Unauthorised Clinical Trials on Bhopal Victims

A year ago, Ajay learnt that his father Ramadhar Shrivastav, a victim of the toxic gas that had engulfed Bhopal in 1984, has been subjected to clinical trials in a hospital that was meant to treat the gas victims.

"We were shocked. We are planning to move legally now against such unauthorised clinical trial," Ajay Shrivastav told IPS.

A Bhopal court last year sentenced eight former top officials of the Indian subsidiary of Union Carbide Corp (UCC) to two years imprisonment each for the 1984 gas leak that eventually killed about 20,000 and left many more incapacitated.

Several of the victims were under prolonged treatment, and some of them fell prey to unauthorised clinical trials without their knowledge.

Ramadhar Shrivastav was part of the Astra Zeneca (a global biopharmaceutical company) trial. He is too sick to speak to anyone.

"At this site in India (Bhopal), some patients were not properly consented," a spokesperson of the company told IPS, admitting that clinical trials indeed took place without patients’ consent.

"These errors were discovered by AstraZeneca through monitoring processes we employ for all of our clinical studies and promptly corrected by the investigator," the spokesperson said.

"Good clinical practice requires investigators to obtain study patients’ informed consent," the company said.

Earlier, Indian health activists in Bhopal gathered proof that the Bhopal Memorial Hospital and Research Centre (BMHRC), which was built with funds from Union Carbide shares confiscated as part of the criminal case on the gas leak, carried out clinical trials on gas victims without their knowledge.

Official documents show that hospital director K. K. Maudar has admitted to the Drugs Controller General of India (DCGI) that there were drug trials. The official documents show that 80 percent of those subjected to clinical trials were victims of the 1984 disaster.

"We have documents showing the details of deaths in the three trials – Fondaparinux (cardiology) and Tigicycline (gastro surgery) and Televancin trial (anaesthesiology) – that took place at BMHRC," Rachna Dhingra of the Bhopal Group for Information and Action told IPS.

"It clearly mentions that almost all people who died were gas victims."

According to the DCGI, six trials were carried out at the BMHRC while the activists say there were more such trials.

"We believe that as many as 10 drug trials were carried out by BMHRC. In their own account statement which was submitted to DCGI they clearly show that they received money for 10 different trials," says Dhingra.

The trials were conducted on 215 gas victims, according to the figures mentioned in the letter of the hospital director to the deputy drug controller of India, Dr R. Ramakrishna, on Feb. 22 this year. The letter also gives a breakdown of the drug trials.

Dr Chandra Gulhati, editor of the New Delhi-based Monthly Index of Medical Specialties, said the BMHRC was set up in 2000 to provide super-specialty care to survivors of the tragedy and carry out research on long-term effects of the methyl-isocyanate (MIC) chemical that caused the deaths.

"But instead of concentrating on MIC-related issues, the hospital became a hot spot for conducting clinical trials on untested drugs that were primarily designed to help pharma companies," he said.

According to a World Health Organisation (WHO) bulletin report in 2008 titled ‘Clinical trials in India: ethical concerns’, transnational drug companies are moving their clinical trials business to India, giving a new urgency to clinical trials registry reform.

India’s powerful industry association Associated Chambers of Commerce and Industry (ASSOCHAM) says the country is set to grab clinical trials business valued at approximately 1 billion dollars by the end of 2010, up from 200 million dollars the previous year, making the subcontinent one of the world’s preferred destinations for clinical trials.

FairDrugs.org, a campaign by a worldwide coalition of health organisations and scientists led by Wemos Foundation in the Netherlands, says people living in countries like India run a high risk from pharmaceutical companies testing drugs on them unethically for the Western market.

An Indian research report published in 2009 shows several pharmaceutical companies’ disregard for ethical rules.

"The Indian Centre for Studies in Ethics and Rights has examined, among other things, the way GlaxoSmithKline tested a breast cancer drug on seriously ill women in India," said Annelies den Boer of the Dutch Wemos Foundation, co-commissioner of the study with the Centre for Research on Multinational Corporations (SOMO).

Sandhya Srinivasan, a researcher who along with Sachin Nikarge documented the report for the Centre for Studies in Ethics and Rights, Mumbai, said it was found that "these trials exploited the fact that most Indians do not have access to good quality and affordable care and therefore may accept offers that might provide better quality and free treatment."

Gulhati says the clinical registration process in India should be more stringent.

"The Drugs Controller General of India should make it obligatory for all trials to be registered on the Clinical Trials Registry site before permission is granted to conduct them."

He said failure to do so should carry a penalty. "In addition, while registering trials, the composition of hospital ethics committees, which approved the trial, should be disclosed. Fewer than 40 ethics committees in India are properly constituted and functioning, which means that the safety of the subjects of clinical trials is on the back burner."

An increasing number of hospitals are now owned by drug companies, he said. "Clinical trials at such hospitals should carry a statement of disclosure about the relationship."

According to den Boer of Wemos, "time after time we see that patients in developing countries are used to test drugs that are primarily intended for the European market. Contrary to the ethical guidelines, these patients do not benefit from the research results."

11-10-2011 © IPS news