Bayer’s IUD Mirena or the cheaper Emily? Indian women need options

Sathyabhama Ganesan, 50, has had trouble with her period since giving birth to her daughter two decades ago. But matters worsened in 2010. She would bleed heavily, and her stomach would clench so tightly that medicines couldn’t really ease her pain. When her period would arrive, 15 days or 25 days or 35 days after her previous cycle, she would lie crumpled on her bed for days at home in Trichy, Tamil Nadu.

“For two days every month, I couldn’t do anything,” she recalled in Tamil. “I would have to lie down. When my daughter was younger, I’d grit my teeth and try to care for her.”

Two doctors advised Ganeshan to remove her uterus in a procedure called a hysterectomy. But a friend suggested she talk to T Ramanidevi, a gynaecologist who has a reputation for avoiding surgery. After a consultation, the doctor implanted Mirena, a hormone-releasing intrauterine device (IUD) made by pharma company Bayer, into Ganesan’s uterus. Within three months, her period disappeared. She became pain-free.

Ganesan is one in a fraction of Indian women who’ve avoided a risky surgery for gynaecological issues. In Dec 2017, the government published the first data on the prevalence of hysterectomies after news reports revealed unscrupulous doctors were pushing the surgery on women. The procedure can cost upwards of Rs 40,000 ($568). Some 700,000 women reported having a hysterectomy and more than half of them were younger than 40. Two-thirds of the procedures happened in private clinics. Extrapolating from other surveys, it is likely that 30% of them had issues related to abnormal bleeding, which may have been treatable using a hormonal IUD.

But though these devices have been available for about 18 years in India, they remain unavailable to poor, uneducated and rural women who undergo the vast majority of hysterectomies, The Ken has found. That’s despite the fact that these devices are on India’s National List of Essential Medicines, which contains 376 medicines that the government mandates must be accessible and affordable. Hormonal IUDs are also on the World Health Organization’s essential medicines list.  

“All that is available currently in the public sector is hysterectomy”

Subha Sri Balakrishnan, doctor

A controversial history of family planning, high prices and a government focus on fertility rather than women’s reproductive health has meant the devices are not widely available, said Subha Sri Balakrishnan, a doctor at the Rural Women’s Social Education Centre (RWSEC) in Tamil Nadu.

“All that is available currently in the public sector is hysterectomy,” she said. “A hormone-releasing IUD would be something that could be very useful, if it came into the public sector, for women having menstrual issues.”

In 2013, HLL Lifecare, a government enterprise in the manufacture of healthcare products, developed a low-cost, home-grown alternative to Bayer’s Mirena, called Emily. The devices could theoretically be channelled into government reproductive health programmes, much like HLL’s condoms and birth control pills have been, with great success. But, three years since its launch, few gynaecologists have heard of Emily.

“I think they stopped making it two years ago,” suggested Ramanidevi, Ganesan’s gynaecologist who had been invited to Emily’s launch event in 2013.

She’s not right. Emily is just very difficult to source.

RS Sharma, head of reproductive health at the Indian Council of Medical Research, acknowledged the potential use of the devices in treating gynaecological issues but declined to comment on whether they should be made available through government programmes.

A difficult birthing

Hormonal IUDs—like their more famous cousin, the Copper T—were developed as a contraceptive and that’s how they are mostly used in the developed world. The devices are slightly larger than a two-rupee coin and get inserted into the uterus, where they release micro-doses of the hormone levonorgestrel, or LNG. The device works for five years before it has to be replaced. Removing it returns the woman to fertility. Like many contraceptives, hormone-IUDs can have mild to severe side effects.

In India, the devices are valued more for a secondary effect: the LNG hormone thins out the lining of the uterus and stops or curbs the period, a desirable outcome in women who suffer from excessive bleeding due to hormonal issues. At present, many women with this condition in India get their uterus removed through a hysterectomy. The National Family Health Survey 2016 found that 30 out of 1,000 women underwent hysterectomies here, which is more than four times the rate in developed countries. Most of them were in their 30s.

Soaring hysterectomies

In Andhra Pradesh, hysterectomies are conducted at the average age of 29, and includes the removal of both ovaries to simulate menopause, according to a recent study

At least some of these women could opt for an LNG IUD.

