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More on the Weldon amendment to Appropriations bill and concerns about its effects on medical research. From 11/25 edition of the Chronicle of Higher Education. Amendment to Spending Bill Would Ban Patents on a 'Human Organism' By JEFFREY BRAINARD Washington Congress is poised to approve legislation that would bar the U.S. Patent and Trademark Office from issuing a patent on a "human organism," including any human embryo created by researchers. ------------------------------------------------------------------------- ------- "Some scientists have worried that the amendment could be interpreted broadly to prevent the development of stem cells for medical therapies, but the final measure includes clarifying language to allow such research. Some research advocates were satisfied with the clarification, which was offered on Tuesday. But others continued to worry about the measure's impact, in part because it was proposed by Rep. Dave Weldon, a Florida Republican who has backed previous efforts to ban the cloning of human cells for medical research and has criticized research on embryonic stem cells. The research is controversial because scientists must destroy embryos to derive the cells, which have the potential to treat diseases. Opponents, including Representative Weldon, regard embryos as human lives. For now, the proposal is in the form of a amendment to a giant spending bill to finance several federal agencies in the 2004 fiscal year. Congress is expected to approve the bill in December or January. Representative Weldon, who is a physician, has said he does not intend the measure to prevent research on stem cells. The patent office has approved patents on stem cells, and its director, James E. Rogan, said last week that Dr. Weldon's proposal was consistent with the office's existing policy, which prohibits patents "directed to or encompassing a human being." Dr. Weldon said he substituted the words "human organism" for the patent office's "human being" because the former was "more politically neutral and more precise." Academic researchers continued to mull the amendment, worrying that it could have unintended consequences that could hamper medical research related to embryos and stem cells. The scientists' ability to patent discoveries can influence whether they work with biotechnology companies to develop findings from their basic research into therapies for patients. Colleges stand to receive royalties and license fees from such work. Dr. Weldon has argued that Congress should codify the patent office's existing policy because of advances in medical research, including the genetic modification of embryos for various research purposes. In particular, he said he was referring to reports this year that Spanish researchers had created a hybrid embryo containing some cells from a human male embryo and other cells from a female embryo, a union they dubbed a "she-male." (The researchers destroyed the hybrid after it had grown for six days.) "We should not allow such researchers to gain financially by granting them an exclusive right to practice such ghoulish research," Dr. Weldon said in July. Absent Congressional support for the patent office's policy, he noted, courts could overrule it. In 1980, the U.S. Supreme Court struck down a patent-office policy when it allowed a gene to be patented -- a decision that has helped fuel a surge of genetic research at colleges. Lawrence S.B. Goldstein, a professor of cellular and molecular medicine at the University of California at San Diego, said that he agreed with Dr. Weldon that human embryos themselves should not be patented. But Dr. Weldon's amendment was too broad, and the word "organism" is vague, he said. "If this is so important," said Mr. Goldstein, "why not write a carefully crafted bill, with definitions and exclusions" for stem-cell research? "What Congressman Weldon would find," the professor said, "is that there would be a lively debate." But because the proposal was offered as an addition to a spending bill, it did not get a Congressional hearing. In response to such criticism, the clarification added on Tuesday contains a reference to Dr. Weldon's July statement that the policy would not apply to "stem-cell research or patenting genes." Should Dr. Weldon's amendment pass when Congress takes final action on the underlying bill, the policy would be in effect for only the 2004 fiscal year, unless it is renewed -- which could provoke another round of debate. " ------------------------------------------ forwarded by: Francesca Fierro O'Reilly Managing Director of Education and Advocacy Parkinson's Action Network 1000 Vermont Avenue, NW, Suite 900 Washington, DC 20005 202-842-4101 phone 202-842-4105 fax [log in to unmask] www.parkinsonsaction.org ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn