India: Feminists oppose "Fatal Third World Guinea Pig Trials" of cervical cancer vaccine, instead.. Print E-mail

demanding: Informed Consent protocols, Systematic Cancer Screening, a Holistic approach to Women’s Heath which includes attention to Nutritious Diets and access to Clean Water for Hygiene Purposes, and that the risks of multiple partners leading to a variety of STDs should be disseminated among the general population, with a focus on men

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 Monday April 19 2010
Life & Style

Trial and Error

What Women Want

Scroll down to also read "Questions asked about the use of tribal girls as guinea pigs for cervical cancer research" and "Fatal Trials"
Dr. V. Rukmini Rao, Gramya Resource Center for Women, Secunderabad

According to WHO statistics, cancer of the cervix is the second most common cancer in women worldwide, with about 500,000 new cases and 250,000 deaths each year. It's a sobering thought, especially in a country such as India where basic health care and reproductive choices are a luxury for most women. The Human Papilloma Virus (HPV) lies dormant for years before it manifests itself as cancer. Hence, the belief that the earlier a girl is vaccinated against HPV, the better her chances of survival. But, the HPV vaccine comes with its own controversies. In Bhadrachalam, Kothagudem and Thirumalayapalem in Andhra Pradesh, where poverty cuts through large swathes of the land, four young girls recently died allegedly from complications after being administered the vaccine. Two others died in Gujarat. This has brought to attention the hazards of exposing women who were not necessarily in the best of health to this kind of medical trials. We spoke to activists and doctors on the urgent need for gender-related health care.
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Follow protocol
Our public health care system needs a comprehensive approach. In India, we need to address issues of maternal mortality, food shortage, inadequate Primary Health Centres and basic vaccine shortage, before we address specific targets such as the HPV. The HPV vaccination drive should be part of an overall public health policy, but there should be a proper protocol in place before it is launched. It needs to address the issues of side effects, informed consent, the target population for the vaccine and their selection. Also, this vaccine tackles only one type of sexually transmitted disease and is effective against just a few strains of HPV. Our focus should be on introducing health hygiene and first aid education in schools. Also, it is wrong to assume that only certain populations are prone to STDs. Social equity must be addressed.

Dr. Mira Shiva (Coordinator, Initiative for Health Equity and Society and Coordinator All India Drug Action Network, New Delhi)
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Change in ideology
Cervical cancer occurs mostly after the age of 40, with a higher rate of incidence in the developing world. Early marriage, early initiation of sexual activity and multiple sexual partners are known risk factors. Immuno compromise, for eg. HIV infection, is a risk factor.

Although the demonstration project of the vaccine has been stopped, it is still available in the private sector. Also, there is no need to treat HPV infection ­ a large majority of it is usually self-limiting. What needs detection and treatment is cervical dysplasia, i.e. cellular changes in the cervix that could result from HPV infection and that could be a precursor to invasive cancer.

Since 1994, the language of our policies and programmes has made a move towards reproductive health. But, this seems to have remained at a rhetorical level. Population control for demographic goals still is the dominant ideology. Reproductive health care as a continuum through a woman's life cycle, and reproductive health as a right are rarely recognised.

We need a systematic screening programme for cervical cancer through the public health care system. The HPV vaccine episode brings out the need for a rational vaccine policy and also stringent ethical regulations of clinical and other trials.

Dr. B. Subha Sri (Director, Reproductive Health Clinic, Rural Women's Social Education Centre, Tamil Nadu)
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Nutrition and hygiene
Gramya Resource Center for Women works to promote girl child rights and the rights of women to live a violence-free life, among others. All over the world, screening, particularly pap smear is the only-known method to identify cancer of the cervix. This has helped reduce incidence of cervical cancer in the developed world by 68 per cent. A vaccine will not necessarily prevent cancer; even if the vaccine is given now, its efficacy is not known beyond five years.

The public health system focusses only on controlling the fertility of women, not on her other problems. If cervical cancer rates are to be reduced, we must ensure women have access to nutritious food, since folic deficiency is known to be associated with cervical cancer. Clean water to ensure basic hygiene is also necessary.

Also, the risks of multiple partners leading to a variety of STDs should be disseminated among the general population, with a focus on men.

