medical neoliberalism and pharma medical trials - fisher

8/3/2019 Medical Neoliberalism and Pharma Medical Trials - Fisher

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FISHER: COMING SOONTOA PHYSICIAN NEAR YOU

Coming Soon to a Physician Near

You: Medical Neoliberalism andPharmaceutical Clinical Trials

Jill A. Fisher, PhD

A woman and her son wait for thedoctor to see them. The doctor,

however, is no longer a clinician.Instead, the white male neurologist hastransitioned from treating patients to con-ducting clinical trials for the pharmaceu-tical industry. Running studies in diversetherapeutic areas, including Alzheimersdisease, arthritis, diabetes, gastrointestinaldisorders, and psychiatric illnesses, thisdoctor recruits and enrolls human subjects

in drug studies through mass media ad-vertisements. This physician is not alonein conducting pharmaceutical research ina research center converted from a privatepractice; pharmaceutical companies are in-creasingly contracting with private-sectorphysicians to conduct their studies. Clini-cal research responds to US federal regu-lations mandating that pharmaceutical

products be tested on human subjects toensure safety and effectiveness before theyare made available on the market. Thisphysician, like many others, has success-

fully established a company to profit fromthe regulations.

On this particular day in December2003, I am shadowing the doctor as partof an extended interview regarding hisinvolvement with pharmaceutical clini-cal trials. He has invited me to observehis interactions with human subjects andtheir families so that I will have a bettersense of his role. One of these interactionsis with the woman and her son. The hu-

man subject in this case is the son, a ten-year-old boy who is enrolled in a pediatricstudy to test the efficacy of a treatmentfor attention deficit hyperactivity disorder(ADHD). Because the purpose of this vis-it is to assess how well the investigationaltreatment is working to alleviate the symp-toms of ADHD, the doctor asks a seriesof questions that are primarily directed to

the mother. She explains that from herperspective her son seems to be noticeablymore mellow, but that she has concernsabout the drug because the boys teacher is

Jill A. Fisher, PhD, is Assistant Professor of Women & Gender Studies

at Arizona State University. She researches the organization of

pharmaceutical clinical trials, especially studies conducted in

private practices and for-profit research settings in the US. Her

book on the topic (Medical Research for Hire) will be published in

Spring 2008 by Rutgers University Press. For more information:

www.jillfisher.net


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still complaining about his disruptive be-havior in the classroom.

While the teachers impressions of theboys behavior could be construed as an-ecdotal or incidental to the clinical trial,they are of primary concern to the woman.This working-class family has no healthinsurance, so standard medical care is notan option for the woman to address hersons disruptive behavior in the classroom.Under pressure from her sons teacher, the

woman has turned to a clinical trial as ameans both to provide some sort of treat-ment for her son and to prove to the teach-er her own commitment to addressing theproblem.

The situation of neither the physiciannor the woman and her son is unique. Inthe past two decades, the pharmaceuticalindustry has reorganized the clinical test-

ing of its products. Currently, about 75%of studies in the US are conducted in theprivate sector by non-academic physicians

who recruit their own patients or local com-munity members into the drug studies.1Over 60,000 of these studies take place inthe US each year, accounting for 75% ofthe 80,000 clinical trials conducted world-

wide,2 at a recorded cost of $34 billionin 2003.3 To execute these studies, morethan 50,000 US physicians registered withthe Food and Drug Administration (FDA)as principal investigators on one or moreclinical trials in 2001.4 As for the humansubjects, 3.62 million Americans partici-pated in clinical trials in 2003 alone.5

Clinical Trials as Health

Care Solutions

The expansion of pharmaceutical clini-cal trials in the private sector can be seen

as addressing two problems in Americanhealth care: decreasing revenue for physi-

cians and decreasing access to health carefor patients. Physicians report diminish-ing income due to restrictive relationships

with insurers and government agencies,ever increasing malpractice insurancepremiums and inflated overhead coststo operate private practices. As a result,many physicians are attracted to phar-maceutical contract research because it is

perceived as a lucrative field. These physi-cians are hired as investigators to conductpredefined study protocols that have beendeveloped by scientists and project manag-ers at pharmaceutical companies. As con-tract investigators, they have no input onstudy design, inclusion-exclusion criteriadictating which human subjects can en-roll in the study, or interpretation of the

study results. The participation of thesephysicians instead involves following theinstructions of the pharmaceutical com-panies in administering the investigationalproduct, collecting the required data, andmonitoring the safety of human subjects.More importantly, participating physicianshave the right combination of financialmotivations and access to patients to makecontract research an excellent arrangementfor themselves and for the pharmaceuticalindustry. Thus, clinical research can nolonger be said to be the domain of eliteacademic physicians, but rather an activityin which many private practice physiciansroutinely engage.

