This is BS. No IRB would approve this study as you say. It's not happening.

Linda Lynch

What about the life saving advantages. Did you interview any people Like Hank Williams' daughter Hillary that believes it saved her life? Did you interview the flight nurses that knew she was given the product and saw her revive?

The non-consent issue is LEGAL and the community is notified!

Don't just take the ethical stance as that is old news. Try a new slant, such as "It saves lives", or "the first blood sub since Saline", or "Support our troops and get it to them because the FDA is dragging their feet". At least do your reasearch and don;t be biased like Burton at the WSJ. Already been there. Be the first to recognize the value and importance of this largely unknown 'holy grail' of trauma therapy.

Thanks

Lyle

I am in total disagreement with this action. We as patients have rights and they should be honored. I think that we Americans should call our Representatives and Congressmen and complain. We need to be heard!

It could just be the only way to save your life. Hank Williams daughter who was an hour away from a hospital and bleeding to death. PolyHeme and God saved her life. Good thing she wasn't wearing a blue bracelet!

Mr. Brian Ross:

I have heard you interviewed Dr. E. E. Moore of Denver Health Medical Center. Dr. Moore has been very clear in stating that PolyHeme has been critical in saving lives. USA Today ran an article last month about PolyHeme apparently saving the life of Hilary Williams, the daughter of Hank Williams, Jr. If you had carefully reviewed the Special Protocol Assessment requirements you would know that attempts are made to contact family members almost immediately upon the patient arriving at the hospital to obtain their consent to continue using PolyHeme if the victim remains in a condition that makes obtaining their consent impossible. Fortunately, in many cases PolyHeme has resuscitated the patient so they can make their own decisions, which is not possible with the alternative saline solution. PolyHeme is a product that will literally save thousands of lives every year including in Iraq and Afghanistan once it is approved, and you raise ethical issues that are now moot, since the trial will conclude enrollments within days. In my opinion your reporting is irresponsible.

Sincerely,

Gary A. Bottinelli

Did you bother asking the pastor if he would have preferred to be dead and not a "guinea pig"? THAT would be balanced reporting. I am sure Hilary Williams, Hank Williams Jr's daughter, is happy to be alive because of Polyheme.

I'd rather be a live guinea pig than a dead human with a blue bracelet.

Why don't you interview the 4 recent trama victims that claim Polyheme saved their lives including singer Hank Williams granddaughter whose commemts were in USA about 1-2 weeks ago. Why not talks to our combat vets coming back and get their comments on the need for such life saving blood substitute?

WHAT ARE THE 27 CITIES? WHy leave that OFF??????

I wonder if you will bring up the good this product will do. Or will you continue to only report on the negative aspects in the world in general. will you stand and shout a major advancement in medicine has been accomplished?, many blood transfusions may be prevented, Multiple Organ Failure may be prevented, and The cost of health care will be less. will you report this???

Several people each year contract various diseases from the full blood received in transfusions. Full blood has not been used in transfusions in Europe for decades, mostly because it can not be sterilized.
Calling the use of properly formulated medically suitable transfusion materials an "experiment" is idiotic, totally incorrect (since it has been the standard practice in advanced countries for decades), and an obvious scare-mongering tactic.

A number of wonderful medical advances have occurred as a result of non consent trials. Imagine if you will heart attack victims without the benefit of defibrilators because that haven't been approved. Obviously, a non consent trial was need for that device.
Tens of thousands of school children recieved the polio vaccine that erradicated that threat. Sometimes it is necessary to use humans as "guinea pigs."
The true story here is not some ethical issue. It's the success of the trial with over 350 patients recieving polyheme and no significant adverse effects that would have caused the trial to be halted. Victims of severe trauma who are in danger of hemmoragic shock and death now have a better chance of survival. This assumes of course that polyheme is approved for use despite the numerous slanted "news" reports that miss the real story.
It's unfortunate that today the story about a medical miracle like polyheme isn't about the lives that will be saved but instead it's about the self-centered "I'm a victim" mentality that never gets the whole picture.
The truly unfortunate ones are not those guinea pigs getting polyheme but the patients in the trial that are dying of blood loss before getting the the hospital because they aren't guinea pigs.

