INJECTABLE CONTRACEPTIVES – SILENT KILLERS

Newsletter July 1994

In the fourth year of Structural Adjustment Programme we are clearly able to see the impact of World Bank/ I.M.F. dictated conditionalities on our day to day life. While most of us have been aware of how these policies have led to loss of jobs, rise in prices and dismantling of government run services in the social sphere, most of us have been unaware of the impact of these supranational institutions in the field of reproduction. Population control is a regular component of conditionalities imposed in the name of economic recovery. This conditionality does not have any connection with improvement in the living circumstances of people, but ensures, by fair means or foul, control over women's fertility. This is while forces which lead to a spurt in population, i.e., rising death rates, loss of social security etc. are unleashed in the country. Production, jobs, distribution are all left to the market forces but the government imposes control over fertility.

Euphemistically, the programme for population control has been known as that of family planning, but the decision about family size is not left to the family but forced upon it, in line with externally imposed desirable family size. Today, no mother of two can escape the governmental pressure to undergo a sterilization, whether she approaches the Government for health care or for contesting an election.

The so called Family Planning programme in India has been guided by the most anti people forces for nearly three decades now. Conditionality associated with aid from the U.S. set the Indian Government moving in the area of population control. Despite a number of methods available for contraception, sterilization found favour with the Government.

The logic was simple. The purpose of this programme was not to help couples meet their reproductive goals and plan and time their children but to ensure that they stopped having children, and demographic goals were met. Once operated upon, women and men could be forgotten about. In contrast, if they used temporary methods, such as condoms, spermicides etc. they could control their own fertility. Contraception as well as conception then remained in people's hands. Yet sterilization alone failed to have an impact on fertility. Many excesses occured, some publicized, as during emergency and some hidden from the public eye, e.g., when women would not even get food for work till they showed their sterilization scars, 01; were forced to foreclose their reproductive options to repay petty loans. Experience made it clear that people went for sterilization only after completing their family. They also proved to be "unreliable" users of contraceptives because their goals never matched those of the government, and contraception was not really high on their priority.

Failure to control fertility led to endless tinkering with trying to shorten the reproductive span and force a birth interval between children. On one hand the government tried to convince people to delay having a first child, then to space children for better health and then to put an early end to their reproductive life. Temporary methods of contraception thus assumed importance in population control. And the Government which has failed to provide two square meals sans choice to a majority of its population was ready to provide Indian women with the latest choices in contraceptive technology. While the rhetoric was of choice, the fact was that choices were being limited to invasive hormonal methods of contraception which did not depend on user motivation or choice to continue to be effective and consisted of exposing women and their children to unknown dangers.

The choice was that of women indeed-the only hitch was that they had to choose in favour of contraception and not for having children. A whole series of contraceptives were put out, with different combinations of hormones all essentially synthetic Estrogens and Progestogens, (somelimes even hormone antagonists) using different delivery routes, from oral pills, to injectables, to nasal sprays, to vaginal rings and implants. These new systems had one common property they are all long acting, with effects varying between a couple of months for injectables, to five years of contraceptive effect with NORPLANT.

In the mid-sixties the hazards of Intra Uterine Devices and oral contraceptive pills were made public because these were used extensively by white middle class women of the First World. Profit being the sole guiding motive in all pharmaceutical research had meant that all caution had been thrown to the winds while dealing with synthetic hormones, not only were they used extensively for contraception, they were also used indiscriminately for other problems of the reproductive system. It was clear that the combined Estrogen & Progestogen oral contraceptive pill was leaving behind a trail of serious diseases. These included metabolic disorders, heart disease, clotting disorders, cancer, birth defects etc. Simultaneously a big scandal was exposed when daughters of women treated with Di Ethyl Stilbesterol were found to develop a rare form of cancer at puberty, making it clear that exposure to hormones had implications which transgressed generations. But most of the scientific community chose to ignore this warning. Instead they found a convenient scapegoat in Estrogen and blamed all ill effects of combined pills also on their Estrogen content. At this time the two injectable contraceptives invented in the late fifties and early sixties, namely Net-En and Depo Provera which only contained Progestogen, were devoid of Estrogen and were long acting and could be given to women considered unreliable in taking pills every day, were heralded as the panacea to all contraceptive needs of women. Being injectables they seemed an easy option in a mass family planning programme where after one injection a woman could be left alone for three whole months (actually one of the dose regimens of Depo Provera provided contraception for six months).

