Combatting Corruption in Clinical Drug Trials in Kerala

Combatting Corruption in Clinical Drug Trials in Kerala

YEARS: 2009-2010
THEME: Health

The primary objectives of Jananeethi project were to regulate clinical drug trials under law, and to ensure ethical standards and best practices; to ensure transparency and accountability; to approve the rights of human participants in clinical trials; to check instances of corruption and unethical practices and to enlighten the civil society and other stakeholders with regard to mandatory norms and rules to be complied with in a clinical trial.

The baseline information we gathered from our initial contacts with researchers, clinical practitioners, medical and Para-medical staff, institutional heads and members of institutional review committees were quite disheartening and embarrassing. What surfaced most was blissful ignorance among all concerned of the statutory norms and universal ethical standards to be strictly followed in any clinical drug trial. There was apparently no interest in the concerned departments and institutions to rectify or to make good of the situation. Further, the emergence of the contract research organizations that have sprouted in almost all cities and towns were pushing themselves into hospitals, laboratories and even clinics of private practitioners. Thus the overall scenarios were gruesome.

Our attempts to identify human participants in clinical trials were repeatedly foiled by concerned investigators/institutions on a reason that the matter was ‘confidential’. We have used Right to Information Act as tool for the collection of data’s. Though we got information on clinical trials from institutions approached, all of them denied the details of trial participants on the ground of privacy and confidentiality. All offenders went scot-free and nothing was left on paper to prove against them. No record was maintained, no consent form was properly signed, and not even a single evidentiary document was traceable in any institution. This delay in identification of participants caused some problem initially but we were able to identify them and record their experiences. Constructive engagement with government and other stakeholders was one of the major activities of our project. Meeting with Dr. Usha Titas IAS, Secretary, Health and Family Welfare, State of Kerala was quite useful.  Meeting with Institutional Review Boards of various institutions helped its inherent weakness and us to know the way IRB’S are working. Engagements with doctors working in field of clinical trials helped us to collect vital information on clinical trials and its loopholes. Constructive engagements with government officials, Heads of medical institutions are still in progress for various purposes like conducting awareness programmes, installation of display boards etc.

In the circumstances, the primary requisite was to create general awareness on the mandatory norms and statutory guidelines among all concerned. Jananeethi published a handbook on the guidelines and circulated it among all. It generated a discussion across the State among medical practitioners and researchers. We also held press conferences and had press releases on the matter. In the meantime, we interviewed several medical personnel who have been involved in trials. We also had extensive consultations across the country with eminent medical practitioners regarding the ethical standards in clinical trials. Knowledge generation among authorities, doctors, and members of ethics committees and among general public regarding the issues and concerns involved in the conduction of clinical trials plays a crucial role in elimination of unethical practices and for the protection of rights guaranteed to the participants of clinical trial.  To achieve this goal we have designed different activities. For example publication of handbook on ethical standards of clinical trials, press meetings, personal discussions with doctors and members of ethics committees, awareness classes for medical students and affected parties with the help of other stakeholders. We have collected various national and international guidelines on clinical trials and codified the same through handbook in Malayalam. We have prepared rights of human participants in Malayalam for display at various centers. We have also prepared a draft Charter of rights of human participants for distribution among authorities and public in general. From our experience it is crystal clear that ignorance about the ethical guidelines and rights of human participants among the doctors who are involved in the drug trials, ethics committee members, and most importantly among the government officials and general public leads to corruption and gross violation of rights of human participants.

In the second half of the first year of our struggle against the engulfing unethical practices leading to corruption, we were able to identify five human participants in a clinical drug trial. Each participant was visited at his/her residence, detailed discussions were held based on a scheduled questionnaire. Innocent patients were not aware of the corruptions implied; they had taken in good spirit. But what emerged from our discussions was that every norm of a good practice was flouted. To prove our stand that the conduction of clinical trials are not in accordance with ethical standards we have interviewed and Recorded the opinions of experts in the field like Dr. Amar Jesani of Centre of Studies in Ethics and Rights, Mumbai, Dr. C.R.Soman, Chairman, Health Action by people, Thiruvananthapuram, Dr. P.V. Gangadharan oncologist, Lakeshore hospital Kochi, Dr.K.G.Radhakrishnan.Hence we started with constructive engagements of the government departments, institutional heads, media and other stake holders. We are building up a critical mass in the society with regard to the clinical trials; we have been successful in few hospitals and research institutes so far. We propose to engage the media and communication strategies on large scale in the second phase of the project.

Post a comment