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The Polyheme® Trial Pt. 3

Objections to the Polyheme® trial are summarized in The Polyheme® Trial Pt. 1

Links to submissions to FDA docket 1995s-0158 for the Polyheme® trial are available in The Polyheme® Trial Pt. 2

Links to articles on Polyheme® published in medical journals are available at The Polyheme® Trial Pt. 4

Media Articles and Related Publications

Blood substitute raises questions. Julie Bell. The Baltimore Sun. 2006-03-24. Available from http://www.baltimoresun.com/news/health/bal-hs.blood24mar24,0,2392664.story?track=rss

Statement regarding PolyHeme. Johns Hopkins Medicine. Press Release. 2006-03-23. Available from http://www.hopkinsmedicine.org/Press_releases/2006/03_23a_06.html

CORRECTING and REPLACING Northfield Laboratories Strongly Disputes Wall Street Journal Story Conclusions. Northfield Laboratories Inc. Press Release. 2006-03-20. Available from http://phx.corporate-ir.net/phoenix.zhtml?c=91374&p=irol-newsArticle&ID=833811&highlight=

Northfield Laboratories Releases Summary Observations from Its Elective Surgery Trial. Northfield Laboratories Inc. Press Release. 2006-03-20. Available from http://phx.corporate-ir.net/phoenix.zhtml?c=91374&p=irol-newsArticle&ID=833808&highlight=

Grassley Asks FDA to Answer Ethicists' Concerns Over Blood Substitute Study. Senator Charles Grassley. Press Release. 2006-03-17. Available from http://finance.senate.gov/press/Gpress/2005/prg031706.pdf

UK says blood substitute is safe. Laura Ungar. The Courier-Journal. 2006-03-15. Available from http://www.courier-journal.com/apps/pbcs.dll/article?AID=/20060315/NEWS01/603150465/1060/NEWS0105

Blood Substitute Study to Begin. West Virginia University. Press Release. 2006-03-14.
URL: http://www.health.wvu.edu/newsreleases/news-detail.asp?ID=276

Northfield Laboratories Receives Informal Request from SEC. Northfield Laboratories Inc. Press Release. 2006-03-16. Available from http://phx.corporate-ir.net/phoenix.zhtml?c=91374&p=irol-newsArticle&ID=832832&highlight=

Utah health board deems PolyHeme study safe. Jason Bergreen. The Salt Lake Tribune. 2006-03-13.
URL: http://www.jems.com/medical-clinical/articles/17924/

Kipnis K, King N MP, Nelson RM. An open letter to IRBs considering Northfield Laboratories' Polyheme trial. American Journal of Bioethics. 2006;15:34. Available from http://www.bioethics.net/journal/pdf/UAJB_A_166837.pdf. Accessibility verified 2006-03-10.

Kipnis K, King N MP, Nelson RM. Trials and errors: barriers to oversight of research conducted under the emergency research consent waiver. IRB: Ethics and Human Research. 2006;28(2):16-19. Available from http://www.thehastingscenter.org/publications/irb/irb.asp. Accessibility verified 2006-03-10. (Free registration required.)

Holloway K FC. Accidental Communities: race, emergency medicine, and the problem of Polyheme. AJOB. 2006;15:10. Available from http://www.bioethics.net/journal/pdf/UAJB_A_166839.pdf. Accessibility verified 2006-03-10.

Officials: Substitute Blood Study Unethical. Washington (AP). 2006-03-14.
URL: http://apnews.myway.com/article/20060313/D8GAV0F8I.html

Northfield Laboratories Statement Regarding Its Pivotal Phase III Trial. Northfield Laboratories Inc. Press Release. 2006-03-14. Available from http://phx.corporate-ir.net/phoenix.zhtml?c=91374&p=irol-newsArticle&ID=831844&highlight=

FDA Needs to Consider Concerns of Human Research Protection Agency in Blood Substitute Study. Senator Charles Grassley. Press Release. 2006-03-13. Available from http://finance.senate.gov/press/Gpress/2005/prg031306.pdf

Attachments to Chairman Grassley's letter. 2006-02-23. Available from http://finance.senate.gov/press/Gpress/2005/prg031306attach%20.pdf

Utah Review Board Gives Green Light to Synthetic Blood Study. Ed Yeates. KSL News. 2006-03-12.
URL: http://www.defrance.org/artman/publish/article_1540.shtml

Duke resumes tests of blood substitute. Ray Gronberg. The Herald-Sun. 2006-03-08.
URL: http://www.herald-sun.com/durham/4-710454.html

