Saturday :: Jul 8, 2006

Flesh Of My Flesh, Blood Of My Artificial Blood Product


by pessimist

This is incredibly outrageous - so much so that I had to interrupt my family's mourning activities to post this news. (Many thanks to those who sent condolences. They are very much appreciated.)

We used to think that we had the right to control our own bodies (with the possible exception for those seeking to control the rights of reproduction - or not - of others). That is no longer the case.

You are nothing more than a laboratory rat to be used in an experiment
- without knowledge or informed consent.

Artificial Blood Experiment: Is Your City Participating?
Hospitals in Twenty Cities Take Part in Polyheme Trials
By ASA R. ESLOCKER and ASTRID HILL
July 7, 2006

Northfield Lab's experimental blood substitute Polyheme is currently in randomized phase III clinical trials recruiting patients without informed consent all over the country. At one point, it was being tested in as many as 27 cities; it is still being tested in 23 hospitals in 20 cities. With the FDA's approval, Northfield Lab has recruited hospitals to participate in the trial study with exemption from informed consent requirements on study participants.
Although Northfield Lab claims that extensive information on the study has been made public,
a vast majority of the general public has never heard of the trial.
Below [under the fold] is a list of the cities and hospitals that are currently participating in the Polyheme trials. Check the list to see if you live [in] an area where you could become a trial participant without your informed consent.

To opt out of the study, contact Northfield Labs or a participating hospital and request a blue bracelet.

If worn, you will be exempt from the trial.

Sure - and your vote in the next election is going to be correct - and accurately counted.

This is the official study release posted at ClinicalTrials.gov, "A service of the US National Institutes of Health":

Safety and Efficacy of PolyHeme(R) in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Pre-Hospital Setting

This study is currently recruiting patients.
Verified by Northfield Laboratories June 2006
Sponsored by: Northfield Laboratories
Information provided by: Northfield Laboratories
ClinicalTrials.gov Identifier: NCT00076648

Purpose

This study is designed to assess the survival benefit of administering PolyHeme to severely injured trauma patients in hemorrhagic shock beginning in the prehospital setting, where blood is not available, and continuing throughout a 12-hour postinjury hospital setting.

Condition: Hemorrhagic Shock
Intervention Drug: Poly SFH-P Injection
Phase: Phase III
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Official Title: A Phase III, Randomized, Controlled, Open-Label, Multicenter, Parallel Group Study Using Provisions for Exception From Informed Consent Requirements Designed to Evaluate the Safety and Efficacy of Poly SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme(R)] When Used to Treat Patients in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Prehospital Setting

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

* Adult patients following trauma who have sustained blood loss and are in shock

Exclusion Criteria:

* Patients who have sustained unsurvivable injuries
* Patients who have severe head injury
* Pregnant females
* Patients found in cardiac arrest
* Patients who object to participation (e.g., religious grounds, wearing exclusion bracelet).

These are the hospitals participating in the trials:
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00076648

California

* UC San Diego Medical Center, San Diego, California, 92103, United States; No longer recruiting
* Scripps Mercy, San Diego, California, 92103, United States; No longer recruiting

Colorado

* Denver Health Medical Center, Denver, Colorado, 80204, United States; Recruiting
Jeffrey S Long, RRT 303-436-7906

Delaware

* Christiana Hospital, Newark, Delaware, 19718, United States; Recruiting
Christine Babenko, RN 302-733-4549

Georgia

* Medical Center of Central Georgia, Macon, Georgia, 31201, United States; Recruiting
Debra Kitchens, RN 478-633-1584

Illinois

* Loyola University Medical Center, Maywood, Illinois, 60153, United States; Recruiting
Marcia Halerz, RN, BSN, MBA 708-327-2457

Indiana

* Wishard Memorial Hospital, Indianapolis, Indiana, 46202, United States; Recruiting
Gretchen Huffman 317-287-3029

* Methodist Hospital of Indiana, Indianapolis, Indiana, 46202, United States; Recruiting
Rick Lowry 317-962-6144

Kansas

* University of Kansas Medical Center, Kansas City, Kansas, 66160, United States; Recruiting
Suzanne Porras, RN 913-588-0068

