Abstract
The complex ways in which technical challenges of trial design provoke, and are provoked by, ethical, commercial and political factors are considered. It is suggested that the quality of the drug trial evidence base greatly depends on the how ethical, commercial and political priorities are set, and not merely on standardized techniques of data processing. Whether such standardized techniques are raising or lowering the quality of safety information about new drugs, and the protection of patients on clinical trials is explored. It is revealed that these international standards, intended to define valid evidence-based medicine for drug trials, are not themselves robustly evidence-based. It is argued that the internationalized regulatory standards developed to frame the evidence base for drug safety and efficacy are frequently inconsistent with furthering patients’ well-being and public health. Rather, those standards reflect a regulatory culture of neoliberal corporate bias, and have been powerfully shaped by the commercial and political interests of the pharmaceutical industry and regulatory institutions. It is questionable that regulatory agencies are thoroughly and robustly scrutinizing the claims that pharmaceutical firms make about their products. New political and regulatory arrangements that could facilitate more ethical drug trials in the interests of patients and public health are proposed.
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Notes
1 The role of CROs has substantially increased since the 1980s (Mirowski and Van Horn, 2005).
2 Such pre-approval hearings generally only occur in the US (Abraham and Sheppard, 1997).
3 Until 2005, pharmaceutical firms generally claimed that the results of clinical trials involving their drugs were their private property and commercially confidential. This convention was upheld by regulatory agencies. However, in August 2004, the New York State Attorney General brought a lawsuit against GlaxoSmithKline (GSK), alleging that the company had concealed negative clinical trial results. As part of the settlement, GSK agreed to set up a public register of all clinical trials on all its drugs. Other companies soon followed suit, and the industry (through trade associations) made proposals in January 2005 to establish a clinical trials register by 2006 (House of Commons, 2005).
4 That is, 60 percent of the trial patients taking the drug found it effective.
5 Norway's legislation regarding drug safety and efficacy dates back to 1928. The Norwegian regulatory framework incorporated a ‘needs clause’, which meant that new drugs that were more effective than placebo could only be approved for entry into the market if their efficacy fulfilled some therapeutic need. However, in 1994, in anticipation of a ‘yes’ vote to join the EU (which did not occur), the Norwegian government abolished its therapeutic ‘needs clause’ in order to come into line with EU directives on ‘fair competition’ and trade (Anon., 1993a). In the post-war period, until the collapse of the Stalinist regimes, Hungary and some other Eastern bloc countries regulated new drugs with a similar type of ‘needs clause’ (Reed, 2002).
6 The problem of a trial's representativeness of the intended patient population may also result from deliberate exclusion criteria designed by the pharmaceutical manufacturer.
7 Personal interests are defined as consultancies, fee-paid work and shareholding; non-personal interests as payments that benefit the department/institution for which the committee member is responsible but not received by the member personally.
8 During the 1990s, the EU, Japan and the US were the three largest pharmaceutical markets in the world. Of the US$ 22.7 billion spent world-wide on pharmaceutical research and development (R&D), they spent about 90 percent (Nakajima, 1996: 32).
9 The ICH guidelines represented minimal regulatory standards that industry testing was required to meet. Pharmaceutical firms could, of course, supersede those standards.
10 Of course, it remains a very serious condition for all those infected and it is still life-threatening for the millions of people infected in the world who cannot access adequate drug therapy and supportive health care.
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Abraham, J. Drug Trials and Evidence Bases in International Regulatory Context. BioSocieties 2, 41–56 (2007). https://doi.org/10.1017/S1745855207005042
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DOI: https://doi.org/10.1017/S1745855207005042