Ethics Questions Add to Concerns About NIH Lines

Abstract

STEM CELLS Some federally funded scientists are having second thoughts about working with the 21 human embryonic stem (ES) cell lines available to them under President George W. Bush's policy, following a report indicating that the cells are getting increasingly stale—not only scientifically but ethically as well. A recent article by Rick Weiss of the Center for American Progress in Washington, D.C., has drawn attention to a paper by bioethicist Robert Streiffer in the May issue of The Hastings Center Report . Streiffer, of the University of Wisconsin, Madison, says consent forms signed by embryo donors for the approved lines are inadequate by today's standards. “We know how to do things better now,” says Streiffer, who believes this is yet another reason why the Administration's policy, which limits federal funding to work with cell lines derived before August 2001, is untenable. Streiffer says most of the consent forms fall short of standards for informed consent in embryo research that were in place as early as 1994. And only one, from the University of California, San Francisco, comes close to meeting 2005 guidelines from the National Academy of Sciences. He singles out forms from two companies—BresaGen, now owned by Novocell, and Cellartis—as particularly inadequate. BresaGen's had only one sentence saying that defective embryos created from in vitro fertilization might be used in research. Cellartis told donors that cells would be destroyed after a research project. Other forms failed to mention that embryos would be destroyed and that cells derived from them could end up in experiments around the world. ![Figure][1] ES cell alternative? iPS cells have been used to create motor neurons ( above ). CREDIT: J. T. DIMOS ET AL. , SCIENCE “I was shocked,” says Lorraine Iacovitti, a neurologist at the Thomas Jefferson University Medical College in Philadelphia, Pennsylvania, who has used one of the BresaGen cell lines. Most researchers “just assumed that the consent had been taken care of.” Now two universities, Stanford and Johns Hopkins, are considering prohibiting work with the companies' five cell lines, which are not widely used. Story Landis, chief of the stem cell task force at the National Institutes of Health (NIH), says no changes are planned in response to the report. Allan Robins of Novocell in Athens, Georgia, says NIH officials told BresaGen in 2001 that “they felt what we had done was reasonable.” He says that ideally, the company would ask the donors for retroactive consent, but it is impossible to trace them. A representative from Cellartis told Science the company is preparing a correction to Streiffer's article. Many scientists say they would prefer to work with new human ES cell lines rather than any of the aging lines on the presidentially approved list. In addition to the ethical concerns, the cells are problematic for scientific reasons—for one, they were grown on mouse “feeder” cells, which makes them unsuitable for use in human therapies. But some scientists have been constrained from switching to new lines because they would lose federal funding. Two pending developments may change that. Both senators Barack Obama and John McCain have said that they support congressional efforts to expand the number of cell lines available to federally funded researchers. If the new president doesn't act fast enough, Congress likely will; both houses have twice passed such legislation only to be thwarted by Bush vetoes. In addition, remarkable progress with a new type of cell—induced pluripotent stem (iPS) cells—promises an alternative to cell lines derived from embryos. When Japanese researcher Shinya Yamanaka announced 2 years ago that he had cultivated colonies of ES-like pluripotent cells by inserting just four genes into mouse skin cells, many thought it would be years before the same could be done with human cells. But last year, two groups pulled it off ( Science , 1 February, p. 560). In the past 4 months, scientists have used iPS-derived cells to treat blood and neurological disorders in rats and mice, for instance. Two groups at Harvard University have developed colonies of iPS cells from patients with a variety of genetic diseases. Yet other work has shown that small molecules can be substituted for some potentially cancer-causing genes used to derive the original iPS cells. Major hurdles remain. It's not clear whether iPS cells will behave exactly like ES cells. And they can't be used therapeutically because the viral vectors scientists use to introduce genes could be hazardous. But given the speed of developments, at least one stem cell researcher, Rudolf Jaenisch of the Massachusetts Institute of Technology in Cambridge, believes “we will solve this much earlier than we think.” [1]: pending:yes