Women at risk

Quinacrine sterilisation, a practice that defies accepted international norms, continues in India.

OVER the last several months, the issue of chemical sterilisation of women in India with quinacrine has been a matter of controversy (Frontline, May 2, 1997). In West Bengal, where Dr. Biral Mullick admits to having sterilised more than 10,000 women over the past two decades, activists of the Ganatantrik Mahila Samiti led by Professor Malini Bhattacharya forced the West Bengal Government to call a halt to the "trials" and initiate an enquiry into Dr. Mullick's practice. In Bangalore, where the Contraceptive and Health Innovation Project (CHIP) of Dr. Pravin Kini and Dr. Sita Bhateja hopes to sterilise 25,000 women over the next two years (having so far sterilised close to a thousand), a coalition of health and women's groups have held demonstrations. On May 2, women's groups held a huge demonstration in New Delhi outside the clinic of Dr. J. K. Jain, former member of Parliament of the Bharatiya Janata Party (BJP) and the kingpin of the network for the conduct of these trials in the country.

The Government of India denies granting approval to quinacrine as an agent for female sterilisation. In Parliament, in response to questions tabled by Dr. Ashok Mitra, Minister of State for Law Ramakant Khalap stated that the Government was aware that the World Health Organisation (WHO) had specifically recommended that pending further studies, trials with quinacrine on human populations be stopped. He said: "Approval for clinical trials of quinacrine pellets has not been granted to any investigator by the Drug Controller General of India." He also stated that "no drug manufacturer has been granted licence to manufacture quinacrine and the drug is not imported." Meanwhile, the Indian Council of Medical Research (ICMR), in published statements, condemned the practice.

Despite these efforts, some doctors in the private sector and some non-governmental organisations (NGOs) are continuing the trials, which defy accepted international norms for the conduct of clinical trials. Indeed, reports indicate that they are spreading. It is in this context that the All India Democratic Women's Association (AIDWA) and the faculty of the Centre of Social Medicine and Community Health of the Jawaharlal Nehru University approached the Supreme Court with a public interest petition seeking an immediate - and enforced - ban on the trials.

THE quinacrine trials raise a host of issues regarding the safety of the particular method of sterilisation, the methodology used in assessing this, and above all the ethical issues concerning the trials that have been raised around the world. The sponsors of these trials, which are said to be going on in 19 Third World countries, are two U.S. doctors: Dr. Elton Kessel and Dr. Stephen Mumford. They are funded by a private foundation and same individuals linked with the Federation for American Immigration Reform, a Washington-based group lobbying for restricted immigration into the U.S.

Kessel and Mumford responded to a number of arguments put forward by their critics when they spoke to the Committee for Women, Population and Environment (CWPE) based at Hampshire College, Massachusetts. However, their response left many questions unanswered.

One major criticism of quinacrine sterilisation pertains to issues of safety. Kessel maintained that risk-benefit assessment, the cornerstone of clinical trials, "favoured the use of quinacrine sterilisation in populations where maternal mortality was high and contraceptive prevalence low." With reference to the WHO's recommendations observing that quinacrine may be cancer-producing and thus warranted further studies, he argued that toxicologists maintain that the duration of exposure is the most critical element when humans are exposed to carcinogenic or mutagenic substances. Laboratory tests indicate that quinacrine causes mutations or changes in cells. (While all substances that cause such changes are not cancer-causing, conventional scientific norms dictate that they should be excluded before human trials are undertaken.) Kessel also said that while there is a lack of data on the long-term effects of quinacrine, the small number of insertions minimises exposure.

Mumford, on his part, said that quinacrine, as an anti-malarial drug, has been used orally "in higher doses, over a longer period of time, on a larger population" with little deleterious effects.

Similar argument have been put forward by advocates of quinacrine sterilisation in India also. What these arguments miss is that reproductive causes account for only a small proportion of deaths among women in the reproductive age-group in India. Indeed, these causes do not account entirely or even largely for the high maternal mortality rate in the developing countries; the majority of deaths occur owing to diseases of poverty, primarily anaemia, undernutrition and infections and lack of access to health care facilities in the event of complications of pregnancy. Contraception or sterilisation alone thus has an extremely limited role to play in the decline of maternal mortality. If this were indeed the case, countries such as Brazil and Indonesia (the latter has a particularly aggressive family planning programme), which have witnessed remarkable declines in birth rate, should also have experienced declines in the maternal mortality rate. This has not happened.

The argument that quinacrine was used extensively as an anti-malarial drug and that therefore as a sterlising agent it is without danger, is equally specious. Quinacrine was primarily used as an anti-malarial drug only till such time as better alternatives such as chloroquine became available. Further, the extremely high mortality rate for malaria at that time far outweighed the risks due to quinacrine. Unlike the case with malaria then, there are alternative forms of terminal contraception today such as tubectomy for women and vasectomy for men.

