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Sunday, November 1, 2009

clinical trial and error

Drug trials in India under investigation after 49 babies die at leading hospital

The deaths occurred over a period of 30 months at the ALl India Institute of Medical Sciences public hospital in Delhi

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

Forty-nine babies have died in drug tests at one of India’s top hospitals, raising concerns that ethical standards are being compromised as the country becomes the world’s leading destination for clinical trials.

The deaths occurred over a period of 30 months at the Delhi-based All India Institute of Medical Sciences (AIIMS), an elite medical college and public hospital renowned for providing low-cost treatment to the poor.

The victims were among the 4,142 infants who were used in a total of 42 clinical trials — one of the final stages of developing a new drug — at AIIMS since January 2006, many for Western companies. Of the children used in the trials, 2,728 were aged under a year old.

The mortality rate among the babies, many of whom were seriously ill before they became part of the clinical trials, was 1.2 per cent — significantly below the 4 per cent for all patients treated at the hospital.

However the age of those selected for testing has shocked many in India and there are fears that the increasingly lucrative drug-testing industry may be cutting corners because of a shortfall of staff trained in medical ethics and best practice.

Manish Tiwari, a spokesperson for the Congress party, which heads India’s coalition Government, said: “The practice of using infants like guinea-pigs for drug testing must end.”

Campaign groups have voiced concerns that the poor, often illiterate, parents who make use of the publicly subsidised healthcare that is available at institutions such as AIIMS do not understand the implications of putting forward children to test new drugs.

Rahul Verma, of the Uday Foundation for Congenital Defects and Rare Blood Groups, which exposed the AIIMS deaths after a request under freedom of information laws, said: “If you are rich in this country you go to a private doctor. You certainly don’t put your child up to be experimented on.”

India has become the leading destination for international pharmaceutical companies to outsource clinical trials, largely because of the diverse genetic pool offered by its population and the low cost of doing business.

Clinical trials on human beings are forecast to become a £1 billion-a-year industry in India by 2010. According to the Indian Pharmaceutical Alliance, GlaxoSmithKline, the London-listed pharmaceutical giant, and Johnson & Johnson, its US-based peer, are the two leading groups engaged in testing new drugs in India, each conducting 22 trials over the past year.

There is no suggestion that either company is involved in the testing that led to the deaths.

However recent research by the Indian Government’s Planning Commission highlighted a chronic shortage of trained staff. A report found that the country is short of between 30,000 and 50,000 research personnel, including trial investigators, auditors, staff qualified to serve on ethics committees and data safety management boards.

The country’s regulatory infrastructure has been found to be weak and the office of the Drugs Controller, which has to approve drugs trials, including those at AIIMS, is understaffed.

A spokesman for AIIMS, which has a strong international reputation, said that it was important to note that it was not yet known how many of the deaths occurred among babies given drugs and how many among those in control groups, who received placebos. “Many of these babies were very ill,” he said.

It is understood that an inquiry into the deaths ordered by Anbumani Ramadoss, the Indian Health Minister, will focus on two trials carried out at AIIMS funded by the World Health Organisation and the Indian Government. It is not known what treatments were being tested.

Experts said that the entry of large Western drugs developers into India has raised safety and ethics standards but admit that India’s regulatory systems are failing to keep pace with a boom in clinical trials.

Rashma Cama, of the Indian Institute of Clinical Research, said: “Informed consent is now the norm and regulations have become stricter but there is a need for savvier investigators.”

AIIMS denied any slip in standards. It said that illiterate parents have a document approved by the hospital’s in-house ethics committee read out to them that “outlines the risks and benefits and emphasises that parents/guardians can opt out of the trial any time they want”.

About 139 new trials were ousourced to India last year, putting it well ahead of the second-placed China, which had 98. The market value for clinical trials outsourced to India is estimated to stand at about £150 million, having increased by 65 per cent last year. It is expected to hit between £750 million and £1 billion in the next two years.

Documents showed that Shire, the British-based group, was named by the hospital as being among the five leading testers of drugs at AIIMS.

Shire, which is testing a treatment for Gaucher’s disease, a rare inherited disorder, at AIIMS, said that no children had died in its trials.

A spokesman for the company said: “All the patients enrolled in the trials must be at least two years of age and there is a vast age range in the trials.

“This trial has been approved by a local ethics committee and regulatory bodies in India, and follows good clinical practices as outlined by the international conference on harmonisation.”

Trial and error



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