Conferences are familiar to the point of banality for academics. From time to time, anthropologists have turned their attention to their own ritual gatherings — and those of others
— in order to analyse what it is that compels people to travel large distances, meet, and discuss.
Anthropologists of policy, expertise and the character of knowledge in contemporary institutions and organisations have found themselves conducting fieldwork at conferences, listening to papers being given and break-time conversation shared (Gross and Fleming 2011, Schwegler 2008, Fortun
Figure 3: FERCAP Strategy Diagram
2001, Shore and Wright 1997, Gusterson 1996, Helmreich 2000, Sunder Rajan 2006, for historical attention see Mead and Byers 1968).
The Annual Conference is FERCAP’s key annual event, where people speak from podiums to colleagues gathered from across Asia. For the observer, it provides a glimpse of the organisation’s self descriptions, the images that constitute its imaginary of place within an international arena.
At the Conference, FERCAP describes itself both to itself and to international guests. It needs to draw a convincing image, and ‘to create the conditions of trust under which their representations will hold conviction’ (Strathern 2006:189). The FERCAP Conferences I attended during fieldwork in Chiang Mai, northern Thailand (November 2009) and Shanghai, China (November 2010), were held, as Conferences usually were, in a vast single room of a large, chain hotel.
Banners detailing the title, venue, dates and sponsors were strung up on vast boards; rows of chairs placed in equally spaced lines. An annual event since 2000, the Conference brings together FERCAP members from around the region, and past titles of the FERCAP Conference give us a sense of the priorities of the meetings: ‘equity and responsibilities’ (2004), ‘roles, responsibilities and relations’ (2006), ‘developing quality systems ‘transparency and accountability’ (2007) ‘ethics of responsibility’ (2007, also 2008) ‘developing leadership’ (2009) ‘towards good practices and integrated systems’ (2009) ‘networking and alliance building’ (2010) ‘innovation and integration’ (2011), and in 2012 ‘ethnicity, culture, religion and ethical research’. The invited guests — international speakers from US NIH, EMEA, regulatory bodies, European Universities and the WHO-Tropical Disease Research arm — speak alongside researchers and ethics committee members from the Asia-Pacific region. All are called upon as ‘stakeholders’ — physicians, researchers, manufacturers and governments, national health authorities and ethics committees — to work together towards human subject protection.
In what follows, I begin by examining the ‘macro-structuring’ (Callon and Latour 1981) active in the Conference through presentations and images. Macro-structuring is the term given by Callon and Latour to the work and techniques by which both actors and analysts structure realities, their point being that each act of definition can be regarded as a negotiated achievement when the
‘large’ and ‘small’ are not pre-assumed. Before I start, I want to emphasise that claims of
‘fragmentation’ originate and circulate within the field; they are a description generated by the field itself, not my analysis or claims. I will revisit the point below in a section on Vocabulary, but because of the similarity the terms have with language anthropologists have used to describe
‘world systems’ (Wallerstein 1974) and fragmented realities (Tyler 1986, Clifford 1986), I repeat
the point for emphasis. Part of the challenge of an ethnographic account of this kind is that the language used to describe the world by those with one whom works resembles (even takes on) certain of the problems of the history of anthropological and sociological thought.
The Cloth: Systems and Fragments
At the 2008 FERCAP Conference in Bangkok, Dr Koski, chair of the SIDCER advisory board and ex-director general of the Office Human Research Protection (OHRP) in the USA, projected this slide to his audience.
The individuals and entities engaged in human research constitute a matrix of overlapping roles and responsibilities that together serve to ensure that the duties are satisfied. This matrix is like a finely woven silk cloth. A single broken thread causes a defect, a single defect spoils an entire cloth. A single hole can result in disaster, a single disaster can shred the fabric of trust. It is our duty to protect not just research subjects, but to protect the integrity of science itself.
What is this image of a cloth? What can it tell us? (Douglas-Jones, forthcoming). Adriana Petryna’s research (2007, 2009) on the spatial mobility of the clinical trials industry shows an ‘outsourced world’ (2007:290) whose scope and reach is vast, but largely unknown (Sim and Detmer 2005).
