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In 2008 prescription medications accounted for $291 billion in sales in the United States. In 2000, the drug industry employed more than 625 lobbyists (1) (there are only 535 members of Congress). Big business. Big money. Big power. Power versus principles – this is an eternal dialectic. If power rules, we might as well shred the Belmont Report right now.Ethical principles are not intended to be convenient – they are intended to guide right conduct and practices. Ethical principles are established to provide a framework and a context in which humans can assist in lifting-up fellow humans – improving medical practices, improving standards of care, improving public health and well-being. How to apply the bioethical principles enumerated in the Belmont Report is an ongoing question in the conduct of international clinical drug trials. If principles are paramount, we can locate the source for ethical standards and conduct in the sponsoring country.Universal ethical standards are meant to apply universally – not locally and selectively, at the whim of the more powerful agency. They are designed to protect the more vulnerable among us – us referring to the international community. And in an ethical world, standards of care should refer to the highest, not the lowest, common denominator.But it’s not an ethical world, is it? Ombudsmen are needed, committed to the principles of respect for persons, beneficence, and justice. Investigators should “assume broad responsibility for the welfare of the subjects they enroll in their studies”. And, welfare “should not be influenced by the political and economic conditions of the region”. (2)Constant vigilance is required. International agencies need to be able to impose meaningful penalties and consequences, but such sanctions need to be backed by meaningful regulation and oversight in the host countries. This has been very difficult. In the United States, at least, the pharmaceutical industry wields great power and influence.And yet, for many years the United States has been a beacon of hope for oppressed peoples around the world. Western democracy has overcome every deadly obstacle placed in its path. As Winston Churchill famously said, “Democracy is the worst form of government except all those other forms that have been tried from time to time”.It is possible for the United States to regain the moral high ground in the conduct of international clinical trials. Patrick Henry points the way – “A vitiated state of morals… is incompatible with freedom. No free government… can be preserved… but by a firm adherence to justice… and by a frequent recurrence to fundamental principles”.We will all benefit from the universal application of the ethical principles enshrined in the Belmont Report.1 Relman A, Angell M: America’s Other Drug Problem. The New Republic, 12-16-2002, p 38
2 Angell M: Investigators’ Responsibilities for Human Subjects in Developing Countries. N Engl J Med 342(13):967-969, 2000