Doctors who endorse the injectable contraceptive DMPA also say they wouldn’t prescribe it to their own patients in the private sector, fearing its side effects. So why does our public healthcare system happily want to inject poor women with it?
By Menaka Rao
Originally published on 14 October 2015.
There’s a new contraceptive drug in the public health system: an injection, taken around once in three months, after which you needn’t worry about birth control. But if you knew that it was a controversial drug that had significant side-effects such as irregular periods or no periods at all, loss of bone mineral density, and worsening of depression, among several others, that needed constant monitoring by a physician, would you still opt for the promise it held out? Particularly if you found out that no trials had been conducted on the drug in India?
On August 18, 2015, India’s Drug Technical Advisory Board (DTAB) cleared the way for the hormonal injectable contraceptive depot medroxyprogesterone acetate (DMPA) to be introduced in the countrywide National Family Planning Programme (NFPP). It’s the first time that injectable contraceptives will be used in public healthcare.
Here’s what’s worrying: DMPA, which has been in the Indian market for a couple of decades, has seen low sales in the private sector, and as government figures from 2006 show, over half of the women who took injectable contraceptives discontinued use within a year. And the casteist and classist attitudes that pervade discussions around the drug will shock you: several doctors who gave ringing endorsements of the drug told me DMPA was suitable for poor women accessing public healthcare, but some of those who had private practices told me they would not prescribe it to their own patients who would hold them accountable, because the side-effects could be severe.
Health rights activists and women’s rights activists have been opposing the introduction of DMPA and other similar injectable contraceptives into the public healthcare system for a number of reasons. But medical care and women’s reproductive health has always had a difficult history, plagued by issues of ethics, consent, and hanky-panky by pharma companies and developed nations (try this on for size: the birth control pill, in an early form, was tested by US researchers on non-consenting psychiatric patients and destitute Puerto Rican women).
In India, the sterilization drug quinacrine – which was not approved by the World Health Organisation (WHO) or the US’ Food and Drug Administration (FDA) – was distributed by US doctors primarily to poor women (and in 18 other developing nations too). The Indian Council of Medical Research (ICMR) prematurely terminated its trials in 1992 because of the high rates of failure and complications, and quinacrine was eventually banned in 1998.
In 2013, an all-panel parliamentary panel used harsh language when speaking of trials for an HPV vaccine by the US-based non-profit, PATH – funded by Bill and Melinda Gates Foundation – and the ICMR, its Indian partner. The vaccine for cervical cancer was administered to over 24,700 adolescent girls in Andhra Pradesh and Gujarat, but after the deaths of seven girls just months into the trial, the government ended its support for the project, though the drug is still available in the market. The panel report said the ICMR had “completely failed to perform [its] mandated role and responsibility as the apex body for medical research in the country”, and had instead been promoting the interests of “other agencies” including PATH. Kalpana Mehta and other health activists filed public interest litigation, stating that the vaccines marketed in India were unproven and hazardous. The case is still pending in the Supreme Court.
Family planning and contraception initiatives in India are targeted towards women, not men. As 2013 figures from the Ministry of Health and Family Welfare show, tubectomies account for 97.4 percent of sterilisation surgeries, while vasectomies accounted for only 3.6 percent. Condoms and vasectomies aside, all other contraceptive methods in popular use today have been devised with women as targets. These include diaphragms, ligation, pills, injectables, vaccines, implants and, of course, abortion when there is no other option. None of the contraceptive measures aimed at women are without side-effects. And at their most extreme, they can cost lives. In November 2014, at least 15 women died after a hasty mass-sterilisation camp at Bilaspur district, Chattisgarh.
With such a history of medical care peddled to Indian women, is activists’ distrust in DTAB’s decision unjustified, and are they wrong to demand more stringent checks before DMPA enters our hospitals?
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What exactly is DMPA?
