Dear All,

Ramadan¹ greetings!

Since the last issue of Scribe, many events of major historical significance has happened that may have affected some of you already and these may influence the field of pharmacoepidemiology in the future. The first of course, was the very successful and the largest ever ICPE in Bordeaux. We have several reports in this issue which cover ICPE: Jennie Chou, John Litaken and James Wilson report on the Academic Showcase; Anoop Shah on the Student Skills workshop; Jeff Guo and Fadia Shaya on the Intro to the Pharmacoepi course; Keith Beard on the Lifetime Fellowship award; Judy Kinman on the Best Paper Awards ceremony; Mark Epstein covers highlights of ICPE Bordeaux and thanks supporters of the Society. We have report from the Finance Committee and the Students' Council. This quarter's Scribeline column features John Urquhart. Additional articles include Bruce Hugman's report on a major training initiative to enhance the safety of HIV/AIDS patients who undergo treatment with antiretrovirals.

Another significant event was the recent worldwide withdrawal of the COX-2 inhibitor rofecoxib. This action has been described as "the largest prescription drug withdrawal in history". In the U.S., lawyers are having a field day and have placed ads in the mass media to solicit individuals who may have suffered serious adverse effects in association with the use of rofecoxib. Following the news of rofecoxib withdrawal, in one day the company share holders in the U.S. lost over 25 billion dollars. According to one prediction this may be the beginning of the end of a major pharmaceutical company and a major class of drugs. Many ISPE members have been in the news in connection with the rofecoxib debacle. Rofecoxib continues to be a hot topic and has now lead to Congressional investigations in the U.S.

SSRIs and the suicide question continue to haunt regulators, industry, and consumers on both sides of the Atlantic. In the U.S., another FDA Advisory Committee meeting was held in September and black box warnings have now been added to the labeling (http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#ssri). In addition, Congressional hearings/investigations on the subject of SSRIs have started in the U.S. In the U.K., another BBC TV Panorama program (http://news.bbc.co.uk/2/hi/programmes/panorama/3677792.stm) on paroxetine has generated lot of media attention and backlash against the regulatory agency. ISPE member and former drug regulator Patrick Waller comments on the Panorama documentary in this issue of Scribe. In another recent event, Members of Parliament in the U.K. heard testimonies on the corporate influence on the drug regulatory agency.

I would like to thank all those who wrote articles for this issue of Scribe and those who are planning to submit articles in future issues. Also, if you receive the questionnaire for the Scribeline column, please respond within a reasonable timeframe. Finally, if you have news that you would like to share with the rest of the membership or you have ideas for articles, please email me.

Thanks.

With peace,

Rizwan²
Ahmads@cder.fda.gov

PS: Work to make Scribe available in pdf format is still in process.

1. Ramadan is the month of fasting for Muslims. It is a time to strengthen one's self-discipline and elevate actions of kindness and generosity.
2. Participating on his personal time and the views expressed do not necessarily represent the views of the FDA or the U.S. government.

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