RU486: Misconceptions, Myths and Morals

Acknowledgments

PREFACE

The steroid mifepristone, best known as the abortion pill RU 486, made its debut in 1988 in France. Janice Raymond, Lynette Dumble and I – all long-term women’s health researchers and supportive of safe, legal abortion – watched in astonishment as international women’s health groups uncritically greeted the arrival of this chemical abortifacient. We wondered why a largely untested chemical was hailed as a new ‘miracle drug’ and the ‘moral right of women’, as its French inventor, Etienne-Emile Baulieu, liked to call it. We already had a tried and tested abortion method – suction abortion (also called vacuum aspiration) – which can be undertaken using a local anesthetic. It is performed in the safety of a clinic, completed in 5–10 minutes, and is 98–99% effective.

When we noticed ‘suction’ abortion increasingly being called ‘surgical’ abortion (although no cutting is involved), and the pill abortion RU 486 ‘medical’ abortion and termed ‘safe, effective, quick and more natural’ we knew we had to investigate the science as well as the politics of ‘chemical’ abortion – our preferred term. We wondered how a procedure could be called ‘quick’ in spite of the fact that it can take more than 6 weeks (45 days) to be completed. We also learnt that RU 486 abortion wasn’t just a simple ‘one stop’ pill abortion: it requires the addition of a second chemical, a prostaglandin (PG), to boost its success rate to the low 90% (sometimes less). When we found out that the most frequently used prostaglandin, a misoprostol marketed under the trade name Cytotec® (an anti-gastric ulcer drug), had been dis-endorsed for abortion purposes by its manufacturer, alarm bells began to ring.

We were particularly concerned when we realized that any questions or criticism of RU 486/PG abortion were immediately condemned. For example, in an article on ‘The politics of the abortion pill’ (Chapman, 1989), International Planned Parenthood Vice President Louise Tyrer stated that such criticism was signing the death warrant for the 200,000 women who die [worldwide] annually from abortion. Criticism was often perceived as emanating from anti-abortionists. But as we saw it, the real problems were that abortion was still illegal in many countries, and that relations between women and men remained unequal; big issues that can not be solved by a new abortion method.

After painstaking research for two years, we did not like what we found. We became convinced that not only was RU 486/PG abortion not a new panacea, but that in fact its potential widespread (and in many countries illegal) use might jeopardize women’s lives and become the new DIY backyard abortion, 21st-century style.

We called the results of our research RU 486: Misconceptions, Myths and Morals to draw attention to the various discourses around this chemical drug cocktail. In 1991, our book was published simultaneously in the USA, Australia and Bangladesh (and distributed in Europe and New Zealand). It was awarded a Certificate of Commendation in the 1991 Australian Human Rights Awards. This was reaffirming of our aim to shed light on the wild claims for this new abortion method; the reality of company-sponsored research that led to its rapid approval in France and the UK; adverse effects, dangers and unknown long-term effects of RU 486/PG; and its potential for abuse of women in the so-called Third World as part of the ongoing quest by ‘the west’ for population control.

Regrettably, the majority of the women’s health movement, especially in the USA, and among US-influenced pro-choice and pro-population control groups in Australia and the UK, saw us as ‘traitors’ to the cause of women’s struggle for abortion rights, and/or as anti-abortionists in disguise and ‘in bed with’ anti-abortion groups who mostly welcomed the findings of our book.

We found out the hard way (by being ignored and treated as pariahs at US conferences or even shouted down) that asking tough questions about chemical abortion, in other words, taking the publicity gloss off the repeated but unproven ‘safe-and-effective’ mantra, was not welcomed by women’s health groups. They preferred the simplistic notion that popping some pills was the solution to pregnancy termination that we had all been waiting for. The reception of our work in continental Europe was much more positive (our book was published in German in 1992) as many women’s health advocates were concerned about RU 486/PG abortion. And many Indian health activists applauded our work.