Polyheme will prove to be the greatest medical advance since Penecillin.

Try giving 20 units of whole blood to a trauma victim - certain death. There are people living today who have received 20 units of Polyheme.

It has taken me 3 years to get a got handle on this ,how long did you spend on your research?

POLYHEME IS NOT ARTIFICIAL BLOOD AND IS PROVINGTO BE A LIFE SAVER. MANY PROCEDURES ARE PERFORMED ON UNCONSCIOUS PEOPLE IN EMERGENCY SITUATIONS WITHOUT THEIR CONSENT. YOUR REPORTING IS OLD HAT AND BIAS. FRANK

Brian; I am looking forward to a fair and honest report about Polyheme.I think the main question you have to consider is,( if your bleeding to death and 45 minutes away from typed and cross-matched blood, do you want saline with no oxygen, or polyheme with oxygen? ) Thanks for the good work you do. James

This is wrong. What if ten years down the road, we find out that this Polytheme is very dangerous to our health?? It the same thing that happened with Teflon and the Dupont factory...Everyone thought this stuff was great until all the birth defect, ect. The whole circumstance of the whole thing nearly parrallel's that of testing World War II victims without concent, these people had no choice, they had no say and this is happening again...Think what ever you want but I rather die than be pumped up with some red plastic.

1. Four interim looks at the data concluded that the product was not causing harm
2. A futility test was conducted
3. Senator Grassley clamed up once he met with Northfield and medical officials

Anecdotal stories that the product is saving lives

Hilary Williams daughter

Erik Silkworth

Jan Dalton

Paramedics praising polyheme

Is the best ABC can come up with is a Guinea pig story?

If you look at the link below every community had tens if not hundreds or radio, TV, Web, and new paper ads.

http://www.fda.gov/ohrms/dockets/dockets/95s0158/95s-0158-sup0047-02-Tab-02-Salt-Lake-City-vol50.pdf

Can the national media be fair for once? I hope so, we will see tonight.

On Nov 15/05 an independent data monitoring committee/IDMC/ reveiwed blinded data on mortality in the first 500 patients enrolled in the study.They recommsnded that the polyheme trial continue without modification.A first ever in a blood substitute trial.All others failed at the starting line with the IDMC.For a balance on your study you should check Northfields web site on the trial.Norb.K.

I like the idea of polyheme, but the thought of having artificial whatever pumping through my veins and arteries doesn't really strike my fancy. Maybe I'm the only one, but I suppose I would rather have that in me then all of my own blood spilling onto a table and not being able to stop it.

Dear Mr. Ross,
Is this it? This is what you have learned about Polyheme and want to tell the public?
Oh my gosh, are you ever uninformed and unprepared to speak to the nation about this extremely important medical development.
Guess your public isn't fussy about the truth.
Mary Lyon

Amazing that journalism is all slanted to the negative point of view. This is a product that will likely change emergency medicine forever. You should be discussing the amazing potential of Polyheme. You should be telling the world that trials such at this are important and serve a purpose. The FDa didn't grant approval for this trial with no data. They looked at the trials and made a decision to allow the trial. That decision was based on the efficacy and safety of prior studies. The trial has included 4 interim looks to ensure the results warranted moving forward. I can only hope there is a positive side to your piece.

Your report gave one side of the story. Logic tells me that there must be a second side to this story. If I were a reporter I would be embarrassed to put my name to this half story.

I hope your presentation is not limited to discussion of the ethics of this trial as depicted in the above lead in. US Law allows such a trial. The enrollees at the time of enrollment are in a condition where they are unable to consent.
Hopefully your report will be balanced and also include reporting of how the trial protocol is conducted in the field. Report on the patient safeguards that are in place. Report on the ongoing monitoring of the progress of the trial and how adverse events, if any, are handled. Please don't forget to mention heart defibulators were, at one time,tested in the field without a patients consent.
These people too were unable to consent to their being used as guinea pigs prior to being shocked back to life.

