2-3 pages reflective essay

Chapter Twenty Nine

Clinical Trials Are Inherently Exploitative The Likelihood That They Are Is High

Jamie Carlin VVtitson

I will offer a set of conditions minimally necessary and sufficient for wrongful exploitation and argue that, while inter- national clinical trials are not inherently wrongfully exploitative, problems with informed consent, the prevalence of misapplied moral theories among researchers, and the weakness of human moral motivation make it likely that any particular international clinical trial is wrongfully exploitative.

Introduction

The term exploitation is often used in politically charged contexts to incite public outrage against some behavior that the inciter finds offensive (e.g., Walker, 2011). Some argue that college athletics programs exploit their athletes, since players' compensation (college tuition) is far outstripped by the schools' proceeds (e.g., Associated Press, 2007; Taylor, 2010). Similarly, some argue that surrogate motherhood should be legally prohibited because such a contract would inevitably be

; ¢Xploitative. The difficulty, of course, is that very few explain what they mean by exploitation, which

'*1akes it difficult to justify such claims. And until . :ently, moral philosophers have expended little ink

. identify precisely what constitutes an exploitative .. Whether any of the above cases is actually exploit-

and, if so, whether these instances of exploitation ,l):lorally impermissible depend on the plausibility of

the account of exploitation invoked. Thus, to evaluate whether international clinical trials are wrongfully exploitative, we will need a plausible account of wrongful exploitation.

As with many philosophical concepts, I take it that the most efficient method of discovering or con- structing an adequate account of exploitation involves testing hypothesized necessary and sufficient condi- tions against rational intuitions about counterexam- ples. Nevertheless, a review of the current literature reveals that there is widespread disagreement over the necessary and sufficient conditions for wrongful exploitation. Some regard wrongful exploitation as a primarily economic term, referring to a particular type of relationship between workers and rulers in a society. Others argue that it requires some sort of harm, or rights violation, or coercion. Some have even rejected the idea that there is a single set of necessary and sufficient conditions and that some types of

.'lfCmporary Debates in Bioethics, First Edition. Edited by Arthur L. Caplan and Robert Arp. '2014 John Wiley & Sons, Inc. Published 2014 by John Wiley & Sons, Inc.

wrongful exploitation may be incommensurable with others. For instance, Alan Wertheimer (1999, 2008) suggests that wrongful exploitation may be analyzed along a number of mutually exclusive dimensions, for instance, exploitation that is consensual or noncon- sensual, volitional or nonvolitional, or identified by outcome or process.

Unfortunately, is not space here to swim these waters deeply. Rather than address these dis- agreements directly, I will begin with Mikhail Valdman's (2009) important recent analysis of wrong- ful exploitation, and I will highlight what I take to be its strengths and deficiencies. In response to these deficiencies, I will offer what I take to be a set of minimally necessary and sufficient conditions for wrongful exploitation that capture the intuitions that Valdman's and others have attempted to isolate, while providing a framework for adapting to various dimen- sions of an action, such as those noted by Wertheimer. The result suggests a way of unifying our intuitions about wrongful exploitation and provides a standard against which to evaluate whether international clinical trials are wrongfully exploitative. In the sec- ond half of this chapter, I offer three lines of evidence to show that it is highly likely that any particular inter- national clinical trial meets the conditions for wrong- ful exploitation.

Exploitation and Valdm.an's Position

Traditional Western usage of exploitation suggests, at the very least, the use of one person by another for the latter's benefit.And it seems intuitive that, in its broad- est sense, exploitation need not imply moral imper- rnissibility. For instance, hiring employees, directing volunteers, and building houses all fall within the scope of colloquial phrases such as "exploiting resources" and "exploiting adv;:mta!l(es" without implying, even prima facie, negative moral implica- tions. As such, these are not the inst;mces of exploita- tion with which we arc p1·imArily concerned. We want to know what comtitittes tnoml/y impermissible, or wrongful, exploitation.

An analysis of wrongful .,xploitation cited widely in the biomedical Ht¢fllt\!rc cmnes from Alan

(1999): A H when B receives an

474 Jamie Carlin Wataon

unfair level of benefits as a result of B's interactions with A (Emanuel et al., 2000, 2004; AAAS Policy Forum, 2002).This analysis has two conditions: (1) A interacts with B, and (2) an unfair level of benefit to one party is a result of this interaction. Though this analysis is fairly clear and captures some of our intui- tions about wrongful exploitation, it is somewhat unfortunate that it is cited so widely; Wertheimer uses this analysis only as a starting-point for a more rigorous discussion of exploitation, and to see why, we need only consider an example. . Consider that most cases of buyer's remorse meet

both conditions. If B purchases object X from A and, subsequently, B decides that X is not really worth the amount that he paid, B now perceives that A has received an unfair level of benefit from the transac- tion. There are at least two problems here: one with the temporal relationship between the transaction and the feeling of unfairness, and one of determining what counts as "unfair." Presumably, irrespective ol temporal considerations, if a transaction is volunt:try. both parties value what they receive more than wh:it they are giving up-I am willing to sell my iPod In you for $100 because I value your $100 more than 111y iPod, and vice versa (and this explains why bot Ii parties can say, "Thank you."). But few would reg;inl buyer's remorse as an instance of exploitation, wro11p, ful or otherwise. This case suggests that this account lacks the sophistication we need to adequately i(kll tify instances of wrongful exploitation.

An alternative starting-point is Mikhail (2009), "A Theory ofWrongful Exploitation.'Vald111,111 asks us to consider what he calls the Antidote ( :,11r; "Person B is bitten by a rare poisonous snake hiking in a remote forest. His death is im111im•1 Fortunately, another hiker, A, happens by and sell B the antidote .... Though it retails for $ 10, insists that he will accept no less than $20,000. Sil B would rather lose his money than his life, he avn A's offer (p. 3)." According to Valdman, not only i• a case where, "A wrongly exploited B;' but, "111. this is about as clear a case of wrongful exploitat · I can imagine. If some theory suggested othnv would take that as evidence against it" (p. 3).Vah argues that A's offer is wrongfully exploitatiw lwt A "extracts excessive benefits from someoll<' cannot, or cannot reasonably, refuse one's offn" (

:l's interactions AAAS Policy

,nditions: (1) A of benefit to

n. Though this ,e of our intui- t is somewhat Tertheimer uses tt for a more I to see why, we

. remorse meet XfromA and, eally worth the ves that A has •ID the transac- here: one with transaction and )f determining irrespective of

cm is voluntary, nore than what sell my iPod to ) more than my ains why both N would regard iitation, wrong- 1at this account ::l.equately iden- t. ikhail Valdman's tation:'Valdman e Antidote Case: )US snake while :h is imminent. by and offers to :tails for $10, A t $20,000. Since is life, he accepts _, not only is this B;' but, "Indeed, tl exploitation as ' ;ted otherwise, l "(p. 3).Valdman'._ loitative because\!

someone whQ •ne's offer" (p. 9)

......... His analysis d11iH' nmditions that,

combined with a drcunManrc• In which A uses B's behavior for his own gain, tin.' sullidcnt for wrongful exploitation: (1) lfs urgt;m 1wod; (2) A's monopoly power; and (3) A's excessive lic1w!k'l'h us, the Antidote Case is wrongfully exploitative hccnusc A uses B's behavior for his own gain in nmditfons where (1) the antidote is something th:H H H(J!Cnt/y t/C'l'ds, (2) A holds monopoly power over the such that Bis not in a position to "reasonably .. any offer A makes, and (3) A exacts excessitle bcnqflt fr()lll B in charging him $20,000 rather than the market rate of$l0.

While I ultimately agree with Va1dman that this is an instance of wrongful exploitation, I am skeptical of his analysis. I take it, first, that condition (1) is irrele- vant. Unless you are a certain type of consequentialist (a la Peter Singer and Peter Unger), need alone, even urgent need, does not establish a moral obligation that someone meet that need.And even if a refusal to meet some types of need is immoral, it is not clear that such a refusal meets conditions sufficient for wrongful exploitation. We can see this clearly with a slight mod- ification of the case, in which A, who still has the antidote in his possession, thinks it likely that he will need the antidote soon, either for himself or for a member of his family. Ifhe thinks the likelihood high enough, he might reasonably decide to refuse to give or sell the antidote to B. In this case, A refuses to sell or give B what B urgently needs, and A holds monopoly power over B, and yet it would be inappro- priate to say that A exploits B.AndValdman agrees that "an obligation not to wrongly exploit is different from an obligation to rescue" (p. 12). Therefore, by "urgent need;' he must mean something other than desperate or vital need. And, in fact, B's need seems rel- evant only insofar as B's death is an unreasonable option for B in the contract offered by A, so that B cannot reasonably refuse any offer. But this points us away from need and toward condition (ii).

Condition (ii) is more intuitive. but, I think, misdi- rected except as it relates to B's ability to reasonably refuse. Hold fixed B's urgent need, but consider a modification in which another hiker, also with the antidote, approaches, learns of the situation, and offers to sell hers to B for only $15,000. This removes A's monopoly on the antidote. And, if one additional antidote-seller is not enough, increase the number as

much as you like until you are confident that there is no longer a "monopoly" on the antidote. Presumably, none of these competitors would sell it for $10, given its worth to B at that particular moment. And yet something about this bidding war strikes us as "unfair" to B. Therefore, that someone holds monopoly power does not add .any force to a case of putative exploita- tion. More plausibly, the worry about A's offer stems from the fact that B cannot reasonably refuse A's-or any number of other vendors'-offer. I will return to the ability to reasonably refuse below.

