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Amar Jesani
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Science is a new religion of society. The globalisation of clinical trials (CTs) by pharmaceutical companies with the expansion of activities of the contract research organisation (CROs) to whom the former outsource CTs, have sought to convert many doctors who were hitherto involved in only clinical practice into ‘scientists’. The doctor-clinical investigators as new converts, along with the clinical investigators in the industry, are dismayed by the recent political developments demanding more stringent regulations on the CTs. The extreme positivist members of the scientist community is therefore struggling to uphold its unfettered or ‘self-regulated’ right to research people, including experimenting on them in the same way that natural scientists would like to do, or are doing, on the inert material available in nature.
Science without ethics is like economic growth without concern for the good of masses labouring for it and the inclusive redistribution of the surplus created by the growth. The science of CTs demands experimentation on the living human beings. A large number of them come from the excluded strata of the society. In the ethics discourse they are termed as vulnerable participants in research. They suffer medical and social handicap – inadequate access to health care in their diseased state, low education, poverty, low social status, discrimination and so on.
The ethics of science would demand that the CTs are conducted primarily for their good, their autonomy respected and are not tricked into participation, they are not harmed, are compensated when harm occurs, they are provided medical and other benefits for volunteering to be a part of the experiments, and they and the other similar members are not left high and dry from post-research benefits after experiments are concluded.
The social value of the CTs must be evaluated in terms of its benefits to them, and not merely in terms of new knowledge created, the experience gained by clinical researchers and above all, the business such research brings.
Thus, ethics while taking care of science of the CTs (unscientific research is unethical per se) and its relevance to people, also demand high ethical standards in the very performance of scientific activities. These ethical considerations are absolutely essential for upholding science of CTs, and more importantly, their credibility.
The regulations coming from the state are therefore only a response to increasing erosion of this credibility brought about by last eight years of failure of the ‘self-regulations’ by the clinical researchers. While they may taste as bitter pills today, if the regulations take the basic logic of transparency, accountability, respect for rights of participants and independent oversight of the CTs to logical conclusion, they may do good to the clinical research in the long run in the country.
Vulnerability v/s ‘cheap’ and ‘quick’ research
The international selling pitch of CROs in India to get more business of the CTs in last eight years has been the idea of ‘cheap’ and ‘quick’ research — both general for resources needed and early conclusion of CTs as well as in terms of recruitment of participants and absence of accountability for provision of trial and post-trial benefits.
This marketing mindset is contrary to the fundamental principle of research ethics when vulnerable people with reduced autonomy, comprehension and power to exercise their rights are used in experiments. That is, vulnerable people need more protection, more benefits, longer and aided process of comprehension and specialised assistance to exercise their rights. This can neither be cheap, nor quick.
The earlier such a mindset is changed, the better it would be for the science of CTs. The investigators and clinical researchers, as professionals, should have been the first to raise objection to such marketing gimmicks. Not they, but the people in civil society and enlightened media professionals seem to be doing their job at present. That does not do any good for the credibility of the science of CTs and professionals involved in it.
Ethical obligation to participants
As a member of ethics committees of several biomedical institutions in last over a decade I observed that doctor-investigators in India suffer as much from the therapeutic misconception (conviction that the new drug being tested is better) as the patients they recruit for the CTs. This situation introduces bias, which they help transmit to the participants in the recruitment process. It also signifies that these investigators have not imbibed the scientific temper, a hallmark of good researcher.
There is some strong clamour against the new regulation providing right to compensation for serious adverse outcomes of the CTs and not merely due to the adverse effect of the experimental drug.
This opposition is based on the faulty ethical understanding that only those who receive the experimental drug are being experimented upon, and others are not. In clinical practice, a doctor designs therapeutic measures solely based on the best interests of the patients. In the process, those measures are modified from time to time keeping in mind the needs of the patients and progress of disease.
This flexibility of clinical practice is seriously curtailed in CTs, as experiments necessarily demand standardised constant protocols. There is space to manage adverse events of experimental as well as standard drugs, but there is hardly any space to prevent them by making timely adjustments as on blinded trials it is not known who is receiving what. This creates an ethical obligation to provide full free medical management for all adverse events in all participants, and compensation for all those who suffer injuries or deaths.
There is no doubt that the credibility of clinical research has been seriously dented in last eight years of liberalisation of CTs in India. The data coming in the public domain on the number of serious adverse outcome and deaths reported show the lack of transparency on how they are related to the CTs and very few provided compensation of measly amounts. Added to that are recurrent reports of violation of other ethical standards. They make the situation only worse.
It is no use blaming others – the civil society, media or politicians. They are doing their jobs. The credibility of clinical research will not be re-established by playing the blame game, but by strictly ensuring that high ethical standards are observed in the CTs. Not just that, like it is said in reference to dispensation of justice, they must also be seen to be observed.