This report is far too sketchy and superficial to be of any value. It's also about two years old. Why the sudden interest now that the hospitals' trial is concluding? The evidence I have seen clearly indicates Polyheme should be a valuable life-saving treatment.

Also don't forget to add that the risk of serious infection goes up by 10% with every unit of blood given -- but does not with polyheme.

If I were in an accident...and needed blood to stay alive and Polyheme was available, you can darn well bet I'd be more than happy about receiving it!! There ought to be wrist bands that say
"ABSOLUTELY"

Have you mentioned that the Navy is trying to get a non-consent trial to use Biopure Corp. cow blood product on unconscious patients? This product has been on clinical hold by the FDA for safety reasons for several years. Don't you think THAT'S a big deal?

1. Four interim looks at the data concluded that the product was not causing harm
2. A futility test was conducted
3. Senator Grassley clamed up once he met with Northfield and medical officials

Anecdotal stories that the product is saving lives

Hilary Williams daughter

http://www.theithacajournal.com/apps/pbcs.dll/article?AID=/20060622/LIFESTYLE18/606220301/1025

Erik Silkworth

http://www.highbeam.com/doc/1G1:134119871/
Test+shows+fake+blood+could+be+a+real+find.
html?refid=SEO

Jan Dalton

http://transcripts.cnn.com/TRANSCRIPTS/0603/
13/lt.02.html

Paramedics praising polyheme

http://www.kykernel.com/media/storage/
paper305/news/2006/01/17/CampusNews
/Paramedics.Praising.Polyheme-1370753.shtml?norewrite200607071243&sourcedomain=
www.kykernel.com

Is the best ABC can come up with is a Guinea pig story?

If you look at the link below every community had tens if not hundreds or radio, TV, Web, and new paper ads.

http://www.fda.gov/ohrms/dockets/dockets/
95s0158/95s-0158-sup0047-02-Tab-02-
Salt-Lake-City-vol50.pdf

Can the national media be fair for once? I hope so, we will see tonight.

Polyheme shows tremendous promise as a life-saving blood substitute, and it should be tested and approved if it passes. But, it should not be tested on patients without their or their family's consent.

If that slows testing down, so be it. If that means we have to revert to traditional methods to treat trauma patients -- even ones who might be saved with Polyheme -- so be it.

I don't want the federal government giving consent for this on my behalf, and I know others feel similarly.

Many of you criticizing the ethical issues raised fail to distinguish between experimental and approved substances. There are federal laws protecting experimental subjects, requiring approval and informed consent. I know of no precedent for uninformed non-consent use of drugs or substances.
You can cite all the anecdotal events and "what if it saves lives" all you want. That only legitimately applies to materials that have been properly tested and found save and approved for general use. In this case, it's simply unethical, because we don't know yet if it is safe, and people are being used as lab rats in violation of the ethical principles behind federal laws on informed consent and Institutional Review Boards.

I think this negative reporting is just a way of ABC to get us to respond on the comment button so they can say to advertisers "Look at how many people look at these pages." and therefore raise their price for advertising on certain links and stories. Its all part of the machine, don't give in.

what are the side effects down the road from this stuff? does any one know that? i definitely would not want to die within a few weeks because this stuff was not good for my body. i cannot believe that anyone has the right to give the approval to use this without the patient's or families consent. this is obserd.

There are a lot of misguided people like Pastor Paul Burleson... most ideologues lack the ability to reason... as demonstrated by our national leaders...

Mr Ross. EXCELLENT unbiased and insightful research into this clearly unknown product.I am looking forward to the full report tonight, but ethics is not the only shadow here...

