Artificial Blood Experiment Hits 27 U.S. Cities

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!

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!

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

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

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

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.

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.

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

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.

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.

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

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.

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.

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”

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=
http://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.

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.

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.

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?

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?

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

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.

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?

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.

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 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!!!!

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 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.

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!!

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

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

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.

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.

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.

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.

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.

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

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.

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.

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

I tuned in to your report on the Northfield Labs and Polyheme news broadcast this evening and was reminded why I watch CNN instead of network news. Your biased, negative, sensationalized report failed to disclose:
1. That Northfield complied meticulously with FDA regulations in meeting the requirements for community consultation for a non-consent trial.
2. That the 10 MIs in the ANH trial sited in your story were considered by experts (FDA) as probably related to fluid overload and poor trial design and not to the use of Polyheme.
3. That there have been 4 independent safety monitoring looks at designated points in the current trial that identified NO SAFETY ISSUES – the trial could continue without modification. While I certainly agree that there could be improvements in the procedures for testing new therapies in situations where obtaining informed consent from potential subjects is difficult or impossible, I am deeply disturbed by your lack of fairness in reporting. I will NOT be watching the 20/20 edition of the story tonight. I will NOT be watching ABC news in the future.

THE BELMONT REPORT
ETHICAL PRINCIPLES AND GUIDELINES FOR THE PROTECTION OF HUMAN SUBJECTS OF RESEARCH
1. Respect for Persons. — Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.
An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation. To respect autonomy is to give weight to autonomous persons’ considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an autonomous agent is to repudiate that person’s considered judgments, to deny an individual the freedom to act on those considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling reasons to do so.
However, not every human being is capable of self-determination. The capacity for self-determination matures during an individual’s life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated.
Some persons are in need of extensive protection, even to the point of excluding them from activities which may harm them; other persons require little protection beyond making sure they undertake activities freely and with awareness of possible adverse consequence. The extent of protection afforded should depend upon the risk of harm and the likelihood of benefit. The judgment that any individual lacks autonomy should be periodically reevaluated and will vary in different situations.
In most cases of research involving human subjects, respect for persons demands that subjects enter into the research voluntarily and with adequate information. In some situations, however, application of the principle is not obvious. The involvement of prisoners as subjects of research provides an instructive example. On the one hand, it would seem that the principle of respect for persons requires that prisoners not be deprived of the opportunity to volunteer for research. On the other hand, under prison conditions they may be subtly coerced or unduly influenced to engage in research activities for which they would not otherwise volunteer. Respect for persons would then dictate that prisoners be protected. Whether to allow prisoners to “volunteer” or to “protect” them presents a dilemma. Respecting persons, in most hard cases, is often a matter of balancing competing claims urged by the principle of respect itself.

Can anyone please independently verify the “no informed consent”? Relying on an unsourced blog/’news’ item to ask a rhetorical “which would you rather be” question is pointless either way. As far as “so-and-so was saved by it” and other anecdotals, one can also find 4 Jehovah’s Witnesses that will argue that they were saved by prayer and NO transfusion. Let’s be objective and use facts. FDA has rushed bad products like aspartame on the public with no regard to side effects in the recent past.
As Don Best mentioned above, most regions of the US have a ONE to THREE day supply of whole blood. How many of you opposing PolyHeme donate? The vast majority of donations in the US come from type O donors over age 50. If you don’t want PolyHeme, you better figure out a better alternative, or come up with an injury and illness free planet.
If Northfield wants live test subjects, I’d gladly try 1 unit, because from what I have read, I believe it is safe. But nothing, no matter how swell, merits non-consensual testing IF proven treatment is available. Let’s validate the veracity of the no informed consent part before rushing to judgement.

This is another case of BS. I can’t believe the FDA gave approval for any private medical company to administer ANYTHING to me, without my permission. But what the crap, this happens daily in almost every facet of American’s lives. We don’t get a say in anything anymore, because somebody is crossing some polititions hand with money. Just look at the fraudelent gasoline prices.
Why don’t the brain dead lemmings making all these positive statments volunteer to be the guina pigs for this company, and save the rest of us from another case of malpractice. The medical industry in this nation is an abortion. You have to pay $300. a month for hospitilazation insurance, then at least $100. in co-pays every time you go near a doctors office. Then you are seen by a P.A. who isn’t even a doctor. I should go down and apply for the job. I can do as much as most of them with my experience as a parent for 40 years.
When I get through writing my worthless senators, congressman, and the Nazi FDA, I will at least make sure they understand my contempt for letting anyone put anything in me without my knowledge, nor consent. How is this much different from RAPE!!~!
I am surrounded my brainless, dumbies daily with their cellphones stuck in their ears, and their brains sticking out of their ears.
All these people approving this atrosity are just a perfect examples!

