The Ethics of Medical Participation in Anti-Rejection Drug Trials in China

Abstract

Introduction: The presentation would set out information about organ transplant anti-rejection drug trials conducted by multi-national pharmaceutical companies in China as well as the positions of these companies on the conduct of these trials. The presentation would further provide the relevant ethical standards of The Transplantation Society, the World Medical Association and the World Health Organization, as well as the position of non-governmental organizations, including Amnesty International, on the trials. The presentation would conclude with an analysis of the ethics of medical participation in these sorts of drug trials. The Government of China acknowledges that organs for transplants done in China come overwhelmingly from Chinese prisoners and claims that these prisoners are convicted criminals sentenced to death and then executed who consented before execution to the use of their organs for transplants. David Kilgour and David Matas in a study released in report form in July 2006 and then January 2007 and in book form in November 2009 under the title Bloody Harvest concluded that the bulk of prisoners who are the source of organs for transplants are practitioners of the spiritually based exercise regime Falun Gong practitioners, who are killed by the organ harvesting operation and who are not sentenced to death. The Government of China acknowledges that sourcing of organs from prisoners is wrong and has committed itself eventually to ending the practice. This acknowledgement stands regardless what position one takes in the debate between the Government of China, on the one hand, and David Kilgour and David Matas, on the other hand, about which prisoners are sources of organs for transplant Methods: The method would be descriptive, legal and prescriptive. David Matas gave a poster presentation at the American Transplant Congress in Philadelphia in April 2011 as well as a talk at a parallel event on this subject. The presentation at The Transplantation Society Congress would reconsider and update the research on this work. Arne Schwarz, an independent researcher living in Switzerland, has contributed to this work. Results: Given the high proportion of organs sourced from prisoners, many, if not most of the organs used in clinical trials for anti-rejection drugs in China likely came from prisoners. Some, but not all multinational pharmaceutical companies participate in these trials. Conclusions: Pharmaceutical companies should not be participating in clinical trials in China unless they are satisfied beyond a reasonable doubt that that the organs transplanted to the patients on whom the drugs are used are received from a proper source. Doctors should not participate in clinical trials in China unless the doctors themselves ensure beyond a reasonable doubt that the organs transplanted to the patients on whom the trials are conducted are received from a proper source. Regulatory authorities should not approve drugs based on data from clinical trials in China.