In the fall of 1960, a newly hired pharmacologist named Frances Kelsey received her first assignment at the FDA: review a drug called Kevadon [1]. It was, by all appearances, a routine case. The drug was already sold across Europe and Canada, prescribed to pregnant women to ease morning sickness. The manufacturer’s application was thick …
Continue reading “RWE: From Regulatory Footnote to the Future of Medical Affairs, Part 1.”
Do you ever wonder why pharmaceutical ads on Canadian TV stations are so radically different from US ads? That’s because Canada has distinctly different regulations, stemming from Health Canada, regarding pharmaceutical advertising. In Canada, the Pharmaceutical Advertising Advisory Board (PAAB) is the independent, not-for-profit preclearance agency recognized by Health Canada to review and approve pharmaceutical …
Continue reading “What Canadians Don’t See: Inside the Rules Governing Pharmaceutical Advertising”
Many guideline failures are not failures of evidence alone, they are failures of process. Economic constraints, logistical complexity, and political realities exert a profound influence on guideline development, yet these forces are rarely discussed in the methodology literature despite being obvious to anyone who has lived through a guideline development process. The previous posts …
In 2025, a systematic review assessed the methodological rigour of 76 clinical practice guidelines published by the European Society of Cardiology (ESC) and the American College of Cardiology/American Heart Association (ACC/AHA) between 2013 and 2024. These are not obscure documents from minor societies. They are among the most cited, most influential guidelines in medicine, …
In 1951, the United States Air Force had a question that could not be answered by experiment: how many atomic bombs would be required to significantly disrupt U.S. industrial capacity under nuclear attack? There were no historical precedents to draw on, no experiments to run, no datasets to analyse. All the Air Force had …