Withdraw decision to allow injectable contraceptives, they increase risk of women and their partners to be infected with HIV

contraAround 70 NGOs, people’s organizations and activists – including Jan Swasthya Abhiyan, Sama Resource Group for Women and Health, Action India, Saheli, All India Democratic Women’s Association, Delhi Science Forum, Mahila Sarvangeen Utkarsh Mandal Pune, All India People’s Science Network, Bharat Gyan Vigyan Samiti and National Federation of Indian Women – have strongly protested against the approval to introduce injectable contraceptives in the National Family Planning Programme (NFPP). Working in the field of medicine, public health and women’s rights, they letter have have written a letter to Jagat Prakash Nadda, Union Minister for Health and Family Welfare, condemning the government move. Excerpts:

We are extremely disturbed by the news report published in the Times of India (dated September 16, 2015) that the Union Health Ministry has approved Depo Medroxy Progesterone Acetate (DMPA) for use in the National Family Planning Programme (FPP).

It may be re-called that following a Supreme Court case filed in 1986 by women’s groups regarding serious problems with injectable contraceptives like Depo and Net-En, the Court directed the government to monitor safety issues in use of injectable contraceptives but did not ban its use. While they are available in the private medical sector, the Drugs Technical Advisory Board (DTAB), the highest decision-making body on technical matters in the Ministry of Health &Family Welfare, in 1995 held that Depo-Provera is not recommended for inclusion in the FPP.

In its meeting in February 2015, the DTAB once again refused to give its nod to the recommendations of the Department of Family Welfare for the introduction of Depo-Provera in the FPP. At this meeting the DTAB noted that “it has long been known that Depo-Provera causes bone loss, it has recently been discovered that the osteoporotic effects of the injection grow worse, the longer Depo-Provera is administered and may remain long after the injections are stopped, and may be irreversible”. In view of this it recommended that the Department examine the matter in consultation with the leading gynecologists of the country for examining the effects of the use of the drug (Depo Provera) under the NFPP of the Government of India.

However, we are shocked that the DTAB has now recommended DMPA use, opening up the way for the Ministry to introduce it in the FPP. Given that the safety and other concerns regarding Depo Provera remain and have not been resolved, we wish to know the basis and the rationale for this sudden granting of approval by the DTAB.

Depo Provera has long been the subject of considerable medical controversy. Its known side effects include prolonged and irregular bleeding, amenorrhoea, suppression of immune response, loss of bone mineral density in young women, significant weight gain, depression, and loss of libido among many others. In fact, the US FDA in 2004 asked Pfizer to insert a black box warning on Depo’s label highlighting the loss of bone density associated with the drug. Another problem with Depo-Provera is its possible effect on breast feeding infants. One study from Thailand suggests that Depo-Provera in breast milk lowers immunity in children, making them more susceptible to illnesses like diarrheal diseases that kill more than five million children in the world annually.

For over a decade now, medical studies have provided compelling evidence that Depo-Provera increases the risk of women and their partners becoming infected with HIV. A growing number of contraceptive researchers and epidemiologists are now questioning the wisdom of Depo Provera’s continuing promotion, especially in populations at high risk of HIV. They have spearheaded a petition to get the US Food and Drug Administration (FDA) to make Pfizer, the manufacturer, include the following warning in prescribing information: “Depo-Provera Cl may increase the risk of HIV infection (AIDS). Patients at risk of HIV infection (AIDS) should be counseled to only use Depo-Provera Cl in combination with an HIV-prevention method.” Sub-Saharan Africa is the region of the world where most of the 16 million women living with HIV are located. Yet this seems to be of little concern to Sayana Press, promoters of DMPA, who are moving full steam ahead, not only there but in South Asia.

What is equally important is to note that continuation rates with Depo have been rather low, as indicated by pilot programs undertaken by agencies such as the Population Council (around 50 per cent in the first six months of use and 23 per cent at end of one year). This could well be due to the serious problems experienced by the women choosing to use this injectable.

Women’s organizations and health groups have consistently opposed the introduction of injectables and implants since many years. They have repeatedly raised concerns regarding serious health risks and adverse effects of Depo. The use of Depo-Provera needs continuous medical follow-up by health staff in a well-functioning health system. Without a good health infrastructure, there are risks that the women are not given enough information to make an informed choice of contraceptive method. The health budget has stagnated while the salary and medicine costs have gone up. Health human power shortages are acute; the shortage of specialists trained in Obstetrics and Gynaecology is even more severe.

Hence, the health system remains incapable of dealing with the safe delivery of a contraceptive requiring intensive medical support. The few NGOs and other international agencies arguing in favour of Depo, especially for poor and powerless women to exercise control over their own bodies and lives do not seem to be concerned that while widening the choices available to women, the risk of morbidity and mortality associated with unwanted pregnancies must always be weighed against the side effects of contraceptive methods on the women themselves. Nor is the medical infrastructure adequate to ensure the screening and follow-up care this method requires if it is to be safe.

While there is no doubt that women need contraceptives to exercise their right to birth control, however, safety needs to be the priority while taking decisions to adopt contraceptives.

In the light of all of the above concerns, we urge the following:

  • The government must immediately reconsider its decision to introduce the injectable DMPA in the Family Planning Programme
  • Convene a meeting of health and women’s activists who have been raising concerns about the safety of injectable contraceptives
  • Explore non-invasive safer options for contraception for women
  • Increase awareness raising campaigns and availability of condoms for men
  • Accord utmost priority to improving health services in general, including of FPP

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