Read the latest HealthWatch newsletter:  Newsletter 116, Summer 2021

by Till Bruckner

“Transparency, Power and Influence in the Pharmaceutical Industry: Policy Gain or Confidence Game?”, edited by By Katherine Fierlbeck, Janice Graham and Matthew Herder, was published 4 July 2021 by University of Toronto Press. RRP £23.59, paperback, 304 pages.

Public and academic discussions around transparency tend to take on Manichean overtones. Transparency, like democracy or participation, is often conceived as an intrinsic good worth pursuing for its own sake, and more transparency, more democracy, and more participation are always better. The edited volume “Transparency, Power and the Influence of the Pharmaceutical Industry” provides a welcome departure from this simplistic framing.

Katherine Fierlbeck throws down the gauntlet in the first chapter. After providing a detailed overview of the different kinds of transparency applicable to pharmaceuticals, including a typology of clinical trial data, she warns that transparency does not always translate into real-life benefits. For example, making data accessible does not automatically result in more data being accessed, and “too much transparency” can drive decision-making processes underground.

The following chapters describe the evolution over time of transparency policies of the European Medicines Agency, the US Food and Drug Administration, and Health Canada. The key takeaway is that transparency victories are not won in one-off epic battles. Instead, past transparency gains have been achieved by diverse coalitions of actors persistently pushing for more access to data and information, which often required deploying a broad variety of tactics and engaging with arcane policy making processes over many years.

But does more and better information automatically lead to better patient care? Nav Persaud persuasively argues that this is not always the case, citing Tamiflu and three other examples in which shifts in the evidence base failed to produce shifts in public procurement and clinical practice. “Producers of clinical practice guidelines seem largely unmoved by new information,” he concludes.

Three subsequent chapters explore the interplay between the pharma industry and regulators in greater detail. Joel Lexchin warns that in Canada, the state has in some instances “voluntarily turned over de facto regulatory power to industry,” while Marc-Andre Gagnon provides a detailed examination of how pharma influences not only regulators, but the framing of public and expert discussions about medicine and medicines. Kanksha Mahadevia Ghimire and Trudo Lemmens tackle the thorny issue of striking the right balance between data transparency and patient confidentiality in rare diseases, concluding that “the fear of privacy breach is often overstated” and should be balanced against the potential benefits to patients of greater transparency.

Tom Jefferson’s chapter on the European registration of the flu vaccine Pandemrix raises issues that, with the benefit of Covid hindsight, many in the field probably wish they had paid greater attention to years ago. These include the assumption by European governments of all legal and financial liabilities for problems with pandemic vaccines, and concerns about the different safety profiles of vaccine batches produced at different manufacturing sites.

Rounding off the volume on a positive note, Rita Banzi discusses opportunities for increasing data sharing, based on her experience with the Mario Negri Institute, and the editors draw on all contributions to plead for a more politically savvy approach to advocating for greater transparency in the pharmaceutical sector.  

Taken as a whole, the volume has two major limitations. First, it does not unpack the concept of the “public interest,” by default equating it with patients’ interests. This narrow public health perspective obscures the fact that policy makers typically pursue a broader conception of the public interest, occasionally trading off patient interests against maximising domestic pharma companies’ contributions to employment, tax revenue, and strategically important economic sectors.

Second, the book focuses exclusively on Europe and North America (a sin of which this reviewer has also been guilty). As the recent development, production and export of Covid vaccines by Russia, India and China have shown, the quality and transparency of regulation in these countries is now a key factor shaping global health outcomes. Arguably, raising regulatory and industry standards in the Global South has become a more urgent priority than pursuing ever greater transparency within OECD countries.

Despite these caveats, this volume is very refreshing in its rejection of simplistic framings and its deliberate embrace of a political economy analysis approach. Detailed accounts of protracted legal, technical and bureaucratic struggles with, and within, regulatory agencies are hardly airport bestseller material. However, the accounts contained within the book provide an extremely valuable resource for advocates by highlighting possible pathways, opportunities and limitations for changing medical regulation – and hopefully medical practice – for the better.

Till Bruckner, TranspariMED

This article is published under a Creative Commons BY 3.0 license. Anyone is welcome to repost and/or reuse parts or all of its contents as long as they credit Dr Till Bruckner as the original author and provide a hyperlink to, or otherwise reference, the original document. Author contact: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

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