Jill Fisher, Medical Research for Hire. The Political Economy of Pharmaceutical Clinical Trials, Rutgers University Press, 2009In Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials, Jill Fisher presents the results of 12 months of fieldwork conducted around 2003 in two major cities in the southwestern United States. During this period, the author analyzed "more than twenty" for-profit research organizations performing clinical trials for the pharmaceutical industry. The main output is an ethnography of the identities adopted by the different participants in those trials. On this basis, Fisher denounces how unfair to patients this system is.
A clinical trial is a medical experiment in which a new drug is compared to the standard treatment or a placebo administering them to two groups of patients in order to test its efficacy. The American Food and Drug Administration (as most other regulatory agencies around the world since the 1960s) requires statistical evidence derived from clinical trials in order to authorize the commercialization of new drugs. Whereas until the 1990s a majority of these experiments were conducted in public medical centers, nowadays the pharmaceutical industry is contracting most of them with a variety of private companies. In exchange for many billions of dollars, these companies promptly deliver trial results that generate early profitable patents for their sponsors. The protocol of the experiment is pre-arranged by the pharmaceutical company, so the contractor can only play with the efficiency of the implementation, particularly in the recruitment and involvement of patients.
Fisher analyzes through interviews and direct observation the different roles involved in the management of these private trials. According to Fisher, driven by purely financial incentives, the physicians in these organizations adopt both of these two distinct roles (chapter 3): entrepreneurial agents (they run their companies) and pharmaceutical emissaries (they implement their sponsors' experimental design). Fisher shows that these two roles set very strict limits on their therapeutic obligations with their patients. Chapter 4 is devoted to research coordinators, whose assignment in the trial is namely to deal with patients (recruiting, screening, obtaining consent) and manage part of the trial bureaucracy. Their professional identity is defined mostly in terms of their obligation to care for the patients (many of them are former nurses and a majority are women). Again, their corporate responsibilities often constrain their care duties. In chapter 5, Fisher analyses the monitors appointed by the pharmaceutical sponsors to audit the trial and prevent frauds. This is a feminized profession too, with a very demanding administrative task and a multifaceted symbolic role, often contradictory: "protector of the public health, coordinator's 'best friend,' and scapegoat for the problems of outsourcing".
In chapter 6 Fisher profiles the types of patients most likely to be involved in private trials. In research conducted on healthy subjects to test the safety of a new drug, most of the volunteers are men from a minority (very often Hispanic), seeking a financial reward. In efficacy trials on patients, there is an increasing participation of white middle class women, who are sought by the companies because they are available and compliant with the protocol. According to Fisher, most of them are "neoliberal subjects motivated by their social and economic positions to benefit the best they can from the system of drug development" (p. 178). In the two following chapters Fisher tries to show that the informed consent that such patients sign is often conditioned by the weakness of their positions in American society (poor, uninsured, uneducated). Moreover the therapeutic benefit they derive from their participation in the trial is often minimal. This hinders their compliance with the trial protocol and puts the "managers in a difficult ethical position to persuade them to comply.
Medical research for hire combines indeed ethnography and ethics. The former prevails: the book is rich in quotations from the many interviews conducted by the author and we get to know how the participants in the private clinical trials studied perceive themselves. However, the author only visited a minor fraction of the many organizations conducting trials in the USA and had unequal access to the different types of participants. Her description may ring true, but I am afraid further studies are necessary to confirm that it is representative of a broader pattern. Informative as this ethnography is, its theoretical analysis is not satisfactory, at least in my view (the authoritative endorsements in the cover say otherwise). A substantial part of the analysis consists in glosses over the quotations, in which the author generalizes about her subjects as if they represented the "social and economic positions" of participants in trials across America. Her analysis is very local though (just two major southwest cities) and I would have appreciated a situated analysis in which the particular circumstances of the participants explained their testimonies. The author appeals instead to the "political economy" of "medical neoliberalism", understanding these concepts in a vaguely Foucaultian sense: pharmaceutical capitalism would be constraining the choices of trial participants to a point that often distorts their perception of their own actions. Perhaps it is just an effect of my excessive exposure to experimental social sciences (or actual political economy), but I miss an actual explanation of how this is happening.
I do not find the ethical analysis much deeper. Fisher shows that the discourses of the professionals involved in clinical trials often misrepresent the situation, making it better for the patients than it actually is. I will not dispute this (and it is certainly good to try to inform them). But I guess that Fisher's ethical target is more the for-profit conduction of clinical trials than the discursive misrepresentations of their conductors. Is there an ethical standard for private clinical trials? I guess the author is not very confident about it, but I would have appreciated a more explicit and articulated answer.
