on april 7, the Indian Council of Medical Research (ICMR) stopped its cervical cancer vaccination drive in Andhra Pradesh and Gujarat, which it started in August last year. Several girls—10-14-year olds who were part of the vaccination drive—suffered side effects, and six died. The link between the vaccines and deaths has not been established. But health groups have alleged that ICMR’s vaccination project did not conform to the guidelines for clinical trials in India. In response, the ICMR has commissioned an enquiry.
ICMR partnered with path Interna-tional, an ngo in the US, for the project—currently under India’s National Rural Health Mission. path’s motivation to bring the vaccines to India was based on their experience that it could take decades for new vaccines to be made available in developing countries.
“Market forces are often not strong enough…we are preparing the way for the new…vaccines by providing decision makers with the information...whether and how to add vaccines to health programs,” its website says.
Does India need the vaccine? Activ-ists and doctors say screening methods for cervical cancer are more urgent than the vaccines, which cost Rs 3,300 per dose—one course comprises three doses.
Besides, the vaccine against human papilloma virus (hpv), which causes cervical cancer, does not cover all cancer causing hpv types—a fact that path admits. Then, why were the vaccines, Gardasil and Cervarix, given?
Half truths
Heena Zubanu, 14, goes to Vishwa Bharati School in Dhaboi block in Vadodara. Last year her teacher asked Heena to get a form signed by her parents. “She told me it will take care of all health problems after marriage and I would have no difficulty in bearing a child,” Heena said.
The form said the vaccine, available for free in the region, would protect girls from cervical cancer, cause no harm and if there was any serious side effect, the parents could take their daughter to a government hospital. It added that the vaccination was not mandatory and no action would be taken if they decided not to get their child vaccinated.
The vaccine works for seven years, which the form does not mention. Screening for cervical cancer therefore is crucial. In some schools, the state did not follow the prescribed dosage. Heena got three injections—one every two months. Ideally, the second dose should be given a month after the first and the third dose, six months after the first.
More than 30,000 girls have been vaccinated in Vadodara. B R Solanki, the chief district health officer, claimed the causes of the deaths of the two girls in Gujarat were not related to the vaccine because they happened 28 and 58 days after the vaccine was given. “One died of snake-bite and the other was anaemic,” Solanki said.
In Khammam district in Andhra Pradesh, parents were not informed about the vaccine, said Sama, a women’s health group in Delhi. Wardens of a school hostel signed on behalf of the parents, the group found. Of the 14,000 vaccinated in Khammam, over a hundred complained of headaches, stomach disorders and early onset of menstruation. Some even had epileptic fits.
One reason for the side effects, said Pradnya Parulekar, a gynaecologist in Mumbai, could be that the vaccines were given to girls under 15. “The age group targeted is way too young because girls in India do not become sexually active so early. This could result in acute demyelinating encephalomyelitis, caused by an infection in the brain,” Parulekar said.
Some doctors believe vaccines work best before a woman becomes sexually active because there are minimal chances of the virus being present in the body. “Vaccines help in developing antibodies against hpv. They don’t make sense if a woman is already immune to hpv,” said Bela Kedia, consultant gynaecologist with Wokhardt and Guru Nanak hospital in Mumbai. “Women between 35 and 39 are a high-risk group. Pre-cancerous lesions in cervical cancer develop eight to 10 years before the disease is detected. Screening for the disease once every three years is a must—even after vaccination,” she added. Usually, a Pap smear test is conducted to check for pre-cancerous lesions. Other less expensive screening methods also exist (see box).
If the government introduces screening methods and focuses more on nutrition of women, vaccines would not be required, said Jana Swasthya Abhiyan, a group of non-profits working on health. Besides, it will take 30-40 years to observe any changes in the incidence of cervical cancer in the vaccinated population. “If the government is administering the vaccines as the third phase of clinical trials, will it monitor the vaccinated population for the next 40 years?” asked Amar Jesani, trustee of Anusandhan Trust in Mumbai, which works on medical ethics.
The vaccine is effective because it stops the virus from colonizing, said V M Katoch, director-general of ICMR. He, however, admitted that the project did not plan to monitor the girls later.
But this is not clinical trial
The project is not a clinical trial for the simple reason that the vaccines are approved and available in the market, said a path official who did not want to be named. India approved both the vaccines in early 2009. After the clearances, path proposed the project and ICMR approved it. Katoch also said that the vaccination drive was a demonstration project, not a clinical trial.
“Is the project designed as an experiment with a control group or a demonstration to check if health workers can conduct such a programme?” asked Jesani. “The protocol for a demonstration project is not clear,” he added. cpi (m) MP Brinda Karat also wrote to the Union health minister asking him about the status of the clinical trials. “The minister (Ghulam Nabi Azad) told me these are bridge studies,” Karat said. (Bridge studies check the ability of a drug to provoke response from the immune system.) “But, on April 16, the minister of state for health informed Parliament that they had halted the third phase of clinical trials. It is indeed shocking that they are misleading Parliament,” Karat added.
A demonstration project is to see how masses respond to the vaccine, said ICMR officials. “Since this is administered to adolescent girls as mass vaccines in schools, we need to see if the community accepts it. We might include them in the National Immunization Progr-amme if they do,” Katoch said.
Private hospitals in Delhi have started recommending the vaccine. “But it is not a foolproof measure,” said Suchi Katyal, a gynaecologist in Sitaram Bharatiya Institute of Science and Research in Delhi. It’s best when given to teenagers and should be followed up by screening, she added.
“Unless the government details a plan for cervical cancer control, with boosters, screening and treatment, the vaccination drive is just an experiment with the innocent and the vulnerable sections of the society,” wrote the Jan Swasthya Abhiyan in a letter to the Union health minister.