{blr 1244} fetal tissue - nih

10 Biotechnology Law Report 726 (Number 6, 1991)

{BLR 1244} Fetal tissue-

NIH.

BLR UPDATE: RECENT LEGAL, ETHICAL, AND SCIENTIFICDEVELOPMENTS IN FETAL TISSUE TRANSPLANTATION

WASHINGTON, DC, 8/91—The battle continues over the ban on fetaltissue transplantation research, with action to overturn it being led in Congressby Rep. Henry Waxman (D-Calif.) and Rep. Ted Weiss (D-NY). The originalversion of the Health Reauthorization Bill (H.R. 2507), including a liftingof the ban, was passed by the House in July 1991.

The extension of the ban by DHHS Secretary Louis W. Sullivan, M.D.,has generated controversy even within the agency since it was promulgatedin November 1989. Sullivan had acted on the grounds that the clinical useof fetal tissue would encourage abortions. He therefore extended the banon the use of federal funds to support research on fetal tissue transplantion.His action was applauded by antiabortion groups, but critics objected inlight of the evidence of the potential value of fetal tissue transplants inmanaging conditions such as Parkinson's disease.

The scientific rationale for such transplants is that fetal tissue, beingin an earlier stage of development and lacking many antigens that are presenteven at birth, has a greater ability to adapt to a new host and less chanceof being immunologically rejected.

Concern about Legal Basis of Ban

Attorneys within Sullivan's agency questioned whether the ban had beenproperly carried out. In February 1990, Rep. Weiss, Chair of the House Sub-committee on Human Resources and Intergovernmental Regulation, releaseda November 11, 1989, memo from Richard Riseberg of the Office of theGeneral Counsel to the Executive Secretariat of the DHHS. That memostated that the extension of the transplant research moratorium was on a

"shaky legal base" and warned of possible legal vulnerability. In Riseberg'sview, making the ban on fetal tissue transplantation research permanentcould be construed as a rule, in which case, it should have been handledby the formal rule-making process of the Administrative Procedures Act,including publication in the Federal Register. Instead, the moratorium wasannounced in a grant application manual published by the National Institutesof Health (NIH).

Advisory Panel Saw No Risk of Increasing Abortions

The Human Fetal Tissue Transplantation Research Advisory Panel con-vened by the NIH had earlier rejected the idea that fetal tissue use wouldencourage abortions. The Panel did recommend, however, that women havingabortions be prevented from designating a specific recipient for a fetal tissuetransplant. The Panel's report noted: "Research using fetal tissue has beenconducted and publicized for over 30 years. There is no evidence that this


use of fetal tissue for research has had a material effect on the reasonsfor seeking an abortion in the past." In many countries, use of tissue fromaborted fetuses is accepted provided the decision to abort and the decisionto donate tissue are separated.

My Son/Daughter the Donor?

There clearly have been some conceptions and abortions with goal ofobtaining antigenically compatible tissue for someone else. The most publicizedcase of a baby born to be a tissue donor is that of Anissa Ayala, whoseparents had a baby to provide bone marrow in the hope of saving Anissafrom death from chronic myelogenous leukemia. Many similar but unpublicizedinstances are known. In one complicated case, a woman was artificially insem-inated with sperm from her former husband when a child from that earliermarriage needed bone marrow. In another case, a child was conceived toprovide a kidney.

Medical ethicists are divided on this practice. Arthur Caplan, M.D.,of the University of Minnesota's Center for Bioethics, notes that "Basically,people have babies for all sorts of screwy reasons ... [or] without thinkingwhy. At least in this case, they are having a child partly from this notionof altruism." However, other commentators see unsettling implications.Said Robert Levine, M.D., of the Yale University School of Medicine, "Itseems to me that when a primary motive for conceiving a child is to producea tissue or an organ, we are getting very close to seeing this new beingas a means to another end."

The aborting of fetuses of the wrong tissue type raises other questions.Norman Fost, M.D., of the University of Wisconsin School of Medicine, andMark Evans, M.D., of the Hutzel Hospital in Detroit, know of or were involvedin cases where requests for in utero tissue typing were denied either duringa pregnancy or before conception. Presumably, the pregnant woman intendedto end the pregnancy if the fetus was of an inappropriate antigenic typefor the intended recipient.

"I do not believe that the creation of a pregnancy for the sole purposeof creating an organ donor is ethically acceptable," Dr. Evans said. Quotinganother ethicist with a contrary view, Dr. Levine noted, "The law of theland says you can have an abortion without giving a reason, so why can'tyou have an abortion for a good reason?"

