Fake Blood

[McDoctor]

http://www.wired.com/news/medtech/0,1286,62955,00.html

The disturbing aspect about this story is how little play it has gotten in mainstream TV and cable news. I live near one of the hospitals particpating in this study, yet have heard very little about this in local news as well. Either the FDA is deliberately keeping this quiet or even more journalists are asleep at the wheel than I thought.

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[johnny pollen]

I remember trying to find stuff on this when Miss Elisabeth Corday, the trauma surgeon and resident Brit on ER, was doing a research study on it in season 4. Called it "Hemoaid." I thought it was cooler than cool, but yeah -- the ethics of it are pretty complicated.

 

[CatsandCradles]

http://www.wired.com/news/medtech/0,1286,62955,00.html

The disturbing aspect about this story is how little play it has gotten in mainstream TV and cable news. I live near one of the hospitals particpating in this study, yet have heard very little about this in local news as well. Either the FDA is deliberately keeping this quiet or even more journalists are asleep at the wheel than I thought.

wait a second I saw an article about it in the WSJ. I'm searching for it!

 

[Josh L.Ac.]

We talked about this in my medical ethics class a few weeks ago. Apparently in some of the areas in Colorado where this trial is underway, the hospitals / drug company attempted to set up community meetings to tell the public about the study, then considered it informed consent.

It is odd that the medical ethics professor from Udub suggested that the lack of informed consent wasn't important enough to stop the research since there is the possibility of great benefit. From what I was taught, utility doesn't trump respect. In addition, the claim that it should be the burden of those that don't want to be involved in the research to opt out because "...it may be very difficult to find citizens willing to volunteer for a study of trauma patient...because people don't like to think about the prospect of an accident" is just ridiculous.

I think the effect of electro-acupuncture for the treatment of laboratory-induced tooth pain should be tested on medical ethicists. I'll set up a web-page to inform all medical ethicists that they might be randomly selected to be research subjects unless they email me. Now I would set-up a typical study with informed consent, but it would be a hassel to get medical ethicists to volunter for the study since most people don't like the idea of undergoing laboratory-induced tooth pain for the sake of research.

 

[mshheaddoc]

I have seen alot of information over the past 3 years and actually did a marketing project on Polyheme (there is an animal product that came to market first).

http://www.northfieldlabs.com/polyheme.html
http://irb.ucsd.edu/notices/polyheme/FAQs.htm


First off its not "fake blood". Secondly, its the ethics here not the product that is questioned. As the product has been proven to increase the chance of survival to extreme blood loss, but as stated, ethically, should these results count? Unfortunately they need the clinical trials in order to get FDA approval which is sort of a catch 22. I know there are areas where they are going door to door to get consents but I wonder by reading into these concerns published recently if their studies are relaly the problem.

http://blog.bioethics.net/2006/03/polyheme.html
http://www.bioethics.net/journal/pdf/UAJB_A_166837.pdf
http://www.bioethics.net/journal/pdf/UAJB_A_166839.pdf


The response from makers of Polyheme which doesn't address all issues ... http://phx.corporate-ir.net/phoenix.zhtml?c=91374&p=irol-newsArticle&ID=824752&highlight=

I'm trying to find out how polyheme can transfer HIV/HepC ...

 

[McDoctor]

I'm sure this has been in the papers here and there. But, the first I heard about this was on 20/20 last night, and although I don't comb the newspapers on a daily basis, I do read them and I tend to think of myself as generally informed about what is going on in the world.

I live within twenty miles from a major trauma center participating in the phase III clinical trial. Why is it that I can't go 30 minutes without getting an update on the Duke Lacrosse team or that gray-haired jackass from American Idol yet I remained uninformed of the fact that I am potentially an unwilling participant in a major clinical trial whose duty of informed consent has been waived?

(actually, I believe Duke University Hospital is one of the participating trial centers. Couldn't one of these vultures drop that line of info on me as they scramble to interview the brother of a guy who knew a lawyer who once considered representing the neighbor of the alleged rape victim's freshman year roommate on an unrelated charge...etc...)

I think reasonable people can disagree as to whether or not the study is ethical. The appalling aspect lies within the degree to which the public is not informed.
In my own unscientific study, I compared the length of the Wikipedia entry on "Polyheme" to the length of the Wikipedia entry on "Scientology". (Did you know Jerry Seinfeld once dabbled in Scientology?). Guess which one's longer.

