RU486: Misconceptions, Myths and Morals
250
RU486: Misconceptions, Myths and Morals
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| ISBN-13: | 9781742198446 |
|---|---|
| Publisher: | Spinifex Press |
| Publication date: | 09/01/2013 |
| Sold by: | INDEPENDENT PUB GROUP - EPUB - EBKS |
| Format: | eBook |
| Pages: | 250 |
| File size: | 399 KB |
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RU 486
Misconceptions Myths And Morals
By Renate Klein, Janice G. Raymond, Lynette J. Dumble
Spinifex Press Pty Ltd
Copyright © 2013 Renate Klein, Janice G. Raymond, Lynette J. DumbleAll rights reserved.
ISBN: 978-1-74219-844-6
CHAPTER 1
THE HISTORY OF RU 486
RU 486 is a recent discovery. In April 1980, Georges Teutsch and Daniel Philibert of Roussel Uclaf, with French scientist Etienne-Emile Baulieu, a consultant to the company, succeeded in synthesizing RU 486, a steroid now with the trade name Mifégyne (mifepristone). Ten years later, Roussel Uclaf employees Ulmann, Teutsch and Philibert denied that the research which led to the synthesis of RU 38486 (later shortened to RU 486) was performed with the intention of discovering an abortifacient. They claimed it was a by-product of the company's active search for a molecule which would bind strongly with the glucocorticoid receptor. However, 'Initial tests in several species soon revealed that RU 486 was [also] a progesterone antagonist' (Ulmann et al., 1990: 45 [our emphasis]). Baulieu's longstanding interest in hormonal contraception prompted Roussel Uclaf to focus further investigation of RU 486 on the drug's potential to impede ovulation, act as a 'morning-after' pill, and interrupt pregnancy.
A mere 17 months of animal research on rabbits, rats and monkeys was deemed sufficient to judge RU 486 promising and 'safe' enough to warrant clinical trials on women. As early as October 1981, the first study on eleven women took place at the University Hospital in Geneva, Switzerland (Herrmann et al., 1982). Promoters of RU 486 such as Sheldon Segal, director for population sciences at the Rockefeller Foundation, admitted this move to be 'an unusual example of the rapid clinical application of basic research findings ...' (1990: 691). A member of the Geneva team indicated that the rush to clinical trials was a move to 'beat' other pharmaceutical companies researching a similar compound (Rina Nissim, pers. comm. to RK, June 1990). Indeed the competition came from the US-owned company Sterling Winthrop (epostane), and the German company Schering Laboratories (two ZK analogues, onapristone and lilopristone). Currently, neither drug is marketed for abortion purposes.
In the Geneva trial, eleven women, six to eight weeks pregnant, received 200 mg of RU 486 per day for three consecutive days. Nine pregnancies were terminated, in eight women after five days, in one woman after nine days. One of the women initially claimed as 'success' later needed a uterine evacuation and, in another, heavy bleeding necessitated blood transfusion and emergency surgery (Baulieu, 1989a: 1811). The Paris newspaper Libération commented that, given these associated complications and risks, RU 486 was no 'abortion miracle'. Libération also reported that RU 486 is not only an antiprogesterone but an anti-glucocorticosteroid which can take the place of cortisone in the adrenal glands, and that contraindications emanating from this double action of the drug could be a problem (Lépinay, 1982: 2). This suspicion was confirmed in the first RU 486 toxicological study in monkeys, which led to adverse reactions affecting the adrenal glands (see Chapter Threefor details).
Despite scant research on animals and the dubious results from Geneva, clinical trials on women began in France, Sweden, Australia, Holland, USA, England, Finland and China. Roussel Uclaf supplied the drug and its staff and consultants are listed among the authors of the resulting publications from many of these trials. André Ulmann of Roussel Uclaf is even credited with designing a Chinese study of RU 486 (Zheng, 1989).
In these trials, reported 'success rates' – that is the numbers of women for whom the administration of RU 486 resulted in a complete termination of their pregnancy without the need for further medical intervention – varied considerably from 54 per cent (Herrmann et al., 1982), 60 per cent (Kovacs et al., 1984) to 85 per cent (Couzinet et al., 1986) and even 90 per cent (Grimes et al., 1988). The research papers concluded that RU 486 was a promising alternative to conventional abortion, and a medical 'break-through', but the number of complete terminations achieved with this drug was well below the established 99 per cent of conventional abortion (Chavkin and Rosenfield, 1990). In order to improve these negative results, the next step in the development of the 'abortion pill' was to combine RU 486 with prostaglandins.