Use of Fetal Tissue

In the case of fetal tissue transplantation, an aborted fetus is usedspecifically as a source of tissue. Approximately 90 such transplants havealready been performed around the world. In most of the early cases, thegrafts apparently failed. However, with changes in technique based on thefindings in these cases, the procedure began to produce successes. In a Febru-ary 1990 issue of Science, physicians at the University of Lund in Swedendescribed clinically significant post-transplant improvement according to


standardized testing in a 49-year-old man who had severe Parkinson's disease.The implication was that the graft was producing the dopamine that is defici-ent in patients with this condition.

Another clinical success, a 53-year-old with severe Parkinson's diseasewho was the first U.S. recipient of a fetal tissue transplant, was profiledin Business Week in July 1990. This man had recovered the use of his lefthand and had little need for crutches several months after his transplant.(For an extensive medical report on this case, see JAMA 47:505—512, 1990.)

Fetus-to-Fetus TransplantsA fetus-to-fetus transplant, apparently the first ever, took place in

May 1990. The parents of the recipient testified before Congress in April1991 in hearings on continuing the ban on fetal tissue transplantation research.

The couple, a minister and his wife, had lost two children to Hurler'ssyndrome, a rare fatal genetic disease that also causes severe crippling andretardation. Although they are opponents of abortion, the couple agreedto the transplant in an attempt to save the life of their unborn son. Thebaby appeared normal at birth. The couple told Congress that in their view,fetal tissue transplants are consistent with an antiabortion—prolife positionin that they are like transplantation of tissue from murder victims. In bothinstances, the death of the donor is an accomplished fact.

An opposing view was articulated by a professor of women's studiesat Massachusetts Institute of Technology. She told Congress that "Fetal tissueresearch and transplants make women into mere environments and containersfor the fetus. Abortion is a hard enough decision for many women...withoutbeing burdened with another decision of whether or not to donate fetal tissue.... More and more, it is the women who are expected to be altruistic withwhat issues from their bodies."

Medical Societies Establish Advisory Board

These thorny issues have engendered a private initiative on the questionsraised. Moving into what they described as a "scientific and moral vacuum"that has existed since the government failed to re-establish its Ethics AdvisoryBoard in 1980, the American College of Obstetricians and Gynecologists(ACOG) and the American Fertility Society (AFS) announced in January 1991that they were establishing a National Advisory Board on Ethics in Reproduc-tion. The new board, which is to have 15 representatives from medicine,public policy, law, ethics, and religion, is charged with establishing guidelinesand peer review procedures for research on pre-embryo and fetal tissue andfetal transplantation activities. The board also will monitor developmentsin infertility research and reproductive genetics technology.

ACOG spokesman, Dr. Kenneth Ryan, who is Chairman of the Departmentof Obstetrics and Gynecology at Harvard Medical School, said, "Researchon fetal tissue and reproductive technologies is going on in this country and


will continue with or without government regulation. The time is ripe fora private group to shoulder the task of setting standards to ensure that suchresearch is ethically and scientifically sound." He expressed concern aboutpremature clinical application in the absence of research guidelines.

Dr. Howard Jones of the AFS noted that "a respected interdisciplinarynational body to evaluate and monitor basic and applied research in the sensi-tive areas of embryo research and assisted reproductive technologies" wasneeded "to better serve patients, physicians, scientists, and the public interest."

# # #

{BLR 1245} Genetic Engineering Dictionaries-

Genetic Engineering Abstracts-

Literature Searching.

BLR BIBLIOGRAPHY

Bilingual Genetic Engineering VocabularyJust in time for holiday giving comes a French-English/English-French

dictionary of more than 1000 genetic engineering terms, the first in a seriesof specialized works in biotechnology being published by the Canadian Govern-ment Publishing Centre for researchers, students, terminologists, translators,and, presumably, attorneys. Order it from the Centre in Ottawa, Ontario,Canada K1A 0S9. CGPC Code 022001. ISBN 0-660-558122. Price: C$25;outside Canada: US$30.

ISI Offers CD-ROM Citation Indexwith Abstracts in Biotechnology;

Abstracts Also Available in Printed Form

The Institute for Scientific Information has a Biotechnology CitationIndex with abstracts available on CD-ROM. The Index covers the relatedsubjects of molecular biology, genetics, applied microbiology, and environmental,social, and political issues. There is complete coverage of 150 technicaljournals and selective coverage of 7000 more. The index includes Biotech-nology Law Report.

A unique feature of the Index is its use of the ISI hypertext featureRelated Records , which links articles having reference citations in commonto make searching more efficient. It also permits cited reference searching,which allows users to identify all articles that cite a given paper.

{blr 1244} fetal tissue - nih

Documents