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LATEST NEWS UPDATES | '436 killed in clinical trials last year'-Durgesh Nandan Jha

'436 killed in clinical trials last year'-Durgesh Nandan Jha

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published Published on Feb 23, 2013   modified Modified on Feb 23, 2013
-The Times of India

As many as 436 people died last year due to serious adverse events (SAE) during clinical trials. Investigations are now on to ascertain how many of the deaths were caused by drugs administered to the trial subjects.

Union health minister Ghulam Nabi Azad said on Friday that deaths could be due to life-threatening diseases such as cancer, heart failure and stroke or side-effects of the drugs or their administration to critically or terminally-ill patients. "Such deaths are investigated to arrive at the causal relationship, if any," Azad said in parliament.

In 2011, 438 cases of SAE were reported, of which 16 were found to be due to clinical trials. The previous year, 668 cases of SAE were reported, of which 22 were caused due to trials.

The union health ministry says there were alleged irregularities in nine cases of clinical trials during the last three years.

According to the ministry report, tribal persons were included in one case of phase IV trial of Human Papilloma Virus (HPV) vaccine, granted to an NGO, on April 22, 2009, to conduct trials in Khammam district, Andhra Pradesh and Vadodara district, Gujarat.

"There were also reports of deaths of seven girls in the same trial which led to suspension of the whole process a year later (April 7, 2010) and a committee was constituted to enquire into the alleged irregularities," said a senior health ministry official. He added that the committee indicted the NGO on several counts including irregularities in methods of monitoring the serious adverse events and remedial measures for the same and indirect coercion through the statement in consent forms stating "you will not be charged for your daughter to receive the vaccine". "However, the NGO conducting the trials was let off with a warning letter only asking them to be careful in future," the official said. Sources said that most of the clinical trials involving patients who died 'due to clinical trial' involved global pharmaceutical giants testing drugs for different types of cancer and antibiotics.

The Supreme Court had recently pulled up the Centre for its insensitivity to scores of deaths and serious adverse effects to thousands during clinical trial of new drugs.

"We have taken steps like mandatory registration of clinical trial in ICMR registry to ensure that safety, rights and well-being of clinical trial subjects are protected," said the health minister.

The health ministry data shows the number of trials being approved has also gone down: from 529 permissions granted in 2010 to 283 in 2011 and 253 in 2012.

The Times of India, 23 February, 2013, http://timesofindia.indiatimes.com/india/436-killed-in-clinical-trials-last-year/articleshow/18638079.cms


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