Two prominent indian physicians recently described the clinical trials of new drugs in India as a ‘new colonialism’. In an article published by a leading us medical journal, Samiran Nundy and Chandra Gulhati drew particular attention to ‘illegal and unethical trials’ conducted without regulatory approval.footnote1 But a moral critique of this kind, however legitimate in its own terms, does not adequately grasp the network of economic and social relations that the international health industry has established on a global scale. Even if all clinical trials conducted in India or other Third World countries adhered to the letter of the law and the spirit of ethical codes, the very structure of this network would remain one of exploitation. I shall outline here the dynamics of clinical trials in India, focusing especially on the huge capacity currently being built up in anticipation of the transfer of global trials to the subcontinent. This will provide a basis for interpreting the phenomenon in terms of concepts developed by myself and others currently researching this field, particularly those of biocapital and surplus health.
Clinical trials are the set of practices required to certify a new drug molecule as safe and efficacious for the market.footnote2 In the United States, the clinical-trials procedure is an elaborate one, conducted in a number of stages and contributing to the immense time, risk and expense of the drug development process. First, there is pre-clinical toxicological testing of a potential new drug molecule. This is usually performed on animals, in order to determine whether the molecule being tested is safe enough to put into a living system. The second stage is that of dosage studies, designed to come up with a metric for the dose of the drug to be administered. Predictably, the efficacy of a drug increases with its dose, but so too does its toxicity; the aim is therefore to find an optimum range within which efficacy is maximized without too greatly compromising safety. If the drug is too toxic when tried on animals, the trial will not proceed any further, but if acceptable dose ranges can be determined, the third stage is a three-phase trial in humans. Phase 1 trials are conducted on a small number of healthy volunteers to test the drug’s basic safety, since drugs that seem safe in animals may still show adverse effects in humans. Phase 2, which serves as a bridge, involves larger, scaled-up efficacy and safety trials on as many as a few hundred subjects, who may be either patients or healthy individuals. Phase 3 involves large-scale randomized trials on several thousand people, usually patients suffering from the ailment for which the therapy has been developed. These trials are frequently co-ordinated across multiple centres, increasingly on a global scale.
The sponsors for trials are generally biotechnology or pharmaceutical companies, since drug development in the us and most other parts of the world is undertaken largely by the private sector. Universities and publicly funded laboratories play a major role in the early stages of discovery—the identification of potential lead molecules and the conduct of pre-clinical tests—but the institutional structure of drug development is such that they increasingly license promising molecules to corporations that take them through clinical trials. This means that the biomedical and experimental rationales for clinical trials are completely entwined with the market value these companies see in the drugs that eventually get developed, and the market risk that attends the drug development process. According to the Healthcare Financial Management Association’s newsletter, ‘twenty years ago, 80 per cent of clinical research trials were conducted through academic medical centres. In 1998, estimates indicated the number of [these] centres as investigator sites had dropped to less than half.’footnote3 Health research and production is thus progressively captured by capital, and now needs to be seen as a semi-autonomous branch of it.footnote4 The organizational complexity of clinical trials does however mean that it has been hard for pharmaceutical companies to manage them, leading to the emergence of an entirely new sector devoted to the management and administration of clinical trials. These companies, known as clinical research organizations (cros), are now an integral part of the overall biomedical economy.
The movement of clinical trials to international—non-us—locations started in earnest in the mid-1990s. Adriana Petryna cites figures that point to a dramatic growth in the number of human subjects recruited into these trials, from 4,000 in 1995 to 400,000 in 1999.footnote5 A recent study by the consulting firm A. T. Kearney shows that roughly half of the 1,200 us clinical trials in 2005 made use of an international site.footnote6 In the 1990s, as Petryna notes, most of this growth occurred in countries that had agreed to harmonize standards in commercial drug testing with the guidelines set by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. These primarily included Latin American and Eastern European countries, but not yet India. Over the past two years, however, India has become one of the most dynamic sites for the establishment and growth of clinical research.
In India, a range of local actors currently see the country as providing an extremely attractive destination for outsourced clinical trials from the West. Contract research in the Indian pharmaceutical industry is already robust, and was estimated by the Chemical Pharmaceutical Generic Association to be worth between $100 and $120 million in 2005, while growing at 20 to 25 per cent per year.footnote7 A further influx of global clinical trials is eagerly awaited. Who are these actors, and upon what do they base their expectations?
The most central, perhaps, are members of the burgeoning cro industry. These are the most immediate beneficiaries of trials coming to India, and are therefore keen to create conditions for these trials to grow in a sustained and streamlined fashion. cros are the major drivers of the build-up of clinical-research infrastructure, and particularly influential in building a regulatory framework for the conduct of trials. It is estimated that there are approximately a hundred cros of reasonable size operating in the country at the moment. Some of these are fairly well established, with a couple being fifteen to twenty years old. A number of the better-known cros were seeded in the late 1990s; many, however, have emerged only in the very recent past.
The Indian pharmaceutical industry is another interested party. It is in the process of retooling its business model in the wake of India’s signing of the patent regime imposed by the wto. Indian patent laws formerly allowed only process and not product patents on therapeutic molecules. This meant that one could not patent a drug itself, only the specific manufacturing process that produced it—allowing Indian pharmaceutical companies to reverse-engineer generic versions of drugs that had product patent protection in the West. The wto regime now rules out such reverse engineering for the twenty-year duration of the patent. This has forced a number of leading Indian drug companies into an r&d-driven business model, whereby they, like their Western counterparts, engage in the much riskier process of new drug discovery and development. Clinical trials become a constitutive part of this business model, because new drugs cannot be developed without subjecting them to an elaborate regime of safety and efficacy testing. In other words, the Indian pharmaceutical industry has itself served as a spur to the cro sector. wto entry may also have made India a more attractive research destination from the perspective of Western trial sponsors seeking to outsource, since their intellectual property is better protected under such a regime.