Science, Politics and the Pharmaceutical Industry (1995)

“Drug disasters from Thalidomide to Opren, and other less dramatic cases of drug injury, raise questions about whether the testing and control of medicines provide satisfactory protection for the public. In this revealing book, John Abraham develops a theoretically challenging realist approach, and probes deeply into the work of scientists in the pharmaceutical industry and governmental drug regulatory authorities on both sides of the Atlantic, Through the examination of contemporary controversial case studies, he exposes how the commercial interests of drug manufacturers are consistently given the benefit of scientific doubts about medicines safety and effectiveness, over and above the best interests of patients. A highly original combination of philosophical rigour, historical sensitivity, and empirical depth enables the ‘black box’ of industrial and government science to be opened up to critical scrutiny much more than in previous social scientific studies. All major aspects of drug testing and regulation are considered, including pre-clinical animal tests, clinical trials, and post-marketing surveillance of adverse drug reactions. The author argues that drug regulators are too dependent on pharmaceutical resources and expertise, and are divorced from public accountability. His combined historical and contemporary analysis leads him to develop corporate bias theory as a way of explaining the behaviour of the regulatory state. The problem of corporate bias is particularly severe in the UK where regulatory decisions about medicines safety are shrouded in greater secrecy than in the US. Since the purpose of drug regulation should be to maximize the safety and effectiveness of medicines for patients, the public needs and deserves policies to counteract corporate bias in drug testing and evaluation. John Abraham’s analysis provides a robust basis for policy interventions at the institutional and legislative levels. He proposes that corporate bias could be reduced by more extensive freedom of information, greater autonomy of government scientists from the pharmaceutical industry, the development of independent drug testing by the regulatory authorities, increased patient representation on regulatory committees, and more frequent and thorough oversight of regulatory performance by the legislature. Science, politics and the pharmaceutical industry will be of interest to anyone who cares about how medicines should be controlled in modern society.”

“John Abraham’s book on the relationship between the regulators and the pharmaceutical industry is a classic. Now, with the publication of Science, Politics and the Pharmaceutical Industry, Abraham has shown many of us up as amateurs. By systematically comparing licensing episodes relating to Opren, Feldene, Zomax, Naprosyn, and Suprol in the United States and in the United Kingdom, by taking advantage of the greater access to information in the USA, by scouring the literature and badgering the authorities, he shows convincingly that, when options present, regulators in both countries favour the industry. Moreover he demonstrates that such bias is as old as regulation itself. Much of the bias is the result of the industry’s lobbying skills, but there is also structural bias – if the bulk of government’s advisers are close to the industry their collective opinion will tend to favour the industry.”

British Medical Journal

“This book is a study of scientific research in the drug industry, and of its dissemination, publication and interpretation in the process leading to government approval of new pharmaceuticals. Abraham explores the selective acceptance of data that reflects the tendency of all involved to doubt results that threaten corporate interests. While focusing on the fine details of drug cases, John Abraham illuminates broader questions about truth, political power, and corporate science. The text is disciplined and meticulously documented and has explicit policy implications. Most compellingly, the author attends to the internal contradictions in the process he studies as a way to elucidate its ideological structure. This is the sort of book that demonstrates just how far we can take the methods of science studies and sociology of science. It draws on the excesses of epistemological chicken to present a realist analysis, and the end result is serious work that tries to understand a process that should be appreciated not only for its potential to play a role in improving drug regulation but also for its contributions to the respectability of our scholarly enterprise.”

