Wed23Apr2014

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Women as wombs

The unethical use of technology to control reproduction has a long and contentious history, writes Sarojini N B. There can be no doubt that women need effective contraception. The question is: Are the contraceptives being tested and promoted both effective and safe? Shouldn’t women be able to control their use? Shouldn’t women have the right to choose, with complete awareness of the risks involved?

Just because we can do something, should we do it?

As medical technologies develop in ways that were unimaginable only a few decades ago, this is a question that has come to plague all of us since the second half of the 20th century. Advancements in the field of reproductive medicine, reproductive technologies in particular, have prompted this question. In a sense we ‘can’ do something because it has been made possible; research in medical technologies, whose direction and type have been shaped by the needs of the state and international bodies, has furthered intervention in the reproductive potential of women.

The contemporary construction of reproductive technology is not without a past. It is important to historicise the ‘modern’ new reproductive technologies (NRTs) and see them not as isolated scientific breakthroughs but as contained within this particular context. However, the unprecedented expansion of these technologies, further impacted by developments in the field of biotechnology, has resulted in an urgent need for interrogation into issues that lie at the interface of technology, health and society. It is in this context that a focused understanding about the health and social implications of NRTs for women becomes essential.

International agencies, family planning organisations and governments have justified invasive medical interventions -- hormonal contraceptives, anti-fertility vaccines, chemical sterilisation, and tubectomies performed in unsafe conditions -- in developing countries using arguments such as fertility rates are ‘out of control’ and a ‘population explosion’ is imminent. Scientists have collaborated in this enterprise, testing contraceptives on poor women without their consent, despite evidence of the side-effects and serious health consequences of this practice. When research towards the approval of such contraceptives has been opposed, regulatory authorities have permitted their introduction through the back door, often solely on the basis of their ‘approval’ elsewhere, even if the mandated India-based trials have not been conducted.

The unethical use of technology to control reproduction thus has a long and contentious past, primarily because of the dubious historical association of ‘family planning’ with ‘population control’. Women’s and health rights activists have raised questions about the safety of hormonal contraceptive technologies, the way in which clinical trials are conducted, collection of informed consent, and the family planning programme’s inadequate efforts towards women’s health in general. Furthermore, women’s health activists have protested the inclusion of women in the healthcare system essentially as reproductive beings, to the exclusion of their other health needs.

This paper looks at the framework within which particular hormonal contraceptive methods are developed, the concerns they pose, and some associated interventions made by the women’s movement. Drawing on the histories of the women’s and health movements -- starting in the 1970s -- it sketches a broad picture of ethical concerns in contraceptive technologies such as injectables and implants.

Background

A qualitative leap in contraceptive research came in 1960 when the US Food and Drugs Administration (USFDA) approved the oral contraceptive pill containing hormones which interfered with the reproductive process in various ways, including by preventing ovulation and by making the uterine lining incapable of sustaining a pregnancy. The hormonal contraceptive freed women from both the fear of an unwanted pregnancy and, significantly, male consent or cooperation. The pill was thus promoted as liberating, especially in circumstances where women were unable to insist on the use of barrier methods. However, problems soon began to be reported -- it was suspected, for instance, that the oral contraceptive raised women’s risk of a stroke -- and newer versions of the pill with lower doses of the hormones were developed which reportedly have lower risks.

Medical exploitation of poor women, particularly in the third world, has been and continues to be rampant. In her 1993 book Women as Wombs, Janice Raymond points out that women in developing countries have been the primary experimental population for multi-centre testing of contraceptive implants, injectables, and anti-pregnancy vaccines. Research has targeted the female reproductive system because it is easier to interfere with. The consequences of this deployment are a whole range of side-effects, from irregular and severe bleeding, loss of libido, weight gain and severe headaches, to serious risks that include osteoporosis, blood clots and strokes. Public health services in India do not provide women the kind of screening and related care that must accompany these methods of contraception. Such methods are ‘effective’ for population control, but may not always be what women themselves want, and there is enough evidence that these contraceptives have been tried on women in circumstances that preclude their informed consent.

