SCIENCE STEERING CLEAR OF 'DESIGNER' BABY ISSUES
BY THERESA CHA -- Lincoln Journal Star

The words gene therapy may give rise to visions of Nazi-like eugenics projects, "designer" babies or strange, genetically engineered creatures gone awry.
    But experts say the type of gene therapy - in particular, germline gene therapy, in which parents' reproductive cells are changed with the goal of passing on the changes to their children - is simply not being done.
    Dr. Ira Fox, associate dean of research and development at the University of Nebraska Medical Center College of Medicine, believes people attempting germline gene therapy at this point "would be run out of town."
   "It just wouldn't happen," said Fox. "I can't say it's going to be true in 100 years, but our society is not prepared today to deal with germline gene therapy. We're just not ready for it."
   Although we're all gene-modified to some degree through natural selection, artificial manipulation of the germline is taboo for now, said Clague Hodgson, CEO of Nature Technology Corp., a Lincoln biotechnology company, and former head of cancer biology at the Creighton University Cancer Center in Omaha.
   "They're beginning to have discussions about germline modification," he said. "Currently, it's forbidden, and nobody wants to go there."
    News reports of parents selecting a genetically tested egg for in vitro fertilization or choosing the sex of their unborn child may lead to the misconception, but in those cases no genetic manipulation is involved. Rather, genetic information is being used for selection.
    Dr. G. Bradley Schaefer, a clinical geneticist at UNMC, agrees germline gene therapy is not something the public needs to worry about.
    "No one's doing it because we're not even close," he said. "You've got to crawl before you can walk. And before you start monkeying around with that stuff, you've got to have a lot more things figured out."
    Many regard the field of gene therapy to be in its infancy or adolescence at best. Current gene therapy is mostly experimental. Of the estimated 100,000 human genes, scientists know the function of very few. Beside dozens of ethical issues involved in germline gene therapy, attempting it without knowing how everything works could spell professional suicide for scientists.
    "Germline gene therapy is an ethical issue that just about everybody will strongly agree with," said James Talmadge, a UNMC scientist. "I'll simply fall down on the side of the angels on that one."
    Still, any sort of gene therapy comes with ethical questions. For now, ethics concerning somatic gene therapy, in which the recipient's genome is changed but the change is not passed on, seem more pertinent.
    The death of Jesse Gelsinger, a patient in a somatic gene therapy study in Pennsylvania, for example, brought to a head many issues, including the processes by which gene therapy trials are reviewed, conducted and monitored, conflict of interest issues that may skew the way researchers interpret data, taking advantage of clinical trial participants.
    "The ethics is much less related to the putting genes into germline issue (than to) are we taking advantage of people who can't make a rational decision," Fox said. "Why expose someone in a gene therapy trial when there's nothing to be gained? You can always claim that you're going to gain something, but is what you're going to gain worthwhile?
    "Whenever you manipulate some aspect of biology, you're going to get data but not all data collection is equal."
    Fox was referring to "marking" studies where trial participants receive no benefit other than making a possible contribution to future treatments. He believes 90 percent of the gene therapy trials today shouldn't be happening.
    Talmadge, a scientist whose research focuses on clinical development of adenovirus vectors for cancer treatment, agrees too many clinical trials are going on in areas unsubstantiated by basic research. But he disagrees about the value of marking studies.
    "There's some good scientific questions you can do with gene therapy that you cannot ask any other way on the face of the earth," Talmadge said. "And as long as it's not life-threatening, to me, it's just great stuff. You're not going to hurt the patient. You're not going to help the patient, but you will help future patients based on what you learn so marking studies are very powerful."
    Risk is a part of any experimental process, said Becky Anderson, an ethics professor at UNMC.
    "But the question, inevitably there, is: Were you attempting something so risky that it shouldn't have been offered to humans yet?" she said. "It's challenging to know when to start human protocols."
    Fox believes that's where gene therapy jumped the gun. He believes much more basic research needs to be done before clinical trials.
    "In any other field other than gene therapy, most people don't make that sort of a leap," he said. "People got caught up in the high-tech DNA sort of stuff."

Learn more
    Find more information on the Human Genome Project and its implications at http://www.ornl.gov/hgmis/faq/faqs1.html.

HUMAN GENOME PROJECT

   The Human Genome Project is an international, 13-year effort to identify human genes and find genes for various genetic diseases. Scientists have identified more than 8,000 human genes, including those linked to breast and colon cancers and Alzheimer's disease.
  The project formally began in October 1990 and was to last 15 years, but rapid technological advances have accelerated the expected completion date to 2003. Project goals are to discover all the approximately 100,000 human genes -- the human genome, make them accessible for further biological study and determine the complete sequence of the 3 billion DNA subunits, or bases.
  As part of the project, parallel studies are being carried out on such selected model organisms such as the bacterium E. coli to help develop the technology and interpret human gene function.
  The U.S. Department of Energy's Human Genome Program and the National Institutes of Health's National Human Genome Research Institute together make up the U.S. Human Genome Project. A rough draft of the human genome was completed in June 2000. Efforts are still under way to complete the finished, high-quality sequence.
  Just whose genome is it anyway?
  No one person was chosen to be the human in the Human Genome Project. Instead the genome is a composite of genetic material taken from 10 to 20 different women and men. Many people donated their genes, but only a fraction of the samples were processed. The names of the individuals have been protected. Neither the donors nor the scientists know whose DNA was actually sequenced.