus that has something in it," he says. They just don't call that an abortion, they call it a D & C.

He said, "given that 15-20 percent of pregnancies end in spontaneous abortions, most gynecologists know how to take care of this. But if what I read is true, this would disqualify [not only] family doctors and internists - but most gynecologists too." He adds that there's certainly a medical rationale for prohibiting "psychiatrists or dermatologists" from prescribing a drug this far outside their medical expertise, but that an internist could successfully administer mifepristone.

Allowing med students to opt out of training for a legal, medically safe, surgical procedure is part of the problem with women's reduced accessibility to safe abortions, according to Edger.

He says, "in those bad old days [pre-Roe v. Wade] when I trained, we saw women dying of illegal botched abortions performed on kitchen tables, or self-inflicted....Young doctors today not only aren't learning [the procedure], they're also not seeing what we saw. Women who bled to death. Who died from infections."

When Roe v. Wade was legalized, Edger said he was faced with a choice: performing the procedure, which had been seen as a "bad, illegal, immoral thing," as he was growing up (prior to Roe). Or, he said, "I could always send 'em down the street," where they'd become someone else's problem.

He says finally, "they were my patients, and I was their doctor," and he ultimately decided abortion services were a vital part of a gynecological practice, if he was going to truly meet the needs of all of his patients.

Elizabeth Strom, administrator at EMW Women's clinic on Lexington's south side (which currently offers abortion services), concurs with Edger's assessment that doctors caving in to political/religious pressures has added to the problem: "I think it's unconscionable for doctors not to provide this option to their patients... I think it's unconscionable for ob-gyns not to be surgically trained to perform abortions."

Leaving it off the curriculum says, to her, "Your health as a woman is not that important to us, and if you have a pregnancy that you've not planned for or that might not be in your best medical interests - you're on your own honey."

If doctors had stood up for their patients in the early days of Roe v. Wade - if they hadn't allowed abortion services to be exiled to the ghetto - doctors and patients might not be held hostage to minority opinion now.

As Strom puts it, "if more doctors were willing to provide a full range of health benefits to their patients, these people would not stand a chance of terrorizing every doctor in the nation."

She is adamant on the subject: "if a doctor signs on to practice medicine as a gynecologist, they are saying I want to give proper health care to women who need it. And that includes everything. If they are able to opt out, for religious reasons, let them get out of the field."

Strom also finds the FDA-proposed restrictions oppressive. Her fear of the possible registry is that "a doctor [on the list] stands a chance of being intimidated, harassed, and threatened by people who are opposed to women having reproductive choice" and possibly even subjected to violent retribution. Such fears "make a lot of doctors think twice."

Of the ongoing campaign against abortion, she says, "We're getting back into sort of an undercover, word of mouth situation if you need this service. Women are still being made to feel afraid of this legal procedure."

"We are getting so judgmental and so morally twisted in how we respond to the crying need of individuals who need medical care," she adds, "I think we're swimming backwards."

The Politics of Medicine

Strom argues that no one would stand for this sort of regulation of any other valid medical alternative to surgery. She asks, "why should we restrict this one drug because of ideology?"

For those who argue it's all about medical "safety," and not ideology, she responds, "do they require someone on strong heart medicine to live within an hour's drive of a cardiac specialist? Or someone who's diabetic to be within an hour's drive of an emergency center?" She argues that those conditions - and the medications which treat them - can have far more severe ramifications, but they are not regulated half so strictly.

She adds, "even [former surgeon general] C. Everett Koop said abortion is one of the safest surgical procedures... and safer than a full-term pregnancy," and he was vocally opposed to abortion.

The potential for mifepristone initially seemed clear to Strom, before all the proposed restrictions were announced. "If any doctor can provide this, they won't know who's getting RU-486 and who isn't. Then [anti-abortion activists] can't know who to protest."

That was the drug's chief virtue to many pro-choice advocates.

When in France

Strom considers it a uniquely American detriment that we have "a government body - congress or a legislature - so interested in practicing medicine."

The American College of Obstetricians and Gynecologists has generally concurred, opposing government intrusion into these matters, and insisting that it is not the appropriate role of government to tell physicians how to practice medicine.