But this story is by now thirty years old. These popular injections have by and large failed to gain a foot hold in the lives of those very women for whom they are supposed to be attractive because of the injection culture. All women educated, uneducated, young or old, white or black, Indians or Bangladeshis, have rejected them unequivocally, unless they have been compelled to use them through denial of marriage licences, welfare benefits, etc. or by ensuring that no other contraceptives reach them.

Yet, even today, injectables are being promoted relentlessly. Although a number of properties of Net-En and Depo Provera are different, there do exist a number of similarities in the way they act and affect women. Of course the effect is at two different levels-first being that which women experience immediately and can correlate with the injection and second which they experience after a time lag or are at risk of experiencing but never get any wiser about because of incomplete information being available to them.

Adverse reactions which can be linked to the drug by the user: These injections invariably throw the menses of users into utter chaos. Even though these injections do have one ingredient in common with the combined oral pills, there are two differences,' firstly all contraceptives which have only progestogen as the active ingredient cause menstrual chaos regardless of how much is administered, e.g., NORPLANT, mini pills and injectables. Injectables have another problem-their effect has to last for a long time and hence they are administered in a rather large dose and reach a high concentration in the blood and take a long time to be metabolized. This means that side effects also last that much longer.

In addition, women on injectable contraceptives may feel bloated, feel dizzy, suffer from migraines, feel exhausted, lose interest in sex, suffer a loss of appetite, and if they are breastfeeding may find their milk supply affected. They may have a tender abdomen, breasts, suffer from varicose veins, feel depressed and nervous, and may have an allergic reaction to the injection, their heart and clotting mechanism may be affected. In all there are 78 side effects which are accepted by Up John for Depo Provera and a similar number for Net-En are referred to in medical literature. These not rare side effects, most of them are suffered by all users, particularly, menstrual chaos and weight changes and mental disturbances. In one study with Net-En only one in ten users was found to have one normal cycle in one year, in other words, nine out of ten women' had no regular cycles in the whole year. No wonder women are attracted to these injections and, begin using them. But for as many as one third of the users, one injection is more than enough. Some continue with the second one because health service personnel try and convince them that these side effects are transient in nature and will soon disappear.

Repeated rejection by women has not deterred the multinationals to use all tactics, ethical and unethical, to promote these products. More and more Third world Governments trying to meet population control targets are persuaded to licence these hazardous preparations.

Adverse reactions the user does not know: Cyclical integrity is very important to the woman and affects her physical and mental well being. Although Progesterone is present in large quantities in pregnant women, the difference arises in artificial preparations being different in character and being able to simulate only partially the natural ones. It is also worth noting that hormonal contraceptives do not work only at the level of reproductive organs but affect the higher brain centres also.

One big question mark with respect to these contraceptives is that of carcinogenicity. Contraceptives are used by healthy people and for a long part of their life. In this way they differ from other drugs used for treating illnesses. Carcinogenicity tests are vital because once in the market a large number of women, probably in millions, will be exposed to them. Routinely, before Net-En and Depo Provera became the subjects of controversy, all hormonal contraceptives were tested on four animal species to assess cancer risk. These species are beagle dogs, Rhesus monkeys, rats and mice. Both the drugs proved to be carcinogenic in all the animal species. But the power of these multinational companies and the support of the protagonists of population control were such that instead of these injectables being thrown in the dust bin, the animal models used were declared invalid. No one questioned the safety of earlier drugs tested on these very animals. No one asked why these animals continue to be used for testing the carcinogenicity of other compounds. Even the WHO took a very adventurous stand and declared that Third World women could be used as guinea pigs because animal models were inappropriate. But after taking this stand when the WHO did design a carcinogenicity study among users of Dep Provera it was inconclusive even though it indicated an increased risk of breast cancer among women. These data were corroborated by breast cancer in beagle dogs. But the conclusion remains the same-Depo Provera is safe, studies which show otherwise are declared and poorly designed, animal models which develop cancer are unreliable, in fact everything which shows Depo Provera in a poor light is wrong, women's groups notwithstanding. To cap it all, the manufacturer is allowed to claim that Depo Provera is safe and cannot cause cancer because it is used for the treatment of cancer. But if one was to take the case of radiation probably the same thing could be seen where certain levels of exposure cause cancer, but certain other levels are used for treating cancer. Yet no one claims that radiation is safe or advises regular exposure.

