Quinacrine: the non-surgical sterilisation method that refuses to die

16/01/2016 § Leave a comment

A response to all the articles on so-called “permanent contraception” in Contraception 2015;92(2):89-176)

It is with a deep sigh, after more than 10 years, that I sit down to respond to your articles on “permanent contraception”, particularly the one by Jack Lippes pushing quinacrine sterilisation, that dead letter, to the fore once again, in your August journal issue (Contraception 2015;92(2):89-176).

Dr Lippes whitewashes the history of why quinacrine was rejected as a female sterilisation method,[1] rejected not only because of concerns about its carcinogenic potential but for many other reasons as well. Dr Jaime Zipper from Chile, who invented the method, would never be allowed today to get away with the “research” he carried out on women with quinacrine for tubal sterilisation in the absence of any pre-testing of the drug for safety, dosage or efficiacy ‒ before it was ever injected into a single woman. Women were treated like guinea pigs in his and other “research”, and no proper long-term work on safety or optimal dosage was ever completed. Not was the method in fact ever properly approved or registered in any country. There were only a handful of countries where quinacrine sterilisation was ever used, and even in those cases, it was always individual doctors who used it, while others carried suitcases full of quinacrine pellets across borders to share with them, e.g. in a remote rural area of India.

The early high failure rates Dr Lippes reports of 9-12% were indicative of the absence of proper research, since they should have led to a rejection of the method early on. The far lower failure rates shown in the studies in his Table 1 were all from very small studies except for one; most had too short follow-up periods and the findings were never confirmed in larger randomised, controlled studies. The very large study by Dr Do Trong Hieu of Viet Nam, published in the Lancet, in which over 30,000 women were subjected to the procedure, led to the closure of the programme in Viet Nam following a critical analysis of its findings. I was personally involved in creating an outcry about it at that time. (I will return to this below.)

The dismissal by Dr Lippes of the data on cancer risk arising from inflammation in rats, and indeed his whole article, is an example of how the proponents of quinacrine did then and continue to minimise the negative evidence and exaggerate the positive evidence to claim the method is safe.

Dr Lippes’s review of the literature ignores several articles I published in the early days of Reproductive Health Matters (RHM) and one in the BMJ almost ten years later. In 1993 in RHM, Amy Pollack and Charles Carignan[2] examined the same evidence examined in Contraception by Lippes. They noted, for example, that in the Viet Nam paper, 20,000 of the 31,000 women in the total study sample were excluded from follow-up for pregnancy rates, and the finding in one province of 91 pregnancies out of 937 women was also excluded. A year after their article was published, concern was expressed by Ralph Heywood, consultant toxicologist to WHO in 1994,[3] that more research needed to be done to exclude toxicological effects related to mutagenicity, teratology and persistence of the compound in tissues. He recommended that toxicological testing of quinacrine in animals should be done prior to any further clinical trials or any other provision of the method to women.3 Dr Lisa Rarick, the then Medical Officer at USFDA, also raised concerns, given the uncertain failure rate, that a quinacrine failure might increase the risk of ectopic pregnancy.3 Yet despite this published concern, a number of individual doctors continued to promote and perform quinacrine sterilisations ‒ e.g. in rural India and Pakistan. I asked what should be done when consensus views are ignored or rejected by individual providers. The question still holds. A year later, and following a further statement on toxicity and quinacrine by Ralph Heywood,[4] quinacrine sterilisations were still being done in Chile too, led by Dr Jaime Zipper, but challenged by the Foro Abierto de Salud y Derechos Reproductivos (Open Forum for Reproductive Health and Rights).[5] It was this and other feminist activism that led to the decision by WHO not to recommend quinacrine sterilisation of women to be continued, until far more rigorous examination of safety and efficacy was carried out.

But the problem of promotion of untested methods remains with us. In 2004, the BMJ published an article about a “clinical trial” in India evaluating the antibiotic erythromycin as a female sterilisation method,[6] following the ban by India on the use of quinacrine for that use, due to safety and efficacy doubts. Quinacrine’s dwindling supporters were looking for an alternative. They tried erythromycin tablets, which were placed in the upper part of the uterine cavity in 790 women “volunteers”. The failure rate was unacceptably high at 28–35% after 12 months. This “trial” was criticised as illegal and unethical, and highlighted the ease with which unethical clinical trials could still be conducted in India on vulnerable populations by errant doctors.

The FHI360 article was a real eye-opener for me, as it seems they were responsible for the erythromicin study in India, which I do not recall. It is not surprising, however, as FHI was a driving force in this whole history. The history revealed in this article is indicative of the determination not to let this idea go, and even to bring unnamed advocates on board to try and legitimise what could not be justified.[7]

Turning to the other articles on the subject of non-surgical sterilisation in your August edition, I was interested to see how the article by Elizabeth K Harrington et al[8] quietly denigrated the whole idea of surgical sterilisation because it is surgical, in that it requires training and a decent service delivery setting. Is training and a decent service delivery setting still not a reasonable expectation for women in the global South? She is right, not everyone prefers a surgical method. Yet she admits that surgical female sterilisation has not only been shown to be very safe but is also the most widely used fertility control method globally.

Interestingly, none of these articles takes up the alternative of vasectomy ‒ an unfinished job if ever there was one ‒ let alone the idea of a permanent non-surgical male method. Odd that no one has tried inserting quinacrine in men’s nether parts, or is it? The biases may not seem obvious in the absence of a thorough review of the issues, but bias there is indeed among the cluster of authors who populate this whole journal edition.

