Jump to ContentJump to Main Navigation
Contested KnowledgeScience, Media, and Democracy in Kerala$

Shiju Sam Varughese

Print publication date: 2017

Print ISBN-13: 9780199469123

Published to Oxford Scholarship Online: February 2017

DOI: 10.1093/acprof:oso/9780199469123.001.0001

Show Summary Details
Page of

PRINTED FROM OXFORD SCHOLARSHIP ONLINE (www.oxfordscholarship.com). (c) Copyright Oxford University Press, 2018. All Rights Reserved. Under the terms of the licence agreement, an individual user may print out a PDF of a single chapter of a monograph in OSO for personal use (for details see www.oxfordscholarship.com/page/privacy-policy). Subscriber: null; date: 22 January 2019

Public Regulation of Science

Public Regulation of Science

Clinical Trials at the Regional Cancer Centre

Chapter:
(p.77) 4 Public Regulation of Science
Source:
Contested Knowledge
Author(s):

Shiju Sam Varughese

Publisher:
Oxford University Press
DOI:10.1093/acprof:oso/9780199469123.003.0004

Abstract and Keywords

The chapter discusses how an internal conflict between two groups of researchers within the Regional Cancer Centre at Thiruvananthapuram in the context of clinical trials triggered a public controversy on the regulation of drug research. The credibility of the cancer research institute was at stake, and the public trust on the researchers deteriorated. The chapter demonstrates how the trust in the scientific community has been regained and the credibility of the institute restored through a complex deliberative process wherein media institutions, scientists, health activists, government officials and national regulatory bodies participated. The involvement of the Johns Hopkins University, USA, in the clinical trials triggereda debate on the changing dynamics of drug research in the neoliberal context. The controversy was one of the earliest of its kind which alerted the medical research community and policy makers about the escalating commercial interests in the drugs and pharmaceuticals sector in India.

Keywords:   biomedicine, civic culture of policy making, clinical trials, contract research organization (CRO), drug research, ethics of research, neoliberal science, patients’ rights, regulatory science

The outbreak of and the subsequent negotiations over a dispute among the scientists at one of the most prestigious medical research institutions in Kerala, the Regional Cancer Centre (RCC) in Thiruvananthapuram, which is the most important cancer research and therapy centre in the state, is the focus of this chapter.1 The functioning of the institute and its role as a research institute came under public scrutiny in the aftermath of a scientific controversy that appeared in the regional press in July 2001. The controversy revealed the internal conflicts within the scientific institution and the ambiguities surrounding scientific knowledge production practices in biomedicine. It raised serious concerns about the ethical protocols in research, scientific collaborations with Western research institutions, changing configuration of biomedical research under neoliberalism, and patients’ rights. Public anxiety about subjecting unassuming patients who seek cancer treatment at the institute to undisclosed medical experiments was central to the evolution of the controversy. It particularly offers us insights into the regulatory mechanism that came under public scrutiny. The controversy was one of the earliest of its kind that alerted the medical research community and policy makers about the escalating commercial interests in the drug and pharmaceutical sector in India.

The events that triggered off the controversy occurred between 12 November 1999 and 8 April 2000, when 27 oral cancer patients awaiting surgery were injected with chemical substances called tetra-O-methyl (p.78) nor-dihydro-guairetic acid (M4N) and tetraglycinal nor-dihydro-guairetic acid (G4N) (Krishnakumar 2001). These phase I clinical trials carried out at the RCC through a contract research organization (CRO) called Quintiles India2 were part of an ongoing drug research carried out by Dr Ru Chih C. Huang, faculty member of the Krieger School of Arts and Sciences of the Johns Hopkins University (JHU), USA (Krishnakumar 2001).3 The clinical trials were administered by the research team at the RCC, headed by Dr M. Krishnan Nair, the then director of the institute.4

Dr V.N. Bhattathiri, Associate Professor of Radiotherapy at the institute,5 filed a complaint regarding the clinical trials with the Human Rights Commission (HRC) of Kerala on 18 March 2001 (Krishnakumar 2001). The complaint ‘sought a detailed inquiry, appropriate action for the violations and preventive steps’, and stated that Dr Krishnan Nair, who was the ‘principal investigator’, should be held responsible for the unethical drug trials (Krishnakumar 2001: 124). The complainant also contended that the clinical trials had been performed before the study was sanctioned by the Drug Controller General of India (DCGI) (Krishnakumar 2001). Civil society organizations and a Malayalam television channel called Surya TV initially brought the issue to public attention. The TV channel’s prime time programme called Aniyara,6 which used to discuss issues of political and social concern with a flavour of investigative journalism, took up the issue and constantly followed it up.7 Slowly the issue developed into a public controversy when the regional press took it up, opening an intense public deliberation. Although it remained unacknowledged by most of the regional newspapers, the role of Surya TV was crucial in exposing the issue. It should also be noted that without the intervention of the newspapers, the dispute would not have probably prompted public deliberations that continued for the next six months.

Drawing the Battle Lines

The issue was first reported in the newspapers in July 2001 when a petition was submitted to the chief minister (CM) of Kerala,8 demanding a proper enquiry into corruption and other ‘disorders’ in the RCC, and a news report on the petition appeared in Madhyamam.9 It was stated that the chemicals involved in the clinical trials had already been banned in many of the developed countries. The petition alleged that the RCC (p.79) had injected a chemical substance that catalysed cancerous growth in patients without their consent and exported the malignant tissue collected from patients to the JHU for further research.10 The petition was not reported in other newspapers, but Surya TV’s reporting invited wide public attention. After a while, Madhyamam reported a demonstration organized by the Thiruvananthapuram district committee of the Youth Congress in front of the RCC, demanding a vigilance enquiry into the clinical trials.11 Other newspapers continued with their silence, indicating that the battle lines were fixed well in advance, before the issue erupted into public view: Dr V.N. Bhattathiri, Surya TV, and Madhyamam were on one side, and the director of RCC, Dr Krishnan Nair, and the other newspapers on the other side.12

The divide became more noticeable in the following days. The news report in Madhyamam attempted to expose the ongoing conflict within the RCC over the corrupt practices of its director and his allies. The newspaper referred to the verdict of the Kerala High Court on a petition filed by Dr V.N. Bhattathiri regarding his removal from the chairpersonship of the Head and Neck Clinic.13 The petition was filed in the wake of a major administrative reform in the RCC, when new speciality clinics were inaugurated in the institute. Interestingly, it was only Malayala Manorama and Kerala Kaumudi—the two main dailies which backed the RCC director throughout the deliberations—which reported the administrative reforms in the institute and the reports were highly appreciative of the reforms.14 The High Court urged the RCC to settle the seniority dispute amicably within the institute.15 After the High Court’s verdict on the issue, the Citizen’s Protection Forum of Thiruvananthapuram filed a public interest litigation (PIL), questioning the administrative reforms that denied the right of the patients to consult the doctor of their preference, and questioned the director’s right to regularize temporary appointments.16 The PIL also demanded cancellation of a recent extension of the tenure of the director. The allegations clearly show that the conflict within the institution was multifaceted and with a long history, finally generating public debate as a controversy over the clinical trials.

All the newspapers continued to ignore the issue even at this stage of high newsworthiness,17 but Madhyamam carried on with its exposition of the malpractices in the institute. It reported the ban on the research projects of the School of Medicine of the JHU by the US government,18 (p.80) emphasizing the ethical violations involved in the clinical trials undertaken by the RCC for the JHU. This ban was enforced following the death of Ellen Roche, a healthy woman who was a volunteer for the clinical trial of a drug used to treat asthma, allegedly due to the injection of an experimental drug.19 It was reported that the state withdrew all federal funding to the School of Medicine of the university and criticized the researchers for not informing the volunteers about the possible side effects of the drug.20 The news report in Madhyamam, thus, suggested the inhuman nature of the medical research being carried out at the JHU and made public the research collaboration between the university and the RCC.

These preliminary interventions of different actors that included a scientist, a television channel, a newspaper, and a few civil society organizations were minimally successful in pushing the issue into the public domain. The RCC administration that had thus far been silent was now forced to speak, and it responded to the allegations through the newspapers which had been defending the institute through their active silence so far. This was the moment of initiation of the scientific public sphere. The newspapers in the following days reported intensely on the controversy, spinning it into rigorous public deliberation and in due course enrolling a wide range of actors. Kerala Kaumudi reported the RCC administration’s ardent denial of the allegations, pointing out that it was not NDGA (nor-dihydro-guairetic acid), which had been banned by the Food and Drug Administration (FDA) in the United States, that was administered but M4N, a derivative of NDGA, which was neither fatal nor banned.21 It was also stated in the news report that M4N was found to be completely secure in the first phase of the experiment in different countries including the United States. The research institute further claimed that its ethical committee had actually approved the clinical trials and consent had been obtained from all the 25 patients to whom the drug was administered.22 The argument was further supported when Dr Krishnan Nair, the senior researcher who was responsible for the clinical trial, released a press note defending the experiment.23 Dr Krishnan Nair reiterated that the drug used for the clinical trials was not a banned drug and that it did not have serious side effects, but rather had a positive impact on the majority of patients. It was also claimed that out of the patients, 1624 were cured and 5 responded positively, only 1 patient showed the development of (p.81) a secondary tumour. Responding to an allegation that 2 patients who had been subjected to the clinical trials died,25 the director suggested that the drug was not the cause of death, but medical complications such as diabetes were to be held responsible (Krishnakumar 2005).26 The careful bracketing out of the death of the patients from the reporting of the success of the experiment also should be noted here. Dr Krishnan Nair said that Dr Ru Chih C. Huang and her team would arrive on 2 August and conduct a press conference explaining the research project to the media (Krishnakumar 2005).27

Governmental Interventions

The dispute entered a new phase during the following days when A.K. Antony, the then CM of Kerala, entered the scenario with a damage control mission. All the five newspapers began reporting the issue from this point. The long silence of many of the newspapers on the dispute was broken by now, and the control over the reins had gone out of the hands of the backstage managers who had tried to suppress the controversy’s public outbreak so far. The CM declared that his government was highly concerned about the unfortunate developments and would enquire into the charges of the malpractices in the RCC, though utmost care would be taken to safeguard the credibility of the institute.28 The CM also hinted that punitive measures would follow if the allegations were confirmed.29 The central government was also reported to be concerned about the issue.30

Such statements from the government had a very strong impact on the debate, although the state was clearly performing its conventional role of safeguarding the scientific institution from public exposure. In the following days, the RCC administration became very vocal in their denial of the allegations. It was reiterated that the drug used in the RCC was the harmless M4N31 and not the banned NDGA.32 It was explained that these were two different chemicals and unlike the latter, M4N did not dissolve in water and thereby did not affect other organs.33 This explanation was to refute the allegation that the drug under experiment affected mainly the liver and the kidneys. The tumours were removed from the patients 72 hours after the drug was injected in order to conduct pathological tests, the administration explained.34 It is important to note that the controversy was no more limited to the external ‘social’ (p.82) aspects of the experiment; rather, the core ‘technical’ aspects of the experiments were mooted and debated in the scientific public sphere and the researchers were forced to defend their research by divulging out more and more scientific details.

The RCC emphasized the transparency of the clinical trials when they contended that the patients were informed about the experiment a priori and that a letter of consent was signed by all the patients and their relatives.35 It was emphasized that treatment was provided free of cost to the patients, adding a humanitarian and ethical dimension to the clinical trials in their attempt to safeguard themselves from public ire. Such research projects had to be undertaken by the RCC since it was part of its mandate as a leading cancer research institute, the public was told.36 It was clarified that the anti-viral agent developed by the JHU was also undergoing clinical trials in South Korea to indicate that the clinical trials in the RCC was a common research practice.37 In India, the institute revealed, the ethical committees of the Banaras Hindu University (BHU) as well as the J.K. Cancer Institute at Kanpur had agreed to collaborate with the research project of the JHU.38 A similar study on the impact of the drug on skin cancer was to be undertaken in Singapore.39 Such references were used to reassure the public about the wide social acceptance of clinical trials as well as to emphasize its status as a normal and integral part of science. This move was intended to check the erosion of public trust in the institution as well as the credibility of the RCC clinical trials.

Interestingly enough, the RCC also warned that any public criticism of scientific research would affect the progress of the institute as well as the trust of the patients admitted to the institute.40 It was pointed out that such negative criticism would discourage international research institutions and multinational drug companies from entering into research collaboration with the institute. The RCC administration was clearly attempting to situate the institute as possessing a high global reputation as a frontier research institution—any attempt to bring politics into science, hence, would be detrimental. The endeavour of the RCC administration to defend the institution was strongly supported by the RCC Employees’ Association when it demanded an immediate scrapping of the public debate on the issue.41 The Employees’ Association pointed out that any public debate on the issue would only tarnish the reputation of the RCC, and (p.83) hence insisted on an immediate withdrawal of all the parties from the controversy.42

The RCC director called for a press conference43 in which he reiterated the earlier arguments, but ostensibly divulged more technical details about the contract research project. He claimed that the experiment had been continuing at the RCC since 1998, and the patients were chosen for clinical trials with the permission of their doctors.44 The director pointed out that none of the doctors had opposed the clinical trials at that stage.45 He also stated that the drug (M4N) was a derivative of NDGA developed by the JHU. The drug was proven to be harmless and effective in experiments conducted on 36 mice. Following the success of the experiment on laboratory animals, the JHU approached the RCC for undertaking clinical trials on humans, the journalists were told.46 The RCC was approached because the drug was targeted at oral cancer, which was very common in India.47 The RCC had received 2.5 million rupees per year for the clinical trials. The director also clarified that the RCC and the JHU would equally share the royalty of the patented drug as collaborators in the project, which later turned out to be a blatant distortion of facts.48 Nevertheless, he offered to enquire into the allegation that another chemical substance called G4N was experimented at the RCC though the ethical committee of the institute had granted clearance solely for the trials of M4N.49 Dr Krishnan Nair agreed that the approval from the DCGI was not received despite moving the application in September 1999.50 Although the role of the institute was minimal in conducting the test of the drugs under trial on humans for a Western research institution, the RCC administration and its director continuously tried to confuse the public by projecting the experiment as a collaborative research with a world renowned university department in the United States.51

A few days later, the regional press reported that an enquiry had been ordered by Dr C.P. Thakur, the then health minister of the Government of India (GoI).52 The minister emphasized that the enquiry would also look into whether M4N had been banned in the United States.53 The state government in turn appointed a single-member enquiry committee (the Purvish Parikh Commission) to probe into the clinical trials controversy.54 The HRC of Kerala accepted the complaint filed by Dr Bhattathiri and summoned the RCC director to appear before it since the RCC failed to submit an explanatory report on the clinical (p.84) trials as demanded by the commission.55 In its editorial, Mathrubhumi raised the legal and ethical issues associated with the controversy and demanded a judicial enquiry into the matter.56

The intervention of the state government was, however, not wholeheartedly welcomed by the rival coalition. Dr Bhattathiri criticized the state government for trivializing the issues he had raised by appointing Dr Purvish Parikh, who was a junior doctor, as the single-member enquiry commission.57 Bhattathiri demanded that a committee consisting of medical and legal experts and social activists in lieu of the Parikh Commission be instituted to carry out a proper investigation into the dispute.58 Following Dr Bhattathiri, the Madhyamam criticized the creation of a single-member commission, pinpointing the allegation that the objective of the commission was to safeguard the RCC director who was quite influential at the governmental level.59 The newspaper also pointed out that Dr Krishnan Nair and Dr Purvish Parikh were friends and that they had even co-authored a research paper.60 By challenging the technical and moral legitimacy of the expert committee, rival actors were trying hard to expose the tacit nexus between the state government and the RCC administration. They strongly opposed the governmental strategy to salvage the RCC and its researchers.

Strengthening of Coalitions

The entry of governmental regulatory mechanism stirred up the controversy, offering space to new actors who added fresh dimensions to it. The newspapers continued to be allies in the already formed coalitions, but by this time they had begun to report the opponents’ arguments more openly, stripping down the veil of silence. This openness of the media indicated that the controversy had gained full momentum by then, growing beyond the control of any single actor or coalition. The deliberations during the following days indicated that the rival coalitions were gradually acquiring legitimacy and acceptance with the public. This was catalysed by the JHU’s direct entry—the university published a disclaimer on its website denying any association with the clinical trials undertaken by the RCC. This denial was widely reported, and it was highlighted in the regional press that no financial assistance was offered by the university to the research project undertaken by the RCC,61 and Dr Ru Chih C. Huang had been directed to withhold the (p.85) research.62 The university administration constituted an enquiry committee to probe into the allegations and stated that punitive action would be taken if the protocols and code of conduct of the university were breached by its faculty member.63 This act from the side of the JHU devastatingly eroded the public support and trust enjoyed by the RCC and its researchers. The deterioration of public trust in the institute and the gradual public recognition of the rival scientists’ arguments led to a diversification of the subjects debated and hence expanded the scope of the controversy.