You should also be aware that Northfield has NOT PUBLISHED data from a previous ANH trial, but quietly closed the trial, never published the data, and has continued to lament (without substanitive proof) that the SAE's that were NOT caused by Polyheme (10 in 81 patients had HEART ATTACKS) but were caused by something other than Polyheme (but what?). Wow, imagine that! No data that can substantiate their claim and yet FDA gives them carte blanche to a new trial?? I guess we all just believe the company, right?? When they tried to solicit a doctors explanation (Dr Norris of John Hopkins), he flatly refused, and forced NFLD to retract the press release, and therefore, to date, they have never explained the SAE's from that trial. Is it not odd that a trial can be shut down to begin a new one without the data being at least reviewed by peer review committee, especially with SERIOUS SAEs attached to it? I would surely like someone with medical expertise to get to the bottom of this aborted trial and find out the REAL reason for the SAE events. The non-consent issue is not the issue here, its the previous trial that was never reported and the fact that this protocol is based upon giving Polyheme to the patient 12 hours AFTER they arrive at the hospital, where blood (the standard of care) is available. Thats what the ethicists are reeling over, and rightly so.

A bigger pandoras box may be why the FDA is granting them each and every request, winking their approval, and supporting their cause by not stopping or revising this trial. But, I guess thats politics, huh?

What are your options? Die for sure if they don't use it, or have a chance to live by being a guinea pig? I'll take the latter.

Are you a guinea pig when you are in an accident, lose 70% of your blood, the EMT at the scene injects saline solution (the current standard of care)where statistical proof shows survival is zero? In a prior trial 7 of 10 "guinea pigs" survived on Polyheme where 10 of 10 "guinea pigs" on saline solution died. Which group of "guinea pigs" would you choose to be in?

ABC is making themselves look stupid by coming after this trial when it's all but over.

Dear Mr. Ross:

If you, your wife, or one of your children were dying as the result of an automobile accident, or if you or a member of your family were wounded in the military, would you want the best product available?, or would it not matter to you? I think there will be many people watching your report tonight that have never been seriously injuried and have actually thought about the fact that if it really happened to them what would they want the EMS to be carrying "salt water or PolyHeme" I know for fact that I would prefer the PolyHeme over salt water! Good luck with your report.

KR

Isn't interesting that Mr. Ross, an esteemed FDA watchdog and University of Iowa grad is in bed with Clueless Chuck Grassely on this issue.........

Looking forward to watching this report. I do hope that you have the integrity to report on the subject in a neutral unbiased manner. I have to question the timing of your report though, why wait until the trial is over/near over if you are going to take a negative stance on it? The guinea pig story is sooo over...did you know that blood transfusions are far from safe and were never approved by IRB's before they were tried? The polyheme trial was approved by numerous IRB's, the FDA, and experts far more qualified than you, or Chuck Grassley to make a judgement. The army is just waiting for a product like this to be able to save lives, it's unethical for people in the press like you to be so biased against a product that could be really useful for humanity.

Hopefully the "guinea pig" reference in your report teaser is merely for sensationaist audience draw. I hope the actual report is balanced and also "exposes" the dramatic potential promise of this product. The trial is essentially over with no significant drawbacks reported thus far. I would be interested in how Polyheme detractors would propose getting such a product tested and approved for trauma without a non-consent study.

Brian,

I was wondering if you were in a major accident on your way to the airport after doing this story and you were bleeding to death. Would you want the EMT's to give you saline or polyheme?

Where were you for the last two years while this trial was taking place? There are a lot of companies that have tried to make a similar product and failed misserably. There are also a lot of people who have financially bet against Northfield Laboratories never thinking the product would actually make it this far. Your timing is very suspect. I wonder who turned you on to this story?

Good god...you people need to read the information on the Northfield Labs website before you start talking about ethics. Polyheme is meant to be a "temporary" solution (not a permanant one). It is for "large volume blood loss in trauma and resultant surgical settings, with a particular focus on settings where blood is not immediately available." just to carry you over for the next few minutes till they are able to get your the REAL stuff. Also...it is NOT artificial (not 100%) it is a derivative...from REAL red blood cells. Kind of like Splenda...is made from REAL sugar. Yet no one knows this. Splenda is a better choice than the fake stuff that is all chemical based. Ehtics aside...this seems to be resonable...as long as it is not a permanent means of sustaining life...but to keep one alive till they are able to get to the facilities with the REAL stuff.