The comparison I felt was most relevant and most missing in these papers, however, was that between surgical vs. medical abortion, the only existing surgical and non-surgical methods of fertility control. Both these abortion methods are easy to provide in the first trimester of pregnancy, and both have been shown by WHO to be safe for mid-level providers to offer at primary care level, with simple training.[9] Both have advantages as well as disadvantages, but the real value is that women have a choice between them.

My generation put the notion of “choice” in fertility control on the global map and showed that the more and varied methods there were to choose from, the more people were likely to find at least one method that was acceptable and met their needs. Your authors in this edition have quite a different perspective. They want something that will end fertility, and the less likely it is to “fail” or “fail to be used” the better. From this position, Elizabeth Harrington et al3 and Jeffrey Jensen[10] seem to assume that a long-acting method of contraception is always preferable to the others. This has not been shown, nor is it likely to be true ‒ if one asks a large enough number of women and their partners, and especially young people. And in spite of the still rising numbers of people with HIV and other sexually transmitted infections, the importance of condoms seems to have passed these authors by altogether. In fact, both qualitative studies by Elizabeth Harrington et al3,[11] find the demand for safety to be uppermost as a value among study participants. Moreover the preference expressed for a non-surgical sterilisation method is hypothetical and with caveats ‒ and not based on the experience of surgical sterilisation or an actual non-surgical method.

I would also question these authors’ preference for the term “permanent contraception” rather than “sterilisation” and “vasectomy”. Both these surgical methods can be reversed, and although Jeffrey Jensen likes to think women’s fertility intentions fall rigidly into only three categories, there are quite a few people who have opted for sterilisation or vasectomy who have later changed their minds, and for whom reversal methods were consequently developed. To use the term “permanent” belies that availability, and might even put people off. It would certainly mislead them into thinking there is no going back. Perhaps that is what the supporters of quinacrine sterilisation are aiming for. They seem not to have considered that the lack of potential for reversal with quinacrine might greatly decrease its appeal, even among those for whom “something non-surgical” may be preferable. Of course, no one has attempted to reverse a quinacrine sterilisation. Once the fallopian tissue is thus scarred, it is presumably very permanent indeed.

Lastly, I must say that for a journal that publishes first class research on abortion, I was very disappointed to see you allowing remarks about the need for abortion as a sign of failure ‒ whether of contraceptive methods themselves or of the women who choose them. Can we not finally acknowledge contraception as a fallible form of prevention and abortion as a solution when prevention fails? The belief that contraception which never fails is possible is, in my view, a chimera. Moreover, if women were given proper information and unrestricted access to safe abortion methods, most abortions would take place well before 8 weeks LMP, and even (with medical abortion) as early as 35 days of pregnancy (Beverly Winikoff, personal communication, July 2015). Let’s try developing new non-surgical post-fertilisation methods of birth control, for example.[12]

However, whether or not one thinks a non-surgical method of sterilisation would be preferable to a surgical method, quinacrine is not the answer. Let’s re-bury it and keep it buried.

References

[1] Lippes J. Quinacrine sterilization (QS): time for reconsideration. Contraception 2015;92(2):91-95. http://www.sciencedirect.com/science/article/pii/S0010782415002322.

[2] Pollack AE, Carignan C. The use of quinacrine pellets for non-surgical female sterilisation. Reproductive Health Matters 1993;1(2):119-22. http://www.rhm-elsevier.com/article/0968-8080(93)90018-O/pdf

[3] Berer M. The quinacrine controversy one year on. Reproductive Health Matters 1994;2(4):99-106. http://www.rhm-elsevier.com/article/0968-8080(94)90016-7/pdf.

[4] Berer M. The quinacrine controversy continues. Reproductive Health Matters 1995;3(6):142-44. http://www.rhm-elsevier.com/article/0968-8080(95)90169-8/pdf.

[5] Shallat L. Business as usual for quinacrine sterilisation in Chile. Reproductive Health Matters 1995;3(6):144-46. http://www.rhm-elsevier.com/article/0968-8080(95)90170-1/pdf.

[6] Mudur G. Use of antibiotic in contraceptive trial sparks controversy. BMJ 2004;328(7433):188.

Summarised in: Law and Policy Round Up. Reproductive Health Matters 2004;12(24):2111. http://www.rhm-elsevier.com/article/S0968-8080(04)24153-2/pdf.

[7] Katz KR, Nanda K. A nonsurgical permanent contraception stakeholder advisory committee: FHI 360’s experience. Contraception 2015;92(2):139-42. http://www.sciencedirect.com/science/article/pii/S0010782415000384.

[8] Harrington EK et al. Conceptualizing risk and effectiveness: a qualitative study of women’s and providers’ perceptions of nonsurgical female permanent contraception. Contraception 2015;92(2):128-34. http://www.sciencedirect.com/science/article/pii/S0010782415000955.

[9] Health worker roles in providing safe abortion care and post-abortion contraception. Geneva: WHO Department of Reproductive Health and Research; July 2015. http://www.who.int/reproductivehealth/topics/unsafe_abortion/abortion-task-shifting/en/.

[10] Jensen JT. Nonsurgical permanent contraception for women: let’s complete the job. Contraception 2015;92(2):89-90. http://www.sciencedirect.com/science/article/pii/S0010782415002486.

[11] Harrington EK et al. Interest in nonsurgical female permanent contraception among men in Portland, Oregon and eastern Maharashtra, India. Contraception 2015;92(2):135-38. http://www.sciencedirect.com/science/article/pii/S0010782415001006.

[12] Berer M. Compelling arguments for developing new post-fertilisation methods of birth control. Berer Blog. 11 July 2015. https://bererblog.wordpress.com/2015/07/11/compelling-arguments-for-developing-new-post-fertilisation-methods-of-birth-control/.

