The outsourcing of clinical trials in India is still making headlines because of questionable ethics. Now recent questions are being raised regarding the ethics of recruitment strategies.
Tim Sandler, from NBC, talked to Rajesh Nadia in Ahmedabad, who is paid $12 for each participant he recruits to the three Indian research labs with whom he works, a sizable sum in an area where the average pay is only 50 cent per day. To Nadia, he is doing a humanitarian effort for advancement of medicine and getting well paid. “But a year-long Dateline investigation into one of the preferred destinations for overseas drug trials, India, raises questions about lax regulatory oversight in these studies, the integrity of some of the companies contracted to run them and the reliability of the data they produce.”
In regards to the recruitment strategies, Nadia believes that many of his desperately poor recruits are so eager to enroll that they disregard potential risks. The problem is more profound because the recruits may participate in more than one trial simultaneously to acquire more money. As result of inefficient washout of drugs, the data of the study could be inaccurate. In addition, there are concerns over research participant safety because they would tolerate side effects to keep themselves enrolled and thus acquire more money anticipated to be as much as $400, depending on the length of the trial. This is considered an undue inducement by India’s Drug and Cosmetic Act.
Some social workers believe what is happening in Ahamedabad is a human rights violation because ‘there are swellings in the limbs, loss of eyesight’ and ‘several deaths have occurred’. Since 2008, there have been 1,500 deaths among clinical trial participants according to the Indian government. Most have not been well investigated since most of the official documentation is non existent. Commentators complain of a deficient audit system and a lacking of official oversight on clinical trials.
To read more about what is happening on ground please follow the link Be sure to watch the full report: “The Hansen Files” on “Dateline NBC” Sunday at 7 p.m. ET/6 p.m. CT.
Adapted from NBC news by Tim Sandler