Vol , Issue Date of Publication: April 01, 2004
DOI: https://doi.org/10.20529/IJME.2004.033

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DOI: https://doi.org/10.20529/IJME.2004.033


The author clarifies

All the cases of illegal (not merely unethical) drug trials cited in the article have been widely reported in the highly circulated print and electronic media. References are required for scientific articles where data are being quoted or interpreted and not to support the occurrence of events or while reporting plain news. Besides, none of the sponsors or investigators have raised any objection to the factual part of these press reports.

Webster’s unabridged dictionary defines ‘hyperbolic’ as ‘exaggerating or diminishing beyond the facts or exceeding the truth.’ Not one word in the article meets this definition. I may add here that several newspapers such as the Hindustan Times, The Indian Express and Business Standard have picked up large portions from this article to focus the nation’s attention on the malady of illegal and unethical drug trials. They have used exactly the same language as I did.

How can there be ‘references’ for poor protocols? The quoted protocols have been examined and reported in the article.

Foreign sponsors have been publicly arguing that drug trials require ‘competent investigators, efficient infrastructure (research hospitals with world-class laboratories) and multi-ethnic patients’ in support of their reasons for selecting India as the base for clinical trials. The real reasons are of course different: lower costs, lax implementation of laws and abundant availability of poor, illiterate patients. My reference to Vietnam is to show the hollowness of the sponsors’ claims. Vietnamese doctors may be good clinicians but they do not have the infrastructure for drug trials comparable to those in India. Besides, there is only one ethnic population. Why, then, are American companies conducting drug trials there?

In an editorial, it is not possible to cover all aspects of drug trials such as improving the oversight functions. In any case, the Central Government is moving in the reverse direction: the new Schedule Y that governs trials is being ‘liberalised’, so that it would be easier to conduct trials in future.

CM Gulhati, Editor, Monthly Index of Medical Specialities 90, Nehru Place, New Delhi 110019. e-mail: [email protected]

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Monthly Index of Medical Specialities 90, Nehru Place, New Delhi 110019
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