Thanks for the stock tip. Northfield Labs symbol NFLD will make billions of dollars with this amazing new product.

do you think that the doctors who are giving this stuff out would use this product?

While we believe that the potential for life saving is incrediable, we are without respect hat this can be given without consent of the victim or a member of the victims family.With given consent, you are honoring free agency, with out it, you are invoking your beliefs, medical and scientific upon others. Draw a line, choose which side of the fence you will be on, and stay there.

When is the “government” going to stop running roughshod over our rights. I am an adult human being and I (or those designated to speak on my behalf) can make informed decisions about using Polyheme or not. Not giving me the opportunity to consent or deny is DISGRACING my humanity. Quite a thing from such “morally righteous” government leaders.

For example, if you live in, next to, or travel through a state participating in the PolyHeme Study – California, Colorado, Delaware, Georgia, Illinois, Indiana, Kansas, Kentucky, Michigan, Minnesota, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Utah, and Virginia – and you suffer a traumatic injury and receive emergency medical treatment at a participating trauma center in that state, you may, without your consent, become a human research subject for an experimental blood product (if other contingencies are also met). That is, unless you happen to be wearing a light-blue wristband imprinted with the following: “I decline the Northfield PolyHeme
Study” . I suspect many people, if they knew this, might reasonably ask,“where do I get my wristband?”
It also comes as no surprise that this question is not a readily answerable one. Certainly, it’s not apparent from any information on the FDA’s website. Nonetheless, an unknown number of community meetings were reportedly held in the participating states. At these meetings, anyone who knew of and took time to attend a meeting could opt out of the PolyHeme Study by requesting – and wearing continuously for an undetermined period of time – one of these light-blue wristbands. However, I am skeptical that any participating medical centers managed to conduct effective, practical outreach to the
community and to provide a meaningful, informative warning to the public about the PolyHeme Study. Researchers in at least one state (Oregon) suspended participation in the PolyHeme Study when it was unable to obtain local approval because the community meetings were sparsely attended.

I am astounded that so many are happy to allow a pharmaceutical company to make money from their bodies, without recompense, without permission. If this is such a great product, why not try it on elective surgery patients, who have all their faculties and plenty of time to make a decision? I suspect the reason is that the relative risk is too great in that group to justify use of an experimental product.
The pharm company is trying to pull a fast one, and our watchdog, the FDA, is looking the other way. The goal of Northfield is to make money; will they and their investors share their profits in perpetuity to the families of all those who unwittingly participated in this experiment? Remember, it was big pharm that wrote its own sweetheart Medicare prescription drug plan. I would be interested to know the political donation record of Northfield and its officers and investors.
I have to hand it to Northfield, though, they have done their PR work to a “T” to have convinced so many that the unsubstantiated stories of 4 people (who may or may not have been paid for their testimonials) in a national newspaper (not a scholarly, peer-reviewed journal) have convinced so many to relinquish their rights to privacy and their rights to the current standard of care.

How will we make medical advances if we don’t have trials like this? The patients can’t give consent–they aren’t conscious. By carefully designing the protocol, the FDA is taking a calculated risk that a major break through is made. They do interim looks at the data to check if the trial is harming people and cut if off it is. Eliminating this method of testing will impact the ability to advance medicine.
As for making investors rich, it has taken over a decade and $145 Million to develop and test this product, and it is still in the process. The real story is the staggering cost to develop a drug and how to streamline the FDA process so we can encourage more innovation. How many companies are willing to make a $145 Million dollar bet? Those that do, and succeed should be rewarded. If we don’t know new drugs will be created.

It should be my decision if I want to participate in an experiment, to take the choice out of my hands should be against the law . What country is this anyway? I anticipate lawsuits in the future.

Wow! This sounds like Tobacco Companies all over again. The government knowingly has given permission to companies to test people and kill without any repercussions.

this is absolutly ridiculous. why would we try to come up with a replacement for blood when we have real blood. the makers of this product must realize they are dealing with peoples lives.

How many doctors would allow their family members to be used in this study? I like the idea hospitals are opting out of the study. The big story here is that the FDA and other govt dept are in the pockets of the drug companies. Watch the key FDA govt officals take lucrative jobs at these same drug companies once they leave office!

I Think if your for the study you should have to where a wrist band other than inconveincing The Person that doesn’t want to be a human guinea pig Im just a kid so don’t belittle me because of my spelling

There are several steps to authorize a Drug or medical product by FDA. And I think they have regulations to test such materials in Human subjects. The way they doing the sudy is a violation of Human rights. I hope the appropriate authority would take tough action in this particular matter.