Further, Valdman's condition (iii)-that A extracts excessive benefit from B-seems unnecessary because it depends on the implausible assumption that there are objective normative standards of exchange value by which to evaluate the permissibility of transactions. In this case, Valdman assumes there is some objeclitJe truth about what the antidote is worth independently of any consideration of B's interests (cf. Snyder, 2008, 2012). But value transactions (e.g., monetary exchanges, barter exchanges, companionship, love, etc.) are not conducted according to objective standards of value; they are conducted according to subjective, consumer standards of value. The fact that most peo- ple are not willing to pay more than $10 for the anti- dote does not mean it is not worth vastly more to B in these circumstances. We can imagine some piece of sci-fi memorabilia that is not worth a dollar to most people, but for which some eager fan is willing to pay a large sum. In that .case, we would not say the seller has exploited the fan. (Valdman seems to agree with this point, as indicated by an example he offers of a stamp collector willing to pay an exorbitant rate for a stamp in advance of its official release.) The seller has no obligation to sell the item at all, much less for some "objectively" determined normative value. Similarly, if B'has no money whatsoever, even $10 is "excessive," since it is physically impossible for him to pay it. Thus, whether the demanded price is "excessive" can only be determined by the consumer. Absent other considerations, A is merely acting prudently.Therefore, contra Valdman, it is implausible that a theory of wrongful exploitation depends on a case's meeting such a condition. Incidentally, Valdman argues that, without condition (3), the Antidote Case is no longer exploitative. In a modification of the Antidote Case where A offers B the antidote for $10,Valdman writes,

Clinical Trials Are Inherently Exploitative 4 7 5

" ... surely A did not wrongly exploit B. Indeed, here it seems that A didn't even wrong B" (p. 12).

So, if the Antidote Case really is wrongfully exploitative, but none of Valdman's conditions are independently or jointly sufficient for wrongful exploitation, what accounts for the wrongness of A's offer to B? It is now time to consider the previous suggestion that it is B's inability to reasonably refuse A's offer. As with "excessive benefit," saying precisely what is "reasonable" is tricky; all sorts of conditions may undermine our abilities to reasonably refuse a contract without broaching wrongful exploitation. A car salesman may be able to take far greater advantage of me than my father. But I have not btren wrongfully exploited when I have bought cars; I have simply lacked the requisite virtue of fortitude for pursuing my interests. Nevertheless, there seem to be some unambiguous cases in which it would not be my fault that I could not enter appropriately into a contract, particularly cases where I would stand an unreasonable risk ef losing something of fundamental value. Recall that, if Bis destitute, A's charging B $10 for the antidote is as inappropriate as A's demand of$20,000. We may note, similarly, that $20,000 would not seem inappropriate or excessive if B were extremely wealthy. Therefore, what seems relevant to wrongful exploita- tion is not A's excessive benefit, or A's monopoly over the antidote, or B's mere need, or any combination of the three, but B's risk ef excessive loss, as determined by B's subjective assessment of his values.

Thus,Valdman's intuitions about "urgent need" and "monopoly power" can be captured more plausibly by a condition that a responsible agent cannot reasonably reject a contract, where the inability to reasonably reject means that the agent perceives that he stands an unreasonable risk of losing something he considers fundamentally valuable (e.g., his lifo, the lives of his family, his religious commitments, his financial stability, etc.). In the Antidote Case, if Bis like many of us in that he is not very wealthy, B stand$ a 100% chance of losing something he considers of fundame11tal value: if he refuses the offer, he will k)s\:! his life; ifhe accepts the offer, he will lose his fin:nteial Since it is likely that B perceives either choice as an tmreasonable risk, any contract that A enters with 13, apart from brute charity (which may be wrongfully exploitative for other reasons), -is wr¢nRfullyexploitative.

4 76 Jamie Carlin Wll.t11on

This subjective condition allows responsible agents to enter into employment contracts as firemen or sol- diers without the spectre of wrongful exploitation. Similarly, in cases where a corporation opens a plant in a rural third-world country, workers are wrongfully exploited only if they accept an agreement that, to them, constitutes an unreasonable risk of losing something of fundamental value (life or health in return for insufficient financial return).

So far, I have attempted to show that intuitions that the Antidote Case is wrongfully exploitative are not supported by considerations stemming from the particular amount A is charging B (there is no objective standard of value), A's monopoly over the antidote (we would think it exploitative even if A were not the only vendor), or A's obligation to rescue B from death (even if refusing is immoral, it is not obviously exploitative). What does seem relevant is that B is in a position in which he cannot reasonably any offer A is willing to make. B's life is on the line, so it may be that the stakes are too high for him to entt'l' competently into an exchange of value (money for life) with A, irrespective of who else is selling, and regardless of any particular price. If this is right, H lacks the requisite capacity to enter into a mor;illy binding contract with A. Thus, in order to avoid wrongful exploitation, it would seem that A is 1110.1 ally obligated either to withhold the antidote or Ill give B the antidote for free.

The ability to reasonably refuse an offer is clmdy related to the capacity to consent to a morally bi11di1 · agreement. By "the capacity to consent," I mea11 th a subject, S, has both the autonomy and the ratio ability to enter into a contractual relationship V another agent similarly situated. By "rational abilir mean the ability to draw reliable inferences fr information relevant to S's decisions pursuit of her values. We restrict children and severely mentally handicapped from drivi111-1 owning firearms on the grounds that they arc rn1t position to understand the moral implications n'' decisions and are, therefore, not morally resp1 for their actions. The ability to reasonably H' morally binding agreement entails the c:1p:1t' consent. Thus, if someone (a child, coma patit•ll lacks the ability to consent, she also lacks to reasonably refuse an offer. This

1onsible agents iremen or sol- 1 exploitation. opens a plant

:i.re wrongfully ement that, to isk of losing

or health in

intuitions that itative are not ng from the

(there is no . •poly over the ive even if A ltion to rescue ioral, it is not :m relevant is ·easonably refuse on the line, so r him to enter 1e (money for is selling, and his is right, B nto a morally rder to avoid :hat A is mor- antidote or to

::iff er is. closely ,orally binding t;' I mean that id the rational itionship with ional ability;' I ferences from regarding the ldren and the

driving and .ey are not in a. :ations of their" lly responsibl¢ nably refuse 1e capacity ta patient, etli cks the abili :elationship

however, asymmetrk. Soll1\:0l\1,' hick the ability to reasonably rcfust> :rn offor, yt't hnvc the ability to consent more generally (t'.!{., a victim of fraud, Valdrnan's snakebitt' vktim). All of implies that not committing wrongfol t'XploitAti<m requires that A knows something of B's v:ih1cs prior to offering a voluntary exchange.

Given these considerations, I propose the following analysis of what I will call a St't of minimally necessary and sufficient conditions for wrongful exploitation, or Minimally Wrongful Exploitation (MWE):An act by a morally competent person or group of persons, A, is wrongfully exploitative if and only if that act employs the behavior of a moral subject, B, in successfully obtaining A's ends under circumstances in which B stands an unreasonable risk of losing something of fundamental value to B.

I take it that wrongful exploitation occurs only in instances where A successfully obtains his ends at B's unreasonable expense. Instances where other condi- tions are met but A is unsuccessful constitute attempted wrongful exploitation, which may have similar moral implications to actual wrongful exploitation. Further, an "unreasonable risk of losing something of fundamental value to B" is an epistemic condition (hereafter, URLV). To avoid wrongful exploitation, A must be justified in believing that B has the ability to reasonably refuse a morally binding contract, and B must agree. In the Antidote Case, for example, under the putatively normal circumstances in which B is not wealthy, A has independent reasons for believing that, ifhe were to charge $20,000 for the antidote, B stands a URLV A would have these reasons irrespective of what B says under duress.

MWE implies that some acts are wrongfully exploitative, even when consistent with B's ends, for instance, when some child performers are paid hand-

for exploitative performances. MWE rules out Wrongful exploitation in cases where a subject is

ered an opportunity that merely constitutes a risk flosing something B perceives to be of fundamental

uable, either for the sake of other values or out of a , nse of self-sacrifice. Instances of this may include

hlnteering for charity organizations, or working as olice officer or emergency medical technician, re a subject is often called to aid strangers in

To be sure, one or more of these conditions may need to be expanded to accommodate more compli- cated cases. Nevertheless, MWE accounts for most intuitive cases of wrongful exploitation. Cases of coercion or deception are paradigm cases, including fraud, slavery, armed robbery, lying for personal gain, and Ponzi schemes. It also includes, somewhat less intuitively, many violations of intellectual property law, including nonconsensual plagiarism. In addition, cases of factory "sweatshop" labor, an oft-decried example of putative exploitation, meet the condi- tions for MWE if the workers are enslaved or sexu- ally abused, or have their wages withheld. Further, even in cases where these other conditions are not present, if factory workers perceive that they have nothing of value to offer in exchange for pursuing their interests other than their labor in a particular factory, such that their livelihoods depend on it and they cannot reasonably refuse the offer of a job, then the factory owners are wrongfully exploiting them. Similarly, surrogacy is wrongfully exploitative if and only if the surrogacy contract implies that one party stands a URLV

The challenge, now, is to evaluate international clinical trials in light of MWE. In the next section, I will briefly review some of the motivations for con- ducting research in places other than researchers' home countries and the conditions under which research is conducted in them, and I will then show that these lead to a high likelihood of wrongfully exploitative behavior.

The Motivation for International Clinical Trials

In first-world countries, researchers seem to have access to an ample number of willing research partic- ipants. So, why conduct clinical trials in countries outside researchers' own, especially in developing, third-world countries? A survey of the literature reveals two primary reasons. First, some diseases for which researchers are seeking treatment affect people in higher concentrations in developing countries. For example, on the continent of Africa, approximately 22. 9 million adults and children are infected with AIDS, compared to only 1.5 million in N orthAmerica

Clinical Trials Are Inherently Exploitative 477

(WH 0, 2009). Similarly, in 2009 the incidence rate of tuberculosis in Zimbabwe was 742, and in the Asian country of Timor-Leste, the rate was calculated at 498. In stark contrast, in the same year in the US, the incidence rate of tuberculosis was only 4.1 (WHO, 2011). By conducting trials in areas with higher concentrations of affected people, research can be conducted more efficiently than is possible in researchers' home countries, which then decreases the amount of time it takes for a new discovery to be introduced into the market, thereby increasing the profits of the researching agencies and more quickly alleviating much suffering around the world.

