Without Consent: How Drug Companies Exploit Indian `guinea Pigs`

Ethics is a branch of philosophy which helps one to decide the right course of action in morally challenging situations (Mepham, 2005). Ethics is usually confused with morality and the two terms are often used interchangeably. According to Caplan (1995), morality refers to what people normally believe to be "right and wrong, good and bad," beliefs they generate as a result of their upbringing, cultural influence and religious and intellectual experience. Ethics involves more than just sharing one`s belief; it involves supporting a moral opinion with consistent arguments that can be challenged factually and rationally.

The origin of ethical norms and moral values dates back a long time. The Hippocratic Oath, which is the code of ethical conduct for doctors, was coined as early as in the fourth century BC; similar examples exist in other civilisations and in almost all religions about the origin of morality (Encyclopedia Britannica, 2013). It is likely that ethics conceptualised only when people started living together in societies and began thinking about formulating commonly acceptable standards of social conduct. Regardless of the ambiguity on its origin, we have evolved to include ethics as a major part of any discussion about the decisions we make and actions we take as individuals and members of the wider society.

Self-regulation of ethics is unreliable because people may interpret ethical dilemmas differently based on their morality. The research community lacked a code of conduct before the Second World War and as a result many unethical practices were observed (Klien, 2013). The experiments on human subjects carried out by Nazi physicians are examples of such terrible acts. In order to prevent such atrocities, the international community agreed on a code of conduct called the Nuremberg code in 1947, which advocated the need for subjects to provide voluntary consent for any research (Lancashire University, 2013). This was the first major step towards introducing ethics in research. The Nuremberg code was extended to form the Declaration of Helsinki, under the directive of the World Medical Association, in 1964. This international initiative updated the ethical issues in research and made the declaration an internationally binding code of conduct for researchers (Lancashire University, 2013). At present, there are many national and international ethical standards and numerous regulatory bodies, as a result of which research is more ethical and transparent. It is important to adhere to these ethical norms because this helps to promote the aims of the research, enables the public to hold the researchers accountable and builds public confidence on the study (Klien, 2013). The importance of ethically approved research can be understood by studying examples of unethical research practices and their consequences, as discussed in the case-study below.

Drug discovery is an extremely expensive process. Pharmaceuticals spend around $500 million to bring a drug to market and most of the money is spent on conducting clinical trials to prove its safety and efficacy (Lipsky, 2001). As it is a risky business companies try very hard to minimise expenses, which is why they have ventured to developing countries like India. It is up to 60% cheaper to conduct clinical trials in India than in the USA. Additionally, India has a large diverse patient pool and good hospitals with English speaking doctors, which makes it a perfect venue for clinical trials (Yee, 2012).

In 2011, The Independent made serious allegations against a team of senior doctors at MY hospital in Indore. The article claimed that these doctors received personal payments of around Rs. 50 million (£625,000) for conducting unethical clinical trials on behalf of international pharmaceuticals. The investigation found that participants had not given an informed consent to the trails as the fine-prints on the contract were in English. The absence of informed consent makes the study unethical and the data thus generated cannot be assured (Klien, 2013). Additionally, it was found that the ethics committee that approved the trials included the investigating doctors and patients were not offered insurance or compensation in cases of adverse effects. These are significant shortcomings because investigators need to declare conflicts of interest and ensure patient welfare throughout, for the study to be considered ethical (Klien, 2013).

Following these revelations, health activists filed official complaints against the hospital and the state government placed a ban on all new clinical trials in Madhya Pradesh (Yee, 2012). The ban, however, did not stop the clinical trials that were already underway, which indicates lack of stringent regulations. The issue also caused uproar with international policy makers. Some MEPs demanded a more robust action, including banning the sale of drugs, against companies behind such unethical studies (The Independent, 2011). Clinical Trial Registry of India, the body responsible for overseeing clinical trials in India, also raised concerns and called for efforts to strengthen ethics committees and rules to make investigators declare their conflict of interests (Yee, 2012). This indicated that there was a lack of accountability in the system.

The government was also forced to make some policy changes in an effort to strengthen the clinical trial regulations in the country. The reforms included mandatory registration of organisations conducting clinical trials, a draft bill to legalise compensation to patients in case of injury or death inflicted by the trial, and cancellation of trials or restrictions on investigators in cases of non-compliance (Biospectrum, 2012). Regardless of these serious commitments, the public and the international community still have little confidence in the system because there is a lack of a strong regulatory body in India. This is reflected in the recent figures which show a reduction in clinical trials to almost half after the incident (Biospectrum, 2013). This case demonstrates the importance of ethical research and the impact unethical study could have on the research community.

Ethics does not provide an answer to a dilemma but facilitates a debate whereby a consensus can be reached. It is vital to formulate and adhere to the ethical codes of conduct because the adverse outcomes could be detrimental to the overall research community.

References 1. Biospectrum India. 2012. Indian Clinical Trial Regulations to get Tougher. [Online] Available at: http://www.biospectrumindia.com/biospecindia/news/122996/indian-clinical-trial-regulations-tougher [Accessed: 9 Oct 2013]. 2. Biospectrum India. 2013. Clinical Trial Numbers in India Drop Drastically. [Online] Available at: http://www.biospectrumindia.com/biospecindia/news/175324/clinical-trials-india-drop-drastically [Accessed: 9 Oct 2013]. 3. Caplan, A. 1995. Moral Matters. New York: Wiley. 4. Encyclopedia Britannica. 2013. Hippocratic Oath (ethical code). [Online] Available at: http://www.britannica.com/EBchecked/topic/266652/Hippocratic-oath [Accessed: 8 Oct 2013]. 5. Mepham, T. 2005. Bioethics. Oxford: Oxford University Press. 6. Klien, A.V. 2013. Ethics in Clinical Trials and Drug Development - Clinical Trials - Issue 4 2007 - via Pharma Focus Asia. [Online] Available at: http://www.pharmafocusasia.com/clinical_trials/ethics_clinical_trials.htm [Accessed: 9 Oct 2013]. 7. Lancaster University. 2013. Ethical Review: Background and History. [Online] Available at: http://www.lancaster.ac.uk/researchethics/2-2-background.html [Accessed: 9 Oct 2013]. 8. Lipsky, M. and Sharp, L. 2001. From Idea to Market: The Drug Approval Process. The Journal of the American Board of Family Practice, 14 (5), pp. 362 367. 9. The Independent. 2011. Delhi to Examine `weak regulation` of Clinical Trials. [Online] Available at: http://www.independent.co.uk/life-style/health-and-families/health-news/delhi-to-examine-weak-regulation-of-clinical-trials-6262754.html [Accessed: 9 Oct 2013]. 10. Yee, A. 2012. Regulation Failing to Keep up with India`s Trials Boom. The Lancet, 379 (9814), pp. 397-398