Pharmaceutical clinical trials also serveto fill the health care gap in the US byproviding limited medical access to indi-

viduals who have no or inadequate healthinsurance. Clinical trials are frequentlymarketed to the general public as a wayto obtain free doctors visits, diagnos-


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tic tests, and medications. Not only doclinical trials promise access to the medi-

cal establishment, they also commonly of-fer stipends to encourage human subjectsparticipation. On one hand, pharmaceu-tical clinical trials can be seen as a servicefor individuals who have health problemsbut no other means of getting treatment orfor individuals who desire to supplementtheir incomes. On the other, pharmaceu-tical clinical trials can be seen as exacerbat-

ing and profiting from existing social andeconomic inequalities. The US, with itsgrowing number of uninsured citizens andindividuals and families living in poverty,provides fertile ground for recruitment ofsubjects into drug studies. Although clini-cal trials provide them with temporary ac-cess to medical treatments that they mightneed, these groups disproportionately bear

the burden of risk associated with clini-cal testing of investigational products andare the most unlikely to benefit long-termfrom advances in pharmaceutical medi-cine.

The high prevalence of uninsured Amer-icans in clinical trials is a trend of whichmost individuals working in the pharma-ceutical and clinical trials industries are

well aware. Outside of these industries, itis a phenomenon rarely discussed. For in-stance, there are very few scholarly or pop-ular press publications that focus on theethics of enrolling the uninsured in clinicaltrials.6,7 The lack of attention to the extentof uninsured Americans contributionsto clinical research may have two causes.First, no federal agency currently requiresthat data be collected about the insurance

status of subjects participating in clinicaltrials. One research team, however, thatcollected data on the insurance status oftheir participants found that uninsured

individuals were seven times more likelythan those with insurance to enroll in their

heart studies. Other research teams havestrategically recruited uninsured popula-tions to fill studies.8 For example, a groupof researchers found that through the pro-cess of direct solicitation, 96% of recruitedLatino immigrants a segment of the USpopulation that tends to have the least ac-cess to health care agreed to participatein their cancer control studies.9

A second factor contributing to lowlevels of awareness regarding the participa-tion of uninsured Americans in clinical tri-als could be that they participate in clinicaltrials other than those that usually attractthe most public attention. The bulk ofpopular press coverage of medical researchfocuses on cancer or HIV/AIDS clinicaltrials. Cancer studies, in particular, attract

a different demographic of participantsthan do clinical trials for other illnessesthat are not fatal or those that already havetreatments available on the market. Infact, some evidence suggests that becausecancer studies are likely to share costs withinsurance companies, Americans withoutinsurance may actually be excluded fromparticipating in those clinical trials.10 Ifmore public attention turned to clini-cal trials for chronic yet, by and large,treatable conditions such as insomnia,depression, allergies, and weight loss, a dif-ferent portrait of human subjects wouldemerge. In other words, what is invisibleto most Americans is that the clinical test-ing of prescription drugs is conducted onuninsured individuals who then lose accessto those treatments when they are made

available on the market.Discussions concerning the ethics of

clinical trials should be grounded withinthe twenty-first century context by focus-


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ing on the pharmaceutical industry andthe participation of private-sector physi-

cians and members of local communitiesin human subjects research. In order tobe relevant to policymakers as they grapple

with finding ways to better protect researchparticipants, approaches to the regulationof human subjects research must attend tothe social and economic inequalities em-bedded in the research enterprise and thebroader political economy. Specifically,

more attention must be given to one im-portant and often overlooked charac-teristic of the political economy in the US:the trend toward the neoliberalization ofhealth care.

