QUINACRINE STERILISATION:  ILLEGAL AND UNETHICAL EXPERIMENTS ON WOMEN‘S BODIES

QUINACRINE STERILISATION:

ILLEGAL AND UNETHICAL EXPERIMENTS ON WOMEN‘S BODIES

Newsletter Sep 1997

Amidst all the propaganda surrounding World Population Day, 11 July 1997, Saheli spoke out against the aggressive population policy of the government, and illustrated the hazards it presents to women's health by releasing a report on the Quinacrine method of chemical sterilisation of women, titled Quinacrine: The Sordid Story of Chemical Sterilisations of Women.

Tracing the history of Quinacrine from its sordid beginnings in Nazi concentration camps to its contemporary ‘status’ as a method of sterilisation, the report exposes the vested interests of racist anti-immigration groups in the First World which are leading the promotion of the method, like Elton Kessel and Stephen Mumford, who believe that Third World populations are a security risk to the First World. The report clearly establishes that all those involved in using Quinacrine as a method of sterilisation in India are guilty of flouting, medical and ethical norms and the law of the land.

Over the past 20 years or so, the Quinacrine method of female sterilisation has been used on women in 15 countries including India, Bangladesh, Chile, China, Indonesia, Philippines, Vietnam, Iran, Venezuela, Romania, Malaysia, Pakistan, Costa Rica, Croatia and Egypt. In India, its history is almost 20 years despite the fact that the method has never received official approval. Today, the majority of Quinacrine sterilisations are being carried out by the NGO sector and private practitioners all over the country. It is obvious that in the rush to promote Quinacrine sterilisations as widely as possible, the women subjected to the procedure have been completely lost sight of.

Medical Issues:

Too Many questions with No Answers

From the earliest experiments in which Quinacrine was used as an agent of chemical sterilisation of women, controversy has dogged its footsteps. The very proposal that a corrosive agent be used to create scar tissue in order to effect sterilisation has always been problematic. But over the years, the dangers that it poses to women's health have become more apparent and consequently, the voices against it much louder.

The blind procedure of instilling Quinacrine for sterilisation has been one of the first causes of concern. Problems associated with the procedure itself include possible adhesions between the anterior and posterior uterine walls, perforation of the uterus, cervical stenosis (closure of the cervix) etc.

The question of efficacy: Even the promoters of the method acknowledge that failure rates vary substantially depending upon the skill of insertion of Quinacrine, the additional contraceptive cover included, etc., and that the efficacy of the method is not yet satisfactory.

Another serious issue is that of increased risk of ectopic pregnancies. This potentially fatal possibility has also received insufficient attention. The advocates of the method brush the issue aside by saying that the rate of ectopic pregnancies is equivalent to that of IUD insertions. But the fact remains that high incidence of ectopic pregnancy was one of the main reasons for termination of the ICMR trials of Quinacrine sterilisation. In fact, in the study conducted at Lady Hardinge Medical College (LHMC), New Delhi, out of a sample of just 32 women, at least one ectopic pregnancy was reported. With approximately 100,000 women all over the world having undergone the procedure, the prospects are frightening.

Long terms effects: Three decades after its introduction, animal testing is still inadequate and hardly any data are available about the mutagenic potential (potential to cause changes in tissue), teratogenicity (effect on the foetus), carcinogenicity (potential to cause cancer) and the ability of Quinacrine to persist in the tissues. The few studies that have been done, indicate that Quinacrine can cause mutations, and therefore press the need for further testing. There are no documented studies on the teratogenic potential of Quinacrine and this lack of information has been conveniently portrayed as absence of the effect.

Even the claim of ‘no fatalities due to the method’, the basis on which Quinacrine is called the safer option to surgical sterilisation, cannot he substantiated. Three deaths due to the use of Quinacrine slurry were reported by the manufacturer of the drug. Additionally, Dr.Zafrullah Chowdhury, a renowned doctor from Bangladesh in a meeting on May 10, 1997 in Delhi reported the death of a woman due to Quinacrine sterilisation performed by him 20 years ago. He immediately sent a cable to Kessel, but received no response.

Moreover, lack of proper data maintenance may be the other reason for no ‘reported’ deaths due to the method.

Reversibility of Quinacrine sterilisation: In the developing countries where it is being promoted, poor healthcare systems, high infant and child mortality rates and an early age of female sterilisation, make the option of reversibility important. But all the available data indicate an unacceptable return of fertility rate of just 50%.

