More than a month after a "Dateline" NBC special painted an unflattering picture of clinical research trials in India, reactions from officials there have ranged from one extreme to another. While national officials are now focused on tightening policy and procedure, others are crying foul at what they believe is a decent system damaged by "negative propaganda" and "inaccurate reporting," as one high-ranking official with the Association of Clinical Research Organizations (ACRO) India describes.
Much as he does when catching sexual deviants on "To Catch a Predator", NBC reporter Chris Hansen traveled undercover--this time to India. He and his news team caught Indian CROs Lambda Therapeutic Research and Synchron Research Services willing to conduct clinical trials on a copy of the anti-inflammatory Vioxx--once believed to provide pain relief, but whose use resulted in the deaths of thousands--on subjects who would get paid a fraction of what those in the West would receive. The sting illustrated a lack of oversight in research, as well as the exploitation of test subjects.
As reported by Outsourcing-Pharma, the country's spotty history in clinical research opened the eyes of Minister of Health and Family Welfare Ghulam Nabi Azad, who wants to strengthen government monitoring of CROs. India has witnessed the deaths of more than 1,700 individuals in the past three years as a direct result of drug research.
While national officials are acknowledging a broken system, Ashish Dasgupta, ACRO India vice chairman, accuses the media of generalizing an entire country's clinical system based on the actions of a couple of dishonest CROs, like Lambda and Synchron.
"Over the past few months, however, the Clinical Research Industry has been besieged by media reports and statements from various government quarters reflecting abject ignorance about the CR industry, inaccurate reporting as well as political twists and turns. All of this has created an extremely bad name for this vital industry, for healthcare, and the nation," he says in a statement.
For someone who described poor actions of some CROs as "irregularities" that are akin to plane crashes, Dasgupta makes a somewhat valid point. Still, it certainly speaks volumes that Azad, easily one of India's highest ranking officials, has highlighted the industry's flaws and backed the need for government reform to fix them.
On the other side of the world, the perks of retaining CROs from abroad are just too hard to resist, so long as the costs are low and the efficiency of work is high. And if the biggest need for change has to come in the form of bioethics and the change of heart and morals of some CROs, revolutionizing a national system will be incredibly difficult to realize.
- read the Outsourcing-Pharma story here
- check out a PharmaTimes piece on Dasgupta's statement
- read Dasgupta's statement discrediting the Dateline report
- read the Dateline story on clinical research in India