Varmus proposes guidelines for stem cell research.

After almost a year of discussion and debate, Harold Varmus, MD, director of the National Institutes of Health (NIH), has proposed guidelines under which federally funded scientists can pursue research using human pluripotent stem cells. The issue has been politically charged. Conservative members of Congress have gone on record against the use of the cell cultures because they believe it violates the federal ban on research using human embryos. In response, petitions from well-known US researchers and Nobel laureates arrived, stating that to ignore such an opportunity would delay, and even prevent, the development of treatments for many nowuntreatable and incurable diseases. In December 1998, 2 different research groups reported that they had isolated and cultured human pluripotent stem cells from 2 different sources. Pluripotent stems cells are early progenitors of most of the specialized cells in the human body. The various tissues and organs in the body are composed of these cells. In culture, stem cells can divide for an indefinite period of time. However, the 2 methods used by the researchers raised ethical issues. One group derived their cells from early-stage human embryos that were created and then not used for the in vitro fertilization of women seeking treatment for infertility problems. The second group derived their cells from fetuses that had been aborted. In each case, the patients involved gave consent to have their embryos or fetal tissue used in the research. Neither of the groups used federal money. Shortly after the research findings were released, Dr Varmus requested a legal opinion from the general counsel to the US Department of Health and Human Services as to whether federal funds could be used in research using human pluripotent stem cells. The attorney found that federal funds could be used in such research because cells are not embryos. However, the opinion also stated that the human pluripotent stem cells derived from fetal tissue fall within the definition of human fetal tissue and are subject to federal restrictions on the use of such tissue in transplantation. In a statement released by the NIH, Dr Varmus said, “It is essential that the federal government play a role in funding and overseeing the conduct of this research. Federal funding will make it possible for scientists—both privately and federally funded—to have the opportunity to pursue this important line of research. Federal funding will provide oversight and direction that would be lacking if this research were the sole province of private sources of funding and will also help ensure that the results of research will be accessible to the public.” In the guidelines, Dr Varmus and the committees that worked with him on the issue proposed the following: ● Studies using pluripotent stem cells derived from early human embryos may be conducted using NIH funds only if the cells were derived from early human embryos that were created for the purposes of infertility treatment and then were not needed in the treatment.