Private Researchers Raise Ante by Creating Blastocytes to Grow Stem Cells in Culture
When a group of Virginia fertility researchers created embryos specifically to harvest pluripotent stem cells, they inflamed the debate over stem cell research at the same time that they demonstrated the problems that result when there is no federal oversight of such work. In a report published in the journal Fertility and Sterility, researchers from the Jones Institute for Reproductive Medicine at the Eastern Virginia Medical School in Norfolk solicited the donation of the sperm and oocytes from consenting men and women, created blastocytes, and manipulated them to produce 3 cells lines, one of which may contain pluripotent stem cells (Fertil Steril. 2001;76:132–137).
According to the report, the Institute’s Ethics Committee in July 1997 considered the literature on the ethics involving embryos and the decisions of the American Fertility Society Ethics Committee and decided that “the creation of embryos for research purposes was justifiable and that it was our duty to provide humankind with the best understanding of early human development.” At present, the cell lines cannot be used therapeutically, but the researchers said that they plan to resubmit their experimental plan to the ethics panel for possible therapeutic use in the future.
“Currently, there is a ban on the use of federal funds for human embryo research. However, recognizing the potential of human embryonic stem cell lines for the treatment of diseases, the National Institutes of Health (NIH) set up a medical panel to assist them in forming guidelines for the funding of human embryo research. The recommendations being considered include only the use of preexisting embryos resulting from in vitro fertilization. Funding for the production of “new” embryos for what NIH considers justifiable research has also been recommended. One must keep in mind, however, that NIH may not accept any of the panel’s recommendations. Regardless, any restrictions imposed by NIH do not apply to studies that are privately funded,” noted the researchers, who included Susan E. Lanzendorf, PhD, Catherine A. Boyd, BS, Diane L. Wright, MS, Suheil Muasher, MD, Sergio Oehninger, MD, and Gary D. Hodgen, PhD.
The report of the experiment comes at a particularly sensitive time. The issue of studies using pluripotent embryonic stem cells has become stridently politicized, with the scientific and advocacy communities pointing out the potential of such work to treat diseases and disorders that are virtually untouchable from a therapeutic standpoint at this time. However, members of the anti-abortion community stridently oppose the use of embryos in research because they believe that embryos represent human life and that their destruction is murder.
The NIH-proposed plan walked a fine line, allowing the use of existing embryos in such research but forbidding the use of aborted embryos. The Clinton administration was prepared to put the plan into motion, but when President Bush assumed the presidency, his administration put a hold on the research.
The researchers who published their work in Fertility and Sterility said they thought it would be more ethical to use embryos that were products of gametes from donors who knew from the beginning that their eggs and sperm would be used for research purposes.
Alexander Capron, a professor of law and medicine at the University of South California, did not agree with the research at this time. He told the Los Angeles Times, “It seems an unnecessary step, and it certainly raises the ante politically. It suggests that the scientists themselves don’t see a reason to abstain from something that seems of marginal medical utility, and which is much more problematic ethically, and is therefore certain to inflame people.”
Without a change in federal law, the decision about stem cells now pending in the Bush administration would not affect such research done with private funds. The private sector, without the governance of such a law, could continue to pursue such research.
Framingham Coronary Heart Disease Predictions Validated in Other Races and Ethnicities
Although the landmark Framingham Heart Study resulted in sex-specific coronary heart disease (CHD) prediction functions, they were specific to assessing the risk of developing heart disease in a white, middle-class population. A panel of the National Heart, Lung, and Blood Institute was assembled to assess whether the functions could be generalized to other populations (JAMA. 2001;286:180–187).
The workshop members applied the CHD functions for the prediction of coronary death and myocardial infarction to 6 ethnically diverse cohorts that included whites, blacks, Native Americans, Japanese American men, and Hispanic men. The 23 424 individuals were part of the Atherosclerosis Risk in Communities Study (1987–1988), Physicians’ Health Study (1982), Honolulu Heart Program (1980–1982), Puerto Rico Heart Health Program (1965–1968), Strong Heart Study (1989–1991), and the Cardiovascular Health Study (1989–1990).
After evaluating the data, the researchers determined that the Framingham functions worked well for white and black men and women, with an acceptable prediction of coronary heart disease within 5 years of follow-up. However, the Framingham functions systematically overestimated the 5-year CHD events for Japanese American and Hispanic men and Native American women. However, if the function was recalibrated, taking into account risk factors and underlying rates of CHD, it worked for these populations as well.
Anti-Bioterrorism Chief Named
Scott Lillibridge, MD, has been chosen to lead the US Health and Human Services (HHS) Department’s anti-bioterrorism initiative. Dr Lillibridge had previously led similar efforts for the federal Centers for Disease Control and Prevention in Atlanta.
As a special assistant to US HHS Secretary Tommy G. Thompson, Dr Lillibridge will coordinate the anti-bioterrorism efforts across the department. He has been involved in anti-bioterrorism efforts internationally; he led the 1995 US medical delegation to Japan after an attack with sarin gas killed 10 people in the Tokyo subway. He also participated in the federal public health assessment after the Oklahoma City bombing in the same year.