developing world bioethics

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BOOK REVIEW

Pharmaceutical Research, Democracy and Con-

spiracy: International Clinical Trials in Local

Medical Institutions by Edison Bicudo. Surrey, UK

and Burlington, VT: Gower Publishing Limited and

Ashgate Publishing Company, 2014. 175pp (including

bibliography and index). US$94.96 & £54.00 (Hard-

cover). ISBN: 978-1-4724-2357-3 (hbk).

Global clinical trials bring together two groups that need

each other and are coming to depend on each other more

andmore. Pharmaceutical companiesneed sick patients to

test their drugs and have been offshoring an increasing

number of their trials for recruitment purposes. Patients in

the offshore locations, in turn, are easier to recruit becausecash-strapped health care systems cannot meet their

needs. Consequently, these patients are turning to clinical

trial participation as an alternative. Research ethicists

have given careful thought to the ethics of these transac-

tions between pharmaceutical companies and their over-

seas subjects. They have paid special attention to the issue

of whether the terms of these transactions can be consid-

ered fair, even if they are acceptable to the subjects only

because their health care system is failing them.

But these transactions are just one piece of a much

larger story on the local ends of global clinical trials.

Trials may be conceived by a pharmaceutical company,but the patients are not helicoptered to the company’s

location to be studied. Rather, they are recruited and

studied by local actors in local hospitals. These local

actors and institutions, like the patients, do not offer their

services to the pharmaceutical company because the

company’s goals are their goals as well. They must

instead be incentivized to cooperate with the company,

which creates another set of transactions to consider.

Edison Bicudo’s new book, Pharmaceutical Research,

Democracy and Conspiracy, spotlights the full range of

local contributions and accommodations that make the

transactions between pharmaceutical companies and

patients possible. He labels the activities that bring thesetwo parties together ‘mediational actions.’ Unlike the

more predictable and stable motives of the corporations

and the patients, the motives behind mediational actions

vary. His methods and approach to the topic are socio-

logical, and much of the information presented in the

book about these activities comes from fieldwork he con-

ducted in the UK, Spain, France, Brazil, and South

Africa. He interviewed a number of people who play

these mediating roles and quotes liberally from them,

conveying their reflections on their activities and motives

in their own words.

Although the author’s purposes are largely descriptive

and explanatory, the book also raises a number of con-

cerns. As Bicudo emphasizes, attracting and conducting

these trials requires significant and enduring institutional

transformations in hospitals, and the long-term conse-

quences of these transformations for patients and the

public are difficult to project. He does not believe it

would be best to abolish industrial trials from these sites,

given that they do infuse much needed money and

resources into health care systems. But he does believe

these incursions by companies into health care systems

need to be managed and contained in order to reduce the

likelihood of conspiracies against the public and to

ensure that these institutions will remain thoroughly

subject to democratic control.The focus of the first half of the book is on the local

institutional transformations that need to take place in

order to attract and facilitate industrial trials. New offices

may be established for accepting and distributing phar-

maceutical company money; new roles like research

coordinator are created; and physicians serve as physician-

recruiters and physician-investigators. Even though the

motivation for these transformations is usually to enable

hospitals and medical professionals to better carry out

their primary mission of serving patients, these new func-

tions are always in potential conflict with that mission.

Hospitals and medical professionals are now serving anadditional master, one whose interests are at best only

contingently aligned with those of the patient population.

Furthermore, the resources and services for which the

pharmaceutical company is contracting do not belong to

the individuals who will provide them, but rather to the

hospital and, in the case of state-owned hospitals, the

public. Proper stewardship of these resources requires at

least that the hospital or the public be appropriately com-

pensated by the corporation for the use of its resources

and staff and arguably that they receive the very best

return that the corporation can be induced to give. But if

the pharmaceutical company negotiates terms directly

with principal investigators (PIs) and their teams, as theyoften prefer to do, there is a danger that the public will be

shortchanged in the transaction. The PI may not be

knowledgeable enough or motivated enough to negotiate

the best possible deal for the hospital or the public. Even

worse, the PI may be willing to permit the pharmaceutical

company to use the hospital’s resources or the PI’s own

services without compensation in exchange for a portion

of the money this arrangement saves the company.

The possibility of such conspiratorial arrangements

cannot be eliminated entirely, but Bicudo argues that

their likelihood can be reduced by means of institutional

Developing World Bioethics ISSN 1471-8731 (print); 1471-8847 (online) doi:10.1111/dewb.12075Volume 15 Number 1 2015 pp 55–57

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engineering. He cites with his approval the example set by

a number of countries that have established public offices

to handle clinical trial transactions. These offices are

granted the sole authority to negotiate terms with phar-

maceutical companies and to disburse the money that is

collected. Although parallel negotiations between phar-

maceutical companies and research teams are still some-

times carried out in secret, there is less to be gained from

them, and so they are less likely to occur and less dam-

aging when they do. However, some countries, such as

South Africa, have established no such offices and in

these countries negotiations must be conducted directly

with PIs. This leaves hospitals and the public more vul-

nerable to shortchanging. As another illustration of the

advantage of channeling negotiations through public

offices, Bicudo presents data gathered in his fieldwork

that suggests that when decisions about hosting academic

or industrial trials are made by a public office rather than

by individual research teams, a higher proportion of aca-

demic trials are chosen. The explanation would seem tobe that these academic studies are more likely to generate

results of local relevance and that these offices are more

responsive to the public interest than are individual

research teams.

