Testimony before the Subcommittee on Human Resources, Committee on Government Reform and Oversight, U.S. House of Representatives

3. The research protocol does not provide adequate assurance that the
subjects will receive hepatitis B vaccine. It is highly inappropriate to
monitor injecting drug users in both research groups contracting potentially
fatal hepatitis B infection when an extremely effective vaccine for hepatitis
B exists. It is difficult to imagine an analogous study in which babies were
monitored for the occurrence of tetanus, while not being provided with the
existing vaccine. But the researchers are faced with a conflict of interest
analogous to that regarding behavioral counseling in HIV vaccine trials: if
compliance with vaccination is high, there will not be enough new hepatitis
B infections to permit statistically meaningful conclusions.
The parallels between the Alaska study and the notorious Tuskegee syphilis
study are clear. In Tuskegee, poor rural African American men were denied
access to proven treatment for syphilis and went on to develop the disease's
complications, including death. In the Alaska study, another group of
vulnerable Americans, injection drug users, many of whom are Native
American or African American, are being placed at risk for life-threatening
infections by being denied adequate access to not one, but two, proven
medical interventions: sterile syringes and hepatitis B vaccine.
Indeed, there is an ugly racial dimension to the issue of sterile syringe
availability in Anchorage. When we sent casually dressed volunteers to
survey pharmacies in Anchorage, only 14% of pharmacies were willing to
sell syringes without encumbrance. But an African American woman
volunteer was refused syringes at all five pharmacies she visited, including
two that had sold syringes to non-African Americans the day before.
When Public Citizen's Health Research Group raised these issues in a series
of letters to NIH Director Harold Varmus beginning in October 1996, he
immediately put the study on hold and convened a ten-person panel to
review our concerns. The panel did not include anyone who could represent
the concerns of drug users (such as injection drug users themselves or people
who operate needle exchange programs) and instead was comprised
primarily of academics, many of whom have obtained research funding from
the National Institute of Drug Abuse and may have been reluctant to criticize
the Institute. It was no great surprise, therefore, when the panel found no
problems with the study design and recommended that it proceed as
approved. To his credit, Dr. Varmus went beyond the blanket endorsement
of the panel to require expanded efforts to provide hepatitis B vaccine, but
still fell short of offering on-site vaccination, which would be the best way
of increasing compliance with the three-injection vaccination regimen.
Counseling patients about the hepatitis B vaccine and then sending them
elsewhere to receive it not only introduces a delay in receiving the vaccine,

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