Targetting the Scientific Community

TARGETTING THE SCIENTIFIC COMMUNITY

The Campaign Against Anti-Fertility Vaccines

All over the world, a relentless search continues for ‘appropriate sites’ within a woman’s (or a man’s) body that can be targeted by Anti-Fertility Vaccines (AFVs) for contraceptive effect. In India, as in several other countries, despite years of animal and human trials AFVs remain scientifically unsound and inherently unsafe.

For many years now, women’s groups have been campaigning against such hazardous contraceptives and demanding a radical reorientation of contraceptive research. We have been specifically calling for a halt to the research of AFVs because of the high potential risks they pose for women’s health.

From 27 – 30 October 1998, New Delhi played host to the VII International Congress of Reproductive Immunology. New developments in the field of immunological contraceptives, including AFVs were also discussed in the Congress. This Congress was also a precursor to the International Immunology Congress held in Delhi from 1 – 6 November 1998.

This was an opportune moment to draw attention to our concerns regarding the anti-woman direction of the research promoted by the scientific and medical establishment. Such a congregation of immunologists and other scientists gave us the opportunity to engage with them, critique the direction of their work and impress upon them the need to accept social responsibility for their work. In addition, this also gave us the opportunity to bring issues of undesirable and unethical contraceptive research into the public eye.

About five years ago, women’s and health groups from various parts of the world joined together to address issues of concern surrounding the worldwide stress on population control, and the subsequent license for research into and the use of hazardous contraceptives, primarily on poor women of the Third World. We formed an International Campaign Against Population Control and Abusive, Hazardous Contraceptives, a group that both Saheli, New Delhi and the Forum For Women’s Health, Mumbai have been active in. One of the major focus areas of the campaign has been to bring a halt to research and trials of AFVs. Hence, we all joined hands to take on the scientific and population control establishment in New Delhi in October 1998.

Anti Fertility Vaccines: Another Weapon in the War for Population Control

The world-wide obsession with ‘over population’, relentlessly propagated by the population control establishment has resulted in making women the target of coercive policies, and subjected them to the trials and use of many invasive contraceptives. In the name of ‘increasing women’s choices’, long-acting, hazardous contraceptives are dumped on women. Implants and injectables such as Norplant, Net-En and Depo Provera have been tested and used on countless women, especially in the Third World.

Scientific research to contr ol women’s fertility by causing immune reactions has been continuing for almost three decades now. This desperate search for ‘suitable targets within the body’ that has dominated the work of several scientific institutions and reproductive immunologists all over the world, has been extremely controversial. National and international action by women’s groups and health activists has opposed the development of the ‘vaccine-approach’ to contraception that treats pregnancy as a disease. It has highlighted the unethical and unsound scientific basis of this research, the health hazards it poses for women and the social implications of its use.

On one hand, this debate has forced the scientific establishment to become more accountable to health activists. But on the other hand, concerted attempts have been made to obscure the issues at hand. Changes in the nomenclature of Anti-Fertility Vaccines, from Birth Control Vaccines to Fertility Regulatory Vaccines and now, to Immunological Contraceptives reflect no real shift in the perspective of the developers of such a technology. Research and funding institutions claiming to be pro-women repeatedly reassure women’s groups that the development of Anti-Fertility Vaccines for men is also under way. Yet, serious concerns about the health risks of these vaccines on men persist. Moreover, the fact is that most of the vaccines being developed to be used on women.

Provoking an Immune Response against Pregnancy: A Problematic Premise

Anti-Fertility Vaccines, or immunological contraceptives, aim to prevent conception by inducing an immune response in the body. In order to understand the basic premise of these vaccines, the way in which they are meant to work and the potential health risks they pose, we need to begin by taking a brief look at the immune system of the body. The immune system is an integrated system of vessels, organs, cells, and molecules that help protect an individual from infectious diseases. This sophisticated body system is designed to recognise micro-organisms such as viruses, parasites and bacteria as being ‘foreign’. The body then generates specific protective responses - in the form of antibodies - to combat them. Typically, the first immune response against specific micro-organisms is slow and not very effective. Over a period of time, after the primary exposure to micro-organisms, the body develops a specific immune response as a consequence of exposure to these foreign components (called ‘antigens’). This is the fundamental characteristic of the immune system used to protect the body against specific diseases by traditional disease vaccines. (See Box on Traditional Vaccines vs Anti-Fertility Vaccines).