A clinical trial is a medical experiment in which a new drug is compared to the standard treatment or a placebo administering them to two groups of patients in order to test its efficacy. The American Food and Drug Administration (as most other regulatory agencies around the world since the 1960s) requires statistical evidence derived from clinical trials in order to authorize the commercialization of new drugs. Whereas until the 1990s a majority of these experiments were conducted in public medical centers, nowadays the pharmaceutical industry is contracting most of them with a variety of private companies. In exchange for many billions of dollars, these companies promptly deliver trial results that generate early profitable patents for their sponsors. The protocol of the experiment is pre-arranged by the pharmaceutical company, so the contractor can only play with the efficiency of the implementation, particularly in the recruitment and involvement of patients.
Fisher analyzes through interviews and direct observation the different roles involved in the management of these private trials. According to Fisher, driven by purely financial incentives, the physicians in these organizations adopt both of these two distinct roles (chapter 3): entrepreneurial agents (they run their companies) and pharmaceutical emissaries (they implement their sponsors' experimental design). Fisher shows that these two roles set very strict limits on their therapeutic obligations with their patients. Chapter 4 is devoted to research coordinators, whose assignment in the trial is namely to deal with patients (recruiting, screening, obtaining consent) and manage part of the trial bureaucracy. Their professional identity is defined mostly in terms of their obligation to care for the patients (many of them are former nurses and a majority are women). Again, their corporate responsibilities often constrain their care duties. In chapter 5, Fisher analyses the monitors appointed by the pharmaceutical sponsors to audit the trial and prevent frauds. This is a feminized profession too, with a very demanding administrative task and a multifaceted symbolic role, often contradictory: "protector of the public health, coordinator's 'best friend,' and scapegoat for the problems of outsourcing".
In chapter 6 Fisher profiles the types of patients most likely to be involved in private trials. In research conducted on healthy subjects to test the safety of a new drug, most of the volunteers are men from a minority (very often Hispanic), seeking a financial reward. In efficacy trials on patients, there is an increasing participation of white middle class women, who are sought by the companies because they are available and compliant with the protocol. According to Fisher, most of them are "neoliberal subjects motivated by their social and economic positions to benefit the best they can from the system of drug development" (p. 178). In the two following chapters Fisher tries to show that the informed consent that such patients sign is often conditioned by the weakness of their positions in American society (poor, uninsured, uneducated). Moreover the therapeutic benefit they derive from their participation in the trial is often minimal. This hinders their compliance with the trial protocol and puts the "managers in a difficult ethical position to persuade them to comply.
Medical research for hire combines indeed ethnography and ethics. The former prevails: the book is rich in quotations from the many interviews conducted by the author and we get to know how the participants in the private clinical trials studied perceive themselves. However, the author only visited a minor fraction of the many organizations conducting trials in the USA and had unequal access to the different types of participants. Her description may ring true, but I am afraid further studies are necessary to confirm that it is representative of a broader pattern. Informative as this ethnography is, its theoretical analysis is not satisfactory, at least in my view (the authoritative endorsements in the cover say otherwise). A substantial part of the analysis consists in glosses over the quotations, in which the author generalizes about her subjects as if they represented the "social and economic positions" of participants in trials across America. Her analysis is very local though (just two major southwest cities) and I would have appreciated a situated analysis in which the particular circumstances of the participants explained their testimonies. The author appeals instead to the "political economy" of "medical neoliberalism", understanding these concepts in a vaguely Foucaultian sense: pharmaceutical capitalism would be constraining the choices of trial participants to a point that often distorts their perception of their own actions. Perhaps it is just an effect of my excessive exposure to experimental social sciences (or actual political economy), but I miss an actual explanation of how this is happening.
I do not find the ethical analysis much deeper. Fisher shows that the discourses of the professionals involved in clinical trials often misrepresent the situation, making it better for the patients than it actually is. I will not dispute this (and it is certainly good to try to inform them). But I guess that Fisher's ethical target is more the for-profit conduction of clinical trials than the discursive misrepresentations of their conductors. Is there an ethical standard for private clinical trials? I guess the author is not very confident about it, but I would have appreciated a more explicit and articulated answer.
A.Geltzer reviews Jill Fisher's book in the latest issue of Social Studies of Science [(2009)39/3]. Here is a glimpse:
ResponderEliminar"Thus it isn’t surprising that the argument stumbles in places and that the structure of the book – which jumps from broad questions of governance and informed consent to the individual roles of physicians, patients, clinical trial coordinators, and monitors, and then to the practical challenges of drug testing such as recruiting patients and ensuring compliance – is somewhat disjointed. But these shortcomings are outweighed by the importance of the book’s subject matter and analytical insights"