This is my first time hearing of this experiment. I’m glad 20/20 opened my eyes to such an unethical experiment.

I thought these types of blind “experiments” were stopped years ago? Simply…What happen to personal choice in this country?

OH NO THEY WON’T!!!! WHAT GIVES THE FDA THE RIGHT TO MAKE DECISIONS ON MY BODY!!!! THAT IS MY DECISION AND MY DECISION ALONE, OR MY FAMILIES. HOW DARE THEY???? SOMEONE NEEDS TO STEP IN AND GET VOLUNTEERS NOT UNWILLING VOLUNTEERS!!! NOT ME I WANT A BRACELET NOW!!!

It is disgusting that the FDA is in bed with yet another private pharmaceutical interest. None of us are safe when the profit motive eclipses the public’s sacred right to choice. There should be a requirement to “opt in” to this experiment, not opt out.

The point is why such secrecy? Simply inform people. The fact that you’re not informed or cannot opt out
once at the hospital and be given blood is crazy. How much were all the participating hospitals compensated for participating in the study?

Which cities are participating?

I’m surprised this passed IRB, but not surprised the FDA passed this. They pass items that can make billions, yet claim natural remedies are unsafe.
For those saying that no-consent trials are effective, if you ever took training on IRB and those studies, you’ll know that US citizens were unknowingly injected with syphillis!!! Come home and explain THAT to your spouse.

Chemicals in our food, chemicals in our hair products, chemicals in body products, chemicals in medications, and now chemicals IN the body, posing as blood?
NO WAY! This fake blood cannot be healthy. This chemical blood cannot be good for people and other living things. I am appalled of what the world is coming to. What would prompt people to use it? Hospitals must be getting paid for this “experiment”. This is highly unethical in my humble opinion.
If this is the future of our world, let me off!

I am a critical care trauma nurse.
From time to time, we have a shortage of blood, or we cannot get blood in time, even when it’s stocked in our hospital blood bank. I have seen countless patients die because of this. I believe this product has excellent potential.
However, the manner in which they are conducting this experiment is completely unethical and it astonishes me that it is allowed. There are plenty of patients who undergo routine surgery who require massive blood transfusions post-operatively who could be consented for use of polyheme in advance. If polyheme then became standard medical treatment, it would be acceptable as a replacement for donor blood to give emergently without consent.
I personally would not administer this product without seeing a consent form for it. It’s unethical and goes against the oath I took when I became a registered nurse.

I would just like to read where this is happening. Let me decide what goes into my body. Thank you for bringing this to my families attention!

This is an outrage patients should be advised of this information, what gives our government the right to do this to American citizens without our knowledge. This is experimental blood treatment and we should be given a choice, what can we do as citizens of the United States to stop this practice ????

are you out of your mind! no way are putting that fake blood in me

Once again the medical community, with its superior “we know whats good for you” attitude, decides that they are allowed to make decisions on behalf of the rest of us. With patient consent necessary for a simple flu shot, it seems very out of place to say “you don’t know better” for something as experimental as Polyheme, and that may potentially have life threatening side effects.

It is not right for americans to not know that they are being used as guinea pigs. we live in a free nation and we have the right to decide what we want in our bodies, no matter is the stuff is lifesaving or not, we should all have a choice!!

This can’t be the United States that we’re talking about. I don’t want to visit the wrong city and wind up in an experiment. This is criminal. Speaking of criminals … I’ll bet the government wouldn’t the product on criminals without their consent. Might violate their constitutional rights.

I’m surprised at the number of comments from either terribly trusting or naieve respondents who would rather ‘kill the messenger’ than think about the report. Thank you for bringing up the subject!

I am personally shocked, I have never heard of this study nor have I ever heard of the bracelet that must be worn in order not to become an instant victim of a study that may very well affect the rest of your life. I think it would rest much better with the public to wear the bracelet if you consent to be a part of this type of experiment. The FDA has gone way too far this time. I certainly hope this is not the end of the reporting on the subject. Please allow the American public to use their own common sense not that of the cowards hiding behind the glass doors who refuse to be interviewed, that in itself is suspicious. If the product is such a wonderful invention why not place it on the table with all the great review memtioned in prior comments. I for one do not want it and would like to get a web address for Northfield Industries to obtain a bracelet for me and my family.

It’s my body and I should have a choice at what goes in my body. Anybody who can not understand that should move to Cuba or Saudi Arabia Where the government makes your choices for you and base their decisions on gender and social class.
What the hell happened to this country? How did we become so shallow about our liberties?

