America Living With AIDS

A M E R I C A Living With

as well as the variables that force some
people to seek participation in trials
because they have no other health care
options.
For people with HIV disease, access
to experimental treatments is an essential component of their basic health care
needs. The fast pace of HIV-related
research often results in experimental
therapies becoming the standard of care
for people with HIV disease. Experimental drugs are the only option for
many. Access to these drugs through
traditional clinical trial programs and
the community-based clinical trials
program, as well as new expanded
access programs, is imperative.
New safe and effective drugs to
treat HIV disease are urgently needed.
Although there are some drugs currently available that either attack the
human immunodeficiency virus
(HIV) or treat or prevent the many
opportunistic infections that characterize HIV disease, these drugs are, at
best, half-way measures. They may
extend life and minimize suffering of
people with HIV disease, but they are
far from a cure. Currently available
HIV treatment drugs are expensive
and the means of delivering them may
be cumbersome, involving aerosolizers
or intravenous infusions. All of these
factors may present barriers to those
who could benefit from their use.
HIV treatments may also be toxic;
some patients are unable to tolerate

certain drugs. Without new safe and
effective drugs, many thousands of
people living with HIV disease face
suffering and death.
In this chapter the Commission
looks at how HIV-related clinical trials
have been conducted, highlights ways
in which access to these trials can and
should be improved, and explores
ways in which the drug development
and approval process can make experimental drugs more accessible to people with HIV disease.
CLINICAL TRIALS
Typically it takes many years to get
drugs from the laboratory bench to
the pharmacy. This process includes
extensive laboratory testing, animal
testing for safety, and early human
testing. This sequence of carefully
designed scientific methods also
includes a regulatory process to ensure
the safety and efficacy of drugs. These
methods and processes have long been
in place to ensure that information is
accurate and that drugs are safe. For
many in need of these potentially lifesaving therapies, this process can be
lengthy, laborious, and frustrating.
Examples abound of drugs, widely
believed to be effective, that were
proved ineffective or even harmful
when subjected to rigorous scientific
study. In fact, the brief history of the
HIV epidemic includes several examples of such drugs, such as suramin,
which actually hastened the death of
people with AIDS, and dextran sulfate,
which was used widely before it was
learned that it was not absorbed into
the body when taken orally.

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