India’s drug trials fuel consent controversy

KHANDWA, India — Two months after he lost his wife to Alzheimer’s disease, 80-year-old Sharad Geete made a shocking discovery. The free drugs his wife, Sheela, had been receiving for two years before she died were part of a clinical trial.

“The doctor told us that the medicines will be given free and that they were going to be launched soon by a foreign company. Not once did he say it was an experiment or a trial. If I knew, would I have taken the risk?” asked Geete, sitting in his home in Khandwa, a small town in the central Indian state of Madhya Pradesh.

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(Rama Lakshmi/ The Washington Post ) - Sharad Geete, 80, with a photograph of his radio-singer wife, Sheela, who died last year. For two years before her death, Sheela was a participant in a clinical drug trial for a new dosage of Alzhiemer's Disease drug.

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Since India eased guidelines for conducting drug trials in 2005, the number of Indians participating has shot up to 150,000 from close to zero, as international drug companies take advantage of lower costs here. But questions about the consent process have fueled fears that many Indians are entering the trials without knowing the risks.

A Madhya Pradesh state government probe found that six doctors had violated ethical standards in gaining patients’ consent for participation in drug trials and did not compensate those who suffered adverse side effects in 76 drug trials on 3,300 patients since 2006, according to results released last June.

In the wake of the recent controversies, the Indian Council for Medical Research invited public feedback on draft guidelines about compensation for injuries that occur during clinical research.

The consent form that Geete signed said the medicines were part of a study. “I was so stressed about my wife’s health, I said okay, okay to everything and signed on the form. We never questioned the doctor, we trusted him blindly,” Geete said about his wife, who was a singer. “She became bedridden and stopped speaking or hearing us. She became a vegetable.”

Across India, 1,700 people who participated in clinical drug trials died between 2007 and 2010, the government’s drug regulatory agency said, although no autopsies were carried out to determine the causes of the deaths. In 2010, 22 families of the dead were compensated by U.S. and European drug companies, ranging from $2,000 to $20,000.

Clinical drug trials in 2010 generated business worth $300 million in India, according to the Confederation of Indian Industry. Conducting drug trials here saves the companies almost 40 percent of the total cost of drug development because health-care professionals are cheaper and liability is not very high, analysts said. The large pool of patients with diverse illnesses and doctors who speak English also make it an attractive destination for outsourcing trials.

“India is emerging as a hub for drug trials, and Indian patients are like guinea pigs,” said C.M. Gulhati, editor of the Monthly Index of Medical Specialities journal.

“The ethical review panels are bogus,” he said in an interview. “The drug control authority approves almost all the trial applications without rigorous scrutiny. And poor, unsuspecting patients get duped, while doctors and hospitals earn money.”

In the central Indian city of Indore that Geete and his wife visited for treatment of Alzheimer’s, patients participated in trials for Indian subsidiaries of companies including Novartis, Pfizer, Merck, Glaxo SmithKline and Boehringer Ingelheim, according to documents retrieved by activists using the right-to-information law. U.S. drug companies have conducted trials for Parkinson’s disease, seizures, eye infection, and heart and gastric illnesses.