It is pretty funny….When you go to the Northfield Labs site to see how to order a bracelet to decline to participate in the study, the contact us address is investor_relations@northfieldlabs.com…Makes me wonder what this is really all about…BTW, nothing on the site about the bracelet…

Two equally good and bad sides to this…just makes one to wonder, what OTHER trials have been performed upon people without their knowledge…funny how AIDS and other strange diseases showed up out of thin air, ya think???….we are, after all, humans with morals and obligations to one another…
On the other hand, if it’s truly a blessing, so be it…but it’s kinda rude in the way they need to find out….especially if it’s out of pure greed and recognition for power and prestige…no life is worth playing with, to make someone king of the mountain…or to fill their pockets…

That so many of the people commenting here think it is ok for a company to experiment on a person without his permission because it supposedly suits the common good is a sad comment on the fascist depths to which this country has sunk.

Hmm, Loyola, Wishard, Methodist, UCSD, Christiana, Denver Health, MetroHealth in Cleveland and the MAYO CLINIC! So, if 20/20 is to be believed, the institutional review boards of many of the nation’s most prestigious trauma centers have been hoodwinked. Come on!?! Face facts, in order for this lifesaving product to reach the market, it has to be tested in the manner it will be used. Not on elective patients, administered by doctors, but on the street, given by paramedics and flight nurses. That is how science works. And before you rant against one company, realize that AEDs, transport ventilators, portable CPAP machines, etc. have all been tested this way. It happens, and is part of the advances of science, this was a slam piece, done for ratings, pure and simple. It is the last episode of 20/20 I will ever watch. You simply cannot be trusted.

It is amazing that the FDA and Labratories think they can choose to experiment on people. If someone wants to be used in experiments, then it should be indicated on their driver’s license. If they need permission to allow our bodies to be used for organ transplants, shouldn’t they do the same with experiments? There are moral and spiritual issues involved with many people. I think the FDA needs to re-evaluate who is really important in this country. The American people rely on them to keep us safe and protect thier rights. Thank you for bringing this issue to my attention.

I think this is crap as well. I work in the medical field and if the doctor I work for didn’t ask the patient for consent, that is a law suit waiting to happen. That’s like telling a patient you the doctor are going to preform a colonoscopy and then the doctor removes you colon instead. I think this is morally and ethically wrong.

If some one were to give me blood or a blood product that would be inviolation of my belief. No one and I mean no one has the right to force any treatment into someone that would violate that persons right as ahuman being. Not the FDA or any government office. Anyone who agrees to this non consent issue should have their rights taken away from what ever they want and see if they like it. Some how I think those people with the convoluted thought that it is for the betterment of peoples lives should have their head examined. This is about money and doing what another pharaceutical company wants to do.

I don’t care about the stories people are using claiming that Polyheme saved lives. Or, that polyheme worked better than saline would have in a certain situation.
What you people should be concerned about is that the federal government legalized this test without the citizens consent and before the substitute was labed “safe.” I think there is something wrong in this nation when the people have no say, especially if you are conscience.
Many of you are ignoring the fact that the test was unethical and are just focusing on studies where it did work. Like many people in this nation, just go about your lives and let others decide everything for you. Let them tell you what is best before you stop to think yourselves.
I can’t believe people don’t care that they don’t have a say about what goes ito their own bodies. It’s scary that people just accept so willingly.

Does anyone remember the Tuskegee Experiment from 1932-1972? If the Polyheme trial is successful, GREAT! I deserve the right to decide if I’m able, as to whether I want to recieve it.

I haven’t heard of this use before the broadcast. There obviously has to be testing to prove a product, but I want to know before hand if I am a study patient. My biggest gripe is that there are coprorations and people that make a conciderable amount of money from this, so the “guinee pigs” should be compensated in some way for participating in a study.
http://www.nittanypages.com

There are some important facts that I think are being left out of the discussion.
First, Polyheme was tested extensively in a surgical setting to determine its safety and efficacy before the field trial began.
Second, The study complies with FDA rules and policies regarding informed consent that have been in place for many years. This is not a new process.
Third, as a Paramedic, I can tell you that the situations in which Polyheme would be most effective make it nearly impossible to obtain “informed” consent prior to administration for all patients.
Fourth, I have seen the enrollment criteria for the Polyheme study. The study is very carefully controlled, and there are VERY specific inclusion criteria. This is not something that would be administered to people in a minor car wreck. To be a study candidate, you have to have injuries that would probably otherwise prove fatal.
Fifth, Polyheme is not entirely synthetic. It is derived from human hemoglobin, that neat little stuff in your blood cells that carries oxygen through your body.
I am so sick of the bias presented by the “news” organizations. Instead of focusing on what you interpret as a negative, report the whole story. Talk about the lives that have been and will be saved by this and other products yet to be developed.
And to all those who would “rather die that have that stuff pumped in me” – I’d be interested to see what you’d really say if you were the one bleeding to death.

