Don't believe everything you see on TV.
Executives from Indian CROs Lambda Therapeutic Research and Synchron Research Services want you to apply that mantra to a recent report on NBC's "Dateline," a sting suggesting that they were more than willing to test a copy of Merck's ($MRK) Vioxx on poor people without thinking of human health. That's a big deal, because the drug, a now-banned treatment for pain and inflammation, was linked to heart attacks and large numbers of deaths. They told Outsourcing-Pharma that the report was taken out of context, often just plain wrong, and that it painted Indian CROs in an unfair light that sought to damage the surging sector.
Synchron's managing director, Shivprakash Rathnam, is quoted in the publication as saying that neither his nor any other Indian CRO would have performed the study because "the regulators do not permit Phase I studies for molecules discovered outside the country."
Similarly, Mrinal Kammili, Lambda's associate vice president of business development, denied that his company had ever agreed to take on such a trial. But as Outsourcing-Pharma reports, another Lambda executive is shown in the "Dateline" story expressing the opposite, stating that the company was "willing to give it a fair trial" and was evaluating "how challenging" the trial would be. The executive also noted, however, that such a trial would be a regulatory struggle and that testing Vioxx would need a "huge, huge scientific argument" behind it before it could happen, according to the story.
Both company's executives also criticized "Dateline" in the Outsourcing-Pharma report for not talking to Indian officials, or at least members of the Indian version of the Association of Clinical Research Organizations.
An ACRO spokesperson told Outsourcing-Pharma that the program could hurt the business of smaller CROs such as Lambda and Synchron, even as drug companies increasingly seek to test and market their new products in India, leaving them to rely more on larger companies, which are more likely to be ACRO members (making them safer to use).
- read the Outsourcing-Pharma story