The growth of multi-centered clinical trials and contract research organisations (CROs) mean that not only is information being generated in many different places by many different people, but the sites of responsibility and oversight seem confused and overwhelming (Etkowitz and Leydesdorff 2000; Nowotny et al. 2002; Ong and Collier 2005). Petryna writes as an American who has researched this outsourcing, but at the FERCAP conference, we begin at what are imagined as the further reaches of these networks. For both analysts and researchers, finding a vantage point from which to view the research process — from the study design to the subject recruitment, data collection and analysis, preparation of report manuscripts creation of strategies for data dissemination and publication (Lemmens 2006) — seems impossible. In Koski’s image, the system is imagined in such a way that any point in it — the committee, the standards, the people, the personalities, the institutions — could be ‘broken.’
Clinical Trials
When FERCAP presents its program to committees, it describes a world in which trials happen. It is not just that the world contains clinical trials, but that the trials are composed from research done in different parts of the world. ‘The same trial being done in Asia, we see it in being done in Africa, in the West. No matter where,’ they say, ‘the concern is about quality of research.’ At a cancer centre in southern China, Cristina explained:
Basically we work in an environment where clinical trials are globalizing. In your cancer centre, you’re doing some of the global trials. I have visited many countries in Asia. Cancer clinical trials are most frequent and popular, and I see the same design being adopted — indication that clinical trials are globalized — one protocol done in different countries all at the same time.
Contemporary biomedical research has the objective of producing a very specific kind of knowledge. The clinical trial, preferably a double blind, randomized control trial (RCT), has become the “gold standard” of medical research; the technique considered to produce the ‘best’
evidence (Williams and Garner 2002, see also Marks 1997). As Kelly and Geissler remark, The RCT provides a statistical framework to interpret the merits of new drugs against the biases of patients and doctors[...] The method can be understood as part of a general epistemic shift across the sciences to practices that privilege objectivity and disinterestedness, the particular objectivity of the RCT is defined by the needs of the market place (2011:4).
Some voices from my research attest to the changes brought about by the RCT and the effects they have had on their practice. Evidence, and the nature of it, is at the center of their experiences:
This is the thing about presenting evidence. You have to compare it with something else, and there comes this question of double blind trials. Or ‘class one evidence.’ You have to have a control group, individual patients as per random number and you have to do away with bias on the trial. As a result, class one evidence is very hard to come by, nearly impossible.
Ecks (2008:S80) argues that ‘the rise of EBM [Evidence Based Medicine] can be interpreted as one more phase in a systematic devaluation of immediate visibility as a reliable source of scientific evidence,’ and he goes on to make the rather astonishing claim that ‘[d]octors are trained to believe more in statistical evidence than in what they observe in clinical practice’ (2008:S80).
Jesse, a researcher with whom I had lunch in Bangkok, repeated this feeling:
In the old days they did not stress RCTs. Now we have realised to make results reliable, [we need to] make sure groups are equal, that there are control and test groups. But placebos are hard to get. You need a package of something of the same colour, the same size, you need to order them and get someone to make them for you. It’s more difficult than in the old days, when you said [to the patient] ‘I’ll give you this’ and not give the full information.
The research conducted in institutions in Asia is shaped by the changing expectations of ethics review committees. Cristina reminds her audience at the Cancer Center that:
Because of [the globalization of clinical trials] it becomes more important that standards are harmonized and there’s some assurance that no matter where the trial is held there’s some harmonization of standards. All, no matter where, the concern is about quality of research
and the clinical trial and to talk abut quality you need some kind of oversight, monitoring.
That monitoring at the lower level is being done by the EC.
Jesse had found this to be the case in her field. ‘IRBs want a good methodology,’ she said.
No more observation. You have to do a RCT, give a participant information sheet, explain the risk. But this is different, and it’s hard because the patient may not want to know. In the old days, they didn’t want to [know]. 30 years ago, the doctor may not want to tell the patient that they have cancer, because the patient could be sad. That was the ethical thinking of the doctor. But now if he wants to do a trial, he has to prepare an information sheet. The education level of the patient may be low. They may be very frightened.
The difficulty of conducting an RCT led some to claim ‘lower classes’ of evidence were being produced. According to one of my interviewees, a practicing researcher in Sri Lanka:
Evidence itself can never be absolute. Unless it is double blind, controlled and free of bias [...] In the past, where you compared something with virtual zero, then a trial was very easy.
