April 18, 2010
|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?
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.
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.”
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.
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