The ethical and political aspects of the medical research were a crucial concern in the scientific public sphere at this juncture and the newspapers cultivated such a debate by presenting expert opinions. Malayala Manorama on its editorial page presented the arguments of the RCC director and the counter arguments of Dr C.R. Soman, a public health expert with great public acclaim for his timely interventions as a public intellectual and social activist.64 In his article, Dr Krishnan Nair contended that the controversy was part of an ongoing slander campaign against him and the RCC.65 On the contrary, Dr Soman’s arguments were strictly impersonal and technical. He pointed out that M4N was not radically different from the banned drug, as the former was a tetra-methyl derivative of NDGA, the basic molecule.66 He also argued that G4N which had been used in the clinical trials along with M4N was a tetra-glycinal derivative of NDGA. Further, he explained that the primary objective of the research was to test whether these chemicals would decelerate the growth of the human immuno virus (HIV) and later it was tested specifically in the treatment of oral cancer, and to study its impact on the growth rate of the human papillomavirus (HPV). Dr Soman alleged that the protocol for medical research was not properly followed by the JHU and the RCC as the chemical was directly administered to human beings after conducting experiments on mice. The drug under trial was injected into cancer patients who were not in a critical stage of the disease, he noted. He pointed out that this was against medical research ethics which allow such dangerous clinical trials only on chronic patients for whom all available treatment had been exhausted. Dr Soman contended that it was not possible to say that the chemicals did not cause any side effects, because it was for the first time that clinical trials were being performed anywhere. The argument that the RCC ethical committee had approved the clinical (p.86) trials was preposterous, he pointed out, since the RCC director himself was the chairperson of the committee. He also alleged that a new drug company was registered in Singapore to manufacture the drug, if the research was successful. The claim that the RCC would get royalty for the research was rejected by him, showing that the JHU exclusively owned the patent for the drug. Based on these arguments, Dr Soman emphasized the unethical and unlawful nature of the RCC clinical trials.

The editorial page articles in Malayala Manorama presented the pros and cons of the controversy by providing space for the RCC director and Dr Soman under the guise of ‘media neutrality’, despite the newspaper’s open defence of the RCC. This indicates that even though a powerful ally of the RCC in the controversy, the newspaper was forced to enter into a dialogue at this stage, relinquishing its early strategy of suppressing the dissenting actors. The entry of Dr Soman as a strong associate, who had great public reputation as a medical science expert, made the rival coalition more powerful and he became the main protagonist of the rival coalition henceforth. On the other hand, the RCC director’s attempt to gain public sympathy by construing the controversy as a slander campaign against him backfired. A lot of technical information about the clinical trials had already been available in the public domain, helping other actors to construct their own arguments. The rival coalition’s success at this stage was largely due to their skilful presentation of new and relevant interpretations of the case based on these resources.

The internal ambiguities of medical research became the focus of discussion as the controversy unfolded in the following days. Two public discussions on the controversy organized by the Forum for Patients’ Rights (FPR)67 and the Indian Medical Association (IMA) were widely reported in the regional press, influencing the course of negotiations in the subsequent days. In the debate on 2 August 2001 at Thiruvananthapuram organized by the FPR, a strong opponent of the clinical trials, the prevalence of similar unethical research practices in different parts of the country was noted.68 The forum demanded a judicial enquiry into the issue.69 Advocate Vincent Panikkulangara, who was an activist of the forum, pointed out that a ‘chemical substance’ and not a ‘drug’ was injected into the patients and explained that a chemical substance under clinical trial attained the status of ‘drug’ only after (p.87) getting the approval of the DCGI.70 This ontological rephrasing seemingly aimed at drawing public attention to the risk dimension involved: it was no more a drug, but a risky chemical substance that had been injected into the unassuming patients. He opined that a doctor did not have the right to prescribe a chemical substance masquerading as a drug to a patient.71 Dr V.N. Bhattathiri reiterated his earlier statement that the Parikh Commission was simply a charade established to rescue the culprits.72 He also denied the charge that his expose of the issue to the public would damage the institution since such a move was inevitable to safeguard ‘public interest’.73 At the meeting, Dr Gangadharan, another member of the rival group of RCC researchers, described the unethical administration of the drug under research to Mr Gopal, a patient from Tamil Nadu, without his or his doctor’s consent.74 It was alleged that the procedural lapses in the experiments thus amounted to human rights violations.75 In general, the meeting concluded that the clinical trials were proof of the unethical practices and human rights violations prevalent in the field of medical science research in the country. The FPR seminar thus led to the consolidation of the voices of the opponents of the RCC clinical trial.

This public mood was further accentuated by the ‘open debate’ organized by the IMA, on 3 August 2001, titled ‘Drug Trials: Right and Wrong’.76 While the FPR seminar accorded space exclusively to the opponents of the clinical trials, the IMA seminar was inclusive in terms of participation. Therefore, the regional press extended wide news coverage despite the seminar ending in pandemonium followed by heated arguments between the rival groups. The forum resolved that transparent guidelines had to be developed for medical research and expressed its concern over the erosion of public trust in the RCC.77

The erosion of public credibility of the RCC, which was simultaneously a research institute and a super-speciality hospital, was pointed out by several actors. A.K. Antony, the then CM of Kerala, requested the rival groups of scientists as well as the media to abstain from any act that might damage the reputation of the RCC.78 He pointed out that the RCC was an institution that acquired its fame as a result of years of painstaking hard work.79 The CM cautioned the scientists against any attempt to take the issue to the streets as it would end up in the decline of the institute.80 He also pointed out that the state government, the central government, the HRC, and the High Court had been (p.88) investigating the issue and therefore a public, ‘political debate’ on the issue was unnecessary.81 And it was more or less mandated by him that any destructive move against the institute would be regarded as a serious public offence.82 The CM’s intervention was in line with the state’s endeavour since the beginning of the controversy to insulate the institute from public scrutiny. The statement also indicated the government’s fear of the role of the mass media in exposing the political dimensions of science.

This pro-RCC statement by the CM did not go unopposed. M.N. Vijayan, a renowned Marxist intellectual of Kerala, wrote an editorial in the Deshabhimani magazine83 that was quoted widely in the regional press, suggesting that the actors in the scientific public sphere largely endorsed his views. He strongly argued for the public deliberation of science for effective governance of science and denied RCC the privilege of immunity from public scrutiny. The CM’s statement that justified unscientific and inhuman research in the RCC, in his opinion, went against the democratic spirit.84 He emphasized the need for democratization of medical research while arguing that patients’ consent was imperative for the conduct of such experiments on their bodies.85 Similarly, in a statement issued by the EMS Cultural Forum, a leftist outfit, the opinion of the CM was criticized for his defence of Dr Krishnan Nair and the unethical clinical trials.86 The debate on safeguarding scientific institutions from social audit thus was critiqued, to assert that public deliberations were inevitable for better governance of scientific institutions. Staging of public deliberation over science in mass media was hence ascertained as a greatly positive, democratic practice to be cultivated. This also indicated that the actors and newspapers were well aware of what they were doing; they defined their participation in the scientific public sphere as a highly moral action that aimed at democratizing science.

However, the pro-RCC coalition gradually recuperated from the lethargy of loss of credibility by forming a strong defence of the institution through the enrolment of more actors. The CM’s open defence was a huge motivation for the supporters of the RCC and a great hue and cry was raised against the rival coalition’s attempt to spoil the institute’s reputation. The RCC Doctors’ Association and the Employees’ Association strongly supported the researchers and demanded action against Dr Bhattathiri and Dr Gangadharan for leaking the issue into (p.89) the public domain, on the grounds of violation of service rules.87 They also asked the Surya TV and rival doctors to immediately stop the smear campaign. Both the organizations declared their solidarity with the RCC director. The health minister of Kerala also criticized the attempts to tarnish the RCC, and warned against the conspiracy mounted against the institute and its ‘dedicated’ director.88 Similar charges of character assassination of the director and defaming of the institute were raised by several public intellectuals.89 Many of them demanded the suspension of the dispute till the reports of the enquiry commissions were published or made public.90

The involvement of the JHU in the controversy urged the regional press to report the international spillover of the dispute concerning the RCC clinical trials. It was reported that the JHU had appointed a three-member commission to investigate the allegations against its involvement in the controversial clinical trials.91 Madhyamam emphasized that in the preliminary investigation undertaken by the university it was made clear that Dr Ru Chih C. Huang had not sought permission from the scrutinizing body of the university to carry out the research.92 The regional newspapers also took note of a move in the United States to amend the export law of the country to regulate clinical trials carried out on patients from developing countries.93 A journalistic report that had been published in The Washington Post titled ‘The Body Hunters’ on clinical trials performed by Western scientists in the developing countries had stirred up a big debate in the United States, the readers were told.94 Newspapers informed that the concerned law was amended in the wake of this uproar, so as to prevent the export of those drugs which were still undergoing clinical trials into Afro-Asian countries.95 After a few days, Madhyamam published another report quoting the reputed journal Science.96 According to the newspaper, Dr Manoj Pandey, one of the members of the RCC research team, had disclosed to Science that the RCC had received 19,400 dollars for the clinical trials.97 The newspaper presented it as a strong evidence against the JHU’s disclaimer on its collaboration with the RCC.98 Quoting the report in Science, Madhyamam also exposed the university’s controversial tie-up with a drug company to conduct clinical trials in four more Asian countries.99 The newspaper reported the alleged involvement of a foreign drug company called Quintiles in the RCC clinical trials.100

(p.90) Thus, a controversy originating in the violation of ethical codes in an institution had now snowballed into a larger critique of unethical practices that characterized the world of medical research and of the global politics of knowledge production. Several civil society organizations intervened in the dispute at this juncture demanding a fresh enquiry and argued for better regulatory measures in medical research. The IMA-Kerala took note of the allegations against the RCC and suo motu constituted an independent committee to investigate the case.101 The Kerala faction of the Indian Pharmaceutical Association as well as the Prathikarana Vedi102 demanded a more democratic, non-partisan, and transparent enquiry by a committee consisting of experts from different backgrounds.103 The KSSP and the Human Rights Protection Council of India pressed for strong action against those who conducted unethical and inhuman research at the RCC.104 The Prathikarana Vedi conducted its own investigations into the matter and submitted a study report to the CM, which found the RCC administration guilty of not following the guidelines for clinical trials as stipulated in the Drugs and Cosmetic Rule of 1988.105 The report noted that the ethical committee in the RCC was not constituted in compliance with the accepted standards. The forum also alleged that the Helsinki Declaration which safeguarded patients’ rights was violated by the RCC.106 Seminars were organized on the controversy by several organizations, deliberating the pros and cons of the issue.107 Most of them discussed the controversy in the light of the corrupt practices that afflicted medical research.108

The internal dynamics of medical science research, which is usually insulated from public view, thus became an open subject of public scrutiny in the context of the clinical trials controversy. The endeavour to use people of the developing countries as guinea pigs and the operations of multinational drug companies were emphasized as grave concerns for the public at this juncture, thanks to the persistent effort of the Malayalam press to report to its readers the debates taking place in the Western media. The linking of regional concerns with the debate in the West facilitated the expansion of the scope of the regional deliberations and an intense involvement of civil society organizations. There was also strong resentment about the regulatory mechanism that was introduced by the state. The governmental enquiry committees were seen as highly partial and inefficient, and civil society organizations constituted their own expert committees and research teams, which (p.91) sought to demonstrate what a robust regulatory mechanism was supposed to be. These committees included a wider range of experts.109

The patients who had been subjected to the drug trials momentarily appeared as actors in the public deliberations at this juncture, as a result of the organized effort of the rival coalition. Dr Gangadharan, advocate Vincent Panikkulangara, and the Madhyamam had a key role in bringing in the voices of the patients. Madhyamam published an exclusive report on the victimization of the patients, presenting the case of Gopal, who was suffering from cancer of the tongue.110 Gopal was quoted as suggesting that he had been unaware of the clinical trials. He alleged that when the drug under experiment was injected he had been misinformed that it was a local anaesthetic administered to remove the malignant tissue from his tongue. The news report pointed out that the document which explained the nature of the experiment that Gopal had to undergo was in English and Malayalam, and therefore he could not follow its contents, as he knew only Tamil. The drug did not produce any positive change in him and he came back again to the RCC with throat cancer, according to the news report. It was hinted in the news report that this could have been caused by the experimental administration of the drug. Gopal soon filed a formal complaint against the research team with the HRC of Kerala with the aid of his advocate, Vincent Panikkulangara.111 Dr Gangadharan also appeared before the commission and alleged that the drug had been administered to his patient without his consent.112

Later, advocate Panikkulangara appeared before the Parikh Commission and stated that two of the patients who had been administered the drug died within 50 days, and submitted the case documents from the RCC as evidence.113 Lalithamma was one of the female patients who allegedly died after undergoing the clinical trials; her son too approached the enquiry commission appointed by the central government and complained that his mother passed away after being subjected to the experiments.114 Thus, ‘the suffering of survivors became an occasion for the exercise of power’ in the scientific public sphere (Das 1995: 156). The RCC director denied the charges forwarded on behalf of the patients pointing out that the deceased was a chronic cancer patient at an advanced stage of illness and therefore her death was not caused by the drugs under trial.115 On the day when Gopal’s story appeared in Madhyamam, a joint meeting of the staff associations of the (p.92) RCC alleged that the rival scientists were trying to provoke people by propagating that the clinical trials were carried out on Dalit patients.116 They also criticized the media for selectively presenting the case of terminal patients before the public.117

The rival coalition’s strategy to employ the discursive frame of patients’ rights eventually lost ground, apparently because of the lack of convincing medical evidence to substantiate the claim that the patients developed secondary tumours due to the drugs under trial. The suffering of the patients who underwent the experiments was thus delegitimized through the effective employment of a medico-legal discourse (Das 1995). Although the attempt to raise the question of patients’ rights largely failed, the image of the patient’s body as subjected to the unethical and harmful drug trials by the medical research establishment had been actively maintained in the deliberations, thereby separating the real victims from their experience of suffering. As Veena Das has argued in the context of the Bhopal disaster, ‘every reference to victims and their suffering only served to reify “suffering” while dissolving the real victims in order that they could be reconstituted into nothing more than verbal subjects’ (Das 1995: 164). Since the RCC had been the major medical institution available in the region for cancer diagnosis and treatment, the controversy over unethical research practices was perceived in connection with the risks that the global politics of medical science research created for patients in developing countries like India. References in the public discourse to the patient’s violated body reinforced the perception of the possibility of being subjected to dangerous chemical substances under the guise of cancer treatment, while the patients who underwent the clinical trials themselves lost their voices in the scientific public sphere.118

‘Safeguard the RCC!’ The Public Consensus

However, a general consensus about safeguarding the status of the RCC as a reputed medical research institution gradually began to emerge in the scientific public sphere. At the same time, it is evident that the crystallization of this consensus did not close the controversy; deliberations continued, but most of the actors agreed on defending the institution while continuing to debate the issues involved. This consensus was accomplished through the concerted campaigning of a wide range of pro-RCC actors. Although the need to safeguard the institution had begun surfacing since the CM’s plea to the public, it was the public (p.93) intellectuals and literati of Kerala who forced it as a central concern for all Keralites. They signed a joint open letter that requested the public to desist from tarnishing the institution while criticizing the clinical trials.119 Many of the intellectuals used the ‘Letters to the Editor’ columns as well to express their concerns.120 The ‘RCC Protection Forum’ was a general platform created exclusively for the purpose of the campaign by the pro-RCC actors, mainly the staff of the institute. They had rigorously campaigned against any attack on the RCC through demonstrations, public meetings, and press conferences.121 There were also a considerable number of letters to the editor that appeared in different newspapers authored by medical professionals.122 Most of them found the allegations against the RCC clinical trials as a threat to the autonomy of the medical establishment itself, and thereby to their own professional authority. These interventions clearly indicate how professional interests motivated actors to participate in a controversy.123 It is also interesting to note that while the entire RCC staff and their organizations defended the institution, most of the youth wings of political parties (especially the All India Youth Federation [AIYF], the Democratic Youth Federation of India [DYFI], and the Youth Congress) came out against the RCC and demanded strong action against the culprits.