Injectable contraceptives

Norethisterone Enanthate, or Net En, is a synthetic form of the hormone progesterone in an injectable form, and is manufactured by the German company Schering. The 200 mg injection must be administered every two months to prevent conception. Depo-Provera is the brand name of Depot Medroxyprogesterone Acetate (DMPA), which is manufactured by Upjohn Co and must be administered every three months. Both prevent pregnancy mainly by stopping ovulation through the injection of a high dose of a synthetic hormone like progestin into the body.

Unethical testing has been a hallmark of clinical trials for long-acting contraceptives in India

Before their introduction in India, injectables had a controversial run in other countries. Depo-Provera was denied approval by the USFDA when Upjohn made its first application in 1967, and later in subsequent applications. It was eventually approved by the USFDA in 1992. Clinical trials of Depo-Provera have been going on in India since the 1970s. However, in 1975, Depo-Provera trials were discontinued without providing any explanation. As part of a study on Depo by the WHO, in the late-1970s, about 1,700 women from 10 centres all over the world -- including Mumbai and Chandigarh in India -- were given either Depo or Net En once in three months. At the end of the first year in Chandigarh, 60% of women on Net En and 82% on Depo dropped out of the trial. The discontinuation rates because of amenorrhea -- absence of menstrual bleeding -- and bleeding irregularities were much higher in Chandigarh than in all the other centres, including Mumbai. However, when reporting the results, researchers conveniently excluded the Chandigarh data from the calculation of averages. This is described in Contraceptives: Our Choices, Their Choices, bythe Forum for Women’s Health.

Net En, on the other hand, was withdrawn from markets in the US in 1971 following animal toxicology tests which found that rats administered the contraceptive developed tumours, indicating that it could be hazardous to women. Approval was finally given to Schering by the Federal Health Office in Germany, in 1983, with the press and information section of the National Health Authority issuing a statement that read: “Their (injectables) use can only be justified in rare cases; the products are clearly second rate,” but with a qualifying label stating that the drug was what they described as being “second rate” (as quoted in a 1994 interview with the Drugs Controller, by Rukmini Anand and C Sathyamala).

However, in 1983-84, the Indian Council of Medical Research (ICMR) initiated what it described as a Phase IV trial in urban and rural centres to assess the acceptability of Net En towards its introduction into the National Family Welfare Programme. Paramedics were given the task of recruiting women for the trial from a rural health centre in Patancheru, a village close to Hyderabad in Andhra Pradesh, which was to be one of the sites of this study. While 2.1% of women in the trial got pregnant, 41.21% experienced menstrual abnormalities. On the basis of these trials, ICMR, in its recommendations, stated that Net En could be made available at urban health centres where a doctor is present, and where comprehensive medical care can be provided.

Members of Stree Shakti Sanghatana, a women’s collective in Hyderabad, who visited Patancheru, found that the poorest of women had been recruited for the study, that too without being informed about the drug’s side-effects and contraindications. They were routinely told: “Injectable le lo, baccha nahin hoga.” (“Take this injection, you will not conceive.”)  When the Sanghatana provided information on side-effects and contraindications to the participating women, only five out of 50 remained in the trials. This was not an isolated incident; in Jaipur, the Sawai Man Singh Medical College issued posters and pamphlets advertising the injectable incorrectly, touting it as a “miracle” solution to unwanted pregnancy. Saheli-Women’s Resource Centre, Chingari, and other women’s groups filed a writ petition in the Supreme Court against the Union of India, ICMR, Drugs Controller General of India (DCGI) and others, asking for a stay on the Net En trials. The story of this case is given in Saheli’s Enough is Enough -- Injectable Contraceptive Net En: A Chronicle of Health Hazards Foretold (1999).

