This information is intended to be read with the Bloomberg News story titled Big Pharma's shameful secret
(With interviews and updates). David Evans, Michael Smith, and Liz Willen. Bloomberg News Special Report. 2005-11-08. Accessed on 2010-06-29 at: http://web.archive.org/web/20060112034853/http://www.bloomberg.com/specialreport/bigpharma.html
PDF file: http://web.archive.org/web/20060210224412/http://www.bloomberg.com/specialreport/pharma.pdf
In re SFBC International, Inc. Securities & Derivative Litigation, Case No. 2:06-cv-00165 (SRC) (United States District Court for the District of New Jersey). Bernstein Litowitz Berger & Grossman LLP Press Release. Accessed on 2006-12-08 at: http://www.blbglaw.com/cases/SFBC_securities.html
Consolidated Class Action Complaint. Case No. 2:06-cv-00165 (SRC). 2006-11-01. United States District Court for the District of New Jersey. Accessed on 2006-12-08 at: http://www.blbglaw.com/complaints/SFBCClassActionComplaint-11.01.06.pdf (Courtesy of Bernstein Litowitz Berger & Grossman LLP)
SFBC International Inc. web site
SFBC International Inc. web site at Archive.org. Accessed on 2006-12-08 at: http://web.archive.org/web/*/sfbci.com/*
Tew Cardenas LLP and Winston & Strawn LLP. Report to Senator Grassley from Independent Counsel to the Board of Directors of SFBC International Inc., Concerning Allegations Related to SFBC in Bloomberg's November 2, 2005 Article, Big Pharma's Shameful Secret,
and Bloomberg's Related Article of November 16, 2005. 2005-12-12. Accessed on 2006-12-08 at: http://web.archive.org/web/20051221050949/http://www.sfbci.com/sfbc/upload/sfbc/banniere/sfbcrept.pdf (5)
SFBC International Inc. Dear Friends Letter. Accessed on 2006-12-08 at: http://web.archive.org/web/20051223112226/http://www.sfbci.com/downloads/Dear+Friends.pdf (6)
Form FDA 483 Issued to Antonio R. Pizarro M.D. / SFBC Fort Myers. 2005-06-03. Available from http://www.bioethicswatch.org/foia/sfbcinternational483_20050603.pdf (4)
Form FDA 483 Issued to Lisa A. Krinsky / SFBC International Inc. 2005-05-02. Available from http://www.bioethicswatch.org/foia/sfbcinternational483_20050502.pdf
Form FDA 483 Issued to Lisa A. Krinsky / SFBC International Inc. 2004-09-15. Available from http://www.bioethicswatch.org/foia/sfbcinternational483_20040915.pdf
Form FDA 483 Issued to Lisa A. Krinsky / SFBC International Inc. 2004-07-23. Available from http://www.bioethicswatch.org/foia/sfbcinternational483_20040723.pdf
SFBC International Inc. Form 10-K Annual Report [Section 13 and 15(d), not S-K Item 405] Index. 2006-03-31. Available from http://www.sec.gov/Archives/edgar/data/1089542/000095014406003058/0000950144-06-003058-index.htm
SFBC International Inc. U.S. Securities and Exchange Commission Form 10-K Annual Report (Pursuant to Section 13 or 15(d) of the Securities and Exchange Act of 1934) for the fiscal year ended December 31, 2005. 2006-03-31. Available from http://www.sec.gov/Archives/edgar/data/1089542/000095014406003058/g00183e10vk.htm
SFBC International Inc. / Index of U.S. Securities and Exchange Commission filings (1999-08-17 — )
Below is a list of data tables created by CIRCARE consisting of entries from the U.S. Food and Drug Administration Bioresearch Monitoring Information System (BMIS) File for a) drug studies subject FDA Investigational New Drug (IND) regulations conducted by SFBC International Inc. and its subsidiaries, and b) drug studies subject FDA investigational new drug (IND) regulations reviewed and approved by institutional review boards (IRBs) owned by SFBC International Inc. or an individual related to a senior employee of SFBC International Inc. The BMIS file includes information on drug studies conducted under FDA Investigational New Drug (IND) applications only. It does not include FDA-regulated bioequivalency studies conducted for generic drug marketing approvala or medical device studies. (1)
