[IWAR] BIO xenotransplantation

From: 7Pillars Partners (partnersat_private)
Date: Thu Jan 22 1998 - 20:18:44 PST

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    Xenotransplantation Guidelines Out Soon
    By Therese M. Droste 
    BETHESDA (Reuters) -- On Thursday, the second day of the conference on
    Developing US Public Health Service Policy in
    Xenotransplantation, experts continued their debate on the issues surrounding
    use of animal organs in the treatment of humans. 
    Dr. Harold Y. Vanderpool of the University of Texas Medical Branch at Galveston
    said transplantation of animal organs and
    tissues into human subjects calls for examining four critical ethical issues. 
    "These are not daunting issues" but they must be addressed, Vanderpool said.
    First, scientists must consider judgments
    regarding permissible harm-benefit thresholds for the initiation of clinical
    trials involving human subjects. It encompasses three
    factors that must be played off one another: scientific-medical feasibility,
    clinical urgency, and the potential of scientific
    discovery, Vanderpool said. 
    Second, it's necessary to secure informed consent from third-party groups such
    as medical personnel and patients' close
    contacts, Vanderpool said. This will protect researchers and medical
    institutions from lawsuits from medical personnel and
    close contacts of patients who might claim that they were never told about the
    risks they might run from dealing with patients
    who have received animal organs. 
    Third, there are serious difficulties in securing informed consent from
    research subjects, Vanderpool said. Some subjects for
    xenotransplantation are sick and desperate to extend their lives, "but they
    still must understand the complex concerns"
    surrounding xenotransplantation, he said. 
    And fourth, there are problems regarding who approves and oversees clinical
    trials, Vanderpool added. 
    Dr. Leroy Walters of Georgetown University provided several elements to help
    devise xenotransplantation policy: 
    -- Conduct regular public discussion and review of xenotransplantation
    protocols that typify the major lines of current research
    or that raise issues; 
    -- Publicly list all clinical studies of xenotransplantation into humans,
    without regard to the funding sources; 
    -- Run a registry tracking all volunteers in early xenotransplantation studies.
    "The question will be... whether or not the registry
    should also include and track members of immediate families," Walters said; 
    -- Have an annual accounting of the number of animals used by a species for
    transplants into human beings; 
    -- Have an annual assessment based on a global literature review of the public
    health risks associated with xenotransplantation; 
    -- And have an external review at the end of the first five years and every two
    years thereafter of whether a special oversight
    system continues to be needed for this innovative field, Walters said. 
    Developing public policy for xenotransplantation is controversial due to
    potential dangers to public health, especially the
    potential risk of animal viruses mutating into forms that can infect humans.
    Such risks are enunciated in the February 1 issue of
    Nature Medicine, in which Dr. Fritz Bach of Beth Israel Deaconess and Harvard
    University in Boston, Massachusetts, calls for
    a "moratorium" on xenotransplantation on humans. 
    Bach told Reuters that it's necessary to get public input on
    xenotransplantation by way of a broad-based national committee
    that will educate the public of the viral and other risks of
    xenotransplantation. Such a committee could be put together by the
    President or Congress, he said. 
    The moratorium, Bach said, "could be lifted the first time the committee meets,
    if that's what they decide," but that it's crucial for
    the public to be involved. He stressed that the moratorium need not impact
    either xenotransplantation research or its funding. 
    Dr. Louisa Chapman of the Centers for Disease Control and Prevention said that
    revisions to the xenotransplantation
    guidelines, first published in the December 1996 Federal Register, will be
    completed in the first half of 1998.

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