It's Not Safe. Period!

By Anuja Agrawal

The strong opposition to implants and injectable contraceptives by women's groups in India has been almost synonymous with the women's health movement in the country and can be traced to the mid-1980s. A high level of awareness about the realities of such contraceptives has led to women's groups consistently opposing attempts made by the government to introduce the drugs into the National Family Welfare Programme. So, a feeling of deja vu is bound to be experienced by many activists, as they prepare once again to deal with the latest attempts by the government towards this end.

Required to be administered after every one to three months, injectable contraceptives, such as Net-En (Norethisterone Enanthate), DMPA or Depo Provera (Depot Medroxyprogesterone Acetate) and Cyclofem, which consists of DMPA, are promoted as highly effective birth spacing methods.

Net-En and Depo Provera were developed in the 1950s but registered by the Drug Controller General of India only in 1986 and 1994, respectively. While this allowed their use to private practitioners, the Indian government has been trying to bring them into mass use through the public health system. And despite the serious objections women's groups have taken to these attempts, the Indian Council of Medical Research (ICMR) has recently concluded a round of trials (Phase IIII) on Net-En and Cyclofem.

From the very beginning, the government and the ICMR, which has been conducting the trials, have been reticent in imparting information about the trials. In fact, it took a memorandum endorsed by 53 groups, individuals and organisations and submitted to the Ministry of Health and Family Welfare (April 2008); and continued pressure from women's groups, for the authorities to finally make information about these trials public in July this year. (The report can be accessed from: http://mohfw.nic.in/dofw%20website/Final_Cyclofem_Report.pdf and http://mohfw.nic.in/dofw%20website/Final_Net-En_Report.pdf)

Pushing a method that allows for spacing between children is high on the agenda of the government because it is one of the quickest ways to bring down birth rates in a context where fertility is highly valued, men are unwilling to use contraception and methods like sterilisation are resorted to only after many children have been born. But in the haste to push forward the agenda of population control and, may one add, the interests of the pharmaceutical companies, the government consistently overlooks the dangers these drugs pose to women.

The hazardous character of injectable contraceptives has made them controversial all over the world, including in the countries of their origin in the West. Net-En is known to cause serious disturbances in the menstrual cycle, leading to what is known in medical terms as 'menstrual chaos'. The medical reasons behind this are far more complex than a simple change in the cycle.

In the report on the trials on Cyclofem, a once-a-month injectable contraceptive, released by the Ministry of Health and Family Welfare in July, 71.3 per cent of the women who underwent the trial felt that menstrual irregularities set off by the drug was its chief disadvantage. Despite the fact that at least half of the women did not have a normal menstrual cycle, the report concludes that 'the method is highly efficacious as no pregnancy has been reported'. It is obvious that there is a vast gap between the interests of the women and those keen to establish the usage of this drug.

Some of the less obvious changes in women's bodies include the thickening of blood vessels, leading to cardiovascular diseases such as strokes and heart attacks. The injectables are also said to cause osteoporosis, weight and metabolic changes and cancer.

Given that these hormonal injectable contraceptives are a highly invasive spacing method with known side-effects, their safe administration requires continuous medical screening and supervision. And such health monitoring facilities are a far cry for the main targets of the family planning policies - the masses of poor, rural, illiterate and disadvantaged women. The ethics of promoting such a contraceptive that could have serious irreversible health consequences for the women, in a country with a very poor public health system, is far from established.

Furthermore, this method of contraception has the potential for abuse by providers and other agents having control over women's lives and bodies. This possibility of abuse becomes obvious by the manner in which the clinical trials are conducted by the state. While informed consent is a must for conducting trials for any such drugs, permission is hardly ever sought.

In the mid-1980s, on a visit to a Primary Health Centre near Hyderabad where trials for Net-En were being conducted by the Osmania Medical College, members of the Hyderbad-based NGO, Stree Shakti Sangathana were aghast to see the ground reality of 'informed consent'. The para-medics assigned the job of recruiting women for the trials readily accepted that had they informed the poor rural women recruits about the side-effects of the drugs, none would have consented to the trial. All that the women were told was 'if you take this injection, you will not have children'. Following this a writ petition was filed in the Supreme Court by Stree Shakti Sanghatana, Saheli, Chingari and seven individuals, asking for a stay on the trials, but in vain.

While the report of the recent ICMR trial states that 87 per cent of the recruits were literate, no information is given regarding the urban or rural location of these women. The trials have also used the 'cafeteria approach' in recruiting participants. This involves offering a range of contraceptives to women who have sought public health services to this end. It is not hard to imagine that under such conditions the choices that women make are heavily influenced by the manner in which the choices are offered to them. Given the manner in which state practices translate into ground realities it seems that 'informed consent' is little more than a bureaucratic safeguard for the state and has little to do with the safety concerns of women.

That Indian women need safe, effective, reversible contraceptives that they are able to control goes without saying. Effective barrier methods that do not interfere with the entire body system are the condom, diaphragm and cervical cap. Some of these have the additional advantage of being reusable for 2-3 years and of being cheap in contrast to the injectable contraceptives that are invasive, abusive and expensive. It is doubtful that even the state can really afford to provide this means of contraception through the public health system.

Despite this, the vigour with which the government has been pushing these drugs makes one suspect the real interests (read: the profit motive of pharmaceutical companies) behind these "worthy" attempts. Meanwhile, women's groups get ready to wage another prolonged battle against this ill-conceived and dubious population control measure.

(Courtesy: Women's Feature Service)