Infant deaths in clinical drug trials in India raise concern about ethical standards

The revelation that 49 babies died at a top Indian hospital during drug tests has shocked many and raised issues concerning ethical standards at the hospital.

The deaths of the infants at the All India Institute of Medical Sciences (AIIMS) public hospital in Delhi occurred over a period of 30 months.

The AIIMS is an elite medical college and public hospital with a robust international reputation and is renowned for providing low-cost treatment to the poor; the 49 babies were among 4,142 infants, 2,728 of whom were under age 2.

The 42 clinical trials, conducted since January 2006, represent the final stages in the development of new drugs designed in the main for Western companies.

The mortality rate of 1.2 per cent is in fact significantly below the 4 per cent for all patients treated at the hospital, most of whom are very poor, very sick and as a consequence - desperate.

Even in India the age of those selected for the trials has shocked many and raised fears that the lucrative drug-testing industry may in such circumstances, be compromising ethical standards because of a shortage of staff trained in medical ethics and best practice.

Both politicians and campaign groups have voiced their concerns that the poor, often illiterate, parents who make use of the publicly subsidised healthcare available at institutions such as AIIMS, simply do not understand the implications of allowing new drugs to be tested on their children.

The AIIMS infant deaths were exposed by a request under freedom of information laws, by the Uday Foundation for Congenital Defects and Rare Blood Groups.

India has become attractive to international pharmaceutical companies regarding clinical drug trials, because of the diverse genetic pool offered by its population and the low costs of conducting such business.

Clinical trails are carried out to test the efficacy and safety aspects of a new vaccine or therapy and a test on human patients is the last stage of a drug's development after it has been tested in a laboratory on animals and human volunteers.

Experts forecast that human clinical trials will become a multi-million dollar industry in India by 2010; both GlaxoSmithKline and Johnson & Johnson have been involved in 22 trials each, testing new drugs in India over the last year (neither company is involved in the current furore).

However there is a recognised, documented, chronic shortage of trained staff, including researchers, trial investigators, auditors as well as staff qualified to serve on ethics committees and data safety management boards, and experts say India is struggling in all ways to keep abreast of the boom in clinical trials.

A spokesman for AIIMS says in defence of the deaths that many of the babies were very ill and that it is unclear as yet how many of the deaths occurred among babies given drugs and those given placebos.

An inquiry into the deaths will focus on two trials carried out at AIIMS funded by the World Health Organisation and the Indian Government.

AIIMS says illiterate parents are read the approval document which outlines the risks and benefits and says parents/guardians are free to opt out of the trials at any time.

Last year, 139 new drug trials were outsourced to India and 98 to China; the lucrative business is worth about U.S. $280 million to India and expected to reach between U.S. $1.4 billion and U.S. $1.85 billion in the next two years.

The average cost of getting a new drug onto the market is around U.S. $900 million and human clinical trials are the most expensive phase of drug development - by holding the trials in India that cost can be reduced by as much as 60%.

Around 400 trials are thought to be now under way in India.

Drugs currently on trial at AIIMS include zinc tablets for treating deficiency, olmesartan and valsartan for treating blood pressure-related problems, rituximab for treating chronic focal hepatitis and gene-activated human glucocerebrosidase for treating liver-related ailments.