Deadly shots

The death of four tribal girls in Khammam, Andhra Pradesh, who were vaccinated with the human papiloma virus (HPV), shows, yet again, the lack of control over clinical trials in the country. The vaccination was a demonstration project and was intended to prevent cervical cancer. It was  undertaken by an NGO on behalf of a pharma multinational and the vaccine was administered to thousands of girls. The authorities have denied the deaths were caused by vaccination and have claimed the girls committed suicide. But there are serious doubts about the project. Though the authorities have denied any side-effects, it has been confirmed that many girls suffered from problems like epileptic fits and nausea after the vaccination. As in the case of many clinical trials, the full truth is not revealed to the public.

In the strict sense of the term the HPV vaccination programme was not a clinical trial as the vaccine is ready and is even sold in the country. But the demonstrative nature of the project makes it a clinical trial.  It has now come to light that the vaccine has not undergone country-specific safety trials. The International Agency for Research in Cancer (IARC) is conducting these trials and before the results are known the vaccine was administered to thousands of girls and is being sold over the counter. The dangers posed by unregulated clinical trials to human lives and health are well-known. Many of the companies that undertake such trials are known for their unethical conduct.

The government has claimed that the regulatory system is strong. But it can be made stronger. The testing procedures and processes should be more transparent. The rules are not implemented effectively. Otherwise how can a vaccine which is only undergoing trials in controlled conditions be administered to thousands of school girls? The authorities even tried to defend themselves with the claim that the girls’ parents had given their informed consent for the vaccinations. What does consent from illiterate tribal parents mean? Such trials have resulted in deaths in the past, including in the premier medical institution AIIMS. A Delhi court issued a notice to the health ministry last year for giving permission for use of untested vaccines. All this underlines the need for more caution and vigil in dealing with clinical trials. Poor and ignorant people should not be allowed to become victims of the use of untested vaccines and unsafe trials.