Sunday, April 18, 2010

Uninformed consent

The Hindu, Sunday Magazine, April 18, 2010

THE OTHER HALF

KALPANA SHARMA

What women need is basic healthcare. Not costly medical experiments involving vulnerable sections who don't know what they are getting into…


Were they informed about adverse health impact and were these monitored and treated?

Photo:G.N. Rao. THE HINDU

Controversial: Tribal girls treated with the cervical cancer vaccine interact with Brinda Karat.

Marie Antoinette told her people to eat cake when they needed bread. Our government encourages people to buy cars — from Rolls Royce to the Nano — when they need affordable public transport. And when people, especially women, want simple, basic health care — and clean water and sanitation — they are being urged to inject their daughters with a Rs. 9,000 vaccine against cervical cancer. If some of us conclude that the priorities of our decision makers are more than slightly skewed, we should not be blamed.

The recent controversy over the use of the Human Papilloma Virus (HPV) vaccine on tribal girls in Andhra Pradesh has once again brought into focus several ethical and gender-related issues in the arena of public health that need to be openly debated. In India, we have many recent examples of women, particularly poor women, being subjected to clinical trials for contraceptives, including injectable contraceptives. These women have suffered after-effects and not known fully what was happening to them. It is only when women's groups and health groups raised an alarm about the way these trials were being conducted did the government intervene.

Goverment intervenes

Once again, the government has intervened and stopped, for the moment, the project in three districts — Bhadrachalam, Kothagudem and Thirumalayapalem — of Khammam district in Andhra Pradesh where 14,000 girls, mostly tribal, between the ages of 10 and 14 have been given three doses of a vaccine that is supposed to protect them from cervical cancer. The project is headed by a well-known international NGO and is supported by the Indian Council for Medical Research (ICMR). The official district health authorities and health personnel have been fully involved in every aspect of the project. So it is not something that has been done clandestinely.

The alarm bells first rang when four girls died after they had received the vaccine. Whether they died due to complications caused by the vaccine, or from other factors, has not been established. Perhaps it cannot be conclusively established. But the very fact that the parents of one of the girls believes that her problems arose after she was administered the vaccine suggests that it is an issue that has to be investigated further.

Of course, there is little doubt that cervical cancer is an important health risk that millions of women face. A quarter of all deaths due to cervical cancer worldwide occur in India. The infection can lie dormant in a woman for 20 to 40 years before it manifests itself as cancer. Hence the belief that if young girls, before they become sexually active, are administered a vaccine, they might be able to avoid getting infected by HPV and thereby lower their risk of getting cervical cancer.

The first HPV vaccine came into the market in 2006 in the United States. After trials, it was declared safe for use in young women, and men. While it provided women cover against cancer and genital warts, it protected men from genital warts. However, once you were infected with HPV — of which there are at least 15 strains that can cause cancer while the vaccine protects you against only two — the vaccine was of no use. Also its efficacy in the long run has not yet been tested because the infection takes such a long time before it shows up as cancer. So young girls who have received the vaccine in the last years would have to be followed for that length of time before we can be completely sure that the vaccine actually works. Meanwhile, the best protection against cervical cancer remains regular checks — with or without the vaccine — to catch any early signs of the cancer.

So what then is the basis of the opposition to the project being conducted in Andhra Pradesh?

SAMA, a Delhi-based women's health group, has done a detailed study of the problem in Andhra Pradesh. Its members have spent time speaking to the girls who received the vaccine, to their teachers, to the health workers, to the parents and the district authorities.

What emerges is a disturbing tale of young tribal girls who are not necessarily in the best of health in the first place, given their background of poverty and under-nourishment, being given this vaccine. The information provided to them is in English, which neither they, nor their parents, nor the health worker giving them the vaccine, can read. Even the exact age of many of these girls is not certain as births are not regularly registered in large swathes of this country. Hence how were these girls chosen for the project? Were they informed about adverse health impact and were these monitored and treated? And did they really give “informed consent” to be a part of the project when they could not read the literature? In fact, many of the girls did not know the meaning of the word “cancer” or “cervix” or even “uterus”. So did they know what they were being given and why? It would appear not.

Of course, the company providing the vaccine does not deny contra-indications. Its website states: “The side effects include pain, swelling, itching, bruising, and redness at the injection site, headache, fever, nausea, dizziness, vomiting, and fainting. Fainting can happen after getting GARDASIL. Sometimes people who faint can fall and hurt themselves. For this reason, your health care professional may ask you to sit or lie down for 15 minutes after you get GARDASIL. Some people who faint might shake or become stiff. This may require evaluation or treatment by your health care professional.”

But how do you deal with all this when the girls live in a tribal hostel, or in areas where the health facilities are abysmal? In the case of 13-year-old Sarita, who is one of the four girls suspected to have died from complications connected to the vaccine, by the time her parents managed to go to the nearest big hospital in Bhadrachalam, she was dead. This is what they said to the team from SAMA:

“Our child was active and happy. We lost our child, and we know the pain and the agony of that loss. We don't want any other child to die. We don't want any other parent to suffer. Care should be taken for other children who received vaccination. Even though some girls are suffering from side effects like severe stomach pain, teachers are not letting them go home… We want the government to take immediate action. This is our only appeal. This is why we are speaking out.”