The Kerala Kaumudi was a major actor that supported the campaigners by relentlessly voicing their concerns and reporting their campaigns. The newspaper strongly defended the RCC and its director in its editorial on 18 August.124 The editorial argued that Dr Krishnan Nair must not be criticized, as he was the singular person who created the institution from almost ‘nothing’.125 The ‘Letters to the Editor’ column was meticulously utilized by Kerala Kaumudi to articulate the campaigners’ concerns.126 The newspaper skilfully selected and published letters to the editor, a strategy which helped the newspaper in voicing its own concerns as readers’ opinion. This was accomplished mainly by organizing the column in such a way that the majority of letters expressed the views and interests of the newspaper, with a few others presenting counter-arguments. Most of the letters that appeared in the newspaper expressed the readers’ reservations about the orchestrated attempt at character assassination of the RCC director, which was seen as a serious threat to the reputation of and public trust on the institute.127 Some of the letters supported the statement of the CM and in so doing defended the institute and the director.128 Many readers attacked the rival group of scientists for their ulterior motives.129

(p.94) Some of the letters which presented the counter argument linked the controversy to the wider question of ethics in medical science research. One reader, for example, invited public attention to the fact that several of the drugs banned in the West were still used in India.130 This unethical evasion of all regulatory measures was indicative of the larger malaise exemplified by the RCC clinical trials, the letter argued. Another reader, a doctor by training, expressed the same concern by pointing to the unholy alliance between doctors and multinational drug companies.131 As a solution, he suggested medical research be restricted to universities and demanded the proscription of all contract research projects being carried out for foreign agencies. He also suggested the formulation of a new drug policy that curtailed unethical and inhuman practices in medical science through stricter regulatory measures. However, the genre of letters to the editor was not intensely used in this manner by other newspapers in the clinical trials controversy, despite a large number of letters being published.

Such an organized campaign had a deep impact on the course of the dispute. Nevertheless, by then the need to safeguard the RCC was disconnected from the democratic imperative of constant public scrutiny of scientific institutions. The consensus shared by the participants in the deliberations (irrespective of their affiliations) was that the prestige and reputation of RCC as a medical institution had to be safeguarded while public debate was expected to continue in reference to the malpractices in medical science research. Even the opponents of the clinical trials softened their attack against the RCC as a regional scientific institution. This is quite evident from a later statement of Dr C.R. Soman wherein he stated that he had not had any intention to malign the institution, and his criticism was directed against the unethical clinical trials.132 The letter to the editor from a reader who identified himself as a medical doctor was highly suggestive of the mood that prevailed; he defended the RCC while strongly recommending an immediate moratorium on the controversy pointing out that an enquiry into the matter was already on.133 In the same vein, he acknowledged the prevalence of unethical practices in medical sciences and demanded punitive action against those who prove to be guilty. Following this reorientation of the debate away from the institute, the rival alliance tried their level best to bring the RCC back to focus, but in vain. The consensus thus achieved at this stage was highly nuanced; on the one hand it was agreed that the (p.95) institute had been a great medical institution that delivers meticulous service to the public, but on the other, the public anxiety about the malpractices in the institute continued, and corrective measures were sought through governmental interventions. Safeguarding the RCC did not hinder endorsing the need for continuous public scrutiny of scientific institutions in the region, and the role of mass media in creating a deliberative space for public regulation of science was ascertained, especially in the context of lack of a strong regulatory mechanism in the country to control clinical trials. The RCC case was rather influential on the future development of strict guidelines for contract research in the country, as we are going to see later.

Enquiry Commission Reports and the Closure of the Controversy

A closure of the controversy was attained in the following months as a result of fresh developments after the appointment of the enquiry commissions. Four such enquiries were on at the time: the Parikh Commission constituted by the state government, the commission sent by the central government,134 the HRC, and the enquiry instituted by the IMA-Kerala. The investigations of these bodies became the focal point of attention in the regional press in the last phase of the controversy, and the deliberations reflected the public demand for better institutional mechanisms for regulating science in the country. Therefore the expert commissions appointed by various governmental regulatory agencies were closely watched and their actions debated in the scientific public sphere.135

The Parikh Commission appointed by the state government commenced its hearing on 9 August 2001. The Commission never enjoyed great public legitimacy due to the general perception about its allegiance to the RCC administration, and the newspapers in the rival coalition tried to surf on the public sentiments. Madhyamam reported that Dr Parikh arrived for the hearing in a vehicle provided by the RCC.136 The news report also claimed that the person who assisted the commission was an employee of the institute. In yet another report, the newspaper argued that the assistant originally belonged to the personal staff of the RCC director.137 The Parikh Commission was a charade staged by the state government hand-in-glove with the RCC administration to (p.96) salvage the culprits, the newspaper alleged.138 Dr Bhattathiri declared that he would not cooperate with the commission and demanded the replacing of the single-member commission with an expert commission comprised of experts from different fields.139 This argument gained wide currency as organizations like the KSSP and the AIYF supported the demand.140 Dr Parikh denied all charges against the credibility of the commission and assured a just and transparent investigation.141 The HRC was not criticized by the anti-RCC group, because its functioning was indirectly supportive of their cause from the beginning. In the days that followed, the regional press began reporting the functioning of the Parikh Commission, the Health Ministry Commission and the HRC on a regular basis. The newspapers reported the statements made before the commissions by a wide range of people who were involved in the controversy.

It was at this point that Kerala Kaumudi attempted to steer away the whole controversy in another direction in favour of the RCC, sensing a gradual emergence of the institute once again as the target of public criticism. The investigative news report of P.V. Murukan presented certain ‘evidences’ for the vested interests of the rival group of scientists in fanning the controversy.142 According to the report, Dr Bhattathiri and Dr Gangadharan, two scientists who sparked off the controversy, had registered a cooperative society with the intention to start a cancer treatment and research institute at Kollam.143 The report alleged that the controversy was a vicious and concerted endeavour to create public distrust in the RCC in order to promote the new hospital and research institute the rival scientists were planning to establish. The report appeared as a piece of investigative journalism; however, it was not an exclusive one. Malayala Manorama, another strong defender of the RCC, on the same day reported sealing of the documents of registration of the ‘Janatha Health and Radiation Research Society’ by police on a request from Dr Krishnan Nair.144 The appearance of the news reports on the same day in two newspapers which had offered relentless support to the RCC director and his team of researchers suggest that this was a well-planned ambush on the rivals. The registration of the society was apparently an already known fact among the scientists and staff of the RCC, but revealed to the public at this decisive moment to win over the rival coalition.145

The investigative report of Kerala Kaumudi had a big impact. The pro-RCC speakers effectively manoeuvred the situation to their advantage: (p.97) the RCC Protection Forum attacked their opponents virulently and demanded immediate dismissal of those who were involved in the venture.146 At this juncture, Madhyamam endeavoured without much success to arrest the setback by publishing an exclusive report on the financial side of the clinical trials. According to the report, the institute had received 4 million rupees from the JHU as remuneration, and the money was kept in a special bank account directly controlled by the RCC director.147 The news report alleged that this was indicative of the financial corruption involved in carrying out the research. The newspaper also revealed that foreign funds received by the institute for the purpose of research were not audited for several years, further reinforcing charges of financial corruption on the institute.

The endeavours of the rival scientists and their allies to fight back further proved unsuccessful when the investigative reports of the enquiry commissions were released.148 All the reports shared the consensus that had already been attained in the scientific public sphere—that the credence of the RCC as a medical research institution must not be tampered with. At the same time all the three commissions recommended revision of the medical ethics guidelines to avoid violation of research protocols in future and reconstitution of institutional regulatory mechanisms. Once the commission of the Ministry of Health and Family Welfare submitted its enquiry report, the ministry promptly suspended all the ongoing human drug trials at the RCC for six months.149 The enquiry report revealed that the guidelines of the Indian Council of Medical Research (ICMR) for research were not followed by the RCC during the clinical trials.150 According to the enquiry report, the research had been carried out in collaboration with the JHU and the drug involved was a derivative of NDGA.151 The enquiry commission also revealed that research had commenced well before permission was granted by the DCGI.152 However, the report emphasized that there were no human rights violations involved in the clinical trials and instead highlighted the infringement of ethical protocols.153 The report pointed out that the specimens collected from the patients had been sent to the JHU without permission from the concerned regulatory bodies.154 On the basis of the report, the Health Ministry sent a show-cause notice to the RCC and directed the institute to reconstitute its ethics committee.155 The government decided to make the ICMR guidelines for medical research mandatory for all medical research institutions in the (p.98) country.156 It was reported in the media that punitive action against the accused would be sought by the government.157 However, the Health Ministry of India did not feel the need for any punitive action against the institute and its researchers on the grounds that the drug used for the clinical trials was not banned.158 The IMA-Kerala also published its report around this time, with almost the same conclusions.159 The rival group of researchers’ act of raising the matter in the media rather than ‘handling it officially’ was staunchly criticized in the report. Both the reports were criticized by the newspapers in the rival coalition without much impact. They contended that by rejecting the charge of human rights violations in the clinical trials, the reports safeguarded the scientists and the RCC administration against any strong punitive action.160 Dr V.N. Bhattathiri challenged the conclusion of the reports that there was no human rights violation involved.161

The Parikh Commission’s preliminary report was made public on 4 October 2001, and it was more sympathetic to the RCC than the other commissions.162 The report observed that other than ‘minor procedural errors’, the clinical trials were not erroneous at all.163 According to the report the research agreement between the RCC and the JHU was transparent.164 The commission pointed out that the drug used was not banned and it was effective when administered to patients and no side effects were reported.165 It was asserted that prior consent had been given by the patients.166 Similar to the IMA report, the Parikh Commission’s report also criticized the rival scientists for creating a public controversy over the issue by ‘misleading’ the media.167 The commission, nonetheless, suggested reconstitution of the institutional ethics committee of the RCC. The Parikh Commission report also invited much criticism from the allies of the rival scientists.168 In a news report, Madhyamam asserted that the reports of the Parikh Commission and commission appointed by the Health Ministry were orchestrated attempts to absolve the RCC scientists.169 Meanwhile, Kerala Kaumudi published an editorial page article and a news report strongly supporting the findings of the commissions and criticizing the tendency to pursue the controversy even after the enquiry reports had been published.170

Quite contrary to the enquiry reports from India, the conclusions of the JHU Enquiry Committee were against the principal researcher, Dr Ru Chih C. Huang. The enquiry report published by the JHU revealed that the researcher had not followed the guidelines of the university (p.99) as well as the scientific protocols for clinical trials.171 The JHU enquiry committee also assessed that the clinical trials undertaken by the RCC as a client of Quintiles India had several shortcomings. Based on the enquiry report, the university forbade Dr Huang from being the principal investigator in human drug trials. The stark contrast between the Indian and the US reports was highlighted by some actors, pointing to the failure of the regulatory mechanism in India.172

Since the publication of the reports, the regional and central governments began vociferously defending the RCC and the clinical trials. The union health minister, Dr C.P. Thakur, told the Indian Parliament that the banned drug had not been experimented at the RCC and therefore human rights were not violated.173 The state minister of health, P. Sankaran, declared the same in the state legislative assembly, though the opposition staunchly criticized the government and the Parikh Commission.174 The opposition demanded immediate scrapping of the Parikh Commission report for its contradictory and counterfactual findings and urged the government to order a fresh enquiry.175 However, the health minister of Kerala reiterated that any false propaganda against the RCC would affect its reputation, although the government was willing to enquire into any complaint against the institution.176 Based on the assessment of a cabinet sub-committee, the report of the Parikh Commission was accepted by the government in February 2002.177

The controversy made the public as well as policy makers realize the political, ethical, and legal complications in allowing Western research institutions to carry out clinical trials in India through CROs. On the one hand, the use of patients from India as ‘guinea pigs’ for drug research in prestigious Western scientific institutions became exposed and the commercial and political interests that played out in outsourcing clinical trials to client organizations like the RCC became a serious issue for deliberation for the regional scientific-citizen public.178 On the other hand, the controversy brought to light the inadequacy of Indian regulatory measures and the lack of a proper understanding—even among Indian researchers—about the global dynamics of drug research shaped by neoliberal market economy. Following the controversy, the Ministry of Health and Family Welfare, as we have seen, took initiatives to develop better institutional mechanisms to regulate clinical research. Agencies like (p.100) the ICMR also became proactive in reframing ethical guidelines for government research institutions to take part in drug trials in the country. Of late, the courts also became actively involved in regulating drug research in India (Prasad 2009). The institutional ethics committee of the RCC was reconstituted in the wake of the controversy and new ethical procedures are being set up. The RCC clinical trials and the public deliberations that followed were a milestone in the path towards developing robust ethical and legal regulatory protocols to curb the onslaught of commercial interests that eclipsed the character of science as public knowledge.

The public deliberations over the drug trials at the RCC brought out the internal ambivalences and complex power relations of biomedicine to the public domain. The deliberations in the scientific public sphere revealed the transformation of science within the neoliberal paradigm: in the post liberalization phase, drug research has been increasingly carried out through a global research network that brought in new private players like CROs and their client organizations like the RCC into picture. The emergence of CROs as major players in drug research represents the accelerating commercialization and privatization of scientific research (Mirowski and Van Horn 2005). While the state and the regulatory institutions were largely lackadaisical in responding to the changed paradigm, it was the mass media that brought the issue into public attention.

The controversy disclosed several unique features of the case. The deliberations revealed an important aspect of medialization of science: Originally the case had begun as a scientific controversy within the RCC when some dissenting voices emerged among the scientists about the everyday governance of the institution. Once the splinter group of scientists realized that they were vulnerable within the institute, the issue was leaked to the public with the help of the media. They actively made alliances with media institutions, journalists, and civil society actors to fortify their position. The development of the intra-institutional conflict into an intense public controversy forced the research team that conducted the clinical trials also to form their own coalitions to participate in public deliberations and (p.101) defend their actions. The researchers on both sides of the dispute actively approached the media and invited public attention to gain trust and credibility. Press conferences were organized, press notes were released, and the researchers gave interviews to journalists and wrote articles in newspapers during the controversy. Suddenly, scientists found it important to engage with the media to safeguard their interests.

The regional press was not active in the initial phase to bring the dispute into the public domain. As we have seen, the issue was taken up by a news channel and some civil society organizations. However, thereafter the regional press became proactive and turned into the major site of deliberations. This vividly suggests that more than any other sites/social agents, the regional press held the potential to generate public controversies. Once the scientific public sphere became activated, new actors appeared on the front stage, and political alliances were formed. These alliances were also active at the backstage, aggressively trying to steer the controversy. They staged the performances and designed rhetorical strategies to influence the deliberations. However, due to the presence of a large number of actors, and their complex interactions, the scientific public sphere continued to enjoy deliberative autonomy, making it functionally open and dynamic. The KSSP was not an important mediator anymore, nor was it an actor of any significance in the scientific public sphere constituted by the regional press, unlike the public debates of the 1980s.179 Nonetheless, there existed many parallel sites of negotiations in the form of citizen forums, political organizations, and other civil society groups who took serious interest in the controversy. These alternative sites of deliberation were weak and dispersed and hence highly media-dependent for organizing their campaigns. The civil society organizations and their spokespersons turned to be actors in the scientific public sphere. Their voices were amplified to a wider audience by the regional press. Any decline in media attention directly affected their visibility and status as actors. To put it differently, it was their mediation that shaped them into important actors in the controversy. At the same time, their participation helped expanding the contours of the controversy as well. The citizen forums and initiatives which critically participated in the controversy were successful in bringing in new perspectives and adding new dimensions to the deliberation.

(p.102) Another aspect of the controversy was the perceptible existence of a strong filtering mechanism that largely determined the course of the deliberations. The regional press in the beginning of the controversy attempted to regulate the dispute in an explicit manner and many of the newspapers were strong allies in the competing coalitions. The dynamics of the journalistic production of news—the backstage activities—were strong in the clinical trials controversy. However, this does not imply that the trajectory of the controversy was engineered by a hidden network functioning behind the scene. On the contrary, the controversy demonstrated that its course of evolution had been guided by a complex deliberative process which was not controlled by any single actor/alliance. The media was not simply reflecting the public mood, but actively shaping the controversy by participating in it. The media institutions were functioning simultaneously as gatekeepers and agenda brokers. This double role of the newspapers was crucial in the initiation, evolution, and closure of the controversy.

