Objections to the Polyheme® trial are described in The Polyheme Trial Pt. 1
Links to media articles and related publications about the Polyheme® trial are available in The Polyheme Trial Pt. 3
Links to articles on Polyheme® published in medical journals are available at The Polyheme® Trial Pt. 4
BB IND 10719 Poly-SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme®.] Protocol RTBSE-11-(N). 1995S-0158 Vol. 29 Sup. 29. Northfield Laboratories Inc. Public disclosure information re: institutional review board, Virginia Commonwealth University Medical Center. 2004-09-14. Available from http://www.fda.gov/ohrms/dockets/dailys/04/sep04/092004/95s-0158-sup0029-01-vol29.pdf
BB IND 10719 Poly-SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme®.] Protocol RTBSE-11-(N). 1995S-0158 Vol. 47 Sup. 43. Northfield Laboratories Inc. Community consultation and public disclosure, University of Utah Medical Center (Salt Lake City, UT). 2005-12-16. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0047-02-Tab-02-Salt-Lake-City-vol50.pdf
BB IND 10719 Poly-SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme®.] Protocol RTBSE-11-(N). 1995S-0158 Vol. 38. Rpt. 18-01. Northfield Laboratories Inc. Public disclosure information re: institutional review board, MetroHealth Medical Center. 2005-02-09. Available from http://www.fda.gov/ohrms/dockets/dailys/04/apr04/040904/95s-0158-rpt0018-01-vol25.pdf
BB IND 10719 Poly-SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme®.] Protocol RTBSE-11-(N). 1995S-0158 Vol. 38 Sup. 34. Northfield Laboratories Inc. Community consultation and public disclosure, Denver Health Medical Center and MetroHealth Medical Center. 2005-02-09. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0034-Tab-01-Letter-vol38.pdf
Denver Health Medical Center community consultation and public disclosure. 2003-12-23. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0034-Tab-02-01-Denver-Health-Medical-Ctr-vol38.pdf
Denver Health Medical Center community consultation and public disclosure cont. 2005-02-09. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0034-Tab-02-02-Denver-Health-Medical-Ctr-vol38.pdf
MetroHealth Medical Center community consultation and public disclosure. 2003-08-06. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0034-Tab-03-01-Metro-Health-Medical-Ctr-vol38.pdf
MetroHealth Medical Center community consultation and public disclosure cont. 2003-08-28. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0034-Tab-03-02-Metro-Health-Medical-Ctr-vol38.pdf
Denver Health Medical Center community consultation and public disclosure cont. Variously dated including material from 2003-06-24. Available from http://www.fda.gov/ohrms/dockets/dailys/04/jan04/011404/95s-0158-rpt0013-08-Denver-07-vol21.pdf
Denver Health Medical Center community consultation and public disclosure cont. Variously dated including material from 2003-06-13. Available from http://www.fda.gov/ohrms/dockets/dailys/04/jan04/011404/95s-0158-rpt0013-14-Denver-13-vol21.pdf
Denver Health Medical Center community consultation and public disclosure cont. Variously dated including material from 2003-05-20. Available from http://www.fda.gov/ohrms/dockets/dailys/04/jan04/011404/95s-0158-rpt0013-03-Denver-02-vol21.pdf
Current Information: Polyheme® Trial. Denver Health Medical Center. Available from http://www.denverhealth.org/TraumaCenter/Polyheme.aspx
BB IND 10719 Poly-SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme®.] Protocol RTBSE-11-(N). 1995S-0158 Vol. 26 Sup. 26. Northfield Laboratories Inc. Public disclosure information re: institutional review boards, UCSD Medical Center (San Diego, CA) and Scripps Mercy Hospital (San Diego, CA). 2004-05-19. Available from http://www.fda.gov/ohrms/dockets/dailys/04/may04/052504/95s-0158-sup0026-01-vol26.pdf
BB IND 10719 Poly-SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme®.] Protocol RTBSE-11-(N). 1995S-0158 Vol. 39 Sup. 35. Northfield Laboratories Inc. Community consultation and public disclosure, University of California San Diego (USCD) Medical Center. 2005-02-11. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0035-01-Letter-vol39.pdf
University of California San Diego (USCD) Medical Center community consultation and public disclosure. 2003-07-30 and 2003-08-06. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0035-02-UCSD-Medical-Ctr-vol39.pdf
Current Information: UCSD Medical Center and Scripps Mercy Hospital invite the public to attend a community meeting to discuss the study of an investigational blood substitute in trauma patients to be conducted in our community. Undated. Page modified 2003-07-22. Available from http://irb.ucsd.edu/notices/polyheme/CommunityMeeting.pdf
Comment: Nothing like a fait accompli, eh? What happened to the regulation that the IRB consider the opinions of community members during review and approval of a trial to be conducted under FDA exemption from requirements for informed consent?
