In a letter to the Union Health Minister, Ms. Karat demanded compensation for the clinical trial victims.
Brinda Karat, Communist Party of India (Marxist) Polit Bureau members and former MP, has demanded action against those involved in the Human Papilloma Virus (HPV) vaccine trials.
Seeking immediate compensation of Rs. 10 lakh to each of those who were made subjects in these irregular trials in gross violation of their rights, Mr. Karat said the fine should be levied by the government on PATH (Programme for Appropriate Technology in Health), the two companies and the promoter, and the Gates Foundation. Additional compensation must be given to the families of those children who died during the course of the trial.
Ms. Karat also demanded action against officials in ICMR and DCGI for permitting the project in the first place in violation of Rules and then subsequently in the conduct of the project including compromising on the issue of informed consent of the subjects.
Recommending blacklisting of PATH, an international non governmental organisation that conducted the trials, Ms. Karat said it should be barred from any activity in India.
In a letter to Ghulam Nabi Azad, Union Health and Family Welfare Minister, Ms. Karat has said as Cabinet Minister for Health Affairs, he cannot escape responsibility. She has impressed upon the Minister to act without any delay so as to send a strong message to other potential exploiters of India’s poor through such irregular clinical trials.
“Indeed, it is deeply regrettable that in spite of the assurances you made on the floor of the House when these issues, now validated by the Parliamentary Standing Committee were raised by me through a Calling Attention motion you have not taken any action against those responsible. I have written to you on several occasions urging you to act, but you have refused to do so. In the light of the report of the Standing Committee, it would be legitimate to ask is it because the health interests of poor adivasi and dalit children have little value for you that you did not act,” Ms. Karat said in her letter.
Ms. Karat had been instrumental in highlight violations during the trials in Khamman and Vadodara district in Andhra Pradesh and Gujarat respectively in 2010. The trials were performed on young girls living in tribal hostels and the consent forms were signs by their wardens and parents, in some cases, in violation of ethics.
She said individuals in the Drugs Controller General of India, Indian Council of Medical research and the National Rural Health Mission working under his Ministry have in this case been shown to have manipulated, violated rules and regulations and have acted to facilitate the interests of the two foreign pharma companies. “If they can act in this criminal manner and compromise the health of children as young as nine years, can they be trusted with taking any other decisions on policy matters? It is true that some of the senior officials who deposed before the Committee on this issue when I was a member of the Standing Committee did frankly express their own criticisms of what happened, but why did they take no action against those concerned,” Ms. Karat has asked.
Importantly, she has said action would also be taken against the officials who misused the NHRM logo in Andhra Pradesh and a time-bound inquiry by an impartial agency into the irregular process of granting marketing permission to the two pharma companies.