However, it is essential that any vaccine must not disturb the delicate balance of the immune system and impact its overall functioning. This also applies to the development of Anti-Fertility Vaccines that aim to intervene in the immune system to disrupt the human reproductive process.

In medical terms, the potential risks that all subjects of human trials have been exposed to range from allergies and hypersensitivities to auto-immune diseases and permanent infertility. Almost three decades after the research on Anti-Fertility Vaccines began, the method still has an efficacy rate that is at best is an unacceptable 80%, its safety is not yet conclusively established; its long term toxicity and teratological effects have not been ruled out and its effect on pregnant women or children born during or after the trial not conclusive.

Moreover, reversibility of the method, a key factor in any spacing method of contraception, has also not been proven. And the impact of AFVs on the risk of HIV infection has also not been systematically studied. While scientists and institutions engaged in the pursuit of Anti-Fertility Vaccines cite lack of data as the very reason for continuing this line of research, women and health groups have consistently contested this argument on several grounds.

Opposition has been raised against the very principle of ‘treating pregnancy as a disease’ and causing an immune response against it. Other characteristics of Anti-Fertility Vaccines like the long duration of effect, and the fact that they can be used on a mass scale, and administered to people without their knowledge, open up another critical area of concern: their inherent potential for abuse. Experiences of women all over the world have highlighted the numerous situations in which such long-acting, invasive and provider-controlled methods of contraception are abused. This is of particular significance in a country like India where the ‘population control’ agenda of the state, has already cost countless women their health and well-being.

Research into AFVs: Unethical all the way

The unethical research carried out so far on AFVs has further substantiated these apprehensions. (See Box on Worldwide Research on AFVs: Who foots the bill?). Human trials have been initiated without adequate or conclusive animal studies. Contrary to all ethical norms of scientific practice, the interests of science and society have taken precedence over the interests or well-being of trial subjects.

India has the dubious distinction of “pioneering” this research, with the anti-hCG vaccines having entered Phase II clinical trials on women. The trials in Delhi, Mumbai and Chandigarh, were initiated in the early 1990s without adequate or conclusive animal studies. Internationally accepted requirements for ‘informed consent’ have been flouted and long term follow-up remains, till date, completely unsatisfactory. In another blatant contravention of internationally accepted norms of research on human beings, the ‘father of AFVs, Prof. GP Talwar even conducted trials on lactating women! It is clear that contrary to all ethical norms of scientific practice, the interests of science and society have taken precedence over the interests and well-being of trial subjects. It is clear that such contraceptive research is guided by the imperatives of population control.

The Proceedings of the Congress of Reproductive Immunology: Insufficient Concern for Social Implications

In order to confront the scientific community and force to address these and many other issues of concern, several members of the International Campaign Against Population Control and Abusive, Hazardous Contraceptives (from Canada, Germany, Nigeria and India) attended the Congress on Reproductive Immunology, and made relevant interventions. At the inaugural session, we heard Prof. Talwar blatantly state the ‘population control agenda’ of AFV research when he stated, “What can be a more fitting justification for research on an Anti-Fertility Vaccine? Since the inauguration of this Congress, 2054 people have been added to the Indian population.”

But during the entire Congress, crucial issues of ethics and social applicability of this research were conspicuously absent from their deliberations. Hence, on the last day of the Congress, we read out a joint statement on behalf of the campaign, outlining the major problems with AFVs, the hazards they pose for women’s health and the futility and dangers of pursuing this line of research. Needless to say, even this mild intervention was met with a lot of hostility from scientists, who felt it was not the ‘right forum’ to raise questions of ethics. We also distributed copies of the Statement, and discussed issues of ethics and the social context of medical research with the scientists present, a few of whom were fairly receptive to our ideas and concerns.

