Script: Artificial Blood Experiment
July 7, 2006 — -- 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.
Dr. Moore says that anyone concerned about safety has a built-in protection -- that blue bracelet from Northfield Labs -- a way for residents to supposedly opt out of being included in the Polyheme experiment.
Brian Ross: (#19/06:00:52) Doctor, how many people do you know who wear one of these?
Dr. Ernest Moore: None.
Brian Ross: None? So that's not a very effective way to stay out of the study, is it?
Dr. Ernest Moore: Well, my acquaintances that I have apparently believe the study is perfect.
Brian Ross: (06:01:09) And you think most people in Denver know they have to wear this 24/7 if they don't want to be part of your study?
Dr. Ernest Moore: I believe the majority do, yes.
Brian Ross: (#14/01:05:40) Have you ever heard that you have to wear one of these?
Woman: No, I haven't.
Despite the supposedly widely advertised experiment, we couldn't find a single person in downtown Denver who had heard of the blue wristband, or the prospect they could become part of the experiment.
Man 2: (01:10:00) I read the newspapers, we read so much and we never heard about it.
Even the head of a Denver alliance of churches, Pastor Paul Burleson, was unaware of the tests until 20/20 told him about them.
Pastor Paul Burleson: (#17/04:03:12) Never heard of Northfield, never heard of the experiment.//(04:05:46) Something is wrong when people are not given a chance, or a voice, or a choice, as to whether or not they want to be an experimental person.
27-year-old Erick Silkworth was given Polyheme after a car accident in Pennsylvania, and now says it may have saved his life.
Silkworth: (#25/2:09:15) I was just very thankful that they did use something that they thought would help and it did help.
But he was unaware he was part of the experiment until he emerged from a coma four weeks later.
And his mother insisted he be given real blood when she learned of it.
Nora Silkworth: (#25/2:04:40) He was in a controlled environment and we felt that blood would have been the thing to do.
But unless a relative demands it, the rules of the experiment require that accident victims be kept on Polyheme for 12 hours straight - meaning they would not get real blood even when they arrived at the hospital.
To the outrage of many leading doctors who say Polyheme is no substitute for real blood.
Dr. Alasdair Conn: (#8/02:08:00) Call us skeptical. We were concerned that this substance may have side effects.
Dr. Alasdair Conn, the chief of emergency medicine at Massachusetts General Hospital, says his hospital refused to be part of the Polyheme experiment.
Dr. Alasdair Conn: (#8/02:06:10) We have an excellent blood bank, and we thought, why tie the trauma surgeon's hands into using this particular product when, if you like, we have the gold standard? We have blood.
Dr. Ernest Moore: I would submit they do not understand the scientific evidence available.
Brian Ross: The doctors up in Boston?
Dr. Ernest Moore: Exactly.
Brian Ross: (05:22:14) You know better?
Dr. Ernest Moore: Exactly.
While millions of units of human blood are used in this country every year, Dr. Moore takes the position that there are problems and risks with stored blood.
Dr. Ernest Moore: (#19/06:06:10) I'm saying that it's unsatisfactory.
Brian Ross: (05:21:10) Human blood is not as good as this experimental product you are working on?
Dr. Ernest Moore: That's correct.
To the astonishment of many, the federal Food and Drug Administration, the FDA, actually accepted that argument in approving the experiment.
The official provided by the FDA to talk to us about the subject was Dr. Robert Temple, who helped design the rules for such controversial experiments.
But as we got started, he told us he didn't have enough information to answer our questions about Polyheme, or even a general question about whether blood is or is not unsatisfactory.
Brian Ross: (#12/01:12:45) Would you call human blood an unproven or unsatisfactory...
Dr. Robert Temple: (Overlap) No, again. Um, if I ...
Brian Ross: (Overlap) ... alternative?
Dr. Robert Temple: ... if I knew more about the situation, I might offer an opinion. But I'm….
Brian Ross: 01:12:54 You're a doctor at the FDA, would you call human blood an unproven or an unsatisfactory...
At this point, an FDA press representative declared the interview was over.
Woman: Let's go. Thank you very much.//
Brian Ross: You can't answer that question doctor?
Sen. Charles Grassley: (#13/01:04:52) The FDA has approved those set of circumstances and it's beyond me how they could do it.
Iowa Senator Charles Grassley, a Republican, says the Polyheme experiment is another example of how the FDA has become too cozy and lenient with pharmaceutical companies.
Sen. Charles Grassley: (#13/01:08:30) They have gone too far in allowing the company do it in their way.//01:08:33 John Q. Public is the only person who should be across the table from the FDA.
The president of Northfield Labs, Dr. Steven Gould, refused repeated requests to appear on 20/20.
But he has been busy talking, with investment bankers, as we saw at this conference in Boston where he said the experiment was going well and predicted Polyheme would soon be on the market, which, if true would make his company and its Polyheme product worth hundreds of millions of dollars.