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Pill of contention
Take a chill pill" screams the headline of an article that talks about the use of emergency contraceptives for preventing unwanted pregnancies in the Indian edition of a popular international women's magazine which is often bursting with tips for spicing up one's sex life. Doctors say this is exactly what young women in India are doing these days. They are indulging in unprotected sex repeatedly and then just casually popping an emergency contraceptive pill (ECP) to avoid conceiving.
Anyone can buy an ECP, which prevents a fertilised egg from implanting in the uterus, in India. One can even call the chemist and get the Rs 55 pill delivered to the doorstep. But in the US, girls under 17 need a prescription to get the drug. Earlier this week, President Barack Obama endorsed health secretary Kathleen Sebelius' decision to overrule the Food and Drug Administration's recommendation to make the drug available over the counter (OTC) to all, regardless of age. This was the first time the government overturned an FDA decision and it has sparked much criticism, with women's groups saying the administration is ignoring science and "playing politics" with women's health. Obama defended his decision by referring to his daughters. "As the father of two young daughters, I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine, " he said, adding that 10-yearolds should not step into a drugstore and be able to buy, "alongside bubble gum or batteries", a medicine that could have adverse effects if used incorrectly.
His remark makes one think of the situation in India. At least seven different brands of ECPs, including the popular I-pills and Unwanted-72, are sitting on shelves at chemists' stores, with chocolate bars, condoms and balm bottles. As many 10-year-olds in the country would have heard of the I-pill as those who know about I-pods. The sales of the I-pill have rivalled those of condoms at many points since Cipla started advertising the drug in 2007 and even outstripped them in some centres like Ahmedabad, according to local media reports. Is this bad news?
Gynaecologist Dr Kiran Coelho thinks so. Almost every day, she meets a girl who has used, or rather over-used, ECPs. "Some girls are taking a pill every three days and even using it instead of a regular contraceptive. I have seen girls as young as 12 and 13 years who have taken many ECPs and that too in a haphazard fashion because they have little awareness about the drug. Even girls who don't want to take the pill are forced by their boyfriends to do so, " she says.
Coelho, who is attached to Mumbai's Lilavati Hospital, feels the Indian government, too, should make ECPs a prescription-only drug for minors. "People under 18 years should get an ECP only after consulting a doctor, " she says.
Dr Veena Bhatt, director of obstetrics and gynaecology at Artemis Health Institute in Gurgaon, agrees. "The misuse is more common among college-going girls as older women are more informed about regular methods of contraception and have the patience to use them, " she says. "ECPs are meant to help when one commits a blunder. But that does not mean one should commit blunders repeatedly, " she adds.
Talk to any gynaecologist these days and he or she will be able to rattle off a range of complaints they have come across since pharma companies started aggressive advertising campaigns of ECPs in 2007. Women are reporting menstrual delays, missed periods and excessive bleeding. While these are temporary problems which can be corrected, it is believed - though not yet proved - that long-term abuse of emergency contraceptives can cause severe hormonal imbalance and even lead to infertility. Worse still, there have been cases where women have not realised that they are pregnant till they were well into their second or third month because they thought their periods were delayed due to the pills, says Coelho.
Doctors point out that advertisements that promote the Levonorgestrel tablet as the key to "tension-free sex" fail to mention that it is only 95 per cent effective if taken within the first 24 hours. On Day 2, the efficacy of the drug drops to 85 per cent and slides to 58 per cent when taken on Day 3. The Indian Council for Medical Research has declared its intent to fund research on the use and abuse of ECPs, especially among teenagers and sex workers.
Bhatt believes that the misuse of ECPs would be greatly reduced if girls were required to get a doctor's nod. Dr Nozer Sheriar, a senior gynaecologist in Mumbai, however, feels the involvement of a doctor would defeat the very purpose of emergency contraception. "Going to a doctor would increase the time and cost of emergency contraception. Women would be more likely to avoid it altogether and risk an unwanted pregnancy and unsafe abortion, " he says.
An estimated 6. 5 million abortions take place in India every year. More than half of these - 56 per cent or 3. 6 million abortions - are 'unsafe', according to the estimate arrived at during the 2004 Abortion Assessment Project, which was conducted by the Mumbai-based Centre for Enquiry into Health and Allied Themes and the Healthwatch Trust in six states. Unsafe abortions are those that are performed illegally, by quacks or under-qualified doctors with faulty equipment, leading to injuries and infections. They are the third most common cause of maternal mortality in India.
Sheriar, who is the deputy secretary general of the Federation of Obstetric and Gynaecological Societies of India, considers the Obama government's ruling discriminatory. "Why should people of a certain age be singled out? If it is legal to be sexually active, one should be legally permitted to access emergency contraception and have the same rights to abortion, " he says.
The move to ban OTC sale of emergency contraceptives - it is a prescription-only drug in Germany, Italy, Russia and several other countries - is often supported by the "baseless" argument that their availability would promote promiscuity and that people would use them instead of regular contraceptives, says Sheriar. "Many studies have proved that the availability of ECPs does not make people more careless or promiscuous. And, no woman gives up a reliable method of contraception to take an ECP. It is usually due to non-availability of a contraceptive, a condom leak or the lack of male participation that she decides to take the emergency measure, " he adds.
Vinoj Manning, country director of Ipas, a global non-governmental organisation dedicated to ending preventable deaths and disabilities from unsafe abortions, too, felt there is no reason to ban OTC sale of emergency contraceptives. "There is global and domestic evidence that ECPs are safe drugs to use, " he says.
Prescription or OTC, there is one point that all experts agree upon: there is not enough awareness about the safe and correct use of ECPs. "The advertisements should carry a clear message that ECPs are not very effective as a long-term method of contraception and that after one use, it is important to switch to a regular and more dependable contraceptive, " says Sheriar,
If a woman uses only emergency pills for contraception for an entire year, her chance of becoming pregnant is 20 per cent whereas with the use of regular contraceptive pills the chance is less than one per cent and with hormone intra-uterine device it is less than 0. 1 percent, according to doctors. Sheriar adds that the government should run a nationwide campaign that is as "emotionally appealing" as the ECP advertisements to educate the masses about the dos and don'ts with regard to the pills.
Manning says pharma companies should be required to put better, more informative and honest inserts, which spell out the potential effects of excessive use of the drug, in ECP packs. Experts also feel people need to know that the pills contain a high dose of hormones, almost two to five times more than a regular birth control pill, according to studies.
Emergency contraceptive pills contain a synthetic hormone called Levonorgestrel in a high dose. This stops an egg from being released from the ovary. If an egg has already been released, the pill may prevent the sperm from fertilising it and if fertilisation has occurred, it prevents the egg from attaching itself to the lining of the uterus.
Even if they are used correctly - time and dose as prescribed - after a single act of unprotected sexual intercourse, ECPs fail to prevent pregnancy in about two per cent of women.
ECPs are legal in over 140 nations and available over the counter in 60 countries. The ECP market in India is reportedly worth Rs 100 crore.
The pills were made available over the counter with the hope of reducing the incidence of unwanted pregnancies and unsafe abortions. Eight per cent of all maternal deaths are due to unsafe abortion, according to data from the Registrar General of India.
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