Some of my non-medical colleagues in the academia who read my article on clinical trials (The Nation, December 25, 2011) astutely observed that this was one part of a broader pattern of events. The common thread that runs through this pattern is, I believe, how the market appropriates science to suit its own interests, rather than allow the latter to serve the interests of the wider society.In this article, I will explore how clinical trials, the dominant model for medical research today, can be placed on this broader pattern, and how conceptualisations such as ‘research’ and ‘knowledge creation’ can be seen on it.
Modernity’s lesson
Social scientists generally agree that the Holocaust was a creation of modernity. It systematically killed six million people within a few years. The crematoria at Auschwitz could burn 12,000 bodies daily – but could not meet the demand, which was for 20,000! (See Box 1.)
The mastermind behind the Holocaust was Adolf Eichmann. When political philosopher Hannah Arendt saw him for the first time at his trial in Jerusalem in 1961, she was shocked: Eichmann looked an ordinary, simple man, not at all the personification of evil that everyone had expected. It was then that she identified ‘the banal face of evil’: in the modern world, evil is carried out by “rational, ordered bureaucracies,” not marauding murderers.
Of course, one still requires human beings – who possess values, families and cultural backgrounds – to push the buttons or crunch the numbers. How does an Eichmann make one do such work? By converting The Evil Task into The Project backed up by The Ideology that enjoys widespread acceptance and justifies button-pushing, number-crunching, bureaucratic tasks by ordinary people. This is the lesson of modernity that the Holocaust gave us, which Arendt saw in Jerusalem and wrote down in The Human Condition.
The world has moved along since the Holocaust, of course, and nothing we see today can match its evilness. But the lesson remains pertinent. For instance, in the minds of development economists, the irrigation project is such a Project and technology transfer an Ideology: it was up to the poor, helpless and hopeless victims of the Narmada Project to show World Bank economists that dams can be evil too.
Innovation chain and risk
Anthropologist Shiv Visvanathan used the term ‘innovation chain’ as a metaphor for the way science, technology, innovation, commodification, investment, markets, profits, etc combine in the era of globalisation, to shape the world we live in. (See Box 2.)
The innovation chain is like the bicycle chain that runs between two axels. The ‘core’ creates knowledge, uses it to manufacture a new commodity, and markets it in the ‘periphery.’ The innovation chain connects this core and periphery. Commoditised knowledge is conveyed along the chain to the periphery, and the periphery’s wealth (and raw materials) is conveyed back to the core. The core consists of industrialised, knowledge-creating countries; the periphery consists of the markets in underdeveloped and industrialised countries.
The wealth accumulating in the core then enables it to invest in research and more knowledge creation, helping to maintain its knowledge hegemony. The periphery continues to underdevelop. Here, ‘knowledge’ is not the state of enlightenment that we traditionally hold in high regard, but rather a composite term for a loose packing of some selected items of science, innovation and commodities.
As sociologist Ulrich Beck wrote in the 90s, when technology’s effect upon the environment shifts from visible ‘hazards’ (such as garbage and vermin) to invisible ‘risks’ (such as radioactivity and arsenic in water), the focus changes from the distribution of wealth to the distribution of risk. The risk of technology is then globally redirected to the periphery: beggars can’t be choosers. While French nuclear power research lights up houses in Paris, its nuclear waste is deposited near the ‘French’ Polynesian islands. Closer home, the rich in the north-central province now consume bottled water from the hills to avoid chronic kidney disease, and the land value in the vicinity of the Maharagama cancer hospital is plummeting as buyers avoid the risk of cancer.
Science and society
In modernity, what gives the chain its legitimacy in the public’s eye is science. The scientific mode of inquiry is certainly a good thing with much potential. Butthe scientific enterprise is a social institution that serves the powerful – from Archimedes to Imperial Science to Monsanto Science, etc.
The scientists are (to use sociologist Lewis Coser’s terms) merely ‘mental technicians,’ not ‘freely speculating minds.’ While scientists and professionals are busy with their number-crunching tasks, science itself is re-directed to serve the interests of those who command the chain. A new Science Discourse is brought forth to legitimise the chain in our eyes; it appropriates the language of science, but serves the interests of commerce and feeds upon our consumerism.
On our part, we easily mistake the commodities – which is the form in which knowledge is packaged and delivered to us – for the science. There is a science apart from such commodities (e.g., ‘appropriate technology’), and that may be more effective and cost-beneficial, and less harmful, than the commodities we consume.
The Science Discourse lulls us with the ‘scientific value’ of the commodities. Jean Baudrillard wrote of consumerist America: “The only physical beauty is created by plastic surgery, the only urban beauty by landscape surgery, the only opinion by poll surgery.”
Science in medicine
The current biomedical establishment has its own Science Discourse, called ‘evidence-based medicine’ (EBM), which arose with much innocence in the nineties.
Modern medicine was always evidence-based since William Harvey, but what EBM did was to create a hierarchy for the evidence. There are several types of studies that could yield useful evidence, but the randomised controlled trial (RCT, see Box 3) was given priority over all else. The large, double-blind, multi-center RCT, involving tens of thousands of patients, conducted by academic medicine departments and analyzed by statisticians and research epidemiologists, became the new site for legitimising knowledge for medical practice.
Caught
It did not take long for EBM to subsequently get caught in the innovation chain.
