How much oversight is too much?

A recent article in the May 14 issue of the New England Journal of Medicine, titled, 'Globalized Clinical Trials and Informed Consent', expressed concern that the increasing globalisation of clinical research trials calls for more effective ethical and legal rules to protect both research subjects and scientific integrity. It notes that the situation observed more than a decade ago that research was being conducted in developing countries without concern for adherence to the international ethical principles for human-subjects research contained in the 1947 Nuremberg Code and the 1964 Declaration of Helsinki, has not improved.

The article goes on to cite Pfizer's medical experiments in at the Kano Infectious Diseases Hospital, Nigeria where in 1996, they conducted a study involving 200 sick children, over a two-week period, after which the Pfizer team abruptly left. After the story broke in 2000 and press coverage detailed how researchers monitored the slow death of a 10-year old girl, families of the children filed a suit alleging that the pharma company did not take the informed consent of either the children or their guardians.

More such experiments were uncovered in other lesser developed countries which were ‘poorly regulated’ and ‘dominated by private interests’ studies, that ‘far too often betray’ their promises to research subjects and consumers. Similar examples exist in India and there are many efforts on (like the recent workshop at Mumbai's Tata Memorial Hospital) to educate non-technical members of ethics committees. In the US too, a report released in March this year, by the US Government Accountability Office (GAO) gave testimony to the fact that in the course of an undercover operation, GAO proved that the Institutional Review Board (IRB) system was vulnerable to unethical manipulation. For example, GAO investigators created a website for a bogus IRB and succeeded in obtaining approval from an actual IRB to test a fictitious medical device on human subjects, even though the device had fake specifications and matched several examples of 'significant risk'.

These situations only show that regulatory oversight needs to be tightened in clinical research. However, there are cases where strict laws can keep affordable medication out of reach of needy patients. Kenya's move to pass anti-counterfeit legislation that allows generics having patent protection anywhere in the world to be considered counterfeit in case of an intellectual property dispute with the patent holder, is a case in point. This law has been branded anti-patient as the African continent which bears a major portion of the AIDS/HIV infected burden, is a beneficiary of affordable drugs from India, the largest supplier of generic anti-retrovirals to low- and middle-income countries. It remains to be seen if the Indian government's diplomatic efforts to neutralise the propaganda spread by vested interests (read, MNC pharma) are successful.