A second motivation for international clinical trials is that government regulations in some countries are less restrictive than in researchers' home countries. For example, Lurie and Wolfe ( 1997, 2007) claim that researchers often choose test groups in undeveloped or developing countries precisely to avoid the restric- tions of guidelines established to prevent immoral actions. Whether this is morally worrisome depends, of course, on whether these guidelines are appropri- ately aimed at the morality of actions or whether they are overly broad cautions.We know that policy makers are no better than· anyone else at determining the moral permissibility of certain types of research, and we know that most regulations are too broad and too narrow to capture all the cases intended. In one case, for instance, a WHO guideline mandates that researchers from one country apply the same strin- gent standards to their research in a foreign country as they do in their own: "An external sponsoring orga- nization and individual investigators should submit the research protocol for ethical and scientific review in the country of the sponsoring organfa11tion, and the ethical standards applied should be 11() lt-ss stringent than they would be for research cnrried out in that country" (WHO, 2002).

Yet, there are sometimes moral re11so1is for seeking countries with fewer thim researchers' own. For instance, if regulations in nmiarchcrs' home countries restrict research ors1mi1.ations from pursuing treatments that, to the best csti11:11ltt1 ofthc researchers, present no foreseeable d1mg1.1i't ·tc tr.at n1bjects, and in some cases makes them···. betl!fl' pursuing this research in countries wl.t11out thb i'eitriction may be in the moral of'AU in\!tflwd.

4 78 Jamie Cnrlln W1t11C)it

Nevertheless, when strong profit motives and esteemed faculty positions are on the line, researchers can be tempted to ignore moral considerations. We are all tempted to cut corners when we think it is in our long-term interests, and when medical researchers cut corners, wrongful exploitation is one likely result (recall the infamous Tuskegee Syphilis Study). Emanuel et al. (2004) write that, in developing coun- tries, "the regulatory infrastructures and independent oversight processes that might minimize the risk of exploitation may be less well established, less supported financially, and less effective in developing countries." But is there any evidence that interna- tional clinical trials are actually wrongfully exploit- ative? In the next three sections, I offer evidence that it is highly likely that any particular international clinical trial-particularly those conducted in unde- veloped or developing countries-is wrongfully exploitative. To be sure, I do not argue that interna- tional clinical trials are inherently wrongfully exploit- ative.There seems nothing inherent in the construction or implementation of a randomized experimental study that undermines a subject's autonomy or ratio- nality in a way that meets MWE. If researchers are sensitive to linguistic, cultural, and moral boundaries when entering into a morally binding contract with a test subject, and subjects have a reasonable ability to refuse to participate, researchers are lowering likelihood that anyone stands an unreasonable risk or losing something of fundamental value.

Problems with Obtaining Informed Consent in Developing Countries

Informed consent is a psychological state of a subject, in which (1) she understands the nature risks of the experiment in which she is being asked tq participate, and (2) she agrees to participate. The cess of obtaining informed consent typically a written or oral explanation of the experiment its potential benefits and risks by a researcher to patient who the researcher believes mentally cor petent to understand and assent to morally bin contracts. Obtaining genuine informed consent stitutes a necessary (though not sufficient) condi for determining whether a subject stands a URLV.

f ' i !' r 1

(

c

,fit motives and e line, researchers onsiderations. We i we think it is in iedical researchers s orie likely result Syphilis Study). developing coun- and independent

tinimize the risk l established, less tive in developing ,nce that interna- rongfully exploit- yffer evidence that :ular international inducted in unde- =s-is wrongfully ,rgue that interna- rrongfully exploit- in the construction ized experimental mtonomy or ratio- . If researchers are l moral boundaries .ing contract with a =asonable ability to

are lowering the i.nreasonable risk of value.

nforroed untries

gical state of a test ands the nature and she is being asked to Jarticipate. The pro- :nt typically involves the experiment and 'Y a researcher to a eves mentally com-

to morally binding ormed consent con- sufficient) condition :t stands a URLV If a

subject is not in a pos1t10n to genuinely consent, either by lack of physical or mental capacity, or because complete information is withheld or biased, then in offering her admittance to the study, researchers are situating her such that she cannot rea- sonably refuse to participate, and thereby wrongfully exploiting her. Note that "genuine consent" here is a matter not of being able to volunteer or sign a consent form but of having the ability to assess the personal risk involved in participating. There are at least three obstacles to obtaining genuinely informed consent in any particular international clinical trial.

Conceptual obstacles to genuine consent Ruth Macklin (1999, pp. 86-108) highlights the fact that people will often confuse iriformed consent with the informed consent documentation itself. Macklin cites an example from a workshop she attended in the Philippines, where a doctor objected to informed consent on the grounds that, " ... in the Philippines patients place great trust in their physicians. Doctors do not need to protect themselves against lawsuits by having patients sign a consent form." She then notes: "The Filipino physician misunderstood two things: first, the ethical basis for informed consent; and sec- ond, the difference between the process of informing and obtaining ... the piece of paper ... "If physicians and medical researchers are misinformed about the moral justification of informed consent, or are simply lazy in their consideration of their subjects, the likelihood rises that patients and test subjects will be placed in a position where they stand a URLV

Cultural and institutional obstacles to genuine consent Even in cases where a complex medical concept or procedure can be explained in a way sufficient for a subject's understanding, there may be cultural mores

. that inhibit an accurate assessment of procedure options, or reduce a subject to unreasonable treatment

''3 , :t>ptions. What counts as a significant likelihood of ,harm to a researcher from Great Britain may not :sound so daunting to someone who lives under

constant threat of poisonous snake bite, malaria, or gunfire from warring tribes. To someone from a culture that values large families, the threat of impo- tence may be more significant than the threat of prolonged illness. Out of ignorance or a concern for efficiency, researchers may ignore these considerations altogether (for further examples, see Bagenda & Musoke-Mudido, 1997).

In addition, knowing exactly which cultural features will help a test subject make an informed decision about whether to participate is difficult. Torbjorn Tannsjo (1994) explains how a subject's reli- gious commitments can limit the treatment options to which he can reasonably consent: "The doctor should, for example, not force a blood transfusion upon a patient who for religious reasons refuses to accept it, even if it means that patient dies. But the latter is objectionable; it conforms to no reasonable rule of thumb in our medical practice. The doctor should not, ifhe can avoid it, put his religious patient in a situation where the patient needs a blood transfu- sion, if he knows the patient will reject it" (p. 528). A researcher must be aware of the patient's cultural background in order to take these sorts of commit- ments into consideration. And while this may be somewhat easier in countries relatively homogeneous with the researchers', it is certainly more difficult in cultures where a rich religious or social heritage determines much of what constitutes acceptable behavior.

In addition, in less politically stable countries like Mexico, Uganda, and Egypt, exaggerated perceptions of medical professionals and corrupt courts allow little opportunity for challenging medical and research practices. Patients are politically and culturally encour- aged to feel at the mercy of the medical community. Macklin interviewed an Egyptian doctor, who explained that "in Egypt there is no process by which consent is obtained in clinical practice.... Patients who ask questions are viewed by doctors as 'impolite,' and ih any case doctors do not like to answer ques- tions posed by patients" (1996, p. 665). She also spoke with a Mexican colleague, who explained that Mexico does not officially recognize patients' rights, and that the Mexican people · are much more tolerant of corruption in political and legal spheres (p. 666). These cultural tendencies clearly extend to medical

Clinical Trials Are Inherently Exploitative 4 79

research cases, where researchers are perceived as physicians offering a remedy for their suffering.

If a researcher is unaware of cultural distinctives that make some treatments an unreasonable option to a particular subject or if subjects implicitly trust anyone they perceive to be medical professionals, the likelihood of obtaining genuinely informed con- sent is low, and therefore, the likelihood of wrongful exploitation is high.

Urgency obstacles to genuine consent The severity of a potential test subject's disease raises concerns about exploitation in all types of clinical trials. Sherlock (1986) and Cassell et al. (2001) argue that a subject's illness may diminish her ability to reason clearly about her medical decisions. But given MWE, simply facing a life-threatening disease may undermine her ability to reasonably refuse to partici- pate in a clinical trial relevant to treating that disease.

Consider, again, Valdman's Antidote Case. The fact thiit B's life is on the line places B in a position such that he cannot reasonably refuse any request A may make in return for the antidote. Many international clinical trials are designed to discover treatments for or preventions of life-threatening diseases, including HIV, AIDS, malaria, and tuberculosis. If any of these diseases constitute a threat to something of fundamental value, subjects may not be a position to reasonably refuse the risks offered by an experimental treatment. In being faced with the opportunity to participate in a clinical trial, a person may rightly perceive her options to be: (a) do not participate and die, or (b) participate and gamble on obtaining a better quality of life or dying. If a researcher under- stands this, she may be able to avoid placing a subject in a position where he stands a URLV. If not, the risk of meeting the conditions for MWE increases.

The Possibility of Misapplied Moral Theories A second line of evidence showing that international clinical trials are wrongfully exploitative is the possi- bility that moral theories are misapplied in the context

480 Jamie Carlin Watson

of nondomestic trials. While moral philosophy is more visible in the field of medical research than ever before, researchers in developed domestic contexts may comfortably rely on the regulations and guide- lines of their country of origin to protect them from moral failure. Once out of these contexts, researchers are presented with the opportunity to question those regulations and to make independent, morally significant decisions. For researchers who have a grasp of sophisticated models of moral reasoning, this situation is less . worrisome. But for those who are largely ignorant of moral philosophy, making such decisions can have devastating implications.

