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

16/01/2016 Comments Off on Quinacrine: the non-surgical sterilisation method that refuses to die

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/.

Race, Reproductive Politics and Reproductive Health Care in the Contemporary United States

20/07/2012 Comments Off on Race, Reproductive Politics and Reproductive Health Care in the Contemporary United States

This editorial from the journal Contraception offers an important analysis of population and family planning policy in the USA, both in the context of current politics and also from history, starting as far back as 100 years ago.

Carole Joffe, Willie J. Parker

From: Contraception [Editorial] July 2012 reprinted as a blog with kind permission of Carole Joffe

To paraphrase Leo Tolstoy, who famously wrote that all unhappy families are unhappy in their own way, we can say that all nations confront the thorny issue of demographics, but each in its own, typically controversial, way. Various European countries, for example, have anxieties about a “demographic winter,” which is a below replacement birth rate of the native population, which has led to corresponding fears about rising birth rates among Muslim immigrants. China, driven by worries about overpopulation, has instituted coercive reproductive policies that many observers find unacceptably harsh. The United States, a country marked by extreme stratification on both racial and economic grounds, is a particularly interesting case to consider from a demographic lens because there has been a history both of targeting the birth rates of people of color and at the same time deep political divisions about the provision of reproductive health services — particularly abortion but increasingly, as the current election season reveals, contraception as well.

We, a sociologist and physician, respectively, write here of our dismay about the contemporary state of reproductive politics in the United States and particularly the cynical manipulation of racial themes by the opponents of abortion and birth control. However, we are acutely aware of the mixed legacy of the United States with respect to demographic issues. To name but a few examples, in 1905, President Theodore Roosevelt warned of “race suicide” because of his concern about falling birth rates among white Anglo-Saxon women and the higher rates among immigrants.1 In the 1927 Supreme Court case, Buck v Bell, the Court upheld a statute instituting compulsory sterilization of the unfit, including the mentally retarded, “for the protection and health of the state”.2 In the 1960s, impoverished African-American and Latina women, along with some poor whites, were subjected to coerced sterilizations, often without these women fully understanding to what they had ostensibly agreed.3 When the first federally funded family planning centers were established in the early 1970s, as a result of the passage of Title X, they were disproportionately located in African-American communities, although the language of the legislation did not mention race but rather the income status of the intended recipients.4

Co-existing with these events, however, has been a longstanding reproductive freedom movement in the United States, made up of clinicians and lay activists alike. Starting in the early 20th century, doctors and nurses, along with lay allies, fought for the legalization of first, birth control, and, later, abortion, seeing the particular damage done to the most vulnerable women in the absence of such services. In the 1960s and 1970s, feminist health activists raised an outcry about the sterilization abuses mentioned above; indeed, among the most prominent of the reproductive rights organizations to emerge from the “second wave” feminism of that era was CARASA, the Committee for Abortion Rights and Against Sterilization Abuse, providing a template for the principle that abortion rights should ideally be considered in a broader context that includes the right to have children.5 That generation of feminist activists also severely criticized the then-common practice of testing new contraceptive methods on Third World women. Today, there are numerous reproductive rights/reproductive justice groups hard at work in the United States, a number of them specifically concerned with the situation of women of color.

In short, this very brief recapitulation of reproductive struggles in the United States reveals the truism that the world of sexual and reproductive health services is a complex terrain, always containing both liberatory and coercive possibilities, and always with particular implications for people of color in a white-dominated society. But with respect to present-day conflicts, no figure’s legacy has been more contested than that of Margaret Sanger, the founder of the organization that eventually became Planned Parenthood. Anti-abortion forces for years have accused Sanger of being a racist and a eugenicist. Currently, these groups have pounced upon the high rate of abortion within the African-American community — black women have abortions at nearly four times the rate of white women — and have joined forces with some conservative groups within that community to mount a vigorous campaign against Planned Parenthood in particular and abortion provision more generally. Starting in Atlanta, and spreading to other cities, these groups have sponsored controversial billboards — some proclaiming that “black children are an endangered species” and others comparing abortion to slavery.

As Ellen Chesler, Sanger’s premier biographer, has argued, such accusations are a distortion of Sanger’s record.6 Although Sanger did receive some support from eugenicist organizations (at a time when eugenics was a far more mainstream movement than it is currently), her record cannot be construed as “racist.” Among her supporters were numerous black ministers, leading African-American intellectuals such as W.E.B. Dubois, and prominent community leaders such as Mary McLeod Bethune, founder of the National Council for Negro Women. In 1966, when Dr. Martin Luther King accepted the first Margaret Sanger award from Planned Parenthood, he praised Sanger for “her courage and vision,” comparing her struggle for birth control to the civil rights movement. One of the most effective critiques of the billboard campaign, and against the larger agenda of demonizing Planned Parenthood, has come from Sistersong, a coalition of reproductive justice groups of women of color. As Loretta Ross, the executive director of the group told the New York Times, “The reason we have so many Planned Parenthoods in the black community is because leaders in the black community in the ‘20s and ’30s went to Margaret Sanger and asked for them. Controlling our fertility was part of our uplift out of poverty strategy, and it still works”.7

