When Chris Hansen of "Dateline" shows up at the door, you know some predator is about to get very publicly busted. So when he and his team journeyed to India to expose CROs for preying on the poor and operating without any ethical considerations or concern for people's health, you know that somebody is going to wind up running from a camera.
In this case, Hansen nabbed two Indian CROs--Lambda Therapeutic Research and Synchron Research Services--willing to test a copy of Vioxx, the once promising treatment linked to heart attacks and thousands of deaths. And they found that both were more than happy to start testing the drug--identified by its old generic name MK-0966--in Indian patients who would be paid a fraction of what trial subjects earn in the U.S. or Europe. One CRO executive bluntly told them that Indian patients would take whatever a doctor prescribed. "Doctor is god," he told Hansen, "So if I go to him, I will blindly follow what he says."
The FDA, of course, rarely tries to police the overseas CROs. That's a big concern for bioethicists. "We have no idea what's going on in these clinical trials," Dr. Carl Elliott, a professor at the Center for Bioethics at the University of Minnesota, tells Hansen.
The Association of Clinical Research Organizations was not amused by the report. In fact, it found some aspects blown out of proportion. Lambda and Synchron, said the group, are not prominent CROs, as "Dateline" depicted. And they dismissed the implication that an Indian study could substitute for a large U.S. clinical trial for a drug like Vioxx. Nevertheless, the report tarnishes Indian CROs just as more and more developers are looking overseas for CROs who can do the work more efficiently. And India isn't the only country where money can attract fly-by-night clinical research groups.