Laptop Name -- DRL0098686 Spector Client: installed and active since 4/22/10 SUBJECT: Robert C. Smith (RCS) Medical Officer wO66 RM0319G HFZ-470 CDRH -- Search Terms: Colonography -- SUBJECT feels the FDA is not handling this issue well. Allegations: Sending proprietary documents and information out of the FDA. Some documents are may have the letter followed by a string of six (6) numbers. Check to see if SUBJECT is sending these outside the FDA. Probably using Gmail to send out. SUBJECT sent proprietary documents to press, possibly NY Times (Gartner Harris -- sp?) -- (Gardiner Harris -- Corrected) for article alledging the FDA was mis--handling the Colonography topic. His superiors believe HE is "ghost writing" his subordinates FDA reports. Check all possible avenues for possible occurances. subo ates or co--horts: Q1 Pau T. Hardy Ewa Czerska DRL5125449 Nancy Wersto Lakshmi Vishnuvajjala DRLO096322 Check all for possible POP3 or enternal, non--FDA email conversations, either via Websense, Encase, Mandiant, or Spector. 0001854 Interim RCS Report of Anay is Findings Underlined items indicate findings post "Preliminary RCS Analysis Results.doc" Allpgation 1: Qhost Wrig'pg Indications of RCS receiving documents and email from co-workers co- complainants pertaining to investigation via FDA email and Gmail Documents being edited by RCS and retumed via Gmail -- Mostly investigation related documentation. suggestions of content to be used supplied by RCS via Gmail. These are contained in body of email for use by recipients (co?-workers co-complainants) Documents being edited by RCS and returned via Gmail -- Identified Device Review Many of the apgve referepcgd documents and communications are cmrently going to JN for review/input. JN currently, heavily involved in communicatiopg reggding investiggtion View All possible instances of the above allegation in order by date Allegation 2: Supplying Internal Documents and Information to External Sources Multiple Gmail contacts with Gardiner Harris -- NY Times Identified multiple Gmail communications between RCS and Gardiner Harris regarding telephonic cormnunications and in-person meetings View All instances of the above noted in order by date Multiple Gmail contacts with Matthew Perrone -- Associated Press News Identified multiple Gmail communications between RCS and Gardiner Harris regarding telephonic communications and in-person meetings View All instances of the above noted in order by date Multiple Gmail contacts with Alyah Khan Inside Washington Publishers news organization RCS Received intemal document via Gmail from Kahn reference Chris Van Hollen -- Alyah requested in same email not to be revealed as source or distribute document. View All instances ofthe above noted in order by date 1 01 8 RCS currently assisting Khan with editing story regarding Chris Van Hollen View All instances of the above noted in order by date Kahn indicates the "editor" wants to hold the "Van Hollen story" as of May 14, 2010 View All instances of the above noted in order by date RCS and JN are in conmrunication with Kahn regarding articles View All instances of the above noted in order by date RCS and JN are in communication with Robert Lowes (Unknown News Org) may be an associate of Kahn's View All instances of the above noted in order by date Multiple Gmail contacts with Joe Bergantino and Rochelle (unk last name) - RCN Cable Washington based Direct Cable prgvider) multiple Gmail communications between requesting times to meet and talk. View All of the above noted in order by date RCS and JN received communication from Laingy Moseley -- Qhiladelphia Journalist of Unknown News Org) -- Looking for a "Bigger Stogf on CT scans, patient safety and FDA recommendations. View All instances of the above noted in order by date Multiple Gmail contacts with Ned Feder (LOGO -- Project On Govemment Oversight non affiliated non profit) Emails attachments with amount of documents. View All instances of the above noted in order by date Multiple Gmail contacts with Jack Mitchell (aging.senate.gov) -- Emails include attachments with siggticant amount of documents including those self-redacted. View All instances of the above noted in order by date 0001019 Multiple Gmail contacts with JN -- Emails include attachments with amount of dguments including thoee self-redacted View All instances of the above noted in order by date Multiple Gmail contacts with Joan Kleinman (District Director for Rep. Chris Van I-lollen) Emails include attachments with siggticant amount of documents including those self-redacted. View All instances of the above noted in order by date Possible Future Concerns: Gmail trom Paul Hardy stating "Time to pound them into dust I think its time to talk to Joe about the documentary on Frontline" Received May ll, 2010 - (Joe is an unknown person) View All instances of the above noted in order by date Gmail corresgndence indicating that Julian Nicholas has reapplied to CDRH and is being considered for a ppsition. View All instances of the above noted in order by date Possible Potential Issue: Gmail correspondence with outside physician(s) - Possible FDA research