The blatant scientific inaccuracies, gross misinformation and utter irresponsibility that have characterised Quinacrine trials cannot be allowed to continue. Governments, national and international medical associations, councils and other scientific forums in India and abroad must break their silence immediately. Such medical practice directly contravenes accepted national and international codes of medical ethics, and threatens to jeopardise the life and well-being of tens of thousands of women (and possibly that of future generations as well).

Clinical Trials. Unnecessary Experimentation with Women's Lives.

The manner in which the trials of Quinacrine sterilisation have been carried out are problematic. The method of insertion changes midway through studies; combinations of drugs instilled in the uterus change dramatically (e.g. Quinacrine + ibuprofen, Quinacrine + tetracycline and Quinacrine + diclofenac) and yet, these wide variations in protocol do not deter the promoters from clubbing them together for analysis. In some studies, Depo Provera, a long acting hormonal contraceptive replaces the oral contraceptive pill as the additional contraceptive cover. Its inclusion as a contraceptive cover in a large number of trials, including the IFFH protocol is shocking because it is itself known to produce a large number of side-effects, including delayed return of fertility! And yet, such a protocol is approved and used even in a ‘responsible medical college’ like LHMC.

Informed consent is also a contentious aspect of Quinacrine trials. While most of the individual practitioners and NGOs involved in the trials publicly declare that informed consent is adequately obtained, facts speak otherwise. International guidelines on informed consent for clinical trials clearly state that consent must be taken on the basis of complete information, including possible risks, complications, side-effects, etc. The lack of information on Quinacrine sterilisation makes it impossible for this basic requirement to be fulfilled.

The guidelines of the premier research body in the country, Indian Council for Medical Research (ICMR) also specify that in a country like India, participants should be made aware of the trial by a person like a social worker, and not a doctor. This is a condition that few, if any, private practitioners or NGOs care to fulfil. At the Primary Health Centre (PHC) where LHMC carried out many Quinacrine sterilisations, neither the Chief Medical Officer, social worker nor the lady health visitor had any information of the method, the fact that trials were being conducted, or its possible consequences. Not surprisingly, one out of six women contacted had no information that she was being sterilised, much less that she was being used as a guinea pig for Quinacrine trials!

The trials of Quinacrine sterilisation are also marked by absence of follow-up. In writing and in interviews, on and off the record, practitioners involved in Quinacrine sterilisation have cited lack of funds as the reason for lack of follow-up. Dr Biral Mullick of the Indian Rural Medical Association, Calcutta, who has, by his own admission, conducted more than 10,000 Quinacrine sterilisations claims that no women have returned to him with any complaints, and that therefore, Quinacrine sterilisations should be considered as having no side- effects or complications. This plea is echoed by doctors in LHMC. Obviously, such claims are patently unscientific and totally unacceptable and reveal the fact that the people behind the promotion of Quinacrine sterilisations clearly have no commitment to women's health.

An immediate stop must be put to all such clinical trials. NGOs and private practitioners involved in the trials must immediately initiate follow-up of all the women sterilised by Quinacrine, monitor them adequately and provide quality healthcare. A basis must be evolved for providing compensation to all the women who have been subjected to the procedure.

Since Quinacrine trials are not legal in India, stern action must be taken and an example be set to deter such illegal and unethical practice.

A clear cut direction must be given to contraceptive research to ensure that it only strives towards providing safe solutions for the health and well-being of the women and men in the country.

Potential for Mass Use Massive Potential for Abuse

Ease of use -the primary argument in favour of Quinacrine sterilisations is probably the strongest argument against it. Firstly, although the procedure is technically simple, the efficacy of the method is a direct function of the skill with which Quinacrine is inserted. In spite of the, fact that the promoters of the method repeatedly stress the need for giving adequate training to experienced paramedics, ANMs, etc., practitioners like Mlullick carry out only 2-day practical workshops. Given the scale at which they project the potential for Quinacrine sterilisations, how much training will be imparted, skill developed and efficacy reached remains a matter of conjecture. This matter gains even more serious proportions when the procedure is visualised as being conducted in a single visit, with no follow-up visits to check for efficacy, complications or even side-effects.

Secondly, even according to the training manual brought out by the (Institute for Development and Training) IDT, three instillations of Quinacrine are essential in case of any bleeding during the first or second instillation, whether due to menstruation or as a consequence of the procedure itself. According to Dr Bhateja (Bangalore), bleeding during insertions is fairly common, thus necessitating a third instillation. This further belies claims that the procedure is so simple that it can be administered in a single visit.

