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Incomplete consent forms and conflict of interest on the part of Government agencies are some of the discrepancies pointed out by a Parliamentary panel in its stinging report on alleged irregularities in a project using cervical cancer vaccines.
The project had been discontinued in April 2010 following allegations of unethical practices and reports that some adolescent tribal girls involved with the project had died.
Undertaken by an American agency PATH, the project was to evaluate the use of the Human Papilloma Virus (HPV) vaccines in mass vaccination programmes, to help protect from cervical cancer.
“It is established that PATH by carrying out the clinical trials for HPV vaccines in Andhra Pradesh and Gujarat under the pretext of observation / demonstration project has violated all laws and regulations laid down for clinical trials by the Government,” observed the Parliamentary standing committee reported tabled in the Rajya Sabha on Friday.
PATH had used cervical cancer vaccines provided by Merck Sharp & Dohme (MSD) in the Andhra Pradesh study, while GlaxoSmithKline (GSK) provided vaccines for the Gujarat study. The Indian Council of Medical Research (ICMR) played an advisory role to ensure adherence to protocols. And the project agreement had been signed in 2007.
Violations
The panel report points out the careless manner in taking informed consent - forms signed by people when they agree to participate in a trial where a medicine is tested on them.
In this case, the report says, in Andhra Pradesh, of the 9,543 forms, 1,948 had thumb impressions while hostel wardens had signed 2,763 forms.
The committee also questions an earlier independent enquiry that said the death of the tribal girls was not linked to the vaccines.
Pointing out that drugs are linked to suicidal thoughts, the report said: “therefore, HPV vaccine as a possible, if not probable, cause of suicide ideation cannot be ruled out.”
In the dock
PATH had violated medical ethics and rights of the child, the report said, urging the Government to take action against PATH, raising questions on its operations and funding in India.
PATH representatives in India could not be reached for comment.
The committee report also put the ICMR in the dock for its conflict of interest in partnering with a foreign agency, even as it plays a regulatory role in clinical research.
The Drug Controller’s office also came in for the stick, for not showing urgency in tightening the system so that similar violations did not take place in future.
Both GSK and MSD said hey had not seen the panel report, and hence, did not want to comment.
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