Heated exchanges at open forum to discuss ethics in research

By Our Staff Reporter

THIRUVANANTHAPURAM, AUG. 3. An open forum held by the IMA to evolve an ethical code for drug development research triggered heated exchanges among doctors, eventually concluding with an appeal to restore the prestige of the Regional Cancer Centre, which has been rocked by allegations about unethical clinical trials on a group of patients.

Several participants made impassioned pleas for an end to a public debate on the technicalities of the clinical trial taking into account the on-going inquiries into the clinical trial undertaken with financial support of the Johns Hopkins University in the U.S.

It was unfortunate that the public debate had seriously impaired the image of one of the few prestigious institutions in the State, participants said.

Doctors urged those involved in "dragging into the open an issue which should have ideally been resolved in-house', to spare a thought for the serious apprehensions that the debate in the media had created among thousands of patients for whom the RCC was the only refuge.

The views of participants ranged from an interpretation of the entire episode as a product of personal rivalry between clinicians at the cancer hospital to regarding the issue as a reflection of a larger social malaise which had also afflicted unscrupulous elements among the medical profession as well.

Dr. C. R. Soman, health researcher, said it was clear from all available documented information, including the RCC's official press releases, that there were several claims by the RCC authorities that failed to tally with fact.

According to him, it was almost clear that the administering of the NDGA-derived M4N and G4N chemicals was conducted on patients with advanced oral cancers even though the approval from the Drugs Controller General of India (DCGI) was for the "Open labelled single group study into the effect of Nordihydroguaiarectic acid derivatives on oral and cervical pre- malignant lesions associated with the Human Papilloma Virus (HPV) infection".

In other words, the trial was outside the ambit of the project cleared by the RCC's ethical committee and the DGCI clearance, he said.

Questioning the RCC's claim of holding joint patent rights for drug development with the Johns Hopkins University, Dr. Soman contended that the patent appeal filed in the U.S. by the Baltimore-based institution had no mention of the RCC.

He also wondered how the authorities obtained proper informed consent from Malayali patient volunteers when one of the main co- investigators at the RCC was a North Indian.

The RCC doctors, Dr. V. T. Bhattathiri, clinical radiobiologist who petitioned the Human Rights Commission on the patient rights violation, and Dr. V. P. Gangadharan, medical oncologist, explained their rationale for having been forced to bring the issue into the open. The motive was public good, the doctors who expressed solidarity with the RCC, maintained.

Dr. Sreejith, felt that when viewed in its totality, the need of the hour was to evolve stringent guidelines for clinical research not only for modern medicine but to drug development programmes of all systems of medicine.

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