As for the recent developments with mifepristone, ACOG has said, "We would be willing to provide information that would help the FDA understand the ways in which these proposals would interfere with the practice of medicine and put physicians in jeopardy, rather than addressing questions of efficacy and safety."

A New York Times editorial on June 10 described the FDA's actions as "troubling," concluding that "the Clinton administration needs to make sure this proven drug is made safely and broadly available to all American women."

When RU-486 was protested in France, and the manufacturer tried to withdraw it from the market, the government actually stepped in on behalf of the interests of public health. The French Minister of Health declared RU486 to be "the moral property of women" and ordered Roussel Uclaf to return RU486 to the market.

This rather deftly let the manufacturers off the hook. They could continue to manufacture and distribute the drug, without fear of significant reprisal, as they were merely complying with the law.

The American political climate, particularly in an election year, makes such a maneuver unlikely.

Displays of strength against the religious right are generally met with the all-too-Christian response of a well-orchestrated crucifixion.




Clinical trials on the use of RU-486 as a method of early abortion begin in the United States at the University of Southern California.


RU486 becomes available in France in October 1988, after the French Minister of Health declares RU486 "the moral property of women" and orders Roussel Uclaf to return RU486 to the market following the company's decision to withdraw the drug in the wake of anti-abortion pressure.

Anti-abortion forces threaten Roussel Uclaf's parent company, Hoechst AG, with economic reprisal if RU486 is marketed in the United States.

1989In March, Hoechst informs abortion opponents that "it is not our intention to market or distribute RU486 outside of France."

The U.S. Food and Drug Administration responds to pressure from anti-abortion Congressional representatives by banning the import of RU-486 for personal use.

July 1990

A delegation of feminist leaders and prominent scientists travels to Europe to meet with officials of Roussel Uclaf and Hoechst AG to urge U.S. introduction of RU-486. The delegation presents over 115,000 petitions from American citizens in support of RU-486.

November 1990

Congressman Ron Wyden holds hearings on RU486 before the House Small Business Committee. Scientists testify that the import alert has hindered research on non-abortion indications of RU-486, including its use as a possible treatment for breast cancer. Following these hearings, Congressman Ron Wyden introduces legislation to remove the import alert.

February 1991

The American Association for Advancement of Science (AAAS) endorses the testing and use of RU-486.

May 1991

New Hampshire becomes the first state in the nation to pass a resolution urging the commencement of clinical trials of RU-486 in that state. Subsequent RU-486 resolutions are passed in other state legislatures.

July 1992

In the first direct challenge to the FDA import alert on RU486, a pregnant American woman, Leona Benten, returns from Europe with a prescription of RU486. Customs officials seize the RU486 upon the arrival of Benten and Larry Lader of Abortion Rights Mobilization at JFK Airport. Despite a lower court ruling in favor of Benten's right to RU486, the Supreme Court refuses to order Customs to return the RU486 to Benten or the FDA to overturn the import ban.

November 1992

Clinton is elected. During the campaign, Clinton pledged his support for bringing RU-486 to this country.

December 1992

The FDA announces that a review of RU-486 for U.S. distribution could be completed in as short a time as six months. FDA Commissioner David Kessler writes to Roussel Uclaf encouraging the company to submit an application to license RU486 in the U.S.

January 1993

President Clinton issues an executive order instructing the FDA to re-evaluate the RU-486 import alert and directing the Secretary of Health and Human Services to "assess initiatives... [that can] promote the testing, licensing, and manufacturing of RU-486 or other antiprogestins."

February 1993

Larry Lader announces that the Peking Union Medical College has given Abortion Rights Mobilization permission to test the Chinese clone of RU-486.

May 1993

New England Journal of Medicine reports that RU-486, in combination with misoprostol in pill form, is now 99 percent effective in terminating pregnancy during the first nine weeks. This oral prostaglandin, already used in France, replaces prostaglandin injection.

September 1993

The Institute of Medicine releases a report recommending immediate submission to the FDA of a New Drug Application for the use of RU-486 as a method of early abortion and calling for expedited U.S. research on the multiple medical uses of RU-486 and other antiprogestins.

