Thursday, October 9, 2014

#Supreme court hearing on #clinical trials enters crucial phase

The writ petition filed by Swasthya Adhikar Manch came up for hearing on 8th of Oct before the bench of the Supreme Court consisting of Chief Justice H.L Dattu, Justice S.A Bobde and Justice Abhay Manohar Sapre.
This case was filed in February, 2012, this is tenth hearing of the case and the last hearing was held on 25th August 2014.
In the last hearing, the Hon’ble Supreme Court had directed the Petitioners to file an reply  affidavit  based on a comprehensive affidavit filed by  Secretary Ministry of Health and Family Welfare (MoHFW) in respect to the petitioners objection with regard to non-compliance of previous orders dated 21.10.2013 and 10.03.2013 on different aspects concerning Clinical trials of New Chemical Entities.

The petitioners Swasthya Adhikar manch (SAM) has filed its response to the reply filed by MOHFW. In the response SAM has stated that Ministry has not given complete information about 17778 (3458 deaths and 14320 SAEs) which has taken place from January 2005 to December 2013 except stating that in 89 cases compensation has been paid. The Ministry has, however, not  disclosed  the names of persons who have died and to whom compensation has been paid. Regarding 14320 SAEs and 3458 death have occurred from January 2005 to December 2013, no particulars of persons have been provided. The Ministry has also not given any detail of payment of compensation paid to the SAEs. The MOHFW has contended that there were no rules regarding compensation, therefore compensation has not been paid.

The petitioner Swasthya Adhikar Manch has seriously questioned the said stand taken by Ministry of Health & Family Welfare (MOHFW). The petitioner also mentioned in its response that, out of 475 NCEs of, which clinical trials had taken place between January 2005 to December 2012, neither the details of 17 NCEs which have been approved nor the details of remaining 458 have been provided. Response of ministry is that, they do not have any records of 475 clinical trials. This fact speaks volumes about causal and negligent manner in which ministry was acting. Further it also shows that DCGI was functioning in collusion with drug industries. The petitioner has also pointed out that the three parameters namely, risk versus benefits, innovations versus existing therapy and unmet need to the Indian population have not been followed in letter and spirit both by technical committee and apex committee. In a routined way the technical committee had approved 76 clinical trials out of 78 NCEs plus 43 fresh proposals, a total 119 trials in its sixteenth meeting on 10th July 2014 within few hours. It is incomprehensible that the detailed parameters of 78 NCEs could have been analyzed scientifically in one day. The approval granted by technical committee was only an eyewash. Further, the said Technical Committee includes a member – Prof. Ranjit Roy Chaudhary, who has conflict of interest as he is responsible as head of Apollo Hospital's Education and Research Foundation (AHERF) for conducting over 300 global clinical trials. It is also important that Dr. Jagdish Prasad, who is Chairman of the Technical Committee is also a member of the Apex Committee and, therefore, compromises with the independent evaluation by the Apex Committee. The Apex Committee has simply followed what the Technical Committee has decided without independent application of mind.
The MOHFW has also not given details of deaths and SAEs of Bhopal gas victims.  The Govt. of Madhya Pradesh has also not taken any concrete action on unethical clinical trials done In M.Y hospital of Indore despite the departmental enquiry ordered by Chief Minister of Madhya Pradesh dated 17th February 2012.    
The bench of Supreme Court observed that matter requires detailed hearing and hence fixed it in second week of January 2015 on a non-miscellaneous day for final hearing.    
Sanjay Parikh appeared for Swasthya Adhikar Manch. He also represented the Bhopal Gas Peedith Mahila Udyog Sangathan (BGPMUS) and the Bhopal Gas Peedith Sangarsh Sahayog Samiti (BGPSSS) who are interveners in this case.
Swasthya Adhikar Manch has been emphasizing is that the clinical trial of NCEs is not in public interest or in the interest of the country and that the trials vis-a-vis NCEs have been conducted without following the prescribed procedure and in collusion with the drug companies.