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

7. The needle exchange program, unlike the pharmacy, will provide other
free services such as condoms, bleach, alcohol wipes, sterile water and HIV
prevention literature;
8. The researchers will be monitoring drug users to see if they develop
sometimes fatal hepatitis B infection, even though there is a vaccine that
could prevent it; and
9. According to the federal government, providing this vaccine to all
susceptible drug injectors is the standard of care.
In addition, a readability analysis of the original informed consent form
shows that it required a reading level equivalent to 15 years of schooling,
even though Dr. Fisher's own research demonstrates that Anchorage
injection drug users read at a 9th grade level. As a result of the enhanced
scrutiny this grant has generated, the informed consent form has now been
modified from its original two to the present five pages and some, although
not all, of our objections have been addressed. But the researchers have
introduced, and the University of Alaska Institutional Review Board and the
NIH have accepted, a new fiction into the informed consent form: that there
is no other needle exchange program in Anchorage. Actually, in an effort to
reduce the harm from the Alaska experiment, volunteers in Anchorage have
set up a needle exchange open to all injection drug users, a fact that was
noted by Dr. Fisher himself in a national magazine and which received front
page coverage in the Anchorage Daily News on December 23, 1996 and was
featured on an Anchorage television station.
As important as informed consent is in this situation, there is one overriding
point: not even a perfect informed consent form can make ethical a study
that is unethical in design, particularly one that needlessly puts
subjects at risk for fatal infectious diseases. The only ethical solution to the
situation in Alaska is to cut off funding for the study until it is redesigned so
that all drug injectors have access to the needle exchange program and
intensive efforts are made to provide hepatitis B vaccination to all drug users
in the study.

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