[Paleopsych] NYT: A Pioneering Transplant, and Now an Ethical Storm

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A Pioneering Transplant, and Now an Ethical Storm
http://www.nytimes.com/2005/12/06/science/06prof.html
["Ethical Concerns on Face Transplant Grow" appended.]

[These "ethicists" are too risk averse.]

    Scientist at Work: Jean-Michel Dubernard
    By [3]LAWRENCE K. ALTMAN

    Dr. Jean-Michel Dubernard, whose decision to perform the world's
    first partial face transplant has placed him at the center of an
    ethical storm, leads a kind of double life.

    As a surgeon in Lyon, Dr. Dubernard, 64, has been a pioneer,
    developing techniques to transplant pancreas glands and other
    tissues, and organizing the international team that performed the
    world's second hand-forearm transplant in 1998. (The first was
    performed in Ecuador in 1964 before advances in drugs and
    microsurgery.)

    But Dr. Dubernard is also a politician, a former deputy mayor of
    Lyon who is one of the most powerful members of the French National
    Assembly.

    "There's a big brain behind him and a steely will that is willing
    to confront massive criticism," said Dr. Thomas E. Starzl of the
    University of Pittsburgh, who performed the first successful
    [4]liver transplants, in Denver.

    In performing a face transplant on a severely disfigured
    38-year-old woman, Dr. Dubernard has now entered one of the most
    disputed frontiers in transplantation science.

    The transplants are extremely risky, and no one can say what a
    patient will look like afterward.

    Critics have said that in rushing to be first to do a face
    transplant, Dr. Dubernard bypassed standard procedures to
    reconstruct the face of the woman, who was severely bitten by her
    dog last May. Dr. Laurent Lantieri, a rival transplant surgeon in
    Paris, has said that Dr. Dubernard and his team did not follow
    ethical and legal guidelines in performing the transplant.

    Other transplant experts have raised questions about the woman's
    psychological stability and about Dr. Dubernard's decision to give
    the woman an infusion of [5]stem cells from the donor's bone marrow
    shortly after the face transplant in an effort to prevent rejection
    of the new face, a procedure they say is still experimental.

    Dr. Dubernard has responded that the operation, performed in
    Amiens, met all French ethical and legal standards and that the
    patient was examined by psychiatrists and found to be an acceptable
    candidate for a transplant.

    He has also been critical of news coverage of the woman's
    operation.

    Dr. Dubernard withstood similar criticisms after his team gave a
    new hand to Clint Hallam in 1998 and then was deeply embarrassed
    when reporters learned that Mr. Hallam had a criminal record and
    that he had lost his hand while in prison.

    Further, Mr. Hallam turned out to be an unreliable patient,
    refusing to take the prescribed antisuppressant drugs to prevent
    rejection of the graft and to do the regular exercises needed to
    train his new hand. He demanded amputation of the new hand in 2001.

    By applying knowledge gained in Mr. Hallam's case, Dr. Dubernard's
    team went on to perform successful hand-forearm transplants on two
    other patients. Each had lost both hands.

    The hand recipient whose transplant has functioned the longest is
    due to celebrate his sixth anniversary in January.

    Surgeons around the world have successfully performed a total of 30
    hand-forearm transplants, including the three in Lyon, said Dr.
    Nadey Hakim of London, a team member who amputated Mr. Hallam's new
    hand.

    In a telephone interview, Dr. Hakim described Dr. Dubernard as
    "big, pushy and at the same time friendly and kind."

    In juggling his two careers, Dr. Dubernard says he usually commutes
    to Paris for two days each week to tend to politics in the French
    Parliament. On other days, he cares for patients at the Edouard
    Herriot Hospital in Lyon.

    He describes himself as a workaholic and a chain smoker who has
    quit several times over the last 40 years. The last time was two
    years ago.

    Dr. Dubernard was born at the hospital where he works. His father
    was a general practitioner and his mother a pharmacist. To friends
    and colleagues, he is known as Max, a nickname he was given in
    school for always giving his maximum effort, particularly in rugby.

    An illness influenced Dr. Dubernard's decision to become a doctor.
    He was in awe of the surgeon who performed an emergency
    appendectomy on him when he was 11, he said, and he decided to
    become a surgeon himself.

    As a medical student at the University of Lyon, Dr. Dubernard
    caught [6]tuberculosis. After the illness disqualified him from
    military service, he went to Belgium to do research on liver and
    other transplants.

    One day, his Belgian superiors received a call from Dr. Joseph E.
    Murray of Harvard, who had a sudden vacancy for a research trainee.

    Dr. Dubernard volunteered, he said, but his Belgian hosts told him
    that at age 24 he was too young. When no one else accepted, Dr.
    Dubernard went to Boston.

    He said he dedicated the face operation to Dr. Murray, who won a
    Nobel Prize in Medicine in 1990 for helping to perform the world's
    first successful organ transplant, a kidney in identical twins, in
    1954. Dr. Dubernard was unmarried when he worked at Harvard and
    "left a lot of broken hearts when he returned to France," Dr.
    Murray recalled in an interview over the weekend.

