Pharmaceutical Safety Withdrawals: A Comparative Study of the United States and Canada By Dominika Jegen


Temporal variations between the Food and Drug Administration in the United States and Health Canada range up to 14 years in length for pharmaceutical withdrawals. In addition, occasionally an unfavorable risk-to-benefit ratio has led to a pharmaceutical’s withdrawal in one country, while the other country opts for changes to prescribing information. In this book, the actor network theory is employed in order to examine the various “actors” and their resulting networks involved in the withdrawal of two popular pharmaceuticals, pemoline and tolcapone. Through the examination of reviewer documents, letters, press releases, and scientific publications, it becomes clear that each country’s regulations are vague and result in varying withdrawal thresholds dependent upon the individual pharmaceutical being regulated as well as the (non)existence of similarly acting compounds. Critical insight into the appropriateness of subsequent Canadian policy shifts and direction is also provided.

In this sociohistorical case study, Dominika Jegen expands on this important body of work by utilizing international comparisons of regulatory data never before analyzed concurrently. She posits that these cases deserve to be investigated because their identification and contents reveal the nature of what users are not told, while also “opening up” new choices to be made about what users should be able to know. She also investigates why federal regulatory agencies on both sides of the border, although in possession of arguably the same evidence on pharmaceutical safety and adverse reactions for each pharmaceutical in question, made completely different decisions regarding the withdrawal of certain pharmaceuticals off the market. For example, pemoline’s unfavourable risk-to-benefit ratio led to its withdrawal in Canada in 1999, while the Food and Drug Administration instead opted for two separate changes to the pemoline label before completely withdrawing the pharmaceutical in 2005. Although the approval of tolcapone came at relatively similar times in both countries, interestingly, withdrawal decisions once again differed owing to increasing concerns over reports of severe hepatotoxicity: Canada chose to withdraw the pharmaceutical within one year, while it is still available in the United States 10 years later.

This study, although focused specifically on pemoline and tolcapone, poses new crucial questions about the intersection of science, treatment, and capital. On a deeper level of analysis, the cases of pemoline and tolcapone expose how the construction and dissemination of “facts” can be undertaken by corporations, particularly regarding scientific evidence submitted to reviewing bodies and for product monographs. Clearly, current safeguards towards unbiased medical information are lacking. Hence, funding may supply scientific support for a pharmaceutical which can then appease regulators and allow sales. The author raises the point that unfortunately this does not bode well for our society, and increasingly for other societies worldwide.

This is an important book for those in public health and medical care.