 

[CatsandCradles]

Ok I found it. It’s a very big article and I typed a little of it here.

_____________________________________________________________
Wall Street Journal

FDA to Weigh Using Fake Blood In Trauma Trial

Thursday, July 6, 2006
By Thomas M. Burton

If the U.S. Navy gets its way, hundreds of civilian trauma patients could--without their consent--be given a blood substitute that has been linked in other large clinical studies to increases in hypertension, heart attacks and other serious cardiac problems.

The Food and Drug Administration has blocked the new Navy trial three times in the past year, but is now reconsidering after months of jockeying among the Navy, the agency and Biopure Corp., the Cambridge, Mass., maker of the blood substitute.

The agency has scheduled a closed door hearing for next week on whether the Navy-designed trial can proceed. More than 900 badly hemorrhaging civilian accident victims around the country would be involved, with paramedics giving some the blood substitute called Hemepure, and others saline solution en route to hospitals.

Such non-consent trials are rare but legal where federal regulators determine there's no practical way to obtain consent, such as when the patient is in shock or unconscious. There also must be a reasonable likelihood that individuals patients would benefit from the treatment under scrutiny.

Scientist have been hunting for a safe, workable blood substitute for decades. Artificial blood, with oxygen-carrying ability, could eliminate the need to match blood types of donor and recipient in some settings, and enjoy a far longer shelf life than donor blood. It could also reduce the risk of hepatitis or HIV infection, although donor blood has become very safe over the past two decades.

The Navy, which provides all medical care for the injured U.S. marines and sailors, has been particularly eager for a workable blood substitute. Donor blood last only about 42 days before its oxygen carrying capacity is diminished, while artificial blood could be stored aboard ships for an estimated three years.

But efforts to develop blood substitutes have encountered safety problems over the years. Some companies have gone out of business or exited blood-substitute research past efforts failed.

Northfield Laboratories of Evanston, Ill., is nearing completion of a civilian non-consent study involving its own blood substitute, PolyHeme, and 720 trauma patients around the country. In a previous trial of surgery patients, 10 of 81 people who received PolyHeme suffered from heat attacks, versus zero of 71 receiving donor blood. Northfield says it doesn't believe its product caused heart attacks, but the Securities and Exchange Commission and Sen. Charles Grassley, chairmen of the Senate Finance Committee, are investigating whether the company properly disclosed those results in federal filings and community meetings. Northfield says it is cooperating with the investigation but declined to comment further. Nine of the original 31 medical centers that agreed to participate in the trial are no longer testing patients with PolyHeme.

Past Studies have raised questions about Biopure's Hemopure as well. In 1998, the company began a clinical study comparing its substitute with donor blood in consenting orthopedic-surgery patients. William G. Hoffman, then Biopure's medical director and now director of cardiac surgery critical care at Massachusetts’s General Hospital, says he concluded during the study that the blood substitute wasn't working well and was "harmful," and urged Biopure to stop the trial. Edward Jacobs, a Biopure founder and then senior vice president, says the company consulted outside cardiologist and "their opinion was to go ahead."

Evidence from that study, along with a separate study in general surgery patients, linked Hemopure to more complications such as strokes and mini-strokes than donor blood, FDA documents show. Biopure disputes some of the FDA numbers. But in a draft response to the agency, Biopure acknowledges that there were more cases of cardiac arrest, more fluid in the lungs, and more hypertension among patients who got Hemopure than those who received donor blood......

_______________________________________________________________


....and the story goes on to decribe how the Navy has been continously trying to get the FDA to approve of a civilian study with the blood substitute - but the FDA stopped them every single time.

The thing is, the Navy's "Interest is out in the field conditions where there is no blood," and has been proposing a study on civilian trauma patients in 2004 and 2005 - but the FDA rejected them each time citing safety concerns.

A lot of political back and forth in the later sections of the article. There are a lot of coporations and lobbying organizations allying themselves with the Navy. People on the FDA board were dismissed and replaced..etc etc..

After reading this article my humble opinion is this: Be careful with blood substitutes.

 

[CatsandCradles]

I have seen alot of information over the past 3 years and actually did a marketing project on Polyheme (there is an animal product that came to market first).

http://www.northfieldlabs.com/polyheme.html

1 out of 8 will face a heart attack with PolyHeme.....granted these individuals were trauma patients so there are a lot of other variables involved.

If its 1/8 without informed consent - then the FDA had some grounds for red flags.