BB IND 10719 Poly-SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme®.] Protocol RTBSE-11-(N). 1995S-0158 Vol. 40 Sup. 36. Northfield Laboratories Inc. Public disclosure information re: institutional review board, St. Luke's Medical Center (Bethlehem, PA). 2005-03-02. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0036-01-vol40.pdf
St. Luke's Medical Center (Bethlehem, PA) community consultation and public disclosure. 2004-12-16. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0036-02-St-Luke%27s-Medical-Ctr-vol40.pdf
BB IND 10719 Poly-SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme®.] Protocol RTBSE-11-(N). 1995S-0158 Vol. 41 Sup. 37. Northfield Laboratories Inc. Correspondence re: Christiana Health Care Services (Newark, DE) community consultation and public disclosure. 2005-03-01. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0037-01-Letter-vol41.pdf
Christiana Health Care Services (Newark, DE) community consultation and public disclosure. Undated. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0037-02-Christiana-Care-HS-vol41.pdf
BB IND 10719 Poly-SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme®.] Protocol RTBSE-11-(N). 1995S-0158 Vol. 47 Sup. 43. Northfield Laboratories Inc. Public disclosure information re: institutional review board, Inova Fairfax Hospital (Fairfax, VA). 2005-09-06. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0043-01-vol47.pdf
Inova Fairfax Hospital (Fairfax, VA) community consultation and public disclosure. Undated and variously dated including material from 2005-03-02. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0043-02-Tab-02-01-vol47.pdf
Inova Fairfax Hospital (Fairfax, VA) community consultation and public disclosure cont. Undated and variously dated including material from 2005-03-08. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0043-03-Tab-02-02-vol47.pdf
BB IND 10719 Poly-SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme®.] Protocol RTBSE-11-(N). 1995S-0158 Vol. 51 Sup. 48. Northfield Laboratories Inc. Public disclosure information re: institutional review boards, Albany Medical Center (Albany, NY) and University of Kansas Medical Center (Kansas City, KS). 2006-01-05. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0048-01-vol51.pdf
Albany Medical Center (Albany, NY) community consultation and public disclosure. Variously dated including material from 2005-10-07. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0048-02-Tab-01-Albany-Medical-Center-01-vol51.pdf
Albany Medical Center (Albany, NY), community consultation and public disclosure part 2. Variously dated including material from 2005-09-18. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0048-03-Tab-01-Albany-Medical-Center-02-vol51.pdf
University of Kansas Medical Center (Kansas City, KS) community consultation and public disclosure. Variously dated including material from 2005-10-11. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0048-04-Tab-02-Kansas-Medical-Center-01-vol51.pdf
University of Kansas Medical Center (Kansas City, KS) community consultation and public disclosure part 2. Variously dated including material from 2005-10-04. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0048-05-Tab-02-Kansas-Medical-Center-02-vol51.pdf
High marks for equivocation go to investigators at the University of Kansas Medical Center who, in an apparent attempt to impress, inform us that:
Northfield is currently working with the US Army on developing the use of PolyHeme® on the battlefield, reflecting the potential utility of PolyHeme® for the military and the Department of Defense.
What they didn't mention is that Northfield has been developing PolyHeme® with (and without) the US military since 1985. It's also likely that the US military is interested in any artificial blood substitute, exsanguination being relatively problematic in war.