Strengthening the Campaign: Giving Voice to Our Protest

On the afternoon of the 30th, we also held a Press Conference jointly organised by Saheli and Forum for Women’s Health. Members of the International Campaign also addressed the journalists. Although AFVs and contraceptive research are not a “burning issue” in the Indian context, it is clear that over the years, our work has managed to generate considerable concern on the issue. This groundwork helped us mobilise a wide cross section of the press, and we were encouraged by the fact that several newspapers covered the event, and featured stories on the issue. On this occasion, Saheli also released a detailed report on the issue titled, Target Practice: Anti-Fertility Vaccine Research and Women’s Health (See Box).

Then, on the 31st of October, we also had a full day campaign meeting, co-organised by Saheli and the Forum for Women’s Health. While there were a few groups from outside Delhi, the majority were local groups. The morning session of this meeting focussed on an overview of health policy in India, and the shifts in the Reproductive Health Policy. This was followed by a presentation on the direction and politics of Contraceptive Research and the challenges ahead of the women’s movement. The afternoon session was on the International Campaign. This was followed by a discussion on social responsibilities of scientists. Finally, we had a strategy planning session where the discussion, covered important issues of co-option of the agenda of the women’s movement by the population control establishment, and the role of advocacy groups in this context.

On the 1st of November, the International Immunology Congress was inaugurated by the President, Mr KR Narayanan. On this occasion, we held a protest demonstration that aimed at conscientising the entire scientific community to the unethical and undesirable quest for AFVs, and making them aware of our objections to them. In this protest we were joined by women’s groups like Sabla Sangh, students groups like Democratic Student’s Union, and democratic groups like Peoples’ Union for Democratic Rights, among others. We managed to hand out leaflets to hundreds of scientists who were attending the event, and shouted slogans, sang songs and displayed placards to highlight our concerns.

Redefining Priorities for Women’s Health: Many challenges still ahead

While the development of Anti-Fertility Vaccines has broadly followed the pattern of other invasive, provider-controlled contraceptives, certain new elements have characterised it. The media has been consistently used to garner support against, mounting protests from the women’s health movement. Many of the criticisms of the women’s movement about long-acting, provider controlled contraceptives are also sought to be turned on their heads. Researchers claim that Anti-Fertility Vaccines do not cause hormonal disturbances and disruption of the menstrual cycle like other long-acting hormonal methods. Such a claim masks the fact that these vaccines do interfere with the entire body system, including the hormonal balance, and have serious potential heath risks. Researchers claim that they are in agreement that long-acting duration are not in women’s interests, and that these vaccines are not ‘provider controlled’ because a woman can ‘choose’ whether or not to get a booster shot and continue with the vaccine. And so, while these hazardous Anti-Fertility Vaccines work to control women’s fertility by any means, we are told that women’s choices are being widened by the development of these vaccines.

It is clear that most contraceptive research, like that of AFVs, ignores the reality of the vast majority of women in India. Ninety percent women in the reproductive age are anaemic and malnourished and do not have access to adequate food, drinking water and primary health care. Women’s real need for contraception is exploited by the population control establishment which imposes methods which pose serious health risks, and over which women have no control.

We would like to reassert that women do need contraception – safe, effective methods which are within the woman’s control. Top-down, resource-intensive research and planning can only serve the interests of the dominant in any society. A radical reorientation of contraceptive research will of necessity have to encompass women’s need for safe and effective barrier methods, which are within the control of women and help to promote better negotiation between couples. Male responsibility for contraception is another crucial area of concern. Scientific research must take into account the real needs of people, and patriarchal and class biases have to be challenged. Tackling the inequalities between men and women and addressing women’s needs would contribute to overall change.

We need to question why there is a need for a population policy at all, and change the terms of the debate. Land reforms, provision of basic needs, ensuring equitable access to food, housing, health, education and other necessities will contribute to moving towards a more humane society.

We call for an immediate halt to the research and development of immunological contraceptives because of health risks, the potential for abuse, unethical research, and the anti-people assumptions underlying this direction of contraceptive research. The wellbeing of every woman and man must take precedence over scientific goals.