DMPA is a pure progesterone formulation sold under various brand names, the most popular of which is Depo-Provera, made by the US pharma corporation Pfizer. It prevents pregnancy by thickening the mucous in the cervix, which stops sperm from reaching an egg. It even stops ovulation in some cases as it thins the womb lining and prevents the release of an egg. DMPA is delivered every 13 weeks in the form of an injection to the buttock or upper arm.
It’s been available in the private sector since 1993, when it was approved for marketing. There are other injectable contraceptives available in the Indian market (they’ve been around since 1986), currently sold under the brand names Mesigyna (which uses norethisterone enantate or NET-EN, similar to DMPA) and Cyclofem, which are injected once a month. In India, Depo-Provera is sold for Rs 150 an injection (a Copper T or intra-uterine device (IUD), for example, which has a similar rate of effectiveness, costs between Rs 350 and Rs 550, depending on the brand, and lasts around 3 years).
One of the biggest problems linked to DMPA is the side-effects that come with it. In the US, Depo-Provera comes with a boxed warning (designed to call attention to serious or life-threatening risks on its label) from the FDA that states: “Bone loss is greater with increasing duration of use and may not be completely reversible. […] Depo-Provera Contraceptive should be used as a long-term birth control method (longer than 2 years) only if other birth control methods are inadequate.”
Other side effects listed include amenorrhea (no periods) in about 55 percent of women after their first year of use (and 68 percent of women after two years), increased risk of blood clots or stroke, detectable amounts of the drug found in breast milk, allergic reactions, weight gain, fluid retention, skin discolouration, depression and insomnia, among others. Among the FDA’s list of precautions is a “complete physical examination with special reference to blood pressure, breasts, abdomen, and pelvic organs and other laboratory tests.” It also says women with a strong history of breast cancer or those who have breast nodules should be monitored, and physicians should be alert about manifestations of blood clotting, ectopic pregnancy (pregnancy that occurs outside the womb, and possibly fatal if not detected on time), and depression, among other conditions. If not administered properly, or inadvertently in pregnant women, DMPA may be associated with birth defects in the foetus.
In January this year, researchers also found that DMPA increased women’s vulnerability to HIV.
Why is DTAB’s decision to use DMPA so worrying?
At a National Consultive Meeting on “Expanding the Basket of Choice in Family Planning” held on July 24, the DTAB considered the views of top gynaecologists from teaching colleges and the private sector, and reached a consensus on approving DMPA. But as the record of the July meeting – mentioned in the minutes of a later meeting on August 18 – suggests, there was no detailed discussion on the possible side-effects of this drug, and the DTAB held that a pilot study on DMPA was “not required”. The reason cited for this was that DMPA had been used in the private sector for over 20 years “with no untoward events reported”, and that trials using similar drugs had already been conducted by the ICMR (in March 2008, ICMR completed a feasibility study of NET-EN), which cleared them for use.
On August 18, the DTAB said, “Injectable is an important contraceptive method and much in demand by the community, therefore it should be introduced pan India, at all levels up to the Sub centres.” But there isn’t enough convincing evidence to support this: according to the third National Family Health Survey, 2005-2006, “The use of injectables is extremely low in every state. Sikkim is the only state in which the use of injectables is higher than 1 percent.” And although sales do appear to have been growing, there is little evidence to show that the drug is really “in demand”.
In September, health rights workers and activists wrote to Union Health Minister JP Nadda to reconsider the decision to introduce DMPA in the NFPP, especially as the DTAB had until then opposed the move even in February 2015. In their letter, the activists wrote: “[DMPA’s] known side effects include prolonged and irregular bleeding, amenorrhoea [no periods], suppression of immune response, loss of bone mineral density in young women, significant weight gain, depression, and loss of libido among many others.” They also recalled that in the February meeting, the DTAB itself noted, “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.” The activist’s letter went on to say that as the “safety and other concerns” regarding Depo-Provera had not been resolved, they wished to know the reason behind the sudden about-turn.