Clinical trials conducted at SFBC International Inc. registered at Clinicaltrials.gov. (2)
Study Title: A Study on the Efficacy and Safety of Olmesartan Medoxomil and Its Combination With Hydrochlorothiazide Compared With an ACE Inhibitor and Its Combination With a Calcium Channel Blocker in Patients With Stage 2 Hypertension. Sponsor: Daiichi Sankyo Inc. Status: Recruiting. Record First Received: 2005-09-09. Accessed on 2006-04-28 at: http://www.clinicaltrials.gov/ct/show/NCT00185120?order=3
Study Title: An Open-label, Randomized, Cross-over Study in HIV-Positive Subjects to Determine and Compare the Single-dose Pharmacokinetics of Enfuvirtide after a Single 90 mg SC Administration. Sponsor: Trimeris / Hoffmann-La Roche. Status: Completed. Record First Received: 2004-07-08. Accessed on 2006-04-28 at: http://www.clinicaltrials.gov/ct/show/NCT00086710?order=1
Study Title: A Randomized, Parallel Group Safety Evaluation of Electrocardiographic Intervals and Blood Pressure in Normal Healthy Volunteers After Nebivolol, Atenolol, Moxifloxacin, or Placebo Administration After Single and Repeated Doses. Sponsor: Mylan Bertek Pharmaceuticals. Status: Completed. Record First Received: 2005-09-07. Accessed on 2006-04-28 at: http://www.clinicaltrials.gov/ct/show/NCT00158093?order=8
Study Title: Phase I Study Comparing Pharmacokinetics and Safety Profile of Thyrogen Versus a Modified Release of Recombinant Human Thyroid Stimulating Hormone. Sponsor: Genzyme. Status: No Longer Recruiting. Record First Received: 2005-08-26. Accessed on 2006-04-28 at: http://www.clinicaltrials.gov/ct/show/NCT00137891?order=2
Study Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024). Sponsor: MedImmune, Inc. Status: No Longer Recruiting. Record First Received: 2005-08-14. Accessed on 2006-04-28 at: http://www.clinicaltrials.gov/ct/show/NCT00240877?order=4
Study Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults. Sponsor: MedImmune, Inc. Status: No Longer Recruiting. Record First Received: 2005-09-12. Accessed on 2006-04-28 at: http://www.clinicaltrials.gov/ct/show/NCT00192127?order=5
Study Title: An Open-Label, Single-Arm Trial to Assess the Shedding, Immunogenicity, and Safety of FluMist Administered to Healthy Individuals 5-49 Years of Age. Sponsor: MedImmune, Inc. Status: No Longer Recruiting. Record First Received: 2005-09-09. Accessed on 2006-04-28 at: http://www.clinicaltrials.gov/ct/show/NCT00192140?order=6
Study Title: A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-524 (NUMAX TM), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Healthy Adults. Sponsor: MedImmune, Inc. Status: No Longer Recruiting. Record First Received: 2005-09-13. Accessed on 2006-04-28 at: http://www.clinicaltrials.gov/ct/show/NCT00192465?order=7
Clinical trials conducted at SFBC International Inc. available from ClinicalStudyResults.org, the study results database sponsored by the Pharmaceutical Research and Manufacturers of America (PhRMA). This is not a complete list (obviously). (3)
