THERAPY AND ENHANCEMENT

It is common, in classifying interventions, to sort them into those that are therapeutic, that is, directed at diminishing the harms suffered by a patient, and those that are enhancing, that is, directed at increasing the goods experienced by a patient. At least three independent but related questions can be raised about the therapy/enhancement distinction: (1) Can the two terms therapy and enhancement be defined clearly, reliably, and accurately? (2) Assuming they can be satisfactorily defined, under what circumstances is it morally justified for a physician to engage in either activity? (3) Assuming they can be satisfactorily defined, what implications does labeling an intervention as therapeutic or enhancing have on the issue of whether the cost of the intervention should be borne in part or in whole by third-party funding agencies?

Defining Therapy and Enhancement

The distinction between therapy and enhancement can be most clearly made by first having available a clear definition of a third term: malady. The following definition of a malady, adapted from Gert, Culver, and Clouser 1997 (p. 104) classifies all clear cases of maladies as maladies and does not classify as a malady any condition that is clearly not a malady.

An individual has a malady if and only if (s)he has a condition that is not normal for a person in his (her) prime, other than his (her) rational beliefs or desires, such that (s)he is suffering, or is at a significantly increased risk of suffering, a nontrivial harm or evil (death, pain, disability, loss of freedom, or loss of pleasure) in the absence of a distinct sustaining cause.

Therapies are interventions whose intention is to reduce or eliminate the harms that are a defining characteristic of maladies. If an intervention is not directed toward reducing or eliminating the harms associated with a malady, then it is not a therapy. Enhancements are interventions directed toward increasing the personal goods experienced by another person, such as abilities (including knowledge), freedom, and pleasure. If an intervention is not directed toward increasing another's personal goods, then it is not an enhancement. These definitions seem to correctly classify all cases of therapies and enhancements.

An extensive project ("The Enhancement Project") sponsored by the Hastings Center concluded that the two terms could not be defined clearly and could thus serve only as "conversation starters." In the words of the project coordinator, "Like many distinctions, the treatment/enhancement distinction is permeable, unstable, and can be used for pernicious purposes" (Parens 1998, p. 25). In contrast, the present authors think the two terms can be defined clearly and that one advantage of clear definitions is that they decrease the likelihood of any pernicious applications of the terms defined.

There are inevitable borderline cases. For example, how should one classify the administration of growth hormone to a child destined to be very short but who shows no evidence of an endocrinopathy? There is disagreement about this question, but not because of any avoidable vagueness in the definitions given here. Instead the disagreement is about whether this condition is a malady. If it is not, then administering growth hormone is not a therapy; if it is, then it is a therapy. Both Eric T. Juengst (1998) and Norman Daniels (1994) also use the concept of malady in distinguishing between therapies and enhancements, although Daniels's definition of malady differs from the one given here.

The Moral Justifiability of Administering Therapies and Enhancements

There is a general consensus that it is ethically justified to administer interventions when certain conditions are met. First, the intervention must be a rational one for the patient to choose under his or her circumstances. Second, patients must give valid consent to an intervention: They must be given adequate information about the intervention, must not be coerced into consenting, and must be fully competent to consent. If these conditions are met, then it is ethically justified to administer an intervention. If one of them is not met, then it may or may not be ethically justified to administer the intervention.

If an intervention can be accurately predicted to cause only an increase in the personal goods experienced by an individual, and the individual gives a valid consent to the intervention, then there is nothing morally problematic about administering the enhancement. What often makes enhancements problematic is that there is uncertainty about whether there might be significant harms that will, sooner or later, accompany the enhancement. Breast augmentation surgery may result in abscesses or in later disfiguring and irreversible structural lesions. Exogenous growth hormone administration might result in later endocrinopathies or even tumors. Mood-altering drugs might result in short-term tranquility or euphoria but long-term deleterious psychic (or neurochemical) effects. Even in cases of enhancements with possible risks, unless it would be irrational for the adequately informed competent patient to choose to have the enhancement, it seems morally justified to administer the enhancement if the patient has validly consented to it.

