Testimony of David Satcher, M.D., PH.D., Centers for Disease Control and Prevention

in these studies the written consent forms identified the study as research, contained all the
information about the vaccines and the study, and provided the parents with full disclosure. The
consent forms were typed on stationary identifying the vaccine study as the Hepatitis A Vaccine
Prevention Program and may have been perceived as a misrepresentation of the study to the
participants. The use of the stationary was an oversight by the CDC and IHS investigators.
In 1995, the inactivated hepatitis A vaccine we attempted to evaluate in these studies was licensed
for commercial use by FDA based on efficacy data obtained in a clinical trial conducted in
Thailand. CDC's Advisory Committee on Immunization Practices (ACIP) currently recommends
that children 2-14 years of age in American Indian or Alaska Native communities, or other
communities with high rates of hepatitis A, be routinely vaccinated to prevent and control this
disease. Currently, widespread hepatitis A immunization programs are being conducted in the
IHS Aberdeen Area and in other American Indian and Alaska Native populations and have
effectively interrupted and prevented community-wide epidemics in those areas.
Mr. Chairman, I would like to describe to you the importance of conducting vaccine-related
research. Vaccines are the most powerful tools to prevent infectious diseases like measles and
polio. The introduction of polio vaccine into the childhood immunization program has led to a
reduction of wild virus induced disease from about 20,000 cases annually to zero in the United
States. Widespread use of measles vaccine has decreased reported measles from more than
500,000 cases annually during the decade prior to vaccine availability to less than 1,000 cases per

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