The history and role of the criminal law in anti-FGM campaigns: Is the criminal law what is needed, at least in countries like Great Britain?

24/12/2015 Comments Off on The history and role of the criminal law in anti-FGM campaigns: Is the criminal law what is needed, at least in countries like Great Britain?

This article was published online in Reproductive Health Matters 2015;23(46):145-57. DOI: http://dx.doi.org/10.1016/j.rhm.2015.10.001. Here is the abstract in English, French and Spanish:

Abstract

The history of campaigns against female genital mutilation (FGM) began in the 1920s. From the beginning, it was recognised that FGM was considered an important rite of passage between childhood and adulthood for girls, based on the importance of controlling female sexuality to maintain chastity and family honour, and to make girls marriageable. How to separate the “cut” from these deeply held norms is a question not yet adequately answered, yet I believe the answer is key to stopping the practice. Since the 1994 ICPD, national and international action against FGM has grown and resolutions have been passed in global forums which define FGM as a form of violence and a violation of children’s human rights. These resolutions have contributed to building consensus against FGM and developing national legislation criminalising FGM. Prosecutions or arrests involving FGM have been reported in several African countries and Great Britain, but apart from France, there have been very few. This paper summarises this history and how FGM has been criminalised. It argues that criminalisation may not be the best means of stopping FGM, but can have serious harmful effects itself. It calls for community-led educational information and more support for dialogue within FGM-practising communities, and argues that what is important is addressing the sexual and reproductive health consequences of FGM and gaining the understanding of women who have experienced it and their families as to why they should not make their daughters and grand-daughters go through it too.

Résumé

Les campagnes contre les mutilations sexuelles féminines (MSF) ont commencé dans les années 20. Dès le début, il a été admis que les MSF représentaient pour les filles un important rite de passage entre l’enfance et l’âge adulte, fondé sur l’importance du contrôle de la sexualité féminine afin de préserver la chasteté et l’honneur familial, et de permettre aux filles de se marier. Comment séparer la mutilation de ces normes profondément ancrées est une question encore sans réponse ; ce serait pourtant, à mon sens, une démarche essentielle pour mettre un terme à cette pratique. Depuis la CIPD, en 1994, l’action nationale et internationale contre les MSF s’est étendue et des forums internationaux ont adopté des résolutions qui définissent les MSF comme une forme de violence et une violation des droits fondamentaux de l’enfant. Ces résolutions ont contribué à dégager un consensus contre les MSF et à élaborer des législations nationales qui répriment cette pratique. Des poursuites ou des arrestations liées aux MSF ont été signalées dans plusieurs pays d’Afrique et en Grande-Bretagne, mais, à part en France, elles ont été très rares. L’article résume cette histoire et montre comment les MSF ont été sanctionnées par la loi. Il avance que cette pénalisation n’est peut-être pas le meilleur moyen de faire cesser les MSF et qu’elle peut avoir elle-même de graves conséquences. Il préconise une information éducative collective et davantage de soutien au dialogue au sein des communautés qui pratiquent les MSF. Il fait valoir qu’il est important de traiter les conséquences des MSF pour la santé sexuelle et génésique et de faire comprendre aux femmes qui les ont subies et à leur famille les raisons pour lesquelles elles ne devraient pas obliger leur fille ou leur petite-fille à en passer aussi par là.

Resumen

La historia de las campañas contra la mutilación genital femenina (MGF) comenzó en la década de 1920. Desde el principio, se reconoció que la MGF era considerada un importante rito de paso entre la niñez y la adultez para las niñas, basado en la importancia de controlar la sexualidad femenina para mantener castidad y el honor de la familia, y para preparar a las niñas para el matrimonio. Cómo separar el “corte” de estas normas tan arraigadas es una interrogante que aún no ha sido contestada adecuadamente; sin embargo, creo que la respuesta es clave para eliminar la práctica. Desde la CIPD de 1994, la acción nacional e internacional contra la MGF ha incrementado y se han aprobado resoluciones en foros mundiales que definen la MGF como una forma de violencia y una violación de los derechos humanos de las niñas. Estas resoluciones han contribuido a fomentar consenso contra la MGF y a formular leyes nacionales que penalizan la MGF. En varios países africanos y en Gran Bretaña se han reportado enjuiciamientos o arrestos relacionados con la MGF, pero aparte de Francia, ha habido muy pocos. En este artículo se resume esta historia y cómo la MGF ha sido penalizada. Se argumenta que la penalización quizás no sea el mejor medio para eliminar la MGF, ya que puede tener graves efectos dañinos. Se hace un llamado a la información educativa dirigida por la comunidad y a brindar más apoyo para el diálogo con las comunidades que practican la MGF. Se argumenta que lo importante es tratar las consecuencias de la MGF en la salud sexual y reproductiva y lograr que las mujeres que han pasado por esta experiencia y sus familias entiendan por qué no deben obligar a sus hijas y a sus nietas a hacer lo mismo.

What kind of research is needed for abortion advocacy?

24/12/2015 § Leave a comment

At the 5th Research Meeting on Unwanted Pregnancy and Unsafe Abortion, Mexico City, 28-30 September 2015, Silvina Ramos presented an excellent new CLACAI publication (in Spanish) on a renewed agenda for abortion research in the LAC region: “Investigacion sobre aborto en America Latina y el Caribe: una agenda renovada para informar politicas publicas e incidencias”. I was asked to comment in the session:

DATA FOR ADVOCACY

-We need to know more about what post-abortion care involves in order to showcase the failure of post-abortion care to resolve the serious public health problem of unsafe abortion. In 2012 an estimated 6.9 million women globally were treated for complications of unsafe abortion. In Latin America, new estimates of the rate of complications show a 31% decline between 2005 and 2012, from 7.7 per 1,000 women to 5.3 women per 1,000. (Singh et al, 2015) But this is still far too high and there is no excuse for it.

