not been obtained and that families were not told
that an alternative and effective nonexperimental
antibiotic, chloramphenicol, was being adminis-
tered free in the same hospital.
Jesse Gelsinger^20 suffered from a rare genetic
disorder called ornithine transcarbamylase defi-
ciency, which, while requiring cumbersome treat-
ment with diet and drugs, was not a life-threatening
disorder for him. In 1999, hevolunteered for a phase
I experimental gene therapy at the University of
Pennsylvania; his personal goal, it is thought, was
to help the treatment of babies with this disorder
rather than to benefit himself. He was injected with
corrective genes incorporated into an adenovirus
vector, despite animal data suggesting toxicity of
thevector. Three days later, hewas dead from multi-
ple organ failure, apparently due to an overwhelm-
ing inflammatory reaction to the vector which had
unexpectedly regained its virulence. Bioethical con-
cerns raised afterwards included inadequacy of the
informed consent (failure to fully reveal toxicity in
previous animal experiments), bending of the rules
(Jesse’s ammonia levels exceeded the upper limits
set by the protocol) and conflict of interest (one of
the investigators had a significant financial interest
in the study outcome).
In 2001, Ellen Roche, a volunteer in a phase I
study at Johns Hopkins University, died after an
experimental inhalation of hexamethonium.^21 Two
major ethical lapses have been suggested. Firstly,
the toxic nature of the inhalant had been under-
estimated by the clinical investigators, in spite of
(admittedly decades old) literature demonstrating
this toxicity. Secondly, the volunteer had been an
employee in the laboratories of the same Univer-
sity, thus presenting a potential for coercion to take
part in the study.
Allocation of resources
Resource allocation is a bioethical concern for all
aspects of medicine, for instance, how limited
resources should be allocated among different
groups. It applies to the pharmaceutical industry
and its allocation of funds for drug research and
development. Such issues includeexotic therapies versus cheaper more widely
useful therapies;therapies for old versus young, rich versus poor,
one ethnic group versus another and so on;public need versus profitability.Allocation of scarce resources can be decided in a
number of ways, for example by the principles of
utilitarianism (such as by using medical criteria to
select those most likely to benefit) or by random
choice.Ethics committees
Robert Pearlman,^22 a bioethicist and physician at
the University of Washington, asks a series of
questions about hospital ethical committees and
Institutional Review Boards (IRBs) that may be
easily generalized to other settings:Membership – Who should sit on an ethics com-
mittee?Roles – Advisory or mandatory?Outcomes – What to do if consensus is impos-
sible?Ethics education for committee members –
Content?Hospital [or company] policies on ethics – What
should these be?Quality assurance – How to measure?(^20) Sources include http://www.frenchanderson.org/history/
biotech.pdf.
(^21) Sources include http://www.ahrp.org/infomail/0701/19.php
and http://medicine.creighton.edu/idc135/2004/group2b/.
(^22) Pearlman RA. ‘Introduction to the practice of bioethics’, pp.
259–272, in ‘Bioethics: an Introduction to the History,
Methods, and Practice’, Jecker, Jonsen, Pearlman (eds).
Jones and Bartlett Publishers: Sudbury; 1997.
45.5 FURTHER ISSUES OF CONCERN TO THE PHARMACEUTICAL INDUSTRY AND MEDICAL RESEARCH 593