What are the 27 cities????

If I was in a major accident and bleeding to death, I wouldn't care if the blood I got was fake. I would take the PolyHeme in a heartbeat, before I lose it.

I don't understand why we just don't use cadaver blood. Studies have shown that a period of time after death a person's blood still can maintain it's properties. Russia has been doing it. Problem solved.

I agree, the artificial blood is good, BUT, it is a VIOLATION of my constitutional rights and unethical as well as downright CRIMINAL, to give it to me or anyone without thier consent....WE ARE ENTITLED TO THAT CHOICE!!!!

how do I get a braclet so this doesn't happen to me?

THIS IS SO VERY WRONG!!!! The person that it's given to should have a choice, this is not the American way!!! I HOPE THERE IS A HUGE LAW SUIT!!! WHERE ARE OUR RIGHTS?????? This should not be not in my America!!!
Sue

May I ask how many of the people responding to this blog are employees or staff involved in the study and who are being paid for thier participation? I have known doctors with the "God" syndrome, but this is over the top. If is is so good, you should have no trouble getting consent from patients that have conditions which would justify its use.

May I ask how many of the people responding to this blog are employees or staff involved in the study and who are being paid for their participation? I have known doctors with the "God" syndrome, but this is over the top. If is is so good, you should have no trouble getting consent from patients that have conditions which would justify its use.

I don't recall from your news piece that you reported that ambulances CANNOT CARRY BLOOD AND, therefore, CANNOT ADMINISTER BLOOD and than the patient has to wait until getting to a hospital before getting blood. A good blood substitute will help keep the patient alive until blood can be administered.

Okay, this is typical. You give a story that peaks my interest and say to to online to get more information and in this case, the 27 cities experimenting with fake blood. So, I resent that you don't tell the cities but go online anyway. I read all the "crap" (just not the 27 cities of interest) and, in-fact there is no list of cities. Where are they? Why tell a story like that and not follow through with the information or it is so buried, I can't find it!!

I have been on te giving end of Polyheme and the results were life saving. A gun shot victim taken to a level 1 trauma center and the result saved this mans life. I know that the study in around the city which I work full time loves Polyheme. I am lucky enough t also work outside the city and use this product. Our fire chief did not want it to be used in our city due to the fact that is was to be used on traume victims. Out fire chief is on record as saying that with the high number of shooting, mainly black on black inner city violence, that he did not want the numbers posted showing a majority of minorities recieving Polyheme. He believes that it will show the problem we face in our city today. We in the field have been asking and begging for Polyheme because we see the benifits in the county departments. This product is saving lives which otherwise would be in a pine box. Please do not stop the use of this drug because it is truely helping more than it hurts.
Jeff
Firefighter/Paramedic

What I would have liked to have seen on this are the results of the studies, the lab results and the results of the trials to date. Reporting is supposed to be non-biased and this report at first hearing freaked me out. I don't like scare tactics and this report was a scare tactic.

If this product will save lives, then I think it needs a second look. I don't like taking medications unless it is absolutely necessary, so I personally would have problems with a synthetic blood being put into my body, but in a life or death situation, I really have no say in what is being put in my body and have to trust the emergency personnel and the doctors.

What I would have liked to have seen in this report would have been whether or not the body processes PolyHeme out, how it affects the liver, the kidneys, does it carry oxygen, does it collect in any of the organs at all, is it a higher risk to some individuals versus others. Good reporting would have covered this in the broadcast as well as the online print.

Barb

Thank you for bringing this story to light. This shows just how much "Big Business Pharmaceuticals" is getting when they buy our Congress. It is unethical and, most likely, illegal, and everyone who was given this substance without signing an Informed Consent (the prerequisite to any good scientific study) should sue this laboratory out of existence. Anyone who thinks this type of infringement on your right to recieve informed consent is "OK" for the greater good is seriously ignorant.