-As regards the incidence of abortion, we need to know more about pregnancy among girls aged 8-14 resulting from sexual abuse and whether or not they have access to safe abortion, including as a form of emergency obstetric care given how small they are. This emerged as an issue in Paraguay this year. There is little information on this subject though some research has been done (see http://conta.cc/1NNx4FD, http://conta.cc/1NN3sIn and http://conta.cc/1NMS9zS).

HEALTH PROFESSIONALS

-It is important to underscore the importance of the attitudes towards abortion of health professionals, and the importance of promoting training in abortion provision only for those who support women’s right to safe abortion. The current deficit in training should be a major advocacy issue. Why nurses should be less supportive to women needs to be better understood because abortion no longer requires doctors except in emergencies. Abortion care should be in hands of nurses and/or midwives at primary care and community level today.

-The prevalence of abortions among nurses/midwives and how they themselves are treated as patients might help to explain their views and bring them on board as a profession (http://www.rhm-elsevier.com/article/S0968-8080(07)30314-5/pdf).

-Attitudes towards 2nd trimester abortion are a particular problem. Can the number/proportion of second trimester abortions be reduced with better laws and services? Evidence from Sweden and Norway, particularly with good access to medical abortion, shows this can be done. If we knew why women have abortions after 12 weeks of pregnancy in more countries, it would contribute to change. However, this is not an issue of “women’s fault” but of systemic failures on the part of health and sexuality education, laws and policies, and health systems.

CONSCIENTIOUS OBJECTION

-Many who support abortion rights call for restrictions on conscientious objection but few oppose it altogether. Joyce Arthur of Canada and Christian Fiala of Austria have written several articles together and separately on this subject, opposing the whole concept.

-Sweden does not permit conscientious objection. This policy was challenged earlier this year at European level and their law was upheld.

-I agree with these views. I believe anyone who is unwilling to carry out an essential task in their job description should find another job. Abortion services are almost unique in allowing conscientious objection. It is a leftover of anti-abortion hegemony and should be removed.

PUBLIC HEALTH vs. HUMAN RIGHTS POSITIONS TO SUPPORT ABORTION

-I would like to disagree with one of the book’s authors that the public health arguments for safe abortion are less radical than those related to women’s bodily autonomy and rights.

-Public health arguments are not only relevant but also extremely powerful. I don’t think we use them enough anymore. Yet they are likely to have more resonance with health professionals.

-How to get past the huge, irreconcilable differences in thinking? Especially in the face of growing anti-abortion fanaticism?

RESEARCH FOR LAW AND POLICY ADVOCACY

-Campaigns for safe abortion often focus on calling for specific grounds for abortion to be decriminalised. For example, health grounds, rape, serious fetal abnormality, and in some countries in Latin America even for risk to the woman’s life to be permitted.

-I recently looked at the history of how abortion laws in several countries have changed over time, from almost complete criminalisation to allowing abortion at a woman’s request. This showed that a step-by-step process has taken place in some countries over a period of years, but often over decades. The current, limited law reform bill in Chile and recent examples in Africa show this has resonance as a way forward. But is it the only or best way forward?

-It would be good for this history to be studied in depth in many more countries, across both the 19th and 20th centuries and today.

RESEARCH ON ABORTION LAWS & GOALS

-For me, one of the biggest unresolved advocacy issues is whether we are seeking legalisation of abortion or decriminalisation of abortion.

-There a difference between these legal categories and we need to study it more.

-What reforms should we propose to our current laws on abortion that will lead to health system changes that will meets women’s needs and protect and fulfill their right to a safe abortion as part of their sexual and reproductive health and rights?

-In different countries, the answers may be different, depending on the origins of the laws, and more research and critical thought and analysis are needed.

Women’s right to safe abortion: interview for London School of Hygiene & Tropical Medicine Online Course

24/12/2015 § Leave a comment

Improving the Health of Women, Children and Adolescents: from Evidence to Action is a free online course of the London School of Hygiene & Tropical Medicine. I was interviewed on the subject of abortion for one of the sessions; this is what I said below. The course first ran in autumn 2015 and is due to be run again from 29 February – 8 April 2016. Find out more at: http://www.lshtm.ac.uk/study/freeonlinecourses/women-children-health/#sthash.tI7kCuOn.dpuf

1. Please introduce yourself

>>My name is Marge Berer. Since May 2015 I have been the Coordinator of the International Campaign for Women’s Right to Safe Abortion (www.safeabortionwomensright.org), which is a network of over 960 groups and individuals in 100 countries who are working for the right to safe abortion. From 1992 to 2015, I was the editor of the journal Reproductive Health Matters, which I founded with TK Sundari Ravindran. The International Campaign is important because abortion is still restricted by the criminal law in almost every country in the world, including countries where it is widely available, yet approximately one in five to one in three women globally will have an abortion in her lifetime. It is also important because the practice is under constant attack from a small but powerful minority of right-wing and conservative groups who believe women should be forced to carry every pregnancy to term whether they can cope with all the children that would result from this or not. We believe that universal access to safe abortion at a woman’s request is essential for women’s health and a necessary aspect of women’s right of autonomy over their bodies and lives.