There has been insufficient research and testing on contraceptives -- specifically for dosage and long-term side-effects -- for Indian women. By the early-1980s, ICMR concluded that Depo-Provera was unsuitable for introduction in India. Dr C L Jhaveri, a gynaecologist and former chairperson of the Indian Association of Fertility and Sterility, was refused a licence to import Depo, primarily because there was no policy on whether drugs that had not been approved in India, but which had approval elsewhere, should be made available here. Thereafter, Dr Jhaveri contested this decision by filing a case against the DCGI and the Union of India. A women’s organisation (Women’s Centre, Mumbai) and a health network (Medico Friend Circle), along with the Union of India, filed a case against Dr Jhaveri in 1985. They argued that use of the drug in India’s family planning programme could be disastrous for women’s health. Following this, Dr Jhaveri was prohibited by the court from importing the drug or using it on women. This is discussed in The Issues at Stake: Theory and Practice in the Contemporary Women’s Movement in India by Nandita Shah and Nandita Gandhi, and by Padma Prakash in Women’s Health Movement in India: A Historical Perspective (2005).

However, despite the disturbing findings of the clinical trials, the DCGI, on ICMR’s recommendation, approved the marketing of Net En in 1986 and Depo-Provera in 1993. Net En was officially launched in India for ‘social marketing’ by German Remedies Ltd.

Current status of injectable contraceptives

Although injectables have so far been kept out of the family welfare programme, the possibility of their future inclusion remains. It is also well known that these drugs are being prescribed by both private practitioners and those in public hospitals. Both Depo-Provera and Net En are easily available over the counter, without a doctor’s prescription. Moreover, persistent attempts are being made to introduce new injectables through clinical trials and camps set up by NGOs at public health set-ups.

In 2004, in a series of public hearings on the right to health, initiated jointly by the National Human Rights Commission (NHRC) and Jan Swasthya Abhiyan (JSA), testimonies of women’s experiences with Depo-Provera were presented by Sama-Resource Group for Women and Health before officials from different states. The NHRC panel was surprised to find that a public health establishment was administering Depo-Provera and subsequently demanded an explanation from the concerned authorities. 

In October 2004, a workshop ‘Expand Choices of Contraception’ towards the introduction of injectables was organised by Parivar Seva Sanstha, a national-level non-governmental organisation (NGO), in collaboration with the Government of India, UNFPA, Population Foundation of India, and the Packard Foundation. This was met with opposition from a number of organisations including the All-India Democratic Women’s Association, Sama, Saheli and Delhi Science Forum, that collectively submitted a memorandum to the then health minister. The ministry, in a letter to Saheli (No N 14013/22/2000/TO, dated April 19, 2007) responded:

In this connection I am to inform you that injectable contraceptive which was accorded marketing permission is being used in the country on the prescription of a physician since early ’90s. However Government of India is not contemplating to introduce the same in the National Family Welfare Programme till the study on the effects of injectable contraceptive on Indian women’s health is completed by ICMR and the NIRRH, Mumbai, and the findings are favourable. Based on the results of these studies, the department will take a decision on the introduction of injectables under the National Family Welfare Programme.

On April 16, 2008, the Ministry of Health and Family Welfare called a meeting to discuss Phase IV trials to be conducted at 31 district and medical college hospitals through nine NGOs, prior to the introduction of Net En and Cyclofem (a monthly combination injectable) in the public health system. The participants were informed that ICMR had already completed Phase III trials of Net En and Cyclofem, on the basis of which “experts” had approved the initiation of Phase IV trials.

On April 29, a memorandum addressed to the Union Minister for Health and Family Welfare, Anbumani Ramadoss, challenged the basis of these trials as well as the introduction of injectables in the public health system. It demanded to know what new evidence of “safety and acceptability” for Net En had emerged, on the basis of which the ministry was planning to launch Phase IV trials of a contraceptive which had previously been rejected as unsafe for introduction in the public health set-up. The memorandum pointed out that the Technical Committee of the Drugs Technical Advisory Board had already opined that DMPA, the key constituent of Cyclofem, should not be allowed for mass use in the family planning programme, and demanded to know on what scientific basis this recommendation was being overridden. Over 50 organisations and individuals endorsed the memorandum.

Following pressure from women’s groups, the summary reports of the Phase III trials of Net En and Cyclofem were displayed on the ministry’s website for feedback and clarifications. The ICMR website stated that the Phase IV trials would not be launched without taking relevant concerns into consideration:

…The study has only recently been approved. After receipt of budget, the formative phase (six months) will be initiated which includes preparation of various guidelines (technical, operational, etc), procurement of drugs, setting up of various committees for review, monitoring, etc.