Since 1970 prostaglandins, which induce uterine contractions, have been used to initiate labor and to interrupt pregnancies throughout the world. The initial optimism about the use of prostaglandins for abortion was soon dampened by disappointing success rates and serious adverse effects. For these reasons, the European Women's Health Movement organized against the use of prostaglandins in the late 70s (see Chapter Four for details).
In spite of these known problems, Marc Bygdeman and Marja-Liisa Swahn of the Karolinska Institute in Stockholm commenced the administration of RU 486 in combination with a prostaglandin (PG) following the earlier research of Csapo (see Chapter Four). Under the sponsorship of WHO in 1984, their small study included 34 women and seemed promising: complete abortions occurred in 32 women (94 per cent), (Bygdeman and Swahn, 1985). As a result of this research, RU 486/PG was rapidly deemed superior to RU 486 alone. The majority of later studies used varying doses of RU 486 in combination with different types of PGs which were administered as intramuscular injections, suppositories or, as first reported in 1990, orally (Swahn et al.). It is crucial to note that these clinical trials were undertaken without basic research into potential adverse effects from the interaction of the two drugs (see Chapter Four for further details).
Until the publication of the results of Chinese trials with RU 486/PG in 1989, which reported that 2321 women had participated in four multicenter clinical trials, the numbers of women in the clinical trials were small. From the initial 11 women in the Geneva study, the numbers ranged from 35 (Vervest and Haspels, 1985) to 100 (Couzinet et al., 1986) and 271 women (Grimes et al., 1990). Grimes' figures were a total of all the women who had been administered the drug from 1984 to 1989 in his US trials). Even a 1989 WHO publication of a multicenter trial with eight medical centers participating included only 261 women. Two publications in 1990 reported larger numbers: Louise Silvestre of Roussel Uclaf and colleagues Dubois, and Ulmann listed 2040 French women as participants in their study, and a UK multicenter trial had 588 participants, a number still significantly lower that the 50,000 to 60,000 women who are said to have undergone chemical abortion by the beginning of 1991. Importantly, the three largest studies conducted to this point were either undertaken by Roussel Uclaf or were affiliated with the French company. As the authors of the UK multitrial paper acknowledged, they 'prepared their report from data provided by Roussel Uclaf (UK Multicentre Trial, 1990: 480). The general tenor in these publications is one of assured optimism. As Louise Silvestre and colleagues put it, 'We conclude that the administration of mifepristone [RU 486] followed by a small dose of a prostaglandin analogue is an effective and safe method for the early termination of pregnancy' (1990: 645).
Events in France
The history of RU 486 took a dramatic turn in 1988. In September, Roussel Uclaf was licensed by the French Ministry of Health to market RU 486. But on 26 October, Chairman Sakiz of Roussel suspended the distribution of RU 498. The press claimed that Sakiz' action was due to anti-abortionist threats to the company and its employees. In an interview with the New York Times on 28 October, Etienne Baulieu commented, 'He [Sakiz] told me he hopes there is pressure to counteract the decision' (Simons, 1988: A1). Conveniently, the World Congress of Gynecology and Obstetrics in Rio de Janeiro, Brazil, was meeting at this very moment and included a Symposium on RU 486 – organized by Baulieu, Segal and Roussel Uclaf – which sent a petition of 2000 names to Roussel Uclaf, protesting the withdrawal of the drug.
On 28 October 1988, the media reported that the French Minister of Health, Claude Evin, had ordered Roussel Uclaf to put RU 486 back on the market. (The French state owns 36.25 per cent of Roussel Uclaf which, however, is short of the 51 per cent required to enforce a decision.) Evin was quoted as saying that RU 486 had become 'moralement la proprieté des femmes' (Nau and Nouchi, 1988: 9). Since then, the slogan that RU 486 is 'the moral property of women', has been the battlecry of promoters of the drug, including some feminist groups in the USA, Australia and Switzerland. In France, RU 486 was officially back – under tight security – at hospitals and centers licensed to perform abortion in February 1989.
Two years later, in January 1991, a bizarre twist was added to the 'official' story. The French Government Council (Conseil d'Etat) reprimanded Health Minister Claude Evin for exceeding his power in ordering Roussel Uclaf to return RU 486 to the market in October 1988. Surprisingly, however, Evin now claims that he had not issued such an order because 'discussions and exchange of arguments with representatives from Roussel Uclaf had made recourse to this procedure unnecessary' (Vigy, 1991: 18). Combined with the exceedingly convenient timing of events from the Rio de Janeiro convention, this indicates a contrived history of events operative at all levels.
