Posted by Al Gordon on February 09, 1998 at 20:06:36:
Dr. Jay Fishman is a leading scientist in the field of xenotransplantation and has contributed significantly to the current debate and to the existing FDA guidelines.
I have included below a couple of published letters from Dr. Fishman which speak for themselves. At the risk of taking quotes out of context, I am particularly heartened by his statement, "I was a co-author of a recent paper proposing a moratorium on human xenotransplantation. However, because certain of my concerns have been addressed, I no longer feel that a such a moratorium is necessary."
Here are Dr. Fishman's letters:
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January 26, 1998
The Editor
Boston Globe
P.O. Box 2378
Boston, MA, 02107-2378
To the Editor;
I would like to clarify information in several recent articles which appeared in the Globe about transplanting tissues or organs between species, a technology called "xenotransplantation". One article ("Caution with animal-to-human transplants" Jan. 22) tended to overdramatize the known risks associated with xenotransplantation. As was emphasized at a recent meeting sponsored by the United States Public Health Service (USPHS), the level of risk remains unknown at present, though very much worth further investigation. The headline of the follow-up article ("Boston group rebuffed on animal Jan 23) mischaracterizes the intent of a paper (Nature Medicine, February 1) which calls for a moratorium on human studies in xenotransplantation, the response of the USPHS, and also the content of the article by Richard Knox.
As a co-author of the paper suggesting a moratorium, the intent of the article was to encourage the development of strategies to assess potential infectious risks due to xenotransplantation and to communicate this information to the general public. We proposed that the public be involved in measuring and accepting such risks, and in any decision to proceed with development of this technology. This approach seeks to ensure and enhance the safety of xenotransplantation, not to impede progress of this technology.
The Food and Drug Administration and other agencies of the USPHS have directed a careful and open discussion about xenotransplantation over the past four years, focusing attention on the potential risk of infection to the organ recipient and to the community at large. Much new information and an agenda for future research have been developed through this process. The most recent PHS xenotransplantation conference proposed the formation of a national Xenotransplantation Advisory Committee to include scientists, physicians, ethicists, and members of the lay public. The charge of this oversight committee is similar to that proposed by our group: to enhance the safety and public awareness of xenotransplantation while allowing studies of the technology to achieve whatever level of success it may in alleviating clinical disease. It would be, therefore, inaccurate to characterize the PHS response as "rebuffing" the Boston group, but rather as encouraging a dialog about the best approaches to these complex scientific and ethical issues.
Risk is inherent in virtually all nascent medical technologies. Twenty years ago, few could envision that thousands of lives might be saved through then-experimental organ and bone marrow transplantation. Today, xenotransplantation is such an experimental therapy aimed at relieving the dire shortage of voluntary human donor organs and tissues -- and possibly saving more lives in the future.
Jay A. Fishman, MD
Infectious Disease Division
Massachusetts General Hospital
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February 2, 1998
Mr. Adrian Ivinson, Editor
Nature Medicine
345 Park Avenue South
New York, NY, 10010-1707
medicine@natureny.com
Sir-
I was a co-author of a recent paper proposing a moratorium on human xenotransplantation (1). However, because certain of my concerns have been addressed, I no longer feel that a such a moratorium is necessary. The unique aspect of risk of xenotransplantation is the potential spread of infection not only to the recipient of cells or tissues from another species, but also to individuals uninvolved in the clinical decision-making process (2). Our paper proposed that a mechanism be created to involve the public in the on-going review of information regarding the safety of xenotransplantation. As a part of a four year long evaluation, the Food and Drug Administration (FDA) and other agencies of the United States Public Health Service (USPHS) have directed careful and open discussions about xenotransplantation, focusing attention on the potential risk of infection to the organ recipient and to the community at large. Much new information and an agenda for future research have been developed through this process.
The most recent federal xenotransplantation conference included a proposal by the USPHS for the formation of a national Xenotransplantation Advisory Committee to include scientists, physicians, ethicists, lawyers, and members of the lay public (3). The charge to this oversight committee is similar to that proposed by our group: to enhance the safety and public awareness of xenotransplantation while allowing clinical trials to advance. In the meantime, existing review mechanisms will assure that each proposed protocol includes the evaluation of all human subjects for known infectious agents potentially associated with interspecies transplantation.
The risks of xenotransplantation are not zero. Ultimately, these risks can only be measured in clinical trials. The potential benefits of xenotransplantation justify a cautious advancement of such studies. Data assembled as a result of such experiments will allow informed decisions about whether the risks are worth taking.
Jay A. Fishman, M.D.
Massachusetts General Hospital
Boston, MA, 02114, USA
fishman@helix.mgh.harvard.edu
1. Bach, FH, et al. Nature Medicine, 4: 141-144 (1998).
2. Fishman, JA. Kidney International, 51:S41-S45, (1997).
3. U.S. Department of Health and Human Services, "Developing U.S. Public Health Policy in Xenotransplantation, January 21-22, 1998, Bethesda, Maryland, USA.