Kentucky

* University of Kentucky Medical Center, Lexington, Kentucky, 40536, United States; Recruiting
Anna Rockich, PharmD 859-323-6346

Michigan

* Detroit Receiving Hospital, Detroit, Michigan, 48201, United States; Recruiting
Kathy Owensby, MS 313-577-5314

* Sinai Grace Hospital, Detroit, Michigan, 48201, United States; Recruiting
Kathy Owensby, MS 313-577-5314

Minnesota

* The Mayo Clinic, Rochester, Minnesota, 55905, United States; Recruiting
Kelly Sahs 507-272-2158

New York

* Albany Medical Center, Albany, New York, 12208, United States; Suspended

North Carolina

* Duke University Medical Center, Durham, North Carolina, 27710, United States; Recruiting
Paula Sprague, RN 919-681-2406

Ohio

* MetroHealth Medical Center, Cleveland, Ohio, 44109, United States; Suspended

* University of Cincinnati Medical Center, Cincinnati, Ohio, 45267-0769, United States; Recruiting
Kay Vonderschmidt, NREMT-P 513-558-5786

* Miami Valley Hospital, Dayton, Ohio, 45409, United States; Recruiting
Susan Mallett, MS, APN 937-208-5069

Pennsylvania

* Lehigh Valley Hospital, Allentown, Pennsylvania, 18103, United States; No longer recruiting

* St. Luke's Regional Resource Trauma Center, Bethlehem, Pennsylvania, 18015, United States; Recruiting
Christy Stehly, BS 610-954-6076

* Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033, United States; Recruiting
Theresa Novchich, RN, BSN, CCRC 717.531.4703

Tennessee

* University of Tennessee-Memphis, Memphis, Tennessee, 38163, United States; Recruiting
Stephanie Panzer, RN 901-448-5714

* Johnson City Medical Center, Johnson City, Tennessee, 37604, United States; Suspended

Texas

* Memorial-Hermann Hospital, Houston, Texas, 77030, United States; No longer recruiting

* University of Texas Health Science Center, San Antonio, Texas, 78284, United States; Recruiting
Janet McCarthy, RN 210-567-5724

* Brooke Army Medical Center, Fort Sam, Houston, Texas, 78234-6315, United States; Recruiting
Nancy C Molter, RN, MN, PhD 210-916-5690

Utah

* University of Utah Health Sciences Center, Salt Lake City, Utah, 84132, United States; Recruiting
Lisa Reynolds, RN, BSN 801-585-0385

* LDS Hospital, Salt Lake City, Utah, 84143, United States; Recruiting
Jolene Fox, RN 801-408-2295

Virginia

* Sentara Norfolk Hospital, Norfolk, Virginia, 23507, United States; No longer recruiting

* Virginia Commonwealth University Medical Center, Richmond, Virginia, 23298-0454, United States; Recruiting
Judy Katzen, MS 804-827-0283

* Inova Fairfax Hospital, Falls Church, Virginia, 22066, United States; Suspended

West Virginia

* West Virginia University/Jon Michael Moore Trauma Center, Morgantown, West Virginia, 26506, United States; Recruiting
Bill Manley, RN, CEN 304-598-4659

As you can see from this information below, the trial has been going on for a while, as the first record dates back to January of 2004:

More Information Study ID Numbers: RTBSE-11-(N). Last Updated: June 23, 2006. Record first received: January 28, 2004. ClinicalTrials.gov Identifier: NCT00076648. Health Authority: United States: Food and Drug Administration.

ClinicalTrials.gov processed this record on 2006-07-07

As noted above in the box, several hospitals have dropped out of active participation in the study. If any of you readers know something about why they did, please post it in the comments - and provide any links you might have.

It's one thing to conduct medical research utilizing patients who have been informed of the trial, its goals, its potential benefits and hazards.

It's entirely another to treat humans as rats for the profitability of the medical-industrial complex.

I don't know about you, but I'm not interested in waking up one morning to discover that I have become PhuqueSickoz Corp.'s latest Frankenstein's Monster.

[For the record - no Pessimist family member was involved by this trial, so there is no personal ax to grind.]

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