International Affirmation and Criticism
The decision to put RU 486 back on the market pertained only to France. Roussel Uclaf had decided not to market the drug in other countries. Meanwhile, in November 1988, the US-based Reproductive Health Technologies Project was set up by the private consulting firm Bass and Howes in Washington. Assembling an unusual group of people (see Introduction), the Reproductive Technologies Health Project initiated a wellfunded campaign which extended even to Australia. Here, its uncritical pro-RU 486 information packet has been distributed to all women's centers and state-based women's units. With the slogan 'New Technologies/New Choices' it began a campaign to convince politicians and the community at large to put pressure on Roussel Uclaf to distribute the drug in the USA and other countries.
The Reproductive Health Technologies Project is explicit in its support for the abortion pill – based on Roussel Uclaf material. Its packet contains a sample letter which should be sent to Roussel Uclaf and Hoechst to urge them to stop keeping American women – and women elsewhere in the world – from access to their 'moral property'. Their efforts were soon augmented by a 'historical campaign' from the Feminist Majority: 'RU 486 is safe and amazingly effective ... it is simple', and, 'frankly, there are few steps as significant – and long-lasting – as the action we can take to bring RU 486 into the United States' (Communiqué, 1990). Moreover, both groups assert that RU 486 has enormous potential to treat other diseases from glaucoma to breast cancer. Both campaigns are also unequivocal in their assessment that the debate is entirely between the 'bad' anti-abortionists and the 'good' scientists who developed this miracle drug in the service of women. In August 1990, President Eleanor Smeal of the Feminist Majority visited the Paris headquarters of Roussel Uclaf and deposited 400 kg of signed petitions.
Support for RU 486 in the USA also came from the American Medical Association (Lee, 1990: 1). Louise Tyrer, vice president of medical affairs for National Planned Parenthood welcomed the decision 'for advancing a major scientific breakthrough such as RU 486' (idem.).
Others have speculated that it may be necessary to create a company that would solely test and market the drug. Such a possibility was also mentioned by David Grimes. He pointed out that 'RU 486 is a relatively simple molecule to synthesize' and that there were already half a dozen small Californian companies 'that want to run with this thing' and have requested his help. As Grimes put it, The big boys won't touch it' adding, 'The problem is that [to duplicate or import RU 486] you need the consent of Roussel Uclaf (Krier, 1990: E12).
Whether the idea of a special purpose company is a realistic possibility for introducing RU 486 into the USA remains to be seen. Peter Huber, Senior Fellow at the Manhattan Institute for Policy Research is sceptical. He commented that 'readying RU 486 for FDA approval could cost US$50 million to US$100 million in clinical tests and legal fees ... as much as US$125 million to US$200 million into marketing and distribution costs' (Chapman, 1989: 13). In addition, there is the fear of litigation, as Huber puts it: the two to four per cent 'natural' birth defects in children might be blamed on RU 486.
In addition to Roussel Uclaf's reluctance to market RU 486 in the United States, there is the problem of the prostaglandin needed for combination treatment with RU 486. Despite FDA approval for PGs in other areas, for example approval of Cytotec (misoprostol) as an anti-ulcer drug (see Chapter Four), no PG is approved for abortion purposes in the US.
The situation is different in the UK where Roussel Uclaf applied to the Ministry of Health for a marketing license, approval for which, according to Tony Seaton of Roussel Uclaf UK, 'could take from 18 months to two years' (pers. comm. to RK, 28 July 1990). In early 1991, it was rumored that the licensing procedure had been speeded up and approval would be granted by the end of January. Approval was finally granted on 3 July 1991. No application for marketing approval has been made in Australia. In August 1990, former Federal Minister Margaret Reynolds urged women to undertake a letter writing campaign to put pressure on Roussel Uclaf (Gillies, 1990). Another action undertaken to bolster chemical abortion came in November 1990 at a conference sponsored by the Abortion Providers Federation of Australasia in Melbourne. Etienne Baulieu was the invited keynote speaker and with the exception of the critical voice of one of us (LD) all speakers hailed RU 486 as a major medical breakthrough which was being unfairly withheld from Australian women. However, a spokesperson from Roussel Uclaf–Australia (Sydney) repeated that they had not yet submitted an application to the Federal Department of Health. Similarly with New Zealand, Roussel Uclaf said they were not open to invitation (Coney, 1990a: 11).
Predictably, Australian anti-abortion groups protested promotion of RU 486/PG. 'This drug kills unborn babies' said Margaret Tighe, Chairman [sic] of Right to Life Australia. 'There are complications with the drug and they are frightened they might face litigation' (Gillies, 1990).Outside the right-wing perspective, the only criticism of chemical abortion was heard on TV and radio in Australia and New Zealand where our non-aligned feminist perspective opened the debate.