2. Can you explain the human rights dilemma that affects access to safe abortion?

>> As a human rights issue, access to safe abortion is inextricably linked to the first principle of human rights, that is, the right to life. An estimated one million women have died from the complications of unsafe abortion in the past 20 years, and almost all their deaths would have been prevented had abortion been safe and legal in their countries. The anti-abortion movement claims that the right to life begins at conception. If this were accepted in human rights principles it would subsume a woman’s right to life to that of any pregnancy she was carrying, making her into a vessel, and would mean that no abortion would be permissible. In fact, every human rights body, from CEDAW to the Committee that interprets the Convention on the Rights of the Child, agrees that rights in general, including the right to life, begin at birth

3. What are some examples where the rights of the woman are violated?

>> There are unfortunately many examples of the ways in which the rights of women are violated, and one of them is when abortion is illegal.  For example, let’s take 3 cases that were determined by Catholic health policy.

The first is the case of a woman who was 17 weeks pregnant, and began to miscarry. The miscarriage was inevitable, and the baby could not have survived no matter what was done because it was too early in the pregnancy. Because her cervix was open, the woman was highly susceptible to infection even though she was in hospital, and in fact she did develop a life-threatening uterine infection. Yet the hospital failed to provide the only treatment that would have saved her life before the infection became uncontrollable, that is, an abortion, because they waited until there was no longer a fetal heartbeat, even though the fetus was not viable. She was a young healthy woman and she died completely unnecessarily.

The second case is of another young woman who was an asylum seeker. She fled the conflict situation in her country of origin, where rape was being used as a weapon of war. She had been raped herself. After she arrived in the country that gave her asylum, she discovered she was pregnant as a result of the rape. She was unable to obtain a visa to travel for an abortion. She became suicidal and although the threat of suicide should have meant she had a legal right to an abortion, it was refused. Instead, she was locked up in a hospital, supposedly for her own protection, until her pregnancy was far enough advanced that the baby could survive independently and then she was forced to have a caesarean section.

Both these cases come from Ireland. Something similar happened to a ten-year-old child in Paraguay this year who had been sexually abused by her stepfather for two years. She too was locked up in a hospital and subjected to a caesarean section to save the baby, instead of an abortion.

These cases are horrific; they represent the worst sort of misogynistic treatment of girls and women. But there are thousands of cases every day in many countries, especially in the global South, where safe abortions are not available. Some 42 million women have an abortion every year. Half of those abortions are unsafe in the following ways:

  • Illegal or legally restricted
  • Dangerous method
  • Untrained/unskilled provider
  • Unsafe conditions
  • Self-induced without help or information
  • Incorrect usage of abortion pills through lack of information
  • Little or no access to treatment for complications
  • Stigma, fear and isolation
  • Violence, rejection (by family, school, work) and murder, both of women and of doctors providing abortion care
  • Threat of arrest, and prosecution and imprisonment.

Here is what a young girl who was put in prison in Rwanda at the age of 17 for having an abortion said:

“I am 20 years old and… have been in Karubanda prison since 2007 for committing abortion. I am the 3rd born in the family and the only girl. I was raised by my dad after my mum died when I was still young. I was in the 5th year of my secondary education when a teacher at my school started dating me. I needed school materials and since I could not afford them, I allowed to have sexual intercourse with this teacher at that tender age. With limited knowledge on contraceptive use, I got pregnant and had to drop out of school since it’s against school regulations. I decided to have an abortion and my elder brother out of fear reported me to the police. I am supposed to serve a period of 9 years of which I have so far completed 3 years.” Crying she says: “I have lost hope and this is the end of my life”. (Abortion and young people in Rwanda: a collection of personal stories about abortion. Family Planning Association of Rwanda (ARBEF), ARBEF Youth Action Movement Rwanda, Rutgers WPF

This young girl’s story is why I am devoting my time to campaigning for women’s right to safe abortion, along with thousands of others all over the world.

4. Do you see the situation changing? Are more women around the world being given the right to safe abortion?

>> The situation is improving in many ways in many places. Countries are reforming their abortion laws, for example, just this year Mozambique completed a change for the better in its law, and in Chile, Morocco and Malawi positive law reform is being proposed. At the same time, women who do not have access to safe abortion services are learning from other women through safe abortion information hotlines and from courageous health professionals in their countries about how to have a safe abortion with medical abortion pills on their own. They are accessing the pills from pharmacies and from trustworthy providers through the internet, and taking control of their lives in spite of the laws against abortion. This is not an ideal situation but deaths from unsafe abortion have been decreasing rapidly because of it and that can only be a good thing.

Let me close by saying that one in three women is a lot of women who will need an abortion in their lifetimes. It was me once, and it could be many of you who are listening today, or your partners. Safe sex is sex in which you and your partner protect yourselves and each other from unintended and unwanted pregnancy and from sexually transmitted infections. Protection can fail, however, and sometimes people fail to use it. We need our health systems to be there before and after to help us ‒ with contraception, condoms, emergency contraception, safe abortion, and treatment for HIV and other sexually transmitted infections. Each of these is part of a larger package of essential sexual and reproductive health care. I invite you to study how well your countries are doing in offering these services and get involved today to make the situation better for everyone, especially for young women, and also for yourself ‒ in case you may need it.

Abortion today: what women need and want

18/10/2015 Comments Off on Abortion today: what women need and want

Berer Presentation to Gynuity Medical Abortion Meeting NY 9 June 2015

This is a presentation I gave to a meeting about medical abortion, organised by Gynuity Health Projects in New York, 9 June 2015.

Click on the link to read it.

