Indian women could not be used as guinea pigs…” Justice A.S. Anand, when he pronounced these words in last month’s judgement banning the use and sale of Quinacrine for female sterilisation, was only reiterating a basic article of human rights. Yet the fact that he had to do it at all is an eloquent comment on the manner in which research trials are being conducted.
Justice Anand’s judgement in the Quinacrine case has been widely welcomed by women’s groups. But will it work? Vinita Bal, a spokesperson for Saheli, a Delhi women’s group, is sceptical: “The judgement upheld the recommendation of the Drug Advisory Board and that’s good news. But whether it will be implemented is a different issue altogether.” Her doubts are valid.
Researchers in fertility control methods adopt the most cavalier attitude to the human, particularly female, body and get away with it. The rationale seems to be that in the larger cause of controlling the country’s population, a few shortcuts can be winked at.
Quinacrine,itself, was a particularly gross instance of this. A derivate of acridine orange, a yellow dye, it was used to treat malaria decades ago. However, it was also discovered to have a corrosive action that causes sclerosis, or the fusing of adjoining tissue surfaces. This led doctors to use Quinacrine pellets to create a blockage in the fallopian tubes of the uterus for purposes of sterilisation.
But given its high failure-rate and the potential dangers of this method, ranging from pelvic infections to the possible perforation of the uterine wall, no responsible medical authority had ever approved of it. Even the Indian Council of Medical Research (ICMR) had abandoned its chemical trials in 1993-94 because of the high incidence of ectopic pregnancies in the cases it handled. Yet, this did not prevent doctors in this country from sterilising over 40,000 women in India using Quinacrine. They justified it in the name of research, claiming that the dangers were far outweighed by the advantages, since it was cheap– just a few rupees per insertion and easy-to-administer.
In fact, if women’s groups and health activists had not raised an alarm, doctors like J.K. Jain in Delhi or Pravin Kini and Sita Bhateja in Bangalore would have persisted with Quinacrine sterilisations. Calcutta’s Dr Biral Mullick, known to be one of the oldest practitioners of this method, even upbraided members of the Ganatantrik Mahila Samiti who had protested against his sterilisations in August 1996 and is believed to have angrily asked: “What do you mean by monitoring women patients? If they have problems, they will come to me.” Similarly, in Delhi, when Dr J.K. Jain, a general surgeon, and one-time BJP MP, was interviewed by members of Saheli, he claimed that by promoting Quinacrine he was only performing a “a national service”.
Last July, the All India Women’s Democratic Association, and the Centre of Social Medicine and Community Health, Jawaharlal Nehru University, decided that the only way to challenge such doctored common sensewas to file a public interest litigation against the Indian Government. Justice Anand’s judgement, quoted earlier, was given in response to this petition.
But the Quinacrine story is a familiar one. Right from the 1960s, when Lippes loops were casually inserted into women living in rural areas with no access to medical supervision, the family planning programme in India has witnessed many unorthodox, even unethical, fertility control practices.
In the mid-70s the contraceptive injectable, Depo Provera, composed of the hormone progestogen was suspected to be carcinogenic and was banned in the West. The injectable prevented ovulation by causing the thickening of cervical mucus and slowing down the rate of travel of the ovum down the fallopian tubes into the uterus. The controversy surrounding it forced the ICMR to shelve its proposed experimental trials using Depo Provera, but the drug itself was not banned.
The ambiguity in the official position led, predictably enough, to great confusion. When a Mumbaidoctor, C.L. Jhaveri, was refused a licence to import the drug and filed a case against the Drug Controller and the Union of India, women’s groups and the Medico Friends Circle became co-respondents to the Government’s petition in February 1985 and argued against Dr Jhaveri’s use of the drug as a family planning method. The court ruled against Jhaveri using Depo Provera on human beings.
It wasn’t long before Net-en, the bi-monthy injectable introduced by the German pharmaceutical Schering AG, created waves. This drug worked by inhibiting the production of gonadotropin, a hormone secreted by the pituitary gland which prevents ovulation. The ICMR began conducting trials on the drug, beginning in August 1984. The fact that the women who were undergoing these trials were not properly briefed about the possible side-effects of this drug, like heavy bleeding and hypertension, goaded the Stree Shakti Sanghatana of Hyderabad and Saheli to file a joint writ petition in the Supreme Court in 1986, demanding a halt tosuch trials. Their argument was based on Article 21, or the right of a woman to a life with dignity: “Net-en trials are being conducted without the informed consent of participants. They have violated the ICMR’s own stated criteria of ethics and also transgressed the Helsinki Declaration on Human Experiment to which India is a signatory.”
In the early ’90s, came the Norplant trials. The women who had participated in them later went on record to state that they were forced to continue with Norplant against their wishes. Consisting of flexible tubes or rods filled with the synthetic hormone of progestogen, Norplant is implanted, under the skin on the inside of a woman’s upper or lower arm, through a minor surgical procedure that requires local anaesthetic and a small incision. The hormone is slowly released over, say, a period of five years.
While the medical fraternity argued that since only very small quantities of the hormone was released, Norplant was less harmful than many other hormonalcontraceptives, women activists pointed out that in a situation where basic health care is practically non-existent, and screening and monitoring systems totally absent, using such devices posed a distinct danger.
What is at issue here is ordinary people’s right to safe contraception. Whether as participants in research trials or as users of medical technologies, people need to know how the drugs and surgical interventions they are being subjected to affect their bodies.
Mohan Rao of the JNU’s Centre of Social Medicine and Community Health and a co-petitioner in the Quinacrine case, believes that this trend of imposing controversial fertility-control technologies on target groups will only get worse: “With the Government increasingly withdrawing from the health sector, NGOs, not accountable to any authority, will trade on people’s ignorance and push controversial fertility-control technologies in the name of population control,” he predicts. Ashish Bose, demographer and emeritus professor, Institute ofEconomic Growth, agrees: “Of late, a lot many donor agencies have entered the arena. These people have more money than ideas.”And, it seems, even less sensitivity than ideas.