From the July 2006 Idaho Observer:

FDA waives "informed consent" for phase III of nationwide artificial blood clinical trials

Emergency responders from 27 cities across the nation to subject serious accident victims to medical experiment without their knowledge or consent


compiled by The IO

Northfield Laboratories (NL) has been given FDA approval to begin conducting "randomized phase III clinical trials" for PolyHeme®—an experimental artificial blood substitute—in 27 cities across the country. PolyHeme is a solution of chemically-modified human hemoglobin intended to simultaneously replace lost blood volume and hemoglobin levels. NL claims its blood substitute, made from human red blood cells "using steps to reduce the risk of viral transmission," is designed for rapid and massive administration and "developed for the treatment of urgent, large volume blood loss in trauma and resultant surgical settings, with a particular focus on settings where blood is not immediately available."

Under an exception in Title 21 of U.S. Code, PolyHeme can be used by participating emergency medical personnel at the scenes of accidents where unconscious, badly-bleeding trauma victims are unable to give informed consent to the administration of the experimental substance. The exception provision was granted based upon the fact that these test subjects will be requiring emergency medical intervention in life-threatening situations where ordinary treatments are either unavailable or deemed unsatisfactory.

PolyHeme is described as hypoallergenic and compatible with all blood types. Therefore ALL trauma victims qualify as potential unwitting test subjects unless they (we) obtain a special blue bracelet from NL in advance of an accident. In other words, by our failure to obtain a bracelet in advance of an accident that requires trauma care, we tacitly accept our status as guinea pigs in a medical experiment.

The NL website confirms the comments made above and only sketches the developmental history, production methods and potential applications of PolyHeme. According to ABC News, most people are completely unaware that the trials are currently underway in the following cities, although NL claims the public has been notified of the study:

California: UC San Diego Medical Center,

San Diego, Calif. (no longer recruiting)

Scripps Mercy, San Diego (no longer recruiting)

Colorado: Denver Health Medical Center, Denver

Delaware: Christiana Hospital, Newark

Georgia: Medical Center of Central Georgia, Macon

Illinois: Loyola University Medical Center, Maywood

Indiana: Wishard Memorial Hospital, Indianapolis

Methodist Hospital, Indianapolis

Kansas: University of Kansas Medical Center, Kansas City

Kentucky: University of Kentucky Medical Center, Lexington

Michigan: Detroit Receiving Hospital, Detroit

Sinai Grace Hospital, Detroit

Minnesota: The Mayo Clinic, Rochester

New York: Albany Medical Center, Albany (suspended)

North Carolina: Duke University Medical Center, Durham

Ohio: MetroHealth Medical Center, Cleveland (suspended)

University of Cincinnati Medical Center, Cincinnati

Miami Valley Hospital, Dayton

Pennsylvania: Lehigh Valley Hospital, Allentown (no longer recruiting)

St. Luke’s Regional Resource Trauma Center, Bethlehem

Penn. State Milton S. Hershey Medical Center, Hershey

Tennessee: University of Tennessee-Memphis, Memphis

Johnson City Medical Center, Johnson City (suspended)

Texas: Memorial-Hermann Hospital, Houston (no longer recruiting)

Memorial-Hermann Hospital, Houston (no longer recruiting)

University of Texas Health Science Center, San Antonio

Brooke Army Medical Center, Fort Sam Houston

Utah: University of Utah Health Sciences Center, Salt Lake City

LDS Hospital, Salt Lake City

Virginia: Sentara Norfolk Hospital, Norfolk (no longer recruiting)

Virginia Commonwealth University Medical Center, Richmond

Inova Fairfax Hospital, Falls Church (suspended)

West Virginia: West Virginia University/Jon Michael Moore Trauma Center, Morgantown

Roots in Vietnam

Particularly on the battlefield, humans are merely a collection of moving parts capable of following orders and accomplishing military objectives. According to NL, the development of a hypoallergenic substance that can be universally administered to hemorrhagic humans regardless of blood type was commenced by the U.S. Army following the Vietnam war. "The objective was to develop a preparation that could be infused rapidly and in massive quantities to injured battlefield combatants in far-forward areas and mobile surgical theaters before the injured could be evacuated to more sophisticated field hospitals for definitive care," NL explains at its website.

Earlier preparations produced a variety of unacceptable adverse effects such as major organ dysfunction and rejection. NL claims that PolyHeme, due to its high-yield polymerization, advanced filtration and purification processes and increased molecular weight does not generate such adverse responses.

Post-trial surveillance

According to NL, "Treatment begins at the scene of injury, continues in the ambulance during transport, and for up to 12 hours post-injury or 6 units in the hospital. The trial is designed to evaluate PolyHeme compared to the current standard of care, namely salt water in the ambulance followed in the hospital by donated blood, when needed. The primary endpoint is survival at 30 days."

There is no mention of checking up on test subjects beyond 30 days.

Endnote: Hospitals that "suspended" the trials did so because the manufacturer was not forthcoming with data showing that PolyHeme recipients were experiencing adverse reactions such as heart attack. See The IO "Back to Basics" column Oct., 2001, to see how chlorophyll perfectly replaces lost blood.

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