New Delhi, Feb. 19: Sections of India’s infirm and sick have emerged easy-to-recruit experimental subjects for US companies testing drugs primarily intended for western markets, a study has indicated.

The study, which analysed more than 500 clinical trials of drugs by the 20 largest US-based pharmaceutical companies, has indicated that companies may be testing drugs in countries where they are unlikely to capture large markets.

Medical researchers at the Duke University Medical Centre have found that one-third (157 of 509) of the clinical trials evaluating various candidate drugs during 2007 were being solely conducted outside the US. Their study, published today in the New England Journal of Medicine, has also shown that more than half of trial sites (13,521 of 24,206) were located outside the US.

Among the trials they examined, none was for diseases such as tuberculosis which are significant problems in developing countries. But they found trials involving drugs for overactive bladders and allergic rhinitis which may not have large markets here.

“It appears many companies are testing drugs in countries where they do not intend to sell them. This creates serious ethical concerns,” said Seth Glickman, a co-author of the study and assistant professor at the Duke Clinical Research Institute.

Clinical trials in low- and middle-income countries also raise issues of ethics because of inadequate local reviews or lack of appropriate informed consent from the participants, the study has suggested.

“An additional cause for concern is that many studies in the low and middle income countries are being conducted in the private domain with no scrutiny from outside eyes,” Glickman told The Telegraph.

Several doctors in India have in the past voiced similar concerns. “The companies conducting trials in India may claim that they have every intention of introducing the drug at the earliest, but know very well that Indians will not be able to afford it,” said Chandra Gulhati, editor of the Monthly Index of Medical Specialities, India, an independent journal of drugs.

“The issue is will the drugs tested on Indian patients be available here at affordable prices?” Gulhati said. A drug named trastuzumab used in the treatment of breast cancer evaluated through clinical trials in India now costs about Rs 20 lakh a year, he said.

The Duke University researchers have also cautioned that standards of healthcare in developing countries might also allow “ethically problematic” study designs or trials that would not be allowed in the wealthier countries.

The study has cited a previous survey that had shown that only 56 per cent of 670 researchers surveyed in the developing countries had their research reviewed by local institutional boards.

“In many situations, we can never be certain whether informed consent provided by volunteers is genuine or under coercion because they're being offered treatment which they would otherwise not get,” said Samiran Nundy, a gastrointestinal surgeon, and former editor of the National Medical Journal of India. “We’re also likely to see more poor or less educated people recruited for trials than rich or educated ones,” he said.

The low cost of clinical trials in India or China and their large pools of patients which allow quick recruitment of volunteers are among factors luring US drug companies to such countries, the Duke University researchers said.

Their study has cited a report from a drug company executive indicating that a first-rate academic medical centre in India would charge $1,500 to $2,000 (Rs 75,000 to 1 lakh) per case report (patient), less than one-tenth the cost at a second-tier centre in the US.