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.
“A handful of doctors had turned it into a business on the side. And most patients had no idea what was going on,” said Anand Rai, a doctor at the government-run M.Y. Hospital and a whistleblower. “Many of the trials were conducted on children, mentally ill patients and illiterate people.”
Rai said he retrieved forms that showed thumb impressions and were countersigned not by independent witnesses but by doctors. The Hindi form was one page long, “with difficult words,” Raid said, and the English forms he retrieved were about 30 pages long.
Last month, Rai said he received an e-mail from the U.S. Food and Drug Administration office at the U.S. Embassy in New Delhi seeking “specific information on the clincial trials of concern” that were conducted in Madhya Pradesh.
A Merck spokesman said in an e-mail that the company was aware of the allegations but its subsidiary MSD in India had provided information about their trials to the Indian drug regulatory agency, and “was not found liable for any compensation” and no deaths were reported in their trials, which have been continuing for five years.
A spokesman for Pfizer said that the company canceled its trial in Indore because proper processes were not followed, and that it has produced an audio book in Indian languages that is shared with staff and patients, to educate participants about their rights and responsibilities.
“People will think twice and thrice before coming to a hospital in Indore now because of this scandal,” said Sharad Pandit, chief medical health officer in Indore.
But one doctor named in the probe said that all the trials have been ethical and legal, and that the protocols were the same as those followed in South Korea, Malaysia and Thailand.
“The consent process is very detailed, meticulous and standardized. Even less-educated and illiterate patients understand the nuances of blinding, control and randomization,” said Apoorva Puranik, a neurologist who said he conducted trials on 40 patients on behalf of MSD, Pfizer and Eisai, a Japanese drug company.
The FDA has already approved the new dosage of Eisai’s Donepezil tablets for patients suffering from Alzheimer’s disease, partly based on the Indore trials, he said. An FDA spokesman declined to share any information on the drug.
Questions about the consent process arose last year in a demonstration project of a vaccine for sexually transmitted cervical cancer carried out by the Seattle-based charity PATH International and the southern Andhra Pradesh state. Hundreds of young school girls were vaccinated after obtaining consent from their teachers and dorm wardens, instead of their parents. The immunization card given to the girls was in English instead of their native language, activists said.
PATH International had said the goal of the study was not to assess the efficacy or safety of the vaccine but generate evidence to introduce it into India’s immunization program. But an investigative report by Sama, a New Delhi-based women’s health advocacy group, said many young girls suffered from acute stomach aches, headaches and dizziness. The government subsequently stopped the study.
Last month in Indore, a government probe recommended that doctors videotape the process of securing consent, and put up large signs on the hospital walls that inform patients about ongoing drug trials.
Meanwhile, health activists across India are collecting signed testimonials from hundreds of drug-trial participants and their families. “We will soon launch legal claims” against drug companies, said Amulya Nidhi, a health activist with the Health Rights Forum in Indore.