Fatal trials

Print edition : May 07, 2010

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 womens organisations and health groups, together with media reports, has finally woken up the countrys 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 Pradeshs 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).

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 ICMRs 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 They pointed out that entire batches of the vaccine had been withdrawn in other countries where hospitalisation and deaths were reported following its use.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 ICMRs 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 Womens Association (AIDWA), the Committee against Violence on Women, the Jan Swasthya Abhiyan, and the Saheli Womens Resource Centre demanding, among other things, the complete suspension of all studies and trials with Gardasil and Cervarix.

The organisations questioned the veracity of PATHs 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 ICMRs 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.

T.K. Rajalakshmi
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