I tried to find all the cities using the artificial blood, but the link doesn’t work. Could you give me the list of the cities?
Thank you,
Zong Hou

If I’m in a serious accident and need blood I hope this stuff is kosher. Actually, just smear my face with Crisco or Bacon greases and throw me out of the window.
Thank you.

The issue is not that it saves lives, but notification and consent. A slippery slope is created by NOT telling people they are part of an experiment and that they have no choice (when possible). The real issue is not how great Polyheme is, but who has the right to decide. Without certian rights as a patient, or even the right to say what happens to your body, well we are back to Dr. Mengele and someone else deciding. Good luck when it is happening to you.

I am a person against stem cell research. I don’t believe I organ transplants or taking their organs when they die. I believe in God, eat healthy, and would be appalled to find out that any foreign substance was put into me without my consent. I am most concerned, with the fact that the TV news media, did not get this story out to the public, a year ago, when they can overplay silly celebrity divorces and nonsensical political posturing on a moments notice.

FWIW …to all you folks wanting to get you blue braclets…you have a better chance of winning the Mega lottery than being enrolled in this phase 3 clinical trial.Among the many facts reporter forgot to mention was that the trial had 700 patients out of 720 enrolled as of mid June and most likely finished by the time the story aired.

As a stroke survivor I take Coumadin and have blood tested monthly. I am concerned w/the long term effects of this drug. Now I have to worry about this. I was treated at a prominent University hospital and suspect they would be part of such experiments.

Where might one obtain the blue braclett?

The issue is not that it saves lives, but notification and consent. A slippery slope is created by NOT telling people they are part of an experiment and that they have no choice (when possible). The real issue is not how great Polyheme is, but who has the right to decide. Without certian rights as a patient, or even the right to say what happens to your body, well we are back to Dr. Mengele and someone else deciding. Good luck when it is happening to you.

Here’s the Bottom line…If it’s in an experimental stage, it should be an option to those who want to recieve it….You should have to obtain the bracelet to recieve the experimental blood. It’s not an option, if you learn about it after the fact.

I live in Chicago and none of my friends had ever heard of this even though Loyola uses Polyheme and the company is located in nearby Evanston. Also there needs to be an easier way to get the bracelet because Northfield’s website only provides contact info for Investors!

This is bull crap. Human guinea pigs that have no say, no choice, and most likely no foreknowledge in a clinical trial of a chemist’s creation happening in North America, Sad!
What is worse, after being advised of the clinical trial (on ABC’s 20/20), I scoured the internet looking to order the blue armbands required to be worn to be exempt from the clinical trial. Guess what, they are not available! I cannot find any website including Northfield’s that provide any info on how to obtain the required armband…
Guess Norfield and the FDA assume that everyone in the United States and everyone that may be flown in from Canadian boarder cities and all visitors in the US want to be a guinea pig and play Russian Roulette should they be in need of blood and are incapacitated…

We are a free country and we fight for our freedom….polyheme may be a miracle or not..but if people can have adverse reactions to it..should we not be able to decide if we want this in our body. Have my medical rights been taken from me? Why bother asking me if I want to be a organ donor or not…why ask me if I want to be put on life support or not? I have rights whether this fake blood is a miracle or not! Should I not be able to decide on this as well…..Hello America!!!We should fight for the right to decide and keep our freedom..not the govt. or FDA..thank you

It looks like this company and their paid, arrogant doctor instructed everyone to post pro polyheme comments

The point is “choice” , we are in the US, right???

Well we have pointed out that it is life saving but the cost of giving up your rights. You have to go to this place and get a braclet to say no 24/7. The advancement of medical science is great but they even have to have regulations and protocals that the FDA have just swept aside. How much do these people, who created this Polyheme, and the FDA stand to make. How much of your rights are you going to give up to people like this. It shows that people really do anything to live.

There are only two possibilities in an ambulance; Polyheme or saline. Saline can’t carry oxygen needed to keep the brain aiive. Polyheme can. Let’s see now, body or brain AND body, body or brain AND body. Still can’t decide? Need another review? 20/20 failed to mention these options.

Wow, you sure got a blasting here for
trying to warn the public about something they might want to know.
Just like things today, no one wants anyone to tell the truth.
I thank you for letting us know so we can make up our own minds.
That Denver doctor looked like a deer caught in headlights.
I’d like to know if he would let them give that stuff to his family.
He might be the type that really cares but he sure didn’t give that impression. How much money has changed hands on this deal?
I am not saying I know if he’s a caring guy or not and I am not saying whether the product is ok, just thanks for letting people know. Knowledge is power, not poison.

