For the past three decades women’s groups in India have been fighting against the inclusion of Depo-Provera, the injectable contraceptive into the country’s family planning programme. With signs of a renewed interest from the government on the inclusion of this drug, it is imperative that activists discuss and articulate their views on this issue of grave importance to women and public health
By Sarojini N and Priya Ranjan
After the London Summit- FP2020, a renewed interest is being witnessed, amongst funders, foundations, NGOs, UN agencies and Ministry of Health and Family Welfare (MOHFW), in Depot medroxyprogesterone acetate (Depo), an injectable contraceptive.
Many international organizations/agencies/foundations are advocating that the Government of India introduce Depo-Provera (the brand name of DMPA) into the national family planning programme.
In fact, the Ministry of Health and Family Welfare (MOHFW) had recently recommended Depo’s inclusion in the Family Planning Programme (FPP) ostensibly to provide an alternative choice to women seeking to plan their families. However, the Drugs Technical Advisory Board (DTAB), the highest decision-making body on technical matters in MOHFW, has refused to give its nod on the recommendation of the department of family welfare for the introduction of Depo-Provera in FPP and has asked the Department to “examine the matter in consultation with the leading gynaecologists of the country for examining the effects of the use of the drug (Depo Provera) under National Family Planning Programme of the Government of India”.(Pharmabiz April 16, 2015).
There are a few NGOs and other international agencies who are working on issues related to Family planning, contraception and reproductive and maternal health that are in favor of Depo. They argue that injectables and implants provide better contraceptive options particularly for the poor and powerless women to exercise control over their own bodies and lives (since the contraceptive is injectable, neither husbands, nor in-laws would come to know of the contraceptive method used by women). Those who are in favor of injectables are also of the opinion that women should have freedom to choose the kind of contraceptives they want. They believe that the idea of offering injectables as a method of contraception is to widen the choices available to women and that the risk of morbidity and mortality associated with unwanted pregnancies must always be weighed against the side effects of contraceptive methods. There are also suggestions to introduce Depo initially at district level assuming it is equipped to ensure the screening and follow-up care for this method.
On the other hand, many women’s organizations and health groups have consistently opposed the introduction of injectables and implants for many years. Women’s groups have raised concerns regarding serious health risks and adverse effects of Depo on women along with the unequipped public health system to ensure the screening and follow up at all levels. Several studies have shown that the use of Depo leads to loss of bone density in young women. In fact, the US FDA in 2004 asked Pfizer to put black box warning on Depo’s label highlighting potential medical complication associated with the drug. The findings of more recent studies conducted in Africa demonstrated that the use of Depo-Provera may also increase the acquisition risk of HIV infection.
There are also other proven measures to reduce maternal (and infant) mortality besides preventing pregnancy.
Unfortunately, there has been hardly any discussion/debate on injectables and implants in recent years. It is important to speak to women who have used and are using Depo as a method of family planning. It is available in the private market and used extensively in regions such as Jharkhand. Data from this experience needs to be compiled and analysed. From anecdotal evidence it seems that the discontinuation rate appears to be high among the users of Depo. At the same time we should clearly articulate the other alternatives, as women do need safe contraceptive methods.
Given the fact that there is a renewed attempt to introduce it in FPP, it is imperative to discuss and articulate our views on this very important woman’s and public health issue.
History of Depo-Provera
Depo-Provera (Depo) is a synthetic hormonal drug with medroxy-progesterone acetate (MPA) manufactured by Upjohn Pharmaceuticals which was later acquired by Pfizer. In 1963, it was sold in the US as a treatment for incurable, inoperable cancer of the en-dometrium (lining of the uterus).
In 1967 Upjohn decided to sell DP as a long-term contraceptive and applied to FDA (Food and Drug Administration) authorities. As per news reports, two animal trials – mandatory for FDA approval—a seven-year long beagle dog trial and a ten-year long rhesus monkey trial began. DP was granted a conditional approval for use by those who could not use other methods of contraception.
In 1973 the FDA’s Advisory Committee on Obstetrics and Gynaecology recommended the Depo-Provera drug, DMPA, for use as a contraceptive.
In 1975 the FDA convened a joint meeting of its Advisory Committees on Obstetrics and Gynecology and on Biometric and Epidemiologic Methodology. The Committees in turn jointly constituted a sub-committee task force which, after open hearings, recommended that the FDA approve Depo as a contraceptive.
Following the implication of Depo in cervical cancer, the US Congress objected and in March 1978, the FDA stayed the issuing of the license to sell DP as a contraceptive in the US. By then Upjohn had already begun selling the drug especially in third world countries with a large amount of sales going to the International Planned Parenthood Federation (IPPF) which had begun distributing it in 12 countries, the World Health Organisation and the US Agency for International Development (AID).
