"Fraud at Investigator Sites: Tales from the Trenches and Lessons Learned"

Presented at the
Regulatory & Clinical
Research Institute
Minneapolis, MN
September 14, 2009

Copyright© - P. Below Consulting, Inc. 2010
All rights reserved.

• Testimony by Ann Marie Cisneros before the House Energy and Commerce Subcommittee on Oversight and Investigations:
  • February 2008:
    • Video of entire proceedings (WMV 288 MB)
    • Video of Cisneros testimony only (WMV 29 MB)
    • Transcript of Cisneros testimony (PDF 30 KB)
  • February 2007:
    • Video of entire proceedings (WMV 234 MB)
    • Video of Cisneros testimony only (WMV 6.3 MB)
    • Transcript of Cisneros testimony (PDF 30 KB)
• NIDPOE Letter to Ann Kirkman-Campbell May 2006 (PDF 199 KB)
• Warning Letter to Sanofi-Aventis for Ketek trials, October 2007 (PDF 687 KB)
• "Drug's chilling path to market," article on Ann Kirkman Cambell, MD and Ketek case, St. Petersburg Times, May 27, 2007 (PDF 38 KB)
• “At Your Own Risk" article on research abuses, Time Magazine, April 22, 2002 (PDF 34 KB)
• “A Doctor's Drug Studies Turn Into Fraud” article on Robert Fiddes, MD, New York Times, May 17, 1999 (PDF 33 KB)
• Robert A. Fiddes - Debarment Order, Federal Register, Vol 67, No. 215, November 6, 2002 (PDF 33 KB)
• Laverne M. Charpentier - Disbarment Order, Federal Register, Vol 67, No. 231, December 2, 2002 (PDF 38 KB)
• 60 Minutes Program "Of Mice and Men" on Robert Fiddes, MD, April 1, 2001
  • Video (MPEG, 241 MB)
• Transcript (PDF 35 KB)
• 48 Hours Program "Drug Money" on Richard Borison, MD and Bruce Diamond, PhD, July 31, 2000
  • Video (MPEG 157 MB)
  • Transcript (PDF 135 KB)
• "Test Case: Drug Makers Relied On Two Researchers Who Now Await Trial - ‘Checks and Balances’ Failed" article about Richard Borison, MD and Bruce Diamond, Wall Street Journal, August 18, 1997 (PDF 32 KB)
• "In Harm's Way: Abuses Endangered Veterans in Cancer Drug Experiments” article about Paul Kornak, New York Times, February 6, 2005 (PDF 42 KB)
• "Patient Non-Compliance With Paper Diaries," Stone et al., British Medical Journal, 324, 1193-1194, 2002 (PDF 212 KB)
• HHS Public Health Service Office of Research Integrity: Handling Misconduct (link to external site)
• "How to Blow the Whistle and Still Have a Career Afterwards,” Gunsalus, C.K., Science and Engineering Ethics, 4:51-64, 1998 (link to external site)
• “Scientific Misconduct – The ‘F’ Word”, Stan Wollen and Antoine El Hage, FDA Clinical Trials Meeting, October 2001 (PDF 251 KB)
• “Who’s in Charge Anyway? Responsibility in Today’s Clinical Trial Environment” Stan Wollen, DIA Meeting, June 2000 (PDF 121 KB)
• “Patient Misuse and Investigator Fraud in Clinical Trials: What Can Be Done?” Stan Wollen, DIA Meeting, June 2000 (PDF 98 KB)
• “Detecting and Handling Scientific Misconduct and Persistent Noncompliance” Stan Wollen, DIA Meeting, June 2000 (PDF 241 KB)