More recently, teaching hospitals and other tertiary-level hospitals have been known to offer their premises and infrastructure to researchers and NGOs that set up camps offering these injectables at discounted rates. For instance, at the Sardar Vallabhai Patel Hospital attached to the Lala Lajpat Rai Medical College in Meerut, an NGO, in collaboration with a post-graduate student at the college, set up a camp distributing information about Depo-Provera and also offering the injectable for use. The injectable was being given at a discounted rate of Rs 50 as opposed to Rs 180, the rate in the private market. Later it was confirmed that this was part of a two-year research being conducted by the student, and that Depo was not otherwise available on a routine basis at the hospital OPD. However, all women who approached the hospital for contraception were told about Depo as part of their “basket of choices”, and were then directed to the table set up by the NGO outside the OPD, for further information.

Contraceptive implants

Norplant is a contraceptive implant initially developed at the US-based Population Council. It consists of six capsules, each the size and length of a matchstick, containing the steroid Levonorgestrel. The hormone is released slowly over five years, and prevents ovulation for that period. It was distributed in the US by Wyeth-Ayerst and is also licensed to the Finland-based Leiras Pharmaceuticals for low-cost provision to governments and family planning organisations in developing countries. Norplant received approval by the USFDA in 1990, but by 1994 at least 200 lawsuits had been filed in the US against its distributor Wyeth-Ayerst as women started reporting serious health problems. This raised doubts about the drug’s long-term safety, and was of particular concern because the implant was promoted among poor women who have little access to healthcare for treating side-effects and are likely to suffer because of delays in detection and treatment of illnesses like ovarian cancer that have been linked to the implant.

In 1985, the World Health Organisation (WHO) declared Norplant to be an “effective and reversible method of fertility regulation particularly advantageous to women who wish an extended period of contraceptive protection” and “suitable for use in family planning programmes along with other methods of fertility regulation”. However, the WHO simultaneously recommended training and supervision of medical personnel; more research on the implant’s long-term side-effects and its use during lactation; post-marketing surveillance and acceptability studies. The WHO document emphasised the importance of screening women carefully “especially bearing in mind the side-effects” (‘Facts About an Implantable Contraceptive’, in Bulletin of the World Health Organisation 1985: 63(3): 485-94).

As with injectables, there has been a constant attempt to push for newer implants to be introduced within the public health system

According to ICMR, at the end of five years of clinical trials almost 25% of Norplant users had requested its removal because of bleeding problems, and another 15% for medical problems including headache and weight gain. This was stated by R S Sharma, M Rajalakshmi and Jeyaraj A in 2001, in their article ‘Current Status of Fertility Control Methods in India’, in the Journal of Bioscience published by the Indian Academy of Sciences. Concerns associated with Norplant included difficulty in removal of the implant. To reduce the incidence of side-effects and the number of implants to be inserted, new implants have since been developed.

As is the case with injectables, there has been a constant attempt to push for newer implants to be introduced within the public health system. After the unethical trial of Net En in Patancheru became publicly known, research switched to hormonal vaginal rings, nasal sprays and a new Norplant. Norplant-2 trials were conducted on women in India during the 1980s. ICMR stated that due to financial constraints, it had not followed the 1,500 women who were given Norplant-2. On December 6-7, 1990, ICMR had a closed-door meeting with “health advocates” to discuss the introduction of Norplant and other spacing methods in the National Family Planning Programme. In this meeting, ICMR reported that 1,466 women were given Norplant-2 between January 1986 and September 1991. Discontinuation after 36 months was 36-40%. ICMR stated that the method was safe and did not affect a return to fertility. Trials of Norplant-2 were discontinued when the council could not get supplies.

More recently, in August 2004, ICMR started a 17-centre, Phase III study evaluating Implanon, a single-rod contraceptive implant made by the Dutch manufacturer Organon, which provides contraceptive protection for three years. The study sought to assess its efficacy, side-effects, return to fertility following discontinuation, and acceptability in terms of the percentage of women who would continue using it. The study also sought to gather users’ perspectives on the method and relative popularity of the method when offered in the “cafeteria” approach. As of February 2006, 2,550 women had been enrolled in this study. According to the ICMR report, 813 women completed one year of use, and 76 women completed more than 18 months of use (ICMR Annual Report on Reproductive Health [2005-2006]). 