Dr. V. Rukmini Rao (President, Gramya Resource Center for Women, Secunderabad)
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Holistic approach
Lack of awareness among women about cervical cancer, lack of health personnel who can do visual inspection or pap smear, and inadequate treatment facilities even after diagnosis lead to high mortality rates.

In recent years, maternal health has got a lot of focus. However, the tendency to view women's lives in bits and pieces has always resulted in failure. Why don't we train the health worker who can insert an IUD, to take pap smears? We need trained health workers with good referral support and access to the required drugs, equipment and materials.

HPV vaccine has been used effectively in many countries, but how well will it work in India, where the delivery mechanism is faulty, there is poor follow-up and the cost is prohibitive? Both the science and the ethics of the research is questionable. The use of vulnerable participants is worrying. We need transparency and accountability in health research.

Most important, we should recognise the need for a holistic view of women's health needs.

Neha Madhiwalla (Centre for Studies in Ethics and Rights, Mumbai )

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 Tuesday 06 April 2010

Were tribal girls guinea pigs for cervical cancer research?
By R Akhileshwari in Hyderabad

The Union Governmentand the ICMR are divided in their opinion on the research by an MNC.

Four tribal girls in Khammam district of Andhra Pradesh have died in the past one year after they were given three doses of vaccine of a multi-national company to prevent cervical cancer as part of drug trials by an American multinational pharmaceutical company in cooperation with the Andhra Pradesh government and with the approval of the Indian Council of Medical Research. None of the girls had any medical condition.

All of them incidentally were residents of government-run hostels for tribal children.

Civil society organisations were up in arms over the shroud of secrecy under which the 'demonstration trials' were conducted, the misleading claims of life-long protection by the vaccine, and a 'cover-up' of the side effects suffered by a large number of the girls and subsequent death of four of them. As a memorandum submitted by 70-odd NGOs and individuals to Union Health Minister said, "It is beyond doubt the worst case of human rights violation, where young healthy girls have to die for being part of a state-endorsed experiment, initiated by a profit-making private company."

The Centre suspended the trials last Wednesday but Director General of Indian Council of Medical Research Dr V M Katoch insists that the girls died of extraneous reasons and not due to the vaccine. He said he was suspending trials of cervical cancer vaccine Gardasil as a precautionary measure. "I decided to suspend the trials because I wanted to first prove to the public that the allegations are false. I also want the general public to know that all ethical guidelines would be followed in this trial," he said.

Activists believe this is 'ostrich-like' behaviour and want an investigation done into the deaths by independent body since the state governments which have shrugged off all responsibility, are not likely to be objective.

The drug 'demonstration trials' were being implemented in Khammam district of AP and Vadodara district of Gujarat. In both states, the India branch of the international NGO PATH was overseeing the implementation of the demo trials. Girls between the ages of 10 and 14 were administered three doses of the cervical in July, October 2009 and February 2010.

The AP government denied the deaths were related to vaccine and that they were suicides by the children. This is flatly denied by the parents of the girls who insist that there was no indication that their daughters were either having problems or that they were suicidal.

Dr B. Jaikumar, district immunity officer, Khammam, who heads the implementation of this programme insisted that "The three post-mortems show that these are cases of suicide. The girls who were administered this vaccine showed mild side effects such as headaches and swellings but nothing serious," he maintained.

However, Dr Rukmini Rao whose Gramya Resource Centre for Women has been working among tribals of Nalgonda and Khammam for more than a decade confirmed that as many as 120 girls experienced adverse reactions such as epileptic seizures, severe stomach ache, head aches and mood swings.

There have also been reports of early onset of menstruation following the vaccination, heavy bleeding and severe menstrual cramps. "We learnt that one of the girls died due to convulsions while another had an epileptic fit. But the doctors there are passing these deaths off as cases of suicide," said Rukmini Rao.

The claims of the NGO and the government health officials that the permission of parents was taken in writing to administer the vaccine are questioned by activists. In the first place, the parents are too poor and illiterate to understand the implications Activists point out that this claim too was false as the vaccine had manifested severe side effects including deaths in the US, UK and other European countries.

Rukmini Rao asked if the vaccine was really so effective why was it not tried out in elite schools in urban areas,” she asked. "Now that the hoo-ha over cervical cancer has died down in the western countries the manufacturers are trying to create a market in India," she said.