Maintaining that sterilisation by the quinacrine method was extremely safe, Dr. Kessel claimed that there were no deaths in the 40-day period following the insertion of quinacrine in 100,000 women. There are, however, a number of problems with such a facile presentation of data. Included in this huge number are presumably the 31,781 women sterilised in Vietnam between 1989 and 1992. Following WHO recommendations the Vietnamese Government called a halt to the trials.

The New York-based Association for Voluntary Surgical Contraception (AVSC) found serious scientific flaws in the Vietnamese study. The data on side-effects and failure rates, for instance, were not derived from the full sample of women but from much smaller sub-sets among them. The findings from these varying sub-sets of the study population were then extrapolated to the entire sample. For instance, failure rates were calculated based on only a third of the total population. Again it is unclear as to how the ectopic pregnancy rate was calculated: in one province, two out of nine pregnancies were ectopic - a hugely unusual occurrence. Yet, according to the AVSC, "this troubling finding is not mentioned in the analysis of ectopic pregnancies." The AVSC thus maintains that "it is not possible to conclude that quinacrine pellets are a safe and effective non-surgical method of female sterilisation."

In addition, given the fact that a variety of protocols of dosage, number of insertions and adjuvants have been followed, it is not methodologically legitimate to calculate mortality rates from data obtained by diverse and often unspecified methods pooled together. Indeed, it has been revealed that three known deaths due to quinacrine sterilisation were not reported in these findings. This further undermines the credibility of the data.

Questions have also been raised about the standard cut-off date of 40 days after surgery being used to determine mortality rates in the case of quinacrine sterilisation. Potentially fatal ectopic pregnancy can occur as long as a woman sterilised with quinacrine is in the reproductive age-group. The use of this cut-off date thus does not constitute a long enough period to assess the mortality risks associated with the method.

WHILE Dr. Kessel said that records are being maintained and that cases are followed up long enough to establish mortality rates, Dr. Mumford acknowledged that they have no resources for follow up. Indeed, Dr. Bhuiyan in Bangladesh and Dr. Mullick, in published interviews, admit their failure to follow up cases. Similarly, in Pakistan where women were, according to a participant, "picked off street corners", there were no follow up efforts. It is, therefore, not surprising that the data presented by Kessel are met with scepticism.

Kessel stated that government approval for quinacrine sterilisation is "desirable but not essential" since guidelines from the Food and Drug Administration (FDA) of the U.S. "permitted off-label use (that is, the use of drugs approved for another purpose) under medical supervision." The training literature for quinacrine sterilisation, however, states that one of the advantages of the method is that it "can be provided by many types of trained health care workers, not just doctors." Indeed Dr. Mullick is on record that he has trained "hundreds of health workers" to use quinacrine for sterilisation.

The argument that approval for quinacrine for the treatment of other diseases precludes the need for a licence to use it as an agent for female sterilisation is baseless. Under the Drugs and Cosmetics Act of India, a new drug is defined to include "a drug already approved.... which is now proposed... with new claims, namely, indications, dosage form and route of administration."

The Drug Controller of India has only granted approval for the use of quinacrine in tablet form, orally for the treatment of malaria, giardiasis and amoebiasis. The drug is thus not approved for female sterilisation. It has not received this approval from any authority anywhere in the world, including the U.S. The FDA recently issued a warning on the Internet where quinacrine was being promoted as a method of self-sterilisation. The warning noted that the kit advertised "uses pellets of quinacrine hydrochloride, an unapproved drug which can cause ectopic pregnancies, abnormal pregnancies and permanent damage to a woman's reproductive organs."

Despite the blatantly illegal nature of this practice, some of India's leading doctors continue to take part in this dubious enterprise. At the World Congress of Gynaecology and Obstetrics in Copenhagen in August 1997, a special session on quinacrine sterilisation was organised by Dr. Kessel. It was chaired by Dr. J. K. Jain. Prominent doctors from India making presentations included Dr. Biral Mullick, Dr. Ashi Sarin, Dr. Pravin Kini, Dr. Sita Bhateja and Dr. Ajay Ghosh.

Given the globalised, liberalised nature of the Indian state today, wherein independent institutions of health research established by the state are being systematically undermined, it is not surprising to witness yet another instance of Third World women being subjected to such experiments. Notwithstanding the commitments made at the United Nations Conference on Population and Development in Cairo in 1994 to enhance women's health and reproductive rights, the impunity with which U.S.-based NGOs are violating human rights in countries of the South shows up the need to monitor health systems that have been rendered vulnerable by the incorporation of the Indian economy in the global market. It is ironic indeed that this is being done in the context of neo-liberal rhetoric on reproductive health rights.

Dr. Nalini Visvanathan is a U.S.-based public health researcher and Dr. Mohan Rao is on the Faculty of Social Medicine, Jawaharlal Nehru University, New Delhi.