[Paleopsych] NYT: Group of Scientists Drafts Rules on Ethics for Stem Cell Research

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Group of Scientists Drafts Rules on Ethics for Stem Cell Research 
http://www.nytimes.com/2005/04/27/health/27stem.html
April 27, 2005

[Adults do not seem to realize how many science fiction and movie enthusiasts 
very much WANT "to create some nightmarish menagerie of half-human animals." It 
will happen, whatever laws the United States passed, since God created 
off-shore islands for a reason. The United States has, so far as we know, been 
able to prevent atomic bombs from falling into the hands of anyone outside 
governments, but labs to create chimera are far easier to set up.

[I don't remember any passages in the Bible having to do with chimera. There 
were "giants in the earth" (Gen. 6), but I don't know about chimera.]

    By [1]NICHOLAS WADE

    Citing a lack of leadership by the federal government, the National
    Academy of Sciences proposed ethical guidelines yesterday for research
    with human embryonic stem cells.

    Scientists have high hopes that research with those all-purpose cells,
    which develop into all the various tissues of the adult body, will
    lead to treatments for a wide variety of diseases by enabling them to
    grow new organs to replace damaged ones.

    But because of religious objections - human embryos shortly after
    fertilization are destroyed to derive the cells - Congress has long
    restricted federal financing of such research; President Bush has
    allowed it to proceed, but only with designated cells. As a result,
    the government has not played its usual role of promoting novel
    research and devising regulations accepted by all players.

    The academy, a self-elected group of scientists that advises the
    government, recommends setting up a system of local and national
    committees for reviewing stem cell research. It also tackles a new set
    of ethical problems raised by creating organisms composed of cells
    from two different species, and in this case animals that include
    human cells.

    The academy hopes its proposals, which are nonbinding, will be
    accepted in the private and public sectors, particularly in states
    like California that are creating ambitious stem cell programs. Its
    report is also likely to influence the debate in Congress, where some
    lawmakers wish to allow new human stem cell lines to be derived and
    other lawmakers are seeking tighter restrictions.

    Heightened and universal oversight "is essential to assure the public
    that such research is being conducted in an ethical manner," the
    academy's report says. The guidelines were drawn up by a committee led
    by Dr. Richard O. Hynes of the Massachusetts Institute of Technology
    and Dr. Jonathan D. Moreno of the University of Virginia.

    The report paves the way for research involving animals called
    chimeras that have been seeded with human cells. The purpose of such
    experiments is not to create some nightmarish menagerie of half-human
    animals, but to test first in animals the human organs that could be
    grown from embryonic stem cells.

    Foreseeing that such research will be required for tests of
    effectiveness and safety, the academy says most chimeras should be
    permitted. But it places certain types of experiments out of bounds,
    at least for now. These involve inserting human embryonic stem cells
    into an early human embryo, a technically promising method of genetic
    engineering, or into apes and monkeys.

    The academy's guidelines would impose limits on three kinds of
    experiment that involve incorporating human embryonic stem cells into
    animals. Undesired consequences could follow if human cells were to
    become incorporated into the sex cells or the brains of animals. In
    the first case, there is a remote possibility that an animal with eggs
    made of human cells could mate with an animal bearing human sperm. To
    avoid human conception in such circumstances, the academy says
    chimeric animals should not be allowed to mate.

    A second possible hazard is that the human embryonic stem cells might
    generate all or most of an animal's brain, leading to the possibility
    of a human mind imprisoned in an animal's body. Though neuroscientists
    consider this unlikely, it cannot be ruled out, particularly with
    animals closely related to people, like monkeys and apes. The academy
    advises that human embryonic stem cells not be injected into the
    embryos of nonhuman primates for the time being.

    Third, like many previous committees, the academy says human embryos
    should not be grown in culture for more than 14 days, the time when
    the first hints of a nervous system appear.

    The academy advises that all institutions conducting human embryonic
    stem cell research set up local committees, including scientific
    experts and members of the public, to review all experiments. And it
    says a national committee should be formed to update regulations and
    relax the constraints if warranted by new evidence.

    The academy also says that donors, including women who donate
    unfertilized eggs, should not be paid.

    The academy's guidelines could be widely followed if adopted by
    leading institutions, funding agencies and journals. Scientists at
    Rockefeller University, the Burnham Institute in California and
    Stanford University said the academy's rules were similar to their
    in-house versions and could probably be adopted with ease.

    "It relieves a lot of pressure on the scientist in the absence of any
    advice or policy," said Dr. Ali H. Brivanlou, a researcher at
    Rockefeller who has been waiting for guidance about an experiment with
    human embryonic stem cells.