More than 20 years later, the situation has changed little. Our ongoing feminist critique of chemical abortion is mostly ignored or dismissed by pro-choice groups who continue to uncritically praise RU 486/PG abortion as safe and effective, akin to a miscarriage (Cannold, 2012) and ‘more natural’ for women. We did – and do – understand that ongoing attacks from the extreme right-wing on women’s reproductive rights (particularly in the USA) pose challenges for the continued safe provision of vacuum aspiration abortion services in clinics. However, we question that instead of keeping up the fight to safeguard and improve abortion services, as feminists have had to do since the 1970s when the liberalization of abortion laws began – and, importantly, work hard to reduce the overall number of abortions – RU 486/PG is uncritically accepted as the easier option.

1. Why a New Edition?

When RU 486 Misconceptions, Myths and Morals was published in 1991, RU 486/PG was only available in France (since 1988, for pregnancy termination up to 49 days from the last period), the UK (since 1991, up to 63 days) and rumored to be used in China. Despite concerted efforts from the pro-population control lobby – strongly supported by many US women’s health groups – it took until the year 2000 for The Population Council (who had been given the patent from French manufacturer Roussel Uclaf) and its licensee, private company Danco Laboratories, to distribute RU 486 as Mifeprex in the USA, available for pregnancy termination up to 49 days from the last period. A number of European countries had legalized chemical abortion in 1999 (in Sweden as early as 1992). In New Zealand, where (as in Australia) no pharmaceutical company was going to apply for RU 486 approval due to the country’s small population, a private medical consortium called Istar was given permission in 2001 to import the drug from French manufacturer Exelgyn as Mifégyne. Italy, with its predominantly Catholic population, strongly lobbied against RU 486/PG abortion, including vocal feminist voices who opposed this method on health and safety grounds and its impact on women, just as we have done (La favola dell’aborto facile. Miti e realtà della pillola RU 486 by Assuntina Morresi and Eugenia Roccella, 2006/2010), but State approval was granted in 2009.

By June 2011, according to Gynuity Health Projects,¹ 50 countries had approved Mifepristone (a far cry from the 193 countries recognized by the UN). On 29 August 2012, Australia was added to this list on (announced publicly on 30 August). MS Health, Marie Stopes International’s not-for-profit subsidiary company, was approved by the Therapeutic Goods Administration (TGA) to be the sponsor (importer and distributor) of RU 486 (Mifepristone Linepharma) for use up to 49 days since the last period. The prostaglandin approved by the TGA, also on 29 August, is a misoprostol called GyMiso® (see p. lviii and p. lxviii). Predictably, pro-choice advocate Leslie Cannold greeted its arrival as a crucial victory for women and choice (Cannold, 31 August 2012) and immediately asked for RU 486 to be listed on the Pharmaceutical Benefits Scheme (PBS) so as to make it cheaper. Equally predictably, the Australian Christian Lobby condemned the decision (in Harrison, 31 August 2012).

In a ‘For and Against’ column in the Opinion pages of The Sydney Morning Herald I was able to raise our long-standing concerns about RU 486/PG abortion as an unsafe, second-rate abortion method with significant problems (Klein, 30 August 2012). This article (republished in an expanded version on the Spinifex Press website; Klein, 31 August 2012) resulted in a number of women contacting me as they wanted to tell me about their negative experiences with RU 486/PG abortion.

This then seems an appropriate time to republish our book and add new data and analyses. I have not made changes to the original text as the information on the history of RU 486; its incomplete and company-sponsored research before it became widely used; the chemical properties of both RU 486 and prostaglandins; health and safety concerns; and unanswered questions about long-term adverse effects for women; remain absolutely pertinent today and deserve to be widely read. (When referring to issues discussed in this book I use the abbreviation MMM – Misconceptions, Myths and Morals.)

A NOTE ON TERMINOLOGY

The use of different words to refer to the same method is confusing. Here is some of the terminology used in this Preface (and MMM):

MEDICAL ABORTION is the term used by promoters of RU 486/PG abortion. When I use it, I put it in inverted commas – ‘medical’ abortion – to problematize the (falsely) soothing tone of this being a nice, natural and private ‘medicinal’ abortion method: ‘medical’ abortion.