In 1989, RU 486 made the news again in France when, in order to recoup its investment costs, Roussel Uclaf set the price of RU 486 at FF517 (approx. US$100). This was at odds with the Ministry of Health's decision that had fixed the drug's price at FF93.5 (approx. US$17) (Coles, 1989: 6). The result appears to be a compromise in favor of Roussel: La Révue Prescrire of July/August 1990 (p. 286) quotes FF265 (approx. US$48) for 600 mg Mifégyne (three pills), noting that the cost for the initial consultation including prescription of RU 486 is FF388 (US$70), and the total cost for chemical abortion is set at FF1408 (approx. US$255). In comparison, surgical abortion in France costs $150 (ISIS Women's Health Journal, 1990: 8).
An even greater controversy erupted in early 1990, when an international group of scientists and doctors based at the Necker Hospital in Paris, reviewed the data of 30,000 women who had used RU 486 (Ewing, 1990: 1) and issued a stern warning against it. They urged the Ministry of Health 'to enforce what was inevitable: the immediate suppression of the distribution and use of RU 486' because of 'the grave secondary effects of chemical abortion which is falsely seen as an alternative to surgical abortion' (Kami, 1990: 9). Their concern arose from the associated bleeding necessitating emergency curettage and sometimes blood transfusion, from reduced hemoglobin and hemocrit levels, and from two severe cases of cardiovascular accidents associated with the addition of prostaglandin to RU 486 (see Chapter Four). Shortly afterwards, 15 centers which performed chemical abortion responded by defending RU 486/PG abortion (Caro, 1990: 10). Nevertheless, the 'Direction de la Pharmacie et du Médicament' (DMPH, the French equivalent of the US FDA or Australian Drug Evaluation Branch) had already demanded that Roussel Uclaf issue stricter guidelines. On 20 April 1990, the company sent a circular to all clinics providing chemical abortion. Roussel Uclaf specified that cardiovascular risk factors, e.g. heavy smoking, obesity, elevated serum lipid (related to cholesterol), diabetes and high blood pressure restrict the use of chemical abortion. They also cautioned against administering it to women over 35 (see Chapter Two).
(Continues...)
Excerpted from RU 486 by Renate Klein, Janice G. Raymond, Lynette J. Dumble. Copyright © 2013 Renate Klein, Janice G. Raymond, Lynette J. Dumble. Excerpted by permission of Spinifex Press Pty Ltd.
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Table of Contents
Contents
PREFACE,1. Why a New Edition?,
2. What is a 'safe and effective' abortion method?,
3. How does RU 486/PG abortion compare to 'surgical' abortion?,
4. Adverse effects and what women say about their pill abortion experience,
5. The RU 486/PG story in Australia,
6. RU 486/PG use in poor countries,
Conclusion: Where to from here?,
Bibliography,
Acknowledgments,
INTRODUCTION,
CHAPTER ONE The History of RU 486,
Events in France,
International Affirmation and Criticism,
The Role of the International Press,
The 'Father' of the Abortion Pill?,
CHAPTER TWO Claims for RU 486/PG Abortion,
Privacy versus Control,
Safety versus Contraindications/Complications,
Contraindications,
Complications,
Chemical Abortion versus Conventional Abortion,
CHAPTER THREE What Is RU 486 and How Does It Work?,
Hormonal Interactions,
How RU 486 Works,
Other Sites of Actions and Applications of RU 486,
The Effect of RU 486 on Women's Menstrual Cycles, Fertility, Eggs and Embryos,
CHAPTER FOUR The Role of Prostaglandins: Known and Unknown Dangers,
What are Prostaglandins?,
Prostaglandins in the Treatment of Human Health Disorders,
The Role and Application of Prostaglandins in Obstetrics and Gynecology,
Prostaglandin/Antiprogesterone-induced Abortion,
CONCLUSION,
Endnotes,
Chapter One,
Chapter Three,
Chapter Four,
Bibliography,
Acknowledgments,
What People are Saying About This
"RU 486: Misconceptions, Myths and Morals is an important contribution to a discussion which until recently has been dominated by drug company press releases." —Claudine Holt, Green Left Weekly
"An important contribution to the debate surrounding RU 486, a debate which the tragedies of history—those associated with other reproductive technologies—tell us, we have every need to involve ourselves in, to acquaint ourselves with and above all, to have our say in." —Australian Women's Book Review
"One of the most important studies on abortion to be published in recent years." —Care Review
"An excellent case study for medical, health, and women's studies practitioners and students." —Australian Scholarly Newsletter
"This is an eminently readable and thought-provoking book. The authors' concern for the rights and welfare of women is evident throughout. . . . RU 486: Misconceptions, Myths and Morals was published in 1991, and it still provides the most up-to-date, independent analysis of information available to us. As such, it is an invaluable knowledge base from which to evaluate the information and publicity generated by the Australian trials." —Women's Library Newsletter