The fact that private agreements between pharmaceu-

tical companies and PIs risk shortchanging hospitals and

the public is not, however, Bicudo’s most fundamental

worry about such arrangements. As he relates in an espe-

cially interesting chapter, PIs frequently negotiate deals

that are highly favorable to the hospital and the public.

There are certain PIs whose expertise and prestige in a

therapeutic field make their involvement in a trial highlydesirable to pharmaceutical companies and give them an

unusually strong bargaining position. These ‘opinion

leaders’ can and often do use this power for the benefit of

their patients and hospitals by, among other things,

getting companies to expand inclusion criteria, to commit

to providing post-trial access to drugs, and to pay for

expensive technologies that hospitals could not otherwise

afford. Despite the fact that these private arrangements

are made in order to serve public good, Bicudo still

regards them as objectionable on the grounds that these

PIs are making decisions that are not properly theirs to

make. However well-intentioned they may be, the PIs are

still usurping the authority of hospitals and the public todecide these matters for themselves.

The second half of the book is more loosely organized

than the first, but is for the most part oriented around the

examination of a number of factors that contribute to the

successful recruitment of patients. Here attention is

drawn to the networks of communication upon which

recruitment depends, which makes cities with dense net-

works of communication particularly attractive sites

for industrial trials. Patients’ trust in their physicians

(derived, he believes, from a more generalized trust in

hospitals) is another important factor that is sometimes

necessary for overcoming patients’ reservations about

serving as a ‘guinea pig’ in a clinical trial. And perhaps

most importantly, recruitment depends on the hopes of

desperate patients for novel treatments and on the

chronic under-funding of health care systems. This final

factor is contributing to a growing and rather alarming

trend of patients who view the care available in clinical

trials as the gold standard while viewing the care pro-

vided by their health care system as second-best.

Although this is a sociology book and not a book on

ethics, there is much in it that ethicists, particularly

research ethicists, will find of interest. International clini-

cal trials involve two distinct transactions: a transaction

between the sponsor and the subjects, and a transaction

between the sponsor and the community hosting the trial.

Ethicists have been thinking about standards for evalu-

ating the former transaction for longer, but they have

also paid a great deal of attention to the latter transac-

tion. They have achieved some consensus on certainstandards, such as that sponsors should obtain authori-

zation from legitimate local authorities, that they should

not free-ride on public resources and services, and

that they should provide communities with a fair share

of benefits to be determined in consultation with the

community.

Bicudo does not dwell on the responsibilities of spon-

sors, the customary focus of research ethicists. (Through-

out the book pharmaceutical companies are depicted as

responsive only to power, not moral persuasion.) But his

accounts of the local contributions upon which pharma-

ceutical companies depend and of the dangers of con-spiratorial arrangements clearly have relevance for how

sponsors should interact with local communities and

institutions. And it is valuable in turn for ethicists to

consider responsibilities on the local end, as Bicudo

invites his reader to do. These include the responsibilities

to set up offices to negotiate with these companies on

behalf of the public, along with the responsibilities of

individual PIs to cooperate with these offices where they

exist.

I’ve highlighted what I take to be the main points of

interest for those who study the ethics of international

clinical trials. I have not discussed the more theoretical

aspects of the book, but these should at least be men-tioned since a fair portion of its content is dedicated to

achieving theoretical goals. The book has theoretical

underpinnings drawn from Habermas, and the author

intends his notion of ‘mediational actions’ to fill a critical

gap in Habermas’s theory. Those who are familiar with

Habermas will recognize that the broad themes of

Bicudo’s book reflect Habermas’s concerns about the

colonization of the lifeworld by system. These concerns

are illuminating as applied to the entanglement of phar-

maceutical companies with local medical institutions,

Book Review 56




and Bicudo conveys them in a way that would enable

readers who are not familiar with Habermas to appreci-

ate them.

However, readers who are not knowledgeable about

Habermas will have difficulty in grasping the explicitly

theoretical claims and arguments of the book. Technical

terminology from Habermas is frequently employed, but

there is virtually no exposition of these terms or of the

theories in which they play a role, apart from a few

unhelpful quotations from Habermas himself.

Although the book does contain content that is

addressed to a more limited audience and makes a few

rather puzzling excursions into bioethical territory, such

as an uncompelling argument against the very possibility

of therapeutic misconceptions, the bulk of the book is

dedicated to providing a richly detailed description of the

contributions made on the local end of global clinical

trials and to making the case for asserting democratic

control over the incursions of corporations into local

medical institutions. Those who know Habermas well

might profit more from the book, but there is plenty to

engage the interest of anyone who enjoys thinking about

the ethics of global clinical trials.

COLLIN O’NEIL

Assistant Professor

Department of Philosophy

Lehman College, CUNY

Bronx, New York

Book Review57


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