Also, since the method of insertion and immediate side- effects like pain in the lower abdomen, etc., of Quinacrine sterilisation are so similar to that of IUDs, it is highly probable that the women undergoing sterilisation with Quinacrine actually mistake it for a Copper-T. An instance of this has already been seen in the LHMC trials.

This is precisely the ‘potential’ that promoters of Quinacrine sterilisation like Jain believe ought to be ‘exploited’. Towards this end, they have established a nationwide network for the distribution of Quinacrine pellets for sterilisation. In the bargain unfortunately, it is the women, mostly those belonging to poorer, marginalised sections who are getting exploited.

Obviously, the only way to ensure that Quinacrine sterilisations are not [mis]used on a mass scale, is to ensure that they are not used at all. Whenever instances of Quinacrine sterilisation come to light, penal action must be initiated - irrespective of whether it is been conducted by private practitioners, ‘charitable’ trusts, NGOs or government hospitals.

Population Control. Vested Interest in Quinacrine Sterilisations

The case of Quinacrine sterilisations is direct fallout of the population control lobby worldwide and the coercive population policy of the Indian government. For the First World population control lobby, it is a permanent method that can help ‘control the fertility of women in developing countries’ that they believe poses a security threat to the First World. Although the procedure of Quinacrine sterilisation is simple, it is nevertheless, controlled by the provider of the method. Thus making it a powerful weapon in the hands of the population control lobby.

Not surprisingly, some of the most active promoters of Quinacrine sterilisation worldwide are Kessel and Mumford, whose respective organisations, IFFH (international Federation for Family Health) and CRPS (Centre for Research on Population and Security), are funded by right-wing anti-immigration groups. Mumford has gone on record saying, “If the borders of the US are not closed, the US would become a Third World country”.

They argue that it is appropriate for developing countries because it can play an important role in lowering maternal mortality. But this reasoning is obviously faulty. The only way to lower maternal mortality is to improve health services, not to introduce a hazardous means of sterilisation like Quinacrine.

They also contend that the gap between developing and developed nations is so wide in terms of health and contraceptive prevalence, that it is inappropriate to apply a single standard for clinical trials to both. In its place they propose the WHO “risk/benefit criterion for tropical diseases”, i.e. that the risk of the disease is high enough to justify the use of inadequately tested drugs. In the first place, allowing the use of inadequately tested drugs even for treating diseases is itself unethical and medically unsound. Secondly, viewing reproduction as a disease to be ‘treated’ with untested drugs reveals the anti-woman bias of such research. Women's fertility is regarded here as uncontrolled, to be reined in by any means, and at any cost to the woman.

The Government of India, which was one of the first Third World governments to implement a population policy targeted at the poor, gains its legitimacy from this international lobby. Indian policy makers have always contended that population growth is the root cause of poverty and underdevelopment. They fail to recognise that unequal access to resources, and domination of a moneyed elite has been at the crux of 'under' development.

Third World governments must stand up for the health and well-being of their populations, and bring Quinacrine sterilisations to an immediate stop.

Quinacrine in the Age of Privatisation. Frightening implications.

It is the process of de-regulation of the economy and privatisation of the health sector over the last few years that is translating into the horrible reality of Quinacrine sterilisation today.

Today, it is the market that rules. Concern for peoples’ health has been replaced by concerns of cost-efficiency. Long-term studies have given way to post-marketing surveillance programmes. And government responsibilities in the health sector are being hurriedly farmed out to the NGO sector which is not accountable to anyone.

A combination of vested and commercial interests are coming together to influence the procedures and decisions of governments and regulatory authorities. In the case of Depo Provera, after the US Food and Drug Administration (FDA) sanctioned its use as a contraceptive numerous regulatory bodies all over the world including the DCI in India, granted approvals for the marketing of Depo Provera, subject only to a post-marketing surveillance. Needless to say, this only served to open the floodgates for the manufacturers and their Indian subsidiary.

The apprehension that this may be repeated in the case of Quinacrine sterilisation is a very real one.

The dismantling of health services: When high infant mortality, maternal mortality, death during childbirth, etc., are a function of the abysmal health infrastructure in the country, how can the consequences of replacing them with family planning centres or handing over the primary responsibilities to NGO programmes be anything less than disastrous? The government must evolve clear guidelines for all NGO functioning in these areas, and develop mechanisms to implement them.

If the government is to make credible its claims of being committed to the health and welfare of its people, it has no alternative but to halt the process of dismantling the health infrastructure, and strengthen primary healthcare services available in every part of the country.