Second major hazard associated with these injections consists of the damage caused to children exposed to the hormones while In their mother's womb, or through mother's milk when lactating women use these injectables. The immediate well documented effect of exposure of the fetus is virilization of female and feminization of males in the external genitalia. Traces of these hormones have been discovered. In the fatty tissue of infants exposed via breast milk It is worth noting that teratogenic effect is found in the animal species as well. These results have been overlooked while declaring injectables safe. On this very ground of causing birth defects other high dose Estrogen-Progestogen combination drugs have been declared unsafe and banned. Why are then contraceptive preparations treated differently? Does family planning not deal with increasing happiness and healthy children? Can this be the case when incidence of birth defects goes up?

These products also affect the composition of the breast milk and lower the resistance of the users in fighting disease. In many industrialized countries injectables are not at all meant to be used by lactating women. In India, breast milk is the main source of nutrition for infants for a long time. All effort is put into enhancing breast feeding because this milk provides a hygienic source of fluid and nutrition tailored to meet the needs of human children and also guards children against many ailments by passing on mother's immunity to the child. Why is this source of nutrition being contaminated by allowing contraceptive injections to be used by women wanting to space their children, while they are breast feeding?

Last but not the least, one needs to look at the menstrual changes which are admitted to but called minor inconveniences as opposed to being dangerous or serious side effects. When we actually turn the pages of scientific records we find that what is commonly called minor is in fact not even understood by the best medical scientists in the world. Bleeding disturbances caused by these progestin-only preparations include, amenorrhoea or complete absence of periods, spotting, and heavy bleeding. The nature of heavy bleeding is quite serious and in New Zealand where Depo Provera is in wide use among tribal women, on an average one woman is admitted to the city hospital with uncontrolled bleeding from Depo Provera. For this heavy bleeding there is no known treatment. Heavy bleeding is known to occur in up to 15% of the users of both these injectables. The treatment advised consists of repeated shots in the dark. WHO first recommends oral Estrogen. If this does not work, Estrogen injections are to follow and if those fail to contain the bleeding, D&C (dilation and curettage) or an abortion-like procedure is to be performed till such time that the bleeding stops. From personal accounts of women we know that when D&C has not worked they have had to undergo surgery to remove their uterus-minor inconvenience indeed.

In Bangladesh certain projects are giving oral contraceptive pills in addition to the injection in the hope that menstrual disturbances do not get out of control, and in one Inject the most bizarre of all treatments-an additional shot of Depo Provera has been known to have been given in the hope that the second one may cause amenorrhoea. There could be no greater example of irrationality in the practice of medicine. But everything is okay as long as injectables are a part of the Family Planning Programme.

When we look at the scientific explanations or hypotheses to explain these disturbances, the attitude of the dominant medical community towards women's bodies becomes clear. Heavy bleeding is, for example, supposed to be caused by allergic reaction. Spotting is probably indicative of a change in the nature of blood vessels, which is not limited to the uterus alone, or is an indication of a clotting disorder. Amenorrhoea is an indication of the atrophy of the endometrium (the lining of the uterus) which may be temporally or permanent. Yet the WHO in its publication is advising health workers to do better counselling of clients so that these very dangerous side effects become acceptable to them. Again the injection must be given even if women are in addition forced to take contraceptive pills as in Bangladesh.

