New Delhi, March 10: The Supreme Court today expressed shock at what it said was a “disturbing” figure of 3,458 deaths and 14,320 serious adverse events documented among volunteers in clinical trials in India conducted by drug companies between 2005 and 2012.
However, additional solicitor-general Sidharth Luthra told the apex court that not all deaths and SAEs can be attributed to the clinical trials as only 89 deaths and 506 SAEs were attributable to the clinical trials.
In other words, the rest of the 13,814 SAEs and 3,369 deaths were unrelated to the clinical trials. Those deaths, Luthra said, were because of the natural progression of terminally ill diseases.
The figures are based on an affidavit filed by the Union health ministry.
The apex court bench of Justices R.M. Lodha and Kurien Joseph apparently was not convinced with the stand of the government.
“Look, it is not a question of one, two or three deaths. The figures say that there were 3,458 deaths. It is a very serious matter and disturbing. We want to know what is the mechanism that you have put in place to prevent it.”
“We also want to know whether you have paid compensation to the 14,320 persons who had serious adverse effects, apart from the 3,458 person who had died,” Justice Lodha told Luthra, appearing for the Union health ministry.
It was at this stage the ASG chose to say that all the deaths and SAEs cannot be attributed to the clinical trials.
But the bench brushed aside the argument saying: “There are trials going on. One thing is obvious that these are not unrelated to the clinical entities and trials we are examining.”
The apex court was dealing with a PIL filed by a non-government organisation named Swasthya Adhikar Manch which, through counsel Sanjay Parikh, had alleged that a large number of gullible patients were being used by pharmaceutical companies as guinea pigs for their clinical trials of new drugs.
A senior drug industry analyst said the absolute figure of 3,458 deaths by itself cannot tell whether it is unusually high or is an acceptable figure, comparable with the deaths of participants in clinical trials in other countries.
“We need to know other figures to determine whether this is something unusual or not,” the industry analyst said. “We need to know the total number of volunteers who participated in clinical trials and we need to segregate the 3,458 deaths according to their health conditions.”
Health ministry figures suggest that between January 2005 and June 2012, about 57,000 people volunteered for clinical trials among whom about 39,000 actually completed the trials. During this period, there were 2,644 deaths.
“This would mean about 6 per cent deaths among participants,” the analyst said. A segregation of the health status of volunteers who died would reveal how many had been terminally ill, mildly ill and how many healthy volunteers died after participating in clinical trials.
Parikh said the health ministry has not disclosed important details such as why certain new drugs were required to be tested through clinical trials, and whether these drugs had been subjected to clinical trials outside India.
The health ministry had already confirmed that the 215 Bhopal gas victims who were subjects of clinical trials were not paid the requisite compensation and that the SAEs including death cases were not reported on time, the NGO said.
Senior counsel Colin Gonzalves, appearing for the NGO, said there was a conflict of interest as a technical committee set up by the government to revise rules for clinical trials included Ranjit Roy Choudhary, who chairs a task force for research at the Apollo Hospital which has conducted 300 clinical trials on behalf of multinational pharmaceutical companies.
In spite of this being a clear case of conflict of interest, Choudhary was still selected to be a member of the technical committee.
The apex court granted four weeks to the Centre to file its affidavits on the points raised by the NGO.