Role of the Government. No Governing Role At All.

The controversy surrounding Quinacrine sterilisation in India has been marked by an interesting official response. Concerned officials like P Dasgupta, Drugs Controller of India (DCI) and BN Saxena, Addl Dir Gen, ICMR, met Saheli with righteousness, claiming that they had nothing to do with the ongoing Quinacrine sterilisations, and that they had, in fact, played very responsible roles. However, Saheli's investigations revealed otherwise.

Saxena's claim that ICMR had called off its trials due to a high failure rate and that they have had no dealings with the private practitioners or NGOs involved was belied by two important facts. Firstly, despite these dissociations, ICMR legitimised Mullick and his ‘research’ by quoting it in their protocol for Phase 2 clinical trials of Quinacrine. They also invited him to a meeting in 1992 on “The use of Quinacrine for Tubal Sterilisation”. Similarly even though Saxena behaved as though he had no knowledge of Jain, the latter was a Consultant to the ICMR study on Quinacrine. Lending such credibility to the unauthorised and illegal activities of Mullick and Jain hardly qualifies as having had nothing to do with them.

The DCI’s response to the Quinacrine situation was as much of a farce. At an hour-long interview with Saheli, he claimed that he was very perturbed with all that was happening. He repeatedly clarified that legally, Quinacrine pellets used for sterilisation are a new drug that requires new approvals. He also asserted that he had not given any approvals except for the ICMR study, and that every clinical trial, be it at a medical college like LHMC or at an NGO like Indian Rural Medical Association, needed his permission. Further, he said that without his approval, any import or manufacture of Quinacrine pellets is illegal. But he claimed that since he is ‘only a licensing authority’, all he can do is investigate the matter, after that it was upto the law enforcing authorities.

The DCI is not as powerless as he would have us believe. The Drugs & Cosmetics Act specifically empowers him to conduct investigations into matters of illegal import and manufacture of drugs, confiscate stocks and even initiate proceedings. The DCI’s investigations leave much to be desired. He revealed the bias of his investigations when he generously excused Mullick for having given the inspectors a wrong name of his suppliers’ source. When questioned about why Jain’s operations including his source of Quinacrine supplies had not been investigated, the DCI pretended he had never heard of Jain.

It is obvious that authorities like the DCI are well-aware of the trials of Quinacrine sterilisation being conducted all over the country, and that these ‘experiments with women's bodies’ do in fact, have his tacit approval.

On 30 May 1997, in response to a question raised in Parliament by Ashok Mitra, on the legality of the use/trials of the Quinacrine method of female sterilisation, Ramakant Khalap, Minister of State of the Department of Legal Affairs stated, “Approval for trials on Quinacrine pellets has not been granted to any investigator by the DCI.” Mr Khalap further stated, “There have been some reports in newspapers about dissemination-use of Quinacrine by some individual doctors, but no specific instance has been brought to the notice of the government”. This is despite the fact that Saheli raised the issue citing specific instances of illegal use of Quinacrine in several communications, including a meeting with the DCI.

Despite its official position against the trials of Quinacrine sterilisation, the government is turning a blind eye to gross violations by the promoters and practitioners of Quinacrine sterilisation.

Protests Against Quinacrine Sterilisation. Legitimate Demands.

The medical concerns compounded with the social implications of use of Quinacrine as an agent for female sterilisation has sparked off protests from women's groups all over the world and here, in India. In Calcutta, the Ganatantrik Mahila samity was instrumental in getting Mullick to abandon his trials of Quinacrine sterilisation. In Delhi, several women's groups like All India Democratic Women's Association (AIDWA), Centre for Women's Development Studies, Joint Women's Programme, Saheli Women's Resource Centre, etc., jointly staged a demonstration at Jain's clinic to protest against his role in the promotion of Quinacrine sterilisation in India. Women's groups in Bangalore held press conferences and also demonstrated outside clinics promoting the Quinacrine method. Letters of protest, urging immediate action have also been jointly sent to the DCI and the Minister of Health

& Family Welfare; but no action has yet been initiated. AIDWA and the faculty of the Centre for Social Medicine and Community Health, JNU, Delhi, have jointly tiled a public interest litigation in the Supreme Court.

The need of the hour is that immediate action be taken to prevent the continuation of Quinacrine sterilisations of women all over the country. It is essential that women’s groups and other concerned organisations and individuals strengthen their voice against such illegal and unethical medical practice.