Take, for example, an attempt to apply consequen- tialism to the question of how to conduct a clinical trial. Consequentialism is the normative moral theory that the consequences of an action determine whether that act is permissible, impermissible, obligatory, or supererogatory. Rule utilitarianism-as opposed to act utilitarianism, according to which an act is morally obligatory if the consequences of that particular action increase the overall happiness of all involved- is, in its most general formulation, the consequentialist view that an act is morally obligatory if it is the result of a principle of reasoning that, in general, leads to greater overall happiness, where overall happiness is defined as the most pleasure for the largest number of people over the longest amount of time, and where pleasure includes both sensual pleasure and deep faction. For instance, in the standard trolley dilemma, five people are stuck on one trolley track, and one person is stuck on a side track; you, as the conductor, face the mutually exclusive options of doing nothi and allowing the trolley to kill the five people and changing the track so that the trolley kills only o person. According to standard accounts of rule u tarianism, you have an obligation to change the tr Performing the action increases the happiness of five and decreases the happiness of the one (plus Y' for having to participate in such a horrifying e thereby increasing overall happiness.

Now, in contrast to very general formulatio the theory, which are subject to damning cou examples, sophisticated versions of rule utilitar · often yield intuitively satisfying results. Sophis rule utilitarianism offers powerful explanatio our intuitions about the "rightness" of helpii\:

i j

. poor and hungry, and for our desire that a certain J.oral philosophy

15 minimum amount of healthcare is available to

al Ch than ever hi . d ·1· . resear everyone. Some sop stJ.cate ut1 itanans even argue d Stic contexts h . h ail d . . h 'mil l lide- that t eII_t _eo11'. .ent s ec1s10ns very s1 ar,

mlations and gt if not indisti.ngrnshable, from soph1st1cated deontolog- protect them from ical theories (Railton, 1988). But many who come

esearchers · h d contexts, r away from basic courses in moral ph1losop y o not ity to question thoallse grasp the subtleties of sophisticated versions of moral

d nt mor Y · · h al .depen e ' theories. They often come away wit very gener iers who have a grahis? views that sound more like Sunday School ethics ilian

. t s ioral reasomng, serious moral philosophy. t for those who Unfortunately, however, on the basis of quite osophy, making sue unsophisticated versions of utilitarianism, many nplications. medical researchers defend "paternalistic" policies in

ly consequen- h di hi h " .c: • 1 : to app . . al : medical researc , accor ng to w c pro1ess10na s nduct a clime ' h · k I d f d' · h .c: to co . t ave a superior now e ge o me icme; t ere1ore,

· moral theory ' · il d b f h · >rmative . whether I iliey and ?nv ege '. ecause _o . t eII ::in r l long and specialized trammg, to decide what is m the nissible, obhgatory,

0 } best interest of patients and their families" (Thiroux &

Posed to act ' . 1 h ,m-as op all ; K.rasemann, 2D07, p. 342). Consider, for examp e, t at . t is mor y j h 1 ich an ac . ul j Susan Dodds and Karen Jones (1989) argue t at aw- ;es of that. partlc d ar makers are in a better position than a mother to · of all mvolve d 'd h · · h ' b · "C 'nl >mess . ali ;1 ec1 e w at is m a mot er s est mterests: ertal y,

)n, the consequent! slt it would be paternalistic to interfere with a woman's Tt is the resu t .

[gatory 1 1 ds choice to become a surrogate moilier, but this does Lat, in general, not mean that it must be wrong to do so" (p. 101, italics

ll h ppmess 1s · overa a b f theirs). Similarly, Laura Purdy (1996, pp. 39-49) argues

>r the largest num ehr 0

that doctors are better able to assess wheilier citizens f . and w ere . mt o ume, . have a right to reproduce than the potential parents:

d deep satls- pleasure an . a " .... it is morally wrong to reproduce when we know andard trolley d1lemrn ' there is a high risk of transmitting a serious disease or

k and one ! trolley trac ' d defect. This thesis ... denies that people should be free

the con uctor, ,, h" c.; you, as . hin to reproduce mindless of the consequences. In is

· of domg not g · all · · · "Ii · will " ptions d f . _.-case agamst owmg patients to sign · vmg s, h fi People an o . ··.. "d h ll t e ve · -. ·.Christopher James Ryan (1996) cites ev1 ence t at:

ll kills only one . ' · . :ie tro ey til" :: ·. bemgs are, I suggest, very poor at deter- d accounts of rule u '::;;mining their attitudes to treatment for some hypo- tion to future te_rminal and vei: frequently i.ses the happi . "_·_· . __ _"". _ ssly_ under-estimate ilieII future desire to go on (pl our · .,_ · of ilie one us y :; <11. ,, (p 99) ess . t" ... _,_, :Jj.ilg . .

h h rifying even -r ••(c.Jf•·•"• . . 1. · · sue a or ? all of these cases, the underlymg imp 1cat10n 1s ppiness. ulations ·r·.Jr:As an expert in medicine, I know how to

general · '.the risk of procedure X better than my patient/ to ;; · \aubject, and regardless of any particular negative

f ule utilitanams "' ·c,,_ -·. • • la . I b" ions o r . . · ··equences to this particu r patient test su · ults Sophisucat ··· · ff · th 1 A d ying res · . < . people will be better o m e ong run .. n owerful f ft also seems dear how each of these claims could rightness" of helping ·.

lead to clinical circumstances meeting MWE. Researchers restrict the options a test subject is per- mitted to choose from on the basis of unreflective utility calculations.

To be sure, a researcher's utility calculations may, in fact, be more accurate ilian a test subject's. But at least two factors challenge the plausibility of this claim for any clinical context. First, the difficulty already mentioned with cultural obstacles is relevant here. If a researcher does not know what a subject values, then regardless of how accurate her calculations on the information she has, she does not have all the relevant information. Carl Elliott (2003) describes a growing phenomenon of people who desire to have healthy limbs amputated. Although some anecdotal evidence suggests iliat this desire is not different from desires for cosmetic surgery or trans-gender operations, the medical community stigmatizes this desire as a disease, and seeks to ban it.Yet Elliott points out that the same reasons given for categorizing this desire as a "psy- cho-sexual disease" were also offered against gender modification, which is now largely viewed as elective surgery.

The question is: Who 1s m the best position to determine what is in a subject's best interests? Researchers can make informed judgments about treatments and outcomes, but subjects know their values. Therefore, presumably, researchers and test subjects must communicate in an atmosphere of mutual respect. Thus, any utilitarian calculation that does not take subjects' personal value assessments into consideration is likely to place those subjects at risk in ways they could not genuinely consent to accept and, ilierefore, is more likely to exploit iliem for what researchers take to be the greater good.

A second challenge to the idea that researchers are better suited to calculate ilie risks ilian test subjects is that there is no objective standard for calculating utility in complicated medical cases. This becomes clear when we look at cases where utilitarian calcula- tions differ among professionals.For example,Torbji:irn Tannsji:i (1994) cites a clinical trial for which he was asked to be an ethical advisor. Researchers were attempting to detennine wheilier a new drug, ddI, is as effective at postponing the time it takes for an HIV-positive patient to develop AIDS than the most effective drug at the time, zidovudine. At the outset,

Clinical Trials Are Inherently Exploitative 481

there was no reason to believe that ddI alone was more or less effective than zidovudine alone, there was some evidence available that the combination of the two was more effective than zidovudine alone, and there was also evidence that about one in 500 patients who took ddI died because it seems to cause a fatal form of pancreatitis. Subjects entering the new trial were assigned to one of three groups: the first third received zidovudine only, the second third received ddI only, and the third group alternated between the two drugs.

After calculating what researchers took to be the relevant considerations, Tannsji::i concluded: "Given our assumptions, it turned out that, if a patient in the third category, who alternated between the two drugs, gained on average more than, roughly, one week of life without too serious symptoms of AIDS, it would be rational to volunteer" (p. 19). Unfortunately, however, not every consequentialist agreed with this conclusion. Some critics objected on the basis of a calculation principle used by insur- ance companies, which starts from a baseline assumption about which risks "just aren't worth taking" (p. 19):

A company selling insurance does not sell if it means that, should the worse come to the worst (no matter how improbable this is), the company would go bank- rupt. Only after such alternatives have been eliminated is the company prepared to maximize expected utility. By the same token, these doctors argued, we ought not to try a new drug, even if it offers good hope of prolonging (somewhat) the life of a patient if, at the same time, there is a not negligible probability that it will end at once. (pp. 19-20)

Which utility calculation is morally best? It is not the case that both conclusions avoid placing a test subject in a position where he stands a URLV, since they have vastly different implications, and it is possible that nei- ther will.What is the solution? l)rcsumably, a rejection of this sort of paternalistic model of decision-making. Even John Stuart Mill (1859/2002), the most out- spoken proponent of utilitarianism, admits that such a calculus is implausible and l\tgues · that attempts to protect test subjects from thei:nselves are wrong- headed. It would seem tlm this implication applies

482 Jamie Culln Wat1on

mutatis mutandis to all unsophisticated versions of plausible moral theories, especially those that include no obvious method for resolving conflicts among values. And if the number of researchers reasoning from these unsophisticated theories is nontrivial, then the likelihood that international clinical trials are wrongfully exploitative increases.

