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regulatorsFRONTLINE presents Organ Farm
a patient and a pig
who's regulating this and what are the ethical and social concerns?

For xenotransplantation research in the U.S., there is already a well-defined regulatory context set up by the Food and Drug Administration in partnership with the National Institutes of Health and the Centers for Disease Control, all overseen by the Secretary of Health and Human Services at the presidential cabinet level. This section collects information on their guidelines, criticism of the agencies' oversight, and the new ethical and social issues these bodies confront with the experimental field of xenotransplantation.

four patients
animal welfare
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the regulators

the oversight agencies

U.S. regulatory bodies have adapted several sets of voluntary federal guidelines to govern xenotransplantation technologies and their public health implications. In addition, responsibility for ensuring that proper protocols are followed often falls to local institutional review boards. Here's a summary.
How Do We Regulate and Safeguard the Larger Public Risks?

In these excerpts from their interviews with FRONTLINE, xenotransplantation researchers and a medical ethicist discuss what will be asked of the individual xenotransplant recipient, as well as the larger population, if pig-to-human transplants moves forward.
The Ethical and Social Questions

These excerpts from FRONTLINE's interviews for "Organ Farm" address the costs of financing xenotransplants, conflicts of interest in its development, unknown risks to the population, and the need for more open public discussion.
You Can't Go Forward Without Taking Some Risks

In his FRONTLINE interview Dr. Walid Heneine, an expert on retroviruses at the Centers for Disease Control, discusses the PERV virus threat. He argues that limited human clinical trials should proceed, albeit with caution and stringent monitoring.
This Little Piggy Went to Market:  The Xenotransplantation and Xenozoonose Debate

In this 1999 article in the Journal of Law, Medicine and Ethics, professor Margaret A.Clark lays out her concerns about the clinical risks and ethical and policy issues surrounding xenotransplants. She recommends a moratorium be placed on any human trials with whole organs "until a track record is established with xeno cellular transplants." This excerpt focuses on the ethical and public policy questions she poses.
A Critique of Clark's Frightening Xenotransplantation Scenario

Here is part of medical ethicist Harold Y. Vanderpool's response to Margaret A. Clark's critique of xenotransplantation. It was published in the same issue of the Journal of Law, Medicine and Ethics and focuses on the ethical issues raised by Clark.
Xenotransplantation At A Crossroads:  Prevention Versus Progress

In this 1996 article from Nature Medicine reprinted on the CDC's web site, Jonathan Allan argues that public health agencies in the United States have been reluctant to regulate xenotransplantation, despite the evidence of cross-species virus threats (he focuses specifically on baboon-to-human viruses). He writes, "In choosing voluntary guidelines to be enforced at a local level, rather than federal regulations, the FDA/CDC committee has chosen the least stringent and possibly least successful method of policing these transplant procedures."
Animal to Human Organ Transplants-A Solution or a New Problem?

(Note: Pdf file requiring Acrobat 4.0.)  

This article by A.S. Daar in the 1999 Bulletin of the World Health Organization presents a more international perspective on xenotransplantation's policy and social issues. It covers religious belief, biomedical ethics, community consent, the restrictions imposed on patients and problems in allocating resources to xenotransplantation.

A Round Table Discussion on Darr's article

(Note: Pdf file requiring Acfrobat 4.0) includes: retrovirus scientist Jonathan Allan, professor of surgery A.P.R. Aluwihare, xeno researcher Fritz H. Bach, bioethicist Arthur Caplan, law professor Bernard Dickens, infectious disease expert Jay A. Fishman, Netherlands Scientific Secretary Eric van Rongen and xenotransplantation professors of surgery C.G. Groth and M.E. Breimer.
The Present Status of Xenotransplantation and Its Potential Role in the Treatment of End-Stage Cardiac and Pulmonary Diseases

(Note: Pdf file requiring Acrobat 4.0.)  

This December 2000 report by the International Society for Heart and Lung Transplantation advises that human clinical xenotransplantation trials are still far in the future. It advises that clinical xenotransplantation trials should not be undertaken until authorities have determined a minimal virus risk, and until 60% of pig heart and lung organs survive in non-human primates for a minimum of three months.

How Will We Know When We're Ready?

Many scientists agree that before allowing human clinical xenotransplant trials, scientists must achieve survival rates of three to six months in animals. In this 1996 article from the journal Emerging Infectious Diseases, heart surgeon Robert Michler illustrates the history of the first attempts at cardiac allotransplants (transplants from individuals of the same species) in order to provide a comparison for the prospect of clinical xenotransplant trials.
Uncertainty in Xenotransplantation: Individual Benefit Versus Collective Risk

The focus of this 1998 paper in Nature Medicine is ethical issues raised by the trade off of individual benefits from xenotransplants against societal risk. Its authors are doctors and health policy experts. They propose a temporary moratorium on new clinical xenotransplantation trials while a national review is undertaken to examine uncertain public risks and develop effective, responsible policy before new trials can proceed. At the time of publication, over 200 participants in clinical trials already had been exposed to cells, tissues or organs from other species. (Also, see FRONTLINE's interview with Fritz H. Bach, one of the paper's authors.)
FDA's Proposed Rule Change on Sharing Information

In January 2001, the FDA proposed a new rule which would greatly increase information the agency makes public about the safety and progress in experiments into gene therapy and xenotransplantation. The proposed rule would require the FDA to release full descriptions of all clinical studies, safety test records, copies of informed consent forms participants must sign, procedures for monitoring, and updated records of safety problems on humans. "Today's action is an important step in ensuring greater public confidence in these revolutionary therapeutic technologies," said FDA Commissioner Jane E. Henney. This proposed change came sixteen months after Jesse Gelsinger, an Arizona teenager died in a gene therapy trial. It spawned intense scrutiny of this experimental field and the FDA's regulation of it. It also came several months after a lawsuit was filed against the FDA in November 2000 by the Campaign for Responsible Transplantation, a coalition of 90 public interest groups opposed to xenotransplantation. The group charges that the FDA had violated the Freedom of Information Act by witholding records of xeno clinical trials.
Developing U.S. Public Policy for  Xenotransplantation

These transcripts of a January 1998 Department of Health and Human Services workshop include discussion on the pilot study to implement a National Xenotransplantation Registry Database (see the 1/22/98 transcript).

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