Another FGM case in Britain that found no harm

05/09/2015 § Leave a comment

Another FGM case, which did not involve the criminal law but family law, and that took place in November 2014 in Leeds, two months before the first criminal trial in London,[1] involved an attempt to take two small children into care: a girl G aged ±3 and a boy B aged ±4, whose parents were of African origin. The children had temporarily been placed with foster parents as the mother was having mental health problems. The judge’s write-up of the case,[2] on which this blog is based, said:

“The suspicion that G had been subjected to FGM first arose in November 2012 in country S after blood had been found in her nappy when she was at nursery. She was examined by two doctors who found (I quote the translation) ‘no sign [she] had any damage to female organs’. A further medical report states ‘outer and inner labia normal and the clitoris is normal. No sign of any circumcision’. The question was raised again in November 2013 when the foster carer reported G’s ‘irregular genitalia’.”27

Three people, invited to examine the girl and give evidence because all were considered to be experts and presented themselves as such, gave testimony in court. According to the judge’s report, Expert 1 was an expert in child sexual abuse and described herself as an expert in the assessment of female genitalia ‒ but not for FGM. She had examined approximately five girls with FGM over the previous three years, but only one was a baby. Expert 2 was a midwife with extensive experience of pregnant women with FGM; she described herself as an FGM, reproductive and public health specialist. She had knowledge of and expertise in many aspects of FGM and its medical and other consequences, which she has published and spoken on extensively, both in Britain and abroad. When she gave oral evidence, however, it became clear she had almost no experience of FGM in babies. Expert 3 had established a specialist clinic in 1999 for women with health consequences of FGM, and had a great deal of experience of them; moreover, her clinic was the only specialist paediatric FGM clinic in the country.

Experts 1 and 2 both examined G and both said in written and oral evidence that they thought they had seen evidence of FGM. However, their descriptions of the mutilation differed from each other’s. Expert 1 later changed her evidence and admitted to having made a mistake. Expert 2’s evidence was described by the judge as: “confused, contradictory and wholly unreliable”. Expert 3 did not examine G in person but saw the reports of the other two and watched the DVD of their examination of G. She said she saw no evidence of FGM. Both parents also denied that G had been subjected to FGM. The judge dismissed the FGM charge.

The local authority who brought the case argued that if G had been subjected to FGM it was reason enough to initiate adoption proceedings. Sir James Munby, President of the Family Division, who heard the case, said there were three issues to consider: Had FGM occurred? Did it amount to significant harm, and if so, what were the implications. Having heard the evidence, he concluded that the “local authority is unable on the evidence to establish that G either has been or is at risk of being subjected to any form of FGM”. In a lengthy and thoughtful consideration of the implications, he also cautioned that even had FGM been found, “local authorities and judges are probably well advised not to jump too readily to the conclusion that proven FGM should lead to adoption”.

This case illustrates that even experts cannot always tell or agree whether a child has had FGM. The implication, as I see it, is that allowing uncalculated numbers of children to be examined for FGM by people who are likely to have even less expertise than the witnesses in this trial, is a recipe for disaster.

References

[1] See Berer M. Acquittals in the FGM case in London, justidce was done and was seen to be done, but what now? Berer Blog, 10 February 2015. https://bererblog.wordpress.com/2015/02/10/acquittals-in-the-fgm-case-in-london-justice-was-done-and-was-seen-to-be-done-but-what-now/.

[2] Sir JamesMunby, President of the Family Division. In the matter of B and G (Children) (No 2). Neutral Citation Number: [2015] EWFC 3. Case No: LJ13C00295. 14 January 2015. https://www.judiciary.gov.uk/wp-content/uploads/2015/01/BandG_2_.pdf.

Is the NHS collection of patient identifiable data of women with FGM unethical and a breach of confidentiality?

16/08/2015 § 2 Comments

Female genital mutilation (FGM) has been illegal in the UK since 1985, and taking a child abroad to undergo FGM, as legislated in the 2003 Female Genital Mutilation Act and 2015 Serious Crime Act is also illegal and is recognised as a form of child abuse. Until 2014, however, no one had been prosecuted  for FGM and to date, no one has been convicted of this crime.

In response to calls for ‘something to be done’ to address this failing, the UK government has taken a number of steps. They include encouraging the Crown Prosecution Service to scour the landscape for possible perpetrators, sending the Police to airports to hand out leaflets to suspicious travellers and tell them that FGM is illegal, and encouraging Border Agency staff to be on the lookout for victims who might have undergone the procedure abroad, particularly during the so-called ‘cutting season’ (summer holidays).

New regulations and guidance have also been issued to professionals. Among them has been a requirement to gather data on the prevalence of FGM among girls and women living in the UK. Contrary to long-established practice in epidemiological study, however, the data include a long list of identifying information on the women, including their names and NHS numbers, and the governmental Health and Social Care Information Centre are being sent this data, quarterly, since April 2015.

Epidemiology, according to a BMJ handbook, is “the study of how often diseases occur in different groups of people and why. Epidemiological information is used to plan and evaluate strategies to prevent illness and as a guide to the management of patients in whom disease has already developed.” Epidemiological study requires the identification of the population at risk. Not everyone with a disease or who is at risk is studied, however; rather, a representative, sample population is identified for study. Individuals being studied remain anonymous because the aim is not to study or treat individuals, but to study them as a population group, through random selection among those at risk. There is almost never an attempt to find everyone who may be at risk or affected, but only a representative sample. On the basis of this information, health professionals can be trained in addressing the disease concerned and services directed at those who need them.

FGM is not a disease, of course, but a harmful traditional practice, However, FGM is not a new condition nor one about which little is known. For women with problems arising from FGM, a number of NHS specialist centres have existed in Britain for many years and provide care for women with these problems. They are staffed by specialist clinicians, mainly midwives and doctors.

