Pharmacoepidemiology has been much noticed by regulators, manufacturers and the press in the past few months. What has been going on and how can the Society contribute to a productive dialogue and appropriately take advantage of the heightened publicity on the need for drug safety.

The global withdrawal of rofecoxib, a multibillion dollar product in September was accompanied by enormous media, regulatory and legal attention. Triggering the withdrawal was the detection of a two-fold increase in risk of myocardial infarction during a long-term, placebo controlled, colon cancer prevention trial with several thousand patients. The trial results were foreshadowed by an epidemiologic study done using the Kaiser database of COX-2 and NSAIDs and the risk of acute cardiac events by Graham, Ray and colleagues. As presented at ICPE in Bordeaux (abstract 571) in August, these researchers found an increased risk of myocardial infarction and sudden cardiac death and this generated considerable interest. Prior to all this, there had been concern about a relationship between rofecoxib and myocardial infarction since the presentation of the VIGOR study in 2000 as shown in subsequent labeling warnings about a possible relationship.

Now the public and scientific focus is on other COX 2 agents. Is the risk mediated by the COX 2 pathway? Does it vary by drug? Is it a class effect? There is some evidence of differences between the risk patterns, which might suggest that there are differences; trial data are being examined. Meanwhile heightened scrutiny is continuing for the COX 2 agents and a FDA regulatory review is scheduled.

Several fundamental questions for the Society and its members arise from this experience. When and how can epidemiological studies contribute to the better definition of post-approval risk and regulatory and medical action? Do we need to wait for controlled studies? Just how great are confounding effects in situations such as these. No doubt we will have the opportunity to address such issue in the context of the COX 2 agents in coming months. Indeed one of the questions is whether there is a role for the Society to advocate for the expanded use of epidemiological approaches. Your comments on this would be welcomed.

On another front, there has been considerable interest in and discussion of the FDA's draft guidances for risk assessment, pharmacovigilance and risk minimization. The FDA is likely to finalize soon the guidance to meet PDUFA (Prescription Drug Users Fee Act) requirements. The guidance provides a further wakeup call for greater use of postmarketing surveillance, large simple studies, and registries. All this is consistent with ISPE's explicit focus on therapeutic risk management, which will be a major focus at our 2005 Mid Year Symposium (April 18, 2005 in Barcelona; visit the ISPE website for more information.).

There can be no doubt that the increase in awareness and need is driving the expanded membership ISPE is enjoying, the increase in abstracts submitted for presentation at the annual meeting, and the recognition in the media we have been receiving. This is clearly a time of opportunity for the Society. I ask every member to help the Society in the furtherance of its three fundamental program goals: provision of scientific forums, advocacy for the field of pharmacoepidemiology, and expansion and provision of educational opportunities. We are most available to hear your suggestions and to use volunteer efforts. Please email me your ideas and suggestions (gfaich@yahoo.com).

ISPE Executive Committee

I want to thank all the members of the Executive Committee, our Executive Secretary, Mark Epstein, all the committees, councils and volunteers for their continued strides in making our Society ever better. I look forward to working with you in the coming year.

Sincerely,
Jerry

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