According to a 2010 USAID report titled Injectable Contraceptives in India: Past, Present and Future, when NET-EN was introduced in India in 1986, women’s groups petitioned the Supreme Court to stay its trials. They cited safety issues, violation of ethics in conduct of trials, and inadequate health delivery systems. The case ended in 2000, and the Supreme Court did not grant a stay on trials or bar its use in the NFPP. Soon after DMPA was approved for use in India in 1993, health activist groups and women’s rights groups filed a public interest litigation seeking a ban on DMPA. In 1995, the USAID report says, “DTAB made an interim recommendation that DMPA should not be allowed for mass use in the National Family Welfare Programme and its use should be restricted to women who would be aware of all the implications of its use.” The case ended in 2001, and DMPA was not banned.
Ambitious about its plans for the distribution of the injectable, the DTAB says the drug should not be restricted to just the teaching hospitals and district hospitals, but the sub-centres too or else it “defeats the purpose of its introduction as a beneficiary.” A sub-centre – the most peripheral link to a public health centre, and which does not have a full-time medical officer – is meant to be manned by two health workers (including an auxiliary nurse midwife). Considering patients injected with DMPA require follow-up sessions and monitoring, it is unclear how equipped these health workers are with training to counsel women about contraceptives, screen patients and manage possible side effects, let alone inject DMPA, the effects of which are irreversible for three months.
Activists feel that the programme is not ready to promote this drug. “It has so many side effects which are dangerous. Only qualified doctors can detect it. In our system, nurses give contraceptives. There is such a range of sub-conditions which they will not be able to detect as a side-effect,” says Dr Anant Phadke of Jan Abhiyaan, an umbrella of health rights organisations in Maharashtra. This reference chart prepared by WHO that healthcare workers can follow to determine which contraceptive methods are best suited for their clients, gives one an idea about the complexity of the process of counseling and patient screening.
Some also believe that the drug was made part of the family planning programme because of renewed pressure from the pharmaceutical industry. In 2014, Pfizer collaborated with several global aid groups such as the Bill and Melinda Gates Foundation to push for a redesigned form of Depa-Provera in developing countries throughout Africa, Asia, Latin America and Eastern Europe.
Will women really be able to say no to injectables?
Doctors tend to speak of the “cafeteria approach” to birth control, which means presenting the consumer with an array of choices. “The cafeteria approach is a scientific way of approaching contraception for women. Women should be allowed to choose whatever method suits her. All the pros and cons should be explained to her. Depending on the circumstances and physical conditions, the woman can choose her contraceptive,” says Dr Rajshree Katke, Medical Superintendent of Cama and Albless Hospital, a public maternity and childcare hospital in Mumbai.
Sona Sharma, additional director, advocacy and communication, Population Foundation of India, welcomes the introduction of DMPA into NFPP, like many organisations working on family planning. “Two decades ago, there was not enough evidence. Now, the World Health Organisation, which had recommended it earlier, has recently revived its eligibility criteria and has placed injectable contraceptives on category II, which means that it can be used without restrictions, but require some follow up. Things have changed in the public sector too. Now, the public sector is much more conscious of quality and there are family planning counselors posted at the district level.”
When I ask Sharma why this method should be promoted, as opposed to possibly safer methods, she says, “Who are we to decide what method a woman should use? All contraceptives – oral contraceptive pills, intra-uterine devices, sterilisation – all have side effects. Right now, there is not much counseling on that either. Let us insist on the improvement of counseling services and improving the level of care. We are trying to push for choice. Injectable contraceptives are not available for those who cannot afford it. We need to have more options available in the public sector.”
From the conversations I had with doctors, it seemed that the question of “choice” only really applied to women who could afford private healthcare. Some private doctors who endorsed DMPA’s use told me outright that it was not suited for more affluent patients. “It is extremely bad for private patients,” says Dr Kiran Coelho, who runs a practice in Bandra. “It causes weight gain, water retention, and irregular periods. It is not acceptable to Muslim and Hindu women who offer prayers, to have irregular periods. And during the bleeding periods, you cannot have intercourse,” she adds.
