The globalization of health law: the case of permissibility of placebo-based research.

If any trend can be confidently predicted for the next millennium (or, more modestly, for our lifetimes) it is the globalization of health law. We live in an age of global markets and global communications. While care of the individual patient has remained largely local, national borders are quite porous to health care professionals. The cross-border flow of patients is a significant factor in some regions, and the development of telemedicine and internet pharmacies is radically expanding the possibility of cross-border medical practice. The most important effect of globalization on health care, however, is probably found in the international market for drugs and medical technology. Large pharmaceutical firms and medical technology companies have long operated at the global level. Increasingly, moreover, they conduct research on an international basis for producing new drugs and products. Though individual nations have a legitimate interest in protecting their own populations from defective drugs and devices, it is also essential that nations cooperate to assure that new drugs and devices can be made available to patients promptly once they are established to be safe and effective. The research that grounds the development of necessary drugs and devices requires the use of human subjects. Thus, this research raises important ethical issues, indeed human rights issues. Research is increasingly taking place on an international basis as large, multi-center, trials become more common.2 Though there are international expressions of principle that address these issues, most notably the Revised Declaration of Helsinki on Research Involving Human Subjects (or "the Revised Declaration"),3 research, including international research, is also addressed by substantive regulations governing at the national level.4 These regulatory instruments reflect different approaches to the ethical issues grounding human subjects research. If international research projects are to be effectively overseen, it is important that international protections be afforded. For this to happen, however, it may be necessary for national principles to be harmonized. This, in turn, requires an understanding of cross-national similarities and differences. Globalization thus requires the application of both international and comparative law. An ideal case study for understanding the globalization of health law is the regulation of placebo-controlled human subjects research. The word placebo comes from the ecclesiastical Latin, meaning "I shall please."5 It came to be used in medical practice as a term describing "all medicine prescribed more to please the patient than for its therapeutic effectiveness."6 In modem clinical research, placebos are inert substances, prepared so as to appear identical to the active substances being tested. They are provided to a control group in a randomized trial to give the control group an experience as similar as possible to that of the investigational group, except for the presence of the active ingredients being tested.7 In theory, any differences in response between the placebo control and investigational group (if the members of the two groups are assigned randomly and their identity is blinded both to the researchers and to the participants) are due to the active ingredients tested and not to a placebo effect or to chance.8 Placebo-controlled studies are often championed by drug or medical device companies, who are often more interested in demonstrating that their product works than in comparing its effectiveness with that of existing drugs or devices. The studies are, however, also often demanded by regulatory agencies, who believe that placebocontrolled studies offer the most unassailable evidence of the effectiveness of a product.9 Those who oppose the use of placebos in clinical trials argue that the use of placebos violates all four of the principles generally thought to underlie bioethicsbeneficence, nonmaleficence, respect for personal autonomy and justice. …