November 14

Waived consent controversy: Video available_CNN: Paula Zahn

From messages received, I gather that many of you missed the CNN-Paula Zahn News segment about FDA's controversial approval of a commercially sponsored experiment on trauma patients in 38 American urban centers. [1]   

The video of the segment with Dr. Sanje Gupta is posted at CNN–however, you must first get past a commercial for cereal….:  or  (Video: Tested Without Your Consent)

The experiment tested the artificial blood product, PolyHeme, manufactured by Northfield Laboratories, without the informed consent of the subjects. The FDA violated its own standards for  "waived consent" research–which is applicable only if there are no alternatives.  However, blood is the universally acknowledged safe and effective standard of treatment available in urban centers.

In a previous experiment on surgery patients who gave consent, 10 of 81 people who received PolyHeme suffered heart attacks, 2 died. None suffered heart attacks in 71 patients who received real human blood. 

The trauma patients in the communities in which the expeirment was conducted were actually denied the benefit of life-saving real blood. Their lives were put at increased risk of death–in order to test whether an anrtificial blood product could be substituted.   The experiment is an obvious commercially driven test. 

The CNN report presents both sides of the debate: Sara Goodkind, the FDA official who defends the experiment claiming there are "no good alternatives"–given that human blood is safe and effective, the argument is disingenuous.

Joining me in the critic's corner is Dr. Robert Klitzman, a bioethicist at Columbia University. Also presented is a single patient who survived treatment with PolyHeme who believes that  that the product saved her life.  However, the "belief" of an individual is not science-based evidence. The issue is whether the artificial product is as safe as human blood.

The video of the segment with Dr. Sanje Gupta is posted at CNN–you must get past a commercial for cereal….:

In this brief news report, CNN did not include mention of the blistering letter by Senator Charles Grassley to the Secretary of Health and Human Services about the complicity of the FDA and Northfield Laboratories in the approval of this experiment and the deception of the communities in which it was conducted. [2]

“I am personally troubled that, for all intents and purposes, the FDA allowed a clinical trial to proceed, which makes the inhabitants of 32 communities in 18 states, and anyone living or traveling near these communities, potential “guinea pigs,” without their consent and, absent consent, without full awareness of the risks and benefits of the blood substitute.”

Sen. Grassley informs the Secretary that the senior officials of the Office of Human Research Protections (OHRP), wrote (then) FDA commissioner several times expressing their concerns. OHRP officials informed the Senator and his staff at a meeting that “OHRP would not have approved the PolyHeme Study because its design and implementation remains unethical.”

1. On March 2, 2006, AHRP filed a complaint with the federal Office of Human Research Protections–correspondence is posted at:

2. See Sen. Grassley letter, March 14, 2006 :

Contact: Vera Hassner Sharav

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