And if the medical director of the Biopure says that his own company's product is screwed up, then I'll take his word for it.

yet I remained uniformed of the fact that I am potentially an unwilling participant in a major clinical trial whose duty of informed consent has been waived?

Better help your local church to start a protest

 

[McDoctor]

I have seen alot of information over the past 3 years and actually did a marketing project on Polyheme (there is an animal product that came to market first).

http://www.northfieldlabs.com/polyheme.html
http://irb.ucsd.edu/notices/polyheme/FAQs.htm


First off its not "fake blood". Secondly, its the ethics here not the product that is questioned. As the product has been proven to increase the chance of survival to extreme blood loss, but as stated, ethically, should these results count? Unfortunately they need the clinical trials in order to get FDA approval which is sort of a catch 22.

I know there are areas where they are going door to door to get consents but I wonder by reading into these concerns published recently if their studies are relaly the problem.

http://blog.bioethics.net/2006/03/polyheme.html
http://www.bioethics.net/journal/pdf/UAJB_A_166837.pdf
http://www.bioethics.net/journal/pdf/UAJB_A_166839.pdf


The response from makers of Polyheme which doesn't address all issues ... http://phx.corporate-ir.net/phoenix.zhtml?c=91374&p=irol-newsArticle&ID=824752&highlight=

I'm trying to find out how polyheme can transfer HIV/HepC ...

First off, I realize its not "fake blood"

Secondly, in general, I don't consider the need to demonstrate safety and efficacy by clinical trials as "unfortunate". Sure, it makes things complicated at times. But it also prevents my children from being born without kidneys at times too.

I suppose I'd be more informed of all this if I browsed bioethics.net blogs or happened upon Northfield labs website.
But as someone who relies primarily on local newscasts, nightly newcasts and the local paper (as I'm sure the majority of Americans do) to let me know when there is a clinical trial going on in the area that it is assumed I will want to be a part of unless I tell the clinical investigators otherwise, I have to admit that I've been in the dark about this.

 

[southerndoc]

1 out of 8 will die from a heart attack with PolyHeme.....granted these individuals were trauma patients so there are a lot of other variables involved.

If 1/8 die in a study without informed consent - then the FDA was on the ball to put up red flags.

Please note that 1 out of 8 patients suffered an MI, but 1 out of 8 did not die. Only 2 patients died of an MI out of the total 10 that suffered an MI.

Secondly, the definition of MI remains to be seen. Was this an ST-elevation MI (a "true" MI), was it significant troponins (i.e., trops of 5+), or did they include troponins that were only slightly positive (i.e., troponon if 0.08)?

I've seen plenty of patients who have bled down and had anemia-induced myocardial ischemia and had slight bumps of troponins (trop of 0.1-2 or so). Were these patients included as MI's? Was analysis done to see if those patients had more intraoperative hypotension or difficult post-operative management that could have confounded the results? Were these patients at higher risk?

I think with such a small number of patients, it is extremely difficult to show with confidence that Polyheme was the cause of these MI's.

 

[CatsandCradles]

Please note that 1 out of 8 patients suffered an MI, but 1 out of 8 did not die. Only 2 patients died of an MI out of the total 10 that suffered an MI.

Secondly, the definition of MI remains to be seen. Was this an ST-elevation MI (a "true" MI), was it significant troponins (i.e., trops of 5+), or did they include troponins that were only slightly positive (i.e., troponon if 0.08)?

I've seen plenty of patients who have bled down and had anemia-induced myocardial ischemia and had slight bumps of troponins (trop of 0.1-2 or so). Were these patients included as MI's? Was analysis done to see if those patients had more intraoperative hypotension or difficult post-operative management that could have confounded the results? Were these patients at higher risk?

I think with such a small number of patients, it is extremely difficult to show with confidence that Polyheme was the cause of these MI's.

Eeek! You are right. The article didn't say 1 out of 8 will die! Yet I read that and assumed it was 1 out of 8.

Obviously this just shows my poor reading comprehension!

 

[mshheaddoc]

I also want to point out that you have to look at the study itself. As I hinted to if you actually read through all of the articles I posted. This is mainly developed as a blood substitute with the idea in mind that this can be used for trauma emergencies where it is hard to keep blood for a long period of time. By keep I mean store. Such as paramedic units, rural communities, etc. For that purpose this product serves well. BUT my point that I want to make is they are pushing the boundaries by doing varies studies of first 12 hrs (6 bags) of saline vs polyheme, then second 12 hrs (6 bags) of blood (those on saline when get to hospital) vs. polyheme. By studying the characteristics of this blood substitute this this only comprises a portion of all blood components needed, in which the other components are available to be transfused separately.

