(Circulation. 2000;102:e9003.)
© 2000 American Heart Association, Inc.
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Cardiovascular News
American Heart Association Takes a Stand on Stem Cells
Research involving pluripotent or embryonic stem cells will be eligible for funding from the American Heart Association (AHA) under guidelines approved by the group’s board on June 25, 2000. However, said Rose Marie Robertson, MD, AHA president, grants involving such research cannot be accepted until guidelines for performing the work and monitoring compliance with those guidelines are presented to the organization’s board. She anticipates this will happen in October.
The issue of research involving human embryonic stem cells has been contentious since the first publications reporting that such cells had been isolated and cultured (Science. 1998;282:1061–1062, Science. 1998;282:1145–1147, Proc Natl Acad Sci U S A. 1998;95:13726–13731). Opposition to research involving such cells arises not because of the potential of such work but because of the source of the cells. In one of the above-noted studies, stem cells were derived from embryos that were made for in vitro fertilization and later discarded because they were not needed. In the other studies, the cells were derived from aborted fetal tissue.
The US Congress has banned the use of fetal tissue in federally funded research, but the potential of these cells has raised the question again. Human embryonic stem cells have the potential to become almost any kind of cell in the human body. They might be used to grow new skin for burn patients or to produce heart muscle tissue to replace that destroyed by a heart attack.
The US Senate held hearings on the issues involved in human stem cell research in December 1998 and January 1999, shortly after the research announcing such a discovery was reported. During those hearings, Harold Varmus, MD, who was the director of the National Institutes of Health (NIH) at the time, was enthusiastic about the potential of such cells. "At the most fundamental level, pluripotent stem cells could help us to understand the complex events that occur during human development. By studying the cell lines, scientists could determine which factors are involved in the determination of which cells give rise to more specialized cells that carry out the body’s work. This differentiation of cells could help people understand why embryonic development goes right and why it sometimes goes wrong. Cancer can occur when cell differentiation is abnormal, and it is hoped that research along these lines will unravel the mysteries of why this occurs."
In January 1999, the US Department of Health and Human Services (HHS) announced that it would fund such research once the NIH had formulated guidelines about how such work should be performed. At the request of the President, the National Bioethics Advisory Commission studied the issue. In September 1999, the Commission reported that it was ethically acceptable to derive and use stem cells from early-stage human embryos from in vitro fertilization and from fetuses from elective abortions in federally funded research, but the group prohibited research involving the derivation of such stem cells from embryos made solely for the purposes of research.
NIH guidelines first proposed in December 1999 set certain limitations on such research. In part, these guidelines limited the source of the stem cells. An NIH-issued fact sheet states: "HHS will fund research using human pluripotent stem cells derived from early human embryos only if investigators use cells derived from frozen embryos that were created for the purposes of infertility treatment and were in excess of clinical need. In addition, the investigator can offer no inducements, monetary or otherwise, for the donation of the embryo, and there must be a clear separation between the infertility treatment and the decision to donate embryos."
The guidelines also stated that no NIH funds could be used to derive the pluripotent stems cells from human embryos. In January 1999, Harriet Rabb, general counsel to HHS, said research involving pluripotent stem cells did not violate the federal ban on fetal research. Ms Rabb differentiated between the use of stem cell lines and their development. Although using fetal tissue to develop the cell lines would probably pass muster, she said, using embryos would not. However, the law does not apply to the use of stem cells derived from either source. Because stem cells cannot develop into an embryo, they are not organisms and do not violate the federal ban.
The AHA, in making its recommendation, said that the appropriate committees of the organization would develop amendments to the AHA Research Standards that are consistent with the board’s recommendations on stem cell research. The group’s research committee would be charged with monitoring AHA-funded stem cell research and determining if the research complies with AHA stem cell policies and the restrictions on such work that will be included in the research standards.
In writing the guidelines, the AHA task force charged with the task polled the American Cancer Society, the American Diabetes Association, the American Lung Association, the Arthritis Foundation, and the National Health Council about their positions on stem cells. The American Lung Association and the Arthritis Foundation did not respond. The American Cancer Society, the American Diabetes Association, and the National Health Council all support such research, with restrictions similar to those in the NIH guidelines. Many other disease-specific groups were publicly on record as supporting such research as members of the Patients’ Coalition for Urgent Research (CURe), which had testified in Congress about the potential benefits of work with such cells. The task force had in the hand the public statements by the National Conference of Catholic Bishops, which opposed the research, and it sought out the positions of other mainstream religious groups, including the Episcopal, Lutheran, Presbyterian, and United Methodist churches. Many of the religious groups had yet to address the issue specifically, but an evaluation of previous statements showed that the attitudes toward such research varied among the denominations.
The task force also polled various components of the AHA itself, and a large majority of those groups polled supported the potential scientific and medical value of funding the research as a general matter—and as a policy of the AHA. The group evaluated the benefits and risks of funding such research. One benefit was the important knowledge and potential for medical benefit from such research. The risks included the potential for a decrease in financial support from people opposed to such research, possible backlash, and the possibility that someone might abuse the knowledge gained from the work.
Dr Robertson said the decision was consistent with the organization’s mission to reduce death and disability from cardiovascular disease and stroke. However, she said, she and the task force were well aware of opposing opinions.
"Many organizations, including religious ones, find themselves torn between the moral commitment to heal and to develop new ways to heal and the complex issues regarding the use of embryonic tissue. In a diverse society, those issues are likely to continue to engender discussion," she said. "There was good discussion on the board and, in the end, members were impressed by the potential for saving lives."
Prominent Scientists Affirm That HIV Causes Aids
On the eve of the 13th International AIDS Conference in Durban, South Africa, >5000 scientists signed a statement declaring that HIV causes AIDS. The statement, called the Durban Declaration, appears in the July 6, 2000 issue of the journal Nature (Nature . 2000;406:15–16). It can also be found at the following website: http://www.durbandeclaration.org
The statement was designed to answer critics who claim that the evidence that HIV causes AIDS is still equivocal. Recently, South African President Thabo Mbeki publicly stated he has doubts about the AIDS-HIV connection.
In their statement, the scientists said: "The evidence that AIDS is caused by HIV-1 or HIV-2 is clear-cut, exhaustive, and unambiguous, meeting the strictest standards of science... It is unfortunate that a few vocal people continue to deny the evidence. This position will cost countless lives." The list of signatures includes many of the most prolific researchers in the field today. However, a press conference on the statement planned at the opening of the AIDS conference on July 9, 2000, was abruptly canceled after pressure from government officials.
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