Still, the study of FGM epidemiologically is valid in that the findings can be used to ensure that the services women may need can be planned and made accessible to them. It has long been recognised that some of the women who migrated to the UK from FGM-practising countries had experienced FGM as children in their country of origin. Bindel estimated that the numbers could be as high as 170,000. A provisional estimate of FGM prevalence in England and Wales, published by City University and Equality Now in 2014, however, suggested this figure was 137,000 women and girls. This is a not inconsiderable difference. (Note: Neither the Bindel nor the City University data were accessible on the web at this writing.)

In the latter estimate, prevalence data were “derived from reports of household interview surveys in 2011 in the countries in which FGM is practised and extrapolated to the number of women living here who came from those countries of origin. Thus, the figure is based on two sets of estimates. Yet another study published by the UN Refugee Agency looked at the number of initial applications for asylum from women from FGM-practising countries, to Europe, covering the UK between 2009 and 2011. It found that an average of 2,350 females per year had applied for asylum in the UK. This does not mean all of them were granted asylum or had entered the country, nor that they even had FGM. So the value of these numbers is dubious.

What is certain is that none of these estimates were derived from a bona fide epidemiological study and should never have been accepted and treated by officials, the media or campaigners as if they were. But they were, and they continue to be cited by those pressurising the government to ‘do something’. In reality, there are no accurate data on the number of women in this country who have undergone FGM. Nor is there evidence that FGM is being carried out in the UK on children. Although it is presumed that some British families take their girl children back to where their relatives came from or elsewhere for FGM, the numbers involved are also unknown. These are all good reasons for why accurate epidemiological data should be collected. So, how is the government addressing this need?

Starting in 2014, the Department of Health (DH) mandated that the Health & Social Care Information Centre (HSCIC) collect monthly prevalence data from NHS health professionals working in acute hospital settings, of women who had previously been identified and were being treated for FGM-related or non-FGM-related conditions, as well as newly identified women. This continued to March 2015.

Then in April 2015, prevalence data collection was replaced by an FGM enhanced dataset. Clinicians in England, working in Acute Trusts, Mental Health Trusts and GP Practices now have to record demographic and other data (including patient identifiable data) when a patient with FGM is identified during a consultation for health care of any kind, including the type of FGM she has undergone. The data has to be entered every time the woman or girl seeks care or gives birth to a baby girl (because the baby may be at risk of being subjected to FGM), and every time FGM is identified (by a clinician or self-reported), not just the first time. The data must be sent quarterly to the HSCIC. But this is not the way to do an epidemiological prevalence study. How is it different?

First, its goal is to record data on every woman and girl found to have had FGM. This is neither necessary or cost-effective since the point of epidemiological studies is to obtain representative data on the “group”, not the individuals.

The sort of ‘blanket’ data collection demanded by the DH was not even carried out to identify people living with HIV, for example, even after the extent of the epidemic became clear. Although it was certainly proposed, it caused a great deal of debate and controversy ‒ and was rejected. People living with HIV fought against named data collection as a violation of privacy and medical confidentiality, and as a human rights issue ‒ not only because of the stigma related to being identified as having HIV or AIDS, but also because, in those early days, there was no benefit for patients as no treatment had been developed.

Are not the rights of patients with FGM also being violated when they are identified and recorded as having had FGM? Some activists who have undergone FGM have expressed feelings of being stigmatised and fear of speaking out about it. But unlike with HIV, this fear is because their families are also implicated and might be exposed. Perhaps they do not want themselves and their families to be investigated by the justice system? Or they may be afraid of the racism and condemnation resulting from such exposure?

Secondly, the HSCIC regulations now require that a host of information be recorded, with or without the patient’s permission. The mandatory and required (i.e. if appropriate) non-pregnancy-related data that must be collected include: the woman’s full name, birth date, post code, NHS number, country of birth, country of origin, GP practice, care contact date, details of referring organisation, details of treatment site, existence and type of FGM, details of de-infibulation, pregnancy status indicator, FGM family history, number of daughters under 18, that the woman was advised on the health implications of FGM and on the illegalities of FGM, daughter/s born at this attendance, woman’s age at FGM and country. Optional information includes age and country of origin of the father of any the woman’s daughters aged under 18.

Ironically, despite all of the claims in these regulations that the main purposes of interviewing women who have had FGM is to record information that will be used to help them, there are no questions on the form asking health professionals to confirm that they have given women information on where to find clinical, psychological or social support for FGM if it is needed.

I can understand that recording a woman’s NHS number might be considered necessary to avoid the possibility that, with totally anonymised data, a woman with FGM who attends for health care in more than one place might well be counted more than once. This is a valid concern, considering the flaws in the initial regulations. However, in my opinion, there are serious new concerns here no matter which way one looks at it. The value and purpose of the extent of the information health professionals are now required to record is, epidemiologically speaking, highly questionable, despite HSCIC reassurance that no patient identifiable data (PID) will ever be published. This is because the woman’s personal data may be handed over to the police, social care authorities or the courts if she has girl children who are deemed, during the course of data collection or afterwards, to be at risk of FGM.

This is because FGM is not just a health condition, it is a crime. Consequently, only one of the purposes of data collection by the HSCIC is to determine prevalence and to make information and treatment available to women and girls as victims. Another is to share the information with other governmental authorities, so that they can investigate whether these same women’s daughters are at risk of becoming the next generation’s victims, thereby turning the adult victim into a potential perpetrator or accessory to the same crime she herself was the victim of.

On top of this, even if she does not give her consent to do so, the victim is required to provide health professionals information about herself. On page 48 (of 53 pages), the regulations say: “It is not intended that patient-identifiable data will be shared with other parties. Such activity would require explicit patient consent…. It is intended, however, that the FGM information collected and disseminated using the Clinical Audit Platform will support the publication of patient-anonymised Official Statistics.”

