Pharma majors under fire over trial compensation

A Union health ministry probe has revealed that pharmaceutical majors conducting clinical trials in India have not given compensation to majority of the volunteers who died during the trials.

Of the 671 deaths that were reported in 2010, the ministry has evidence of just three cases of compensation.

The ministry has asked 44 pharmaceutical companies, including global drug majors such as Eli Lilly, Novartis, Pfizer, Bayer, Merck, Johnson & Johnson and Sanofi Aventis, to explain why they have not given the compensation, which is mandatory under the current drug laws.

A Novartis spokesperson said the clinical trial investigator (who conducted the trial for Novartis) had asserted the deaths were not because of the study medication but due to progression of underlying disease (which won't necessitate compensation).

Similar arguments were made by most pharmaceutical firms that figured in the list.

The data compiled by the ministry show there were 152 deaths reported during Sanofi Aventis' clinical trials, while in the case of Bayer, the number stood at 138.

The probe, carried out by the ministry under the instructions of a parliamentary panel - Committee on Government Assurances headed by Bharatiya Janata Party MP Maneka Gandhi - also revealed that 88 per cent of the deaths pertained to diseases of cancer and cardiovascular and cerebrovascular disorders.

In a submission to the committee, ministry officials said that except in 26 cases, all other deaths seemed to have occurred due to the advanced stage of illness the clinical trial volunteers were in.

Eli Lilly, Amgen, Bayer, Bristol Squib Myers, Boehringer, Quintiles, Sanofi Aventis and Pfizer are among the companies whose clinical trials figure in this list of 26 cases.

The argument, however, has not gone well with the committee. "Of the 671 deaths they (ministry) have mentioned, 26 are directly related to the administration of the experimental medicine. But they are not sure about the other cases as they use terms like 'could be' and 'may be', instead of outright rejection. They need to be more specific," said Maneka Gandhi.

Gandhi said the committee was compelled to seek such information as the ministry did not have any records on the number of deaths and the socio-economic status of the clinical trial subjects who died.

According to Gandhi, the increasing number of clinical trial deaths - 137 deaths registered in 2007, 288 in 2008 and 637 in 2009 - is turning regulatory monitoring increasingly important.

The number of clinical trials going on in India is not more than 1,500, a meagre number as compared to over 100,000 trials that are happening across the world.

The number of trials happening in the US in a year is about 52,000. However, there is no country-specific data on the number of deaths in such trials.

"I am almost sure that other countries do not have this data. This is because there is no centralised body that collects this type of data in those ministries.

Clinical trials in those countries (mainly developed) are a more decentralised affair with regulation at regional/local level being sufficient to ensure protection of subjects in such trials," a World Health Organization (WHO) official said.

Experts, however, feel that identification of actual clinical trial victims and compensating them is a universal practice and needs to be followed in India as well.

"There cannot be a comparison based on deaths as deaths during clinical trials can happen due to various reasons. But what excuse can one give when it comes to compensation? While every clinical trial volunteer is entitled to compensation in case of a severe adverse reaction, is it the same here? In India, it is zero," said C M Gulhati, a Delhi-based medical expert.

McKinsey estimates that the clinical trials industry in India will touch Rs 5,000 crore (Rs 50 billion) by 2011.