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Supreme Court seeks report on HPV vaccine trials by PATH in Andhra, Gujarat

Joseph Alexander, New Delhi
Thursday, October 3, 2013, 08:00 Hrs  [IST]

The Supreme Court has sought a report from the Centre on the reported irregularities during the conduct of studies using Human Papilloma Virus (HPV) vaccine by international organisation PATH in Andhra Pradesh and Gujarat.

The notice to the Centre was issued by the Apex court during a hearing on the ongoing case about the violations of norms during the clinical trials on a petition filed by public interest organisation Swasthya Adhikar Manch.

Sanjay Parikh, senior counsel appearing for Swasthya Adhikar Manch, made the intervening application based on the 72nd Parliamentary standing Committee on Health and Family welfare report dated August 30, 2013 where in it has been recommended that action should be taken against PATH, state governments of Andhra Pradesh, Gujarat, ICMR, and other government officials including Drug Controller General of India (DCGI).

In the said case HPV vaccine was given to 14,091 girls in Khammam district of Andhra Pradesh and 10,686 girls in Vadodra, Gujarat. These girls were between age group of 10-14, of which seven girls died due to these illegal vaccine trials, the NGO argued.

It may be noted that the Parliamentary panel had severely came done on matter, questioning the roles of ICMR and DCGI in the trials conducted by two US-based pharmaceutical companies through PATH on tribal school girls in Khammam district in Andhra Pradesh and Vadodara in Gujarat in 2010. The trials were stopped only after the matter received media attention following the death of seven girls. The CDCSO had then also examined the issue.

While hearing the case, filed in February 2012, the Supreme Court on Monday also stayed the approval given by the DCGI to 162 clinical trial applications and asked the Centre to put in mechanism to monitor the trials in the country.

The counsel for the NGO highlighted the facts contained in the two affidavit filed by the Ministry of health and family welfare. In the additional affidavit filed by the Ministry it was stated that out of 475 New Chemical Entities only 17 were approved for marketing which comes to less than four per cent. But in these clinical trials 2,644 persons died out of which only 80 deaths were attributed to clinical trials. Similarly, out of 11,972 SAEs, 506 alone were attributed to clinical trials.

He mentioned that total 259 applications regarding NCEs/NMEs have been recommended for approval between July 3, 2013 to August 31, 2013 out of them 162 have been approved for clinical trials by DCGI. The court asked the Government to submit all data related to approved 162 clinical trials to review.

The Petitioners pointed that in their affidavit Ministry had mentioned that due to clinical trials of New Chemical Entities/New Molecular Entities (NCEs/NMEs) 164 deaths had occurred in the year 2010, out of which 125 alone had died on account of clinical trial of rivoroxaben by Bayer. However, as per the Ministry office memorandum dated 26.04.2011 to the Lok Sabha Secretariat a total 671 cases of death occurred in the Year 2010 out of which 89 deaths were related to clinical trial.

“The above data is contradictory to Ministry of health and family welfare in which they are claiming that only 80 deaths due to clinical trials occured from year 2005 to 2012. The list of drug companies that conducted the trials included several pharmaceutical companies such Bayer, Eli Lilly, Pfizer, Sanofi Intas, Merck, Boheringer, Astrazeneca, Novartis, etc.,” said a spokesman of the NGO.

Counsel for Swasthya Adhikar Manch mentioned that the reason for so many deaths is because NCEs/ NMEs are being tested on Indian citizens without following the regulations and taking necessary precautions taking advantage of poverty and tardy implementation including corruption. It was also urged by the Counsel that the clinical trial of NCEs/ NMEs is not at all beneficial to the Country and therefore, should not be allowed.

As per the letter dated 26.04.2011 written by the Ministry to Lok Sabha Secretariat, from the year, 2005 to 2010 alone 1243 global clinical trials has been permitted. In the other letter dated 06.06.2011 by DCGI it has been mentioned that out of 645 cases of death response has been received only in 300 cases and out of 300 in only two cases compensation and treatment expenses have been paid, according to the petitioner.

The Court has given 10 weeks time to the MOHFW to come out with the actual implementation of the suggestions given by State Government, NHRC, Petitioner and NGOs to strengthen the regulatory framework of clinical trials in the country.


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