“This drug has limited use in the higher-socio economic rung because of irregularity of cycle,” says Dr Sita Telwani, who practices in South Mumbai. Why irregular periods shouldn’t affect poorer women to the same degree is baffling.
Dr Kavita Gujar, who practices in Mulund, says, “Not having periods or irregular periods is not socially acceptable for our women. They are happy in the beginning when we just inject them. But once the menses become irregular they start nagging. One of my patients who took three to four injections got periods after one and half years after her last injection. I do not advise my clients to use this contraceptive.”
A 2003 study conducted by the non-profit Sama – Resource Group for Women and Health on women who had been administered Depo-Provera in a public hospital showed that most of the women were not given other contraceptive choices, were not told about the side effects, or screened, or asked to come for follow-ups. Sixty percent of the women who went for follow-ups or complained about side-effects said that the hospital staff, including doctors, were “particularly harsh and prejudiced towards them, often displaying complete apathy towards their complaints.” It’s a very real cause for concern: in May this year, an investigative report on how women were treated in the labour room of a Kolkata public hospital showed how doctors had little respect for the women who came to them for treatment, and would even slap them, treating them like animals. In June, a similar report on women getting tubectomies from a hospital in Faridabad, Haryana, showed that the women were made to sign consent forms in English, which they did not understand, and were not given adequate care before or after the surgeries.
In this scenario, is DMPA really just an addition to the “basket of choice”, as DTAB puts it? Will healthcare workers under the NFPP be diligent about explaining the side effects of DMPA to patients, and can women refuse to take the injections from doctors and health workers?
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What do the doctors say?
“[DMPA] causes temporary bone density – about 2-3 percent in a year,” says Kolkata-based Dr Basab Mukherjee, chairperson of the Family Welfare Committee, Federation of Obstetric and Gynaecological Societies of India (FOGSI), who was part of the consultation meeting with DTAB. “But the bone density is revisable and it comes back in 3-6 months of stopping the drug. The loss of bone density does not result in fracture, the WHO has said. And that is what matters. The overall benefits far outweigh the side effects. This drug can prevent unwanted pregnancies and unsafe abortions.” When asked about the possible side-effects of prolonged use, Dr Mukherjee says, “It is hardly used for a prolonged period of time. The drop-out rate is pretty high. It is used as a spacing method [between pregnancies].” The US FDA actively discourages women from using it long term, and states that women who use it for a prolonged period of time should be evaluated regularly for bone mineral density.
In 2005, WHO said that the benefits far outweigh the risk for most women, while also saying in 2007 that “[w]omen aged 18-45 should be able to use DMPA (and other progestin-only injectables) without any limits. A teenager or a woman over 45may use DMPA if she and her health care provider decide that it is the best method for her, even if it may decrease her bone density. None of the other progestin-only forms of birth control have restrictions on use because of issues of bone health.” The American College of Obstetricians and Gynaecologists says, “Although the use of DMPA is associated with loss of bone mineral density (BMD), current longitudinal and cross-sectional evidence suggests that recovery of BMD occurs after discontinuation of DMPA.” Importantly, however, they add, “No high-quality data answer the important clinical question of whether DMPA affects fracture risk in adolescents or adults later in life.”
Some doctors I spoke to say that DMPA is suitable for women who cannot use other contraceptive methods. “We cannot use estrogen and progesterone pills for lactating women,” says Dr Rekha Daver, Head of Gynaecology and Obstetrics at JJ Hospital, Mumbai, who has conducted research on injectable drugs in collaboration with the ICMR. “We can use the progesterone-only injectable for lactating women. Some side effects are there, such as reduced bleeding or no bleeding at all. That is good, since during delivery there is a loss of blood. The woman can recover her iron store. The other side effect is weight gain, so it cannot be used for obese women. But in general, it is an excellent addition to the basket of contraceptives,” she says.
