Trudo Lemmens’ reply to Jon Jureidini’s comment
Trudo Lemmens: Promoting pharmacological treatment in case of knowledge deficit:
the case of the CINP Task Force in Depression
Jon Jureidini rightly points out that trial registration will not be sufficient to combat the misrepresentation of the safety and efficacy of pharmaceutical products. It is on its own indeed not an effective tool to curb the overall use of science as a marketing tool even if it is and certainly has been an important first step of an overall transparency approach.
Trial registration has been heavily promoted by scientific organizations, medical journals, international organizations such as the World Health Organization, drug regulatory agencies and funding agencies in the wake of the exposure of some serious forms of hiding and misrepresentation of safety and efficacy data. The hiding of clinical trials data related to the use of Paxil for the treatment of depression in children and adolescents was one of the seminal controversies that convinced experts and politicians around the world that action was needed. Mandatory trial registration, which was widely implemented around the world, allows us at least to know what type of research is being undertaken, and can help avoid the hiding of the mere existence of a clinical trial, as happened in the context of some historical controversies such as the one related to Paxil. But it indeed does not help us to address misrepresentation, skewed methodology and the potential hiding of adverse event data.
I wholeheartedly agree with Jon Jureidini’s assessment and in my presentation and my published work on these issues (Lemmens, 2013; Lemmens and Gibson, 2014), I discuss the need for more fulsome transparency of data, including adverse event data. Having participated myself in some of the early initiatives of the World Health Organization and the Pan American Health Organization with respect to the promotion of trial registration and the development of primary registries that comply with the WHO International Clinical Trials Registry Platform criteria (Krleza-Jeric, 2011), I asked myself at times if it was a mistake to initially focus on this specific first step towards meaningful transparency. Incrementalism can be problematic, since it can lead to complacency, and can create a false impression that the problems have been dealt with. Not surprisingly, trial registration has relatively quickly been introduced around the globe, with industry relatively easily agreeing with the registration requirements. Implementing further transparency measures appears to face much stiffer resistance. The real battle will indeed be around access to all meaningful data, as recent court challenges in Europe against the European Medicine’s Agency clinical trials data transparency policy highlight.
The work of Jon Jureidini and colleagues in unravelling the concrete ways in which pharmaceutical companies have used scientific publications to misrepresent drug safety and efficacy has been hugely important in this context and a real source of inspiration, as I discuss in a recent analysis of some of their work (Lemmens, 2016). Data transparency implemented through new data sharing policies such as those of the European Medicines Agency and through the clever use of data access in the context of litigation has enabled people like Jon Jureidini to verify the claims made by industry and to expose the various ways in which data has been misrepresented. Will this form of transparency be sufficient to put an end to this type of fraud, which has huge public health implications? It remains an uphill battle, even with better transparency measures in place. As others, I have also argued (2004, 2013, 2016) that we need to reorganize the entire drug regulatory review structure, so that the scientific knowledge used in support of regulatory and health care decision making is no longer controlled by those who have a direct financial interest in shaping and distorting that knowledge. In the absence of such fundamental reform, we will have to continue to push for systematic access to data so that people like Jon Jureidini and others can continue to challenge the claims made in the scientific literature. Trial registration should clearly not be seen as the ultimate solution, but should be accompanied by results reporting, and sharing of all relevant data, including the trial protocols and adverse event data. Considering the massive resources of industry, and the colluding interests of individual researchers, medical journals, professional organizations, and a billion dollar clinical trials and medical publications industry, it will unfortunately remain a never-ending and unequal battle.
Krlezˇa-Jeriç K, Lemmens T, Reveiz L, Cuervo LG, Luis Gabriel Cuervo, Bero L.mProspective registration and results disclosure of clinical trials in the Americas: A roadmap toward rransparency” Pan American Journal of Public Health 2011; 30: 87-96.
Lemmens T. Leopards in the temple: Restoring scientific integrity to the commercialized research scene. Journal of Law, Medicine & Ethics 2004; 32: 641-57.
Lemmens T. Pharmaceutical knowledge governance: A human rights oerspective. Journal of Law, Medicine and Ethics 2013; 41: 163-84.
Lemmens T. Restoring the integrity of the pharmaceutical science record: Two tales of transparency. Jotwell July 14, 2016.
Lemmens T, Gibson S. Decreasing the data deficit: Improving post-market surveillance in pharmaceutical regulation. McGill Law Journal 2014; 59: 943-88.
September 21, 2017