October 1993

Negotiations to allow the Population Council to seek FDA approval for RU-486 stall.

January 1994

20th anniversary of the Roe v. Wade Supreme Court decision legalizing abortion.

February 1994

British health authorities allow Marie Stopes Clinic in London to administer RU 486 to American women who travel to Europe for the early abortion procedure.

May 1994

On May 16, Roussel Uclaf assigns its U.S. patent rights for RU-486 without remuneration to the Population Council. Since this drug will not be licensed or developed in the U.S. by Roussel Uclaf, it no longer will be called RU-486, but instead will be referred to by its scientific name, Mifepristone.

Population Council plans next steps of conducting clinical trials on early abortion use, identifying a manufacturer, and winning FDA approval.

Winter 1995

The Population Council successfully concludes clinical trials for mifepristone at over a dozen sites around the US, involving 2100 women.

April 1995

Dr. Faina Rose announces study results showing that mifepristone inhibits the growth of cancer cells. Dr. David Weiner announces that mifepristone effectively prevents activation of the GRII receptor. By blocking this glucocorticoid receptor, mifepristone may prevent the cell infection and subsequent replication of the HIV virus.

March 1996

The Population Council submits FDA New Drug Application for mifepristone as an early abortion method.

July 1996

The FDA Advisory Committee on Reproductive Health Drugs holds mifepristone safety and efficacy public hearings. After hearing public and scientific testimony, the Advisory Committee recommends approval of mifepristone.

September 1996

The FDA takes the next step in the approval process by issuing an "approvable" letter to the Population Council in response to mifepristone NDA application.

April 1997

Hoechst AG turns over worldwide (non-U.S.) patent rights for mifepristone.

January 1998

Abortion Rights Mobilization announces expansion to U.S. clinical trials on their RU-486 clone.

June 7, 2000

New proposed restrictions for mifepristone announced by FDA.

September 2000

The FDA has until September 30 to respond to the mifepristone application.

SOURCE: The Feminist Majority Foundation and New Media Publishing, Inc.

Mifepristone: an Overview
by Christina Dwiggins

Mifepristone-formerly known as RU-486
, the French Abortion Pill-is a medication that can be used for safe, effective, early abortion. It may also be effective in treating fibroid tumors, Cushing's Syndrome, meningiomas, some types of breast cancer, glaucoma and endometriosis. Other benefits are still being researched (e.g., its impact on the virus that causes AIDS).

Mifepristone is a drug that blocks the body's reception of progesterone and leaves a woman unable to maintain her pregnancy, thus introducing the new choice of medical abortion.

Surgical abortions have long been women's only choice for terminating a pregnancy and have lately become synonymous with harassment and abuse. With the possible release of mifepristone to the public, women could opt for this non-invasive procedure, meaning no surgery and no anesthesia. This affords women much needed privacy in making a decision and enables them to control the entire abortion process.

Between 1994 and '95, the non-profit Population Council sponsored studies using women from various health centers across the United States. These studies endorsed mifepristone as safe, acceptable and highly effective among women who used it within the first 49 days of their pregnancy.

In circulation in Europe for years, it has been estimated that some 500,000 women have successfully aborted a pregnancy through the use of mifepristone, while reporting only mild side effects such as uterine cramps, bleeding, nausea and fatigue - the sort of side effects one would experience during a "spontaneous" abortion, or miscarriage.

Despite the success and potential benefits of such a drug, mifepristone has not yet been granted final FDA approval for personal use in the U.S.

Former President George Bush, a staunch pro-lifer, had mifepristone placed on the FDA's list of banned drugs, limiting both women's opportunity to benefit from the drug and a quicker introduction to the public. President Clinton asked the FDA to re-examine its import ban and the Population Council clinical studies began soon after. Though the FDA has agreed with the findings of the Population Council's studies, the agency is now asking for additional (and pro-choice advocates argue) onerous restrictions.

Currently, Danco, a women's health pharmaceuticals company, has been given the sole rights to manufacture, market and distribute mifepristone after FDA approval.

The drug was initially planned for the U.S. market in 1996. It's now estimated that women might see the introduction of the drug sometime by late 2000.