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Foreign-funded clinical trials under a cloud

By M. Dinesh Varma

THIRUVANANTHAPURAM, JULY 30. The controversy over the alleged subjugation of patient rights at the Regional Cancer Centre (RCC) in Thiruvananthapuram has opened the lid on the highly- exploitative nature of research partnership that the Johns Hopkins University had imposed on the premier cancer hospital.

The issue had been brought into focus when Dr. V. N. Bhattathiri, Head of the RCC's Radiobiology section, petitioned the State Human Rights Commission alleging that a group of RCC patients had been subjected to trials which exposed them to toxicity from drugs which stood banned by the Federal Drugs Administration (FDA) in the United States.

According to the radiobiologist, the tetra methyl form of Nor dihydro Guaretic Acid (NDGA), the M4N developed by the Johns Hopkins University was 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. The allegations assume significance in the context of the importance attached to the safeguarding of patient rights by the Ethical Guidelines for Biomedical Research on Human Subjects (2000) formulated by the Indian Council for Medical Research (ICMR).

But at the same time it is pointed out that the guidelines have failed to address core concerns about foreign- funding institutions setting unilateral terms for collaborative research with Indian institutions.

The chapter on International Collaboration/Assistance in Biomedical/Health Research does not address this issue beyond a passing mention that ``on the one hand, collaboration in medical research suggests an interest in human dimensions and civil society on the other it could give the impression of experimentation on the population of one country by another''.

``Different levels of development in terms of infrastructure, expertise, social and cultural perceptions, laws relating to intellectual property rights necessitate an ethical framework to guide such collaboration,'' the document adds.

Dr. G. Vijayaraghavan, former Head of Cardiology, Thiruvananthapuram Medical College, points out that the Government of India in 1997 clearly signalled that it would no longer tolerate trials of new or unproved protocols if they are carried out exclusively in Indian patients.

Mercenary research

Laxity in addressing this issue would allow foreign institutions such as the Baltimore-based Johns Hopkins University to engage in ``mercenary research'' where patient rights are overwhelmed by pharmaceutical interests, says Dr. C. R. Soman, Chairman of the Health Action by People, an NGO.

The Indian edition of the British Medical Journal (Vol. 13. No.2, April 1997) says the ICMR had refused to fund foetal tissue transplantation trials for retinitis pigmentosa under a protocol developed by Indian and U.S. scientists on the grounds that the proposed experiments would not include U.S. volunteers.

``Undertaking clinical trials on Indian subjects for an experimental procedure not being carried out on U.S. subjects is not ethical or acceptable,'' the ICMR had said.

The ICMR directive had followed rising fears among medical experts that India's poor mechanism for monitoring human trials had made the country a fertile ground to test new treatments.

The ICMR's attempt to frame common guidelines for clinical trials had gained impetus following ``the new sense of urgency about setting uniform standards as scientific research has stormed into critical areas of biogenetic research involving human subjects''.

It is pointed out that the ICMR had set up the Central Ethics Committee in 1996 to address a host of challenging issues involving clinical trials and to frame standard parameters that would dictate clinical trials in institutions in the country.

The elaborate exercise had been launched to resolve a great dilemma over a range of moral, ethical and legal issues involving, not just the mandatory clinical trials on new drugs but a number of diagnostic procedures, therapeutic interventions and preventive measures.

The working draft was a 1980 document titled ``Policy statement on ethical considerations involved in research on human subjects'' prepared by the ethical committee under the chairmanship of Mr. H. R. Khanna.

The document emphasises the need for careful evaluation of risk- benefit and balance the promise of a possible scientific breakthrough against the need to requite genuine public concern.

It also reflects the essence of the Helsinki Declaration (1964) by committing such research to a set of conditions where no person or persons become ``a mere means for the betterment of others and that human beings who are subjected to any medical research or scientific experimentation are dealt with in a manner conducive to and consistent with their dignity and well being''.

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