This manipulation of the history of race and reproduction by those involved in the billboard campaigns and similar efforts obscures the contemporary facts of life faced by the most vulnerable black women. These women experience high rates of unintended pregnancy, low use of the most effective forms of contraception, deep poverty, inadequate educational opportunities, unacceptable levels of intimate partner violence and, very often, lack of support from their churches. It should come as no surprise that these same women would have the highest rates of abortion in this country. Given the conditions, these women need — among many other services — access to comprehensive health care that includes both family planning and abortion. Yet, abortion has long been excluded from most mainstream health care institutions and sources of public funding, and during the current political season, we have watched with dismay the severe attacks on contraceptive coverage as well. The isolation of abortion, in particular, from the rest of health care has contributed to its stigmatization and has helped the development of conspiracy theories, such as we see in the billboard campaign. We decry the inflammatory, false rhetoric of “black genocide” that has been used in this campaign by anti-abortion extremists, and we are hardly the first to point to the hypocrisy of those who oppose contraception and abortion, yet just as fervently oppose any spending for social services.

One of us (WP), speaking from my perspective as a member of the African American community and as a women’s health provider, asserts that this attempt to manipulate my community is made possible by our unresolved issues regarding gender roles and sexuality in a modern context. The failure of our community to promote the agency of our mothers, sisters and partners, and to deal forthrightly with sexual matters, leaves us treating abortion and HIV-related issues as “open secrets.” This evasion results in exorbitant rates for both. To truly confront these issues, our community desperately needs medically accurate sexuality education, improved health literacy and a constructive engagement of religious and spiritual leaders, given the central importance of religion in the African-American community. This type of empowerment effort towards shared reproductive health responsibility is the only effective rebuttal to the mischief occurring with race and reproduction in our community. To paraphrase Dr. King, just as individual wealth is always a function of the commonwealth, thus it too holds true that compromising the reproductive health and rights of individual black women results in jeopardizing the collective well-being of black communities.

If to know is to become responsible, my awareness of black women’s unmet reproductive health needs requires me to provide family planning and abortion care to those most in demand for them. Doing so represents a dual sense of responsibility that I feel as both a women’s health provider and as a member of the African-American community. I join with those in my community who have articulated a vision of reproductive justice, defined as creating a society that enables all women and families to have the children they want, the resources needed to raise them, and the ability to prevent or end the pregnancies that they do not want. I call on my fellow health care providers, of all races, to trust women to make the good and tough decisions about when and whether to expand their families. A fundamental respect for fairness necessitates it, and a respect for human rights demands it.

In conclusion, as already noted, we write in a period of unprecedented political attack on women’s health issues — not just abortion, but also contraception and a range of other reproductive health services. Even the seemingly long settled issue of the importance of programs to combat domestic violence is now being resisted by conservative forces.8 This “war on women,” as it has come to be known, has galvanized a countermovement of health activists, both women and men, who have effectively and creatively protested these developments in a variety of ways. We are greatly heartened by this mobilization, although its eventual impact on elections and restrictive measures is unclear at this time. We close by reminding our readers of what is perhaps obvious: the stakes in this “war” are inevitably the highest for the most vulnerable in our society — those poor women of color about whom we have written in this editorial.

Carole Joffe
Advancing New Standards in Reproductive Health
Bixby Center for Global Reproductive Health
University of California, San Francisco
Oakland, CA

Willie J. Parker
Board member
Physicians for Reproductive Choice and Health
New York, NY

  1. Roosevelt T. On American Motherhood. Available at http://www.nationalcenter.org/TRooseveltMotherhood.html (accessed July 20, 2012).
  2. Buck v. Bell, 274 U.S. 200 (1927). Available at http://www.oyez.org/cases/1901-1939/1926/1926_292 (accessed July 20, 2012)
  3. Schoen J. Choice and coercion: birth control, sterilization, and abortion in public health and welfare. Chapel Hill: University of N. Carolina Press; 2005;
  4. Gordon L. In: The moral property of women: a history of birth control politics in America. Urbana, IL: University of Illinois Press; 2002;p. 289–291
  5. Petchesky R. In: Abortion and woman’s choice: the state, sexuality and reproductive freedom. Boston: Northeastern University Press; 1990;p. 392
  6. Chesler E. Was Planned Parenthood’s founder racist?. Salon. 2012;Nov 2. Available at http://www.salon.com/writer/ellen_chesler/(accessed July 20, 2012).
  7. Dewans S. Antiabortion ads split Atlanta. New York Times. 2012;Feb 5. Available at http://www.nytimes.com/2010/02/06/us/06abortion.html?scp=1&sq=Shaila%20Dewan%20Margaret%20Sanger&st=cse (accessed July 20, 2012).
  8. Joffe C. All common ground lost: the right’s opposition to the Violence Against Women Act. Rhrealitycheck.org. Available at http://www.rhrealitycheck.org/article/2012/03/16/all-common-ground-lost-rights-opposition-to-violence-against-women-act (accessed July 20, 2012).

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