    The system of scientific self-regulation proposed by the academy is
    modeled after the approach to recombinant DNA research, a technique
    for transferring genes between organisms that seemed at first to hold
    possible hazards. In that case, scientists themselves first drew
    attention to the hazards, and in 1975, they held a conference that
    recommended oversight. Their recommendation was then put into practice
    by the National Institutes of Health, the principal federal supporter
    of biomedical research, and the N.I.H.'s guidelines were voluntarily
    followed by the private sector as well.

    The agency has been prevented from playing a similar role with human
    embryonic stem cells because of the Bush policy and the Congressional
    ban. Many scientists regret the forced absence of the health
    institutes' leadership.

    "This shows how far this country has gone toward being controlled by
    religious precepts rather than scientific opportunity," said Dr. David
    Baltimore, president of the California Institute of Technology and an
    architect of the decisions about recombinant DNA.

    It "is a terrible omen for our being able to maintain our position as
    the country that leads in biomedical technology," Dr. Baltimore said.

    Dr. Harold Varmus, president of the Memorial Sloan-Kettering Cancer
    Center and a former director of the health institutes, said the
    academy's proposed rules "offer what the government cannot: reasonable
    guidelines for the several kinds of research being conducted with
    various sources of non-federal funds." Dr. Varmus said he thought that
    nearly all researchers would sign on to the new rules.

    Michael Werner, chief of policy for the Biotechnology Industry
    Organization, said biotech companies were likely to adopt the
    academy's guidelines, at least in principle.

    "What I hope the administration would see," Mr. Werner said, "is that
    leading scientists in our country believe very much that this is an
    area of research that needs to go forward quickly and aggressively but
    with proper oversight."

    Dr. Leon R. Kass, chairman of the President's Council on Bioethics,
    declined through a spokeswoman to comment on the academy's guidelines.
    Dr. Richard Doerflinger, deputy director for pro-life activities at
    the U.S. Conference of Catholic Bishops, said that the guidelines were
    drafted by scientists who favored "creating embryos just to destroy
    them," and that the Roman Catholic Church had not changed its
    opposition to stem cell research.

    "But it would be harder to sustain that policy for the U.S. government
    if it had been shown that embryonic stem cells were the only way to
    cure certain disease," Dr. Doerflinger said, noting that that burden
    "has not been met at present."

    The academy's advice is more permissive than previous recommendations
    in some respects, more stringent in others. President Clinton in 1994
    shot down a panel's suggestion that human embryos should be created,
    from chosen donors, for research purposes - a ban that would still
    apply to federal researchers if they were allowed to derive new cell
    lines. The academy committee, however, says such embryos should be
    generated, subject to review.

    But it seems to be the first panel to say human embryonic stem cells
    should not be inserted into early human embryos, also known as
    blastocysts. This might in principle be a technically efficient way of
    correcting genetic defects. But neither the scientific nor the ethical
    groundwork has been laid for such a development, Dr. Hynes said, so
    the committee has decided to prohibit it for the time being.

    The new guidelines are expected to clarify doubts held by many
    researchers who have held off experiments that ventured into
    controversial territory. Dr. Irving Weissman of Stanford University
    has long planned to insert human neural stem cells into the brain of a
    mouse embryo whose own neural stem cells are dysfunctional. Even
    though neural stem cells are adult in form and belong to different
    category than embryonic stem cells, he asked Stanford to convene a
    group to advise him on the ethics of the experiment.

    The committee chairman, Dr. Hank Greely, said they advised Dr.
    Weissman to go ahead with the first part of the experiment and to see
    whether the architecture of the mouse's brain was mouse-like or
    human-like; if the latter, the panel would discuss whether to proceed.

    Dr. Weissman has not started the experiment because of difficulty
    breeding the required kind of mouse, Dr. Greely said.

    In the Senate, Arlen Specter, Republican of Pennsylvania, and Orrin G.
    Hatch, Republican of Utah, are proposing to expand the president's
    policy by allowing research on leftover embryos.

    At a press conference last week, Senator Specter, who is undergoing
    chemotherapy treatment for Hodgkin's disease, made reference to his
    "new hairdo" as he argued for more studies. "It is just, in my
    opinion, scandalous, scandalous that we do not use all of the
    resources available to us to fight these maladies," Mr. Specter said.

    President Bush has given no indication that he will sign legislation
    changing his 2001 executive order. And opponents of the research say
    they will aggressively fight any attempt to change Mr. Bush's policy.

    Sheryl Gay Stolberg contributed reporting from Washington for this
    article.

References

    1. 
http://query.nytimes.com/search/query?ppds=bylL&v1=NICHOLAS%20WADE&fdq=19960101&td=sysdate&sort=newest&ac=NICHOLAS%20WADE&inline=nyt-per