When hormonal IUDs first entered the Indian market in 2002, gynaecologists were wary, recalled an executive who worked at pharma company German Remedies, which collaborated with Schering AG—Mirena’s first manufacturer, which later got acquired by Bayer. Like all pharma companies with a novel product, German Remedies’ sales reps had to create demand by sponsoring gynaecology conferences and talking to women at ladies’ clubs. They had to create a mind shift that the loss of a period is acceptable, a difficult task in a nation where the monthly cycle is a sign of fertility. The price tag of about Rs 7,000 ($99) was also rather high for a contraceptive, limiting the device to elite clinics in urban areas.

As gynaecologists began implanting Mirena, they realised that the devices were useful in women with abnormal bleeding. Many of them were undergoing unnecessary hysterectomies, a trend that continues to the present day.

“People are very much steeped in the thought process of doing a hysterectomy sooner for heavy menstrual bleeding because they think if a woman is finished childbearing, you don’t need the uterus and ovaries anyway,” said Kalaivani Ramalingam, a gynaecologist in Chennai. “Both the patients and some gynaecologists think that way.”

But few women could afford Bayer’s Mirena; even fewer were presented with the choice.

“Bayer makes every effort to inform the medical community about the availability of Mirena in India since it was launched in 2002,” the company said in a statement. “We are always open to suggestions to improve the access of our innovative products to women and will continue to explore with the relevant stakeholders in this regard.”

Developing Emily

In 2009, gynaecologists who advise HLL Lifecare requested the company to consider developing a low-cost LNG IUD, recalled Rajmohan Gopimohan, a scientist at HLL’s research and development division who worked on the project.

HLL turned to scientists at Sree Chitra Tirunal Institute for Medical Sciences and Technology based in Thiruvananthapuram, which develops medical devices for the government. They developed a prototype and transferred the know-how to HLL in 2012. The device was christened Emily.

After a six-month-long clinical trial, HLL got regulatory approval and launched the device at Rs 2,424 ($34). Then, in 2015, government regulators added hormonal IUDs to the National List of Essential Medicines. They took into account the price of Emily, which prompted Bayer to drop Mirena’s price to Rs 3,500 ($49).

Three other generic brands—Eloira by Pregna International Ltd; Emirelle by DKT India; and Fiona by Meril Life Sciences—have since been launched, all priced at Rs 3,500. The lower price and greater competition have made the devices more affordable, said Ranjit Nair, brand manager at HLL Lifecare.

“Because of price, earlier it was used only by the creamy layer of docs,” he said. “Other people were reluctant to use it.”

Currently, some 25,000 units are sold a year, up from 3,000 from before price control, he said. But most of this is comprised of Mirena.

HLL does not have the manpower to market its IUD to India’s 50,000-odd gynaecologists

HLL has since stumbled. Unlike its condoms or birth control pills, it doesn’t source Emily directly to the government’s public health programme. Rather, it markets the device directly to doctors, who then have to recommend it to patients. HLL simply does not have the manpower to market its device to the 50,000-odd gynaecologists registered in India, Nair said. They have enough sales force to cover about 20,000 doctors and are selling to some government hospitals.

“I had one person come and tell me about [Emily], and every time I’ve tried to source it, it’s not been available,” said Ramalingam.

But even if a greater effort is made by HLL, the economics don’t add up. Contraceptives are not a booming business; Nair projects a Rs 7 crore ($996,380) market for LNG IUDs across the country. Emily retails at a lower price point than Mirena, which means the company offers a smaller profit margin to distributors and doctors. And Mirena is a more recognised global brand with years of clinical trials proving its efficacy.

These points were used by Bayer’s sales reps to market Mirena aggressively, Nair said. So, since the launch, Emily has simply not been widely available. But, Nair insists, “Every month, the stock is available. There are many options to reach out to us.”

Stunted growth

The hope for Emily would be that the government steps in and procures the contraceptive for its family planning programme—an event that could precipitate even lower prices if the devices get manufactured at scale. There should be a push for that, said Uma Ram, a gynaecologist at Seethapathy Clinic and Hospital in Chennai.

“It should be added to the government basket for contraception, firstly,” she said. “It needs to be offered both as a contraceptive and as an option for hysterectomy to women, especially in lower-income groups and in rural areas. Because I believe that they are less likely to have the support and the luxury of rest and recovery from a surgical procedure.”

So far, however, neither the government nor non-profits have prioritised LNG IUDs and there has not been pressure to drop prices to make the device more affordable for government programmes. It’s not a decision that’s based on science, said Balakrishnan of the Rural Women’s Social Education Centre.

“It’s based on what’s seen as a priority, what is seen as bringing in money, what is seen as things that research needs to focus on, what big donors think they need to focus on, what pharma companies think they need to focus on,” she said.

That’s a political question. And frankly, there are no answers.

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