Everything I have read has shown 'low risk' and I think the study needs to be done obviously. But now that this is coming up to informed consent rule, things need to be a little more spelled out for communities for religious purposes if not ethical. Although honestly, you need to have something in you and Polyheme is better than saline in that purpose of preventing brain damage.

 

[mshheaddoc]

But as someone who relies primarily on local newscasts, nightly newcasts and the local paper (as I'm sure the majority of Americans do) to let me know when there is a clinical trial going on in the area that it is assumed I will want to be a part of unless I tell the clinical investigators otherwise, I have to admit that I've been in the dark about this.

This is why our "news" doesn't always do us justice. There is sensor OVERLOAD of information out there that we can just never know anything. This is the sad part.

Although I disagree with you on the clinical trial view. If you are dying and have lost most of your blood and you're in a rural area over 30 mins from a hospital. This is the only thing that might help save your life or reduce brain damage, etc. Someone with more experience (paramedic, ER doc, etc could comment more on the benefits).

Saline can't do all the things that this can do and the benefit risks outweigh the bad by far from what I've read. I just don't know if I agree with using this once you GET to the hospital. That might be pushing the boundaries of this clinical trial, though I understand WHY they are continuing at this point. I just wonder if they are getting the other blood components with Polyheme as well.

 

[McDoctor]

This is why our "news" doesn't always do us justice. There is sensor OVERLOAD of information out there that we can just never know anything. This is the sad part.

Although I disagree with you on the clinical trial view. If you are dying and have lost most of your blood and you're in a rural area over 30 mins from a hospital. This is the only thing that might help save your life or reduce brain damage, etc. Someone with more experience (paramedic, ER doc, etc could comment more on the benefits).

Saline can't do all the things that this can do and the benefit risks outweigh the bad by far from what I've read. I just don't know if I agree with using this once you GET to the hospital. That might be pushing the boundaries of this clinical trial, though I understand WHY they are continuing at this point. I just wonder if they are getting the other blood components with Polyheme as well.

I agree that this could definitely help rural areas. Probably the military as well. I mostly have a problem with the lack of information distributed on the part of some of the hospitals participating in the trial.

I think you could reasonably come down on either side of the ethical dilemma posed by this trial. But the lackluster effort to inform the public is hard to excuse.

 

[QuikClot]

I would like to assess the author of this "fake blood" article for numbness/tingling in the hands and feet, RR, and end-tidal, 'cause the bi%&* is having a panic attack.

It is in the nature of many EM interventions that traditional informed consent can't be obtained. How do you test a new CPR tool? An adult IO? A drug to counteract swelling after a severe head injury? A new intervention in severe hypoglecemia?

As for the danger, all medical interventions have an element of risk. That is why we do trials. Alternatively, we could simply ban all new drugs and therapies. The idea that the public is ill-informed about the dangers is a red herring. I've been reading about various blood substitutes for years. If the public is ill-informed, it is because they don't care. Nor do they need to. The results of this trial will be evaluated and if it helps, it will be approved. If it's not benificial, it's toast. Granted the armed forces are leaning on the FDA, but it isn't time to panic just yet. If the therapy is approved without evidence of benifit, then it is time to talk about danger to the public.

 

[odrade1]

I would like to assess the author of this "fake blood" article for numbness/tingling in the hands and feet, RR, and end-tidal, 'cause the bi%&* is having a panic attack.

It is in the nature of many EM interventions that traditional informed consent can't be obtained. How do you test a new CPR tool? An adult IO? A drug to counteract swelling after a severe head injury? A new intervention in severe hypoglecemia?

As for the danger, all medical interventions have an element of risk. That is why we do trials. Alternatively, we could simply ban all new drugs and therapies. The idea that the public is ill-informed about the dangers is a red herring. I've been reading about various blood substitutes for years. If the public is ill-informed, it is because they don't care. Nor do they need to. The results of this trial will be evaluated and if it helps, it will be approved. If it's not benificial, it's toast. Granted the armed forces are leaning on the FDA, but it isn't time to panic just yet. If the therapy is approved without evidence of benifit, then it is time to talk about danger to the public.

 

[FutureDocDO]

Fake blood has been studied in animals (i.e., dogs). It worked pretty well and has a longer shelf life than real blood. It's actually made from real blood (HgB).

