[SymphonicHealth] FDA Allows Blood Substitute Experiment With No Consent (fwd)

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Subject: [symphonicHealth] FDA Allows Blood Substitute Experiment With No

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FDA Allows Blood Substitute Experiment With No Consent

http://www.ahrp.org/cms/content/view/86/80/

FDA Allows Blood Substitute Experiment With No Consent

Monday, 27 February 2006

The Wall Street Journal reports:

The FDA is allowing Northfield [Laboratories, Inc] to test its blood

substitute without the consent of the trauma patients, who often are

unconscious.

Blood substitutes may be needed on the battlefield. But does that justify

testing blood substitutes in trauma patients in urban communities when

life-saving blood could be tested inasmuch as it has been proven safe and

more effective?

The FDA, beyond all comprehension of a possible rationale, approved

Northfieldâ?Ts multi-site trial at 31 medical centers in December, 2003,

under the stewardship of Dr. Mark McClellan when the agency had knowledge

that the product caused heart attacks in patients in a prior, unpublished

clinical trial whose results have remained concealed:

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.

Whats more, the FDA remained silent as the company continued to hide this

vital information from physicians conducting the trial, from patients, and

the public, is approaching criminal behavior.

Dr. Hoffman, chief of cardiac-surgery intensive-care, at

Massachusetts General, says â?oblood substitutes made with hemoglobin as a

starting pointâ?¦.are associated with heart attacks and strokes.

Human blood is proven safe and effective. Indeed, efforts by (at least)

four companies Baxter, Biopure, Hemosol, Northfeld to produce an artificial

blood substitute have ALL demonstrated that there is no safe substitute for

human blood. Artificial products are made with hemoglobin which binds nitric

oxide. This causes basal constriction seriously raising blood pressure. The

blood platelets become sticky and have been shown to adhere to vascular

surfaces, causing blood vessels to become inflamed and occluded.

ALL of the tested blood products have demonstrated the same adverse effect

profile: they caused hypertension crisis, myocardial infarctions, strokes,

and kidney failure. In clinical trials, no artificial blood product has

compared favorably to human blood.

Human blood requires refrigeration, which is not possible on the

battlefield. To save soldiers lives a blood substitute would potentially be

useful. However, no safe blood substitute has been developedcertainly none

whose use can be justified on civilians who are not far from hospital

emergency rooms. Dr. Hess, who headed the Armys blood-substitute

programs before he shut it down in 1996 after concluding that all the blood

substitutes he evaluated were toxic. With hemoglobin, the lining of the

blood-vessel wall becomes inflamed.

Artificial blood experiments on trauma patients violate that first and

foremost condition set forth in FDA's waiver of informed consent Rule.

In 1996, the FDA adopted a radical rule granting waiver from informed

consent requirements for trauma patients but only under conditions

specified, the first being:

(1) The human subjects are in a life-threatening situation, available

treatments are unproven or unsatisfactory, and the collection of valid

scientific evidence, which may include evidence obtained through randomized

placebo-controlled investigations, is necessary to determine the safety and

effectiveness of particular interventions.

[see: Protection of Human Subjects: Informed Consent and Waiver of Informed

Consent Requirements in Certain Emergency Research; Final Rules. Federal

Register: 51528-51533. Code of Federal Regulations, Part 50 section 50.24]

Human blood is available, and its efficacy and safety is proven and

satisfactory.

FDA's waiver of informed consent rule was first applied in 1998, by Baxter

International (competitor to Northfeld) when it conducted a similar trial to

test its blood substitute, HemAssist, without informed consent. The Baxter

trial was stopped when 24 of 52 patients given the blood substitute died

compared to 8 of 46 who had real blood. This lethal experiment demonstrates

that waiver of informed consent opens the gate to medical disasters.

At the same time, Northfeld was conducting its own abdominal aortic aneurism

trial on surgical patients who underwent elective surgery to repair it these

patients were able to give informed consent. After the suspension of the

Baxter trial, the FDA ordered Northfeld to expand its trial at 21 medical

centers to a voluntary patient base of 600 from 240.

In August, 2001, that trial was abruptly suspended without the company ever

disclosing the results not even to participating trial investigators.

Northfield restricted access to the full data thereby keeping the

participating doctors in the dark about the heart attacks and other serious

adverse events.

The Wall Street Journal reports: These events occurred in 54% of the

PolyHeme patients versus 28% in the control group. Overall, eight PolyHeme

patients died versus four on the conventional therapy. An FDA official is

quoted stating:

" the adverse-event profile in the aneurysm trial, while significant, was not

a show-stopper. How many preventable deaths does the FDA tolerate before it

stops the show?

It is inconceivable how the FDA justifies its approval of the current

PolyHeme trial being conducted on trauma patients in urban centers across

the US without informed consent: In lieu of patient consent, the 31 medical

centers testing the product are required to carry out community-awareness

campaigns about the trials.