CHEMICAL ABORTION is my preferred term to describe the two-part RU 486 (the synthetic steroid mifepristone, a progesterone receptor blocker) and prostaglandin (mostly misoprostol) abortion, abbreviated as RU 486/PG abortion or RU 486/PG termination. It is unpredictable, very painful with excessive bleeding, nausea and diarrhea. It lasts at least three days (sometimes weeks). Dosages have varied greatly but more recent applications tend to use 200 mg of mifepristone (1 pill) and, 36 to 48 hours later, 800 µg misoprostol (4 pills) via oral or buccal administration (letting it dissolve between cheek and gums). Further doses of 200 µm misoprostol are added three times a day on the subsequent two days if the pregnancy is not expelled (completely).

RU 486/PG abortion requires clear estimation of early pregnancy age (best with a transvaginal ultrasound) and a mandatory checkup two weeks after the procedure. It is a drawn-out, multi-step abortion. It fails on average in 5–8% of cases (but 10% is not unusual).

SURGICAL ABORTION/TERMINATION is the term used by promoters of ‘medical’ abortion. It implies knives and cutting (which is incorrect as the much earlier technique of ‘sharp’ curettage is no longer used). The term ‘surgical’ abortion became only widely used when RU 486/PG abortion entered the scene in the 1980s. The misinformation that ‘surgical’ abortion involves sharp instruments goes back to previous use of D&(sharp)C which is no longer used in abortions.

SUCTION ABORTION or vacuum abortion is my preferred term for first-trimester abortions. It is a one-step, low-technology method completed in 5–10 minutes. Including a waiting and recovery time, the whole process usually takes no more than 2 hours. No follow-up visit is mandated. It only requires a local anesthetic, but increasingly, the use of a general anesthesia is promoted. This is one of the reasons – together with the fear of (non-existent) ‘knives’ in ‘surgical’ abortion – that women are led to believe that ‘medical’ abortion is easier, more ‘natural’ and less painful. Suction abortion is successful in 98–99% of occasions.

MTOP (‘medical’ termination of pregnancy) and STOP (‘surgical’ termination of pregnancy) are used in a study from the UK referred to in this Preface. TOP is used for ‘termination of pregnancy’.

I also use the term ‘ choice ’ with inverted commas. From my perspective, ‘choosing’ abortion is not comparable to, say, choosing between a chocolate cake or an apple pie. I prefer to call it a decision : often difficult and painful – emotionally and physiologically – and with possible long-term physical and emotional consequences. I understand that many women simply cannot/do not want to have a(nother) child and I absolutely support women’s access to best-practice safe abortion.

2. What is a ‘safe and effective’ abortion method?

Whenever RU 486/PG abortion is discussed, its promoters assure us that it is ‘safe and effective’, and indeed superior to suction abortion as it is ‘more natural’ and can be done ‘in the privacy of a woman’s home’. This has been the clarion call since RU 486/PG administration appeared on the scene in the late 1980s despite, as we discuss in our book, the many complications women faced in the early company-sponsored studies (see Chapter Two in MMM, p. 37).

Over time this message has not changed. The pattern in medical and media articles is always the same: a great many adverse reactions are mentioned, but at the end of the articles – or already in the Abstract at the beginning of such appraisals – RU 486/PG abortion is declared ‘safe and effective’. Readers might not draw the same conclusion, particularly if they are women who sustained hemorrhage-like bleeding including the need for a blood transfusion and/or re-evacuation, cardiovascular problems, a potentially lethal infection, or an ongoing pregnancy. Nevertheless, the ‘safe and effective’ mantra is the one that prevails, and it is very hard to displace.

Take Régine Sitruk-Ware’s writing for example. An early RU 486 researcher from France (we frequently discuss her 1985 and 1990 work in MMM), Sitruk-Ware has to be credited with taking adverse effects seriously and spelling out contraindications.² In her 2006 review paper that includes large post-marketing studies in the USA and France, she confirms that the antiglucocorticoid properties of RU 486 which block the cortisol receptor may be responsible for fatigue and increased risk of infection – a problem for all RU 486/PG terminations but especially for the 5–8% of women for whom RU 486/PG abortion fails and who need a second abortion, a curettage to remove remaining parts of the embryo and placenta (see MMM pp. 66–69). The antiglucocorticoid properties have also been linked to deaths occurring from bacterial infection after RU 486/PG abortion (see below, p. xxv).