Traditional Vaccines vs. Anti-Fertility Vaccines : A Critical Difference

The difference between vaccines for infectious disease control and Anti-Fertility Vaccines can be discussed within several frameworks. e.g. biological bases, immunological targets, recipient population etc. Other grounds include differing perspectives of developers, providers and users and the right of the state to impose programmes of control.

Almost all of these differences are grounded in the social, economic and gendered aspects of societies. Traditional vaccines aim to provide protection against debilitating or life-threatening diseases, while Anti-Fertility Vaccines aim to prevent conception, which is a normal physiological process, and not a disease. Hence, traditional vaccines are generally administered to susceptible individuals, whether men, women or children, while Anti-Fertility Vaccines are meant for use on healthy persons of reproductive ages. Moreover, while Anti-Fertility Vaccines can theoretically be given to both men and women, most of them are designed to be administered to women.

Furthermore, traditional vaccines, usually aided by a booster, aim to confer long-term/lifelong protective immunity. The ‘memory’ of the immune system continues to protect the body against re-infection. On the other hand, Anti-Fertility Vaccines are ideally meant to act only for a short, well-defined time period, and to be reversible in their effect.

Additionally, in the case of disease control, traditional vaccines may often be the only means of prevention available. However, while understanding and evaluating the risks and benefits of Anti-Fertility Vaccines, it is important to remember that numerous safe and effective alternate methods of contraception are already available to women all over the world.

Worldwide Research on AFVs: Who foots the bill?

The five major institutions involved in AFV research and development are : the World Health Organisation, Switzerland; the National Institute of Immunology, New Delhi; the Contraceptive Research and Development Programme (CONRAD) of the USAID, USA; the Population Council, USA; and the Center for population Research of the National Institute for Child Health and Human Development, National Institutes of Health(NIH), USA. Among other smaller agencies involved in the development of various AFVs, are the Centre for Reproductive Biology and Molecular Endocrinology at the Indian Institute of Science, Bangalore, the International Centre for Genetic Engineering and Bio-technology, New Delhi and the University of Strathclyde, Britain.

WHO through its Special Programme in Research (WHO-HRP), CONRAD, NIH, Population Council, USAID, the Medical Research Council, UK and the International Development and Research Centre, Canada have also played a key role in funding AFV research worldwide. In addition, numerous private trusts in the US that view rapid population growth as a threat to world security, like the George J Hecht Fund, the Andrew W Mellon Foundation, the Rockefeller Foundation, the Dodge Foundation and the Ford Foundation have been more than willing to fund AFV research; while pharmaceutical companies like Johnson & Johnson, Sandoz, Organon pharmaceutical, Ortho Pharma, Zonagen Inc., and Reproductive Biotechnologies Ltd. have considered AFV research a suitable area to make an investment in.

Currently, research is being conducted on more than 27 vaccines, including anti-hCG vaccines, anti-FSH vaccines, anti-GnRH vaccines, anti-sperm vaccines and anti-egg vaccines. While most of the other Anti-Fertility Vaccines are still at the animal testing or Phase I trial stage, the anti-hCG vaccine has entered Phase II human trials.

Target Practice: Anti-Fertility Vaccine Research and Women’s Health

This Saheli report attempts to trace a history of the development of various Anti-Fertility Vaccines all over the world; elucidate the problems inherent in the immunological approach to contraception; discuss the hazards it poses for women’s health; deliberate its immense potential for abuse, and expose the population control agenda of scientific and research institutions.

The women’s movement has for long questioned the proclaimed ‘neutrality’ of science and exposed its patriarchal and class bias. We have placed the Anti-Fertility Vaccine debate in the context of its use in society where women are neither in a position of equality nor have equal access to resources. This problem is further compounded by the misplaced emphasis on ‘population control’ over women’s health needs. In terms of the social implications of the use of these vaccines, we have located our arguments within the Indian context. Finally, we have stressed upon the urgency to redefine priorities for women’s health.

The report is available from Saheli for Rs.25/- (plus Rs.8 for mailing). For a copy, or for more details, please do write to us.