Norms 'violated' in cervical vaccine trial

Risk and benefits of drug were not explained to girls and their parents

Norms 'violated' in cervical vaccine trial

Doctors say vaccine should be the last option for India. AP

The vaccine is to protect girls from human papilloma virus, one of the important causative agents of cervical cancer, whose prevalence is very high in India.

In Khammam district of Andhra Pradesh where the trial was conducted, PATH did not properly explain the risk and benefits of the vaccine to the girls and their parents, many of whom are unlettered.

“In a hostel for Scheduled Tribe girls in Laxminagaram village, where 278 girls were vaccinated, the warden of the hostel was advised by the heath official to sign on behalf of all girls. This is a travesty of informed consent,” said CPM MP Brinda Karat.

“Some of the girls were told that the vaccine would give lifelong protection whereas in reality the vaccine can protect only for five years,” Karat said.

The vaccine’s efficacy would be known only when the girls attain 20-25 years of age. Ideally, they should be periodically monitored till that time.

Even though the trial is being conducted by PATH with financial support from Bill and Melinda Gates Foundation, the logo of National Rural Health Mission was printed on the vaccine card without the approval of the government.

Official look

The card also has address and phone number of the district immunisation officer as the contact person giving it an official look. “Many went for the shots assuming it a government programme,” Karat said.

PATH stated it was a joint project with the Indian Council of Medical Research. But ICMR director general V M Katoch told Deccan Herald that the agency’s role was limited to protocol development, technical supervision and advising the NGO on regulations.
“We do not support any violation of ethical practices in any clinical trial,” he said.

Doctors are now questioning the very rationale of the trial as the Rs-7,500 vaccine (three doses) is too expensive to be incorporated in the government programme in near future.
“In the West, the number of cervical cancer patients has been brought down up to 80 per cent only through a screening programme,” said Elizabeth Vallikad, head of gynaecology division at St John Medical College in Bangalore.

Doctors say vaccine should be the last option for India. An awareness campaign followed by a screening programme can bring down prevalence.

PATH is being accused to push the vaccine for the benefit of the manufacturers — Merck and GSK. Despite repeated efforts, PATH officials were not available for comment but Merck said in a statement that its vaccine is “safe and effective”.

Two vaccine trials were scheduled in Andhra Pradesh and in Gujarat to examine the vaccine’s usefulness in the public health programme. Nobody, however, seems to know the status of the Gujarat leg trial, which was scheduled to start around the same time in Vadodara.

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