The Weakness of Human Moral Motivation and Interpretation

The final line of evidence is simply the weakness of human nature. All of us, from medical researchers to moral philosophers, are not always motivated to act morally. This is not to say we are bad people; it simply means that we tend to allow nonmoral motives to take priority over moral considerations. Consider a series of 16 drug trials in which researchers wanted to evaluate the effectiveness of new, less expensive treat- ments for reducing the transmission of HIV from mother to infants during labor, as compared with an accepted and effective but expensive treatment called the ACTG 076 intervention treatment (Lurie & Wolfe, 1997). The question arose as to how to test the effectiveness of these less expensive treatments: inde- pendently, against placebo groups, or in comparison with groups being treated with the known and effec- tive ACTG 076 regimen.

Researchers, along with the NIH, CDC, and WHO, cite two reasons for preferring the placebo-controlled trials over the nonplacebo equivalency studies. First, they claim that "differences in the duration and route of administration of antiretroviral agents in the shorter regimens, as compared with the ACTG 076 regimen,,, justify the use of a placebo group" (p. 535). Second, they claim that placebo-controlled trials "requ· fewer subjects than equivalency studies and can the fore be completed more rapidly" (p. 536).

Note that both reasons are efficiency consideratio placebo-controlled trials allow researchers more ace rate information about the shorter regimen tr ments in less time. But efficiency consideration not obviously outweigh moral considerations. In if only the placebo-controlled trials are offere potential test subjects, it would seem that these t meet the conditions for MWE.

1ersions of iat include cts among

reasoning rivial, then

trials are

\Teakness of earchers to ated to act le; it simply motives to Consider a s wanted to :nsive treat- HIV from

red with an ment called : (Lurie & v to test the nents: inde- companson n and effec-

:,andWHO, )-controlled tudies. First, m and route 1 the shorter ,76 regimen, 35). Second, als "require ,d can there-

nsiderations: ; more accu-

treat- derations do tions. In fact, e offered to tt these trials

A thought experiment for dett•rtni11ing whether this is, in fact, a case of wrongful exploitation is to imagine confronting potential test subjects with a choice between the placebo- :md nonplacebo- controlled designs. Ifit is conceivable that one person could reasonably conclude that the overall potential benefits of the nonplacebo-controlled trial outweigh the overall potential benefits of the placebo-controlled trial, then in offering only one of the experimental designs, researchers are subjecting subjects to a URLV Lurie and Wolfe (1997) discovered this to be the case in 15 of the 16 trials conducted in developing countries.

The Argument

With MWE and three lines of evidence highlighting the difficulties in developing countries of offering contracts to participate in medical research that present a reasonable opportunity for refusal, we can formulate the following argument:

1. MWE occurs when an act by a morally compe- tent person or group of persons, A, employs the behavior of a moral subject, B, in successfully obtaining A's ends under circumstances in which B stands an unreasonable risk oflosing something of fundamental value to B.

2. Problems with informed consent, the prevalence of misapplied moral theories, and the weakness of human moral motivation make it highly likely that clinical researchers in developing countries employ test subjects' behavior in obtaining their ends under circumstances in which B stands an unreasonable risk of losing something of fundamental value.

3. Therefore, it is highly likely that any particular international clinical trial is wrongfully exploitative.

Conclusions

I have offered a set of minimally necessary and sufficient conditions for wrongful exploitation and argued that three considerations render it likely that any particular

international trial is wrongfully exploitative. The burden is, therefore, on medical researchers trials in developing countries to provide evidence that their experimental designs avoid meeting the condi- tions of MWE. How might we encourage this behavior? The most common response is to introduce more and stricter regulations. But as economists consistently warn, this is almost always an inefficient option; the costs of establishing such regulation are high; the regulation is, by necessity, restricted to its country of origin; and clever lawyers can always discover myriad loopholes. Instead, I suggest two more plausible options: more comprehensive moral edu- cation and freer economic markets.

To efficiently reduce wrongful exploitation, philosophers should encourage better moral educa- tion in secondary schools and more exposure to moral philosophy in college (the International Society for Ethics Across the Curriculum program is a good example of the latter). In addition to expanded moral education, philosophers should not shy away from emphasizing individual rights and personal responsi- bility among patients, medical professionals, and legal organizations in public and political arenas. Just as informed dialogue has moved us away from racism, sexism, and even animal cruelty, so it has the potential to reduce the likelihood of wrongful exploitation committed by medical researchers.

In addition, a renewed public emphasis on individual rights and personal responsibility will encouragy fewer governmental regulations on exchanges of value among free people. Removing policies against the sale of insurance across state lines and restrictions on access to nondomestic pharma- ceuticals will prevent collusion and increase compe- tition among economically powerful entities, reduce costs, and increase access. These changes have the potential to reduce significantly the number of opportunities for wrongful exploitation. In addition, fewer restrictive policies will lead to clarity and sim- plicity in legal proceedings, making corruption easier to eliminate. No amount of well-intended coercion can stamp out immoral activity in any con- text. But freer markets and better access to fair legal reparations will reduce the number and severity of incidents, and, consequently, increase our confidence in the research results.

Clinical Trials Are Inherently Exploitative 483

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Chapter Thirty

International Clinical Trials Are Not Inherently Exploitative

Richard J Arrieson

The act consequentialist holds that one morally ought always to choose the act or policy of those available that would bring about the best outcome. In this chapter, I argue from an act-consequentialist standpoint that international clinical trials have no inherent tendency to be exploitative. They might be, but need not be. My account delivers a principled way of deciding whether fair labor standards or international regulations fixing standards of fairness for clinical trials in poor countries are morally acceptable or not.

Introduction

Corporations that sell prescription drugs for medical treatment have an interest in developing new products for sale. To be able to sell a patented medical prescription drug legally, the company must be able to adduce evi- dence of the safety and efficacy of the new drug for its proposed use. Scientific studies are needed.

There are reasons to carry out these studies in poor countries. If the incidence of the disease of interest to us is much greater in a poor country than in affluent countries, testing a remedy for that disease may be much easier in the poor country, simply because it is easier there to find a sufficient number of cases to treat with the remedy whose efficacy we are trying to determine.Another consideration is that the legal reg-

ulations governing clinical trials may be far more .'extensive and demanding in a rich country than in a

or country, so the cost of compliance with such gulations is much less in the latter setting. Questions arise regarding the moral acceptability of :cursions of profit-seeking companies into poor

countries to conduct clinical trials. Here are two examples (one imaginary) to illustrate salient concerns:

1. Company Z has dispatched a team of medical doctors and staff to a remote rural region in the hinterlands of a poor country. By virtue of its ele- vation· above sea level, the region happens to be an ideal site on which to carry out a clinical trial testing the efficacy of a drug the company is interested in marketing. The test will take a year to complete, and the terms on which the test will be conducted are, let us stipulate, generous and fair to volunteer participants in the study and to inhabitants of the region in which the study is to occur. The hitch is that cultural barriers preclude genuine informed consent on the part of each participant in the study. The villagers have had only slight contact with medical doctors, and the ideas of a doctor being an experimentalist rather than a clinician and of performing a double-blind controlled experiment as opposed to other types

rmporary Debates in Bioethics, First Edition. Edited by Arthur L. Caplan and Robert Arp . .. 2014 John Wiley & Sons, Inc. Published 2014 by John Wiley & Sons, Inc.

are simply alien to them. It is possible to induce potential participants to sign the informed con- sent papers, but genuine informed consent to the procedure being undertaken is not achievable. The medical team makes do by consulting with the village chieftain, who has a reputation for integrity and statesmanship, and who clearly understands the nature of the clinical trial being proposed and negotiates shrewdly on. behalf of the experimental participants and the region as a whole. She agrees to the deal, and following her lead, others cooperate, but the fact remains that the experimental procedure is going forward without obtaining the informed consent of the experimental subjects.

2. In 2000, a private US drug company, Discovery Labs,. proposed to conduct a double-blind, randomized, placebo-controlled trial testing its potential new treatment for respiratory distress syndrome (RDS) in 650 premature infants in Bolivia showing symptoms of RDS (see Hawkins & Emanuel, 2008, ch. 2). RDS is a common cause of fatality in premature infants worldwide. There are treatments involving administration of surfactin-a protein that helps weak infant lungs to function-that signifi- cantly reduce the risk of death from RDS. These treatments are commonly used in affluent coun- tries but too expensive for general use in poor countries including Bolivia.

Discovery Labs calculated it was unclear that a test of Surfaxin versus the best currently approved surfactant treatment would yield a result that would clear the way to Food and Drug Administration (FDA) approval to market Surfaxin. However, a successful clinical trial showing that Surfaxin was an effective treatment by comparison with administration of a placebo would likely yield approval to market. Suppose Surfaxin is tested against the current approved surfactant medication in what is called an active-controlled trial. lt1 a double-blind setting, some research 5urfactants are randomly assigned to get the standard treatment and some Surfaxin. If the tcm does not yield the result that Surfaxin is tu the standard treatment, approval to m:lrkct may be denied.

486 Rh:ho.rdJ. Arnuon

If, instead, Surfaxin is tested against a placebo and proves efficacious in that test, the likelihood of gaining FDA approval, Discovery Labs judges, will be greater than if the active-control trial were run instead and yielded an ambiguous result. Notice that in conducting a placebo-controlled trial, the exper- imenters can be viewed as declining to rescue the sick infants who happen to be assigned the placebo treatment (because they could have been given the standard remedy in the active-controlled alternative trial). Such a study could not legally be performed in a developed country, where legal rules forbid pla- cebo-controlled tests of drugs proposed for treatment of a disease condition for which there is already an established efficacious treatment.

Giving the placebo when the normal standard of clinical care requires administration of an approved treatment violates the ethical duty of the doctor to the patient involved in the trial. However, though surfactant treatments are approved for use in poor countries including Bolivia, they are far too expensive to be standardly used in , treatment of premature infants except those born into wealthy families. So, in conducting a placebo-controlled trial in Bolivia, Discovery Labs would be administering a nontreat- ment (a placebo) to infants at risk of dying from RDS when there is a known efficacious treatment for the condition, albeit one that is not part of standard medical care in Bolivia and not one that any of these infants in the rural region would have received in the normal course of events if the clinical trial had not been conducted.