There’s the famous example — what is the ethics of a parachute? If you jump with a parachute, your chance of survival is very high. If you jump without a parachute, your chance of survival is very low. But to prove the parachute is a useful entity, one has to do a double blind to be absolutely ethical. Well, to be scientific.
In his extraordinary example lies a switch: to be ethical, to be scientific. An essential means by which this relationship is negotiated and in which it is contained is Good Clinical Practice, or GCP.
Good Clinical Practice
At the 2010 Shanghai FERCAP conference, Dr Robert Ridley, then-director of WHO-TDR, linked ‘ethics’ with a turn of the millennium campaign to build capacity in Good Clinical Practice (GCP): ‘one of the logjams that inhibited GCP was the lack of appropriate ethical review.’ GCP is the result of the cooperation between the regulatory authorities of Europe, Japan and the United States (the International Conference on Harmonisation, ICH), working with the pharmaceutical industry to develop international guidelines for:
a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines whilst maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health (ICH 2005).
ICH define GCP as:
an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and wellbeing of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible (ICH 1996:1).
A 20th anniversary booklet celebrating the value of ICH-GCP for regulators contained an account from Toshiyoshi Tominaga, of the Pharmaceuticals and Medical Devices Agency Japan. It gave the story of how Japanese GCP was developed, publicly and contentiously, with consensus forged by the Japanese working group experts and opinion leaders. Tominaga’s narrative ends on April 1st, 1997, the day when Japan was able to ‘generate globally usable clinical data’ (ICH 2010:14). This
‘usability’ was intended for regulators, such as Fergus Sweeney, a European GCP working group member who presented to the FERCAP conference in 2010:
Sitting in Europe, I rely on data coming mostly from countries in other parts of the world.
But if I was to change places, and set up in China, the Philippines, in Africa, the USA or Argentina, wherever I sit as a regulator I have data coming from somewhere else. We think it’s very important to set out a network. It’s very hard for an inspector to inspect 5 different countries [and] it would be impossible to inspect every clinical trial outside Europe. But we receive more and more trials coming from outside Europe. We need a system, we need to network between competent authorities, get some transparency and knowledge of and between different systems.
GCP was about harmonising the regulations and guidelines for drug development, to provide a unified standard to facilitate the mutual acceptance of clinical data by the regulatory authorities.
It was, at the outset, focused ‘on input by industry — the technical submission requirements for pharmaceuticals for human use’ (ICH 2010:2). The submitted information was collated in a
‘consistent harmonized format’ which was named the ‘Common Technical Document’ and this standardised format, it was hoped, would ‘relieve pharmaceutical companies of the time, workforce and financial burdens of assembling a submission for on DRA and then having to reformat it for another.’ The Common Technical Document became electronic, and was widely celebrated:
Seasoned regulatory affairs hands recall with a mix of bemused nostalgia and frank horror the days before the electronic Common Technical Document - or to be more exact, the days, nights, months, weekends and holidays spent by sleep-deprived regulatory staff to build an NDA for the FDA then deconstructing and reformatting it for EU submission [...]
The eCTD has changed all that [...] and the world is better off’ (ICH 2010:10)
Petryna writes that the US FDA took an active role in establishing the International Conference on Harmonisation5 and GCP and it ‘began to actively promote the globalisation of clinical trials, declaring that the search for sites and sources of data is part of its mandate to determine the safety and efficacy of new drugs’ (2009:37). She provides the backstory to Ridley’s ethics logjam:
5 In addition, ICH E5 (1998: 9, 14) encourages sponsors to address ethnic factors of ‘Asians, Blacks and Caucasians’ in early phase clinical trials, prompting further trial internationalisation.
[m]any countries that had already tailored their patent laws according to the provisions of the TRIPS Agreement also signed on to the ICH GCP. They were eager to attract new investments and participate in the booming production of global pharmaceuticals. As ICH-GCP members, they began the costly work of setting up national agencies that could standardise and monitor the conduct and performance of trials in their territories.
Countries were required to create ethical review boards to ensure the rights and protections of patients (2009:37).
In the rush to adopt GCP, which they hoped would ‘attract new investments,’ countries set up ethics review boards. But this quickly became a sticking point: Ridley told the Conference in Shanghai that WHO-TDR recognised ‘a need to develop some documentation to facilitate the creation of ethical review committees, and how those committees might operate.’ These documents are known as ‘The Silver Book’ (2000) and ‘The Blue Book’ (2002), entitled ‘Operational Guidelines for Ethics Committees that Review Biomedical Research’ and ‘Surveying and Evaluating Ethical Review Practices’ respectively (Figure 4).
