Dear All,

We have another issue of Scribe to celebrate! Soliciting articles is a tough job and I wish to thank the following volunteers who contributed articles for this issue: Katrin Kohl et al., describe the Brighton Collaboration initiative about vaccine safety; Yola Moride et al., announce ISPE's Public Relations initiative; Sheila Weiss et al., announce a new pharmacoepi program at the University of Maryland; Sarah Sellers submitted news about the pharmacoepi summer course offered at the Johns Hopkins; Lois La Grenade covered the recent FDA isotretinoin advisory committee meeting; Michele Funk covered the ISPE symposium in Baltimore; and Kevin Haynes submitted a report from the Students' Council. This quarter's Scribeline column features Dr. Bob Nelson who after retiring from the FDA several years ago is currently in the consulting business. Sean Hennessy has proposed that ISPE establish a distinguished scientist award. This is a great idea and in line with other professional societies including ASCPT which last year awarded Rawls Palmer Award to Brian Strom (http://www.ascpt.org/awards).

Three significant things caught my attention since the last issue of Scribe:

• In May, the U.K. Medicines and Healthcare Products Regulatory Agency announced that they will start accepting suspected adverse event reports directly from patients in an effort to further improve the Yellow Card reporting system. This is a great step forward! Kudos to MHRA! Do we know which other countries accept reports from patients?

• Again in May, I read an article in the Wall Street Journal about the removal of a drug company epidemiologist from the list of authors of a study published recently (Circulation. 2004 May 4;109(17):2068-73) since the sponsors of the study did not agree with the conclusion. The study investigators include prominent ISPE members. I have heard about ghostwriters and similar stuff but this is a first for me. This issue is of special interest to me and I would like to solicit your response to the following questions: (1.) Do you think such issues are commonplace and a norm in the industry/government/academia? If yes, please email me with some examples. (2.) What is the best strategy to avoid similar situation in future? I hope to work on this subject and based on your input organize a session at a future ISPE meeting.

• Finally, in February the Canadian Broadcasting Corporation (CBC) posted a subset of adverse reaction data from Canada's adverse drug reactions database on its website. Its release represents the first time Canadian public have access to ADR reports. Health Canada is concerned about the misinterpretation of this data (http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/fact_ar-data-web_e.html). Meanwhile, the Canadian Association of Journalists awarded Health Canada its 4^th annual Code of Silence Award, "which recognizes the most secretive government department in Canada". It would be interesting to see what readers feel about this issue. I will be interested to know which countries allow researchers easy access to national ADR database.

  In the last issue, I requested readers to give me their feedback on the new electronic format of Scribe. I am happy to inform that there was a unanimous preference for Scribe in pdf format and the ISPE Board has decided to support this initiative. Thanks to all those who responded. Scribe in pdf format will go live soon.

  The success of Scribe depends on timely receipt of relevant contributions. So, please continue to send in news about any award you have won, review of any book of general interest in our field, report from any recent meetings of general interest to the membership, or news about personal milestones birth/weddings announcements, etc.

  With peace,

  Rizwan*
  Ahmads@cder.fda.gov

  *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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