Were banned drugs used on patients?

By Our Staff Reporter

THIRUVANANTHAPURAM, JULY 28. The Director of the Regional Cancer Centre (RCC), Dr. M. Krishnan Nair, said here today that he was ready to face any Government inquiry into the controversial clinical trial undertaken in collaboration with the Johns Hopkins University in Baltimore, United States.

At a press conference, convened in the wake of media reports about alleged use of banned drugs and subjugation of patient rights in the clinical trial, he said he had written to the Kerala Chief Minister, Mr. A. K. Antony, to conduct a detailed inquiry to clear the doubts.

However, the RCC Director said that he saw no need for relinquishing office and that the onus of instituting a probe was on the Chief Minister.

The controversy over the clinical trial project surfaced with a senior RCC clinical radiobiologist petitioning the State Human Rights Commission alleging unethical procedures and subjugation of patient rights.

In 1997, the Johns Hopkins University was forced to abandon a proposal for a joint public health venture with Kerala in the face of pressure from the project's critics.

In his petition, Dr. V. N. Bhattathiri, Head of the RCC's Radiobiology section, alleged that patients had been subjected to trials which exposed them to toxicity from drugs which stood banned by the Federal Drugs Administration (FDA) in the U.S.

According to him, the substance used on patients was the tetra methyl form of Nor Dihydro Guaretic Acid (NDGA), the M4N, developed by the Johns Hopkins University in spite of their being removed from the FDA's ``Generally Regarded As Safe'' category.

Dr. Bhattathiri cited the use of a drug developed by a U.K. firm as another instance of violation of patients' human rights as well as physicians' ethics at the RCC. The petition states that the drug was used on patients who could have been given standard treatment in violation of ethical and moral convention of administering experimental medication only on patients after exhausting available therapeutic modalities.

He alleged that the RCC had gone ahead with the project without mandatory clearance from the Government of India.

Today, Dr. Krishnan Nair claimed that the clearance from the Drugs Controller-General of India was superfluous once the ethical committee of the RCC had sanctioned the clinical trial.

Apparently, it was this sanction of the ethical committee which was utilised to use the G4N chemical though it was not part of the original project proposal. Neither the M4N, an acid derivative of the NDGA, nor the G4N chemical had been banned anywhere in the world, he said.

According to Dr. Krishnan Nair, all that was required was a formal ratification from the DCGI, a request for which had been made the other day. This delay in getting the ratification was the only `lapse' that Dr. Krishnan Nair conceded. To another question, he assured that action would be taken against ``three doctors directly involved in the trial'' if the procedures undertaken were violative of the parameters set by the ethical committee.

On why Johns Hopkins was recruiting volunteers from Kerala, Dr. Krishnan Nair said the particular project was related to drug development for cancers caused by the Human Papilloma Virus infection, the incidence of which was higher in India.

Asked why a project to study the effect of NDGA acid derivatives on oral and cervical pre-malignant lesions eventually led to the administering of experimental injections on patients with advanced cancer, Dr. Krishnan Nair said the mandate of the ethical committee was restricted to issuing ``toxicity-based clearance''.

The institution was being given Rs. 25 lakhs annually for the clinical trial project and a portion of the grant had to be given to other partnering institutions in Kanpur, Benares and Jaipur. Moreover, the spinoffs from the research would be equally shared between the RCC and the Johns Hopkins University, he said.

Dr. Krishnan Nair sought to portray chemotherapy as another form of clinical trial on patients. ``At least 60 per cent of drugs used for treatment of solid tumours was trial chemotherapy.''

He criticised a section of RCC clinicians who had raised ``baseless concerns'' in the media and had compromised the confidentiality of cancer patients. According to him, these clinicians could have voiced objections prior to the trial procedures instead of causing embarrassment to the institution.

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