BB IND 10719 Poly-SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme®.] Protocol RTBSE-11-(N). 1995S-0158 Vol. 44 Sup. 40. Northfield Laboratories Inc. Public disclosure information re: institutional review boards, Penn State Milton S. Hershey Medical Center (Hershey, PA) and University of Cincinnati Medical Center (Cleveland, OH). 2005-04-08. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0040-01-vol44.pdf
Penn State Milton S. Hershey Medical Center (Hershey, PA) community consultation and public disclosure. Variously dated including material from 2005-02-08. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0040-02-Milton-S-Hershey-Med-Ctr-vol44.pdf
Penn State Milton S. Hershey Medical Center (Hershey, PA) community consultation and public disclosure [published material]. Available from http://www.fda.gov/ohrms/dockets/dailys/copyrighted.pdf
University of Cincinnati Medical Center (Cleveland, OH) community consultation and public disclosure [published material]. Available from http://www.fda.gov/ohrms/dockets/dailys/copyrighted.pdf
BB IND 10719 Poly-SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme®.] Protocol RTBSE-11-(N). 1995S-0158 Vol. 45 Sup. 41. Northfield Laboratories Inc. Public disclosure information re: institutional review board, The Medical Center of Central Georgia (Macon, GA). 2005-04-15. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0041-01-vol45.pdf
The Medical Center of Central Georgia (Macon, GA) community consultation and public disclosure [published material]. Available from http://www.fda.gov/ohrms/dockets/dailys/copyrighted.pdf
BB IND 10719 Poly-SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme®.] Protocol RTBSE-11-(N). 1995S-0158 Vol. 30 Sup. 30. Northfield Laboratories Inc. Public disclosure information re: institutional review board, University of Kentucky Medical Center (Lexington, KY). 2004-09-27. Available from http://www.fda.gov/ohrms/dockets/dailys/04/oct04/100604/95s-0158-sup0030-01-letter-vol30.pdf
BB IND 10719 Poly-SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme®.] Protocol RTBSE-11-(N). 1995S-0158 Vol. 35 Sup. 31. Northfield Laboratories Inc. Public disclosure information re: institutional review board, Eastern Virginia Medical School (Norfolk, VA). 2004-09-29. Available from http://www.fda.gov/ohrms/dockets/dailys/04/oct04/100604/95s-0158-sup0031-Tab-01-Letter-vol35.pdf
BB IND 10719 Poly-SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme®.] Protocol RTBSE-11-(N). 1995S-0158 Vol. 36 Sup. 32. Northfield Laboratories Inc. Public disclosure information re: institutional review board, Loyola University Medical Center (Maywood, IL). 2004-10-04. Available from http://www.fda.gov/ohrms/dockets/dailys/04/oct04/100604/95s-0158-sup0032-Tab-01-Letter-vol36.pdf
BB IND 10719 Poly-SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme®.] Protocol RTBSE-11-(N). 1995S-0158 Vol. 28 Sup. 28. Northfield Laboratories Inc. Public disclosure information re: institutional review board, Mayo Clinic (Rochester, MN). 2004-08-24. Available from http://www.fda.gov/ohrms/dockets/dailys/04/aug04/083004/95s-0158-sup0028-01-vol28.pdf
Mayo Clinic (Rochester, MN) community consultation and public disclosure. Variously dated including material from 2003-10-01. Available from http://www.fda.gov/ohrms/dockets/dailys/04/aug04/083004/95s-0158-sup0028-02-Mayo-Clinic-Rochester-NM-vol28.pdf
BB IND 10719 Poly-SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme®.] Protocol RTBSE-11-(N). 1995S-0158 Vol. 52 Sup. 49. Northfield Laboratories Inc. Public disclosure information re: institutional review board, Miami Valley Hospital (Dayton, OH). 2006-02-08. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0049-01-vol52.pdf
Miami Valley Hospital (Dayton, OH) community consultation and public disclosure. Variously dated including material from 2005-08-08. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0049-02-Comm-Consultation-Doc-vol52.pdf
BB IND 10719 Poly-SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme®.] Protocol RTBSE-11-(N). 1995S-0158 Vol. 37 Sup. 33. Northfield Laboratories Inc. Correspondence re: Memorial Hermann Hospital (Houston, TX) community consultation and public disclosure. 2005-01-28. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0033-01-Letter-vol37.pdf
Memorial Hermann Hospital (Houston, TX) community consultation and public disclosure. 2004-01-28. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0033-02-Community-Consultation-Documents-vol37.pdf
BB IND 10719 Poly-SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme®.] Protocol RTBSE-11-(N). 1995S-0158 Vol. 49 Sup. 46. Northfield Laboratories Inc. Public disclosure information re: institutional review boards, Detroit Receiving Hospital (Detroit, MI) and Sinai-Grace Hospital (Detroit, MI). 2005-12-05. Available from http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0046-01-vol49.pdf
Last Updated: 2006-04-17
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