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Trial and Error?

Times of India
09 April 2010
By Kounteya Sinha
New Delhi, India

‘Four deaths not due to flawed cervical cancer vaccine trial’
Trial and Error
Suspending trials of cervical cancer vaccine Gardasil was just a precautionary measure and not an endorsement that it caused complications and death in a few, officials said.

Director general of Indian Council of Medical Research Dr V M Katoch told TOI on Thursday that he was certain that the four deaths were not due to the vaccine. “It has been confirmed that while two deaths were due to poisoning, one died of drowning and another due to pyrexia of unknown origin,” Katoch said.

TOI also has official letters written by the district medical officer of Khammam and health minister Danam Nagender saying “deaths reported from project area of 10-14 year girls are not associated with HPV vaccine”.

“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,” Katoch said.

Katoch on Wednesday night asked the state governments of Andhra Pradesh and Gujarat to immediately suspend the cervical cancer control vaccination programme for girls after complaints of violation of ethical guidelines had come in from activists.

“Activists were linking the deaths with the vaccine. There is however no link whatsoever. The vaccine has already been administered to 25,000 girls without any such adverse reports. Till the issue is cleared, there will be no vaccination. An independent committee should look into the matter,” Katoch said. “It was an operational research to see whether mass vaccination is possible and whether people will accept it. It was more to form a future policy based on solid field evidence rather than endorse a vaccine,” he added.

It is estimated that cervical cancer affects about 4.9 lakh women globally each year, with more than 2.7 lakh deaths.

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