Each parent could regard enrolling her sick child in the placebo-controlled trial as gaining a lottery ticket that will pay off if the child gets the nonplacebo treatment and will leave him no worse off if he gets the placebo. (This statement needs to be qualified, because it is possible that the new treatment being tested is actually harmful. But an efficacy trial of sort is preceded by safety trials that are supposed eliminate this risk.)

In the event, the clinical trial had gone forwa and had been successful, the drug Surfaxin approw · for treatment for RDS would be too expensive to affordable for any except a wealthy elite of Bolivi families. The benefits, if any, would accrue Discovery Labs and perhaps to infants with RDS·

ebo and 1ood of ges, will vere run ·tice that e exper- scue the placebo

;iven the ternative

rbid pla- reatment [ready an

mdard of approved doctor to r, though : in poor expensive Jremature lies. So, in 1 Bolivia, nontreat- iorn RDS '.nt for the f standard 1y of these ived in the al had not

ck child in ttery ticket ionplacebo f ifhe gets e qualified, nent being trial of this upposed to

wealthy nations. In these circumstatlccs, was the Surfaxin trial as proposed exploitative in its dealings with Bolivian children enrolled in the study and their parents? Might terms be arranged that would render the proposed clinical trial fair and overall morally acceptable to conduct?

In these examples, the practices of the pharmaceu- tical corporation enterprises appear morally troubling. The practices are morally problematic at best and morally beyond the pale according to some plausible standards of ethical practice.

Are international clinical medical trials inherently exploitative or overwhelmingly likely to be so? Here are two arguments:

1. A distinguished scholar of law and medical ethics, George Annas, once observed, "I'd argue that you can't do studies ethically in a country where there is no basic healthcare.You can tell a person that this is research, but they hear they have a chance to get care or else refuse their only good chance at care. How can you put them in that position and then say they are giving informed consent?" (cited from Hawkins & Emanuel, 2008, p. 7). But one can voluntarily consent to an offer that one cannot reasonably refuse. I can voluntarily and indeed wholeheartedly consent to a marriage offer from Ted, even though I have no other offers, and continued bachelorhood would be, for me, an utter disaster. In this situation, Ted might drive a hard bargain, but his own aims and values, or cultural norms, or legal regulation of marriage contracts might inhibit him from doing that.

Along similar lines, I would urge that where informed consent really is beyond reach, because subjects cannot comprehend the contract that is being

i· offered, nothing inherently precludes proxy consent from working effectively to safeguard the interests of dlese subjects. In my example above, the political •ystem with its checks and balances operating in the . lage, or the virtue and wisdom of the chieftain, may

bring it about that she acts effectively as a trustee, .d that this is manifest to the agents of the company nducting the research, so the study can be done

out wrongfully exploiting participants. he claim I am making is that voluntary mied consent can be given when the person enting lacks other options, and anyway voluntary .

_rmed consent is not a necessary condition for the

moral acceptability of conducting medical research. But neither is voluntary informed consent to an interaction a sufficient condition of its moral acceptability.

2. One can give voluntary informed consent to a wrongfully exploitative deal. The consent neither extinguishes the exploitation nor renders it morally acceptable.There can be mutually beneficial exploita- tion where the victim voluntarily consents to the deal. Assume, as is plausible, that when large medical corporations undertake medical experiments on willing research subjects in poor countries, the deals struck will not take place in a competitive market setting, with many buyers and many sellers of the service being sold. The large corporation will have considerable bargaining power. On this setting, is an unfair deal in which the large company gouges the poor individuals who serve as its research subjects virtually inevitable?

No. Without relying on the conscience of profit- maximizing corporations, one can locate and seek to enhance other mechanisms of restraint. Customers of the medical firm can threaten to boycott its products if it engages in sleazy deals that take milk from the mouths of hungry babes in third-world countries. International ethical guidelines can be promulgated and enforced by treaty or international regulatory bodies or aggressive jawboning by nongovernmental organizations such as Doctors Without Borders. Media campaigns in host countries can target abusers of the weak and vulnerable. Governments in poor countries can establish regulations that offset the undeniable bargaining advantages of powerful corpo- rations. Nothing guarantees that any such mechanism or combination of them will succeed, but nothing guarantees failure either. It all depends.

The remainder of this chapter does not pursue the question, what are the best mechanisms of restraint of exploitative gouging, and how can they be strengthened? The focus instead is on how to charac- terize exploitation and how to draw the line between morally acceptable and unacceptable deals. Mutually beneficial exploitation raises special concern. A trans- action can be mutually beneficial but unfair and hence morally condemnable. Surely, one morally ought not to engage in exploitive transactions. Surely one ought not to be an exploiter.

International Clinical Trials Are Not Inherently Exploitative 487

Three Puzzles

There is a puzzle lying just around the corner, the puzzle of discouraging exploitation. To keep things simple, let us confine our attention to cases of mutually beneficial exploitation in which all participating parties actually benefit ex post from the arrangement. All benefit, but some gain far less than others, and are unfairly treated. Suppose we condemn the exploitive behavior and try to discourage people from engaging in such interactions. We might enforce this condem- nation by making transactions of this type illegal and imposing criminal law penalties on exploiters. We might also enforce this condemnation by peer pressure, avoidance of interaction with the exploiter, shunning, shaming, and so .on. These efforts might be successful or unsuccessful at reducing the incidence of the targeted exploitive transactions: Let us suppose they are successful. This might occur by inducing some who were inclined to engage in exploitive transactions to interact with the same partners but on terms more favorable;: to those who would have been getting the short end of the stick.

But the reduction in incidence of exploitation might occur by inducing those inclined to exploit to )caw the market altogether or cease to interact on any terms with the potential targets of exploitation. As described, this outcome would seem to be in an obvious way morally desirable: we have achieved a reduction of mutually beneficial exploitation. But how can this be morally desirable? Absent our intro- duction of norms and rules against exploitation of this type, people would have made mutually beneficial deals, voluntary on the part of all participants. Some of these deals might have been to the enormous advantage of those getting the short end of the stick. The gains to the potential victims of e)Cploitation that are forgone by our decision to undertake a campaign against exploitation might be literally matters of life and death for these people. How can we thump our chests and take pride in our success in reducing the incidence of exploitation if we are thereby bringing about a state of affairs from which a change could be made that renders some significantly better off without making anyone at all worse offi Call this the significant Pareto improvement norm. (Formulating

488 Richard]. Arneson

the requirement as triggered by significant Pareto improvement blocks it from being deployed to criti- cize a practice that leads to a state of affairs that is trivially worse than an alternative practice would bring about.) A very plausible view maintains that while this Pareto norm is a very weak fairness con- straint, it is nonetheless a fairness constraint. It is unfair to embrace and implement policies that bring about outcomes that are vulnerable to the significant Pareto norm criticism. Such policies are unfair to those who might have been made better off without making anyone else worse off. Countenancing and accepting mutually beneficial exploitation thus appears to be both condemned by fairness norms and required by fairness norms.

There is another puzzle that lurks in discussions of the topic of exploitation. What exactly are we talking about? As is often noted, exploitation when used in a pejorative sense is a moralized notion. To exploit a person is to take unfair advantage of another person. In other words,. the exploiter seeks to advance her aims by using another person in a way that is unfair to that person. To understand how to abide by .a norm against exploiting people, it would seem that one needs a conception of unfairness that enables one to determine whether any given instance of interaction with other persons crosses the boundary into unfair- ness. One needs a standard that tells what constitutes fair treatment. Lacking such a standard, the person seeking to understand the nature of exploitation finds herself, so to speak, with a big hole at the center of the doughnut. But as Alan Wertheimer (1999), perhaps the preeminent contemporary theorist of exploita- tion, observes, "Unfortunately, there is no nonprob- lematic account of fair transactions." He does not make this observation as a prelude to proposing a definitive account. In the same essay from which the quotation just introduced was taken, Wertheimer observes, "Although I cannot produce a atic theory of fair transactions, I remain convinced that some mutually advantageous transactions are quite unfair and exploitative." Now, one can see hO' it might be useful for a language to contain terms th allow people with entirely opposed convictions an judgments to express judgments of approbation a11 disapprobation in some domain. Such terms are han devices. I do not need a theory of beauty to call

:t Pareto to criti-

rs that is e would ains that iess con- : is unfair ng about nt Pareto 10se who : making iccepting 1rs to be 1uired by

issions of re talking used in a exploit a :r person. ·ance her unfair to {a norm that one es one W tteractioll :o unfair .. onstitu te persoll tion fimh tter of tlw

painting or a scene beautiful, and you can understand my meaning even if you find the same scene revolting or obscenely ugly. The same goes with claims of exploitation. Nonetheless, it is disturbing that philosophical attempts to specify standards of fairness for determining when transactions are exploitative seem to have come up with empty pockets. Call this the no standards puzzle.

Another puzzle about exploitation that involves interaction between an agency based in an afiluent nation and poor people in poor countries might be called the irrelevant beneficiaries problem. In discussions of international clinical trials, the idea surfaces that a highly relevant consideration in determining whether proposed research in a poor country is exploitative or not is whether any medical treatment shown to be successful in the experiment will be made available at affordable rates to present or future members of the host country in which the experiment is conducted. The puzzle is this: If we are deciding whether A's treatment ofB is exploitative or not, how can whether or not benefits accrue to some third party C have any bearing on the question? Alan Wertheimer (1999) sensibly observes, "if the principles of medical ethics are primarily interested in the way in which patients or subjects are treated, I do not see why the avail- ability of drugs to other persons has much bearing on the ethical status of a study."

