THE PRESTIGIOUS Institute of Medicine has recommended that
federal
rules be altered to allow drug testing and other
experimentation on
prisoners.
Under the institute's proposal, reported this week in The
New York
Times, three-decade-old bans on prisoner experimentation
would be
replaced with more relaxed rules similar to those
surrounding the
booming industry of experimentation on children.
The equation is problematic. Researchers experiment on
children
despite their developmental incapacity to give informed
consent
because only by understanding how drugs work in their
physiologically
unique bodies can proper treatments be devised. No such
argument can
be made about prisoners, who are physiologically more or
less similar
to those of us on the street. They just happen to be behind
bars.
The protections that the institute recommends to safeguard
prisoners'
rights are minimal. Exposing prisoners to experimental drugs
would be
allowed only after the completion of early toxicity testing.
This will
hardly restrain drugmakers because they don't need
prisoners for early
toxicity testing anyway. Students and homeless people line
up in
droves for the $200 daily fee, plus room and board, on offer
at the
industry test clinics. It's ``money for doing almost
nothing," as one
test subject, a former law student, told me.
The bottleneck for drugmakers is in recruiting warm bodies
for
late-phase trials that establish a new product's
effectiveness with
statistical certainty. These ``Phase 3" trials can
require tens of
thousands of patients to complete, and most drug-saturated
Americans
are reluctant to take part. Eighty percent of trials fail to
meet
recruitment deadlines, bleeding drugmakers of $1 million a
day while
their blockbuster wanna bes remain locked up in development.
To solve the dilemma, many drugmakers have rushed overseas,
to places
like India and Poland, where sick, desperate patients are
abundant.
Now, if the institute's recommendations hold sway, they'll
be able to
access the 7 million souls captive to the US correctional
system as
well. The institute's proposed caveat -- that prisoner
experiments
include subjects from outside prison walls as well -- will
make little
practical difference in such trials. Few, if any, drugmakers
would
want to restrict these huge trials to prisoners anyway.
The institute also recommends that prisoners help oversee
prison
experiments. Unfortunately, often in resource-constrained
environments, most everyone has an interest in the resources
that
well-funded research can bring in. ``It generates quite a
bit of
hard-earned money," one clinical investigator in South
Africa
explained to me. According to the institute, prisoners
shouldn't be
deprived of this by a ``myopic" obsession with
informed consent.
The rationale, according to the institute, is that ``access
to
research may be critical to improve the health of prisoners
and the
conditions in which they live."
This is a bit fuzzy. Research breakthroughs alone don't
change
conditions, as anyone who has seen stockpiles of vaccines
rotting in
tropical warehouses can tell you. Change requires the
implementation
of research, which most researchers are neither responsible
for nor
interested in. Sadly, there's no guarantee that helpful
research on
prisoners will be promptly -- or ever -- applied to improve
prison
conditions.
In fact, the institute can scarcely ensure that research on
prisoners
offers the ``potential benefit" that their proposed
regulations call
for. Pediatric trials are supposed to offer ``potential
benefit" to
children. Why, then, do clinical-trials registries list just
one trial
on pediatric AIDS (a fatal disease for which few pediatric
formulations of needed medicines are available), compared
with no
fewer than 70 on high blood pressure in children?
These experiments are not designed for their potential
benefit to
children, although drugmakers effectively argue that some
subset of
children will benefit from them. Rather, children are
rounded up for
such trials because blood-pressure drugs bring in $25
billion a year
for drug companies, and testing these primarily adult
medications on
children extends drugmakers' brand-name patents by several
lucrative
months.
Since 2000, Food and Drug Administration officials and drug
executives
have led a movement to restrict the rights of human subjects
in
medical research: from making substandard care to the poor
acceptable,
to gutting strict curbs on the use of placebos. The
institute's stance
seems part of the trend. But once the experimenters are
given the keys
to the lockup, the choice for the imprisoned will be stark.
Behind bars, ``death at random is a way of life,"
according to one
prisoner who spoke to government advisers prior to bans in
the 1970s.
``The only place in this prison that people don't die is in
the
research unit," he said. ``Just what is it that you
think you are
protecting us from?"
For this prisoner, at least, the choice was clear: Be
experimented
upon or die.
Source:
http://www.boston.com/news/globe/editorial_opinio
n/oped/articles/2006/08/17/testing_drugs_on_prisoners_the_ea
sy_out?mode=PF
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