Regional Cancer Centre of Kerala has been accused for conducting an experimental trial of M4N, an acid derivative of NDGA, an herbal drug banned for human use in the U.S. In a complaint filed before the state human rights commission, associate professor and head of the radiobiology section of RCC, V.N. Bhattathiri, revealed that a team of doctors had been conducting an experimental trial of M4N. The petitioner had cited that the drug was being injected into patients who have to undergo urgent surgery. The NDGA is categorized as, "for use of research only, not for human or drug use". M4N is an analog of the NDGA.
The study was conducted under a "collaborative project" between the RCC and the John Hopkins Hospital and University, Baltimore. The chairperson of the human rights commission, Dr Balaraman, has asked the RCC for a report.
Meanwhile, the ethical committee of the RCC has withheld its consent to use the drug for Phase II following "apprehension of an improper study". According to Dr Gangadevi of the committee, the use of M4N was for local (external) use and not for injection. Curiously, the RCC has gone in for the study without waiting for the drugs controller general's sanction. The controller's letter for phase II for M4N and G4N came on February 19, 2001, while the clinical trial began in November '99. Evidently, the RCC had not sought permission for Phase I, another senior doctor of the RCC said.
Meanwhile, four of the 25 patients recruited for these projects denied having any knowledge of the drug used on them. 'Foscan' another untried drug developed by Scotia Holdings Plc of the UK for photodynamic therapy has been on use in the RCC, alleged a doctor. This was apparently the main drug that they had banked on for growth. The RCC director, when contacted, suggested that these queries be put to two doctors of John Hopkins who were coming to the RCC on August 2. He argued that the trials were for the benefit of patients.
Meanwhile, in an explanatory note to health minister P. Sankaran, the director said the studies were conducted with the "full consent" of the patients. He argued that it was NDGA, not M4N that was banned for human use. "Moreover, no ill-effects were noticed of this drug. A leading surgeon of the city and medical activist, C.R. Soman, has called for a thorough inquiry into all the foreign-funded studies in government hospitals in Kerala.