The RCC controversy also revealed the pertinent role played by the scientific public sphere in influencing policy institutions through deliberations. The scientific-citizen public were aware of their role in democratizing science and their deliberations initiated a policy discourse on the urgency of developing new regulatory mechanisms directed towards addressing the challenges raised by the neoliberal biomedical paradigm. The scientific public sphere was more rigorous and effective in identifying and negotiating the new mode of knowledge production than the policy institutions and regulatory organizations. The concerted endeavour of the RCC researchers and their associates to project the clinical trials as frontier research they had carried out in collaboration with the JHU was foiled in the scientific public sphere where other actors always showed great clarity in understanding the internal differentiations of science. The need to develop more inclusive mechanisms for democratic governance of science and the need for a wider definition of expertise were debated and demonstrated in the public deliberations, whereas the existing regulatory structures were more recalcitrant. The commissions which looked into the case were appointed by various governmental regulatory agencies, and they spent more energy on defending the researchers who conducted the clinical trials than openly engaging with the issues and concerns being raised in the scientific public sphere. These (p.103) commissions hence enjoyed less public trust, and the experts’ credibility was continuously being contested in public. The emergence of the scientific public sphere was crucial in articulating the anxieties and uncertainties and enunciated new possibilities for democratic governance of science.

Notes

(1.) The RCC was established in the year 1981, and the institute is jointly sponsored by the central and the state governments. Several international agencies including the World Health Organization (WHO), the International Agency for Research on Cancer (IARC), and the United Nations Population Fund (UNFPA) have acknowledged the institute as a centre of excellence. See State Planning Board (2006).

(2.) Quintiles India (or Quintiles Spectral Ltd) was launched in 1997 as a collaborative venture between Quintiles Transnational Corporation and an India-based healthcare firm called Core Healthcare Limited (Prasad 2009). The RCC clinical trials were probably one of their initial projects. See Mirowski and Van Horn (2005) for a detailed analysis of how the rapid rise of the CROs provides impetus to the commercialization of biomedical research.

(3.) The Food and Drug Administration (FDA) is the federal agency in the United States which regulates drug development research. The procedures set by the FDA eventually became the basis for research guidelines all over the developed world (Mirowski and Van Horn 2005: 508). Within the FDA framework, drug research is organized into four stages. These are: a pre-clinical stage where experiments are carried out on laboratory animals, followed by a clinical stage, a regulatory delay, and a post-clinical stage (Mirowski and Van Horn 2005). The clinical stage of drug research consists of four phases where the drug under trial is administered on humans (Mirowski and Van Horn 2005). BioCure Medicals is a company that was established in 2000 by BioCure Technologies to develop M4N and other drugs. The JHU has shares in the company which is currently known as Erimos. See Krishnakumar (2005). The Phase I trials at the RCC were apparently outsourced to the Quintiles International by Erimos.

(4.) The research team had Dr Manoj Pandey and Dr Radhakrishna Pillai as co-researchers. See Krishnakumar (2001). As its founder director, Dr Krishnan Nair had great contribution in building the RCC since its inception (1981–2003). For an autobiographical narration on his close relationship with the institute, see Nair (2013).

(5.) Dr Bhattathiri had finished his PhD research on radiotherapy with Dr Krishnan Nair. See Nair (2013: 159).

(p.104) (6.) ‘Aniyara’ literally means ‘backstage’. The programme was directed and anchored by Alias John, a reputed social activist-turned-TV journalist, and was produced by his own company called National Television (NTV).

(7.) Many of the speakers interviewed by me pointed out the role of Surya TV in exposing the issue. Later on it was alleged that the TV channel had deliberately been trying to defame the RCC, and that it was hand in glove with the Adayar Cancer Institute, Tamil Nadu, though the allegation did not get much currency in the scientific public sphere. Personal interview with Dr Joy Elamon, 24 April 2006, and Dr C.R. Soman, 26 April 2006.

(8.) A previously unheard of organization called the All India Medical Service Centre (AIMSC) was the petitioner. The name of the organization appeared only in this particular news report. The CM of Kerala is the chairperson of the RCC governing body, and hence the petition was submitted to him.

(9.) ‘Cancer Centreile Kramakkedukale Kurichu Anweshikkanam’, Madhyamam, 3 July 2001, p. 2.

(10.) ‘Cancer Centreile Kramakkedukale’, Madhyamam.

(11.) ‘RCCkku Munpil Dharna Nadathi’, Madhyamam, 13 July 2001, p. 3.

(12.) Kerala Kaumudi and Malayala Manorama openly defended the RCC director throughout the controversy as will be discussed. Mathrubhumi did not explicitly support any of the coalitions, but a majority of its news reports represented the pro-RCC actors in the scientific public sphere. Deshabhimani took a non-partisan view on the matter, but critiqued the governmental interventions, especially in the final phase of the controversy. In my personal interview with a reputed media analyst from Kerala (name withheld), it was pointed out that many of the newspaper authorities had a cordial relationship with the RCC administration and especially with Dr Krishnan Nair. If the newspaper owners or the reputed journalists recommended a patient, he/she was given great priority and utmost care in the RCC. In return the newspapers always helped the institute maintain good public relations by publishing reports whenever needed. He also pointed out that the chief editor of one of the major newspapers was a member of the governing council of the institute.

(13.) ‘RCCkku Munpil Dharna’, Madhyamam.

(14.) Each speciality clinic was meant for the treatment of the cancer that affects a specific part of the body. A speciality clinic consists of a team of experts led by a senior doctor. See ‘RCCyil Speciality Clinikkukal Erppeduthi’, Malayala Manorama, 8 July 2001, p. 4; ‘RCCyil Speciality Clinikkukal’, Kerala Kaumudi, 8 July 2001, p. 10.

(15.) ‘RCCkku Munpil Dharna’, Madhyamam.

(16.) ‘RCCkku Munpil Dharna’, Madhyamam.

(p.105) (17.) Kerala Kaumudi‘RCC Directorude Kalaavadhi Neettiyathinu Ethiraya Harjiyil Notice’, Kerala Kaumudi, 25 July 2001, p. 3.

(18.) ‘John Hopkinsinte Pareekshanangalkku America Vilakkerppeduthi’, Madhyamam, 23 July 2001, p. 5.

(19.) The drug was ‘Hexamethonium’ used in combination with sodium bicarbonate, which was not scientifically allowed, according to the Madhyamam report. See ‘John Hopkinsinte Pareekshanangalkku’, Madhyamam.

(20.) ‘John Hopkinsinte Pareekshanangalkku’, Madhyamam.

(21.) ‘Nirodhicha Marunnu Kuththivechittilla: RCC’, Kerala Kaumudi, 15 July 2001, p. 10.

(22.) ‘Nirodhicha Marunnu Kuththivechittilla’, Kerala Kaumudi.

(23.) Malayala Manorama‘Nirodhitha Marunnu RCCyil Upayogichittilla: Krishnan Nair’, Malayala Manorama, 21 July 2001, p. 12.

(24.) Note the confusion regarding the number of patients. According to the news report in Kerala Kaumudi the number was 25, and in the report by Malayala Manorama the number was reduced to 22. Later in an interview with Dr Ru Chih C. Huang, it emerged that 27 patients had been administered the drug. See Krishnakumar (2005).

(25.) The source of the allegation is not clear. As we are going to see, the same allegation reappeared in the scientific public sphere at a later phase.

(26.) However, it was not discussed if the diabetes could have been drug-induced.

(27.) This has turned out to be a false claim.

(28.) ‘RCC Prasnam Sarkar Thalathil Anweshikkunnu: Antony’, Malayala Manorama, 26 July 2001, p. 9; ‘RCCkkethiraya Aropanangal Anweshikkunnu: Mukhyamanthri’, Mathrubhumi, 26 July 2001, p. 5; ‘Cancer Centreinte Visvasyatha Nashtappeduthilla’, Madhyamam, 26 July 2001, p. 5; ‘RCC: Aropanangal Anweshikkum Ennu Mukhyamanthri’, Kerala Kaumudi, 26 July 2001, p. 11.

(29.) ‘RCC: Aropanangal Anweshikkum’, Kerala Kaumudi.

(30.) ‘RCCkkethiraya Aropanangal’, Mathrubhumi‘RCC Vivadam: Kendram Vivaram Aarayunnu’, Mathrubhumi, 26 July 2001, p. 5.

(31.) ‘Nirodhikkappetta Marunnu Upayogichittilla: Krishnan Nair’, Deshabhimani, 28 July 2001, p. 8.

(32.) ‘Nirodhitha Marunnu Pareekshichittillennu RCC’, Malayala Manorama, 28 July 2001, p. 9; ‘Nirodhikkappetta Marunnu Upayogichittilla’, Deshabhimani; (p.106) ‘Gaveshana Sthapanam Ayathinal Marunnu Pareekshiche Theeroo: Cancer Centre’, Madhyamam, 28 July 2001, p. 5; ‘Cancer Chikilsaykku Upayogichathu Paarsva Phalangalillennu Thelinja Marunnu: Dr. M. Krishnan Nair’, Kerala Kaumudi, 28 July 2001, p. 12.

(33.) ‘Cancer Chikilsaykku Upayogichathu’, Kerala Kaumudi.

(34.) ‘Nirodhitha Marunnu Pareekshichittillennu’, Malayala Manorama; ‘Cancer Chikilsaykku Upayogichathu’, Kerala Kaumudi.

(35.) ‘Cancer Chikilsaykku Upayogichathu’, Kerala Kaumudi.

(36.) ‘Gaveshana Sthapanam Ayathinal’, Madhyamam. This claim was problematic, as the RCC was just functioning as a CRO for the JHU researcher.

(37.) ‘Nirodhitha Marunnu Pareekshichittillennu’, Malayala Manorama; ‘Gaveshana Sthapanam Ayathinal’, Madhyamam.

(38.) ‘Gaveshana Sthapanam Ayathinal’, Madhyamam‘Nirodhicha Marunnukal RCCyil Upayogichilla: Director’, Deshabhimani, 29 July 2001, p. 4.

(39.) ‘Gaveshana Sthapanam Ayathinal’, Madhyamam.

(40.) ‘Gaveshana Sthapanam Ayathinal’, Madhyamam.

(41.) ‘RCCyude Salpperinu Kalankam Undakkaruthu’, Kerala Kaumudi, 27 July 2001, p. 3. The Post Graduate Students’ Association and the Junior Doctors’ Association of the Medical College, Thiruvananthapuram, expressed similar concerns. See ‘RCC Vivadam: Asanka Pariharikkanam’, Malayala Manorama, 31 July 2001, p. 9; ‘Cancer Centre: Asanka Pariharikkanam’, Mathrubhumi, 31 July 2001, p. 3.

(42.) ‘RCCyude Salpperinu Kalankam’, Kerala Kaumudi.

(43.) Madhyamam‘RCCyude Pathra Sammelanam Vivadamayi’, Madhyamam, 28 July 2001, p. 5.Chapter 7

(44.) ‘Marunnu Pareekshanam Nadannathu Niyama Vidheyamayi: Dr. Krishnan Nair’, Mathrubhumi, 29 July 2001, p. 5‘Nirodhicha Marunnukal RCCyil’, Deshabhimani

(45.) ‘Nirodhicha Marunnukal RCCyil’, Deshabhimani.

(46.) ‘Marunnu Pareekshanam Nadannathu’, Mathrubhumi.

(47.) ‘Nirodhicha Marunnukal RCCyil’, Deshabhimani‘Marunnu Pareekshichathu Ethical Committeeyude Anuvadathode: RCC Director’, Malayala Manorama, 29 July 2001, p. 7.

(p.107) (48.) ‘Marunnu Gaveshanam RCCyude Joli: Vivada Marunnu Phalapradamennu Thelinju: Dr. M. Krishnan Nair’, Kerala Kaumudi, 29 July 2001, p. 1.Krishnakumar (2005)

(49.) ‘Marunnu Pareekshanam Nadannathu’, Mathrubhumi. See also ‘Marunnu Gaveshanam RCCyude’, Kerala Kaumudi.

(50.) ‘Marunnu Pareekshichathu Ethical’, Malayala Manorama. However, the report in Deshabhimani contradicted this. The report quoted Dr Krishnan Nair as saying that the RCC clinical trials had been approved by both the RCC ethical committee and the DCGI. See ‘Nirodhicha Marunnukal RCCyil’, Deshabhimani. The press note of the Health Ministry of the Government of India which was widely reported in the regional press later on said that the DCGI had approved the import of M4N from the JHU in February 2001. See ‘RCCyile Nirodhitha Marunnu Prayogam Kendram Anweshikkunnu’, Malayala Manorama, 31 July 2001, p. 9; ‘Nirodhicha Marunnu Upayogichathu Anweshikkum’, Deshabhimani, 31 July 2001, p. 1. It was also mentioned that the approval was granted on the basis of the recommendations of the RCC ethical committee. See ‘RCC Marunnu Pareekshanam Kendram Anweshikkunnu’, Kerala Kaumudi, 31 July 2001, p. 1.

(51.) See Prasad (2009) for a detailed analysis of the politics of conducting clinical trials in developing countries like India.

(52.) ‘RCCyile Nirodhitha Marunnu’, Malayala Manorama; ‘Nirodhicha Marunnu Upayogichathu’, Deshabhimani; ‘RCC Marunnu Pareekshanam’, Kerala Kaumudi.

(53.) ‘RCCyile Nirodhitha Marunnu’, Malayala Manorama‘RCC Marunnu Pareekshanam’, Kerala Kaumudi, 2001, p. 1.

(54.) Dr Purvish Parikh who was appointed as the single-member enquiry commission was Professor of medical oncology at the Tata Memorial Hospital, Mumbai, and was also the then secretary of the Indian Cooperative Oncology Network (ICON). ‘Dr Parikh Anweshikkum’, Mathrubhumi, 1 August 2001, p. 1; ‘Cancer Centre Vivadam: Anweshikkan Utharavu’, Deshabhimani, 1 August 2001, p. 10; ‘Dr Parikh Anweshikkum’, Madhyamam, 1 August 2001, p. 1; ‘RCC Vivadam Anweshikkan Ekanga Commission’, Kerala Kaumudi, 1 August 2001, p. 1.

(55.) ‘Director Hajarakanam’, Mathrubhumi, 1 August 2001, p. 1; ‘RCC Directorkku Manushyavakasa Commissionte Summons’, Madhyamam, 1 August 2001, p. 7; ‘Dr Krishnan Nairkku Manushyavakasa Commissionte Summons’, Kerala Kaumudi, 1 August 2001, p. 1.

(56.) ‘Cancer Centre: Judicial Anweshanam Venam’, Mathrubhumi, 1 August 2001, p. 4.

(p.108) (57.) ‘Parikhinte Anweshanavumayi Yojikkanavilla: Bhattathiri’, Madhyamam, 1 August 2001, p. 7; ‘RCC Vivadam Puthiya Vazhithirivilekku’, Deshabhimani, 2 August 2001, p. 7.

(58.) ‘RCC Vivadam Puthiya’, Deshabhimani.

(59.) ‘Cancer Centre: Anweshanam Nishpakshamakillennu’, Madhyamam, 2 August 2001, p. 5.

(60.) ‘Cancer Centre: Anweshanam’, Madhyamam.

(61.) ‘Arbuda Marunnu Pareekshikkan Anumathi Nalkiyirunnillennu Hopkins Sarvakalasala’, Mathrubhumi, 1 August 2001, p. 1; ‘RCC Vivadam Puthiya’, Deshabhimani; ‘Pareekshanathinu Anumathi Nalkiyillennu JHU: RCC Padanam Nirthiveykkan Gaveshakaykku Nirdesam’, Madhyamam, 1 August 2001, p. 1.

(62.) ‘Pareekshanathinu Anumathi Nalkiyillennu’, Madhyamam.

(63.) ‘Pareekshanathinu Anumathi Nalkiyillennu’, Madhyamam.

(64.) Dr C.R. Soman (now late) was formerly Professor and the Head of the Department of Nutrition at the Government Medical College, Thiruvananthapuram. Later on, he became the director of Health Action by People, an action-research NGO in Thiruvananthapuram.

(65.) Dr M. Krishnan Nair, ‘Americayil Nirodhichittilla’, Malayala Manorama, 1 August 2001, p. 4.

(66.) Dr C.R. Soman, ‘Niyama Lankhanam, Adharmikam’, Malayala Manorama, 1 August 2001, p. 4.