I was curious. Was the blood substitute a replacement for blood or plasma. I doubt any ambulance has the capacity to type blood and carry an inventory of all blood types. O neg (only universal donor)is already in short supply. Is this really carried in all ambulances?

Substituting plasma versus substituting blood is a big difference.

Cindy

Once again, biased one-sided reporting and grandstanding for ratings. Did Brian Ross ever ask whether most trauma patients are capable of making an informed consent because their mental status is altered due to blood loss? Did he do any follow up to know that consent is obtained from family or the patient as soon as they hit a hospital and if they do not consent the product is stopped? Did he report that the study involving the fatalities was related to misuse by physicians in non-trauma patients in a hospital setting?
This drug has the potential for svaing countless lives replacing the standard prehospital care of diluting a person's blood with crystalloid solutions to maintain blood pressure and life to get them to hospitals only to promote probable organ failure and death. I have seen the benefits of PolyHeme on a patient who lost enough blood volume to fall into a probable mortality rate category. That person is alive and thankful for this study. Your report is doing a great disservice to the future of trauma care in the United States and in the military. Try reporting the facts and both sides of the story and let you viewers decide; but then again this is ABC.

As a retired nurse I am dissappointed at the one sided picture given of artificial blood. In an emergent situation a person's oxygen level is very low so they do not perfuse their brain correctly hence consent is invalid. Human blood can cause antibody reaction wich can only be known after comparison with donor is a real possibility and done in a hospital situation. What a shame both sides of this issue were not presented.

We are against the transfusions and want to know where we can get the blue braclets to warn them not to give it, in any case. Please tell us where we can get them.

I beleive you have gotten a good picture of how people think about this thru this forum. Advances are difficult and change is against peoples nature but progress is essential. Without "experimental" techniques and products we would never be where we are today. Transplants were considered evil voodoo at one time, so were transfusions, IV's, artificial hearts, etc, etc, etc. Yellow press is dangerous, when your in an emergency situation rules change. It is a fact. That is why EMS works with different rules than hospitals. In the field you don't have the resources you have in the hospital and outcomes can be changed if you are willing to be professionally aggressive. Besides you are basically talking about treating dead people right? Like CPR, you can't kill someone twice but you can just sit there and let it happen. How someone feel if there mother/father, husband/wife, sister/brother, CHILD needed CPR but it wasn't approved so a medic just looked at them and watched them die without any effort. Everything is new once.

Dear Mr. Ross,

THANK YOU for reporting this news. Without it my family and I would not have known about it.

With the info, we can make intelligent choices.

THANKS AGAIN, for "Reporting" and keep up the GOOD WORK.

RS.

We are against the transfusions and want to know where we can get the blue braclets to warn them not to give it, in any case. Please tell us where we can get them.

it's astounding to me the number of people that are willing to jump to the defense of a company that could be experimenting on them without their consent. has the world gone crazy? whether this product saves lives or not is beside the point. this is a product being TESTED. people, you should know when your body is being used in this way. what if the test had failed and the product turned out to be lethal? it seems to me that anyone that has received this product has been quite lucky it didn't go that way. as the test hasn't been completed yet, it doesn't seem out of the question that negative side effects could still surface.

This polyheme sounds like something I read about called HBOC (Hemoglobin based oxygen carrier) This is actually made from blood. It is hemoglobin that has been extracted from blood and then filtered to remove impurities, chemically modified, and purified mixed with a solution and packaged. So Being actually made from blood components may be objectionable to people with religious convictions against blood transfusions. This unconsented use seems to violate these individuals rights. As most carry a no blood card.

Where is the information on obtainig the non-participant bracelet?

I think the key in this study is the individuals right not to participate in this blood test. Regardless of the tentative results of the test, people have a right to decide what kind of treatment they receive. Everyone has the legal right to opt out of taking FDA approved medicine and treatment, so why shouldn't they have the same right on test treatments. And most importantly, there is a mechanism, blue wrist bands, in place to allow people to opt out. It seems that all that has to be done is publicize that fact in the test areas.