Health: Emergency Blood Substitute. Stephanie Stahl. CBS News (Philadelphia affiliate). 2006-03-02.
URL: http://cbs3.com/seenon/local_story_061212930.html

Statement of Northfield Laboratories. Northfield Laboratories Inc. Press Release. 2006-03-01. Available from http://phx.corporate-ir.net/phoenix.zhtml?c=91374&p=irol-newsArticle&ID=824752&highlight=

CORRECTING and REPLACING Statement of Northfield Laboratories Regarding Its Pivotal Phase III Trial. Northfield Laboratories Inc. Press Release. 2006-02-26. Available from http://phx.corporate-ir.net/phoenix.zhtml?c=91374&p=irol-newsArticle&ID=821855&highlight=


KU Med defends study on PolyHeme. Brad Cooper. The Kansas City Star. 2006-02-24.
URL: http://www.kansascity.com/mld/kansascity/news/local/13947451.htm

Despite Heart Attack Deaths, PolyHeme Still Being Tested On Trauma Patients. Thomas M. Burton. The Wall Street Journal (republished by DeFrance Inc.). 2006-02-22.
URL: http://www.defrance.org/artman/publish/printer_1531.shtml

Northfield Laboratories Strongly Disputes Wall Street Journal Story Conclusions. Northfield Laboratories Inc. Press Release. 2006-02-22. Available from http://phx.corporate-ir.net/phoenix.zhtml?c=91374&p=irol-newsArticle&ID=820512&highlight=

Transparency serves the public well-being. Tom Peele. Contra Costa Times. 2006-01-29.
URL: http://www.contracostatimes.com/mld/cctimes/news/opinion/13741421.htm

'PolyHeme' blood substitute testing delayed at Duke. The Herald-Sun. 2006-01-13.
URL: http://www.defrance.org/artman/publish/article_1192.shtml

Northfield Laboratories Inc. to Receive Defense Appropriation for PolyHeme® Development. Northfield Laboratories Inc. Press Release. 2006-01-03. Available from http://news.findlaw.com/prnewswire/20060103/03jan20061417.html

Researchers drop plans to test blood substitute. Andy Dworkin. The Oregonian. 2005-12-23.
URL: http://www.oregonlive.com/search/index.ssf?/base/news/113530650634460.xml?oregonian?lcfp&coll=7

Report on Trial Studies. Commission on EMS. California Emergency Medical Services Authority. 2005-12-07. Available from http://www.emsa.ca.gov/def_comm/x120705.asp

Bad Blood? Matt Potter. The San Diego Reader. 2005-07-28.
URL: http://www.sdreader.com/php/cover.php?mode=article&showpg=1&id=20050728

Duke set to initiate PolyHeme study. Jane Stancill. The News & Observer. 2005-07-16.
URL: http://www.newsobserver.com/150/story/410356.html

Biopure, Navy seek blood-substitute study. Ross Kerber. The Boston Globe. 2005-07-04.
URL: http://www.boston.com/business/globe/articles/2005/07/04/biopure_navy_seek_blood_substitute_study?mode=PF

Dracula. Evan Hessel. Forbes. 2005-06-06.
URL: http://www.forbes.com/business/forbes/2005/0606/080.html

Duke blood test put on hold. Bob Burtman. The Independent Weekly. 2005-02-16.
URL: http://www.indyweek.com/gyrobase/PrintFriendly?oid=oid%3A23687

Blood substitute vexes Jehovah's Witnesses. Doug Guthrie. The Detroit News. 2004-12-24.
URL: http://tinyurl.com/fqrwk

Detroit clinics to test blood substitute. Doug Guthrie. The Detroit News. 2004-12-23.
URL: http://tinyurl.com/em7pk

Report on Trial Studies. Commission on EMS. California Emergency Medical Services Authority. 2004-09-22. Available from http://www.emsa.ca.gov/def_comm/vi092204.asp

A new hope for saving of lives. David Hasemyer. The San Diego Union-Tribune. 2004-03-23.
URL: ttp://www.signonsandiego.com//uniontrib/20040323/news_1m23blood.html

Artificial blood tested on patients without consent. Chicago AP (courtesy of CNN). 2004-02-24.
URL: http://www.cnn.com/2004/HEALTH/02/20/blood.substitute.ap/

City lab's blood substitute currently in clinical trials. Angela Tablac. The Daily Northwestern. 2004-01-27.
URL: http://www.dailynorthwestern.com/vnews/display.v?TARGET=printable&article_id=401616a5557bd
Comment: Fact checkers, anyone?

