In July this year, the Indian government introduced an injectable contraceptive, depot medroxyprogesterone acetate (DMPA), best known as depo provera, into the public health system. The contraceptive would be made available for free through Mission Parivar Vikas, which seeks to improve family planning services in 145 high-focus districts.
This was an important development for India, which is set to surpass China as the world’s most populous nation by 2024 and where millions of women (12.9%) who need contraceptives do not have access to them.
However, DMPA has long been controversial, being linked to a range of health issues including osteoporosis, breast cancer, and delayed return of fertility. Those who support its use, including government agencies, say its benefits outweigh its risks, that it will be administered with informed consent, and that use in the private sector has already settled suspicions about its side-effects.
Women’s rights groups and health activists point out, on the other hand, that widespread illiteracy makes informed consent a farce in Indian settings, where the healthcare system displays a Malthusian aversion to population growth, especially among the poor. They warn that the Rs 100 incentive for the user may unfairly induce women to choose DMPA over more appropriate alternatives, and health workers may push it without properly informing women of its potential risks as required under the rules.
DMPA is a progestogen-only drug injected intra-muscularly. It acts by inhibiting ovulation, thickening the cervical mucus and thinning the endometrial lining to make it difficult for the fertilised ovum to implant itself.
It does not need to be taken daily but once in three months, and women with unsupportive husbands can use it without letting them know.
However, it is suspected to contribute to, as we said, osteoporosis and breast cancer, and to make it difficult to conceive for upto a year after discontinuation. It does not help prevent the spread of HIV, and possibly increases the chances of contracting it. Also, there are practical problems in administering it in India’s public healthcare system.
The contraceptive has been introduced under Mission Parivar Vikas across 145 districts in seven states that have Total Fertility Rates (TFR) of more than or equal to 3, with the aim of reducing this to the replacement-level fertility rate of 2.1 by 2025.
Across India, as per the National Family Health Survey 2015-16 (NFHS-4), 12.9% women do not have access to contraceptives that they need, and 5.7% to spacing methods. India’s maternal mortality rate is among the highest in Southeast Asia–174 per 100,000 live births. Adequate contraception could reduce maternal deaths by 29% a year around the world, according to a 2012 study published in the Lancet.
Source: World Health Statistics 2017, World Health Organization
Different contraceptive options serve varied purposes depending on a woman’s age and stage in life, Abhijit Das from the Delhi-based NGO Centre for Health and Social Justice told IndiaSpend. One type of contraceptive might be useful for someone whose primary concern is to prevent infection, another might suit couples who want to avoid conception, and yet another may work best for those who have intercourse occasionally.
Health concerns and studies in India
So a new contraceptive should be good news for adding to the bouquet of choices available. In the case of DMPA, however, the situation is complicated.
There has been no definitive research in India on Indian subjects to put the question of its suspected health risks such as osteoporosis and breast cancer at rest. A 2006 study showed longer duration of use (2-5 years) was associated with more loss and less complete recovery of bone mass density, which can increase one’s chances of acquiring osteoporosis. A 2012 studyshowed that recent DMPA use for 12 months or longer was associated with a 2.2-fold increased risk of invasive breast cancer, although the elevated risk of breast cancer associated with DMPA appears to dissipate after use is stopped. Both studies were conducted abroad.
“We have always asked for…independent data before you put it out there,” Vani Subramaniam from Saheli said, data that would be generated “in India, and within the populations you are going to reach with the family planning programme. And not by studies that are funded by companies that are making profit from it”.
“Research is not race-, caste- and gender-neutral,” Mohan Rao, professor of Social Medicine and Community Health at Jawaharlal Nehru University in Delhi, said. “Most scientists in the Indian Council of Medical Research (ICMR) would be trained in the neo-Malthusian way of thinking. They believe that population is the biggest problem, and so we should do something about controlling population.”