Medical Neoliberalism

The term neoliberalism has been usedto describe the mode of late twentiethand early twenty-first century governanceemphasizing free markets and free trade.Neoliberalism refers to a variation on liber-alism as a political philosophy, not popularuses of the term Liberal in the US. Infact, neoliberalism is generally associated

with the political and economic agendas ofconservatives labeled as Neo-cons. Al-though the focus of neoliberal economicpolicies tends to be international in scope(advocating for globalization and interna-tional divisions of labor), neoliberalism af-fects domestic policies just as dramatically.Neoliberal policies on the national levelare manifested in state cutbacks in socialgoods through the privatization of thosefunctions and the ongoing deregulation of

the private sector. An interesting aspect ofneoliberalism is that as the state transfersresponsibility to its citizens to provide forthemselves, it simultaneously increases the

amount of monitoring of citizens actions.Within the US, evidence of neoliberal-

ism can be found in policies surroundingwelfare11 and the welfare states surveillanceof the poor,12,13 education14 and social se-curity.15 Regardless of the domain of pub-lic life, however, neoliberal governance hasbeen the recipient of political spin so thatthese policies are being framed as in thebest interest of the citizenry.16 For exam-ple, the rhetoric of neoliberalism extols the

simultaneous benefits that will come to therecipients and the providers of privatizedservices, stressing the increased efficiencyfor beneficiaries and the profitability ofthese systems for private companies. Theresulting cultural logic of neoliberalism isarticulated in a variety of ways with thesame message at its core: what is good forindustry must be good for America. What

counts as America, however, is rarely un-packed. This rhetoric obscures the socialburdens placed on American citizens andothers by focusing on an economy over

which average citizens can make few or noclaims. In other words, neoliberalism mustbe examined on the level of the state andits policymaking but also on the level of itsdifferential effects on citizens dependingon their social locations.

Neoliberalism extends into and hasparticular effects on health care in the US.To understand how the clinical testing ofpharmaceutical products fits into this ide-ology and mode of governance, attentionmust be given to medical neoliberalism17,18 not only as part of broader nationaltrends toward privatized social services,but also as a cultural sensibility toward the

commodification of health and wellness.19Neoliberalism extends the commodifica-tion of health in new ways; under its gov-erning logic, consumption is not only a


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right but also an obligation if one wantshealth care at all.

Within this expanded frame, medicalneoliberalism consists of several strikingfeatures. First, on the policy level, neolib-eral ideologies infuse interpretations of thelimitations of the current health care sys-tem in the US. Rather than the problembeing defined as the system itself, it is in-stead understood in terms of opportunitiesfor choice. True to its roots in economic

liberalism, American health care is definedindividually, according to who is willingto pay and for what kind of care. The fo-cus on individual choice, however, servesto obscure the ways in which health careinequalities are generated by the systemitself. In other words, medical neoliberal-ism leads to a prioritization of choice overequity and access.

Second, on the institutional level,medical neoliberalism is characterized bya commodification of health that trans-forms individuals from patients to con-sumers.20 The difference in terms is notmerely semantic. This new orientationtowards medicine not only emphasizes au-tonomy but also accountability for bothpatients and health care providers. Unlikepatients, consumers seeking health carebear the responsibility for the choices theymake or fail to make regarding theirhealth. Because they are positioned as hav-ing the right to make choices about healthcare, consumers also have the obligation toutilize whatever products and services areavailable to ensure health or to treat illnessand disease. This is not to say that medicalprofessionals are not liable for malpractice

claims. If anything, assessing the appro-priateness of care is another burden onconsumers, and malpractice suits serve asa means to make claims that the products

and services they sought were not deliveredas promised.

Finally, on the cultural level, throughthe process of making health care a com-modity, medical neoliberalism also com-modifies the body itself. Medical neolib-eralism fragments the body by homing inon specific problem areas with or withinthe body to the detriment of holistic analy-sis.21 The implication of this fragmenta-tion is that body parts are seen in terms of

the products designed to maintain, cure,or enhance them. Potential dangers ofthis consumerist mode of fragmentationare new perceptions of disability and therise of technoluxe22 and transhumanist23models of medicine in which the focus isno longer on health per se but on enhance-ment of the body.24

In practice, medical neoliberalism is

most easily identified in two changes inhealth care since the 1970s: managed careand direct-to-consumer advertising. Presi-dent Reagan in the US, along with Mar-garet Thatcher in the UK, significantlyadvanced neoliberalism in the 1980s bycrafting federal policy in accordance withthese political and economic ideologies.For example, in response to the rising costof medicine and the interpretation of thefederal Medicare system as being on theverge of crisis, Reagan ushered in the eco-nomically rational strategy of managed careto reduce government spending on healthcare. After its implementation, the Medi-care model quickly became the dominantform of health insurance in the privatesector as well.25 This widespread move toreduce the costs of health care in the US

was crafted as economic policy. Nonethe-less, the changing structure of payment formedical services had profound effects onthe culture of medicine. For example, it