Moore EE. Clinical Efficacy and Advantages of Polyheme. 89th Annual Clinical Congress. American College of Surgeons. 2003-10-19. Available from http://www.facs.org/education/gs2003/gs14moore.pdf

Edge of Discovery Show / Interview with EE Moore M.D. Earth & Sky Radio Series. 2003-08-17. Available from http://www.earthsky.com/shows/edgeofdiscovery.php?date=20030817


Northfield Reaches Agreement with FDA on Special Protocol Assessment for Pivotal Phase III Trial. Northfield Laboratories Inc. Press Release. 2003-06-12. Available from http://web.archive.org/web/20030721164053/http://northfieldlabs.com/releases/061203.htm

Northfield Laboratories Proposes First Ambulance Blood Substitute Trial. Northfield Laboratories Inc. Press Release. 2002-10-16. Available from http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/10-16-2002/0001820227&EDATE=

Northfield Laboratories Receives FDA Response on Proposed Ambulance Trail (sic). Northfield Laboratories Inc. Press Release. 2002-11-11. Available from http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/11-11-2002/0001838942&EDATE=

Leading Trauma Surgeon Declares 'The Future Is Now' for Blood Substitutes. Northfield Laboratories Inc. Press Release. 2002-10-08. Available from http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/10-08-2002/0001814900&EDATE=

Northfield Labs Receives FDA Comments on Application For Blood Substitute. Northfield Laboratories Inc. Press Release. 2001-11-19. Available from http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/11-19-2001/0001619259&EDATE=

Northfield Laboratories Submits Biologics License Application to FDA For Approval of Its Blood Substitute, PolyHeme(TM). Northfield Laboratories Inc. Press Release. 2001-08-28. Available from http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/08-28-2001/0001562433&EDATE=

Ketcham EM, Cairns CB. Hemoglobin-based oxygen carriers: Development and clinical potential. Ann Emerg Med. 1999;33:326-337. Available from http://www.geocities.com/erjeff/Annals.htm

Northfield Asked to Expand Patient Numbers in Phase III Trials in Elective Surgery. Northfield Laboratories Inc. Press Release. 1998-08-12. Available from http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/08-12-1998/0000730652&EDATE=

Northfield Laboratories Inc. Index of Archived News Releases (via PR News Wire). Available from http://www.prnewswire.com/gh/cnoc/comp/127098.html

Northfield Laboratories Inc. U.S. Securities and Exchange Commission Filings (via EDGAR). Available from http://www.sec.gov/cgi-bin/browse-edgar?company=Northfield+Laboratories&CIK=&filenum=&State=&SIC=&owner=include&action=getcompany

Artificial blood on trial. Brad Smith. The Denver Business Journal. 1996-07-08.
URL: http://www.bizjournals.com/denver/stories/1996/07/08/story3.html?t=printable

Blood substitute saves trauma patients. Healthy For Life. ABC News (West Virginia Affiliate). Undated.
URL: http://www.wchstv.com/newsroom/healthyforlife/2308.shtml
Comment: the story quotes would-be clairvoyant David Hoyt M.D., Polyheme® principal investigator at UC San Diego Medical Center:

This current product does not seem to have any risk at all, and it's been studied in over hundreds of patients, so we think it's a very safe product.

The Unofficial Polyheme Resource Page. Available from http://www.geocities.com/erjeff/. Accessed 2006-03-18.

This is what experts were saying about blood substitutes in 1999; none of them argued that blood transfusion was unproven or unsatisfactory for the treatment of hemorrhagic shock:

FDA CBER Workshop on Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Cell Substitutes. Meeting Minutes. 1999-09-27. Available from http://www.fda.gov/cber/minutes/oxygen092799.htm

FDA CBER Workshop on Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Cell Substitutes. Meeting Minutes. 1999-09-28. Available from http://www.fda.gov/cber/minutes/oxygen092899.htm

Steven Gould M.D., head of Northfield Laboratories Inc., made a presentation on Polyheme® at this meeting:

U.S. Public Health Service Advisory Committee on Blood Safety and Availability. The Reserve Capacity of the Nation's Blood Supply, Eighth Meeting. 1999-04-29. Available from http://www.hhs.gov/bloodsafety/transcripts/apr29_99.html

Fluid Resuscitation: State of the Science for Treating Combat Casualties and Civilian Injuries. 1999. Institute of Medicine, National Academies of Science. Available from http://fermat.nap.edu/books/0309064813/html/

The Polyheme® Trial Pt. 1

The Polyheme® Trial Pt. 2

The Polyheme® Trial Pt. 4


Last Updated: 2006-04-17

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