Script: Artificial Blood Experiment

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This is a story about the victims of serious accidents, being played out in 27 cities across the country.

Sen. Charles Grassley: A violation of everything that we would call ethical.

For the last two years, badly bleeding accident victims have been used in a possibly risky medical experiment without their knowledge -- they have no say about what will be done to them.

Brian Ross: Even if they're conscious in the ambulance, they don't have a choice?

Dr. Ernest Moore: The, well, that's correct, yes.

The only way out of it is to be wearing a blue wristband like this one, provided by the company doing the test -- wearing it 24 hours a day, seven days a week.

Pastor Paul Burleson: (#17/04:11:45) If I'm in an accident, and I just don't happen to have this particular wristband, that I'd be a guinea pig, is unconscionable.

But that is what the federal government has approved.

What's being tested is an experimental artificial blood, Polyheme, developed by a company called Northfield Labs.

Unlike blood, Polyheme has a long shelf life, allowing it to be used in the field.

Ernest Moore: (#18/05:05:44) I think this has the potential to be one of the greatest advances I've seen in my lifetime.

Dr. Ernest Moore, is running the experiment at the Denver Health Medical Center, the single biggest location in the nationwide test.

Dr. Moore says the experiment could not be done if the patients' consent had to be obtained first.

an Ross: And you think that's ethical?

Dr. Ernest Moore: Yes.

In the experiment, ambulance squads give Polyheme to half of the severely bleeding patients they pick up, instead of the normally used saltwater solution. Who gets what is determined at random by a sealed envelope.

Ambulance worker: It's all in here, sir. It's like on a game show, I guess.

A game show in which the contestants, the subjects, are never told a key piece of information. Confidential Northfield Labs documents obtained by 20/20 show that a previous Polyheme experiment had to be stopped because of safety issues - 10 of the patients received heart attack and two died.

Brian Ross: (#18/05:08:52) Would you call that a safety problem?

Dr. Ernest Moore: No.//Potential safety problem.

Dr. Moore wasn't involved in the previous experiment but says he was told the problem was test subjects were given too much Polyheme and other fluids.

Dr. Ernest Moore: What was considered a flawed study design.

Brian Ross: (06;23:00) They died because it was a flawed study?

Dr. Ernest Moore: I don't know why they died.

Brian Ross: They died because of adverse effects from the Polyheme?

Dr. Ernest Moore: That's not been established.

Brian Ross: But that is the suspicion, is it not?

Dr. Ernest Moore: That's a concern.

Brian Ross: How can you not call that a serious safety issue?

Dr. Ernest Moore: Well, it is a serious safety issue.//It was, again, in a flawed study.

Yet despite the questions of safety and of ethics, the federal government approved the unusual experiment based on a promise that the communities involved would be fully informed of possible risks.

But in Denver, only six people showed up at a Polyheme community meeting held in this building. And those who did show up heard nothing about that previous study with 10 heart attacks and two deaths.

Dr. Ernest Moore: (5:28:32) Well, we felt we covered what was necessary and important for them to know.

Brian Ross: In retrospect, would you change it?

Dr. Ernest Moore: No.

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