One moral problem that arises concerning enhancements is not the moral acceptability of enhancing with valid consent, but whether the resources spent developing enhancements detract from the resources that are available for therapy. Except when the harms suffered are trivial and the goods involved are extraordinary, it is almost universally acknowledged that it is more important to prevent or relieve harms than to promote goods. Thus if the enhancements that are developed and marketed decrease the resources that are available for therapy, then it might be argued that it is not morally acceptable to develop and market such enhancements. It is very doubtful, however, that preventing the development of enhancements would increase the resources used for therapy, so that it is not clear how much force this argument would have.

Another moral problem concerning enhancement is that it is sometimes used to gain an unfair advantage over others, such as the case of athletes who take prohibited drugs to gain a competitive edge. The problem here, however, is not with enhancements themselves but with their use to gain an unfair advantage. It might be claimed that the existence of enhancing drugs provides such a strong temptation that merely making them available is morally problematic. But most enhancing drugs are also used therapeutically and, in fact, were originally developed for therapeutic use. That enhancing drugs are sometimes used unfairly is no more of an argument against their morally acceptable use than the fact that automobiles are sometimes used in committing a crime is an argument against their morally acceptable use. Other arguments against the use of enhancements, such as that they cause envy, create social pressure for their use, and increase the disparity between people, are also arguments against elite colleges, expensive cars, and personal trainers.

A rhetorically powerful but completely mistaken argument against enhancement is that it is not natural. This argument has no force because almost the entire world humans now live in is not natural, if by natural one means independent of human artifice. Even most of the trees and plants humans use are not natural. Medicine is not natural. Before abandoning traditional ways of acting and doing, whether natural or artificial, it is certainly important to ensure that the undesirable unintended consequences will not overwhelm the desired consequences. The larger the change the more caution is appropriate, especially if the desired consequences are not the prevention or relief of evils, but only the promotion of goods, such as germ-line genetic engineering that is used solely for enhancing.

HUMAN GENETIC THERAPY AND ENHANCEMENT. An important application of the therapy/enhancement distinction occurs with genetic therapy and genetic enhancement, and examples of both processes may well proliferate in the future. It is important to distinguish germ-line genetic engineering from somatic-cell genetic engineering. Both involve directly altering the genetic structure of an organism, but somatic-cell genetic engineering, which is done by altering the somatic cells of an organism, is not intended to have any consequences for the descendents of that organism. Germ-line genetic engineering alters the genetic structure of an organism in ways that will or may have consequences for all of its descendents. Gene therapy is genetic engineering aimed at eliminating the genetic cause of (a) a serious malady or (b) a significantly increased risk of suffering that malady. Genetic enhancement is genetic engineering aimed at providing an organism with new or improved traits that are deemed useful or desirable by those doing the altering. Genetic engineering for plants and nonhuman animals is almost always genetic enhancement. Gene therapy is now being considered for human beings, but there is already talk of genetic enhancement for human beings.

If somatic-cell genetic engineering does not have any consequences for future generations, it is not considered controversial. Unlike the genetic engineering that is used in plants and animals, somatic-cell gene therapy alters only the genetic structure of the individual who receives the somatic-cell gene therapy; the altered genetic structure is not passed on to that individual's offspring. Although it is possible for somatic-cell genetic engineering to affect the germ line, this is not yet considered a serious risk, and so its effects are thought to end with the individual treated. Unless some argument is provided to show that somatic-cell genetic engineering has serious risks, there is no stronger reason not to have somatic cell gene enhancement than not to have plastic surgery to improve the appearance of normal people. Indeed, it is hard even to imagine an argument against somatic-cell gene enhancement that is not also a general argument against any kind of technological enhancement.

The moral controversy that is the main subject here concerns whether there is any morally significant difference between germ-line gene therapy and germ-line gene enhancement with regard to human beings. In what follows, gene therapy and gene enhancement will always refer to germ-line gene therapy and germ-line gene enhancement. Gene therapy is regarded by some as the best way to correct severe genetic defects such as thalassemia, severe combined immunodeficiency, or cystic fibrosis. One argument is that because there is no nonarbitrary line between therapy and enhancement, acceptance of gene therapy, even to cure a serious genetic malady, makes it impossible not to accept gene enhancement as well.