    In Lyon, Dr. Dubernard earned a doctoral degree, in part for work
    on xenotransplants, or transplants between species, among two kinds
    of monkeys. At age 37, he became chief of urology at the Herriot
    Hospital and at the University of Lyon.

    He has served in the French Parliament since 1986. His interest in
    politics, he said, comes in part from memories of his family's
    involvement in the French resistance movement.

    When Dr. Dubernard could not find a candidate for a hand transplant
    in France, he turned to his friend, Dr. Earl Owen of Sydney,
    Australia, who shared a goal of transplanting a hand. Dr. Owen had
    what the team believed was a good candidate in Mr. Hallam.

    Dr. Dubernard said that he was not anxious before performing the
    operation to give Mr. Hallam a new hand or the one to give the
    woman a partial new face.

    The reason, he said, was his confidence in the drills that his team
    of dermatologists, psychiatrists, nurses and other experts had
    followed in practicing each step of the complicated procedures.

    "Once the preparations were done, I didn't worry anymore," Dr.
    Dubernard said. "But, after the transplants, it was another
    problem."

    Dr. Dubernard said that when he went to sleep after Mr. Hallam's
    operation, he awoke from a dream, horrified that the new hand had
    turned black from acute rejection. It had not.

    Doctors who have examined a number of the hand transplant
    recipients have been impressed with the psychological benefits the
    procedure offered the patients, particularly the double amputees.
    But experts debate the degree of nerve sensation and motor function
    that the recipients have regained from the transplants.

    Dr. Dubernard said he was hesitant about performing the partial
    face transplant until he examined the woman in Amiens and saw the
    severity of the wounds. She had difficulty speaking and eating, as
    food fell from her mouth, he said.

    Independent experts told his team that the wounds were "very
    difficult, if not impossible" to repair with standard
    reconstructive surgery, Dr. Dubernard said. But, he said, "We knew
    we could improve her life."

    Dr. Dubernard said he slept only about three hours each night last
    week, in part because he worried about questions like: Would the
    arteries and veins clot, jeopardizing survival of the graft?

    Now that certain danger points have passed, he said he is beginning
    to sleep better and longer. Still, he says he knows that the
    woman's immune system can reject the new face at any time during
    her life.

    At a news conference in Lyon on Friday, Dr. Dubernard exuded
    confidence. He appeared bright-eyed, eyebrows continually raised,
    energetic, funny and quick to engage reporters.

    He clearly is someone who loves the limelight, as he asserted
    himself over his more subdued colleagues.

    Dr. Dubernard said in interviews this weekend that if a need arose,
    he would not hesitate to receive a new hand or face, or give
    approval for one to his three children or six grandchildren. He
    said he is divorced from his first wife, and lives with Dr. Camille
    Frances, a professor of dermatology in Paris.

    Dr. Dubernard says that under French law he faces mandatory
    retirement from practice in two years and is not sure what he will
    do then.

    A full-time career in politics is one possibility. Another is
    becoming a poet to express his wide-ranging interests, including a
    love of mythology.

    Ariane Bernard contributed reporting from Paris for this article.

References

    3. 
http://query.nytimes.com/search/query?ppds=bylL&v1=LAWRENCE%20K.%20ALTMAN&fdq=19960101&td=sysdate&sort=newest&ac=LAWRENCE%20K.%20ALTMAN&inline=nyt-per
    4. 
http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/transplants/index.html?inline=nyt-classifier
    5. 
http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/stemcells/index.html?inline=nyt-classifier
    6. 
http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/tuberculosis/index.html?inline=nyt-classifier

Ethical Concerns on Face Transplant Grow
http://www.nytimes.com/2005/12/06/international/europe/06facex.html

    By MICHAEL MASON and LAWRENCE K. ALTMAN

    In urgent telephone calls and agonized e-mail messages, American
    scientists are expressing increasing concerns that the world's
    first partial face transplant, performed in northern France on Nov.
    27, may have been undertaken without adequate medical and ethical
    preparation.

    Some scientists say they fear that if the French effort fails, it
    could not only threaten the life of the transplant recipient, a
    38-year-old Frenchwoman, but jeopardize years of careful planning
    for a new leap in transplant surgery.

    "We've been working on the ethics and the science for some time,
    going slowly while we figure out immunology and patient selection
    criteria and indications," said Dr. L. Scott Levin, chief of
    plastic and reconstructive surgery at Duke University Medical
    Center. "This flies in the face of everything we've tried to do."

    The scientists' worries stem in part from the execution of the
    surgery, and in part from news reports over the weekend that called
    into question the patient's emotional state.

    Dr. Maria Siemionow, director of plastic surgery research at the
    Cleveland Clinic, who has been preparing to perform a full face
    transplant, said that the way the transplant was conducted appeared
    to conflate two experimental protocols: the transplantation of
    facial tissue and the infusion of stem cells from the donor bone
    marrow into the patient in an attempt to prevent rejection of the
    new face.