Clinical trials and informed consent -- a revisit

It can be safely concluded that unethical testing has been a hallmark of clinical trials for long-acting contraceptives in India. From lack of informed consent to outright coercion, scientific investigation on contraceptives has fallen woefully short of meeting universally accepted ethical norms. Essential information should compulsorily be made public. This includes existing information on the safety aspects of the hormonal contraceptive, data on complications arising out of the procedure, known adverse effects, time for return to fertility, research design, and basis for approval.

Since the Patancheru experience, women’s groups have monitored violations of informed consent procedures in the administration of contraceptives during clinical trials and research. A study conducted by the Forum for Women’s Health on women who had been part of Norplant trials in Baroda revealed the unethical and unscientific way in which the trials were conducted. In an important work, An Epidemiological Review of the Injectable Contraceptive Depo-Provera, Dr C Sathyamala reviewed the scientific literature on Depo to establish that the risks with use of this injectable were unacceptable. Interviews by Sama in 2000 (‘Unveiled Realities -- A Study on Women’s Experiences with Depo-Provera, an Injectable Contraceptive’) found that women in Delhi were administered injectable contraceptives in a public hospital without their informed consent. Vital information regarding the safety and adverse effects of the contraceptive was withheld from the women, depriving them of their right to make an informed choice.

For safe administration of any invasive spacing method, women need to be screened and supervised by the medical team at regular intervals. These may need to be more frequent, and for a longer period, in the case of hormonal contraceptives: there are serious risks associated with their use, and a quantity of the drug may persist in the woman’s body for some time after the method is abandoned. The return to fertility after the contraceptive is stopped is also a matter of concern. As these methods are provider-controlled, there is tremendous potential for abuse; this needs to be recognised and addressed. There is no such monitoring in India.

Those administered these contraceptives are poor women who visit government hospitals, where they are effectively treated as living laboratories. The testimonies of women who have participated in clinical trials reveal that informed consent is rarely, if ever, taken. Often, women who come to government centres for health services are recruited into trials and may not even know that they are in a trial, and that a drug is being tested on them whose full effects are not yet known.

Side-effects no “old rhetoric”

The side-effects of hormonal contraceptives include menstrual irregularities, cessation of menstrual bleeding, general weakness, migraine headaches, and severe abdominal cramps. In a country where a large percentage of women in the reproductive age suffer from anaemia, irregular and heavy bleeding can have catastrophic consequences. There are also unresolved concerns over the return to fertility and the health of babies born after cessation of use of the injectable or implant.

To give just one illustration, it is now widely accepted that injectable contraceptives like Depo-Provera can lead to reduction of bone density, resulting in an increased risk of osteoporosis. In the‘Important Safety Update on Depo-Provera’from Pfizer, Canada, Depo’s manufacturer and current distributor states:“As a result of new clinical studies, one with adults and one with adolescents, we now have clinical data regarding the use of Depo-Provera and its associated effect on bone mineral density (BMD).” It adds: “Bone loss is greater with increasing duration and may not be completely reversible.” The USFDA has mandated that Depo-Provera carry a ‘black box’ warning label, the agency’s most severe warning, regarding bone loss. The FDA requires that the product label contain information to the effect that “loss of BMD (bone mineral density) in women of all ages, and the impact on peak bone mass in adolescence, should be considered, along with the decrease in the BMD that occurs during pregnancy and/or lactation, for women who used Depo long-term”. Also recommended is the “addition of a statement based on post-marketing experience regarding rare cases of osteoporosis including osteoporotic fractures reported”. The warning will also suggest that Depo use should be limited to two years unless other forms of birth control cannot be used. However, lax laws in India have not mandated this disclosure, as a result of which women users remain unaware of the health risks associated with Depo.

