Times of India
17 June 2010
By Suchandana Gupta
Bhopal, India

Bhopal Hospital Admits Drug Trials, Says Tests Done With Consent Of Patients
A week after light punishment to six accused in Bhopal gas tragedy provoked nationwide outrage, an NGO dropped another bombshell on Wednesday saying the victims of the world’s worst industrial disaster were used as guinea pigs in drug trials at a hospital set up for them.

Bhopal Gas Peedith Mahila Udyog Sangathan (BGPMUS) claimed it had documents to prove that the trials were conducted without the patients’ knowledge and some of them may have even died during the tests at Bhopal Memorial Hospital and Research Centre, which works under the Supreme Court’s supervision.

The hospital director, Dr K K Mauder, washed his hands of the controversy, saying he had issued a circular ordering an end to the trials in August 2008. “The hospital hadn’t issued orders for the trials, but individual faculty members get such assignments from pharmaceutical companies,”he said, adding that proper protocol was followed. “The patients who underwent the trials had signed consent forms.”Dr Mauder said pharmaceutical companies provide funds for such trials.

BGPMUS convener Abdul Jabbar, howecer, debunked the director’s claim and alleged that the patients were duped into signing the consent papers. “Most victims couldn’t read English and were asked to sign papers in the language,”he said. “A copy of the consent statement should have been given to the patients, but that wasn’t done. Victims were used as guinea pigs.”Jabbar said the hospital was forced to issue the circular after similar trials allegedly killed 49 children at New Delhi’s All India Institute of Medical Sciences in July 2008.

Ramodar Shrivastava, a victim, said a nurse asked him to sign the consent paper without explaining why he was doing so. “The nurse told me yahan dastakhat karo (sign here). After that, they gave me a few bottles of redcoloured capsules, which I had to take twice daily. I was asked to return the empty bottles after I finish the dose,”said Ramodar. “I had no clue that they were experimenting on me.’’

Activists have traced 160 patients and medicines used for the trials. The medicines tested included Fonda Parinox (for blood clog removal in the veins), Prasugrel, Clopidogrel (for blood platelets), telavamcin antibiotic (used for anesthesia), mometasm and formoterol (for pulmonary diseases), magnex and tygacil (for gastro-intestinal diseases). The hospital acknowledged that 86 cardiology patients underwent trials for Fonda Perinox, Prasugrel and Clopidogrel.

“Fonda Perinox has very serious side effects and at least two patients succumbed to excessive bleeding while on trial for the medicine,”said a BMHRC doctor. He said normal procedure of briefing patients on the risks involved wasn’t followed. “The patient is also briefed on how to take the drug and what to do in case of an emergency,”he said. “The doctor also has to keep the patient under observation,”he said. He said the patients signed the consent papers without knowing the truth behind the deal.

Laxmi Mishra, a 75–year–old gynaecologist, said she signed the consent paper thinking she was doing it for her angioplasty operation.

“I’m extremely sensitive to certain drugs and would have never consented for a clinical trial under any condition,”she said. “Even in the discharge summary, they didn’t mention the name of the drug which was experimented on me.’’

The hospital hadn’t issue orders for the trials, but individual faculty members get such assignments from pharmaceutical companies... The patients who underwent the trials had signed consent forms
Dr K K Mauder | Bhopal Memorial Hospital
and Research Centre Director
Most victims couldn’t read English and were asked to sign papers in the language. A copy of the consent statement should have been given to the patients, but that wasn’t done. Victims were used as guinea pigs
Abdul Jabbar | NGO Convener