The problem with these injectables also has been in the fact that the side effects of these injection continue long after their effectiveness as a contraceptive is over. Some women have reported years of misery. Any way once in the body there is no antidote for them. '

Finally in 1990, the WHO has deemed it fit to initiate a study into the bleeding disturbances, which have been known for thirty years and have affected millions of women. In the meanwhile the non-acceptability of these injections has led to the testing of two monthly injections which have Estrogen as well and hence cause regular withdrawal bleeding. One of them by the name of Cyclorem is poised for entry into India, if one were to go by the publicity material primed by the Ministry. In other words the whole circle of Estrogen and Progeslogen to Progestogen to Progestogen and Estrogen has been completed without the pertinent question of safety being answered. Estrogen was dispensed with because of safety reasons and is now being reintroduced so that bleeding is regular. Other hazards remain unaddressed. If ever any one from the scientific establishment now speaks against hormonal contraception it is when they try to defend their adventurism of using the immune system to achieve contraception-then the WHO experts do acknowledge that with hormones we are sitting on a time bomb.

Who wants injections in India?

Time and again example is cited of women who cross over to Nepal to smuggle in injectables which are not available in India because of various reasons. Injections are also touted as a means of contraception which women can use without the knowledge of their family. They are cited for their convenience in not having to be remembered every day, or to be stored the way pills have to be. Yet none of this is more than propaganda without factual content-for instance, can you bleed so irregularly or heavily without anyone in the family knowing about it, Women in desperate circumstances have been known to continue with injections but that is when nothing else is available to them. Others do give up after the first one or two shots regardless of the means they use to procure the injections.

Finally, one can see plainly, that the advantage of not having to store pills is more than countered by having to be prepared for an unexpected bleeding episode all the time. These difficulties exist over and above all issues and practices and taboos relating to menstruation, leave alone all the other implications on the health and well being of women and children which ought to be the concern of all medical professionals.

Yet the use of injectables throughout the world is an exercise in malpractice by medical professionals misguided by motives other than the care of their patients and by their own moral judgement about the capacity of their patients. In US itself Pediatricians have been known to use it on sexually active black adolescents even before the approval of Depo Provera for use as a contraceptive in the country. It has been used extensively on Native American populations, on the tribals in New Zealand, on immigrants in U.K. All these happen to be groups whose numbers have to be contained to maintain white supremacy.

Injections are attractive to doctors because they do not have to waste time in giving instructions to their patients and yet achieve a high rate of success in contraception. They are also an attractive option to those who are unaware of side effects. Hence there is every chance that poor women in India can be given at Jea:;t one if not two or more shots. Thus the market potential for injectables in India is mind boggling. Even if the market were restricted to the 11oda million women who undergo abortions, or to millions of women who come into contact with the health system for child birth we find sales reaching a billion dollars a year. The present sales of the company are only one tenth of this amount. Even though the market price of these injectables is fixed at present at Rs. 125/ -it is unlikely that any injection will sell at this price. Most of sale is going to be at Rs. 1000/-per injection which is the price in US and this sale would be to agencies like the US AID which are carrying out population control projects in India with the help of NGO's. At any rate each injection will bring for U.S. a profit of Rs. 900/-while it brings untold miseries to Indian women, at a time when they are being asked to tighten their belts in deference to IMP. But Indian women have said it loud and clear by their behaviour in Net-En trials that they do not want these injections (e.g. opposed to rumours blaming them for smuggling) but who is going to listen to their voices in the orchestra of multinationals which is ably assisted by all favouring coercive population control.

Women's organizations have been waging a struggle against the introduction of these technologies for many years now. We have a case pending in the Supreme Court against Net-En. We have made demands before the government based on existing misuse of these drugs. We have pointed out inconsistencies in the approach to the two formulations. Net-En has been tested for 14 years, including a dose determination study, whereas for Depo Provera only a post marketing surveillance has been ordered. Why? Our arguments remain unanswered but everyone in the establishment is questioning our right to question. When we cite research references and premise our arguments on internationally accepted norms we are supposed to be only lay people. But the doctors can mouth company promotional literature, the Drugs Controller can gloss over legal requirements, and the company can give selective information-women should only listen and accept: theirs is not to question:

This campaign is therefore a campaign for women saying that they do not wish to remain ignorant, it is for women who do not want, to hand their body over to coercive population control, for women who want to be party to decision making.