As the Medical Director of Pfizer Canada, I am concerned about the following statement made by Brophy and Costa (1): “The large financial rewards that the manufacturers of atorvastatin attained with little investment in clinical research risks the encouragement of other pharmaceutical companies to follow the same strategy”.
We agree that physicians’ prescribing should be evidence-based. At the time atorvastatin was introduced, the available evidence suggested that lower low-density lipoprotein cholesterol (LDL-C) concentrations could result in lower cardiovascular (CV) event rates. This principle was embraced by the medical community as it progressively began to treat dyslipidemia more aggressively, as evidenced through guidelines (2,3). Atorvastatin provided a greater reduction in LDL-C compared with the other available statins (4) – a key factor in its success and increased use. Based on its unique profile, atorvastatin underwent review by Health Canada.
The Atorvastatin Landmark Program (ALP) was launched in the early 1990s before the market approval of atorvastatin, and has since enrolled more than 80,000 patients worldwide in over 400 clinical trials, including nine large end point trials (Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering [MIRACL; 5], Treating to New Targets [TNT; 6], Incremental Decrease in Endpoints through Aggressive Lipid Lowering [IDEAL; 7], Collaborative Atorvastatin Diabetes Study [CARDS; 8] and the Anglo-Scandinavian Cardiac Outcomes Trial [ASCOT; 9], to name a few). This innovative program has contributed significantly to the knowledge base on dyslipidemia management. As the authors know, studies of this magnitude take years to plan, recruit and complete. Many studies from the ALP were ongoing at the time of atorvastatin’s introduction in Canada. As part of the ALP, Pfizer Canada has conducted 22 studies with atorvastatin, involving more than 7200 Canadian patients and 279 Canadian investigators. This has resulted in a research and development investment of over $72 million in Canada. In addition, Pfizer has supported numerous Canadian researchers and their projects in the area of dyslipidemia and atherosclerosis through independent research grants, a research investment of over $6 million. Recently, Pfizer has also established an independent, peer-reviewed CV research awards competition, which allocated over $2 million in 2006 to Canadian researchers.
Drug development and other advancements in medical treatment are generated through time, financial and human resources, as well as extensive research efforts in partnership with the medical and scientific community. As Medical Director from Pfizer Canada Inc, I am proud of our company’s support of research, and felt compelled to respond to the comment about Pfizer Canada’s level of investment in its research efforts.
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