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In 2008, prescription drugs totaled $ 291 billion in sales in the United States. In 2000, drug production employs more than 625 lobbyists (1) (there are only 535 members of Congress). Big business. Big money. Big power. Power against the principles – is the eternal dialectic. If the power of the rules, we could also open the Belmont Report right now.
Ethical principles are not intended to be easy – they are intended to serve as a guide for proper conduct and practice. Ethical principles are established to provide a framework and an environment in which people can assist in the lifting-up counterparts – improving medical practice, improving health care, improve public health and welfare. How to apply the principles of bioethics, listed in the report of the Belmont is a constant issue in the conduct of international clinical trials of drugs. If the principles are of paramount importance, we can discover the source of ethics and conduct in the country authors.
Universal ethical standards are intended to apply universally – not at the local level, and selectively, in favor of a more powerful agency. They are designed to protect the most vulnerable among us – we are referring to the international community. And in the world the ethical standards of care should apply to the highest, not lowest, common denominator.
But this is not an ethical world, huh? Should be ombudsmen, commitment to the principles of respect for persons, beneficence and justice. Investigators should “take greater responsibility for the welfare of the subjects they enroll in school.” And, well-being “should not depend on political and economic conditions in the region.” (2)
Requires constant vigilance. International institutions should be able to impose meaningful penalties and consequences, but such sanctions must be accompanied by meaningful regulation and oversight in recipient countries. It was very difficult. In the United States, at least in the pharmaceutical industry with great power and influence.
Nevertheless, for many years, the United States was a beacon of hope for oppressed peoples throughout the world. Western democracy to overcome all the obstacles placed in its deadly path. Winston Churchill once said: “Democracy is the worst form of government except all other forms that have been tried from time to time.”
It is possible for the United States to regain the moral high ground in international clinical trials. Patrick Henry points the way – “invalid public morality … is incompatible with freedom. … No free government can be saved … but firm commitment to justice … and the frequent repetition of basic principles.”
We all benefit from the universal application of ethical principles embodied in the Belmont report.
1 Relman, M Angell: America’s other drug problem. The New Republic, 12-16-2002, p. 38
2 Angell M: Investigators responsible for the people involved in developing countries. N Engl J Med 342 (13) :967-969, 2000