Sitruk-Ware also mentions drug interactions (for example, with anti-epilepsy drugs) that may result in lesser efficacy of RU 486, a precaution that is not mentioned in the mainstream discourse about RU 486 being a universal panacea. And she repeats the warning of serious cardiovascular events from RU 486/PG use in women over 35 years of age who smoke. (The first death attributed to RU 486/PG abortion occurred in France in 1991 when a woman suffered a fatal heart attack, although the prostaglandin administered at the time, sulprostone, is no longer used.) Importantly also, she cautions that due to the antiglucocorticoid activity of RU 486, severe asthma attacks that occur might not be able to be controlled by adjusting the dose of the inhaled corticosteroids (2006, p. 53). This caution is of great concern to the many women who suffer from asthma, but it is absent from public discussions of RU 486/PG abortion. Moreover, as we point out in MMM (pp. 34–37), in many initial studies with RU 486/PG, women who suffered from asthma, epilepsy, kidney or pulmonary disorders, or gastro-intestinal and liver disorders, were excluded; put differently, the effects of RU 486/PG abortion on their health were not tested.

Sitruk-Ware confirms that an average of 10% of women suffered from excessive bleeding, another 1.4% required hemorrhage-controlling curettage, and 0.25% a blood transfusion. These numbers appear low, but extrapolated to approximately 1.5 million women in the USA alone who, according to the FDA, by 2011 had undergone an RU 486/PG abortion, this amounts to approximately 150,000 women who bled excessively, 21,000 women who had to endure a second procedure (a curettage to terminate their pregnancies); and 3750 women who needed a life-saving blood transfusion. (A 2009 study from Finland revealed even higher percentages, see below, p. xix.) It is for these reasons that Régine Sitruk Ware issues a strong caution:

Therefore it is mandatory to inform the women about the risk of heavy bleeding and give them instructions to follow in case of emergency. Women living in areas where no medical facilities are available should not be included in the medical protocol of TOP [termination of pregnancy] unless referrals, and possible transportation are available for emergencies (2006, p. 51; my emphasis).

This is a pivotal warning that flies in the face of RU 486/PG promoters who repeatedly hail the availability of pill abortions as a boon for women living in rural areas in both western and so-called developing countries (see Section 5 for further discussion of this crucial point).

Infection is a further serious adverse effect discussed by Sitruk-Ware. Because of the antiglucocorticoid properties of RU 486, there appears to be general higher risk of infection during the abortion process. In 2001, a Canadian participant in a clinical trial died from septic shock after infection with the anaerobic bacterium Clostridium sordellii. After her death, the research study was terminated. To the present day RU 486/PG abortion is not available in Canada; as in Australia, no pharmaceutical company has applied for a drug license. A cluster of seven US women died in 2005 from septic shock, three after infection with the same bacterium. The particular danger is that C. sordellii does not cause a fever and in the absence of this warning sign the infection spreads. Other bacteria are implicated as well. The death of an Australian woman in 2010 was caused by an aerobic Streptococcus A infection (see below, p. lii). Hence, Sitruk-Ware cautions that attention must be paid to possible symptoms of infection including rare cases of anaerobic infection without fever, during the process of medical TOP (2006, p. 53).

In pregnancies continuing after RU 486/PG abortions, varying in different studies from 2–13%, averaging 5–8%, Régine Sitruk-Ware cautions about malformations, should the pregnancy continue. Again her warning is clear:

Therefore women should be informed that due to the risk of failure of the medical method of TOP and to the unknown risk to the fetus, the posttreatment visit is mandatory and in case of failure, pregnancy termination by another method should be completed (2006, p. 53).