 

[QuikClot]

Calling it "fake blood" is part of the problem with the tone of the article. It isn't fake anything. It's supportive care in an emergency. The way it is intended to be used, it is not replacing transfusions of whole blood, but, rather, balanced salt solutions. If this stuff if fake blood, then IV Dextrose is fake food and a Sager splint is fake bone.

 

[McDoctor]

http://jama.ama-assn.org/cgi/content/full/299.19.jrv80007

Context Hemoglobin-based blood substitutes (HBBSs) are infusible oxygen-carrying liquids that have long shelf lives, have no need for refrigeration or cross-matching, and are ideal for treating hemorrhagic shock in remote settings. Some trials of HBBSs during the last decade have reported increased risks without clinical benefit.

Objective To assess the safety of HBBSs in surgical, stroke, and trauma patients.

Data Sources PubMed, EMBASE, and Cochrane Library searches for articles using hemoglobin and blood substitutes from 1980 through March 25, 2008; reviews of Food and Drug Administration (FDA) advisory committee meeting materials; and Internet searches for company press releases.

Study Selection Randomized controlled trials including patients aged 19 years and older receiving HBBSs therapeutically. The database searches yielded 70 trials of which 13 met these criteria; in addition, data from 2 other trials were reported in 2 press releases, and additional data were included in 1 relevant FDA review.

Data Extraction Data on death and myocardial infarction (MI) as outcome variables.

Results Sixteen trials involving 5 different products and 3711 patients in varied patient populations were identified. A test for heterogeneity of the results of these trials was not significant for either mortality or MI (for both, I2 = 0%, P .60), and data were combined using a fixed-effects model. Overall, there was a statistically significant increase in the risk of death (164 deaths in the HBBS-treated groups and 123 deaths in the control groups; relative risk [RR], 1.30; 95% confidence interval [CI], 1.05-1.61) and risk of MI (59 MIs in the HBBS-treated groups and 16 MIs in the control groups; RR, 2.71; 95% CI, 1.67-4.40) with these HBBSs. Subgroup analysis of these trials indicated the increased risk was not restricted to a particular HBBS or clinical indication.

Conclusion Based on the available data, use of HBBSs is associated with a significantly increased risk of death and MI

 

[david594]

Fake blood has been studied in animals (i.e., dogs). It worked pretty well and has a longer shelf life than real blood. It's actually made from real blood (HgB).

One product was also then approved by the FDA for use in dogs in the USA. The product is called Oxyglobin and is made by the company Biopure. The same company that is trying to get its Hemopure approved for human use.

Northfield laboratories and Biopure are currently the 2 big companies dogging it out to see who can get a product approved first.

 

[kronickm]

The simple fact of Polyheme is that it is being heavily backed by the military. I would venture that they have attempted to suppress information about the trials because they want a large pool of data and don't really wan't to have to deal with informed consent. If sheer will alone could get a product through the FDA, these blood substitutes would have been approved a looooong time ago.

Interestingly enough, a patient at my hospital was just given an infusion of this stuff outside of the study. He presented to the ED with a Hgb of around 3-4, awake alert and oriented believe it or not. Apparently he had some sort of virus induced auto-immune hemolytic anemia, and had been walking around with single digit Hgbs for years unbeknowst to anyone. He had so many antibodies that I believe 2-3 donors in all of the U.S. were compatible. As such he was given this stuff (not sure if it was Polyheme or Hemopure which I believe is the competitor). He did survive, but I know that the FDA got involved, to what degree I do not know.

 

[McDoctor]

Looking back at my old posts, I think I was frustrated by the media's failure to notify the surrounding area that they would potentially be enrolled in this study unless they initiated some sort of "opt-out" procedure. (I live near one of the polyheme phase III investigational sites).

But actually, I would hold the hospital itself more accountable for failing to notify the surrounding residents regarding the opt-out process. A single newspaper notification and a blurb on a single newscast prior to the study was all that occurred in my county. I spoke to many people on this, and nobody was aware of a major clinical trial being undertaken on a potentially unsafe medication, for which it was assumed they would want to participate unless they undertook some sort of "opt-out" process.

On first thought, I thought perhaps it would be impractical to send a letter to everyone in the mail. But I have received mass marketing ads from the same hospital in the mail, so certainly a mass-mailing campaign is feasible in some respect. These institutions deserve any short term bad press they might receive. (doubtful to occur, however, if it hasn't happened already. 60 minutes was too busy interviewing Alec Baldwin this week to mention it.)