Technology and Culture

“In the contested world of regulatory science, ‘bias’ is a contentious term to use. Abraham, in his book on the regulation of pharmaceuticals in the United Kingdom and in the United States, nevertheless uses the concept of ‘corporate bias’ contending that the commercial interests of the pharmaceutical industry have dominated both the construction of regulatory frameworks and regulatory decision making on specific drugs. Abraham rejects the view that drug regulation has evolved primarily to protect patient health interests spurred by drug disasters such as that of thalidomide. Instead, Abraham argues that a significant driving force for drug regulation has been to erect regulatory barriers to create privileged commercial opportunities for the larger drug companies, with the protection of consumers as a goal only at the margins. As a result, regulation has accorded undue weight to the importance of the commercial success of the pharmaceutical industry at the expense of ensuring therapeutic efficacy and safety. Such ‘corporate bias’ has been mediated through regulatory-scientific assessments. Abraham makes this case firstly from a detailed historical examination of policy in this sector. For example, the revelation in the 1970s of the Food and Drug Administration’s (FDA’s) clandestine ‘neutralization’ policy is cited as an explicit attempt to construct a regulatory culture sympathetic to industry by transferring ‘adversarial’ FDA scientists from regulatory assessment of particular drugs. Even in the supposedly transparent and adversarial world of FDA regulation, therefore, the frame of reference for regulation was actively structured to favor industry. In contrast, Abraham argues that in the United Kingdom, the opacity of the regulatory process has masked a permissive policy style of minimal regulatory action. This has resulted from a close relationship between regulators and industry in which the interests of the private and public sectors have become blurred by regulators’ reliance on industrial expertise and the revolving doors of employment between the two groups. To substantiate these claims, Abraham devotes five chapters of the book to the complex details of the regulation of five anti-arthritis drugs. Methodologically, to reconstruct and identify the ways in which corporate interests penetrate and become embedded in regulatory-scientific decision making, Abraham examines the role and character of scientific evidence in regulatory decisions. He examines patterns of systematic inconsistencies in the presentation, evaluation, and interpretation of scientific data on these drugs; scrutinizes the way that the benefit of the doubt has been awarded in technical conflicts and under situations of scientific uncertainty; and investigates how judgements are made about acceptable and unacceptable risk. The chosen cases illustrate the different ways in which regulators’ and industry’s actions, as well as the systems of regulation, may be interpreted as serving commercial interests. The case of the drug Opren is a vivid illustration of how manufacturers withheld evidence to influence the drug’s assessment; this represented a deviation from acceptable practice and resulted in consequent criminal prosecution. In the case of the drug Naprosyn, regulatory inaction pending retesting following the discovery that fraudulent data had been used to support its approval is taken to imply an implicit shift in the burden of proof in a direction that favoured industry. When the drug Zomax tested positive in a carcinogenicity trial, it was nevertheless approved because the regulatory issue became reformulated as one of risk toleration rather than risk avoidance. Using the resources provided by the U.S. Freedom of Information Act, Abraham is able to document in some detail the argument that the U.S. regulatory system, often characterized as transparent, adversarial, and rule based, can be loaded in favor of the commercial concerns of industry. In the absence of such a rich source of information in the United Kingdom, the criticism of its secretive, consensual, and discretion-based system is based on more general imputation. In the case of the drug Feldene, for example, Abraham argues that the opacity of the U.K. system permitted considerable institutional discretion in the closure of the dispute over its safety in a way that was excessively favourable to its manufacturers. In contrast, in the United States, where discretion is narrower, Feldene was approved because of the FDA’s adjustment of the threshold of significant risk. Similarly, Abraham describes how the FDA rewrote its statistical rules so that in the case of the drug Suprol, a significant carcinogenicity finding came to be represented as marginal and thus did not prevent the drug’s approval. At the analytical level, Abraham disputes what he sees as the conflation of ‘bias’ and the mere presence of values. In his view, this conflation underlies prominent cultural relativists’ claims that ‘all is bias’, that, in other words, each interest group simply follows its own impeccable logic. From a realist sociological position, Abraham considers that far from there being plural rationalities for the construction of regulatory-scientific arguments, there is a common rationality of agreed standards through which the plural bases for constructing those arguments can be critically examined. Therefore, for Abraham, the identification of overt lying, of deviation from set standards of scientific practice, or of the more subtle opportunistic interpretation of data in ways that converge with corporate goals is a means of disentangling the relationship between the rhetoric of safety assessment and the practice of regulatory scientific approval. …. The case studies suggest that whereas the commercial interests of the pharmaceutical industry may have pervaded regulatory scientific decisions, there is a constant interplay of interests between and within industry, government, and patients-concerning a drug’s commercial profitability, therapeutic efficacy, and safety. These interests may diverge and converge at different times and have differing influences on regulatory assessment. The import of the book and policy value is in explicitly revealing embedded social assumptions in regulatory scientific decision making and in examining the ways in which these can be changed to serve more explicitly the interests of patients in being given safe and efficacious drugs.”

Science, Technology & Human Values