A winter’s tale: Report from the First Annual Canadian Biomarkers and Surrogate Endpoints Symposium

The International Partnership for Critical Markers of Disease (www.cmod.org), a nonprofit organization, has a mission to accelerate the identification, validation and appropriate application of biomarkers in cardiovascular and related disease. Founded by Drs Therese Heinonen, Peter Libby and Jean-Claude Tardif, the International Partnership for Critical Markers of Disease has sponsored an annual cardiovascular Biomarkers and Surrogate Endpoints Symposium in Bethesda, Maryland (USA), since 2003. These symposia have furnished an unusual forum for ongoing collaboration among academia, pharmaceutical and biotechnology concerns, and regulatory agencies. The United States Food and Drug Administration, Health Canada and the European Agency for the Evaluation of Medicinal Products have all participated in these international conferences. Despite global involvement, each of the six previous symposia took place in Bethesda. This venue did not reflect the ‘international partnership’ proclaimed in the organization’s name. Health Canada, Canadian researchers and representatives from the Canadian pharmaceutical industry all played important roles in the Bethesda symposia. Thus, Ottawa (Ontario) hosted the First Annual Canadian Biomarkers and Surrogate Endpoints Symposium on January 5, 2009. The present article summarizes some of the issues and controversies highlighted during the symposium. Over the past four decades, cardiovascular drugs have contributed to a remarkable improvement in the outcomes of patients with cardiovascular disease. The future of cardiovascular drug development now appears uncertain (1). The cost and time required to bring a new drug to market have escalated. Current clinical outcome trials must include more people, which presents a higher hurdle because patients should receive treatment with the standard therapies that considerably reduce events. In principle, surrogate end points provide a way to obtain efficacy data at a fraction of the cost of a large outcomes trial. However, trials that have used surrogate end points have had their own problems. For example, a null carotid intima-media thickness (IMT) trial (2) for an approved and presumably effective drug has recently evoked a firestorm of controversy (3).