Quintiles and Theravance: telvancin trial followed proper procedures
Last week India’s Livemint reported that the Drug Controller General of India (DCGI) ordered an investigation of the study, which was one of several conducted at the Bhopal Memorial Hospital and Research Centre (BMHRC) in Madhya Pradesh,
The BHMRC, which was set up to care survivors of the disaster at Union Carbide’s pesticide plant in Bhopal in 1984, has been the subject of much debate in recent weeks following the decision to wind up the trust the manages it and the resignation of chairman CJI A M Ahmadi.
The DCGI did not respond to repeated requests for more information about the nature of the telvancin trial audit and has not yet issued any statement detailing its specific motivations for the investigation.
In an email, North Carolina, US-headquartered Quintiles told Outsourcing-pharma that: “All approvals were obtained from the relevant regulatory bodies and ethics committees before the trial began.”
The firm, which is the world’s largest contract research organization (CRO), added that: “We will participate fully in any enquiry as we are confident that all proper procedures were followed.”
In a separate statement, Theravance told Outsourcing-pharma “[it] is aware that the Indian regulatory authorities are making inquiries related to clinical studies conducted at [the] BMHRC between 2004 and 2008.”
The US drugmaker also confirmed “[It] was recently named in an Indian web media article regarding these inquiries because one of the studies conducted at BMHRC during this period was ATTAIN study 0015.”
Theravance explained that the study, which compared telavancin with vancomycin in nosocomial pneumonia caused by methicillin-resistant staph aureus (MRSA), had recruited 7 patients at the BMHRC, three of whom had received telavancin.
In an email, CFO Michael Aguiar told Outsourcing-pharma that: “Theravance hired Quintiles to manage the study in compliance with applicable laws, rules and regulations at multiple ATTAIN study sites in India, including BMHRC.”
He added that: “Prior to enrolling any patients in India, all appropriate regulatory approvals and ethics committee approvals were obtained.
“Theravance and Quintiles are responding to questions asked of Quintiles by India's regulatory authorities as part of their inquiry into drug trials conducted at BMHRC between 2004 and 2008.”