This sentiment was echoed by private doctors I spoke to, who believe that the drug will do well in the public system. “When I did a trial at Cama and Albless Hospital, the acceptability was good,” says Dr Telwani. “Among the uneducated women, the husbands do not allow the use of contraceptives. Also, the fear of Copper-T is very high because of occasional misplacement and bleeding,” she says.
Some women, Dr Telwani said, experienced the side effect of no bleeding during menstruation, and were terrified all the while that they were pregnant. She remembered one patient who had borne 18 children and had not had a menstrual cycle since she got married. “After having her last child, I administered the drug. She did not get her periods for eight months, and was worried sick that she was pregnant. She would visit me often to just check for pregnancy. But we could not do anything then.” Technology has changed since then, Dr Telwani points out. “That was 20 years ago. Now women can use the urine pregnancy test and find out,” she said.
Dr Coelho says, “Women who go for the injection are happy that they do not have to rely on their husbands. It is also ideal for anaemic women, as it sometimes stops bleeding. They are happy that they do not have to worry about periods (for women who have that side effect). These are hard working women who have no time for liberation,” she says, referring to the women’s rights activists who oppose the drug’s use.
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Women in India are most likely to discontinue using injectable contraceptives over other types of contraceptives, according to the NFHS – the discontinuation rate is about 53 percent. Early trials in India show that most often, they were discontinued because of amenorrhea and bleeding irregularities.
It may seem common sense that many women cannot stand irregular bleeding or the absence of it. But many doctors and researchers don’t seem to see this as a problem. Research documents or study material meant for health workers either mention irregular bleeding or amenorrhea as an aside, or curiously discuss various reasons why irregular bleeding or amenorrhea is not “tolerated” among women. One study based in Egypt showed that injectable users had about 11-12 days of bleeding in a month on average and about 70 percent of the women stopped using injectables after one year. A WHO research paper states, “Women perceive their menstrual pattern as the ‘pulse’ of their reproductive health and of their health in general. Furthermore, the natural process of menstruation has been given socio-cultural and religious dimensions which impact on women’s lives. It is therefore not surprising that women do not tolerate vaginal bleeding disturbances induced by contraception and expect help from the medical community.”
In India, we also need to keep in mind ground realities such as lack of water, lack of toilets, and the lack of privacy in homes, activists say. An account by a woman quoted in the Sama study is illustrative:
In April 2000, I took the injection. After that, my periods begun and they are still going on. Sometimes the bleeding is less, but it never stopped. I live in a joint family. Sometimes in front of my father-in-law and brother-in-law I start bleeding, as if a tap has been opened. My clothes become soiled. They have to turn their faces away and my sisters-in-law take care of me. It is so embarrassing. I also have leg cramps, backache and stomach pain. Moreover, it has affected my sexual life terribly. How can I sleep with my husband when I am bleeding so heavily?
“It must be remembered that contraceptives are used by healthy women, who are not sick, and do not want to get pregnant. The side-effects must be bearable. In this case, the side effects are too high a price to pay. Our health care system does not know how to handle a side effect. To find a sympathetic doctor is next to impossible in the public sphere. To top it off, when the side effects become unbearable, you cannot take the injected drug out of the woman’s body,” says Dr Veena Shatrugna, former Deputy Director, National Institute of Nutrition, Hyderabad, and one of the activists campaigning against the introduction of the drug in the NFPP.
In this scenario, the rights argument is a “con-job”, says Dr Shatrugna. “Why should women have a choice only in this aspect? Why should they have choice only in reproductive choice? Why not in education, good safe workplace, good health care?”
Dr Shatrugna says something that makes the push for injectibles sound like the dangerous diversion it is, a diversion from where the government should be making a serious push: “The government needs to cajole men to use condoms, and say this is good for you and your wife. Once they have two or three children, the men should undergo vasectomy. But nobody wants to put money in this endeavour. The government wants an easy way out,” she says. “And they are looking at women as targets.”
Menaka Rao is a freelance journalist based in Mumbai.