Study Title: A Single Dose, Four-Way, Randomized, Crossover Pharmacokinetic Study to Compare Hydromorphone HCl Controlled-Release 24 mg Capsule with Different Dissolution Profiles in Fasted Normal Volunteers to Establish an In-Vitro/In-Vivo Correlation. Sponsor: Purdue-Pharma L.P. Principal Investigator: Stephen R. Scheinman M.D. Drug: Palladone. Clinical Study Report: HD97-0502. Record Date: 1998-12-09. Accessed on 2006-04-28 at: http://www.clinicalstudyresults.org/documents/company-study_86_6.pdf
Study Title: A Single Dose, Three-Way, Randomized, Crossover, Analytically Blinded Pharmacokinetic Study to Compare Hydromorphone HCl Controlled-Release 24 mg Capsule With Different Dissolution Profiles in Fasted Normal Volunteers. Sponsor: Purdue-Pharma L.P. Principal Investigator: Stephen R. Scheinman M.D. Drug: Palladone. Clinical Study Report: HD96-1206. Record Date: 1998-10-30. Accessed on 2006-04-28 at: http://www.clinicalstudyresults.org/documents/company-study_86_5.pdf
Related: FDA Asks Purdue Pharma to Withdraw Palladone for Safety Reasons. FDA Press Release P05-42. 2005-07-13. Available from http://www.fda.gov/bbs/topics/NEWS/2005/NEW01205.html
FDA Public Health Advisory Suspended Marketing of Palladone (hydromorphone hydrochloride, extended release capsules). 2005-07-13. Available from http://www.fda.gov/cder/drug/advisory/palladone.htm
Hydromorphone Hydrochloride Extended-release Capsules (marketed as Palladone™). FDA Alert for Healthcare Professionals. 2005-07. Available from http://www.fda.gov/cder/drug/InfoSheets/HCP/hydromorphoneHCP.pdf
Palladone (Hydromorphone Hydrochloride Extended-Release) Capsules Questions and Answers. 2005-07-13. Available from http://www.fda.gov/cder/drug/infopage/palladone/palladoneQA.htm
FDA Approves New Extended Release Pain Medication: Agency Works with Sponsor to Develop an Effective Plan to Reduce Inappropriate Use. FDA Talk Paper T04-04. 2004-09-24. Available from http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01315.html
FDA Drug Information Page / Palladone Extended Release Capsules (hydromorphone). Updated 2005-07-13. Available from http://www.fda.gov/cder/drug/infopage/palladone/default.htm
Photos: Miami-Dade Building Department inspection of 11190 Biscayne Boulevard, the main research facility run by SFBC International Inc. in Miami, FL.
SFBC International Inc., 11190 Biscayne Blvd. Interior 2005-11-23. Available from http://bldgappl.miamidade.gov/pictures/2006093900-0043.jpg
SFBC International Inc., 11190 Biscayne Blvd. Interior 2005-11-23. Available from http://bldgappl.miamidade.gov/pictures/2006093900-0004.jpg
SFBC International Inc., 11190 Biscayne Blvd. Interior 2005-11-23. Available from http://bldgappl.miamidade.gov/pictures/2006093900-0032.jpg
SFBC International Inc., 11190 Biscayne Blvd. Interior 2005-11-23. Available from http://bldgappl.miamidade.gov/pictures/2006093900-0026.jpg
SFBC International Inc., 11190 Biscayne Blvd. Interior 2005-11-23. Available from http://bldgappl.miamidade.gov/pictures/2006093900-0025.jpg
SFBC International Inc., 11190 Biscayne Blvd. Interior 2005-11-23. Available from http://bldgappl.miamidade.gov/pictures/2006093900-0012.jpg
SFBC International Inc., 11190 Biscayne Blvd. Interior 2005-11-23. Available from http://bldgappl.miamidade.gov/pictures/2006093900-0006.jpg
SFBC International Inc., 11190 Biscayne Blvd. Exterior 2005-11-23. Available from http://bldgappl.miamidade.gov/pictures/2006093900-0048.jpg
SFBC International Inc., 11190 Biscayne Blvd. Exterior 2005-11-23. Available from http://bldgappl.miamidade.gov/pictures/2006093900-0049.jpg
SFBC International Inc., 11190 Biscayne Blvd. Exterior 2005-11-23. Available from http://bldgappl.miamidade.gov/pictures/2006093900-0047.jpg
