‘436 died during clinical trials last year’

As many as 436 people died last year due to serious adverse events (SAE) during clinical trials and the Union Health Minister has said the deaths could be due to life-threatening diseases such as cancer, heart failure and stroke or the side-effects of the drugs or their administration to terminally ill patient or critical 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 believed to be due to clinical trials while the previous, 668 cases of SAE were reported, of which 22 were caused due to trials.

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The health ministry reports that there were only nine cases of irregularities in clinical trials during the last three years. Reports suggested that a phase IV clinical trial for an HPV vaccine was carried out on unsuspecting tribal girls. ‘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.

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There were also indications that on several counts where the NGO which was conducting the aforementioned trials behaved irregularly. In some cases the consent forms actually read ‘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.

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Various sources also suggested that major global pharmaceutical companies were using India as their testing ground for different drugs for cancer and antibiotics.  The SC had also pointed out the government’s failure to halt unethical clinical trials by multinational drug companies on Indian patients who were used as ‘guinea pigs’. Referring to a May 2012 report of the Parliamentary Standing Committee on health and family welfare, Judges R.M. Lodha and Anil R. Dave said ‘it really pains us that illiterate people and children of India are being used as guinea pigs by the multinational drug companies’. 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.