Update, June 1, 2020: Dr. Pattanam Srinivasan provided MassDevice a letter from an FDA official, dated May 5, 2014, saying that Srinivasan had adequately responded to the agency’s warning letter and no further action was required.
FDA regulators this month unveiled a series of warning letters issued to Dr. Pattanam Srinivasan, saying that the doctor authorized, sponsored and oversaw unapproved human experiments at the Indiana-based Advanced Interventional Pain Center.
The federal watchdog agency asked Srinivasan for information regarding human trials of an undisclosed technology, saying that Srinivasan and his clinic failed to obtain FDA approval to launch the study and that operators hadn’t done enough to suss out conflicts of interest.
The agency asked Srinivasan to provide detailed documentation of patients’ pre-treatment informed consent as well as documentation demonstrating that the clinic had taken steps to inform patients that the trials had been halted due to FDA intervention.
Among the FDA’s initial concerns were Srinivasan’s many roles within the study. He was the head of the IRB that approved the trial, as well as a clinical investigator and a sponsor. IRB chairman and voting member Dr. Charles Turner was also treating patients in the trial, the FDA noted.
“Please note that we have concerns about you serving in these distinct roles simultaneously,” according to an FDA warning letter dated February 7, 2014, which was made public this month.
The FDA did not disclose the full name of the study or the type of treatment prescribed, but did say that it was a device-based therapy sponsored by Srinivasan.
According to the Advanced Interventional Pain Center website, Srinivasan is the inventor of “the world’s first minimally invasive laser to selectively target pain nerves. This technology is called DT-ULT and ULA has not been approved by the FDA.”
The FDA warning stemmed from an inspection conducted in September 2013, and notes that the clinic responded to the agency’s concerns over the next few months. The clinic told regulators that it didn’t seek FDA approval for its trial because operators believed they were exempt from “any requirement to obtain IDE approval.” The clinic further told regulators that it had taken steps to correct the mistake and had halted all experiments pending FDA authorization.
“To date, there is no record of you submitting an IDE application to FDA,” according to an FDA letter dated March 14, 2014. “You have not provided documentation that you have informed the study subjects who received the device that the study did not have FDA approval and has been suspended.”
The letter further cites a series of violations associated with the informed consent forms, including a patient-signed agreement containing language aiming to exempt the Institutional Review Board, Advanced Interventional Pain Center, Srinivasan and his associates from liability in case something goes wrong. Such an agreement is against the law, according to the FDA warning.
Doctors involved with the trial ultimately failed to follow-up with all patients as prescribed in the investigational plan.
“Your failure to perform follow up physical examinations according to the protocol increased the risks to subjects because of the potential delay in recognizing and treating any study related complications,” regulators said. “This also affects the integrity of the clinical data you submitted to FDA.”