How about ASKING people if they WANT to participate by wearing a blue band that says “I AGREE TO PARTICIPATE IN THE POLYHEME EXPERIMENT”. As the government slowly takes our rights away one by one and hand them over to private corporations at the very least our bodies should be off limits. I think the members of the three branches of government should be the guinea pigs for this experiment and any other bright ideas they come up with.

It is true that there is always a different side to every story. Though PolyHeme may have its advantages, it is also true that the way the study is conducted is unethical. Patients should be allowed a choice to choose between real blood and the PolyHeme solution. It is beneficial for everyone to be informed about studies like PolyHeme, and I believe that 20/20′s report should only be the first step to our understanding of this new product. Do not condemn 20/20 for bringing up a controversial case study. Research for yourselves if you feel that this report is lacking in information. It is the viewer’s choice to believe or reject what he hears.

so… where is the list of 27 cities you spoke of???

sure are a lot of supporters for this product and im sure it has good intentions. But as a disabled vet and guinie pig I say where is my money ucsf for testing those meds for you? Your drug companies sold you a terd in a box on a daily basis without question and you gave it out and people died or became permanatly disabled. Whats the dogs bullocks you renig on the vets testing monies. How do you tell if a rat is seeing blue? I thought they had poor eyesight. Well this rat sees red at the immorality. If these drugs are a benifit then why dont doctors take them. how much money is spent on that bonner commercial that plays twice in a row 80 friggen times a day? you wore out the subliminal desired effect. You are so 1870s. love my viagra pen, but it wont help you in ethicsland- Mr. logistic

Where is the list of the 27 cities… did I miss something…?

what you are doing is very wrong. You are the antichrist northfield labs. America should not be this way.. not giving us the right to choose wether we want your fake blood or not. No one can make blood but god. and it should stay that way

Wow, I was totally in shock after seeing this story! This blood substitute does sound as if it has promise and could potentially save lives, HOWEVER- the key here is that unsuspecting patients are part of an on-going trial without their consent. People should have the right to choose to paricipate in a trial or NOT!As we all know from new treatments in the past, some are beneficial and some are found to be dangerous at a later date. How could the FDA, who was created to protect the public, so easily put patients’ rights aside for this company to test their product. THis is a case of greed once again rearing its ugly head in drug companies. It sounds as if the greatest motivation for this company is making this standard for emergency treatment, and making millions of dollars with the unsuspecting AMerican as the guinea pig. Will those who have been experimented on be rewarded for their bravery in using this new product, that may have adverse affects? I think not. This company is only looking at the bottom line and we Americans are just lab rats to them. Who is the FDA helping?
I guess it’s the drug companies!

Suppose you are in an accident and bleeding to death at the accident site. Here are your choices….. You make your own decision. 1) Without blood you will die before you get to the hospital where you can be typed and crossmatched (note: A full crossmatch procedure takes about 45 minutes to complete) and receive a normal transfusion. 2) You can receive a good revolutionary experimental blood product that may save your life. 3) You can receive a bad revolutionary experimental blood product that does not save your life.
Personally, I am going to go with number 2. Too bad salt water in your blood can’t carry oxygen. Who do I contact to get the bracelet that tells the EMTs save my life with Polyheme?
Brian Ross’s story is not if Polyheme is a good medical treatment. The story is that people do not have the choice. Looking at all the responses here, I can see that this was a good story. I would have liked to see Mr. Ross present it a little more fairly.
One last point, if you are bleeding to death and unconscious, how can you give your consent to any kind of medical treatment whether it is polyheme or saline? If you were a Christian Scientist, wouldn’t any medical treatment be against your wishes and a “VIOLATION” of your constitutional rights?

Dr. Mengele no doubt had an appealing rational for his experiments on humans, too. Too many people in this country are driven by fear, hence the appeal to “do whatever you want, just save my life.” That’s the mentality of slaves and cowards. Where are the brave and spirited Americans of days gone by who would die rather than give control of their bodies over to others? How low we have stooped from the example of the brave people who have fought for our civil liberties.

This Polyheme Study is hardly a model of scientific research. Doesn’t anyone remember the Tuskegee Study that took place during the great depression?
Take your blinders off folks,if we don’t put a stop to this type of research, what’s next!

