Clinical trials: a matter of principle
While I wholeheartedly support the sentiments expressed by Dr Gulhati in his editorial (1), I have reservations about the data cited and the manner in which they are presented.
Dr Gulhati cites several examples of unethical human research. There is not a single reference given in support of these ‘facts’. It is possible that these data are factual; yet, without appropriate reference to the source, these examples become mere opinions.
Moreover, in an academic journal, the facts should speak for themselves, there should be no hyperbole. There are many differences between the USA and India. Stating that ‘…women have been treated worse than animals in America’ serves no purpose.
The examples of poor protocols for drug trials that were approved by the DCGI also do not cite references. One must assume that these are based on personal communication to the author and the reader has to accept these assessments at face value. In the last paragraph, he writes: ‘No wonder American companies have found doctors in Vietnam as competent as those in India in this field’. The implication here is that Vietnamese doctors are inferior to Indian ones. This smacks of cultural chauvinism.
I wish the author had given concrete suggestions for improving oversight in research trials and ways to decentralise the process so that it becomes more transparent and accountable.
I have come to expect higher academic and literary standards from the Indian Journal of Medical Ethics and hope the editors will sustain these principles.
Bashir Mamdani, 811, N. Oak Park Avenue, Oak Park, Illinois 60302, USA. email: [email protected]
- Gulhati CM. Needed: closer scrutiny of clinical trials. Indian Journal of Medical Ethics. 2004;1:4–5.