Final Report (all chapters)

2.4 Broadening the Ethical Debate
As it stands, the Endocrinologic and Metabolic Drugs Advisory Committee could be
described as a decision-making body that is likely to routinely recast ethical dilemmas in narrow
medical terms. It is also likely to reduce eminently public choices to private decisions. The heavy
reliance on science advisory boards, the skewed composition of these boards, the limited pool of
ethical arguments presented to these panels, and their inadequate statutory authority all
contribute to this outcome.
Some commentators may argue that that the Public Health Service Act and the Food, Drug,
and Cosmetics Act afford the FDA much more regulatory discretion than suggested by current
FDA regulatory practices. In particular, under some legal theories, the FDA would be able to
include considerations other than safety and efficacy in its approval process. We are in no
position to evaluate the merits of this claim, but even if it could be demonstrated that the FDA
would have to statutory authority to inject ethical considerations into its decision-making
process, the agency is very unlikely to do so. The FDA does not consider regulatory demands
other than those pertaining to safety and efficacy as part if its core mission. In the agency’s view,
these demands represent a regulatory distraction, a misallocation of scarce administrative
resources that drag the agency into legal battles with uncertain outcomes. Importantly, the
agency’s organizational culture and its professional expertise, both of which have developed
around safety and efficacy, make the FDA ill-suited to address broad ethical dilemmas.
But what are the ethical dilemmas neglected by the Endocrinologic and Metabolic Advisory
Committee? In the remainder of this chapter, we touch upon some of the arguments that in our
view have not received sufficient attention. Some have argued that severe hGH deficiency is a
physiological impairment that deserves close medical attention, whereas idiopathic short stature
is not at all a medical condition. 16 Children can be unhappy about many things; they may not like
their noses, for example, but should we be in the business of prescribing nose jobs? In this view,
children suffering from severe hGH deficiency and ISS children do not really represent
commensurable cases. By prescribing hGH treatment for idiopathic shortness, are we not simply
indulging profoundly human but nevertheless unjustifiable parental desires? Should health
insurance plans (that is to say, the public) be required to cover the costs of hGH treatment for an
adolescent who is desperate to follow in his father’s footsteps and embrace a basketball career?
At the other extreme, if there is no solid evidence of ubiquitous and systematic harm to short
children, why should the state encourage the misallocation of scarce financial resources?
These arguments have been made often and do not require further discussion. By contrast,
one question that should have received considerable attention but has barely been acknowledged
is what may be called the medicalization of societal problems. Dr. Nancy Worcester, the
consumer representative on the Endocrinologic and Metabolic Advisory Committee, was the
only commissioner who touched upon this concern, although only marginally so. Not
16
Peter H. Schwartz, "Genetic Breakthroughs and the Limits of Medicine: Short Stature, Growth Hormone, and the
Idea of Dysfunction," St. Thomas Law Review 13 (2001).
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