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Friday, June 01, 2001 - 12:00 a.m. Pacific Human cloning called too unsafe to perform By Warren King Seattle Times medical writer Human cloning is so unsafe that it should never be conducted, and the scientific community should speak out clearly on the issue, the director of the federal Human Genome Project told a gathering of scientists in Seattle yesterday. "Regardless of how you feel about the morality of it," Dr. Francis Collins said, "the safety issues are huge. Animals that have been cloned are not normal - and that's not to mention all the stillborns." Collins, here to address a meeting of the American Society of Gene Therapy, said scientists should take a firm stand on this and other ethical issues that are rising at an unprecedented pace with the rapid development of genomic technology. "We ought to identify areas that we are not going [to get into] and say so publicly," the pioneering researcher told an opening session yesterday of the conference at the Washington State Convention and Trade Center. About 2,500 researchers are attending the meeting through Sunday. A Kentucky scientist and a religious group in New York state have said they will try to clone a human. Both disparaged assertions by the federal Food and Drug Administration (FDA) that it has regulatory control over such an effort. In a wide-ranging address, Collins predicted that genes for most of the major illnesses will be identified within seven years. That includes heart disease, common cancers, diabetes, asthma, multiple sclerosis, Parkinson's disease, Alzheimer's and others. But developing effective genetic therapies or drugs for the diseases will not be accomplished until roughly 2020, he said. Collins also predicted that by 2030, genomics-based health care will be widespread and the human life span will be an average of 90 years. Major anti-technology movements also will be raging by then, Collins said, and ethical questions will be more difficult than ever. "There will be serious debate over the possibility of humans taking charge of their own evolution," he said. Collins, who is widely respected among scientists, also said it is still far too unsafe to conduct gene therapy on human germ-line cells, the cells from which eggs and sperm are derived, to prevent genetic diseases. He predicted the safety issues will be resolved and therapies will be under way within 20 years. Gene therapy attempts to treat genetic disease by replacing a flawed or absent gene with a healthy one. Usually, the technique uses a virus to ferry DNA into the defective gene. Only one gene therapy - for two patients with a rare, severe immune-system disorder - has ever worked, and it was only partially successful. Collins said testing for genetic diseases will become widespread in the future, and Congress should act to ensure that people's privacy is protected. He said the human genome will be mapped in detail by spring 2003. Researchers from the federal Human Genome Project and a private company, Celera Genomics, announced a year ago they had completed the first draft of the map. Other scientists attending the meeting said federal regulators have stepped up efforts to protect patients in clinical trials, after the September 1999 death of an 18-year-old Tucson man in a University of Pennsylvania gene-therapy experiment to cure his liver disease. It is the only death directly attributed to gene therapy. Jesse Gelsinger, who had been relatively healthy before the experiment, died four days after a virus was used to ferry corrected genetic material into his body. He was not told that monkeys had died in a similar experiment, that other patients had difficulties with the treatment and that one of the scientists stood to profit financially from the experiment through a biotechnology company he had founded. Dr. Phil Noguchi, of the FDA, said in a news conference that regulators are trying to ensure that patients are more informed in advance of their treatment - especially when others have been harmed by the therapy. Hospital panels that preview and approve human experiments are being examined to make sure they are not overburdened with too many clinical trials. And he said trials are being more closely monitored to ensure that they report adverse events to federal regulators. "It's important to make sure human subjects are protected," Noguchi said. "Clinical research is privilege, not a right of the investigator." Warren King can be reached at 206-464-2247 or [log in to unmask] http://seattletimes.nwsource.com/html/localnews/134301893_gene01m.html ******** ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn