Copyright (c) 2009 All rights reserved. http://works.bepress.com/fazal_khan Recent documents in Fazal Khan en-us Sun, 31 May 2009 05:53:02 PDT 3600 http://works.bepress.com/fazal_khan/2 http://works.bepress.com/fazal_khan/2 Thu, 04 Sep 2008 14:02:45 PDT The article, Paging King Solomon: Towards Allowing Organ Donation from Anencephalic Infants, argues that organ donation from anencephalic infants is ethically and legally justifiable. Anencephaly is a medical condition characterized by a lack of brain development above the brainstem, so such children often lack a cerebrum, cerebellum and a skull. With an intact brainstem, these children can maintain heart and lung function. Without higher brain functioning though, these children are not capable of human consciousness and they typically have very short life spans measured in days or weeks. The way in which an anencephalic infant dies typically destroys the suitability of the infant's organs for transplantation. However, doctors can avoid this problem by artificially maintaining the life of these infants and remove the organs while the infant's heart and lungs are still functioning. Further, some have expressed fear that anencephalic infants will intentionally be created as researchers have been able to delete the mammalian gene for brain development leading to anencephalic laboratory animals. The visceral image of removing organs from a baby whose heart is still beating would obviously be disturbing to many. Some consider this practice tantamount to killing a living child for the benefit of another. In addition, the possibility of opening the door to create anencephalic babies to harvest their organs is extremely frightening. This article acknowledges that there are valid legal and ethical concerns with using anencephalic infants as organ donors, but proposes that these concerns can be overcome in the following ways: a proper biological understanding of this condition; a definition of death that includes absence of higher brain functioning and not simply absence of brain functioning; stiff criminal penalties for anyone who intentionally creates anencephalics; and strict liability for any medical personnel that uses organs from intentionally created anencephalics. Fazal Khan Health Law and Policy Law and Technology Medical Jurisprudence Science and Technology http://works.bepress.com/fazal_khan/1 http://works.bepress.com/fazal_khan/1 Wed, 26 Sep 2007 18:24:10 PDT This paper proposes a framework of international soft law and domestic drug regulations to a priori remove incentives for unethical clinical drug research in developing nations. The globalization of drug testing is very problematic from a bioethics perspective. While stringent regulations in the U.S. or E.U. may pose an adequate check on unethical research practices, many multinational corporations are engaging in regulatory arbitrage by outsourcing ethically questionable research to countries with less restrictive regulations. Given the tremendous financial reward a blockbuster therapy might generate, there is a strong incentive to move more research and development to countries with even looser regulations and less transparency. The danger in this "race for the prize" is the exploitation of vulnerable populations that have little recourse to hold anyone accountable given their low-power status in a globalized society. In particular, this article argues for a combination of "soft-law" techniques including more robust and subaltern-centric surveillance of international drug trials to enforce existing "hard law" rules within the regulatory agencies of the United States and European Union that require clinical drug research to adhere to international ethical standards. The intended result is to create a stiff economic penalty, exclusion from lucrative markets for unethical testing practices. This in turn will create a strong ex ante economic incentive for drug companies to conduct drug trials ethically. Fazal R. Khan Food and Drug Law Health Law and Policy Human Rights Law International Law International Trade Law and Economics Law and Technology Medical Jurisprudence Science and Technology Torts Trade Regulation