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these industries. For example, due to thesethird-party influences, patients percep-

tions of their health are shaped by targetedmessages from the manufacturers of healthcare products.29,30 Nowhere is the extentof neoliberalized medicine more apparentthan in current models of treatment forpsychiatric illness. In this realm, depres-sion, anxiety, and other disorders are de-creasingly located in the contextual lives ofindividuals with these conditions. Instead,

these illnesses are frequently said to inhabitthe brain and can thus be treated solely bychanging the brains chemistry rather thanfinding any psychosocial roots of thoseconditions.31,32

Patients as consumers have embracedthe neoliberal logics of health care so thatthey too see illness in reductionist termsand seek pharmaceuticals as targeted

magic bullets. This orientation towardhealth and medicine has been referredto as the pharmaceuticalization of healthcare,33,34 in which the conditions of healthand illness are ever more cast in terms ofproducts that can be purchased by health-engaged consumers.35 A medical systemthat revolves around pharmaceuticals con-tributes to a culture of medical neoliberal-ism. It ties together the commodificationof health care with the fragmentation ofthe body where illness is treated in termsof discrete systems for which there are tai-

lored products.

Neoliberalism and Clinical

Trials

Within political, economic, and cultur-al contexts of neoliberalism, the offering ofpharmaceutical clinical trials is positioned

can be said to have undermined the au-thority of physicians, who under managed

care must adhere to the rules of medical di-agnostics and treatments set by insuranceproviders.26 In addition, as a response tomanaged care dipping into their incomes,physicians began to invest in for-profit an-cillary-care ventures to spread the reach ofthe products and services they could offerto patients.27 Ultimately, managed careplayed a key role in the commodification

of health care. By assigning values andstandards to clinical practice, medicine be-came less a social good and more a set ofcommodities to which individual patientshave differential degrees of access.

In addition to managed care, anotherkey example of US federal policy contrib-uting to medical neoliberalism was the re-interpretation of US regulation governing

the pharmaceutical industrys right to ad-vertise its products to prospective patients.In 1997, the Food and Drug Adminis-tration (FDA) ruled that pharmaceuticalcompanies could market their products topatients themselves through what becameknown as direct-to-consumer advertis-ing. In large part, discourses about patientempowerment and the creation of in-formed consumers persuaded the FDA toallow mass media marketing campaigns.28

Importantly, the influences of the me-dia and direct-to-consumer advertisinghave also imposed new constraints on thedoctor-patient relationship. These chang-es in the politics, economics, and culturesof health care in the US have succeeded inre-centralizing power toward pharmaceu-tical companies and insurance providers

and away from physicians. By creatingnew structures within which medical de-cision-making occurs, physicians author-ity is shared or at times overshadowed by


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as adding another option for health careconsumers. Because the majority of these

pharmaceutical studies are located in fa-miliar contexts, such as private practices inthe private sector, the process of researchis normalized, meaning that clinical tri-als become a routine part of the clinic.36Equally important, neoliberalism in drugtesting further fragments the body bypositioning illness as a vehicle for testingpharmaceutical products. Under medical

neoliberalism, clinical research becomesthe responsible choice for individuals

who do not otherwise have access to butrequire medical intervention. Or, putanother way, participation in clinical trialsbecomes almost a duty for those who haveno other access to health care because it isavailable as a choice.

By privileging the individual and choice,

a health care system mediated by neolib-eral policies and cultural sensibilities tendsto obscure the inequalities to which those

who participate in clinical trials tend to besubject. Within this frame, the systematicuse of the uninsured or economically dis-enfranchised people as human subjects inpharmaceutical clinical development is notseen as being exploitative, but is insteadpositioned as an opportunity for mem-bers of those groups.37 This discursivemaneuver diminishes both the individualrisks of participating in drug studies andthe broader inequities of the health careand economic systems in the US. Clinicaltrials may indeed function to address twomajor shortcomings in American healthcare decreasing amounts of revenue forphysicians and decreasing access to medi-

cine for patients but they also exacerbateexisting social inequalities and generatenew ethical challenges for human subjectsresearch.

