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REVIEWS: Ike Iheanacho Drug Trials—the Dark Side: This World BMJ 2006; 332: 1039 [Full text]

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Research for Profit

Des Spence   (28 April 2006)

Need for clinical and research ethics simultaneously

Jagdishwar Srivastava   (5 May 2006)

Research for Profit 28 April 2006
Des Spence, GP Glasgow G20 9DR Send response to journal: Re: Research for Profit	The stumbling block for clinical trials both in the developing world and in the developed world are the same, enrolment. It is difficult to enrol patients into trials and we rely on consent forms and the investigating doctor to protect patients. Unknown to most patients, however, is the conflict of interest that exists at the time of enrolment. When I first started in General Practice over 10 years ago I was asked to conduct Pharmaceutical Company research. The motivation to conduct this research was financial with the potential to earn tens of thousands of pounds on top of NHS income. This is still a common situation especially concentrated in the most deprived areas of the UK. I conducted the research and enrolled 10 patients – I told patients that I was being paid but did not disclose the amount. Later I was again asked to act as an investigator in another trial. On this occasion, however, I decided on complete transparency and disclosed the fee to the patients at the time of enrolment. I was unable to recruit any patients. So ended my involvement in research for profit. The greatest incentive for doctors to conduct research and enrol patients for Pharma companies is financial, either directly or to their institution. This situation is not ethical. Patients agree to participate in trials for altruistic reasons and put trust in the professionalism of doctors. Ethics Committees should recognise this and insist the exact amounts paid to doctors and hospitals should be disclosed to patients. Perhaps it is time also that independent non profit groups and charities oversee and organise clinical trials . Money, medicine and research are heady and seductive cocktail but has the potential for excess, risk taking and recriminations. Competing interests: nofreelunch member
Need for clinical and research ethics simultaneously 5 May 2006
Jagdishwar Srivastava, Scientist F Central Drug Research Institute, Lucknow, India Send response to journal: Re: Need for clinical and research ethics simultaneously	Drug trials are being outsourced to developing countries at a faster rate and international research community is viewing vast human resource as potential research participants. However, the clinical studies in these countries have often raised ethical issues and this has led to sincere efforts by international and national agencies to rectify those deficiencies. But efforts to improve research ethics in developing world may encounter serious difficulties in the absence of ethics in clinical care. This may be especially true in developing countries where getting routine health care is difficult. Such discrepancy in care from research to clinical care may result in poor implementation of ethical guidelines. Further this could upset the efforts in building the capacity to conduct or regulate the clinical research in developing counties. This observation is reflected in problems observed by ethics committees to review research proposals in developing countries. The capacity to conduct ethical research has to be viewed in the background of state of current healthcare. Hence there is a need to develop ethics in clinical care simultaneously if we want to see build up of capacity in appropriate ethical review of drug trials. This is so because improvement in application of research ethics shall be long lasting as well as more acceptable in the background of appropriate clinical ethics. Competing interests: None declared