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 Mumbai ~ Volume 27 - Issue 09 :: April 24-May 07, 2010

UPDATE

Fatal trials

By T.K. Rajalakshmi
Andhra Pradesh Minister for Cooperation R. Venkata Reddy inaugurating HPV vaccination at Tirumalayapalem in Khammam district in July 2009 (G.N. RAO)

A CONCERTED campaign by women’s organisations and health groups, together with media reports, has finally woken up the country’s health establishment to the dangers of a vaccination programme against cervical cancer currently under way in Andhra Pradesh and Gujarat.

The programme, under a private-public partnership arrangement involving the Indian Council of Medical Research (ICMR), an international non-governmental organisation (NGO) called PATH, the Bill and Melinda Gates Foundation and the governments of the two States concerned, involved conducting “operational research studies” and vaccinating adolescent girls against the human papilloma virus (HPV), known to cause cervical cancer.

One of the vaccines, Gardasil, manufactured by the pharmaceutical major Merck, has allegedly resulted in the death of four teenaged tribal girls and caused debilitating problems such as epilepsy, headaches, stomach disorders and early menarche to 120 others in Andhra Pradesh’s Khammam district. Since July 2009, a total of 42,000 girls have been administered three doses of Gardasil each.

The controversy began in September-October last year following an advertisement blitz launched by another HPV vaccine manufacturer (Frontline, February 12, read HERE).

The ICMR, though unconvinced that the deaths were caused by the vaccine, has ordered the suspension of the programme in the two States. Its Director-General, V.M. Katoch, and the Andhra Pradesh Health Minister, Danam Nagendar, remain convinced that the benefits of the vaccine far outweigh the risks. The Drug Controller General of India, Katoch stated, had approved the use of the vaccine. All the reported deaths, according to him, were not associated with the vaccination. Incidentally, two of the deaths were certified as suicides in the post mortem reports.

Unsurprisingly, the protesting groups view the ICMR’s half-hearted intervention with cynicism. While welcoming the suspension of the trials, they said that the governments had to ensure the well-being of the children already covered under the programme. They pointed out that entire batches of the vaccine had been withdrawn in other countries where hospitalisation and deaths were reported following its use. They alleged that the other HPV vaccine, Cervarix (produced and marketed by GlaxoSmithKline in India), had been approved for use on children without any trials.

The ICMR’s response followed a memorandum to Union Health Minister Ghulam Nabi Azad on April 7, World Health Day, by organisations such as the All India Democratic Women’s Association (AIDWA), the Committee against Violence on Women, the Jan Swasthya Abhiyan, and the Saheli Women’s Resource Centre demanding, among other things, the complete suspension of all studies and trials with Gardasil and Cervarix.

The organisations questioned the veracity of PATH’s claim that the vaccine has no side effects other than irritation at the injection site and fever and that it has been safely administered to millions of girls in developed countries. They pointed out that the package insert said the vaccine did cause epilepsy-like seizures. A post-marketing surveillance, they said, had observed an increase in the occurrence of blood clotting, autoimmune diseases and disorders of the respiratory and nervous systems. In some cases, death was reported, they said. They said that data from the United States showed that the adverse effects of the HPV vaccine were far more numerous than those of all other vaccines administered to children.

The organisations wondered why and how various agreements were made with Merck and PATH, and why the Institute of Cytology and Preventive Oncology, the ICMR’s own cancer research institute, was kept away from trials. The licensing of Gardasil and Cervarix, they alleged, was done on the basis of sketchy bridging studies. While Gardasil has been approved for the age group of 10-27 years, it has been tried only on a very small sample of girls in the 10-14 age group. Cervarix has been approved for the 10-45 age group, but has been tested only in women aged 18-35.

A report carried by local health organisations in Khammam district noted that 14,000 girls in the 10-14 age group in the district had been vaccinated with three doses of Gardasil. There were reports of these girls having early menarche, heavy bleeding and severe cramps following the vaccination. The “demonstration project” had no follow-up system in place to deal with the after-effects of the vaccination, the report said. It found that in many schools, only the verbal consent was taken from the hostel warden/ teacher-in-charge to vaccinate girls residing in the hostels and the parents had not been informed about it.