The two Indian CROs implicated in US TV show Dateline’s recent undercover operation have branded the report “unfair” and “out of context”.
Aired on March 4th, the show saw Dateline NBC’s correspondent Chris Hansen go undercover as the CEO of a fictitious pharmaceutical company called Malum Kinetics, which wanted to conduct human testing on a compound identical to Merck’s banned pain therapy Vioxx.
The footage shows Lambda and Synchron – both CROs (contract research organisations) based in Ahmedabad – agreeing to test the drug. Synchron seemingly failed to detect that the compound was Vioxx, whilst Lambda admitted it knew the substance was withdrawn and “dangerous”, but agreed to give it a “fair trial”.
Now speaking to Outsourcing-Pharma, both CROs firms have insisted they were unfairly portrayed, and that the studies would never have taken place.
Shivprakash Rathnam, managing director, of Synchron said: “Forget testing a withdrawn substance in India, the regulators do not permit Phase I studies for molecules discovered outside the country.
“This Dateline team must have learned this before trying this trick on Indian CROs. When this is the fact, not we, none of the Indian CROs could have done this study."
Mrinal Kammili, associate VP of business development for Lambda, denied ever agreeing to take on the trial saying: “Please allow us to clarify that we never agreed to test a substance that has been withdrawn from the market. We have never done something like that in the past and our impeccable regulatory track record is testimony to the fact.”
Contrary to Kammili’s response, during the documentary Lambda VP Phillip Matthew is shown saying: “We are willing to give it a fair trial. We are in the business of doing research regardless of how challenging the project is, but we have to be also realistic.”
He said the firm would have a regulatory struggle, and that it would have to make a “have a huge, huge scientific argument to make the case for doing a study with Vioxx”.
Fair and accurate reporting?
In a recent email sent to Indian CROs from the US FDA, alerting companies to the recent sting and other reports in Western media, the body appeared to support the notion that not all information presented was correct.
The email stated:“I feel the information provided in this story was not completely accurate but I will allow you the opportunity to form your opinion. The FDA was never contacted for comment regarding the information presented in this story, which is unfortunate.”
Kammili told Outsourcing-Pharma there has been no regulatory action over the documentary.
A biased attack
Both firms also insist the report was a biased attack on the Indian CRO sector.
Kammili told us: “We feel this misleading article has tried to malign our impeccable reputation and standing in the global research industry with a malicious intention of harming the prospects of the Indian clinical research Industry as a whole.”
Rathnam was more critical, alleging that Hansen used unreliable sources arguing that he should have spoken to Indian officials rather than just “a few illiterate volunteers”.
Rathnam also said he is disappointed the documentary team had only spoken to the US version of ACRO (the Association of Contract Research Organisations) and said he felt its Indian counterpart had been skipped.
He said: “This gives me the impression that his [Hansen's] focus was to target Indian CROs and portray them in poor light.”
In their responses, Kammili and Rathnam were positive the show would not affect their business.
However John Lewis, VP of public affairs at US ACRO, told Outsourcing-Pharma he believed the program could affect business for smaller CROs in the region.
He said: “Pharmaceutical and biotechnology companies want to test and market new products in India, as they should.
“They are likely to look to leading research organizations, like the members of ACRO, to execute all clinical trials to globally-accepted standards, and perhaps will be less likely to use small, local companies that may not be able to meet such standards.”