This argument is used both by those who are opposed to genetic engineering of any kind, and those who favor gene enhancement. The former argue that because scholars are unable to draw a nonarbitrary line between gene therapy and gene enhancement, people should protect themselves against the latter by not even beginning with the former. The latter argue that because it is clear that one ought to accept gene therapy, one ought to also accept gene enhancement. Nevertheless, the objection that gene therapy will lead to gene enhancement presupposes that there is something intrinsically morally wrong with gene enhancement. No one has yet provided a strong theoretical argument that shows that genetic enhancement to produce greater size, strength, or intelligence, or increased resistance to toxic substances, is morally problematic. Yet neither is it clear that one ought to accept gene therapy or that there is no morally significant distinction between gene therapy and gene enhancement.

In fact, it is possible to draw a nonarbitrary line that distinguishes gene therapy and gene enhancement because there is an adequate definition of a genetic malady, related to the above general definition of a malady:

An individual has a genetic malady if and only if (s)he has a genetic condition that is not normal for a person in his (her) prime, other than his (her) rational beliefs or desires, such that (s)he is suffering, or is at a significantly increased risk of suffering, a non-trivial harm or evil (death, pain, disability, loss of freedom, or loss of pleasure) in the absence of a distinct sustaining cause.

Genetic conditions such as hemophilia, cystic fibrosis, and muscular dystrophy all share features common to other serious maladies, such as cancer, high blood pressure, and tuberculosis and so fit the definitional criteria of malady. Genetic conditions that do not meet the definitional criteria of a malady should obviously not be counted as a malady, and gene engineering for these constitutes gene enhancement. Examples of genetic nonmaladies might include blue eyes, widow's peak, freckles, O blood type, or curly hair.

Nonetheless, it is inevitable that there will be some genetic conditions about which there will be disagreement concerning their malady status. The number of such conditions is small, however, and the disagreement is based on the nature of maladies, not on vagueness in the malady definition. Borderline conditions, such as short stature or mild obesity, will be conditions about which people disagree on their malady status because it is not clear whether these conditions significantly increase the risk of suffering nontrivial harms. Because such borderline conditions are not very serious in the medical sense, they are quite unlikely to be candidates for gene therapy, at least initially. For all practical purposes gene therapy would be limited to the clear cases of genetic maladies. Indeed, the moral argument against gene enhancement, outlined below, is also an argument against genetic engineering for mild or borderline cases of genetic maladies.

The moral argument against gene enhancement is fairly straightforward. It is not morally acceptable to cause harm or a significant risk of harm to some people simply in order to create benefits for some other people. It is sometimes morally acceptable, however, to cause harm or a significant risk of harm to some people in order to prevent more serious or more certain harm to others. The government is allowed to quarantine people, that is deprive them of their freedom, even without their consent, if failure to quarantine would cause serious harm, as in the sudden acute respiratory syndrome (SARS) epidemic of 2003. This restriction of freedom, however, would not be justifiable simply in order to provide benefits to people. Gene enhancement does, at present, pose an unknown but possibly significant risk of harm to the descendants of the person who is being genetically enhanced. This genetic enhancement is not done to prevent a more serious or certain harm to this person. Therefore genetic enhancement is not morally justified. As noted, this same argument can be used against gene therapy for mild or borderline cases of genetic maladies. With regard to serious genetic maladies, this argument does not have the same force, for in these cases, the harm being prevented is more serious and certain than any harm that might be created. This does create a morally significant difference between gene therapy and gene enhancement.

Another completely different kind of argument can be given that leads to the same conclusion. Gene therapy simply aims to replace a defective gene with a non-defective allele of the same gene. If the technique for replacing genes is perfected, which at present it is not, then there is little or no chance that some unknown harmful side effect will result. The genetic structure of the organism will be identical in the relevant respect to the genetic structure of the majority of the human species. With gene enhancement, however, a new gene is being introduced with far greater chance of unknown harmful side effects. There are many genetic effects that do not show up for many generations. The identical gene inherited from the mother may have different effects when inherited from the father. There are expanding genes (triplet repeats) that do not have any effect until after several generations. Gene enhancement could create harms for the third or fourth generation, when it may not even be possible to track these individuals. This is another morally significant difference between gene therapy and gene enhancement.