The books are published by the World Health Organizations’s Tropical Disease Research arm (TDR), which, according to its Business Plan (2008-13), saw itself in a ‘stewardship role for Figure 4: Multiple translations of the Silver Book on the left. Blue Book on the right.
infectious diseases research’ (TDR 2008:2). Philanthropic support, the document states, ‘while well meant’ has resulted in ‘fragmentation’ with ‘knowledge on priority needs [...] becoming blurred as different research constituencies define priorities from their own specific perspective’ (TDR 2008: 6). TDR’s Plan writes of a ‘need for a global information platform to facilitate effective collaboration among all stakeholders in order to avoid fragmentation and to enhance effective utilization of available resources.’ In line with this spirit, in 2009, SIDCER and FERCAP came up with a shared vision of ‘a global network that fosters an integrated and sustainable ethical review system toward quality culture in health research’ (FERCAP 2009, Navarro and Na-Bangchang 2011).6
GCP is a measure against which research matters; it also claims the entanglement of scientific and ethical knowledge in the same document. The debate over nature of this entanglement has increased in recent years, as in 2008, the USFDA declared that clinical trials performed outside of the US only had to comply with GCP, not the declaration of Helsinki (DHHS 21 CFR part 312).
In the academic and professional debate which followed, Goodyear et al. argued that
despite assurances by the FDA, GCP is not an ethical code, but a procedural regulatory manual based on the regulatory frameworks of the US, Japan and Europe. Thus it is a description of existing procedures (2009: 1559).
The USFDA has also come under strong criticism from academics, who see the GCP guidelines
— ‘abetted by a rhetoric of universal human rights‘ that steps into ethics and ethics review — turning Research Ethics Committees into ‘mechanisms for creating ‘open’ worldwide markets in pharmaceuticals and clinical devices’ (Abraham and Reed 2002 cited in Dyer and Demeritt 2009:
53). This arena provides perhaps another forum for studies of the co-imbrication of economics and morality (e.g. Bornstein 2003, Coleman 2005).
GCP describes two-fold quality systems: quality control and quality assurance (Bhatt and Pradhan 2008:15), the former checking and testing for quality, the latter designing and planning a process or system which will result in the desired outcome. Comparing the Belmont Report with GCP, a FERCAP trainer said: ‘Those were principles. These are procedures. GCP is the common language.’ At the 2010 FERCAP Conference, Sweeney reminded attendees that:
It’s not regulators from another part of the world which can ensure the patients are protected [...] Therefore we want to reach out more and build and extend our relationships with regulators in all parts of the world. In every case the trial must receive positive opinion, or approval from an ethics committee with appropriate jurisdiction for the
6 I pay closer attention to the notion of quality culture and the use of language in Chapter 7.
investigator sites for the trials concerned. And your contribution to that is enormous. You are the people who can make that happen.
In planning how to ‘make that happen’, models are actively discussed, and are understood to move between places. As one 2009 conference attendee mused while thinking over the possible implications for his country of a Dutch presentation, ‘Foreigners show us different systems.’ I turn now to one of these ‘systems’ and the means of its circulation.
The Warning of Coast
International speakers invited to the FERCAP Conference sometimes presented national versions of their ‘system.’ The tale told here was repeated at several surveys and trainings during my research but I heard it first from Leslie, an employee of the US Food and Drug Administration (FDA) whose first job had been in the Philippines as a paediatrician. Her affinity with the region and support of FERCAP’s work led her to present at the FERCAP general conference in Chiang Mai, in November 2009. Her talk detailed what she called a ‘sting’ operation, conducted by the
International speakers invited to the FERCAP Conference sometimes presented national versions of their ‘system.’ The tale told here was repeated at several surveys and trainings during my research but I heard it first from Leslie, an employee of the US Food and Drug Administration (FDA) whose first job had been in the Philippines as a paediatrician. Her affinity with the region and support of FERCAP’s work led her to present at the FERCAP general conference in Chiang Mai, in November 2009. Her talk detailed what she called a ‘sting’ operation, conducted by the