(67.) The Forum for Patients’ Rights is a civil society organisation which took a strong anti-clinical trials position in the controversy.

(68.) ‘RCC Vivadam: Samagranweshanam Venamennu Charcha’, Madhyamam, 2 August 2001, p. 7.

(69.) ‘RCCyil Judicial Anweshanam Venam’, Mathrubhumi, 2 August 2001, p. 3.

(70.) ‘RCCyil Judicial Anweshanam’, Mathrubhumi; ‘RCC Vivadam: Samagranweshanam’, Madhyamam.

(71.) ‘RCC Vivadam: Samagranweshanam’, Madhyamam.

(72.) ‘Nirodhitha Marunnu Kuththi Vechathu Manushyavakasa Lankhanamennu’, Malayala Manorama, 2 August 2001, p. 9.

(73.) ‘RCC Vivadam: Samagranweshanam’, Madhyamam.

(74.) ‘RCC Vivadam: Samagranweshanam’, Madhyamam.

(75.) ‘RCC Vivadam: Samagranweshanam’, Madhyamam; ‘RCCyil Judicial Anweshanam’, Mathrubhumi; ‘Nirodhitha Marunnu Kuththi’, Malayala Manorama.

(76.) See ‘Marunnu Pareekshanam: Samvadathil Doctormarude Vakku Tharkkam’, Malayala Manorama, 4 August 2001, p. 9; ‘Marunnu Pareekshanam: Samvadathil Doctormar Cheri Thirinju Tharkkichu’, Mathrubhumi, 4 August (p.109) 2001, p. 2; ‘Marunnu Pareekshanam: Samvada Velayil Tharkkavum Bahalavum’, Deshabhimani, 4 August 2001; ‘RCC Vivadam: Doctormar Thammil Tharkkam’, Madhyamam, 4 August 2001, p. 7; ‘RCC Prasnathil Doctors Cheri Thirinju’, Kerala Kaumudi, 4 August 2001, p. 2.

(77.) ‘RCC Vivadam: Doctormar’, Madhyamam.

(78.) ‘RCCkkethireyulla Pracharanathil Ninnu Pinmaranam: Mukhyamanthri’, Mathrubhumi, 3 August 2001, p. 2; ‘RCCye Nasippikkaruthu: Mukhyamanthri’, Kerala Kaumudi, 3 August 2001, p. 3.

(79.) ‘RCCye Nasippikkaruthu’, Kerala Kaumudi.

(80.) RCCkkethireyulla Pracharanathil Ninnu’, Mathrubhumi; ‘RCCye Nasippikkaruthu’, Kerala Kaumudi.

(81.) ‘RCCye Nasippikkaruthu’, Kerala Kaumudi.

(82.) ‘RCCye Nasippikkaruthu’, Kerala Kaumudi.

(83.) M.N. Vijayan, ‘RCC’, Deshabhimani, 33/10, 12 August 2001, p. 12.

(84.) ‘RCC: Mukhyamanthriyude Asahishnutha Janadhipathya Virudham: M.N. Vijayan’, Deshabhimani, 5 August 2001, p. 4; ‘RCC Vivadam: Mukhyamanthriyude Asahishnutha Janadhipathya Virudham: M.N. Vijayan’, Madhyamam, 5 August 2001, p. 7.

(85.) ‘RCC Vivadam: Mukhyamanthriyude’, Madhyamam.

(86.) ‘RCC: Mukhyamanthriyude Prasthavana Dourbhagyakaram’, Madhyamam, 4 August 2001, p. 7.

(87.) ‘RCCye Thakarkkan Sramam: Jeevanakkar’, Malayala Manorama, 3 August 2001, p. 2; ‘RCCye Thakarkkan Goodalochana’, Deshabhimani, 3 August 2001, p. 8; ‘RCC Directorku Pinthunayayi Doctorsum Staffum’, Kerala Kaumudi, 3 August 2001, p. 11.

(88.) ‘RCCkkethire Chilar Dooshitha Valayam Srishtikkunnu: Manthri Sankaran’, Malayala Manorama, 4 August 2001, p. 9.

(89.) See ‘RCCye Rakshikkan Nadapadi Venam: MLA’, Mathrubhumi, 6 August 2001, p. 13; ‘RCCye Thaaradichu Kattaruthu’, Mathrubhumi, 7 August 2001, p. 11; ‘Cancer Centreine Thakarkkaruthu’, Kerala Kaumudi, 8 August 2001, p. 10; ‘RCC Doctormar Aasayakkuzhappam Srishtiykkunnu: K.V. Surendranath’, Kerala Kaumudi, 10 August 2001, p. 10; Vishnu Narayanan Nampoothiri, ‘RCC Erinjudaykkaruthu’, Mathrubhumi, 15 August 2001, p. 4, editorial page article; ‘RCC Vivadam Sthapanathinte Nadathippinu Bheeshaniyakaruthu: ONV’, Malayala Manorama, 17 August 2001, p. 17.

(90.) ‘RCC: Vivadam Venda’, Malayala Manorama, 5 August 2001, p. 2.

(91.) ‘RCC Vivadam: John Hopkins Anweshanam Thudangi’, Madhyamam, 5 August 2001, p. 1.

(p.110) (92.) ‘RCC Vivadam: John Hopkins’, Madhyamam.

(93.) ‘“Pareekshanamriga”makunnathu Thadayan Americayil Niyama Bhedagathi Varunnu’, Madhyamam, 7 August 2001, p. 7; ‘RCCyile Vivada Pareekshanam Angeekarichittillennu Hopkins’, Deshabhimani, 7 August 2001, p. 10.

(94.) ‘RCCyile Vivada Pareekshanam’, Deshabhimani.

(95.) ‘RCCyile Vivada Pareekshanam’, Deshabhimani.

(96.) The journal article being quoted in the newspaper is possibly Bagla and Marshall (2001). The journal also took note of the action taken by the Ministry of Health and Family Welfare in another article. See Bagla (2001).

(97.) ‘Marunnu Pareekshanathinu Hopkins Paththu Laksham Nalki’, Madhyamam, 13 August 2001, p. 1.

(98.) ‘Marunnu Pareekshanathinu Hopkins’, Madhyamam.

(99.) ‘Marunnu Pareekshanathinu Hopkins’, Madhyamam.

(100.) ‘Marunnu Pareekshanathinu Hopkins’, Madhyamam. Mathrubhumi mentioned that the ‘Quintiles International’ was a CRO that operated from the United States. See ‘Marunnu Pareekshanam: Kooduthal Videsa Agencykalkku Panku’, Mathrubhumi, 12 August 2001, p. 5. For similar allegations regarding the involvement of a Singapore-based drug company (seemingly BioCure Medicals), see ‘Marunnu Pareekshanam: Kooduthal Samsayangal’, Mathrubhumi, 3 August 2001, p. 5.

(101.) ‘RCC Vivadam IMA Sangham Anweshikkum’, Mathrubhumi, 3 August 2001, p. 2; ‘RCC: IMA Theliveduppu Thudangi’, Deshabhimani, 5 August 2001, p. 4; ‘IMA Commission Theliveduppu Thudangi’, Malayala Manorama, 5 August 2001, p. 9.

(102.) ‘Azhimathikkethire Prathikarana Vedi Roopeekarichu’, Kerala Kaumudi, 4 July 2001, p. 10.

(103.) ‘RCC Vivadam IMA Sangham Anweshikkum’, Mathrubhumi, 3 August 2001, p. 2; ‘RCC Vivadam: Sarkar Committee Aparyapthamennu Prathikarana Vedi’, Madhyamam, 5 August 2001, p. 3.

(104.) ‘RCC, Karsana Nadapadi Sweekarikkanam: Human Rights Protection Council’, Madhyamam, 9 August 2001, p. 9; ‘RCC: Vazhivitta Pareekshanaththinethire Nadapadi Venam: Sasthra Parishad’, Kerala Kaumudi, 8 August 2001, p. 2; ‘RCC Pareekshanam Adharmmikamennu’, Kerala Kaumudi, 12 August 2001, p. 2; ‘Uttharavadikale Matti Nirthi Anweshikkanam: Parishad’, Deshabhimani, 8 August 2001, p. 6; ‘RCC Pareekshanam: Nadapadi Venamennu Parishad’, Malayala Manorama, 8 August 2001, p. 9.

(105.) ‘Clinical Pareekshana Niyamangal Cancer Centre Avaganichu: Padana Report’, Madhyamam, 7 August 2001, p. 3.

(106.) ‘Clinical Pareekshana Niyamangal’, Madhyamam.

(p.111) (107.) Seminars organized by the Mukthi, the IPA-Kerala, the KSSP, and the Kerala M. Pharm Students’ Forum were widely reported in the regional press. See news reports on 4 August 2001 and 8 August 2001.

(108.) The KSSP was the most vocal speaker in this regard. It also strongly demanded that the ICMR guidelines should be made applicable for all medical science research institutes in the country. See RCC Pareekshanam: Nadapadi’, Malayala Manorama; ‘Uttharavadikale Matti Nirthi’, Deshabhimani; ‘RCC: Vazhivitta Pareekshanaththinethire’, Kerala Kaumudi.

(109.) See Varughese (2014) for a detailed analysis of alternative models of technological governance proposed by social movements in India.

(110.) ‘“Guneappanni” Ayathu Aarkku Vendiyennariyathe Gopal’, Madhyamam, 3 August 2001, p. 5.

(111.) ‘Gopal Manushyavakasa Commissionu Parathi Nalki’, Madhyamam, 3 August 2001, p. 2.

(112.) ‘Gopalil Pareekshanam Nadathiyathu Chattangal Lankhichu’, Madhyamam, 18 August 2001, p. 2.

(113.) ‘Nirodhitha Marunnu Kuththi Vecha Randu Per Neraththe Marichennu Mozhi’, Madhyamam, 11 August 2001, p. 2; ‘Marunnu Pareekshanam: Randu Per Marichathayi Aaropanam’, Deshabhimani, 11 August 2001, p. 1.

(114.) ‘Marunnu Pareekshanathil Amma Marichathayi Makante Parathi’, Deshabhimani, 12 August 2001, p. 1; ‘Amma Marichathu Marunnu Pareekshanam Moolamenna Aropanavumayi Makan’, Madhyamam, 12 August 2001, p. 3.

(115.) ‘Rogi Marichathu Marunnu Pareekshanam Kondalla: RCC’, Mathrubhumi, 14 August 2001, p. 7.

(116.) ‘RCCye Thakarkkan Sramam’, Malayala Manorama.

(117.) ‘RCCye Thakarkkan Sramam’, Malayala Manorama.

(118.) As pointed out by a social activist (name withheld) the author interviewed on 26 April 2006, the patients who underwent the clinical trials had been from poor socio-economic background, and hence were availing financial assistance through the welfare schemes run by the RCC. As chronic patients, they were also completely at the mercy of their doctors. These factors appear to have helped the RCC authorities to prevent the patients’ voices from entering the scientific public sphere.

(119.) See ‘RCCyude Visvasyatha Nashtappedutharuthu’, Mathrubhumi, 19 August 2001, p. 3; See also the personal requests made by some of the signatories; Vishnu Narayanan Nampoothiri, ‘RCC Erinjudaykkaruthu’, Mathrubhumi, 15 August 2001, p. 4, editorial page article; ‘RCC Vivadam Sthapanathinte’, Malayala Manorama, p. 17.

(120.) For a detailed discussion, see Martin (1988). O.N.V. Kurup, ‘RCCye Nasippikkaruthe!’, Mathrubhumi, 17 August 2001, p. 4, letter to the editor; (p.112) Sugathakumari, Thiruvananthapuram, ‘RCCyude Agnipareeksha’, Mathrubhumi, 9 August 2001, p. 4, letter to the editor.

(121.) ‘RCCkkethire Pracharanam Nadathiyavare Pirichu Vidanam’, Deshabhimani, 20 August 2001, p. 8.

(122.) See, for example, Dr K. Balaraman, ‘RCC: Kolahalam Apalapaneeyam’, Kerala Kaumudi, 7 August 2001, p. 4, letter to the editor; Dr N.M. Muhammad Ali, ‘Verittoru Sabdam’, Kerala Kaumudi, 19 August 2001, p. 4, letter to the editor; Dr T.P. Gopalakrishnan, Kawadiyar, Thiruvananthapuram, ‘Doctormar Porvili Nirthanam’, Mathrubhumi, 23 August 2001, p. 4, letter to the editor; Ramesh G., Kozhikode, ‘RCCyude Salpperu Nilanirthan’, Mathrubhumi, 14 September 2001, p. 4, letter to the editor.

(123.) For a detailed discussion, see Martin (1988).

(124.) ‘Gaveshanam Kurisil Thoongunnu’, Kerala Kaumudi, 14 August 2001, p. 4.

(125.) ‘Gaveshanam Kurisil Thoongunnu’, Kerala Kaumudi.

(126.) Mathrubhumi also used its ‘Letters to the Editor’ column in a similar fashion, but more benignly. See, for example, Sugathakumari, Thiruvananthapuram, ‘RCCyude Agnipareeksha’, Mathrubhumi, 9 August 2001, p. 4, letter to the editor; O.N.V. Kurup, ‘RCCye Nasippikkaruthe!’, Mathrubhumi, 17 August 2001, p. 4, letter to the editor. The construction of the ‘Letters to the Editor’ columns by the press to further its interests is a well-noticed fact. See Richardson and Franklin (2003). For a detailed discussion on the letters to the editor as a genre, see Chapter 7.

(127.) Adv. V. Sadasivan, ‘Cancer Centre Vivadam’, Kerala Kaumudi, 5 August 2001, p. 4, letter to the editor; Dr K. Balaraman (former director, Dept. of Health), Thiruvananthapuram, ‘RCC: Kolahalam Apalapaneeyam’, Kerala Kaumudi, 7 August 2001, p. 4, letter to the editor.

(128.) Umayannur E. Asseem Kunju, Perayam, ‘RCCye Nasippikkaruthu’, Kerala Kaumudi, 6 August 2001, p. 4

(129.) Dr N.M. Muhammad Ali, Thiruvananthapuram, ‘Verittoru Sabdam’, Kerala Kaumudi, 19 August 2001, p. 4, letter to the editor; Dr L. Lalitha Kumari, ‘RCCkku Ethire Gooda Padhathi’, Kerala Kaumudi, 3 September 2001, p. 4, letter to the editor. Mathrubhumi published a letter that criticized the free-for-all contest in full public view by the RCC scientists. See Dr T.D. Gopalakrishnan, Kawadiar, ‘Doctormar Porvili Nirthanam’, Mathrubhumi, 23 August 2001, p. 4, letter to the editor.

(130.) Priyanjana Prabhakar, Thiruvananthapuram, ‘Athu Mathramo Nirodhikkappetta Oushadham?’, Kerala Kaumudi, 5 August 2001, p. 4

(131.) Dr M.P. Mani, Kudamaloor, ‘Gaveshanangal Sarvakalasalakalil Mathramakanam’, Kerala Kaumudi, 21 August 2001, p. 4

(132.) Dr C.R. Soman, ‘Cancer Centreine Apakeerthippeduthukayalla Lakshyam’, Kerala Kaumudi, 12 September 2001, p. 4

(p.113) (133.) Dr P.A. Kurup, Thiruvananthapuram, ‘Marunu Pareekshanam: Reportinu Kakkuka’, Mathrubhumi, 23 August 2001, p. 4

(134.) ‘Cancer Centre Vivadam: Kendra Sangham Ethi’, Madhyamam, 9 August 2001, p. 5.

(135.) ‘Cancer Centre Vivadam’, MadhyamamMathrubhumi‘RCC Anweshana Sangham Ethi’, Mathrubhumi, 9 August 2001, p. 5.

(136.) ‘Anweshana Commissionu Sancharikkan RCC Vahanam’, Madhyamam, 10 August 2001, p. 2.

(137.) ‘Anweshana Commissionu Sancharikkan’, Madhyamam‘RCCyude Vahanam Sarkar Nalkiyathennu Thettidharichu’, Madhyamam, 11 August 2001, p. 7.

(138.) ‘Anweshana Commissionu Sancharikkan’, Madhyamam.

(139.) ‘RCC Anweshanam Nale Thudangum’, Deshabhimani, 8 August 2001, p. 6.

