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.
To opt out of the study, contact Northfield Labs (http://www.northfieldlabs.com/...) or a participating hospital and request a blue bracelet. If worn, you will be exempt from the trial.
There is a list of actively participating hospitals on the end of the ABCnews article.
I wanted to publicize this an another failure of the Bush administration to protect people from corporate abuse.
What is an exception from informed consent?
Regulations established by the Federal government, (21 Code of Federal Regulations 50.24) specifies the conditions under which an exception from informed consent so that in emergency situations, research can be carried out even when consent is not possible because of the nature and extent of the patient's injuries.
From an old WSJ article:
Ten in Trial Have Heart Attacks,but Data Aren't Published; FDA Allows a New Study; Doctors' Pleas Are Ignored
Several years ago a clinical trial of a blood substitute called PolyHeme finished with worrisome results. Ten of 81 patients who received the fake blood suffered a heart attack within seven days, and two of those died. None of the 71 patients in the trial who received real blood were found to have had a heart attack.
PolyHeme's maker, Northfield Laboratories Inc., quietly shut down the trial and didn't publicly disclose the results, which are described in internal documents viewed by The Wall Street Journal. It decided the heart attacks might have been due to doctor inexperience in using PolyHeme, not a problem with the product itself.
Now Northfield is in the middle of a new trial. A Food and Drug Administration official, Jay Epstein, calls the earlier data "alarming" but not sufficient to stop Northfield from trying out its product on hundreds of trauma patients.
The FDA is allowing Northfield to test its blood substitute without the consent of the trauma patients, who often are unconscious. In lieu of patient consent, the 31 medical centers testing the product are required to carry out community-awareness campaigns about the trials. Several hospitals have told community meetings that previous trials showed PolyHeme to be safe, failing to mention the 10 heart attacks in their printed materials.
Here is a list of cities they tested this in. Many of the hospitals have stopped due to the questionable ethics involved, but check with them anyway if you live in the area.
UC San Diego Medical Center, San Diego, Calif.
Scripps Mercy, San Diego, Calif.;
Denver Health Medical Center, Denver, Colo.
Christiana Hospital, Newark, Del.
Medical Center of Central Georgia, Macon, Ga.
Loyola University Medical Center, Maywood, Ill.
Wishard Memorial Hospital, Indianapolis, Ind.
Methodist Hospital of Indiana, Indianapolis, Ind.
University of Kansas Medical Center, Kansas City, Kan.
University of Kentucky Medical Center, Lexington, Ky.
Detroit Receiving Hospital, Detroit, Mich.
Sinai Grace Hospital, Detroit, Mich.
The Mayo Clinic, Rochester, Minn.
Albany Medical Center, Albany, N.Y.;
Duke University Medical Center, Durham, N.C.
MetroHealth Medical Center, Cleveland, Ohio; Suspended
University of Cincinnati Medical Center, Cincinnati, Ohio
Miami Valley Hospital, Dayton, Ohio
Lehigh Valley Hospital, Allentown, Penn.
St. Luke's Regional Resource Trauma Center, Bethlehem, Penn.
Penn State Milton S. Hershey Medical Center, Hershey, Penn.
University of Tennessee-Memphis, Memphis, Tenn.
Johnson City Medical Center, Johnson City, Tenn.;
Memorial-Hermann Hospital, Houston, Texas;
Memorial-Hermann Hospital, Houston, Texas;
University of Texas Health Science Center, San Antonio, Texas
Brooke Army Medical Center, Fort Sam, Houston, Texas
University of Utah Health Sciences Center, Salt Lake City, Utah
LDS Hospital, Salt Lake City, Utah
Sentara Norfolk Hospital, Norfolk, Va.
Virginia Commonwealth University Medical Center, Richmond, Va.
Inova Fairfax Hospital, Falls Church, Va.;
West Virginia University/Jon Michael Moore Trauma Center, Morgantown, West Va.