Johns Hopkins varsity censures scientist

By Our Staff Reporter

THIRUVANANTHAPURAM, NOV. 13. The controversy over clinical trials of experimental anti-cancer drugs on patients at the Regional Cancer Centre here has acquired another dimension with the U.S.- based Johns Hopkins University admitting that one of its scientists had flouted Federal and university regulations in testing the drugs.

The university said the scientist had conducted the tests without adequate preliminary tests on animals. A press release issued by the University today said the scientist had been barred from serving as Principal Investigator on any future research involving human subjects.

A faculty investigation committee appointed last summer found that the trial did not meet JHU standards for research with human subjects, the press release said. The consent forms used to recruit patients for the study were also inadequate.

The RCC clinical trials involved the administration of NDGA- derived M4N and G4N chemicals on 26 patients with oral cancer. The tests were carried out with the Hopkins scientist as Principal Investigator with Indian collaborators. The JHU press release said the scientist had carried the drugs to India without either an `investigative new drug approval' from the Food and Drug Administration or explicit FDA export permission.

The project had run into rough weather after a senior clinical radiobiologist of the RCC petitioned the State Human Rights Commission about alleged unethical drug trials on human patients at the RCC. It may be recalled that Dr. V. N. Bhattathiri, Head of the RCC's Radiobiology section, had alleged in his human rights petition that patients were subjected to trials which exposed them to toxicity from drugs which had been banned by the Federal Drugs Administration (FDA) in the United States.

The radiobiologist had specifically cited the use of the M4N, the tetra methyl form of Nor dihydro Guaretic Acid (NDGA), as one the drugs which was being used for human trials at the RCC in spite of their being removed from FDA's ``Generally Regarded As Safe'' category.

This led to a war of words with the RCC Director, Dr. Krishnan Nair, maintaining that there was nothing irregular with the trials, which had the clearance of the RCC's ethical committee and the Drugs Controller General of India. The RCC claims that a ban on M4N and G4N, the chemical derivatives of NDGA, had not been reported from anywhere in the world.

When contacted, Dr.Bhattithiri said the admission by the JHU vindicated his stand.

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