Progressive drug licensing: an opportunity to achieve transparency and accountability?

1 as described in this issue by Neil Yeates, 2 suggests that the present drug regulation system needs improvement. The most substantive change in the new framework is that Health Canada will take a more active role after a drug reaches the market. In addition, Health Canada's decision-making will become more evidence-based, accountable, efficient and transparent, and there will be an increased focus on patients and drug safety. All are important and highly laudable goals; however, one of the less explicit expectations of the framework is that new drugs will reach the market more quickly. Unfortunately, little information is provided about how drug approvals would be granted more rapidly, and I fervently disagree with any attempt to change the process with faster drug approval as an objective. Although earlier release of new drugs would be welcomed by the pharmaceutical industry , Mr. Yeates also implied that this will not compromise safety, because a new and enhanced postmarket surveillance system will identify problems quickly and effectively. This is speculative and is not supported by evidence or by Health Canada's track record. At present, the system for reviewing and monitoring prescription drugs in Canada has serious deficiencies and often fails to consider patients as the primary focus. As a consequence , the system frequently does not adequately protect the public from serious adverse drug events. In this commentary, I describe 2 recent examples to support my assertions. I also offer suggestions for potential changes to the present system that, if properly implemented, should help to improve patient safety and to restore the public's trust in Canada's drug approval and monitoring system. The drug tegaserod (Zelnorm) highlights many of my concerns with the current system. Tegaserod was withdrawn from the market in the United States and Canada in March 2007. In retrospect, tegaserod probably never should have been approved. It was initially marketed in Canada in 2002 for the treatment of irritable bowel syndrome with symptoms of chronic constipation in women. Tegaserod was restricted to women because there were too few men in the clinical trials to demonstrate its efficacy in men. A pooled analysis of placebo-controlled trials provided by Novartis to the US Food and Drug Administration (FDA) led to the withdrawal of tegaserod from the market. This analysis showed that tegaserod increased the incidence of serious cardiovas-cular adverse events, including myocardial infarction, unstable angina and stroke. The FDA concluded that the …