knowledge being leveraged (ref CON and STARK) CSIRT not sure whether or not is these are FDA intemal projects. View All instances of the above noted in order by date . Image of Certificate of Remittance (transfer) from Shinan Bank dated 4/15/09 viewed on 4/26/2010 View All instances of the above noted in order by date 0001020 Possible Collaboration Issue: Numerous FDA emails and Gmail amongst primary and secondary actors indicating collaborative correspondence regarding review, editing, compilation, production or distribution of verbiage, documentation and information pertaining to medical reviews, current investigations, claims against DA, and release of information to extemal organizations. View All instances ofthe above noted in order by date Emails among Actors indicating a collaborative plan to produce a document defamatog; to DA that will be passed to Joan Kleinman, leaked to the press on Chris Van Hollen'; letterhead and returned to Van Hollen's Office View All instances of the above noted in order by date Email among Actgr; indicating a collaborative to modiy documengs) to reflect only inconsistencies and remove any speculative infomiation. View All instances of the above noted in order by date 0001021 Actors List: Primgy Actors l. Robert C. Smith -- Medical Officer, CDRH, WO66, HFZ 470, 10903 New Hampshire Ave, Silver Spring, MD 2. Paul Hardy (also referred to as -- Regulatory Review CDRH, OIV WO66, RM G309, 10903 New Hampshire Ave, Silver Spring, MD 3. Julian J. Nicholas -- Former CDRH Physician Summary -- The above listed actors appear to be the point men. All communications amongst all the actors filter through one or all of these three primary actors. These actors appear to perform the majority of any review, editing, compilation, production or distribution of verbiage, documentation and information. Actors 1 and 3 appear to have the greatest involvement with media outlets and external organizations. Actors 4. Ewa M. Czerska -- Biologist, CDRH, WO66, RMG322 HFZ 470, 10903 New Hampshire Ave, Silver Spring, MD s. visiting conn, ossunuuvi WO62, 10, 10903 New Hampshire Ave, Silver Spring, MD 6. Biomedical Engineer, CDRH, WO66, RM1643, 10903 New Hampshire Ave, Silver Spring, MD 7. Nancy Wersto -- Biologist, CDRH, WO66, RMG320, 10903 New Hampshire Ave, Silver Spring, MD 8. Lakshmi Vishnuvajiala SUPV. Mathematical Statistician, CDRH, WO66, RM2208 HFZ -- 550, 10903 New Hampshire Ave, Silver Spring, MD 9. Physicist, cmui, G308 HFZ -- 470, 10903 New Hampshire Ave, Silver Spring, MD Summary -- The secondary actors listed above are in constant communication amongst themselves and the primary actors via DA email, Yahoo Mail and Gmail. Communications involve review, editing, compilation, production or distribution of verbiage, documentation and information pertaining to medical reviews, current investigations, claims against release of infomiation to the press and extemal organizations. Ancillg; Actors l0. Ned Feder Staff Scientist! Writer POGO (Project On Government Oversight) 0001023 1100 Street, NW, Suite 900, Washington, D.C ll.! Associate of Ned Feder uclear Engineering, Texas University 12. Jack Mitchell -- United States Senate, Special Committee on Aging G3l Dirksen or 628 Hart Senate Office Buildings, Washington, D.C. 13. Joan Kleimnan -- District Director, Congressman Chris Van I-lollen Office of Representative, 51 Monroe Street #507, Rockville, Md. 14. Congressman Chris Van Hollen House of Representatives 1707 Longworth H.O.B., Washington, D.C. District Office - 51 Monroe Street #507, Rockville, Md. Stunmary The ancillary actors above are actively participating with primary and secondary actors with regard to complaints and claims filed against referencing FDA review approval process, discrimination and hostility within the wor lace. The above actors (with the exception of Congressman Chris Van Hollen and directly) have received a substantial number of dociunents primarily om ctors 1 and 3. There has also been numerous communications with many of the secondary actors either directly or through the primary actors. References to one or more of the above ancillary actors providing a conduit to release information to the press has been identified. Media Outlet Actors 15. Gardiner Harris -- Reporter, New York Times 16. Matthew Perrone Reporter, Associated Press 17. Alyah Khan -- Reporter, Inside Washington Publishers news organization 18. Joe Bergantino -- Reporter, RCN Cable Washington based Direct Cable provider 19. Rochelle last name unknown)- Associate of Joe Bergantino 20. Lainey Moseley - Joumalist, Unknown Philadelphia news organization - looking for a "Bigger Story" on CT scans, patient safety and FDA recommendations 21. Joe (last name unknown)- Documentaries, Frontline PBS (Public Broadcasting Service) Summary -- The media outlet actors listed above have actively and recently communicated primarily with Actor 1. Actor has been in constant contact with Actors 15, 16, 17, 18 via email, phone communications and/or in-person meetings regarding "issues with in the Actor 20 was referred to Actor 1 by Actor 3. Actor 21 has been referenced to Actor 1 by Actor 2. 0001024