In this chapter, I shall propose a solution to the three puzzles about exploitation just characterized. The account I propose delivers the result that inter- national clinical trials such as the examples described at the outset of this chapter have no inherent ten- dency to be exploitative. They might be, but need

;· not be. Moreover, there is a general issue here. When ·• .n person in an afiluent developed nation buys · prescription drugs that have come to market · rough international clinical trials, she may be

tnplicit in exploitive practices, just as when a rscin in an affluent country buys cheap good-

ttality cars or clothes or computers manufactured road under conditions of labor that would not

tolerable in the affiuent country itself. My ount delivers a principled way of deciding ether fair labor standards or international regula- s fixing standards of fairness for cl.inical trials in r countries are morally acceptable or not.

Act Consequentialism and Priority

This chapter approaches the topic from a resolutely act-consequentialist standpoint. The act consequen- tialist holds that one morally ought always to choose the act or policy of those available that would bring about the best outcome. There are many varieties of act consequentialism-as many as there are different possible standards of outcome assessment. To give the act-consequentialist idea a fair hearing, one must couple it to the most plausible standard of outcome assessment we can identify. Searching for the best out- come standard is not a task this chapter can undertake. I shall simply adopt what strikes me as the most plau- sible standard and go from there. The standard relied on here is individualist and welfarist. What matters ultimately from the moral standpoint is the well-being of the complete lives of individual persons (Arneson, 1999, 2000). Good or bad that accrues to a collective such as a family or clan or race or nation does not have any intrinsic moral significance and matters only insofar as gains or losses to collectives are instrumental for achieving gains and avoiding losses that accrue to individual persons. What matters ultimately from the moral point of view is entirely a function of good lives for people, fairly distributed across people. The idea of fair distribution that figures in the standard to be employed is a simple prioritarianism: benefits matter more, the worse off in lifetime well-being is the person who would get the benefits (see Parfit, 1997; Holtug, 2010; and for the first statement of the prioritarian idea known to me, Scheffler, 1982). The characteriza- tion so far yields a family of views. To obtain a specific standard for outcome assessment, one would need to determine a priority weighting, a specification of how exactly the moral value of obtaining a benefit or obtaining a loss varies. with the size of the benefit, the number of people who would obtain it, and the life- time well-being these people are headed toward (apart from receipt of the benefit in question).

Multi-Level Consequentialism

It might seem obvious that a welfarist act consequen- tialism of the sort just sketched must bite the bullet in response to the puzzle of discouraging exploitation.

International Clinical Trials Are Not Inherently Exploitative 489

More well-being for a person is always better than none, so the prioritarian act consequentialist must embrace the Pareto norm and reject any principle that condemns mutually beneficial exploitation and thus runs afoul of the Pareto norm. For any variety of act consequentialism, half a loaf is better than none, and a crumb is better than no bread.

Not so, I say. The reasoning in the preceding para- graph gallops too fast.We need to take proper account of levels of moral reasoning. A plausible act conse- quentialism must be a multi-level doctrine (see Hare, 1981; Railton, 1988). Humans have limited cognitive abilities, tend to favor themselves and those near and dear to them in their choices, tend to choose term rewards over greater later gains, tend to be igno- rant or have false beliefs concerning matters germane to their choices, and generally have limited ability to integrate the facts they do know into their delibera- tions of what to do. Given these facts, humans will do better in choice-making and choice execution as assessed by the act-consequentialist standard if they do not use act consequentialism standardly as a guide to choice but instead guide their decision-making by fairly simple rules that do not make excessive demands on their deliberative capacities and on their capacity for making impartial choices.

This point applies when the issue is selection of legal rules. The same point applies when what is at issue is selection {more plausibly, influencing the content) of social norms (norms enforced by informal social sanctions rather than by legal procedures and penalties). I would contend that the same point applies when the issue is selection or alteration. of a public morality, a set of moral norms specifying moral rights and duties and obligations that is to. be promulgated as in some sense the official morality ofthe society.At all of these derived levels, the norms ideally should be selected according to the act-consequentialist stan- dard. The optimal set of norms is the one the intro- duction of which in the actual circunistances would do best in terms of promoting good consequences.

What one should do, according to act conse- is whatever would bring about best

consequences, and the norms in place will have an impact in determinit1g that-more so, the better the norms (assessed by the consequences of having them in place).

490 Richard].Arn••on .

Exploitation

This familiar account of multi-level act consequen- tialism has implications for the consequentialist treatment of issues of exploitation. Norms against exploitation are a good idea from the act-consequen- tialist standpoint. Enforcing them reduces gouging of excessively large profits in beneficial interactions and cooperative schemes. Deals recognized as exploitive will rankle and create resentment in those who get the short end of the stick, especially if they reliably get the worse of such deals. The resentment frays cooper- ation, from which we all benefit. Exploitive deals will also tend to score badly according to prioritarian assessment. Those who are headed for low lifetime well-being are more likely than others to be the exploited parties in these transactions. Actions and policies that improve the deals they are likely to get make the world morally better by prioritarian standards.

A hypothetical example may serve to illustrate tbt· points just made. Suppose that Medical, Inc. is willing to undertake a clinical trial of a product it wishes to test in a certain poor country on certain terms. The terms violate international standards covering such trials propounded by bodies including agencies of tlw United Nations, and following the lead of these inter" national guidelines, the would-be host-country government declares the proposed arrangement with Medical, Inc. to be exploitative and denies legal pQr':' 1 . mission for the clinical trial to be conducted as posed. Medical, Inc. decides it is unwilling to better terms and scraps the proposed study altogclh The clinical trial as proposed would have benefit• the volunteer participants, but only slightly.

Priority is likely to condemn the behavior Medical, Inc. as just described. Suppose that company is breaking off negotiations to send sage. The company's action is aimed to induce t. more favorable to it in future similar negotiatim us suppose this is a rational profit-maximizing on its part. But this does not show that the: R acceptable on prioritarian grounds. The c · surely could have pursued a different course that yields less profit for its well-off and shareholders, and creates greater gains Un'·

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people such as those who will be volunteer participants in its study. According to this version of act conse- quentialism, it is roughly the case that what the company morally ought to do is whatever would maximize priority-weighted aggregate well-being, which would surely be miles apart from the profit- maximizing strategy we are supposing it follows. This is "roughly the case," because. the question becomes, what each of the individuals who wield influence on company affairs ought to do. One might suspect that in a competitive business environment, if the company ceases to follow the path that yields it highest expected profits, it will make zero sales and immediately go bankrupt. Not so! Without raising the price it charges to consumers above the competitive price, the firm CEO could take a big pay cut and give more to vol- unteer medical-trial participants, and what the CEO could do, each person connected with the firm including shareholders could do, and according to priority calculation, likely ought to do.

Notice that showing that the members of Medical Inc. behave wrongly by the act-consequentialist stan- dard does not show that they are being exploitative or that the company policy is exploitative. Whether a policy is exploitative depends on whether it violates anti-exploitation social obligations that apply to it. The character of such obligations depends on what social norms are actually in place and accepted in the society. Even in a society that is ideally run according to act-consequentialist standards, for familiar reasons, the legal rules and social norms and public morality enforced will consist of rules that are less demanding and more administrable than the abstract. prioritarian principle. So, even in a society that was ideally run according to act-consequentialist principles, not every act or policy that fails to bring about the best attainable ;outcome {and so is wrong according to act conse-

will qualify as exploitative. It is of course .. o the case that not every act that violates extant

ms against exploitation will be wrong according ;act-consequentialist principles. Assessments of acts ;different levels of moral thinking can differ. (So,

etimes what one morally ought to do merits · dernnation and punishment.)

commonsense thinking, exploitation wrongs the on who is unfairly used, and is morally 1.maccept-

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particular victim. In contrast, in the consequentialist perspective, whether an act is right or wrong depends on its overall long-term consequences, including its impact on those remote in time or space who are affected, and importantly the effects it might have had on uninvolved persons who would have eajoyed gain or suffered loss had a different action been done instead. So, consequentialist thinking seems just ill- suited to explaining and justifying norms against exploitation, which are part of a different conceptual framework (see Arneson, 2008).

I resist the skepticism voiced in the preceding paragraph. To my mind, it just begs the question against the project of multi-level consequentialism. For starters, notice that any remotely credible view about deontological rules will have to allow that when the consequences of abiding by the rule are sufficiently bad, the rules should give way. So, for example, when it comes to exploitation, if the overall long-term consequences of what in a narrow view looks to be Tom's unfairly taking advantage of Randy are good enough, the presumption that what Tom is doing is morally wrong is overturned. Any sensible view will accept this idea. The question then arises, how do we decide when the offsetting good consequences are sufficient to remove an initial presumption of unfair wrongdoing? The con- sequentialist takes a plausible stance on this: we count effects on the well-being of all affected and possibly affected parties of any act one might do as having exactly the same weight, taking account of proper prioritarian adjustments to weight. This is of course a contestable position but not one that floats in the sky with no footing in commonsense convic- tion. (In passing, I note that perhaps there is a double priority: benefits are morally more valuable, the worse off in lifetime welfare the person to whom they accrue, and morally more valuable, the more deserving this person is (see Arneson, 2006).)

