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Issues & Implications long-awaited entrance into the United States. In combination with The Political Challenges the prostaglandin , the compound was first approved as an And Educational Opportunities method in France in 1988. Because the /misopros- Around Very Early Abortion tol regimen is a “medical”—that is to say, nonsurgical—form of abor- By Rebekah Saul tion, and because it is effective at stages of traditionally Public attention to congressional newly available methods of very considered too early for effective action on abortion last year was early abortion. While last year’s surgical abortion, its development focused almost exclusively on the strategy, in the short term, clearly was considered a major reproductive Partial-Birth Abortion Ban Act—an worked to sow doubts in the health breakthrough. antiabortion initiative designed to of key legislators about the wisdom capitalize on Americans’ concern of congressional meddling in the Ever since mifepristone’s debut in over “late” pregnancy termination FDA drug-approval process, it did lit- Europe, propo- (TGR, Vol. 1, No. 6, December tle to advance the nents have looked forward to its 1998). Meanwhile, in the shadow of by increasing public understanding advent in the United States. The the “partial-birth” debate, a congres- about very early abortion methods. drug’s introduction into this country sional move that could have greatly It, therefore, also did little to close a was stalled by various political impacted the other end of the abor- troubling gap between longstanding maneuvers until 1993, when tion spectrum received very little public support for abortion as early President Clinton effectively attention: Last summer, the House in pregnancy as possible and the endorsed a provision that effectively lack of congressional support for a New technologies that would have barred Food and Drug range of new technologies that enable women to have Administration (FDA) approval of promise a potential shift in that very very early, nonsurgical methods of direction. As a long-term strategy, in the earliest abortion, such as mifepristone (com- closing this gap, while a significant stages of pregnancy monly known as RU-486). challenge, may prove critical for could affect reproductive both reproductive health politics and health politics and In the end, the provision failed to the availability of reproductive become law. The brief debate over health services. service delivery. the measure, however, focused less on abortion than on “science”—on directed FDA to review it. In 1994, Outlawing RU-486... the contention that congressional the Population Council began a year intervention in FDA’s review of any In an unforeseen move last June, of clinical trials in the United States, one category of drugs (in this case, Rep. Tom Coburn (R-OK) offered an which ultimately affirmed the abortion-inducing drugs) would con- amendment to a spending bill to pro- French experience—that the drug stitute an egregious and inappropri- hibit the use of funds by FDA “for regimen is a safe and effective ate interference with accepted scien- the testing, development or method of abortion in the first seven tific processes, one that could have approval...of any drug for the chemi- weeks of pregnancy (measured from negative consequences for a range of cal inducement of abortion.” After the beginning of a woman’s last men- health conditions. During the fight, the briefest of debates, the House strual period). In 1996, the Council the reproductive community approved the amendment, 223-202. submitted a New Drug Application to largely laid low, ceding to these The Senate declined to include a FDA, which in turn deemed the drug more “mainstream” concerns. similar provision in its version of the “approvable,” pending final informa- appropriations measure, so the fate tion on manufacturing and labeling. With mifepristone’s final FDA of the FDA restriction ultimately was Taking advantage of the delay approval still in the offing, reproduc- decided by a House-Senate confer- regarding these final details, Coburn tive health supporters almost cer- ence committee, which rejected it. and like-minded members of tainly will face further attempts by Congress—who believe that abortion antiabortion lawmakers to prevent Though it clearly would have much is murder at any stage in preg- its progress—which, in turn, may broader implications, both sides of nancy—clearly aimed to stop yield additional opportunities to the abortion divide recognized the mifepristone in its tracks. rethink legislative and public educa- Coburn amendment’s fundamental tion strategies around this and other purpose—to derail mifepristone’s