The current system of research ethicsthat is institutionalized through US federal

regulation requiring review of study proto-cols and informed consent of human sub-

jects is disconnected from the political andeconomic context of clinical trials that Idescribe in this paper. Current discussions

within bioethics and by policymakers tendto focus on the moment of participationboth for potential human subjects as wellas physicians and others involved in the

research enterprise rather than the con-ditions that make pharmaceutical studiesappealing to individuals and groups. Forexample, the process of informed consentoperates to prevent deception of subjectsby researchers and to provide informationthat subjects can use in decision-making.

Yet, most empirical research on informedconsent indicates that human subjects de-

cide to participate before reading informedconsent forms and that those forms havelittle impact on subjects participation.38,39Likewise, discussions about physiciansethics primarily concentrate on the effectsof financial conflicts of interests on phy-sicians clinical decision-making or judg-ment about human subjects appropriate-ness for research studies. Yet, these debatesaround conflicts of interest ignore the factthat financial incentives draw physicians toclinical trials in the first place.40 Thus, theapproach of examining the ethics of clini-cal trials at the moment of study participa-tion does not attend to the problems andconditions that make clinical trials an at-tractive option for certain individuals andgroups.

What would it mean for bioethics and

policymakers in the US to take the politi-cal and economic contexts of pharmaceuti-cal clinical trials seriously? Policies regard-ing the governments responsibility to its


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citizens in the provision and distributionof health care may at first blush seem in-

cidental to the protection of human sub-jects, but these policies establish incentivesor disincentives to participate in clinical re-search. By recognizing the ways in whichneoliberal policies have created differen-tial access to health care and exacerbatedinequality in contemporary society, newquestions about the ethics of human sub-

jects research emerge: Is it ethical to rely

on uninsured populations as test subjectsfor the development of new pharmaceu-tical products? What is required to makethe inclusion of uninsured individuals inclinical trials as ethical as possible? Howcan we ensure that the distribution of risksand benefits of pharmaceutical research ismore fair given the problems of access tonew products that are experienced by the

uninsured? Oftentimes, bioethicists areconcerned about reducing coercion thatmay be felt by prospective human sub-

jects, but there is also a danger in exploit-ing individuals if they are not sufficientlyrewarded for their investment of time andexposure to risk.

For example, the woman and son in-troduced at the beginning of this paperillustrate the complexity of the ethics ofincluding uninsured individuals in clinicaltrials. The opportunity that pharmaceuti-cal studies provide for the boy and manyothers should not be disregarded. The

woman is able to leverage this particularstudy to help minimize her sons problemsin the classroom. Yet, what must not beforgotten is that clinical trial participa-tion is not equivalent to medical care. The

extent to which the physician runningthe study can provide medical interven-tion is constrained by the study protocol.The investigational product, its dose, and

even the administration of a placebo arenot chosen by the physician for a patient

but by the pharmaceutical company forthe provision of study results. Moreover,clinical trials are finite. The woman willhave to find another ADHD clinical trialin which to enroll the boy or likely forgoany treatment for him at the conclusion ofthe current study. If and when the producthe is taking is available on the market, thecost of the new medication will cut off his

access to it. Because of these unresolvedissues regarding treatment and access thatare symptoms of medical neoliberalism,clinical trials cannot be said to provide sus-tained or sufficient health care at all.

Conclusion

By expanding our view of ethics to in-clude contextual factors in clinical trialparticipation, the regulatory approach toprotecting human subjects from harm canbe redirected to challenge the status quo ofhealth care in the U.S. Although healthcare and clinical trials have historicallybeen seen as separate issues, they have beenand continue to be intimately connected.

An ethics of human subjects research thatdoes not account for general access tohealth care is dangerously limited. Phar-maceutical clinical trials in the U.S. andglobally as well cannot be fully ethicaluntil social inequalities are recognized andmitigated through more expansive mea-sures to protect human subjects. Univer-sal health care may be our best defense increating an ethical system of research and

development. Even without such radi-cal progressive change in the provision ofhealth care in the U.S., it is clear that itis time for the bioethics debates occurring


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in scholarship, the mainstream media, andpublic policy to contend with the impact

of political and economic constraints uponethical research practice.

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medical neoliberalism and pharma medical trials - fisher

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