Suppose that I am in the back of a crowd with my young child trying to get a view of a passing parade. Seeing that you are wearing sturdy boots, I step on your toes and place my child on my shoul- ders to get a better view for my child. (I borrow this example from Darwall, 2006.) Or I murmur an apology and plop my child on your sturdy shoul- ders for the same purpose. You have a presumptive

International Clinical Trials Are Not Inherently Exploitative 491

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complaint against me-in the familiar idiom, I am using you unfairly to advance my ends, imposing costs on you by unilateral fiat. "Be reasonable," I might say to your complaint. Given the sturdiness of your boots and shoulders, any discomfort I impose on you is trivial, despite its being, strictly speaking, an assault, and my child will get enor- mous pleasure from seeing the (to him) wondrous passing show. You might still object that I should first ask your permission, but we can imagine that had I initiated negotiations of that sort, the parade would have passed before negotiations would have been completed and your fully voluntary consent forthcoming. And perhaps you are in a grouchy mood and would have refused consent.

The multi-level consequentialist assessment of this type of incident is complex. Establishing and sus- taining norms against assaulting persons (touching them without their consent) are surely justified by act utilitarian calculation. The same is true of norms against unilaterally imposing costs on another person in the course of advancing one's projects. Internalizing these norms oneself and training one's children and associates to internalize them are also likely justified acts from the act-consequentialist perspective. Having done that, we then find ourselves disposed to react negatively when people violate these norms, especially when we are in the victim role, and disposed to react negatively to the prospect of violating these norms ourselves. When this is so, thesereactions and their likely consequences are part of the input to act-consequentialist reasoning about what to do in the passing parade situation. In the actual situation, one will have uncertain information: How do I know your toes are not affiicted with painful gout? How do I know I am not inadvertently training my son to antisocial habits of thought? There are strong reasons, weighty in act- consequentialist calculation, for abiding by useful social rules that tend to promote fair resolution of conflicts of interest and· help sustain habits of mutually respectful cooperation in people generally. Nonetheless, all of that can be true, yet in the actual situation, taking all these considerations on board at their true weight, ·it still remaiits the case that the thing to do, the act that brings about the best out- come, is the exploitative act of stepping on your toes.

492 RichardJ.Arneson .:

Exploitation and the Three Puzzles

Adoption of the prioritarian principle enables us to resolve the puzzles about exploitation introduced at the start of this chapter and tells us how to resolve ques- tions about whether particular international clinical trials are exploitative and, if so, whether it would be morally desirable to prevent their occurrence.

Consider, for illustrative purposes, a very simple set of ethical guidelines forbidding exploitation in inter- national clinical trials:

1. If a rich-country business firm or nonprofit agency conducts medical experiments on people in poor countries, special standards apply.A sliding scale applies: the more impoverished the country, and the more impoverished particular persons who are to be research subjects, the more concern must be shown for the welfare of the particular research subjects and the broader community in the host country.

2. Medical experiments governed by these guide- lines are not to be conducted except on persons who give voluntary informed consent to the pro- cedures in which they are to be involved, unless there are intractable barriers to enabling the potential research subjects to achieve sufficient comprehension of the undertaking, in which case proxy consent by parents or guardians of childnm or accountable political leaders of adult citize118 may suffice, these consenting individuals to b1.1 trustees representing the interests of those on whose behalf they tender consent.

3. In no case may research go forward unless th is clear substantial ex ante overall benefit each participant, and no uncompensated loss ex post.

4. The research being conducted must pro substantial benefits to the local community the wider community of the host country which the research is conducted. If the outc of the research itself does not promise benefit, some form of substantial side paymo compensation must be made via indM payments or provision of collective benefit, special concern to benefit especially bad! members of the local and wider commu

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(These rules as stated are too vague to be admin- istrable, but we can imagine specifications of them that would be administrable, and that are altered to suit changing conditions.) We can ima- gine the rules as enforced by international treaties and international law, or instead as mandated as parts of human rights codes promoted by inter- national bodies such as the United Nations.

I shall suppose that some such guidelines in a given state of the world would yield sufficient benefit that it would be morally right to campaign for them and bring about their acceptance in the international community. Now, imagine a business firm that is wil- ling to undertake medical research in a poor country on terms that would elicit voluntary informed con- sent of all research subjects but that would fail to sat- isfy the ethical guidelines just stated. First, we can see that irrelevant beneficiaries is not a puzzle at all. Whether an act that impinges on person A should be regarded as unfair to A all things considered depends on the overall mix of benefits and losses the act generates. A bombing that kills some innocent bystanders is not unfair to those bystanders if the bombing is required to achieve a substantial objective in a just war, and the damage done to the bystanders is not disproportionate to the gains for the just-war cause that the bombing achieves. Whether a medical experiment that involves A as a research subject is fair to A all things considered can depend on the mix of benefits and losses the act achieves taking into account all of its effects and the effects of what might have been done instead.

Second, the puzzle bf discouraging exploitation also loses its sting when seen in the framework of multi- level consequentialism. We need to distinguish assess- 111ents of different types at different levels of moral thinking. The act of conducting a medical experiment i11 an impoverished country, achieving huge profit for

, the medical company and its well-off customers and .iardly any benefit that to its research subjects or to he wider community, is sure to be terribly wrong

CQrding to the priority principle. We are also sup- sing that the act of carrying forward this research as posed also violates the stipulated ethical guidelines made more specific for the times). So, conducting

research would be exploitative and should be tldemned. Note that simply doing a wrong act does

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not render one blameworthy or apt for condemnation (the shortfall between what one does and the best one might have done might be trivial). But doing an act with great shortfall from the best one might have done merits condemnation. Moreover, violating the extant accepted ethical guidelines (provided they are "good enough" as assessed by the prioritarian prin- ciple) is violating a social obligation and rendering oneself apt for blame and punishment.

But why forbid the exploitative act, given that, as described, allowing it makes some better off and no one worse off? Answer: we should consider not only the consequences of doing the act but the conse- quences of not forbidding it. If the ethical guidelines are good according to prioritarian assessment, then accepting and supporting them, and enforcing them, are very likely to be morally right acts. Discouraging mutually beneficial exploitation is morally right to do just in case it brings about better consequences by the priority standard than anything else one might instead have done. This condition can be met. So, there is nothing puzzling from an act-consequentialist stand- point, as to why we should sometimes act to dis- courage or squash mutually beneficial exploitation. Discouraging exploitation by following priority- · approved norms against exploitation either (1) actu- ally works to bring about the best attainable outcomes in the long run or (2) in some cases is itself morally wrong but an unavoidable side effect of pursuing the best-available strategy for bringing about the best- attainable outcomes.

If one asks how we can sensibly deploy norms against exploitation without being able to articulate a clear and compelling standard of fairness that fixes the content of those norms, priority has a ready and plau- sible answer. There are ideas of fairness that partially determine the act-consequentialist best-outcome standard. (In particular, priority to the worse off is a fairness idea.) Beyond that, given unavoidable features of the world we inhabit, the project of trying to live according to act consequentialism requires working with others to establish and sustain and improve legal rules, social norms, and a public morality of con- straints and options. A general deference on our part to such rules, checked by background allegiance to priority itself as fundamental, is the best we can do. These secondary norms and rules are not fixed once

International Clinical Trials Are Not Inherently Exploitative 493

and for all time; they surely should vary with changes in circumstances. What should strike hunter gatherers as fair and reasonable is different from what should strike twenty-first-century participants in democratic market societies as fair and reasonable. But within the idiom of fairness and justice itself, there will be no determinate answer to the question, what is really fair, and hence the no standards puzzle is only superficially puzzling.

Summary

Our ethical concerns about fairness should sweep widely. All effects of what we do and omit doing and might have done instead are relevant to determining whether an action or practice is exploitative. Norms against exploitation should be crafted, anq revised with changing circumstances, so that their operation brings about outcomes as morally good as we can obtain, with our fairness concerns incorporated in the standards for outcome assessment. In the regulation of dealings between rich countries and poor countries, long-term benefit to people whose lives will be going badly is a paramount concern. When interaction pro- duces a large surplus to be divided between wealthy- country company and poor-country people, we should aim to craft rules that channel as much of the surplus as can be squeezed to poor people. But we must avoid killing the geese that lay golden eggs, the geese here being mutually beneficial interaction bet- ween people in rich and poor countries. Our ethical principles should not be leading us to discourage wealthy corporations from setting up factories in poor countries that boost the economic development of poor countries, and for exactly the same reasons, we should eschew principles that would condemn inter- national clinical trials as inherently unjust or tending to injustice.

494 Richard]. Arneson

Proposed fundamental ethical principles that sound high-minded but that would lead us to condemn pol- icies that would produce better outcomes in the long run are a trap for the unwary. Prioritarian act conse- quentialism avoids the trap. This is a big point in its favor.

References

Arneson, R. (1999). Human flourishing versus desire satis- faction. Social Philosophy and Policy, 16, 113-142.

Arneson, R. (2000). Welfare should be the currency of justice. Canadian journal of Philosophy, 30, 477-524.

Arneson, R. (2006). Desert and equality. In N. Holtug & K. Lippert-Rasmussen (Eds.), Egalitarianism: New essays on the nature and value of equality (pp. 262-294). Oxford: Oxford University Press.

Arneson, R. (2008). Broadly utilitarian theories of exploita- tion and multinational clinical research. In J. Hawkins & E. Emanuel (Eds.), Exploitation and developing countries: T11c ethics of clinical research (pp. 142-174). Princeton, NJ: Princeton University Press.

Darwall, S. (2006). The second-person standpoint: Mora/ii)', respect, and accountability. Cambridge, MA: Harv,inl University Press.

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Hawkins, J., & Emanuel, E. (Eds.). (2008). Exploitation t1ilil developing countries: The ethics of clinical research. Prinn•ltifi;; NJ: Princeton University Press.

Holtug, N. (2010). Persons, interests, and justice. Oxfhrtt;: Oxford University Press.

Parfit, D. (1997), Equality and priority. Ratio, 10, 202 21 Railton, P. (1988). Alienation, consequentialism, :1111.I

demands of morality. In S. Scheffler (Ed.), Conseq11rntl and its critics (pp. 93-133). Oxford: Oxford Uni Press.

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