 

[mshheaddoc]

Looking back at my old posts, I think I was frustrated by the media's failure to notify the surrounding area that they would potentially be enrolled in this study unless they initiated some sort of "opt-out" procedure. (I live near one of the polyheme phase III investigational sites).

But actually, I would hold the hospital itself more accountable for failing to notify the surrounding residents regarding the opt-out process. A single newspaper notification and a blurb on a single newscast prior to the study was all that occurred in my county. I spoke to many people on this, and nobody was aware of a major clinical trial being undertaken on a potentially unsafe medication, for which it was assumed they would want to participate unless they undertook some sort of "opt-out" process.

On first thought, I thought perhaps it would be impractical to send a letter to everyone in the mail. But I have received mass marketing ads from the same hospital in the mail, so certainly a mass-mailing campaign is feasible in some respect. These institutions deserve any short term bad press they might receive. (doubtful to occur, however, if it hasn't happened already. 60 minutes was too busy interviewing Alec Baldwin this week to mention it.)

Agreed, but how many of those mailings do you actually read? I know that Philadelphia had a huge push for this being involved in those clinical trials and the media did cover it quite well. Although how many people watch the news every day? Mass-mailings might work or maybe working with the local communities/governments to get the word out might work as well (Fire, police, EMS, etc)

I have heard that most likely human blood substitutes won't be on the market anytime soon. Animals, their mechanisms are a tad bit different so they haven't had as many problems as humans have, or maybe its the human population base that this has been tried on? I know that some studies have been extremely limited.

 

[yaah]

Well, all I know is that if there was a way to provide what blood transfusions provide artificially, almost everybody in medicine would be all over it. Blood transfusions are not innocuous. You can have fatal reactions. You can make antibodies to different antigens, and if you get too many transfusions and you don't have common blood you can be basically screwed in an emergency. If you have IgA deficiency you often can't get a blood transfusion. The red cross and other collection agencies do 8 different tests on every unit of blood collected (HCV, HBV, HIV, Syphillis, Chagas, HTLVI, HTLV II, sometimes west nile, probably others I can't remember). They also have to go through TONS of bureaucracy to actually get someone to donate - donors have to meet lots of stringent criteria, etc etc. It's a veritable nightmare. There is no conspiracy to prevent artificial blood from becoming therapy - there is just lack of evidence. And it's hard to do these studies because complications of transfusion can be vague and not present for months.

But that being said, the standard that artificial blood has to beat is pretty high.

I suspect where these products will be most useful is in trauma (where you can't accurately and expeditiously match the correct blood) and in those situations where you can't find compatible blood.

 

[kronickm]

I suspect where these products will be most useful is in trauma (where you can't accurately and expeditiously match the correct blood) and in those situations where you can't find compatible blood.

Yeah none of these are supposed to be blood substitutes, they are just supposed to keep you alive long enough to get that crossmatch compatible unit of RBCs. The blood supply is icredibly safe, and the main cause of fatal transfusion reactions (TRALI) is being dealt with swiftly by the appropraite agencies, but I can attest firsthand to the beaurocratic nightmare that is bloodbanking. The main purpose of these things is twofold, to expedite treatment, and help meet a demand that is constantly ahead of supply.

 

[McDoctor]

If the medication is projected to be most useful in rural and remote areas, then that's where these clinical trials should have been done.

 

[kronickm]

If the medication is projected to be most useful in rural and remote areas, then that's where these clinical trials should have been done.

Or on the battlefield.

 

[Emilysmile]

I did a research paper on the development of artificial blood. To me the MOST disturbing aspect of this study design was that even AFTER the pts arrived to the hospital where they may have regained enough mental status to withdrawl from the study (or where a family member might be present to withdrawl the patient), the patient STILL was not allowed to receive real, potentially life saving, human blood. I find this unbelievable. Imagine waking up in a hospital bed or arriving to find a family member in the trauma bay and having the doctor tell you, "no, we can't do a blood transfusion for another 10 hours and 45 minutes..."

And on top of that...in North Carolina they had community meetings where you could "opt out" of the study by wearing a blue wrist band that would alert medics that you had opted out. Great idea, but who wants to wear a blue wristband for a YEAR or more!?

Furthermore...Northfield labs, last I checked, STILL has not released any data from the study...even to the ER docs that were involved.