This March, the World Health Organization (WHO) reclassified DMPA from “safe for everyone” to “benefits outweigh the risk” for women at high risk of contracting HIV, after reviewing 35 years of research. Some public health groups insist that women and couples at high risk of HIV acquisition must be provided with male and female condoms, regardless of which family planning method they choose.
Among the dozen public health experts IndiaSpend spoke to, the majority said DMPA must be used cautiously, or not at all. C Sathyamala, author of an epidemiological review (health or disease surveillance to identify risk factors) based on five years of research, said even one injection can be harmful. The Family Planning Association of India (FPAI) and the NGO FHI360 said, respectively, that after two years it should be reviewed “on a case-to-case basis” and used “with caution”.
“There is no perfect method. All methods have some or the other side-effects,” Das said, adding that most neighbouring countries use it, “but we have not seen the kind of complications we expected from there”. He termed it “reasonably safe” for short-term use, but emphasised its use should be limited to short durations.
Source: Trends In Contraceptive Use Worldwide (2015), United Nations
However, the government’s reference manual on DMPA says “there is no limit to the number of years DMPA can be continuously used.” “There are no long-term impacts, even if one uses it for 10 years,” said Suneeta Mittal, a gynaecologist at FORTIS who was engaged with the government on depo provera.
Provider-controlled method in unaccountable system
“Counselling and education of clients are most effective in management of side-effects and certainly influence continuation rates,” Manisha Bhise, Director Clinical Services and Quality Assurance at FPAI, said. Counselling means giving information on all the contraceptive options available, and the side-effects of each.
However, less than half (46.5%) the current users had ever been told about the side-effects of a method of contraception in NFHS-4.
According to the WHO’s Medical Eligibility Criteria 2015, DMPA should not be used by women with multiple risk factors for arterial cardiovascular disease, such as advanced age, smoking, diabetes and hypertension; unexplained vaginal bleeding before evaluation; a history of current or past breast cancer; and other medical conditions.
“Do the doctors have time in primary health system to do the hormonal assessment–and look at contraindications?” N Sarojini, director of SAMA Women’s Resource Centre, asked.
Das argues that all methods of contraception require screening, and that should not deter their use. “Can the system do screening for sterilisation, which has chances for infections, failures, and death if not done correctly? Today even IUDs are pushed in a coercive manner,” he said.
Even in the US, the majority of the 12 million women using depo provera belong to the marginalised or less-empowered communities. A “myth of informed consent is promoted as a safeguard and to protect the manufacturers from liability clause”, Sathyamala said.
Those opposed to DMPA say it is hazardous even if used in the “best” way. “If I were a woman, I wouldn’t use it even if I had the money [to go to private practitioner offering better quality of service],” Yogesh Jain, founder of Jan Swasthya Sahyog (JSS), a people’s health support group in Bilaspur, Chhattisgarh, said.
How it came to be introduced
During 1993-94, when DMPA was introduced in the private sector, women’s rights groups had approached the Supreme Court seeking a ban on it, in addition to other drugs.
In 1995, the Drugs Technical Advisory Board (DTAB) of the drugs regulator, the Central Drugs Standard Control Organization, which decides technical matters pertaining to drugs, issued an order that DMPA should not be allowed for mass use in the National Family Planning Programme and that its use should be restricted to women who are aware of the implications of its use.
The litigation concluded in February 2001. A number of drugs were banned, but DMPA was allowed in the private sector, where, it was hoped, it would be administered after counselling and with informed consent.
More recently, the interest in injectables has grown after the global movement FP2020 was launched by the UK government and the Bill and Melinda Gates Foundation in 2012, aiming to reach 120 million women in poor and developing nations by 2020, 40% of whom live in India.
On February 16, 2015, the DTAB held a meeting to discuss the Department of Family Welfare’s proposal to introduce DMPA into the public health facilities under the Family Planning Programme. “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,” DTAB noted.