    The first procedure, although untried until now, has been well
    studied, and the microsurgical techniques involved are commonplace.
    But the second has been successful in human subjects only rarely
    and only recently. While pilot studies do suggest that an infusion
    of stem cells from the donor can help produce "chimerism" in
    humans, a state in which foreign tissue is tolerated by the body
    with comparatively little or no suppression of the immune system,
    it is far from standard practice in transplantation.

    The French team's decision to perform two novel procedures
    simultaneously means that it may be difficult to determine the
    cause of success or failure of the transplant, Dr. Siemionow said.

    "They should not be doing two experiments on the same patient," she
    added. "Ethics aside, it will make it difficult to get clean
    answers - if it works, why does it work, and if it goes wrong, was
    it the transplant or the stem cells?"

    In a telephone interview yesterday, Dr. Jean-Michel Dubernard, the
    surgeon whose team performed the groundbreaking operation, in which
    the patient received lips, a chin, and a nose from a brain-dead
    donor, defended the infusion of bone marrow stem cells and denied
    that the procedure was a step into uncharted territory.

    "It is not two experiments at the same time," he said.

    But American experts said that the French team's approach diverged
    in other ways from what had been scientific consensus about how to
    proceed. The transplant was performed months after the woman's
    injury, and before any attempt at conventional reconstructive
    surgery.

    The French doctors said traditional surgery could not have salvaged
    the woman's face. Dr. Benoît Lengelé, a Belgian specialist in
    facial injuries, and other experts had judged that reconstructive
    surgery would be "very difficult, if not impossible" in the
    patient's case, Dr. Dubernard said.

    Yet reconstructive surgeons in the United States and in Europe
    routinely operate on patients with similar injuries, some missing
    as much as half their faces. Surgeons like Dr. Siemionow have long
    argued that the first face transplant should be attempted only on a
    patient who has tried to live with the alternatives.

    The psychological issues are as complex as the surgical ones.
    Scientists have been concerned about how thoroughly the patient was
    emotionally prepared for the procedure, concerns that were only
    heightened when The Sunday Times of London reported that she had
    admitted that she sustained her injuries during a suicide attempt.
    According to the newspaper, the woman said that she was mauled by
    her family's Labrador retriever after she took an overdose of
    sleeping pills and collapsed. She believed the dog was trying to
    revive her, the newspaper said. The Times also reported that the
    donor had committed suicide.

    The reports greatly alarmed experts in the field; the experimental
    protocols devised at both the Cleveland Clinic and the University
    of Louisville explicitly preclude emotionally unstable candidates.
    Patients with a history of depression sometimes do not comply with
    the complicated drug regimens necessary to prevent organ rejection.

    The news reports, however, were vigorously denied yesterday by Dr.
    Dubernard, who responded, "No, no and no!" when asked if his
    patient had tried to take her own life. He said the woman had taken
    only two sleeping pills for insomnia after a family argument.

    Dr. Dubernard said that the woman was approved as a candidate for a
    face transplant only after a thorough psychological examination by
    an independent expert and by mental health professionals working
    with the transplant teams in Amiens, where the operation was
    performed, and in Lyon, where the woman is now being monitored for
    rejection reactions.

    "These people are not stupid," he said.

    The patient, who had difficulty eating before the transplant
    because of the injuries, ate dinner Sunday night and lunch on
    Monday, Dr. Dubernard said. Dr. Dubernard said the woman had
    visited the Édouard Herriot Hospital in Lyon "in October and again
    in November to meet the transplant team and to ask questions."

    Yet longer-term psychological evaluation might have been useful for
    another reason, experts said. Since this is the first transplant of
    its kind, and it strikes deeply at questions of personal identity,
    the French patient's emotional stamina will be sorely tested.
    Already some news reports in Europe have identified the woman, who
    requested anonymity, and published pictures of her before and after
    the surgery.

    Scientists planning for the first face transplant knew it would
    happen. One of the Cleveland Clinic's screening criteria is that a
    candidate for this procedure must be able to withstand intense
    public scrutiny - to be able to see pictures of the face's former
    owner, for example, on tabloid covers at the checkout rack.
    Resilience is important both for the first patient, say
    researchers, and for those who would follow.

    "Every patient, when you talk to them, their goal is just to get
    out of the limelight," said Dr. David Young, associate professor of
    plastic surgery at the University of California, San Francisco,
    which also has been drawing up plans for a face transplant. "If
    this works, many potential patients who are on the fence will
    change their minds. But if this thing crashes and burns, it will
    damage the field."

    For some experts, even the best-case situation has a down side.

    "We want for this to go well," said Dr. Siemionow. "But if it does,
    then I am afraid everyone will forget that the ethics were not
    proper here. And if it does not, then they will be blaming the
    transplant procedure but not the ethics behind it."