This also includes informing women very clearly that they must not change their mind about the abortion between taking the RU 486 and, 36–48 hours later, the prostaglandin.³

Finally, Sitruk-Ware cautions against the use of RU 486/PG terminations for women with allergies, renal failure, liver failure, and malnutrition (my emphasis) due to the fact that specific studies have not been conducted on impaired metabolism after use of RU 486/PG. Her warning against administering RU 486/PG to women with malnutrition – if taken seriously – would eliminate its use for most women in poor countries (where anemia is endemic) who are said to be the major beneficiaries of RU 486/PG abortion by its eager promoters (see Section 5 below).

Yet, after mentioning all these problems and the lack of information,⁴ Régine Sitruk-Ware nevertheless concludes that the efficacy and safety of this treatment has been confirmed, albeit with close adherence to the approved recommendations (2006, p. 54). But the fact of the matter is that neither her warnings nor recommendations are discussed in the mainstream promotion of RU 486/PG.

3. How does RU 486/PG abortion compare to ‘surgical’ abortion?

One would think that the ‘gold standard’ for proving that chemical abortion is the new preferred abortion method would be to conduct a series of international trials that compare suction abortion with RU 486/PG abortion – and prove the latter highly superior on all counts. This has not happened. As we wrote in MMM (pp. 47–54), there was a notable absence of trials comparing the two types of abortions before RU 486 registration in France (1988) and in the UK (1991). Neither did this change in the 2000 US registration.

In the meantime, in the absence of controlled trials, studies that look at RU 486/PG abortion per se, come up with an average success rate of 92–95% – and a 90% ‘success rate’ or less is not rare. Thus, in 2013, only the most ardent (or ignorant) promoters of RU 486/PG abortion would still claim that chemical abortion is as successful as suction abortion, with or without a general anesthetic, which terminates a pregnancy in 98–99% of instances.

It is negligent that to the present day comparative trials are wanting. A 2002 Cochrane review (updated in 2005) by Lale Say et al. looking to compare different types of ‘medical’ abortion (including methotrexate/misoprostol) pointed out that, There are no data on the most commonly medical (mifepristone/misoprostol) and surgical abortion available to be included in the review (in 2005, p. 2). Two later studies, however, have revealed worrying findings.

A comprehensive Finnish study, published in 2009 and conducted by Maarit Niinimäki and colleagues, with 22,368 women using ‘medical’ and 20,251 using ‘surgical’ abortion (both groups up to 63 days of pregnancy), concluded that incomplete termination occurred in 5.9% of women using RU 486/PG compared with 0.4% in ‘surgical’ abortion. In other words, 1,320 women had to undergo two abortions to end their pregnancy.

Moreover, the Finnish researchers found that the overall incidence of adverse effects was fourfold higher in the medical compared with surgical abortion cohort (20.0% compared with 5.6%, P<.001) (Niinimäki et al., 2009, p. 795). In ‘real’ numbers this means that 4,479 women suffered from an adverse reaction. The most frequently suffered adverse effect was excessive bleeding (necessitating a medical consultation) in 3,487 women which was eight times higher in the pill abortion group than in the ‘surgical’ abortion group. Excessive hemorrhage which needed a surgical re-evacuation occurred in 645 women, which again makes it clear how dangerous it can be for women in remote areas without access to emergency hospitalization to be told that RU 486/PG abortion is ‘safe and effective’.⁵ Niinimäki et al. conclude:

Both methods of abortion are generally safe, but medical termination is associated with a higher incidence of adverse events. These observations are relevant when counseling women seeking early abortion (2009, p. 796, my emphasis).

An in-depth Health Technology Assessment study conducted by Stephen C. Robson and colleagues at the University of Newcastle as part of the UK National Institute for Health Research (NIHR) also compares ‘medical’ with ‘surgical’ abortion. The objective of the study was

[T]o determine the acceptability, efficacy and costs of medical termination of pregnancy (MTOP) compared with surgical termination of pregnancy (STOP)⁶ at less than 14 weeks’ gestation, and to understand women’s decision-making processes and experiences when accessing the termination service (Robson et