Because preimplantation screening can eliminate almost all of the genetic maladies that would be eliminated by gene therapy, it seems clear that the primary reason for engaging in any kind of genetic manipulation is gene enhancement. Thus, although there is a morally significant difference between gene therapy and gene enhancement, given that the alternative of preimplantation therapy has less risks than gene therapy, it may be that there is at present no moral justification for engaging in either of these practices.

NONHUMAN GENETIC THERAPY AND ENHANCEMENT. As previously noted, genetic engineering is practiced on plants and nonhuman animals, and indeed has a long history in the nondirect forms of selective breeding and hybridization. In these cases what is almost always of interest is not genetic therapy for the good of the organism but genetic enhancement for the good of human users. On the basis of all the arguments already given, there is no reason to make a general objection to the genetic enhancement of plants and nonhuman animals.

Reimbursements for Therapies and Enhancements

Discussions of the therapy/enhancement distinction are sometimes linked to the question of third-party reimbursement for the two kinds of interventions. It may be assumed that therapies should be reimbursed and enhancements should not (see Parens 1998 for a discussion of these arguments). While there may be a societal consensus that most therapies should be reimbursed and that most enhancements should not, this is a contingent and not an invariant relationship.

Suppose two new managed-care companies start up and offer somewhat different ranges of benefits. Company A pays not only for essentially all therapies but also for most borderline cases whose therapy/enhancement status is a matter of dispute, and even pays for a few enhancements that are clearly specified in the terms of the contract. Company B pays only for therapies and states ahead of time that they will not reimburse for borderline conditions (which they might list) and will not reimburse for any enhancements whatsoever. Company A's premiums are higher, while company B is offering a lower cost, less-inclusive policy. Neither company is acting unethically or in an unjust fashion.

If, however, the issue concerns medical plans that are financed by taxes, then there may be an argument that only therapies, and not enhancements, should be covered. Yet even in this case, there is no obvious way to determine which, if any, borderline cases should be covered. In democratic societies decisions about government-financed medical treatments should reflect the prevailing public consensus, as determined through democratic political processes.

BERNARD GERT CHARLES M. CULVER

SEE ALSO Bioethics;Human Cloning.

BIBLIOGRAPHY

Brock, Dan W. (1998). "Enhancements of Human Function: Some Distinctions for Policymakers." In Enhancing Human Traits, ed. Erik Parens. Washington, DC: Georgetown University Press. Discusses circumstances in which it is ethically justified for a health insurance company not to reimburse the treatment of a disease and to reimburse the giving of some enhancements.

Daniels, Norman. (1994). "The Genome Project, Individual Differences, and Just Health Care." In Justice and the Human Genome Project, ed. Timothy F. Murphy and Marc A. Lappé. Berkeley and Los Angeles: University of California Press.

Gert, Bernard. (2000). "Thinking about Huxley's Brave New World: Was It Wrong to Create a Genetic Hierarchical Society? Is It Wrong to Prevent One?" In Etica ricerca biologica [The ethics of biological research], ed. Cosimo Marco Mazzoni. Florence, Italy: Leo S. Olschki. Reprinted in Ethics and Law in Biological Research, ed. Cosimo Marco Mazzoni. Boston: Kluwer Academic, 2002. Explores the issue of whether genetic enhancement should be allowed.

Gert, Bernard; Charles M. Culver; and K. Danner Clouser. (1997). Bioethics: A Return to Fundamentals. New York: Oxford University Press. Contains an extensive discussion of the criteria for a valid consent and the criteria for justified paternalistic interventions.

Gert, Bernard; Edward M. Berger; George F. Cahill Jr.; et al. (1996). Morality and the New Genetics. Boston: Jones and Bartlett. Contains a detailed discussion of the concept of a genetic malady.

Juengst, Eric T. (1998). "What Does Enhancement Mean?" In Enhancing Human Traits, ed. Erik Parens. Washington, DC: Georgetown University Press.

Parens, Erik. (1998). "Is Better Always Good? The Enhancement Project." In Enhancing Human Traits, ed. Erik Parens. Washington, DC: Georgetown University Press.