Outsourcing clinical trials
It is much cheaper to conduct a research trial in a developing nation like India than in the U.S. But sometimes, research subjects pay the price.
Are the children protected?
In August 2008, the All India Institute of Medical Sciences revealed that 49 children died during 42 trials involving 4,142 patients from the pediatric unit. The hospital blamed the deaths on the children's' underlying illnesses, but the news triggered unease about the largely unregulated drug-testing industry.
Lab fees, among other things, are lower
Despite a very low density of doctors, a shortage of hospital beds and relatively poor health outcomes compared with countries at a similar level of development, India has become a favored destination for clinical trials outsourcing. Vedanta Institute in Amhedabad is one such site. With a population of more than 1 billion genetically-diverse people, India has a huge recruitment pool. It also has a large English-speaking medical work force, a relaxed regulatory environment, low costs for conducting trials, and a low frequency of litigation and compensation claims. According to former GlaxoSmithKline CEO Jean-Pierre Garnier, it costs about $2,000 to track the progress of a single Indian patient in a trial, a figure 10 times less than the cost of tracking a U.S. patient.
Overwhelming need
Families cram into plastic chairs, crouch in corners, crowd doorways and clog up aisles at the All India Institute of Medical Sciences' waiting room. The overstretched government hospital in Delhi treats about 4-million people a year, among them the nation's poorest. Despite its limited resources and overburdened staff, the hospital is one of a growing number of Indian facilities that recruit their patients for clinical research. According to the Associated Chambers of Commerce and Industry of India, the country is poised to develop clinical trials business valued at between $500 million and $1 billion (U.S. dollars) by 2010.
Limited options
Despite high poverty rates, most patients in India pay out of pocket for their health care expenses. Ramsakhi Devi, a 55-year-old widow traveled 48 hours by train to receive treatment in Mumbai. She and her son stayed in an ashram, where orange-robed monks offer a haven for destitute cancer patients from all over country. Stories such as Devi's exemplify the worries many doctors, medical ethicists and other experts have about outsourcing clinical trials. Patients who lack money, education and regular access to medical care are easily found and easily recruited, but what do they get out of it? And, is their consent to participate in clinical trials truly informed?
Informed consent?
After doctors at the government-run cancer hospital removed a tumor from her cheek, Ramsakhi Devi was given the option of signing up for a clinical trial, or going home. Like 39% of India's population, Devi can't read or write, so she put her thumbprint on the consent form for the trial. Her youngest son, Bablu Gupta, 21, signed. He said he understood the trial terms, detailed in English and Hindi, but he did not. The form said there were three treatment options, but Gupta was aware of just one. The form said patients can drop out of the trial at any time. Gupta said his mother was told she had to complete the grueling month-long cycle of chemo and radiation. After treatment, she was weak, nauseated and more dependent on her son than ever.
No longer enough pay
The crowded slums of Ahmedabad in northwest India are prime recruiting ground for drugmakers who need healthy subjects for phase I testing. Among those who have responded is Kamlesh Solanki. A member of India's Dalit, or "untouchables" caste, he has volunteered for about nine phase I trials of new generic drugs since 2001. The most complicated trial paid 7500 rupees (roughly $150 U.S.), a godsend in an area where farmers earn about 50 repees ($1) a day. "They assure you that after the test you will be very much OK," he said. Solanki, 24, who lives with his father and two brothers in a room the size of a U.S.-style single-car garage. At the testing centers "there is total AC, TV, videos and a thick cushion on the bed." He became a recruiter, getting 100 to 200 rupees ($2-$4) for each enrollee, but stopped two years ago. As masses of desperate people compete for slots, pay has dropped dramatically, he said.