After watching the 20/20 piece on PolyHeme I have three questions for ABC.
First were the quotes from Senator Grassley taken before or after his meeting with Dr. Gould, Dr Moore and the FDA? As it seems Senator Grassley has been silent on this issue of people unwittingly becoming guinea pigs since then. Perhaps he got a satisfactory answer out of the FDA or one the doctors at the time that resolved his concerns.
Second why didn’t ABC have their health expert Dr Tim Johnson do this piece? One would think he might better understand the science behind PolyHeme and have been able to produce a more balanced report on it.
Third, as for interviewing families effected it was nice to see the Silkworth family involved, but was any consideration given to interviewing Hank Williams who does the introduciton to ABCs Monday Football and or his daughter Hilliary who attributes her survival to God and PolyHeme?
Regards,
Bob
Disclsosure I am investor who owns some NFLD stock

This is a disgrace and totally and completely UNETHICAL!! I feel that we must not let some crazy Hitler scientist control our lives and be subject to becoming lab rats! What an EVIL, dark and twisted thing to do!! Nothing good will come out of this. I cannot believe the idiots who support such studies..and give up their rights as HUMANS. …all for money. It disgusts me! The Hitler doctor (Dr. Earnest Moore) is EVIL and could not even answer major health risks/questions concerning the FAKE BLOOD> WAKE UP AMERICA!!

name the 27 cities

I was shocked when I saw the broadcast of the artificial blood on Primetime. I am even more shocked that we can be in an experiment without our consent or knowledge. The FDA needs restructuring so maybe the department will be solely interested in the welfare of those it is supposed to be working for and not for themselves and these big drug companies. It’s bad enough that animals are used in research. Now we have to wonder if we are being used or not also.
Unbelievable!!
CJ
Nashville

It appears that the actual issue of unsuspecting and non consenting is getting lost in what appears to be the polyheme folks up all hours of the night writing the pro polyheme comments..this is really scary when the pharmaceutical companies are overriding personal rights, its the creepiest part of sci fi…wake up America and make some choices instead of having them made for you!

I’m glad to see that there is something out there to help trama patients make it to a place to receive care. But the fact is that a substance that is not fully tested should nor be given to a person with out there consent. If they are not able to make a decision then fine (you do cpr on an unconsious person but a consious one you have to get permission). From the report not all persons in the cities knew about it and could not make an informed desision. I hpoe this really does save lives, I also hope we don’t find out later that it causes more harm. Bottom line you should not be testing on a person with out informed consent. The FDA knows this.

I think its wrong & its great everyone is being informed about this. But why are hospitalss not being sued because of this? And where can we get the bands to protect ourselves from these people?

What everyone is really challenging is not how effective polyheme may or may not be rather whether unsuspecting people should be used a guinea pigs without their knowledge or consent!

More information should be reported by ABC and Northfield…
Publish data from the previous ANH trial, report the number of persons in the study, the number of adverse reactions (from skin rashes to death), the number of successful treatments, and any long term complications from the use of polyheme. (Note: It’s a great wonder to save a life, but long term quality of life is a consideration, too. Preferrably, long term complications from any medication or treatment should be shown in RATS, rather than in humans.) Facts from a longitudinal study would be helpful. Northfield needs to state who was on the Independent Data Monitoring Committee, their credentials, and whether they have any affiliation with Northfield (Were they paid? If so, by whom? Do they have family members who work for Northfield? Do they, or someone related to them, own stock in Northfield?) I would also request from Northfield, populations, incomes, gender, race, etc. for the cities that were chosen as a pilot for polyheme.
Regarding the response, “350 patients received polyheme with no significant adverse effects” (DEFINE this, please…Out of how many people? What do you consider significant? STATE YOUR SOURCE so that I may research it on my own.)…another response stated, “…consent wasn’t given to use a defribrilator, either, but they have saved many lives.” A defribrilator isn’t something that is processed through all the cells and organ systems in a human body without public knowledge of long-term effects.
As Kent Lee stated in his response, “experimental vs approved substances require approval and informed consent.” I also agree with Zee, “If this is such a great product, why not try it on elective surgery patients, who have all their faculties and plenty of time to make a decision.” It appears unethical.
My request of ABC and Northfield is, “Show me the facts, all the information, and then let me decide what is best for me and my family.”
CW

What of us who refuse all forms of blood for religious reasons? I am one who prefers to obey God’s law (Acts 15:28-29), even if it means my life. Just as a cancer patient has the right to refuse chemotherapy or radiation, so all humans should have the right to decide to accept or refuse medical treatment. That right is taken away in this circumstance. In medicine, there is rarely, if ever, a “magic bullet”. These red blood cells are treated with chemicals to purify them. Like we need more of those coursing through our veins. PlUS, Polyheme does not have the ability to coagulate. Isn’t that a major function of the blood that is active during trauma?

I was totaly against this at first but when I really thought about it, it seems to be a matter of certain death v.s. possible death. If you choose the certain death, then go get a bracelet. Good luck.

how would I be able to receive a blue bracelet.