(140.) ‘Vidagdha Samithi Anweshikkanam’, Deshabhimani, 8 August 2001, p. 6; ‘Utharavadikale Matti Nirthi’, Deshabhimani. The Youth Congress Medical College Committee activists also staged an aggressive demonstration against the commission on 10 August in front of the Medical College auditorium where the hearing was being held. ‘RCC: Commissionethire Youthkar’, Deshabhimani, 11 August 2001, p. 10; ‘RCCyude Vahanam Sarkar’, Madhyamam.

(141.) ‘Vivada Marunnu Pareekshikkappetta Rogikalil Ninnu Thelivedukkum’, Kerala Kaumudi, 11 August 2001, p. 3.

(142.) ‘RCC Vivadathinu Pinnil Gooda Lakshyam: Aropanavumayi Vannavar Swantham Asupathrikku Thudakkamittavar’, Kerala Kaumudi, 22 August 2001, p. 1.

(143.) The news report also mentioned that some more persons from the RCC were involved in the venture.

(144.) ‘RCC-Paraathiyil Puthiya Society Rekhakal Mudra Vechu’, Malayala Manorama, 22 August 2001, p. 13.

(145.) Only two newspapers reported it on the next day, but more joined in over the next few days. ‘Cancer Society Rekhakal Mudra Vechathu Krithrimam Ozhivakkan’, Mathrubhumi, 23 August 2001, p. 18; ‘RCC Vivadam: Swantham Aasupathri Thudangan Lakshyamittathum Anweshikkum’, Deshabhimani, 23 August 2001, p. 3.

(p.114) (146.) ‘RCCkkethire Pracharanam’, Deshabhimani; ‘RCC: Nalu Perkkethire Parathi’, Deshabhimani, 24 August 2001, p. 3; ‘RCC Protection Forum Prakshobhathilekku’, Kerala Kaumudi, 28 August 2001, p. 3; The forum went a step ahead when it filed a petition against Dr C.R. Soman who had spoken against the clinical trials, alleging that he had indulged in a slander campaign against the RCC. See ‘RCC Vivadam: Dr. C.R. Somanethire Protection Forum Paraathi Nalki’, Deshabhimani, 9 September 2001, p. 3.

(147.) ‘Cancer Centreinu Hopkins Nalkiyathu Naalpathu Lakhsham: Thuka Prathyeka Accountil’, Madhyamam, 28 August 2001, p. 1.

(148.) Dr Bhattathiri and Dr Gangadharan resigned from the RCC following the closure of the controversy.

(149.) ‘RCC: Marunnu Pareekshanam Nirthan Kendra Nirdesam’, Mathrubhumi, 10 September 2001, p. 1, lead article; ‘RCC: Doctormarkkethire Nadapadikku Sadhyatha’, Malayala Manorama, 10 September 2001, p. 1; ‘RCCyile Pareekshanangal Aru Masathekku Suspend Cheythu’, Deshabhimani, 10 September 2001, p. 1; ‘RCCyil Gaveshanam Nirthivekkan Kendra Nirdesam’, Madhyamam, 10 September 2001, p. 1; ‘RCCyodu Kendram Visadeekaranam Thedum’, Kerala Kaumudi, 16 September 2001, p. 12.

(150.) ‘RCC: Marunnu Pareekshanam’, Mathrubhumi; ‘RCCyil Gaveshanam Nirthivekkan’, Madhyamam; ‘RCCyile Pareekshanangal Aru’, Deshabhimani.

(151.) ‘RCCyile Pareekshanangal Aru’, Deshabhimani.

(152.) ‘RCCyile Pareekshanangal Aru’, Deshabhimani; ‘RCC: Doctormarkkethire Nadapadikku’, Malayala Manorama.

(153.) ‘RCC: Doctormarkkethire Nadapadikku’, Malayala Manorama‘Anumathiyillathe Vivada Marunnu Konduvannathu Pradhana Pizhavu’, Malayala Manorama, 10 September 2001, p. 11.

(154.) ‘Anumathiyillathe Vivada Marunnu’, Malayala Manorama.

(155.) ‘RCC: Marunnu Pareekshanam’, Mathrubhumi; ‘RCCyil Gaveshanam’, Madhyamam; ‘RCCyile Pareekshanangal Aru’, Deshabhimani.

(156.) ‘RCCyile Pareekshanangal Aru’, Deshabhimani. Earlier the 12 guidelines of the ICMR were applicable only to the research institutions affiliated to the ICMR.

(157.) ‘RCC: Doctormarkkethire Nadapadikku’, Malayala Manorama.

(158.) ‘Nirodhitha Marunnu Upayogichittilla: Chattalankhanathinu Nadapadi, Doctormarkkethire Nadapadiyilla’, Mathrubhumi, 16 September 2001, p. 5; ‘RCC Doctorsinu Ethire Nadapadi Undavilla’, Madhyamam, 16 September 2001, p. 5; ‘RCCyodu Kendram Visadeekaranam’, Kerala Kaumudi.

(159.) ‘Marunnu Pareekshanam: Nadapadi Paalichillennu IMA Report’, Malayala Manorama, 14 September 2001, p. 9; ‘Cancer Centreile Marunnu (p.115) Pareekshanam Krama Virudhamennu IMA Report’, Madhyamam, 14 September 2001, p. 9; ‘Marunnu Pareekshanam: Nadapadikramam Paalichilla’, Mathrubhumi, 15 September 2001, p. 11; ‘IMA Report: RCCye Rakshikkan Sramam’, Madhyamam, 15 September 2001, p. 7; ‘RCC Nadapadikramam Paalichilla: IMA’, Kerala Kaumudi, 15 September 2001, p. 12.

(160.) ‘RCC Prasnam Othukki Theerkkunnu’, Deshabhimani, 16 September 2001, p. 7; ‘IMA Report: RCCye Rakshikkan Sramam’, Madhyamam, 15 September 2001, p. 7.

(161.) ‘Manushyavakasa Lankhanam Illenna Vadam Mandatharam’, Mathrubhumi, 16 September 2001, p. 5; ‘Marunnu Pareekshanam Manushyavakasa Lankhanam: Dr. Bhattathiri’, Madhyamam, 16 September 2001, p. 5.

(162.) Malayala Manorama was the only newspaper which reported the content of the preliminary report. Others published the news when the final report was submitted to the government one month later.

(163.) ‘Nirodhitha Marunnu Cancer Centreil Pareekshichittillennu Anweshana Report’, Malayala Manorama, 5 October 2001, p. 9; ‘RCCyil Nirodhitha Marunnu Pareekshichillennu Anweshana Commission’, Madhyamam, 18 November 2001, p. 6.

(164.) ‘Nirodhitha Marunnu Cancer’, Malayala Manorama.

(165.) ‘Nirodhitha Marunnu Cancer’, Malayala Manorama‘Vivada Marunnu Nirodhichathallennu Report’, Mathrubhumi, 18 November 2001, p. 1.

(166.) ‘Nirodhitha Marunnu Cancer’, Malayala Manorama.

(167.) ‘Nirodhitha Marunnu Cancer’, Malayala Manorama; ‘RCCyil Nirodhitha Marunnu’, Madhyamam.

(168.) ‘RCC: Mukhya Manthri Vittu Nilkkanam’, Deshabhimani, 16 November 2001, p. 6; ‘RCCye Doctormarude Lobbykku Vittu Kodukkaruthu’, Deshabhimani, 6 December 2001, p. 12; ‘RCC Marunnu Pareekshanathinu Pinnil Pravarthichavarkkethire Nadapadi Venam’, Madhyamam, 24 November 2001, p. 3.

(169.) ‘Nirodhitha Marunnu Cancer’, Malayala Manorama‘Marunnu Pareekshanam: Prof. Ru Chihye Baliyaadakkan Aniyara Neekkam’, Madhyamam, 19 November 2001, p. 5.

(170.) See Dr Raveendran Kummil, ‘RCC Vivadavum Vasthuthakalum’, Kerala Kaumudi, 30 November 2001, p. 4, editorial page article; ‘RCC Vivadam Arthasoonyam: Dr. Padmanabhan Nair’, Kerala Kaumudi, 11 February 2002, p. 2. The latter news report was based on an interview with Dr Padmanabhan Nair, who was the former director of the Department of Biomedical Research at JHU. He claimed that it was he who introduced Dr Ru Chih Huang to Dr Krishnan Nair.

(171.) The conclusions of the JHU Commission were reported in the Malayalam press. ‘Marunnu Pareekshanam Hopkins Sammathichu: Sastrajjnaykku (p.116) Vilakku’, Deshabhimani, 14 November 2001, p. 1; ‘RCC Marunnu Pareekshanam Anumathiyillathe: Hopkins Samithi, Gaveshakaykku Vilakku’, Madhyamam, 14 November 2001, p. 1.

(172.) ‘RCCye Doctormarude Lobbykku Vittu Kodukkaruthu’, Deshabhimani, 6 December 2001, p. 12.

(173.) ‘Marunnu Pareekshanam: Nadapadikramam Paalichittillennau Manthri Thakur’, Malayala Manorama, 4 December 2001, p. 9; ‘Vivada Marunnu Pareekshanathil Manushyavakasa Lankhanamilla: Kendra Manthri’, Mathrubhumi, 4 December 2001, p. 5; ‘RCCyil Nirodhicha Marunnu Pareekshichittilla: Manthri’, Deshabhimani, 4 December 2001, p. 5.

(174.) ‘RCCyil Nirodhitha Marunnu Upayogichittilla: Manthri’, Malayala Manorama, 4 December 2001, p. 9; ‘RCCyil Nirodhitha Marunnu Upayogichittilla: Manthri’, Mathrubhumi, 4 December 2001, p. 7; ‘Nirodhitha Marunnu Chikilsakku Upayogichittillennu Manthri’, Deshabhimani, 4 December 2001, p. 8; ‘RCCye Sikshikkan Nivruthiyilla: Manthri’, Kerala Kaumudi, 30 November 2001, p. 4; ‘Prathipaksham Avakasa Lankhanathinu Noticinu Orungunnu’, Madhyamam, 30 November 2001, p. 5; ‘RCC Prasnam: Dr. Parikhinte Report Thallanam’, Deshabhimani, 5 December 2001, p. 9.

(175.) ‘RCC Prasnam: Dr. Parikhinte’, Deshabhimani.

(176.) ‘RCC: Rekhaa Moolam Paraathi Labhichal Anweshikkumennu’, Deshabhimani, 8 December 2001, p. 8. The Petitions Committee of the Legislative Assembly was appointed by the Speaker of the House to investigate the complaints against the RCC. See ‘Sabha Samithi Anweshikkum’, Malayala Manorama, 19 December 2001, p. 9; ‘RCCkkethiraya Parathi Petitions Committee Anweshikkum’, Deshabhimani, 19 December 2001, p. 1.

(177.) ‘RCCye Kutta Vimukthamakkunna Report Manthri Sabha Angeekarichu’, Malayala Manorama, 14 February 2002, p. 9; ‘RCC Anweshana Report Angeekarichu’, Deshabhimani, 14 February 2002, p. 2.

(178.) Quintiles India, the company that was involved in the RCC clinical trials, clearly states why India is a target for them to carry out clinical trials: ‘India has a vast population. Patient access is fast; fully a third of the population lives in urban areas. Large portions of the population have not been exposed to prior treatment. Tropical diseases and diseases of developed countries are both common in India. Trials opportunities include cardio-vascular diseases, diabetes, degenerative neurological diseases, cancers, psychiatric illnesses, and infectious diseases.’ Quoted in Prasad (2009: 5) from www.quintiles.com/Corporate_Info/Regions/south_africa_and_india/India/India.htm, which the author accessed in April 2007 and is not available now.

(p.117) (179.) The KSSP’s interventions in the controversy, though limited, were contingent upon its long history of engagement with issues of public health and medical research. Dr Joy Elamon who represented the KSSP in the RCC controversy also corroborated this in a personal interview on 24 April 2006.

Notes:

(1.) The RCC was established in the year 1981, and the institute is jointly sponsored by the central and the state governments. Several international agencies including the World Health Organization (WHO), the International Agency for Research on Cancer (IARC), and the United Nations Population Fund (UNFPA) have acknowledged the institute as a centre of excellence. See State Planning Board (2006).

(2.) Quintiles India (or Quintiles Spectral Ltd) was launched in 1997 as a collaborative venture between Quintiles Transnational Corporation and an India-based healthcare firm called Core Healthcare Limited (Prasad 2009). The RCC clinical trials were probably one of their initial projects. See Mirowski and Van Horn (2005) for a detailed analysis of how the rapid rise of the CROs provides impetus to the commercialization of biomedical research.

(3.) The Food and Drug Administration (FDA) is the federal agency in the United States which regulates drug development research. The procedures set by the FDA eventually became the basis for research guidelines all over the developed world (Mirowski and Van Horn 2005: 508). Within the FDA framework, drug research is organized into four stages. These are: a pre-clinical stage where experiments are carried out on laboratory animals, followed by a clinical stage, a regulatory delay, and a post-clinical stage (Mirowski and Van Horn 2005). The clinical stage of drug research consists of four phases where the drug under trial is administered on humans (Mirowski and Van Horn 2005). BioCure Medicals is a company that was established in 2000 by BioCure Technologies to develop M4N and other drugs. The JHU has shares in the company which is currently known as Erimos. See Krishnakumar (2005). The Phase I trials at the RCC were apparently outsourced to the Quintiles International by Erimos.

(4.) The research team had Dr Manoj Pandey and Dr Radhakrishna Pillai as co-researchers. See Krishnakumar (2001). As its founder director, Dr Krishnan Nair had great contribution in building the RCC since its inception (1981–2003). For an autobiographical narration on his close relationship with the institute, see Nair (2013).

(5.) Dr Bhattathiri had finished his PhD research on radiotherapy with Dr Krishnan Nair. See Nair (2013: 159).

(p.104) (6.) ‘Aniyara’ literally means ‘backstage’. The programme was directed and anchored by Alias John, a reputed social activist-turned-TV journalist, and was produced by his own company called National Television (NTV).

(7.) Many of the speakers interviewed by me pointed out the role of Surya TV in exposing the issue. Later on it was alleged that the TV channel had deliberately been trying to defame the RCC, and that it was hand in glove with the Adayar Cancer Institute, Tamil Nadu, though the allegation did not get much currency in the scientific public sphere. Personal interview with Dr Joy Elamon, 24 April 2006, and Dr C.R. Soman, 26 April 2006.

(8.) A previously unheard of organization called the All India Medical Service Centre (AIMSC) was the petitioner. The name of the organization appeared only in this particular news report. The CM of Kerala is the chairperson of the RCC governing body, and hence the petition was submitted to him.

(9.) ‘Cancer Centreile Kramakkedukale Kurichu Anweshikkanam’, Madhyamam, 3 July 2001, p. 2.

(11.) ‘RCCkku Munpil Dharna Nadathi’, Madhyamam, 13 July 2001, p. 3.

(12.) Kerala Kaumudi and Malayala Manorama openly defended the RCC director throughout the controversy as will be discussed. Mathrubhumi did not explicitly support any of the coalitions, but a majority of its news reports represented the pro-RCC actors in the scientific public sphere. Deshabhimani took a non-partisan view on the matter, but critiqued the governmental interventions, especially in the final phase of the controversy. In my personal interview with a reputed media analyst from Kerala (name withheld), it was pointed out that many of the newspaper authorities had a cordial relationship with the RCC administration and especially with Dr Krishnan Nair. If the newspaper owners or the reputed journalists recommended a patient, he/she was given great priority and utmost care in the RCC. In return the newspapers always helped the institute maintain good public relations by publishing reports whenever needed. He also pointed out that the chief editor of one of the major newspapers was a member of the governing council of the institute.

(14.) Each speciality clinic was meant for the treatment of the cancer that affects a specific part of the body. A speciality clinic consists of a team of experts led by a senior doctor. See ‘RCCyil Speciality Clinikkukal Erppeduthi’, Malayala Manorama, 8 July 2001, p. 4; ‘RCCyil Speciality Clinikkukal’, Kerala Kaumudi, 8 July 2001, p. 10.

(p.105) (17.) Kerala Kaumudi‘RCC Directorude Kalaavadhi Neettiyathinu Ethiraya Harjiyil Notice’, Kerala Kaumudi, 25 July 2001, p. 3.

(18.) ‘John Hopkinsinte Pareekshanangalkku America Vilakkerppeduthi’, Madhyamam, 23 July 2001, p. 5.