Remember the key is peoples right to make choices not someone else.

I am absolutely astounded that everyone is not outraged by this. It is taking away one of your basic rights. There have been other trials done, but they paid volunteers.

when I read the first paragraph, I looked to see if the date were 2005. The study will be done in a few days when the 720 enrollee figure is hit. This is incompetent reporting

One of American history's medical studies where informed consent was not used, the Tuskegee Syphillis Study (like this study) was a leading factor in Institutional Review Boards for research involving human subjects and protecting subjects by requiring ALL research (particularly ones involving blood)go through a rigorous IRB and using informed consent.

Where was the IRB process in this study?!? How could an IRB Review Board sign off on this study without making sure subjects in the study were allowed to make informed decisions PRIOR to the administering of the blood replacement being test!

Mr. Ross,
When asking the question "Is Polyheme safe?", you missed an opportunity to reference the four Independent Data Monitoring Committee findings to continue the trial "without modification"; the extraordinary safety procedures mandated by the FDA when administering Polyheme to trauma patients; and public testimonials of trauma patients like Hank Williams Jr's daughter who claims that Polyheme "saved her life?" I'm disappointed that you chose to ignore these facts in your story. I guess I expected better of you and your team.

I agree with others who have posted that this story did not present both sides of this issue well at all. I expect more from ABC News and was let down.

Where does the government get the right to use an experimantal anything on us without our consent? Don't we live in "The Free World"?
I have to wonder who all you people are that think this sort of thing is OK... Humm maybe you all work for the company making it? or have some stake in it. This sort of thing should only be done with our consent!

As a participant in the Red Cross Blood Program, I am glad to see this come about. Only 5% of the eligible American adults donate blood nationally. There is always a shortage and this will certainly help the blood supply across the nation. Also, think of what this will mean to the Military. Thanks to Northfield Laboratories and the FDA for moving ahead with this progra.

As a participant in the Red Cross Blood Program, I am glad to see this come about. Only 5% of the eligible American adults donate blood nationally. There is always a shortage and this will certainly help the blood supply across the nation. Also, think of what this will mean to the Military. Thanks to Northfield Laboratories and the FDA for moving ahead with this progra.

After looking at all the facts and the success stories for the so called "guniea pigs" on this blood subsititute shows that Brian Ross is the only one endangering the masses. If the blue bracelets start showing up in greater numbers Mr. Ross should bhe ashamed with himself.

Checked the opt-out contact information you provide. It is invalid. Just a deadend with a corporate address to write for information.

I have been a registered nurse for 22 years. I worked full time for 11/2yrs in an ICU and 5 1/2yrs in the emergency department of a trauma center. When faced with a patient who has endured a trauma,there is what is called a "golden hour" in which everything the team does and does not do has a tremendous impact on the final outcome, life or death. There is no doubt that a product like polyheme can be a miracle for some patients. Without question, the patients whom have received this prduct and had a "good outcome" would be the greatest spokesmen for polyheme. That aside, I beleive there is a slippery slope of medical ethics. Informed consent is absolutly impairitive in medical trials. Without informed consent, people who beleive they know more (doctors, and medical companies) will be able to do what ever they want and virtually go unchecked. I would like to know more about the trial itself. I live in Syracuse New York and from your website I found that SUNY Albany Medical Center has been suspended from the trial, why?
We cannot use people in the most vulnerable point in their lives as test subjects. Are the families of the people who were treated with polyheme and did not survive, notified of the use of polyheme? If a patient dies from their injuries sustained during a trauma, how can anyone be sure that the polyheme did not contribute to the outcome? I would like to kmow about the varialbles. Was this a true experiment that had random paticipants? Did each institution's reveiw board approve this testing? How do they bypass the informed consent ethic? Please follow up on this issue. Thank you.

I tuned in to your report on the Northfield Labs and Polyhem