Brigham and Women's Hospital, where the era of successful transplantation began.

A look at organ transplantation

Friday, February 6, 2009

Written for PHMI WORLD by Regis de Silva, MD, MPA

The era of successful transplantation began in 1954 in Boston when twin brothers served as donor and recipient at the Peter Bent Brigham Hospital (now Brigham and Women’s Hospital). In this case the transplant was an isograft—meaning a transplant of an organ from one genetically identical person to another. However, today most transplants are allografts (from genetically different people). While organ rejection from immunological reactions has been successfully controlled with drugs such as cyclosporine, several other problems have arisen in the interim.

The principal limitation is the lack of availability of suitable solid organs. There are currently around 100,000 people in the United States on waiting lists for kidneys, hearts, lungs, livers, and other organs, with some 78,000 waiting for an available kidney, 15,000 for a liver, and 2,700 waiting for a heart. From January to October 2008, 23,288 transplants were performed in the U.S.; the overwhelming majority of organs (18,140) were procured from the recently deceased.

The New England Organ Bank in Boston is the oldest in the world. Since the original transplant, transplantation programs have developed in all major U.S. cities. A network of non-profit Organ Procurement Organizations (OPOs) coordinated by the United Network for Organ Sharing (UNOS) supports these transplant programs. The main function of the OPOs is to obtain permission for organ donation from the families of deceased or dying persons. UNOS coordinates the activities of OPOs, the Society of Transplant Surgeons, the Scientific Registry of Transplant Recipients (which maintains data including national transplant statistics and survival rates), and other non-profit organizations that are involved in transplantation. Govermental approval and oversight is provided by the Health Care Financing Administration, the federal agency that oversees Medicare, Medicaid, and Child Health Insurance Programs. Thus, there is a high level of oversight and regulation in the area of transplantation where an extremely rapid response is necessary for organ procurement when a person is declared brain dead, or is recently deceased. Such regulation and a high degree of coordination are necessary because of the medical and legal risks associated with both the declaration of death and the removal of organs from a potential donor. Under current U.S. law, payment for organs is illegal.

In many regions of the world, transplantation surgery is non-existent or in an infant stage. Thus, no rules and regulations exist to ensure the appropriate standards will be followed. Moreover, no organ recovery programs exist and there is no computerized system to coordinate organ location and distribution as there is in the U.S. Because of the lack of both a medical infrastructure for organ recovery and the lack of a regulatory superstructure, these issues have to be addressed in tandem with the development of any transplant program. A simple, yet serious, issue is transportation of organs that are recovered. In most large cities where the best hospitals are located, serious traffic jams are common and air ambulances are virtually non-existent. Since organ function and survival depends or rapid implantation of the donor organ, these logistical problems need to be solved.

Because of the shortage of donor organs, an emerging problem is the possible trafficking of illegal organs and the financial inducements that may unduly influence impoverished and illiterate people, illegal immigrants, political refugees, and prisoners to unwittingly “donate” organs. The Internet has made such trafficking easier, and commercial organ “brokers” have already emerged in this thriving market. There are already several scandals and lawsuits over illegal procurement of organs in Brazil, India, South Africa, and Thailand. Cognizant of these issues, the World Health Organization has issued guidelines, and the 2008 Declaration of Istanbul on Organ Trafficking and Tourism aims to halt unethical practices to protect donors and to improve patient safety and increase accountability.

PHMI client Wockhardt Hospitals Limited is an example of a health care delivery organization investigating the feasibility of developing solid organ transplant programs (as well as bone marrow and stem cell transplant programs). In the fall of 2007, Dr. Douglas Hanto, Chief of Organ Transplantation at Beth Israel Deaconess Medical Center, and Dr. Regis de Silva, Director at PHMI, visited Bangalore and Mumbai to review the liver and kidney transplant programs at Wockhardt Hospitals. There are several organizational, logistical, and regulatory issues to be resolved in order to implement these programs more fully in such a way that proper professional and quality standards and patient safety are assured. PHMI can play an important role in this process, not only by enabling clients to access the latest knowledge in the science and structure behind such programs, but also by providing professional and ethical guidance in the proper conduct of such procedures by our clients.

Dr. de Silva is a Director, Global Programs, at Partners Harvard Medical International and Associate Professor of Medicine at Harvard Medical School.