(19.) The drug was ‘Hexamethonium’ used in combination with sodium bicarbonate, which was not scientifically allowed, according to the Madhyamam report. See ‘John Hopkinsinte Pareekshanangalkku’, Madhyamam.

(21.) ‘Nirodhicha Marunnu Kuththivechittilla: RCC’, Kerala Kaumudi, 15 July 2001, p. 10.

(23.) Malayala Manorama‘Nirodhitha Marunnu RCCyil Upayogichittilla: Krishnan Nair’, Malayala Manorama, 21 July 2001, p. 12.

(24.) Note the confusion regarding the number of patients. According to the news report in Kerala Kaumudi the number was 25, and in the report by Malayala Manorama the number was reduced to 22. Later in an interview with Dr Ru Chih C. Huang, it emerged that 27 patients had been administered the drug. See Krishnakumar (2005).

(25.) The source of the allegation is not clear. As we are going to see, the same allegation reappeared in the scientific public sphere at a later phase.

(26.) However, it was not discussed if the diabetes could have been drug-induced.

(27.) This has turned out to be a false claim.

(28.) ‘RCC Prasnam Sarkar Thalathil Anweshikkunnu: Antony’, Malayala Manorama, 26 July 2001, p. 9; ‘RCCkkethiraya Aropanangal Anweshikkunnu: Mukhyamanthri’, Mathrubhumi, 26 July 2001, p. 5; ‘Cancer Centreinte Visvasyatha Nashtappeduthilla’, Madhyamam, 26 July 2001, p. 5; ‘RCC: Aropanangal Anweshikkum Ennu Mukhyamanthri’, Kerala Kaumudi, 26 July 2001, p. 11.

(30.) ‘RCCkkethiraya Aropanangal’, Mathrubhumi‘RCC Vivadam: Kendram Vivaram Aarayunnu’, Mathrubhumi, 26 July 2001, p. 5.

(31.) ‘Nirodhikkappetta Marunnu Upayogichittilla: Krishnan Nair’, Deshabhimani, 28 July 2001, p. 8.

(32.) ‘Nirodhitha Marunnu Pareekshichittillennu RCC’, Malayala Manorama, 28 July 2001, p. 9; ‘Nirodhikkappetta Marunnu Upayogichittilla’, Deshabhimani; (p.106) ‘Gaveshana Sthapanam Ayathinal Marunnu Pareekshiche Theeroo: Cancer Centre’, Madhyamam, 28 July 2001, p. 5; ‘Cancer Chikilsaykku Upayogichathu Paarsva Phalangalillennu Thelinja Marunnu: Dr. M. Krishnan Nair’, Kerala Kaumudi, 28 July 2001, p. 12.

(36.) ‘Gaveshana Sthapanam Ayathinal’, Madhyamam. This claim was problematic, as the RCC was just functioning as a CRO for the JHU researcher.

(38.) ‘Gaveshana Sthapanam Ayathinal’, Madhyamam‘Nirodhicha Marunnukal RCCyil Upayogichilla: Director’, Deshabhimani, 29 July 2001, p. 4.

(41.) ‘RCCyude Salpperinu Kalankam Undakkaruthu’, Kerala Kaumudi, 27 July 2001, p. 3. The Post Graduate Students’ Association and the Junior Doctors’ Association of the Medical College, Thiruvananthapuram, expressed similar concerns. See ‘RCC Vivadam: Asanka Pariharikkanam’, Malayala Manorama, 31 July 2001, p. 9; ‘Cancer Centre: Asanka Pariharikkanam’, Mathrubhumi, 31 July 2001, p. 3.

(43.) Madhyamam‘RCCyude Pathra Sammelanam Vivadamayi’, Madhyamam, 28 July 2001, p. 5.Chapter 7

(44.) ‘Marunnu Pareekshanam Nadannathu Niyama Vidheyamayi: Dr. Krishnan Nair’, Mathrubhumi, 29 July 2001, p. 5‘Nirodhicha Marunnukal RCCyil’, Deshabhimani

(47.) ‘Nirodhicha Marunnukal RCCyil’, Deshabhimani‘Marunnu Pareekshichathu Ethical Committeeyude Anuvadathode: RCC Director’, Malayala Manorama, 29 July 2001, p. 7.

(p.107) (48.) ‘Marunnu Gaveshanam RCCyude Joli: Vivada Marunnu Phalapradamennu Thelinju: Dr. M. Krishnan Nair’, Kerala Kaumudi, 29 July 2001, p. 1.Krishnakumar (2005)

(50.) ‘Marunnu Pareekshichathu Ethical’, Malayala Manorama. However, the report in Deshabhimani contradicted this. The report quoted Dr Krishnan Nair as saying that the RCC clinical trials had been approved by both the RCC ethical committee and the DCGI. See ‘Nirodhicha Marunnukal RCCyil’, Deshabhimani. The press note of the Health Ministry of the Government of India which was widely reported in the regional press later on said that the DCGI had approved the import of M4N from the JHU in February 2001. See ‘RCCyile Nirodhitha Marunnu Prayogam Kendram Anweshikkunnu’, Malayala Manorama, 31 July 2001, p. 9; ‘Nirodhicha Marunnu Upayogichathu Anweshikkum’, Deshabhimani, 31 July 2001, p. 1. It was also mentioned that the approval was granted on the basis of the recommendations of the RCC ethical committee. See ‘RCC Marunnu Pareekshanam Kendram Anweshikkunnu’, Kerala Kaumudi, 31 July 2001, p. 1.

(51.) See Prasad (2009) for a detailed analysis of the politics of conducting clinical trials in developing countries like India.

(53.) ‘RCCyile Nirodhitha Marunnu’, Malayala Manorama‘RCC Marunnu Pareekshanam’, Kerala Kaumudi, 2001, p. 1.

(54.) Dr Purvish Parikh who was appointed as the single-member enquiry commission was Professor of medical oncology at the Tata Memorial Hospital, Mumbai, and was also the then secretary of the Indian Cooperative Oncology Network (ICON). ‘Dr Parikh Anweshikkum’, Mathrubhumi, 1 August 2001, p. 1; ‘Cancer Centre Vivadam: Anweshikkan Utharavu’, Deshabhimani, 1 August 2001, p. 10; ‘Dr Parikh Anweshikkum’, Madhyamam, 1 August 2001, p. 1; ‘RCC Vivadam Anweshikkan Ekanga Commission’, Kerala Kaumudi, 1 August 2001, p. 1.

(55.) ‘Director Hajarakanam’, Mathrubhumi, 1 August 2001, p. 1; ‘RCC Directorkku Manushyavakasa Commissionte Summons’, Madhyamam, 1 August 2001, p. 7; ‘Dr Krishnan Nairkku Manushyavakasa Commissionte Summons’, Kerala Kaumudi, 1 August 2001, p. 1.

(56.) ‘Cancer Centre: Judicial Anweshanam Venam’, Mathrubhumi, 1 August 2001, p. 4.

(p.108) (57.) ‘Parikhinte Anweshanavumayi Yojikkanavilla: Bhattathiri’, Madhyamam, 1 August 2001, p. 7; ‘RCC Vivadam Puthiya Vazhithirivilekku’, Deshabhimani, 2 August 2001, p. 7.

(59.) ‘Cancer Centre: Anweshanam Nishpakshamakillennu’, Madhyamam, 2 August 2001, p. 5.

(61.) ‘Arbuda Marunnu Pareekshikkan Anumathi Nalkiyirunnillennu Hopkins Sarvakalasala’, Mathrubhumi, 1 August 2001, p. 1; ‘RCC Vivadam Puthiya’, Deshabhimani; ‘Pareekshanathinu Anumathi Nalkiyillennu JHU: RCC Padanam Nirthiveykkan Gaveshakaykku Nirdesam’, Madhyamam, 1 August 2001, p. 1.

(64.) Dr C.R. Soman (now late) was formerly Professor and the Head of the Department of Nutrition at the Government Medical College, Thiruvananthapuram. Later on, he became the director of Health Action by People, an action-research NGO in Thiruvananthapuram.

(65.) Dr M. Krishnan Nair, ‘Americayil Nirodhichittilla’, Malayala Manorama, 1 August 2001, p. 4.

(66.) Dr C.R. Soman, ‘Niyama Lankhanam, Adharmikam’, Malayala Manorama, 1 August 2001, p. 4.

(67.) The Forum for Patients’ Rights is a civil society organisation which took a strong anti-clinical trials position in the controversy.

(68.) ‘RCC Vivadam: Samagranweshanam Venamennu Charcha’, Madhyamam, 2 August 2001, p. 7.

(69.) ‘RCCyil Judicial Anweshanam Venam’, Mathrubhumi, 2 August 2001, p. 3.

(72.) ‘Nirodhitha Marunnu Kuththi Vechathu Manushyavakasa Lankhanamennu’, Malayala Manorama, 2 August 2001, p. 9.

(76.) See ‘Marunnu Pareekshanam: Samvadathil Doctormarude Vakku Tharkkam’, Malayala Manorama, 4 August 2001, p. 9; ‘Marunnu Pareekshanam: Samvadathil Doctormar Cheri Thirinju Tharkkichu’, Mathrubhumi, 4 August (p.109) 2001, p. 2; ‘Marunnu Pareekshanam: Samvada Velayil Tharkkavum Bahalavum’, Deshabhimani, 4 August 2001; ‘RCC Vivadam: Doctormar Thammil Tharkkam’, Madhyamam, 4 August 2001, p. 7; ‘RCC Prasnathil Doctors Cheri Thirinju’, Kerala Kaumudi, 4 August 2001, p. 2.

(78.) ‘RCCkkethireyulla Pracharanathil Ninnu Pinmaranam: Mukhyamanthri’, Mathrubhumi, 3 August 2001, p. 2; ‘RCCye Nasippikkaruthu: Mukhyamanthri’, Kerala Kaumudi, 3 August 2001, p. 3.

(83.) M.N. Vijayan, ‘RCC’, Deshabhimani, 33/10, 12 August 2001, p. 12.

(84.) ‘RCC: Mukhyamanthriyude Asahishnutha Janadhipathya Virudham: M.N. Vijayan’, Deshabhimani, 5 August 2001, p. 4; ‘RCC Vivadam: Mukhyamanthriyude Asahishnutha Janadhipathya Virudham: M.N. Vijayan’, Madhyamam, 5 August 2001, p. 7.

(86.) ‘RCC: Mukhyamanthriyude Prasthavana Dourbhagyakaram’, Madhyamam, 4 August 2001, p. 7.

(87.) ‘RCCye Thakarkkan Sramam: Jeevanakkar’, Malayala Manorama, 3 August 2001, p. 2; ‘RCCye Thakarkkan Goodalochana’, Deshabhimani, 3 August 2001, p. 8; ‘RCC Directorku Pinthunayayi Doctorsum Staffum’, Kerala Kaumudi, 3 August 2001, p. 11.

(88.) ‘RCCkkethire Chilar Dooshitha Valayam Srishtikkunnu: Manthri Sankaran’, Malayala Manorama, 4 August 2001, p. 9.

(89.) See ‘RCCye Rakshikkan Nadapadi Venam: MLA’, Mathrubhumi, 6 August 2001, p. 13; ‘RCCye Thaaradichu Kattaruthu’, Mathrubhumi, 7 August 2001, p. 11; ‘Cancer Centreine Thakarkkaruthu’, Kerala Kaumudi, 8 August 2001, p. 10; ‘RCC Doctormar Aasayakkuzhappam Srishtiykkunnu: K.V. Surendranath’, Kerala Kaumudi, 10 August 2001, p. 10; Vishnu Narayanan Nampoothiri, ‘RCC Erinjudaykkaruthu’, Mathrubhumi, 15 August 2001, p. 4, editorial page article; ‘RCC Vivadam Sthapanathinte Nadathippinu Bheeshaniyakaruthu: ONV’, Malayala Manorama, 17 August 2001, p. 17.

(90.) ‘RCC: Vivadam Venda’, Malayala Manorama, 5 August 2001, p. 2.

(91.) ‘RCC Vivadam: John Hopkins Anweshanam Thudangi’, Madhyamam, 5 August 2001, p. 1.

(93.) ‘“Pareekshanamriga”makunnathu Thadayan Americayil Niyama Bhedagathi Varunnu’, Madhyamam, 7 August 2001, p. 7; ‘RCCyile Vivada Pareekshanam Angeekarichittillennu Hopkins’, Deshabhimani, 7 August 2001, p. 10.

(96.) The journal article being quoted in the newspaper is possibly Bagla and Marshall (2001). The journal also took note of the action taken by the Ministry of Health and Family Welfare in another article. See Bagla (2001).

(97.) ‘Marunnu Pareekshanathinu Hopkins Paththu Laksham Nalki’, Madhyamam, 13 August 2001, p. 1.

(100.) ‘Marunnu Pareekshanathinu Hopkins’, Madhyamam. Mathrubhumi mentioned that the ‘Quintiles International’ was a CRO that operated from the United States. See ‘Marunnu Pareekshanam: Kooduthal Videsa Agencykalkku Panku’, Mathrubhumi, 12 August 2001, p. 5. For similar allegations regarding the involvement of a Singapore-based drug company (seemingly BioCure Medicals), see ‘Marunnu Pareekshanam: Kooduthal Samsayangal’, Mathrubhumi, 3 August 2001, p. 5.

(101.) ‘RCC Vivadam IMA Sangham Anweshikkum’, Mathrubhumi, 3 August 2001, p. 2; ‘RCC: IMA Theliveduppu Thudangi’, Deshabhimani, 5 August 2001, p. 4; ‘IMA Commission Theliveduppu Thudangi’, Malayala Manorama, 5 August 2001, p. 9.

(102.) ‘Azhimathikkethire Prathikarana Vedi Roopeekarichu’, Kerala Kaumudi, 4 July 2001, p. 10.

(103.) ‘RCC Vivadam IMA Sangham Anweshikkum’, Mathrubhumi, 3 August 2001, p. 2; ‘RCC Vivadam: Sarkar Committee Aparyapthamennu Prathikarana Vedi’, Madhyamam, 5 August 2001, p. 3.

(104.) ‘RCC, Karsana Nadapadi Sweekarikkanam: Human Rights Protection Council’, Madhyamam, 9 August 2001, p. 9; ‘RCC: Vazhivitta Pareekshanaththinethire Nadapadi Venam: Sasthra Parishad’, Kerala Kaumudi, 8 August 2001, p. 2; ‘RCC Pareekshanam Adharmmikamennu’, Kerala Kaumudi, 12 August 2001, p. 2; ‘Uttharavadikale Matti Nirthi Anweshikkanam: Parishad’, Deshabhimani, 8 August 2001, p. 6; ‘RCC Pareekshanam: Nadapadi Venamennu Parishad’, Malayala Manorama, 8 August 2001, p. 9.

(105.) ‘Clinical Pareekshana Niyamangal Cancer Centre Avaganichu: Padana Report’, Madhyamam, 7 August 2001, p. 3.

(p.111) (107.) Seminars organized by the Mukthi, the IPA-Kerala, the KSSP, and the Kerala M. Pharm Students’ Forum were widely reported in the regional press. See news reports on 4 August 2001 and 8 August 2001.

(108.) The KSSP was the most vocal speaker in this regard. It also strongly demanded that the ICMR guidelines should be made applicable for all medical science research institutes in the country. See RCC Pareekshanam: Nadapadi’, Malayala Manorama; ‘Uttharavadikale Matti Nirthi’, Deshabhimani; ‘RCC: Vazhivitta Pareekshanaththinethire’, Kerala Kaumudi.

(109.) See Varughese (2014) for a detailed analysis of alternative models of technological governance proposed by social movements in India.

(110.) ‘“Guneappanni” Ayathu Aarkku Vendiyennariyathe Gopal’, Madhyamam, 3 August 2001, p. 5.

(111.) ‘Gopal Manushyavakasa Commissionu Parathi Nalki’, Madhyamam, 3 August 2001, p. 2.

(112.) ‘Gopalil Pareekshanam Nadathiyathu Chattangal Lankhichu’, Madhyamam, 18 August 2001, p. 2.

(113.) ‘Nirodhitha Marunnu Kuththi Vecha Randu Per Neraththe Marichennu Mozhi’, Madhyamam, 11 August 2001, p. 2; ‘Marunnu Pareekshanam: Randu Per Marichathayi Aaropanam’, Deshabhimani, 11 August 2001, p. 1.