It also noted that the US Food and Drug Administration had kept DMPA under its strictest ‘black box’ warning since 2004 on similar concerns. It said DMPA should be used as a long-term birth control method only when there is no alternative available.
The DTAB recommended that the Department of Family Welfare “examine the matter in consultation with the leading gynaecologists of the country”.
On July 24, 2015, the head of the family planning division of the department held a national consultation with representatives of government medical colleges and leading civil society organisations including the ICMR, Federation of Obstetric and Gynaecological Societies of India, FPAI, PFI and FHI360 India.
Those opposed to DMPA, such as SAMA, Saheli, Jan Swasthiya Abhiyan (a coalition of more than 1,000 organisations) and respected professionals, were absent from the list of invitees.
It was agreed that since DMPA had been used in the private sector for 20 years with no adverse events reported, no pilot study was required. Working on this recommendation, the DTAB agreed to introduce DMPA in the public health system on August 18, 2015.
Essentially, the DTAB changed its stance without any discussion with the opposing groups and without any scientific evidence, a memorandum signed by more than 70 health groups pointed out. “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,” the memorandum said.
DTAB did not respond to questions for this story.
By introducing DMPA without a pilot and in the absence of any long-term studies, the government has acted on a crucial matter of public health without adequate scientific evidence, Sathyamala said, adding that “anecdotes cannot replace well-designed study”.
Yet, there were few protests against the DTAB’s decision, which Rao blames on “a certain kind of NGO-isation of the women’s movement” that shows a weakened health movement and women’s movement. “When there were early efforts to introduce injectables, there were massive demonstrations at Ministry of Health & Family Welfare,” Rao said. “Today we could only do a signature campaign.”
The campaign against DMPA and the questions around it remain relevant, Smitha Nair, who teaches at the Tata Institute of Social Sciences, Mumbai, wrote in the February 2017 issue of the Economic and Political Weekly. Reproductive rights, when reduced to “choice of contraceptives” without considering the overall health and wellbeing of women, result only in the control and “unfreedom” of women, she wrote.
|Abhijit Das, Centre for Health and Social Justice||Promote the use of condoms.||“Korea and Japan which have a high rate1 of condom use (23.9% and 46.1%, respectively) have low total fertility rates of 1.1 and 1.2 (per 1,000 women). Condoms are a cheap, least invasive, safe, user-controlled and effective option not just for contraception, but for prevention of infection (HIV, STDs, STIs). Men need to be responsible and involved in the decision-making process regarding family-planning.”|
|Any spacing methods which are safe and reliable, such as diaphragms, should be introduced in the public health system.||“Women have to have access to methods. Contraceptive needs of unmarried women also need to be acknowledged… More methods will allow women to chose the one that suits their needs best.”|
SAMA Women’s Resource Centre
|Put DMPA off until 2019 when the result of the ‘Evidence for Contraceptive Options and HIV Outcomes’ (ECHO) trial provides clarity on its potential link with HIV acquisition.||ECHO is an ongoing randomized trial that seeks to provide definitive information on the risk of HIV acquisition associated with different contraceptive methods. Study results will not be available before 2019.|
|Jashodhara Dasgupta, Sahyog||From a civil society point of view, meet the need for information on contraceptive options; and empower users to monitor these services themselves.||“Experience with NRHM had shown that when we are looking at poor people accessing family planning services, they do not work until the poor people are informed and are themselves empowered to actively monitor whether these services are working or not.”|
|Remove incentives.||Under the MPV, the health worker who administers the injection and the woman who receives it both get an incentive of Rs 100 each. “Incentives are considered a form of disguised coercion.”|
|Mohan Rao, Jawaharlal Nehru University||India needs an institution like theNational Institute for Health and Care Excellence (NICE2) in the UK to routinely scrutinise all technologies.||“We can’t blindly accept technologies for what they promise,” he said, citing the example of the ultrasound technology that has been used to determine the sex of the unborn child in order to selectively abort female foetuses, skewing India’s sex ratio.|