Users have inadequate or no information regarding the health risks and side-effects of these contraceptives, a fact reiterated in the recent National Family Health Survey (NFHS-3). Only one-third of women contraceptive users said they were aware of side-effects, while only one-quarter knew what to do in case of side-effects. The survey has also raised questions about the overall safety of injectable contraceptives. NFHS-3 found that among all available spacing methods, the discontinuation rate was the highest for injectables (53%), followed by pills and male condoms.

Engagement of the women’s movement -- challenges ahead

Women’s groups and health groups in India have long fought ethical violations occurring during research on and promotion of long-acting, hormonal contraceptives and other unsafe technologies. The list is endless and includes research on anti-fertility vaccines, illegal trials of quinacrine for chemical sterilisation, trials without informed consent, and coercion in the use of IUDs and sterilisation.

However, public debate on injectable contraceptives in India is still characterised by strident rhetoric that often serves to polarise discussions, including within the women’s movement itself. Some welcome these technologies as products of scientific progress and argue that it is the context that makes them good or bad. There has been debate about whether there should be a blanket rejection of all hormonal contraceptives, or only of those that do not grant control to women as users. One group of health activists defends the use of injectable contraceptives and implants; they argue that such contraceptives are the only way poor and powerless women have control over their lives (neither husbands nor in-laws know if a woman is using an injectable). It is argued that injectable contraceptives have helped expand available choices for effective contraception, and, as such, a woman’s decision to avail of any available contraception should be respected. It is also argued that no available contraceptive is 100% effective or completely free from side-effects, and, as such, the side-effects are more inconvenient than life-threatening. Further, perhaps the high risk of morbidity and mortality associated with unwanted pregnancies needs to be weighed against the side-effects of contraceptive methods, which are much less. 

There can be no doubt that women need effective contraception. The question is: Are the contraceptives being tested and promoted both effective and safe? Shouldn’t women be able to control their use? Shouldn’t women have the right to choose, with complete awareness of the risks involved? Lakshmi Murthy argues in her article ‘The Body as Victims’ in The Hindustan Times, 2000, that the trumpeting of ‘choice’ should be viewed with caution when ‘choice’ is guided by a population control lobby backed by sophisticated marketing by pharmaceutical companies that stand to make huge profits.

Most of the emerging contraceptive technologies have multi-systemic effects and require more careful study in order to ensure their long-term safety vis-à-vis the health of both women users and their future progeny. Therefore, the dynamics of contraceptive use and the issue of informed choice merit close examination.

Radical feminist Renate Klein, in a 2008 article in International Forum, points out that the issue of concern is really about the context in which technologies are developed, and how they come to be used.

However, feminist critiques of the indiscriminate ‘technologisation’ of medical systems and practices have more often than not been interpreted as opposition to all technology. Feminists question the contexts and ab/uses to which technologies are put, because very often they involve adverse consequences for certain segments of the population, and for women in particular. Equally significant is the concern that life-saving healthcare technologies are still not available to most women in the world. Our Bodies, Ourselves (1994) emphasises: “We must judge the value of the reproductive technologies in the context of the social, political and economic setting…” Further, in her paper ‘Feminists Against Women: The New Reproductive Technologies’, Wendy McElroy puts forward the thought that the political effects of medical procedures on women as a class must be pitted against individual benefits, thus transcending the scale of medicine from one of mere science to that of an ideology.

In strategically marketing its products, the pharmaceutical industry has succeeded in appropriating feminist language of choice and empowerment, and deploying it against the interests of women. All women everywhere -- irrespective of race, age, nationality, class, etc -- are being projected as a homogenous whole that will benefit equally and substantially from all types of contraceptives. Vulnerable women are not raw material for research, available for sacrifice at the altar of larger systems of patriarchy, pharmaceutical companies, techno-medicine, etc. Mandated protocols of informed consent, counselling, and the provision of adequate health infrastructure and care cannot be overridden. Inadequate research into long- and short-term health risks must become unacceptable. These are matters not just of ethics, but also of human rights and social justice.

(The author would like to thank Vrinda Marwah and Anjali Shenoi for their inputs to this article)

(Sarojini N B has been working on women’s health and rights for many years and is the director of Sama-Resource Group for Women and Health. She is involved in the coordination of national-level research on reproductive technologies and their implications for women)

Infochange News & Features, December 2010