SFBC International Inc., 11190 Biscayne Blvd. Exterior 2005-11-23. Available from http://bldgappl.miamidade.gov/pictures/2006093900-0051.jpg
SFBC International Inc., 11190 Biscayne Blvd. Exterior 2005-11-23. Available from http://bldgappl.miamidade.gov/pictures/2006093900-0076.JPG
SFBC International Inc., 11190 Biscayne Blvd. Exterior 2005-11-23. Available from http://bldgappl.miamidade.gov/pictures/2006093900-0070.JPG
SFBC International Inc., 11190 Biscayne Blvd. Exterior 2005-11-23. Available from http://bldgappl.miamidade.gov/pictures/2006093900-0066.JPG
SFBC International Inc., 11190 Biscayne Blvd. Exterior 2005-11-23. Available from http://bldgappl.miamidade.gov/pictures/2006093900-0067.JPG
SFBC International Inc., 11190 Biscayne Blvd. Exterior 2005-11-23. Available from http://bldgappl.miamidade.gov/pictures/2006093901-0077.JPG
Source: Miami-Dade Building Department. Case Number: 2006093900 Unsafe Structures. Addresss: 11190 Biscayne Boulevard. Folio Number: 30-2232-008-0030. Available from http://www.miamidade.gov/bldg/regulation.asp. Accessed 2005-12-02.
Honorable Senator Charles E. Grassley. Letter to Daniel Levinson, Inspector General, Department of Health and Human Services. 2005-11-08. Available from http://finance.senate.gov/press/Gpress/2005/prg110805.pdf
Honorable Senator Charles E. Grassley. Letter to Arnold Hantman, SFBC International Inc. 2005-11-17. Available from http://finance.senate.gov/press/Gpress/2005/prg111805.pdf
Honorable Daniel R. Levinson, Inspector General. Letter from the Inspector General for Health and Human Services to Chairman Grassley describing recommendations of last ten years for human drug testing efficacy. 2005-11-28. Available from http://finance.senate.gov/press/Gpress/2005/112805%20HHS.PDF
Honorable Senator Charles E. Grassley. Letter to SFBC International, Inc. requesting cooperation with committee review. 2005-12-16. Available from http://finance.senate.gov/press/Gpress/2005/SFBC%20Letter%202.pdf
Honorable Senator Charles E. Grassley. Letter to Acting Commissioner of the FDA asking for account of FDA monitoring of human drug testing. 2005-12-19. Available from http://finance.senate.gov/press/Gpress/2005/FDA%20SFBC%20Letter.pdf
Honorable Senator Charles E. Grassley. Press Release: Chairman Grassley says review will continue into allegations of problems with human subject drug research. 2005-12-22. Available from http://finance.senate.gov/press/Gpress/2005/prg122205.pdf
Notes
1. FDA Bioresearch Monitoring Information System (BMIS) File (current through 2006-03-31 unless otherwise indicated). U.S. Food and Drug Administration Division of Scientific Investigations. Accessed on 2006-04-28 at: http://www.fda.gov/cder/foi/special/bmis/index.htm
2. About Clinicaltrials.gov. 2006-02-31. Accessed on 2006-04-28 at: http://www.clinicaltrials.gov/ct/info/about
3. Clinical Study Results Database, About Us. Accessed on 2006-04-28 at: http://www.clinicalstudyresults.org/about/
4. Source: Files shed light on SFBC's troubles. John Dorschner. The Miami Herald. 2005-12-30. Available from http://www.miami.com/mld/miamiherald/business/13511187.htm. We thank Mr. Dorschner and the Miami Herald for making this information available to the public.
5. Originally posted at http://www.sfbci.com/sfbc/upload/sfbc/banniere/sfbcrept.pdf
6. Originally posted at http://www.sfbci.com/downloads/Dear%20Friends.pdf
Last Updated: 2010-06-29
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