EBM decreed the hierarchy of evidence for the doctor, with the RCT at its top. Thereafter, relying upon evidence ‘lower down’ in the hierarchy became unacceptable, even ‘unscientific’ and ‘unprofessional,’ once evidence from ‘higher up’ was available. Soon, the biopharmaceutical industry used the RCT to control the ordinary doctor’s prescription. Manipulating the results of an RCT became a subtle, effective way for the industry to misappropriate the ordinary doctor’s judgement of what is best for the ordinary patient sitting in the ordinary clinic. Over the years, medicine itself has become rewritten as a series of questions and answers provided by RCTs.
Ideally, we would have had scientists and professionals identifying important medical problems, devising solutions in the laboratory, and finally testing them out in RCTs where possible. But in real life, the biopharmaceutical industry identifies market potentials instead of medical problems (or creates a market, using the media and the Internet), manufactures a drug that has a potential to monopolise the market niche, conducts an RCT to ‘manufacture’ the ‘evidence’ also, and then markets it. The task of manufacturing the evidence was taken up by a new service industry: contract research organisations (CROs).
Most often, the new drug is not really new, but is simply a slight molecular modification to an already existing drug which has not saturated the market, merely circumventing the pre-existing drug’s patent rights – the so-called ‘me-too drugs’ that copy ‘blockbuster drugs,’ using ‘molecular development’ in state-of-the-art, industry-sponsored laboratories.
In today’s world of ‘knowledge creation,’ the scientist’s value lies in the funds she receives for her research – and funds are disbursed according to market needs. Science, and with it scientists, has lost its way.
Risk
When people in industrialised countries (the core) became aware of these issues, the industry found it increasingly difficult and costly to conduct RCTs there. As a result, it began shifting RCTs to countries in the semi-periphery (e.g., Singapore) and periphery (e.g., India).
Here, medical consultants can be easily ‘identified’ and unsuspecting patients cheaply recruited, especially for hazardous drugs. The same medical consultants do their ‘rounds’ in ethics committees, clinical trials registries and hospitals conducting RCTs, and are sometimes handsomely paid according to the number of patients they recruit for RCTs. Their collusion enables the conduct of RCTs at cheaper cost, in less demanding legal settings, and with less resistance from a less informed public. Gradually, the CRO industry began making inroads to the underdeveloped countries, to exploit their ‘biomass.’
Thus, we have the banality of a new kind of evil: The exploitation of the biomass of the periphery, caught in the medical innovation chain. The biomass in the periphery receives the risk for the creation of the knowledge, which leads to tomorrow’s commodity: the latest ‘evidence-based,’ safe, efficacious, expensive medication, unavoidable in the consumerist society. To paraphrase Baudrillard, the only health is the health created by these pills and gadgets.
(The writer teaches medicine at the University of Colombo.)
Box 1: The Holocaustand modernity
“The Holocaust could not have been carried out except by a modern state. It relied on industrialisation, large-scale production and technological developments to create gas chambers and mass crematoria. It needed railways to transport people. Most important of all it required ‘rational,’ ordered bureaucracies which could identify, process and transport the victims, as well as order the killings without themselves being directly involved in the process.”
From Clive Ponting’s World History (Pimlico, 2000).
“The Holocaust could not have been carried out except by a modern state. It relied on industrialisation, large-scale production and technological developments to create gas chambers and mass crematoria. It needed railways to transport people. Most important of all it required ‘rational,’ ordered bureaucracies which could identify, process and transport the victims, as well as order the killings without themselves being directly involved in the process.”
From Clive Ponting’s World History (Pimlico, 2000).
Box 2: Innovationchain and treadmill of production
The concept of the ever-accelerating ‘treadmill of production’ (by sociologist Alan Schneiberg in the eighties), discussed the increasing conflict between industrial expansionism and environmental degradation in industrial society in the sixties and seventies. The concept of ‘innovation chain’ expands this. Whereas the ‘treadmill’ related to industrial society (mainly Western Europe and North America), the ‘chain’ successfully integrates core and periphery together in one conceptualization, befitting the era of globalization that emerged after the nineties.
The concept of the ever-accelerating ‘treadmill of production’ (by sociologist Alan Schneiberg in the eighties), discussed the increasing conflict between industrial expansionism and environmental degradation in industrial society in the sixties and seventies. The concept of ‘innovation chain’ expands this. Whereas the ‘treadmill’ related to industrial society (mainly Western Europe and North America), the ‘chain’ successfully integrates core and periphery together in one conceptualization, befitting the era of globalization that emerged after the nineties.
Box 3: The RCT
The RCT determines the efficacy of a drug in real-life patients, by randomly giving the drug to one group of patients and a placebo to another group; any difference between drug group and placebo group is evaluated for significance, using statistical analysis. Although the idea goes back to James Lind (‘limey’ sailors, 1747) and Ignaz Semmelweis (hand washing and puerperal sepsis, 1847), it was designed in the current format by Arthur Bradford-Hill and first used by the Medical Research Council (UK) in 1947 (streptomycin for tuberculosis), and popularised by Archie Cochrane in a landmark article published in 1971.
The RCT determines the efficacy of a drug in real-life patients, by randomly giving the drug to one group of patients and a placebo to another group; any difference between drug group and placebo group is evaluated for significance, using statistical analysis. Although the idea goes back to James Lind (‘limey’ sailors, 1747) and Ignaz Semmelweis (hand washing and puerperal sepsis, 1847), it was designed in the current format by Arthur Bradford-Hill and first used by the Medical Research Council (UK) in 1947 (streptomycin for tuberculosis), and popularised by Archie Cochrane in a landmark article published in 1971.