Principles and Practice of Pharmaceutical Medicine

It is true that in the hospital environment, such
committees’ activities may have greater scope
than a clinical trial IRB. Robert Veatch,^23 a bioethi-
cist at Georgetown University, has pointed out that
hospital ethics committees

make specific patient-care decisions;

make broad policy decisions;

provide counseling and support;

establish likely prognosis.

All of these can impinge, directly or indirectly, on
the autonomy of patients, and deflect hospital care
from the best principles of beneficence for each
individual case. Furthermore, Bernard Lo,^24 a phy-
sician and bioethicist at UCSF, discusses possible
pitfalls of ethics committees: There can be exces-
sive pressure to reach agreement, impairment
rather than improvement of decision making and
the broader dangers of ‘Group-think’, that is attrac-
tion toward consensus overcoming the voicing of
independent, and possibly discordant, points of
view.

Bioethicists in the pharmaceutical

industry

Although it is true that most of the egregious viola-

tions of bioethics have resulted from the actions of

governments and academic institutions, we should

nonetheless ask a pivotal question: Is there now a

need for formal recognition of bioethicists as an

integral part of the pharmaceutical medicine

‘team’?

This question has many aspects. Who can be a

bioethicist? – should it be only someone with a

degree from one of the now numerous university

departments of bioethics? Increasingly, bioethics

awareness, training and expertise is needed

throughout the pharmaceutical industry and related

regulatory and research areas. Or is the increasing

use of data safety monitoring boards, together with

their approval of the protocols they monitor, a

better way to go?

These are unsettled questions with able protago-

nists on all sides. We may hope that, in the future,

there ought to be sufficient flexibility to adapt the

necessary safeguards to the type of clinical study. A

‘one size fits all’ approach is hardly likely to be

useful.

(^23) Veatch RM. ‘Hospital ethics committees: is there a role?’
Hastings Center Report, Vol. 7, pp. 22–25, reprinted
(abridged) in ‘Bioethics: an Introduction to the History,
Methods, and Practice’, Jecker, Jonsen, Pearlman (eds). Jones
and Bartlett Publishers: Sudbury; 1997.
(^24) ‘Behind closed doors: promises and pitfalls of ethical
committees’.N. Engl. J. Med., Vol. 317, 1987, pp. 46–50,
reprinted in ’Bioethics: an Introduction to the History,
Methods, and Practice’, Jecker, Jonsen, Pearlman (eds).
Jones and Bartlett Publishers: Sudbury; 1997.
594 CH45 INTRODUCTION TO BIOETHICS FOR PHARMACEUTICAL PROFESSIONALS