The Case Against NET-EN

Souvenir 1988

Population control is one of the most aggressive economic and health policies pursued by the Indian government; economic policy because overpopulation is considered to be the chief cause of poverty in India, and health policy because the birth of too many children at frequent intervals is considered the major cause of mortality among women in the reproductive age group. Dissatisfied with the earlier method of contraception (the pill, IUD, etc), which relies on the users of ‘motivation’ for their consistent use, and with barely 10 years left for achieving a ‘two child’ family by 2000 AD, more and more emphasis is being placed on developing and promoting long term irreversible contraceptives, whose major recommendation often is that they do not need to rely on the users’ compliance. These contraceptives, with their long duration of action, are necessarily invasive, and therefore highly hazardous. Since women have been targets of the population control programme from its very inception (except during the brief period of the Emergency), the newer methods being developed, such as NET-EN, Norplant and the anti-fertility vaccine, are all methods aimed at controlling the fertility of women.

Although concern about the promotion of hazardous contraceptives had been raised by several autonomous women’s organisations and drug action groups off and on in the past, it was only in 1985 that a concerted effort was made to check this trend. In mid 1985, the local dailies in Hyderabad carried the news that Phase IV trials with NET-EN were to be launched at the Patterncheru Primary Health Centre, and the event was to be attended by the District Collector. Some members of the Hyderabad based women’s organisation, Stree Shakti Sanghathana, on attending the inaugural ceremony, were outraged to find that the women at the camp had little or no information about the contraceptives they were to receive, and all the norms regulating the trials on human population were being violated. Suspecting that the same situation prevailed in all the other centres involved in these trials, it was decided to raise the issue at the national-level, through a writ in the Supreme Court.

What followed was a lengthy period f discussion and research. Several more people and organisations became interested, and being in Delhi, Saheli took on the responsibility of co-ordinating the work.

When we initially started work on the petition, we were not prepared for the gigantic conspiracy that seemed to surround contraceptive research in general and NET-EN in particular. For instance, after being withdrawn from the market in 1971 because pituitary and breast nodules were found in rats treated with NET-EN, why was it reintroduced into the market ten years later? Even though it has been established that NET-En passed through breast milk, and animal studies show an adverse effect on breast fed infants, on what basis is the World Health Organisation and the Indian Council of Medical Research confidently asserting that breast-fed infants are not at risk? Why was NET-EN (a progesterone) being promoted as a safer alternative to estrogen contained contraceptives (estrogen increased the chances of blood clots and heart attacks) when by the early ‘80s it was clear that progestins caused their own set of heart problems which could be as serious? As we delved deeper and deeper into the medical literature, it became clear that the contraceptive NET-EN had not been tested adequately either in the animal or human populations. (If any of the animal species tested with NET-EN showed adverse effects, the findings were ignored and the animal species set aside as being an unsuitable model). The little information that was actually available, raised more questions than it set out to answer. By now, we realized that if NET-EN had been a general drug and not a contraceptive, it would not have been approved by any Drug Control Authority, however lax.

In April 1986, we filed the NET-EN petition in the Supreme Court against the Indian Council of Medical Research, the Ministry of Health and Family Welfare, The Drug Controller of India, and the State Government of Andhra Pradesh. He signatories to the petition were three women’s organisations, five doctors and a journalist. In September 1986, the Indian Council for Medical Research and the State Government of Andhra Pradesh filed their counter affidavit, baldly denying our claims. We filed our rejoinder in March this year.

Recognizing that by focussing our energies on the court case, the debate could easily get confined to the court room, simultaneously we attempted to disseminate information about NET-EN as widely as possible. We circulated information to a wide network of women’s organisations, health groups, science groups, consumer groups and health professionals, all over India. To reach women in rural areas, we prepared an exhibition of posters on NET-EN which we displayed at a rural Mahila Mela in Rajasthan. We also had a series of discussions with health activists and women from bastis in Delhi.

The court case itself generated debate, and the issues involved received considerable attention in national and international journals, magazines and newspapers.

At a seminar organised by us for women activists, health personnel and other interested individuals, on ‘Population Policy and its Implications for Women’, in 1986, several critical questions were raised:

· Why is the ICMR experimenting with hazardous preparations such as vaginal rings, sub-dermal implants and the anti-pregnancy vaccine, which are all female methods of contraception? Why are no contraceptives for males being developed?

· Why is research being done on long acting invasive methods of contraception and no attempt being made to improve the existing non-invasive methods such as the condom, diaphragm, cervical cap, etc? Is it because the long acting methods enable the State to have greater control?

· If women’s health is really the concern of the policy makers, as they constantly claim it is, then why do we have a target-oriented Family Planning Programme which leads to so much abuse of the Family Planning Methods?

The seminar concluded that the new trends in the FP policy posed a serious threat to the health and personal liberty of women who are the targets of this programme.

The petition in the Supreme Court is against just one hazardous contraceptive – NET-EN. The ICMR and other research bodies are in the process of completing the formalities for introducing even more hazardous contraceptives. (Norplant, Anti-fertility vaccine, etc) It is not feasible to file a fresh petition each time a new contraceptive is developed. Even if it were possible to do so, one cannot be sure of the outcome. The judges feel they cannot assess the mass of technical information and tend to give more weightage to the evidence of the so-called impartial scientific bodies. It is therefore imperative that we demand a change in the FP policy. This can be achieved if the issues are raised in all feminist, health and human rights fora.

BOX:

The Case against NET-EN, as filed in the Supreme Court raises six areas of concern

· NET-EN disrupts the finely tuned cyclical integrity of the natural hormonal balance in the woman’s body. This causes menstrual chaos, resulting in the depletion of iron stores in an already anaemic population; ameorrhoea, which could be a pre-cancerous condition of the uterus; disturbs the higher function centres, resulting in changes in temperature regulation, hunger and feeding, thirst, sleep, sexual activity and mood. The morbidity thus added by the use of NET-EN is therefore considerable to the women population, which already suffers from several health problems.

· Long term risks with the use of NET-EN are still not known. These include cancer risk to the woman user and effect on her progeny (congenital defects, spontaneous abortions, etc) Risk to progeny could be either due to drug exposure in the uterus, or through breast milk. In the absence of adequate information on these aspects, it is callous to subject millions of women and their progeny to this drug.

· Although NET-En is being promoted as a special method, it does not fulfil the criteria of a spacing method, i.e. it is unacceptable to women because of menstrual disturbances; it cannot be used by women who are breast feeding because the drug is passed in the milk; the return of fertility after discontinuing with the drug is uncertain; it cannot be used at the peripheral health centres because specialisation skills and tests are needed to screen acceptors.

· Women recruited for NET-EN trials have not been given adequate information regarding the hazards of this drug and their informed consent for participating in the trials has not been taken. In fact, by recruiting women from the poorer sections, the concerned authorities are taking advantage of their economic vulnerability.

· Considering that women need to be screened carefully, that the injection itself must be administered in a very careful manner, and that there is need for close and regular follow-ups, NET-EN cannot and should not be introduced as part of the mass family planning programme. The infrastructural facilities in peripheral health units are inadequate to detect or handle emergencies arising out of NET-EN use.

· In the current target oriented family planning programme, there is a grave possibility that NET-EN will be administered indiscriminately, without the knowledge of the women concerned. Since the potential for abuse is great with an injectable contraceptive, NET-EN should not be used as part of the mass FP programme.