Yet the next paragraph on the same page says: “As the FGM Enhanced Dataset will be underpinned as a result of Department of Health directions, this will require no explicit patient consent to be sought in order to collect this information and subsequently share this with HSCIC. However, each patient where FGM information has been identified by a healthcare organisation, must inform each woman or girl as to how and what will happen to the information being recorded, and further to this, where an objection to this is made each organisation must ensure it understands the fair processing procedures outlining where a woman can contact to make an objection to this information being recorded and sent to the HSCIC.” A long set of instructions on how to handle this follows.

Moreover, it also says that the woman can only register a complaint after the fact, that is, after the data have been recorded, but her complaint will not stop her data being retained and used by the HSCIC. It seems that the Health and Social Care Act 2012 allows health professionals to violate women’s informed consent in this way. This is certainly a violation of privacy and confidentiality that must be challenged.

Pregnant women generally come under a lot of scrutiny. Pregnant women with FGM come under particular scrutiny. The HSCIC requirements say that all existing maternity discharge information sent to GPs and health visitors MUST [their emphasis] also include all relevant FGM information, where appropriate, when FGM or family history of FGM have been identified prior to, during or after the birth of a baby. This is another instance in which personal data will be shared.

The pregnancy-related FGM information to be specifically recorded includes: FGM type, confirmation that a de-infibulation procedure took place to facilitate the delivery of a birth, where applicable, and confirmation that no external female genitalia abnormalities were found in girl babies at birth following existing neonatal examinations, confirmation if an interpreter was required during the episode of care, and confirmation that the newborn baby’s healthcare record has been updated to reflect that FGM had been identified in the mother. Additionally, as part of the initial antenatal assessment, every woman MUST [their emphasis] be asked if they have undergone FGM. Where a Health Visitor identifies that there are sisters of a girl with FGM, it is the responsibility of the Health Visitor to inform the GP (pages 12-13). And this is not even the half of it.

The regulations say three times, (pages 8, 11 and 21), that clinical examinations of the woman’s genitalia need only be undertaken “as part of a usual, routine or requested provision of care – there is no intention for every clinician to automatically undertake a clinical examination in order to record the type of FGM”. Thus, there is a presumption that women not requiring examination of their genitalia will “self-report” when asked if they have had FGM. But will all clinicians note this caveat or will we begin to hear stories of women’s genitals being examined no matter what they have attended for?

From the point of view of the woman sitting in front of the doctor or midwife, one might easily imagine that any need for help she may feel would be compromised by the fear ‒ especially if she is pregnant, has girl children under age 18 or has just delivered a girl child ‒ of being investigated, prosecuted and criminalised by the criminal justice system, along with other family members. Will she give all the information asked of her? Will she come back for another appointment?

And what about the health professionals who have to ask women these questions and record their answers in the relevant database? There is an ethical requirement on health professionals not to allow the violation of patient privacy and not to break medical confidentiality, particularly if it is against the woman’s expressed wishes. Yet the HSCIC requirements require just that from health professionals, who must submit the data quarterly and in annual reports.

What if clinicians refuse to collect some or all of the data? The regulations do not say what will happen if they fail to return this information fully and in the required detail, except that “the submission will be rejected”. Will they be required to get the woman back in to obtain more details? Will they be disciplined, as they would if they do not report a suspicion or actual case of FGM in an under-18-year-old? Clinicians already worry about the consequences of not identifying ‒ or mis-managing ‒ women with FGM, and now they also fear prosecution, after what one of their colleagues suffered, in spite of being acquitted.

This is not the first time the Government has attempted to ‘share’ identifiable information from clinical records without patients’ permission. In 2013, they announced they were going to extract ‘identifiable data’ from GP records to be used ‘routinely’ for research by the health service and private entities (which might have included pharmaceutical companies), unless patients asked to opt out. In this instance, there was a public furore and after 700,000 people had opted out, the scheme was ‘indefinitely delayed’. This year, they attempted to do so again on the grounds that they needed to intervene in regard to the care of ‘high cost individuals’.

This time, however, women with FGM are not being given any choices in the matter. It is highly unlikely that they will refuse to provide their personal data in large numbers, as people with HIV did previously, as they do not have the social or political clout, or the public support, to challenge the Government or their health care providers.

Health professionals, on the other hand, do have that power, and just as GPs supported the 700,000 patients’ refusal to allow their data to be shared for unspecified research, so health professionals should stand up in this instance, and refuse to populate the HSCIC database with identifying details about the women involved.

At the end of February 2015, the government reported that 2,603 women and girls who had attended the NHS in the previous six months for health care of some kind had been recorded as having had FGM. Of these, only 44 were under the age of 18. Is it possible to extrapolate from these figures what the estimated prevalence might actually be? Probably it will take a much longer time to accomplish that, depending on how long it takes before the whole population of women and girls with FGM has attended for health care of some kind. Will prosecutions arise from the analysis of those data? Meanwhile, no proper epidemiological study has yet been considered, let alone launched.

Conclusion

I continue to believe, as I did at the FGM trial in January 2015, that this issue is being used politically by people in power, to gain credibility as champions of women only because they can present them as victims of their own culture. Furthermore, when, in reporting the government’s figures, the Guardian quotes Equality Now as saying “this is only the tip of the iceberg”, we can be pretty certain that it is the shock-horror value of FGM that is holding sway here, not concern for the women who have experienced it.

Although the situation is complicated by the criminal aspects of the issues involved, the government clearly needs a rethink ‒ epidemiological data, data for the provision of health care, and information leading to criminal investigation and prosecution should not be conflated in this way.

This blog was written for and appears also on Shifting Sands.

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