Exposing vulnerability

Fortunately, this appeal has been heard and for the moment the project has been suspended. But it has brought into focus once again, the dangers of exposing poor women, in particular, to this kind of medical experimentation. By all means, efforts should be made to try out a new technology. But not at the cost of the health of the woman. And certainly not on the basis of exploiting her ignorance. What is more important? Women's health or promoting a new vaccine? If it is the former, then there is much more that can be done at a fraction of the cost — starting with ensuring that primary health centres have gynaecologists available at all times. Women in this country urgently need basic health care and nutrition, not necessarily advanced medical interventions whose efficacy has yet to be proven.

(To read the original, click on the link above)

Sunday, April 04, 2010

Missing: 42.7 million women

The Hindu, Sunday Magazine, April 4, 2010

THE OTHER HALF


Lack of access to healthcare, malnutrition and selective abortion — all these have contributed to over 40 million women dying in India. And these are the issues the government needs to address now…


In India, women constitute 48.2 per cent of the population, worse than Pakistan...


Photo: V. Ganesan

A struggle all the way...

Last month, on March 8, we celebrated the centenary of International Women's Day. A day later some celebrated the passage of the Women's Reservation Bill in the Rajya Sabha while others ranted and raved against it. Still others asked whether 63 years after Independence, any of this made a material difference to the lives of the majority of Indian women.

The latter were, of course, right. Symbolic gestures have little meaning when every year over 40 million Indian women die for no other reason than not being able to access healthcare, if and when they do being discriminated against, being so malnourished that even if they get treatment they cannot survive, and all this only if they are not eliminated before birth or after being born.

Yes, also on March 8, the United Nations Development Programme (UNDP) released its 2010 Asia-Pacific Human Development Report titled, “Voice and Rights: A turning point for gender equality in Asia and the Pacific”. The picture that emerged of India was not a happy one. In most countries, women generally outnumber and outlive men. As a result, they are a little over half the population. But in India, they constitute 48.2 per cent of the population, worse than Pakistan where the situation is bad enough with women being 48.5 per cent of the population. Even Bangladesh is better at 48.8 per cent. The reason this has happened is a combination of the factors that have led to 42.7 million “missing” women (2007 data).

Chilling reminder

As if we needed another reminder, The Economist magazine carried a hard-hitting feature under the headline: “Gendercide – The worldwide war on babies” (March 4, 2010). “Technology, declining fertility and ancient prejudice are combining to unbalance societies”, stated the article as it reported on several Asian countries, particularly India and China and the skewed sex ratio. The article should have been titled “Femicide” as only one gender is being eliminated — the female. Still, it was a chilling reminder of the reality in the world's two most populous nations, where, as an old Chinese lady who witnessed female infanticide was quoted by The Economistas saying, “It's not a child. It's a baby girl, and we can't keep it…Girl babies don't count.”

But someone is counting baby girls and boys, men and women. In fact, thousands of people are right now fanning out across India for the mammoth exercise, one of the largest in the world, of the 2011 Census.

The 2001 census brought home the point starkly that millions of girls in India never saw the light of day. Either they were never allowed to be born, due to sex-selective abortions, or were killed shortly after birth. As a result, in the 0-6 year age group of children, there was a marked increase in boys as compared to girls in some of the richest districts in the country. Clearly medical technology, that the better off could afford, had been perversely put to this kind of use — of ensuring that girls were eliminated before birth.

The 2011 census will be significant in more ways than one. In 2001, the problem that had been lurking for years was exposed through stark, irrefutable data. As a result, the government had to act. It tightened the Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act 2003 (also known as the PCPNDT Act). Campaigns were run for the “girl child”, incentives given for her education, and threats held out of punishment and fines against those misusing technology for sex-selective abortions. How effective were all these efforts? Results from the 2011 census will tell us.

It is small comfort to know that this problem is not unique to India. The article in The Economist, for instance, gives startling data on the situation in China where decades of son preference and a one-child policy as well as sex selection have resulted in a marked difference between the number of young men and women. The article quotes research by the Chinese Academy of Social Sciences that predicts that by 2020, China will have 30-40 million more men less than 19 years of age as compared to women. (The current sex ratio in China is 123 boys to 100 girls).

Serious consequences

Such a situation fraught with serious sociological consequences, not the least of which is the shortage of brides. In India, in states like Haryana this has already come about with brides from other states being bought by young men who just cannot find a woman from their own region. Every other day we read stories about women from as far away as Kerala or Assam who have made Haryana their home. Nothing wrong with such cross-fertilisation in a country that is so divided by caste, religious and regional identities as long as the women know their rights and have a way out if things don't work out. What is disturbing is the reason this is happening — not free choice but no choice.

Tragically, none of this kind of data seems to create any ripples amongst those in a position to make a difference. Take Maharashtra, for instance, one of the richest states in India. This year's Economic Survey revealed that by 2011, the state's sex ratio would be 915 women to 1000 men, down from 922 in 2001 when it was significantly lower than the national average of 933. Maharashtra also has the dubious distinction of ranking 15 out of 28 states in India in terms of its sex ratio.

Yet, what is preoccupying the men who govern the state? Chief Minister Ashok Chavan has been tying himself up in knots trying to explain how the actor Amitabh Bachchan, who has chosen to identify with Gujarat Chief Minister Narendra Modi as the state's brand ambassador, came to share a dais with him at an official function. How does any of this matter? States like Maharashtra need governance, not showbiz.

The Economist referred to India as “that super giant”. But such compliments count for nothing if our government does nothing about “femicide” and those “missing” women.

(To read the original, click on the link above)