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Proposal To Test Smallpox Vaccine in Young Children

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    NHNE News List Current Members: 738 Subscribe/unsubscribe/archive info at the bottom of this message. ... Thanks to Larry Morningstar. ... PROPOSAL TO TEST
    Message 1 of 1 , Nov 7, 2002
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      NHNE News List
      Current Members: 738
      Subscribe/unsubscribe/archive info at the bottom of this message.

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      Thanks to Larry Morningstar.

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      PROPOSAL TO TEST SMALLPOX VACCINE IN YOUNG CHILDREN
      SETS OFF ETHICS DEBATE
      By Sheryl Gay Stolberg
      New York Times
      November 4, 2002

      http://www.nytimes.com/2002/11/05/national/05SMAL.html?todaysheadlines

      WASHINGTON, Nov. 4, 2002 -- Federal health officials are proposing to
      test the smallpox vaccine in toddlers and preschoolers, a proposal so
      fraught with ethical questions that the Food and Drug Administration is
      seeking comment from the public before allowing the experiment to proceed.

      The vaccine is made of a live virus called vaccinia and poses a risk of
      serious complications, even death. At issue is whether the threat of a
      bioterrorist attack using smallpox -- a disease that was eradicated in
      humans two decades ago -- is serious enough to warrant exposing children
      to those risks.

      "Everyone agrees that the risk of smallpox through a bioterrorism event
      is not zero," said Dr. Karen Midthun, who supervises vaccine research for
      the food and drug agency. "But how small or how large is that risk? Given
      that it is so difficult to quantitate, it makes it difficult to know
      whether there is potentially any benefit to these children."

      Dr. Midthun said the agency would take public comment on the proposal
      through the end of this month. After that, she said, Tommy G. Thompson,
      the secretary of health and human services, and Dr. Mark B. McClellan,
      the new commissioner of food and drugs, will decide whether to approve
      the study.

      The proposed pediatric study comes as President Bush is considering
      whether, and how, to make smallpox vaccine available to the public for
      the first time since 1972, when routine vaccinations were suspended. Mr.
      Bush is considering proposals to make the vaccine available first to
      health care workers and eventually to all Americans.

      The pediatric study would enroll 40 children, ages 2 to 5, at Children's
      Hospital Medical Center in Cincinnati and Harbor-U.C.L.A. Medical Center
      in Los Angeles. Because the vaccinia virus can spread, posing serious
      risk to people with immune deficiencies or skin conditions like eczema,
      the children will be required to stay home from day care or preschool for
      a month after inoculation.

      The National Institutes of Health has been testing the government's aging
      stockpile of 15.4 million doses of smallpox vaccine to see if it can be
      used safely in adults, and to see if it remains effective when diluted;
      research suggests that it does. The goal of the pediatric study is to
      determine if the same is true in children.

      "If we had an attack and we had to use the vaccine in children, you would
      see a lot of eyebrow-raising if we didn't know the effects," said Dr.
      Anthony S. Fauci, director of the National Institute of Allergy and
      Infectious Diseases, the branch of the N.I.H. that is proposing the study.

      But the study is drawing objections from some experts. Among them is Dr.
      Paul A. Offit, chief of infectious diseases at Children's Hospital of
      Philadelphia, who believes the benefits of testing the vaccine do not
      outweigh the risks. Noting that the vaccine offers protection when given
      up to four days after exposure, Dr. Offit said he believed testing in
      children was ethical only after an actual case of smallpox had been
      reported.

      "Smallpox doesn't exist in this world, so the benefits are solely
      theoretical," said Dr. Offit, who serves on a panel of experts that
      advises the Centers for Disease Control and Prevention on vaccine policy.
      "That, in combination with the fact that the vaccine has known and,
      albeit rarely, severe side effects leads one to question whether you can
      ethically do that study."

      When the smallpox vaccine was last in use, 15 people out of every million
      who received it experienced potentially life-threatening complications --
      a risk that experts have said holds true for both adults and children. In
      children, Dr. Fauci said, the most serious risk is encephalitis, a
      potentially deadly disorder that causes inflammation of the brain.

      Dr. Fauci cited statistics from a 1968 study that tracked 5.6 million
      people who received smallpox vaccine, 3.3 million of them children
      between the ages of one and four. Among these youngsters, 10 developed
      encephalitis and three -- all under the age of one -- died from it.

      Federal regulations impose strict oversight on clinical trials in
      children. If studies pose more than minimal risk to children, they may go
      forward only if they offer direct benefit to the child or enhance
      understanding of the child's disorder. If those conditions are not met,
      the studies are subject to federal review, including an evaluation by
      outside experts and public comment of the sort the F.D.A. is seeking.

      Among the experts consulted for the pediatric smallpox trial is Dr. Neal
      Halsey, director of the Institute for Vaccine Safety at Johns Hopkins
      University in Baltimore. Dr. Halsey said he had concluded that the study
      was ethical, but only if it was "done very carefully and done in a very
      limited number of children."

      But he said he had chosen not to take part in the national institutes'
      trial. "I did not care to be involved in exposing children to the known
      risks of the vaccine in the absence of clear benefit," Dr. Halsey said.

      Although the government has contracted with the pharmaceutical industry
      to buy a new version of the smallpox vaccine, the vaccine to be used in
      the pediatric study comes from an aging stockpile of 15.4 million doses
      manufactured by Wyeth-Ayerst and donated to the government.

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      RELATED WEBSITES:

      SMALLPOX VACCINATION 101:
      http://smallpoxvaccination101.com/

      NATIONAL VACCINE INFORMATION CENTER (NVIC):
      http://www.909shot.com

      DR. CLASSEN'S VACCINE SITE:
      http://www.vaccines.net/%c2%a0

      IMMUNIZATIONS:
      http://www.pcslink.com/~klove/immunize.htm

      VACCINE INFORMATION AND AWARENESS (VIA) WEB SITE:
      http://www.access1.net/via/

      CONCERNED PARENTS FOR VACCINE SAFETY:
      http://home.sprynet.com/~gyrene/index.htm

      ANTHRAX VACCINE INFORMATION:
      http://www.anthraxvaccine.org

      VACCINATION NEWS:
      http://www.vaccinationnews.com

      VACCINEWEBSITE.COM:
      http://www.vaccinewebsite.com

      DR. TIM O'SHEA'S THEDOCTORWITHIN.COM:
      http://www.thedoctorwithin.com/index1.html


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