The irony is that even before the US authority could register the drug, it was being used extensively in third world countries, or rather being ‘tested’ on large numbers of women
Following an appeal from the management, and a groundswell of opinion against the injectable contraceptive that in July 1979 the FDA appointed a Board of Inquiry. TheUS FDA was forced to hold a public enquiry, only the second time in its history, to decide on whether the drug should be licensed. Its verdict held that there was insufficient material to show that the drug was safe. This Board convened in January 1983 and a report was issued in 1984. The report stated that there was not enough evidence to prove that the drug was safe for women as a long term contraceptive.
The US FDA did not license Depo for use as a contraceptive until 1990. This was in the context of the resurgence of anxiety about the population explosion especially in the Third World and the fact that the latter had increasingly become cautious about licensing a drug which had not been registered in the country of origin.
Depo Provera had reached India in 1974 and the Indian Council of Medical Research trials had begun testing the contraceptive. However, the trials were soon cancelled apparently due to women dropping out of the trials and so there was no trial report put out. By 1984, the drug was said to be used in a few health projects, though as per news report in the EPW “several professionals and professional bodies have been, after a long silence on the subject, issuing statements urging the government to allow Depo in the Indian market.”
The early 1980s saw women and health groups in India taking a stand against contraceptives especially in the government family planning programmes. In late 1993, India decided to issue Upjohn with the license to market DP for contraceptive use which would be manufactured and sold by Max India. Depo-Provera was approved without the mandatory Phase 3 trials. It was to be sold on prescription, individually, not through the family planning programme. Its price was reportedly, Rs 120 per dose. The company issued a statement saying that they would be doing a Post Marketing Surveillance but they would be doing this on their own without the involvement of the ICMR or the Indian drug control authorities.
In 1993, women’s groups filed a case in the Supreme Court against the introduction of injectable contraceptives into the country’s family planning programme. The court ordered a stay on the drug’s use on the grounds that there was insufficient research on its suitability for Indian conditions.
In 2000, a study conducted by SAMA Resource Group for Women and Health (Unveiled reality: a study of women’s experiences with Depo-Provera, an injectable contraceptive. SAMA, Delhi, 2000) found that in Delhi at public health centers, women were being given injectable contraceptives without informed consent which meant they were not informed of the adverse side effects of the drug.
The potential of abuse, the incomplete mandatory trials and lack of control of government agencies over pharmaceutical agencies that sell the contraceptives were some of the grave concerns of the women, health, and human rights groups. Women’s groups again met with officials from the Health Ministry in 2000 to fight against the government’s intention to incorporate the drug into its family planning programme, though allegedly it had already begun doing so in Uttar Pradesh.
In 2005, a national workshop in October 2004 organised by Parivar Seva Sanstha along with the government of lndia, UNFPA and the Packard Foundation through the Population Foundation of India. The topic at hand was the introduction of injectable contraceptives. Following this a letter signed by 62 individuals and health organisation in India wrote a letter to the then Union Minister for Health and Family Welfare – A Ramadoss. An article based on the letter appeared in the Indian Journal of Medical Ethics written by N B Sarojini of SAMA and Laxmi Murthy of Saheli with title ‘Why Women Group’s Oppose Injectable Contraceptives.
The article stated that the relaxation of Indian drug regulations and the introduction of long-acting hormonal contraceptives such as injectables (Net En and Depo Provera) and sub-dermal implants (Norplant) would cause irreversible damage to the women and their progeny’s health.
According to the article, “administration requires ruling out contra-indications and close monitoring over long periods. Such monitoring is totally absent in this country. Poor women who visit government hospitals where injectables would be offered in the family planning programme would be treated as ‘living laboratories”.
The article pointed out that a five year post-marketing surveillance study was to have been done in place of the final stage of clinical trials. However, this report has not been made public. As per the article, several factors were revealed studying the post marketing surveillance study which had failed to address several serious concerns such as the potential side-effect of bone density loss and subsequent increased risk of osteoporosis, cancer risk, assessment of return of fertility, the effect of Depo on progeny conceived immediately after stopping the use of the drug, amenorrhea, irregular bleeding, generalised weakness and lethargy, migraine headaches, pain in the abdomen and severe abdominal cramps were relegated as “non-serious” medical events by researchers. The article stated that after scrutinisng many studies which favoured the use of DP, women’s groups have found no “scientific/medical justification for the introduction of injectable contraceptives like Depo-Provera or Net-En.”
The above information about the history of Depo Provera was aggregated by the FI Team from the following articles; Why women’s groups oppose injectable contraceptives by N B Sarojini, Laxmi Murthy
http://www.issuesinmedicalethics.org/index.php/ijme/article/view/702
‘Contraceptives: Case for Public Enquiry’, EPW, April 9, 1994
‘Retreat on Depo-Provera?’ by Padma Prakash, December 8, 1984