(114.) ‘Marunnu Pareekshanathil Amma Marichathayi Makante Parathi’, Deshabhimani, 12 August 2001, p. 1; ‘Amma Marichathu Marunnu Pareekshanam Moolamenna Aropanavumayi Makan’, Madhyamam, 12 August 2001, p. 3.

(115.) ‘Rogi Marichathu Marunnu Pareekshanam Kondalla: RCC’, Mathrubhumi, 14 August 2001, p. 7.

(118.) As pointed out by a social activist (name withheld) the author interviewed on 26 April 2006, the patients who underwent the clinical trials had been from poor socio-economic background, and hence were availing financial assistance through the welfare schemes run by the RCC. As chronic patients, they were also completely at the mercy of their doctors. These factors appear to have helped the RCC authorities to prevent the patients’ voices from entering the scientific public sphere.

(119.) See ‘RCCyude Visvasyatha Nashtappedutharuthu’, Mathrubhumi, 19 August 2001, p. 3; See also the personal requests made by some of the signatories; Vishnu Narayanan Nampoothiri, ‘RCC Erinjudaykkaruthu’, Mathrubhumi, 15 August 2001, p. 4, editorial page article; ‘RCC Vivadam Sthapanathinte’, Malayala Manorama, p. 17.

(120.) For a detailed discussion, see Martin (1988). O.N.V. Kurup, ‘RCCye Nasippikkaruthe!’, Mathrubhumi, 17 August 2001, p. 4, letter to the editor; (p.112) Sugathakumari, Thiruvananthapuram, ‘RCCyude Agnipareeksha’, Mathrubhumi, 9 August 2001, p. 4, letter to the editor.

(121.) ‘RCCkkethire Pracharanam Nadathiyavare Pirichu Vidanam’, Deshabhimani, 20 August 2001, p. 8.

(122.) See, for example, Dr K. Balaraman, ‘RCC: Kolahalam Apalapaneeyam’, Kerala Kaumudi, 7 August 2001, p. 4, letter to the editor; Dr N.M. Muhammad Ali, ‘Verittoru Sabdam’, Kerala Kaumudi, 19 August 2001, p. 4, letter to the editor; Dr T.P. Gopalakrishnan, Kawadiyar, Thiruvananthapuram, ‘Doctormar Porvili Nirthanam’, Mathrubhumi, 23 August 2001, p. 4, letter to the editor; Ramesh G., Kozhikode, ‘RCCyude Salpperu Nilanirthan’, Mathrubhumi, 14 September 2001, p. 4, letter to the editor.

(123.) For a detailed discussion, see Martin (1988).

(124.) ‘Gaveshanam Kurisil Thoongunnu’, Kerala Kaumudi, 14 August 2001, p. 4.

(126.) Mathrubhumi also used its ‘Letters to the Editor’ column in a similar fashion, but more benignly. See, for example, Sugathakumari, Thiruvananthapuram, ‘RCCyude Agnipareeksha’, Mathrubhumi, 9 August 2001, p. 4, letter to the editor; O.N.V. Kurup, ‘RCCye Nasippikkaruthe!’, Mathrubhumi, 17 August 2001, p. 4, letter to the editor. The construction of the ‘Letters to the Editor’ columns by the press to further its interests is a well-noticed fact. See Richardson and Franklin (2003). For a detailed discussion on the letters to the editor as a genre, see Chapter 7.

(127.) Adv. V. Sadasivan, ‘Cancer Centre Vivadam’, Kerala Kaumudi, 5 August 2001, p. 4, letter to the editor; Dr K. Balaraman (former director, Dept. of Health), Thiruvananthapuram, ‘RCC: Kolahalam Apalapaneeyam’, Kerala Kaumudi, 7 August 2001, p. 4, letter to the editor.

(128.) Umayannur E. Asseem Kunju, Perayam, ‘RCCye Nasippikkaruthu’, Kerala Kaumudi, 6 August 2001, p. 4

(129.) Dr N.M. Muhammad Ali, Thiruvananthapuram, ‘Verittoru Sabdam’, Kerala Kaumudi, 19 August 2001, p. 4, letter to the editor; Dr L. Lalitha Kumari, ‘RCCkku Ethire Gooda Padhathi’, Kerala Kaumudi, 3 September 2001, p. 4, letter to the editor. Mathrubhumi published a letter that criticized the free-for-all contest in full public view by the RCC scientists. See Dr T.D. Gopalakrishnan, Kawadiar, ‘Doctormar Porvili Nirthanam’, Mathrubhumi, 23 August 2001, p. 4, letter to the editor.

(130.) Priyanjana Prabhakar, Thiruvananthapuram, ‘Athu Mathramo Nirodhikkappetta Oushadham?’, Kerala Kaumudi, 5 August 2001, p. 4

(131.) Dr M.P. Mani, Kudamaloor, ‘Gaveshanangal Sarvakalasalakalil Mathramakanam’, Kerala Kaumudi, 21 August 2001, p. 4

(132.) Dr C.R. Soman, ‘Cancer Centreine Apakeerthippeduthukayalla Lakshyam’, Kerala Kaumudi, 12 September 2001, p. 4

(p.113) (133.) Dr P.A. Kurup, Thiruvananthapuram, ‘Marunu Pareekshanam: Reportinu Kakkuka’, Mathrubhumi, 23 August 2001, p. 4

(134.) ‘Cancer Centre Vivadam: Kendra Sangham Ethi’, Madhyamam, 9 August 2001, p. 5.

(135.) ‘Cancer Centre Vivadam’, MadhyamamMathrubhumi‘RCC Anweshana Sangham Ethi’, Mathrubhumi, 9 August 2001, p. 5.

(136.) ‘Anweshana Commissionu Sancharikkan RCC Vahanam’, Madhyamam, 10 August 2001, p. 2.

(137.) ‘Anweshana Commissionu Sancharikkan’, Madhyamam‘RCCyude Vahanam Sarkar Nalkiyathennu Thettidharichu’, Madhyamam, 11 August 2001, p. 7.

(139.) ‘RCC Anweshanam Nale Thudangum’, Deshabhimani, 8 August 2001, p. 6.

(140.) ‘Vidagdha Samithi Anweshikkanam’, Deshabhimani, 8 August 2001, p. 6; ‘Utharavadikale Matti Nirthi’, Deshabhimani. The Youth Congress Medical College Committee activists also staged an aggressive demonstration against the commission on 10 August in front of the Medical College auditorium where the hearing was being held. ‘RCC: Commissionethire Youthkar’, Deshabhimani, 11 August 2001, p. 10; ‘RCCyude Vahanam Sarkar’, Madhyamam.

(141.) ‘Vivada Marunnu Pareekshikkappetta Rogikalil Ninnu Thelivedukkum’, Kerala Kaumudi, 11 August 2001, p. 3.

(142.) ‘RCC Vivadathinu Pinnil Gooda Lakshyam: Aropanavumayi Vannavar Swantham Asupathrikku Thudakkamittavar’, Kerala Kaumudi, 22 August 2001, p. 1.

(143.) The news report also mentioned that some more persons from the RCC were involved in the venture.

(144.) ‘RCC-Paraathiyil Puthiya Society Rekhakal Mudra Vechu’, Malayala Manorama, 22 August 2001, p. 13.

(145.) Only two newspapers reported it on the next day, but more joined in over the next few days. ‘Cancer Society Rekhakal Mudra Vechathu Krithrimam Ozhivakkan’, Mathrubhumi, 23 August 2001, p. 18; ‘RCC Vivadam: Swantham Aasupathri Thudangan Lakshyamittathum Anweshikkum’, Deshabhimani, 23 August 2001, p. 3.

(p.114) (146.) ‘RCCkkethire Pracharanam’, Deshabhimani; ‘RCC: Nalu Perkkethire Parathi’, Deshabhimani, 24 August 2001, p. 3; ‘RCC Protection Forum Prakshobhathilekku’, Kerala Kaumudi, 28 August 2001, p. 3; The forum went a step ahead when it filed a petition against Dr C.R. Soman who had spoken against the clinical trials, alleging that he had indulged in a slander campaign against the RCC. See ‘RCC Vivadam: Dr. C.R. Somanethire Protection Forum Paraathi Nalki’, Deshabhimani, 9 September 2001, p. 3.

(147.) ‘Cancer Centreinu Hopkins Nalkiyathu Naalpathu Lakhsham: Thuka Prathyeka Accountil’, Madhyamam, 28 August 2001, p. 1.

(148.) Dr Bhattathiri and Dr Gangadharan resigned from the RCC following the closure of the controversy.

(149.) ‘RCC: Marunnu Pareekshanam Nirthan Kendra Nirdesam’, Mathrubhumi, 10 September 2001, p. 1, lead article; ‘RCC: Doctormarkkethire Nadapadikku Sadhyatha’, Malayala Manorama, 10 September 2001, p. 1; ‘RCCyile Pareekshanangal Aru Masathekku Suspend Cheythu’, Deshabhimani, 10 September 2001, p. 1; ‘RCCyil Gaveshanam Nirthivekkan Kendra Nirdesam’, Madhyamam, 10 September 2001, p. 1; ‘RCCyodu Kendram Visadeekaranam Thedum’, Kerala Kaumudi, 16 September 2001, p. 12.

(153.) ‘RCC: Doctormarkkethire Nadapadikku’, Malayala Manorama‘Anumathiyillathe Vivada Marunnu Konduvannathu Pradhana Pizhavu’, Malayala Manorama, 10 September 2001, p. 11.

(156.) ‘RCCyile Pareekshanangal Aru’, Deshabhimani. Earlier the 12 guidelines of the ICMR were applicable only to the research institutions affiliated to the ICMR.

(158.) ‘Nirodhitha Marunnu Upayogichittilla: Chattalankhanathinu Nadapadi, Doctormarkkethire Nadapadiyilla’, Mathrubhumi, 16 September 2001, p. 5; ‘RCC Doctorsinu Ethire Nadapadi Undavilla’, Madhyamam, 16 September 2001, p. 5; ‘RCCyodu Kendram Visadeekaranam’, Kerala Kaumudi.

(159.) ‘Marunnu Pareekshanam: Nadapadi Paalichillennu IMA Report’, Malayala Manorama, 14 September 2001, p. 9; ‘Cancer Centreile Marunnu (p.115) Pareekshanam Krama Virudhamennu IMA Report’, Madhyamam, 14 September 2001, p. 9; ‘Marunnu Pareekshanam: Nadapadikramam Paalichilla’, Mathrubhumi, 15 September 2001, p. 11; ‘IMA Report: RCCye Rakshikkan Sramam’, Madhyamam, 15 September 2001, p. 7; ‘RCC Nadapadikramam Paalichilla: IMA’, Kerala Kaumudi, 15 September 2001, p. 12.

(160.) ‘RCC Prasnam Othukki Theerkkunnu’, Deshabhimani, 16 September 2001, p. 7; ‘IMA Report: RCCye Rakshikkan Sramam’, Madhyamam, 15 September 2001, p. 7.

(161.) ‘Manushyavakasa Lankhanam Illenna Vadam Mandatharam’, Mathrubhumi, 16 September 2001, p. 5; ‘Marunnu Pareekshanam Manushyavakasa Lankhanam: Dr. Bhattathiri’, Madhyamam, 16 September 2001, p. 5.

(162.) Malayala Manorama was the only newspaper which reported the content of the preliminary report. Others published the news when the final report was submitted to the government one month later.

(163.) ‘Nirodhitha Marunnu Cancer Centreil Pareekshichittillennu Anweshana Report’, Malayala Manorama, 5 October 2001, p. 9; ‘RCCyil Nirodhitha Marunnu Pareekshichillennu Anweshana Commission’, Madhyamam, 18 November 2001, p. 6.

(165.) ‘Nirodhitha Marunnu Cancer’, Malayala Manorama‘Vivada Marunnu Nirodhichathallennu Report’, Mathrubhumi, 18 November 2001, p. 1.

(168.) ‘RCC: Mukhya Manthri Vittu Nilkkanam’, Deshabhimani, 16 November 2001, p. 6; ‘RCCye Doctormarude Lobbykku Vittu Kodukkaruthu’, Deshabhimani, 6 December 2001, p. 12; ‘RCC Marunnu Pareekshanathinu Pinnil Pravarthichavarkkethire Nadapadi Venam’, Madhyamam, 24 November 2001, p. 3.

(169.) ‘Nirodhitha Marunnu Cancer’, Malayala Manorama‘Marunnu Pareekshanam: Prof. Ru Chihye Baliyaadakkan Aniyara Neekkam’, Madhyamam, 19 November 2001, p. 5.

(170.) See Dr Raveendran Kummil, ‘RCC Vivadavum Vasthuthakalum’, Kerala Kaumudi, 30 November 2001, p. 4, editorial page article; ‘RCC Vivadam Arthasoonyam: Dr. Padmanabhan Nair’, Kerala Kaumudi, 11 February 2002, p. 2. The latter news report was based on an interview with Dr Padmanabhan Nair, who was the former director of the Department of Biomedical Research at JHU. He claimed that it was he who introduced Dr Ru Chih Huang to Dr Krishnan Nair.

(171.) The conclusions of the JHU Commission were reported in the Malayalam press. ‘Marunnu Pareekshanam Hopkins Sammathichu: Sastrajjnaykku (p.116) Vilakku’, Deshabhimani, 14 November 2001, p. 1; ‘RCC Marunnu Pareekshanam Anumathiyillathe: Hopkins Samithi, Gaveshakaykku Vilakku’, Madhyamam, 14 November 2001, p. 1.

(172.) ‘RCCye Doctormarude Lobbykku Vittu Kodukkaruthu’, Deshabhimani, 6 December 2001, p. 12.

(173.) ‘Marunnu Pareekshanam: Nadapadikramam Paalichittillennau Manthri Thakur’, Malayala Manorama, 4 December 2001, p. 9; ‘Vivada Marunnu Pareekshanathil Manushyavakasa Lankhanamilla: Kendra Manthri’, Mathrubhumi, 4 December 2001, p. 5; ‘RCCyil Nirodhicha Marunnu Pareekshichittilla: Manthri’, Deshabhimani, 4 December 2001, p. 5.

(174.) ‘RCCyil Nirodhitha Marunnu Upayogichittilla: Manthri’, Malayala Manorama, 4 December 2001, p. 9; ‘RCCyil Nirodhitha Marunnu Upayogichittilla: Manthri’, Mathrubhumi, 4 December 2001, p. 7; ‘Nirodhitha Marunnu Chikilsakku Upayogichittillennu Manthri’, Deshabhimani, 4 December 2001, p. 8; ‘RCCye Sikshikkan Nivruthiyilla: Manthri’, Kerala Kaumudi, 30 November 2001, p. 4; ‘Prathipaksham Avakasa Lankhanathinu Noticinu Orungunnu’, Madhyamam, 30 November 2001, p. 5; ‘RCC Prasnam: Dr. Parikhinte Report Thallanam’, Deshabhimani, 5 December 2001, p. 9.

(176.) ‘RCC: Rekhaa Moolam Paraathi Labhichal Anweshikkumennu’, Deshabhimani, 8 December 2001, p. 8. The Petitions Committee of the Legislative Assembly was appointed by the Speaker of the House to investigate the complaints against the RCC. See ‘Sabha Samithi Anweshikkum’, Malayala Manorama, 19 December 2001, p. 9; ‘RCCkkethiraya Parathi Petitions Committee Anweshikkum’, Deshabhimani, 19 December 2001, p. 1.

(177.) ‘RCCye Kutta Vimukthamakkunna Report Manthri Sabha Angeekarichu’, Malayala Manorama, 14 February 2002, p. 9; ‘RCC Anweshana Report Angeekarichu’, Deshabhimani, 14 February 2002, p. 2.

(178.) Quintiles India, the company that was involved in the RCC clinical trials, clearly states why India is a target for them to carry out clinical trials: ‘India has a vast population. Patient access is fast; fully a third of the population lives in urban areas. Large portions of the population have not been exposed to prior treatment. Tropical diseases and diseases of developed countries are both common in India. Trials opportunities include cardio-vascular diseases, diabetes, degenerative neurological diseases, cancers, psychiatric illnesses, and infectious diseases.’ Quoted in Prasad (2009: 5) from www.quintiles.com/Corporate_Info/Regions/south_africa_and_india/India/India.htm, which the author accessed in April 2007 and is not available now.

(p.117) (179.) The KSSP’s interventions in the controversy, though limited, were contingent upon its long history of engagement with issues of public health and medical research. Dr Joy Elamon who represented the KSSP in the RCC controversy also corroborated this in a personal interview on 24 April 2006.