The Guttmacher Report on Public Policy F ebruary 1999 5 While mifepristone is being reviewed first three months of pregnancy. NEW AND RE-EMERGING VERY EARLY ABORTION by FDA in light of its efficacy as an Support for legal abortion drops pre- TECHNOLOGIES , these organizations cipitously after the first trimester, Mifepristone/Misoprostol Regimen—Mifepristone blocks the pointed out, the drug also has shown however. Abortion practice largely hormone progesterone, which is needed to maintain a preg- promise in treating other conditions, mirrors public opinion. American nancy. Misoprostol, an already marketed protaglandin, caus- such as Cushing’s syndrome and women overwhelmingly have abor- es uterine contractions. The combined regimen has demon- endometriosis. Barring mifepristone’s tions early in pregnancy—approxi- strated effectiveness roughly comparable to surgical abortion, approval, then, also would slow mately half of all abortions occur and can be used as soon as a pregnancy is detected up to 49 research on alternative uses, they within the first eight weeks and days from a woman’s last menstrual period (LMP). Barring said. In addition, research advocates almost nine in 10 by the end of the congressional action to the contrary, final FDA approval of the regimen is anticipated later this year. cautioned that the Coburn amend- first trimester. The newly emerging ment could implicate any drug that abortion technologies, taken /Misoprostol Regimen—Methotrexate blocks folic causes an abortion (as a side effect, together and coupled with advance- acid and prevents cell division; already marketed as a cancer- not just as its primary purpose)—for ments in pregnancy detection, have fighting drug, its use as an abortifacient is legal but technically example, drugs used in chemother- the potential to shift the timing of “off-label.” This regimen is also being used from the detection apy. Fearing the Coburn amendment abortion in the United States even of pregnancy up to 49 days LMP. would effectively bar a range of more in that direction, by increasing Manual (MVA)—A surgical procedure that important therapies, the National the percentage performed in the first utilizes a non-electrical suction instrument to evacuate the con- Coalition for Cancer Research went half of the first trimester. tents of the uterus, MVA may be used throughout the first 12 on record opposing it. weeks of pregnancy. Use of MVA was fairly widespread in the Fiction and Fact early 1970s, but technology limited early pregnancy detection, as well as detection of incomplete abortion. Improved preg- If Timing Matters According to the Kaiser Family nancy tests and ultrasound equipment have facilitated MVA’s Downplaying the abortion issue per Foundation, however, the American re-emergence as a surgical method of very early abortion. se while highlighting “larger” ques- public is largely ignorant about these tions has been considered the safest, methods. In 1997, according to a ...Or Hampering Science? if not only, way to prevail in an Foundation poll, only 43% of women In support of the funding ban, Coburn antiabortion Congress on a matter and 51% of men had even heard of and other congressional opponents of impinging on reproductive choice— either mifepristone or methotrexate, abortion rights maintained that especially in recent years, when a long-marketed cancer-fighting drug approving abortion technologies is not antiabortion advocates have focused also being used “off-label” as an abor- an appropriate function for a federal on restrictions that are largely tifacient; moreover, only seven in 10 agency whose mission is to promote backed by the public. In the case of of the women who had heard of these health. advocates efforts to prohibit the approval of drugs knew that they could be used countered that because abortion is mifepristone, however, at least the as a method of pregnancy termina- legal in the United States, it is wholly potential for galvanizing widespread tion. It is likely that recently avail- appropriate that medical methods of public and political support certainly able surgical techniques of very early abortion be considered on an equal exists. The drug is most effective in abortion are similarly unknown. (New basis with drugs used for other legal the first half of the first trimester data from The Alan Guttmacher purposes. and, therefore, offers women a new Institute [AGI] indicate medical abor- option for the earliest possible ter- tions constitute a small but rapidly Notwithstanding these arguments, mination of pregnancy. Moreover, it growing fraction of all abortions; AGI however, a major component of the is just one of a number of emerging estimates that, in 1996, 4,200 med- prochoice strategy was to allow ques- technologies—surgical as well as ical abortions were performed in the tions about the appropriateness of nonsurgical—that allow women to United States and that 4,300 such congressional intervention in compli- obtain an abortion at stages tradi- abortions were provided in the first cated scientific processes and proto- tionally considered too early for half of 1997. No comparable informa- cols, namely, the long-established FDA effective surgical abortion (see box). tion is available on the extent to drug-approval process, to dominate which MVA is being used.) the debate. Indeed, a large and diverse Public opinion in the United States coalition of organizations promoting is highly supportive of early abor- There is also some evidence, at least biomedical research was amassed to tion. According to a New York in the public debate, that support for oppose the provision on the grounds Times/CBS poll conducted in early very early abortion methods, espe- that it could have far-reaching, nega- 1998 at the time of the 25th cially medical methods, may be tem- tive consequences on a range of health anniversary of the Supreme Court’s pered by confusion about how the technologies, not just those relating to Roe v. Wade decision, almost two- methods work and, consequently, how pregnancy termination. thirds of American adults believe they might affect the incidence of that abortion should be legal in the abortion. One myth, in the words of

The Guttmacher Report on Public Policy F ebruary 1999 6 Rep. Joseph Pitts (R-PA), is that they medical abortions and surgical abor- Indeed, a concerted public educa- would make unwanted pregnancy “the tions each have relative advantages tion campaign may be necessary to medical equivalent of a headache: pop and disadvantages from the viewpoint engage the public and build the a pill and it will go away.” The implica- of the women undergoing them; expe- bridge between theoretical support rience in Europe shows that some and public activism. A concerted public educa- women prefer one and some the other. tion campaign may be nec- In countries where it has been avail- Increased activism around very early essary to engage the public able, however, there is no evidence to abortion could have a positive, mul- support the notion that the availability tiplier effect on reproductive health and build the bridge be- of mifepristone increases the overall policy debates. Beyond staving off tween theoretical support incidence of abortion; in fact, the further damaging congressional and public activism. abortion rate in France has declined action, it also could help add a new more or less steadily since mifepris- “winner” to the reproductive rights tion is that mifepristone or methotrex- tone’s advent in 1988. political agenda. That, in turn, could ate, by making the procedure “easier,” re-engage policymakers and the pub- would diminish the seriousness with lic in the basic right to abortion. As From Theory to Practice which women treat abortion. a bonus, prevailing on the issue of Clearly, there is much work to be FDA approval of new abortion tech- In reality, is compa- done to educate the public about the nologies, specifically mifepristone, rable to a miscarriage, but it can take new abortion methods—how they could prove beneficial for a broad considerably longer; the process can work and how they may, and may array of medical conditions—safe- span several days and, though not, impact the overall provision of guarding, at the same time, the inde- extremely safe, involves significant abortion services—so that future pendence and integrity of the FDA medical supervision. In terms of what’s attempts to restrict very early abor- drug-approval process itself. involved in the actual procedures, tion methods can be fought head-on.

The Guttmacher Report on Public Policy F ebruary 1999 7