Monday, April 21, 2014

Why seriously affected clinical trial patients not compensated? Supreme Court

Multinational pharmaceutical majors compensate those who die during clinical trials of their new drugs, the Supreme Court on Monday pulled up the Centre for not forcing the sponsors to provide similar relief to those suffering serious adverse effects during such trials.

Taking up PILs seeking stringent yet transparent guidelines and norms for conduct of clinical trials in India, a bench of Justices R M Lodha and Kurian Joseph asked additional solicitor general Sidharth Luthra for details on compensation paid to patients adversely affected during clinical trial of new drugs.

The health ministry had responded to allegations by NGO, Swasthya Adhikar Manch, that Indians were used as guinea pigs by foreign pharmaceutical majors for human trials of their new drugs and said of the 57,303 enrolled subjects, 39,022 completed the trials.

"Serious adverse events of deaths during the clinical trials during the said period were 2,644, out of which 80 deaths were found to be attributable to the clinical trials," the ministry had said. Luthra said kin of all 80 patients, who died because of adverse effects, were compensated by the sponsors.

But the bench was focusing on the ministry's statement that "around 11,972 serious adverse events (excluding death) were reported during the period from January 1, 2005 to June 30, 2012, out of which 506 events were found to be related to clinical trials".

The bench of Justices Lodha and Joseph asked, "Why those patients who suffered serious adverse effects during the clinical trials be not compensated by the sponsors of the test? They may have endured more suffering than those who died during the clinical trial."

Luthra conceded that the ministry had not looked into this aspect and sought eight weeks to get back with instructions from authorities. Senior advocate Colin Gonsalves, for one of the petitioners, said rules had been in place since 2005 mandating payment of compensation to those seriously affected by such trials.

The bench said, "As per the own admission of the government, 506 patients suffered serious adverse effects. They must be compensated at the earliest. The one visited with serious adverse effects in 2005 cannot be in the same state for the last eight years. They must be compensated immediately by the sponsors of the clinical trial."

When Luthra said the authorities have to dig into the records to locate patients seriously affected by clinical trials, the bench suggested that the government could put out advertisements and seek applications for payment of compensation to such patients.

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