I am dismayed by how many people are for this type of thing. I am not opposed to test trials but am VERY opposed to our own people allowing human testing without consent. Where are our freedoms in this? Are we not supposed to be a free country? This is communistic at its best! The fact that people aren’t outraged just shows how douped America is and how close to loosing our few remaining freedoms. We may as well roll over and give big brother permission to rule our lives!!!!!!! GOD Help us All!!!!!!!!!

We do not know what the long term effects are for people subjected to polyheme and personally I would absolutely NOT want to be part of this study.
Certainly it is great that Hank William’s daughter’s life was saved, but REAL BLOOD would have saved her too! And we don’t know that polyheme will not have bad consequences for her and others down the road.
Under no circumstances should people be part of this study without their concent.
It seems that most of the medical profession has forgotten about “First do no harm.”

At issue here is the fact that regular citizens can be forced to participate in trials without their permission. The question now is why was the american public’s rights violated? There are many cancer treatments that have displayed promise in the treatment of advanced stages of cancer. Should we then give the treatment to any advanced stage cancer patient if they fit the profile? Where does it end? Any company that claims that preliminary research shows that it can save lives, do we allow them to test on us? I just have to say that the FDA is a waste of time because from my experience working for one of these companies is that they have stretigically placed several high ranking politicians on a “political advisory board” and pay them HUGE salaries while this board never meets or meets sporadically to pretend that they actually did something. When they need to call in favors do you think that these politicians will say no? Food for though. How many other studies are being conducted on the public without our knowledge?

No one has the right to give anything to them without their consent. If you don’t believe this, then ask all those in Prisons for giving drugs to others. Some died because of being a “trial victim” without giving consent. The makers, givers etc. should be taken to court and treated as guilty as the drug addict who gave a something to another without their permission. What’s next? Where does it stop? For all those that think this is fine, well the idea is…but the fact that you are being denied your rights is NOT!

The biggest point is that people don’t really know they are going to be used for the experiment. The company was supposed to let people know in the cities conducting the experiment, but that stipulation seems like it has not been fulfilled. I’m truly glad they created Polyheme and I hope it works as it is supposed, but they need to have consenting patients. This isn’t an issue of life or death, this is about ethical decisions.

I’d be very interested in knowing: did your reporter FOLLOW THE MONEY on this?
Does anyone in the FDA hold large amounts of stock in Northfield?
Former FDA commissioner Lester Crawford is already under criminal investigation by a federal grand jury for alleged financial improprieties (including the sale of shares in companies regulated by the FDA). Did he (or anyone else in the FDA) hold a position in Northfield, by which they would stand to profit as a result of approving this “study” of Northfield’s product?
I see no reason why Northfield’s product cannot be tested ONLY in those emergencies where there is a family member present who can give informed consent.
Yes, it would slow down approvals. But so what. It would protect my rights. Like others, I do not want the FDA (or anyone else) using me or my family in clinical trials without my knowledge or consent.
PLEASE, ABC: FOLLOW THE MONEY ON THIS, AND REPORT WHAT YOU FIND!

This product may very well have lifesaving advantages, and it could very well be the best thing since sliced bread, but to experiment on patients without their permission, or not to even give patients the benefit of a warning of its use is simply WRONG! And, wearing the wristband as an indication of an individual’s desire not to participate in the experiment is beyond DUMB.

how do i get this rist band? do you know if they are going to be doing this in orange county, california?
thank you

I don’t care how great something may or may not be, DO NOT take away my right to say NO to something that goes into my body! It is a clear violation of my right as a free American. There are plenty of people who don’t mind being a test subject. I think America is all about freedom. I for one do not wish to be a forced test subject.I am not a lab rat and do not wish to be treated like one! I am a human being, give me the chance to say yes or no. That is my right in this great country. Keep America free.

This may or may not turn out to be a “breakthrough” product. Only time will tell. However, the apparent simplicity in explaining the IRB/consent process for an experiment such as this is simply poor reporting.

I want to thank Brian Ross & 20/20 if it wasn’t for these news shows we would be unaware of such BS. What’s next? We are suppose to be the land of the free. Don’t you all see how slowly are rights are being taken away. No one has mentioned the 10 heart attacks, 2 of them died from polyheme. If i’m gonna be a lab rat I want to get paid! Keep up the good reporting 20/20!

if i receive this product can i still be a blood donor?

Hmm… From someone who has read these comments but would still ask more questions… it would be me.
What goes in to the body does not defile the body. But what comes out of the body… that defiles the body.
Once Polyneme is introduced in to the body…
Will it always be in your body ?
Can you have a transfusion to remove it later ?
Can you donate or give give Blood if hospitals ask for donations ?
Just a little thought to pass on to your readers.

I strongly protest. Whether or not it is a good product, ALL experiments/studies should be participated ONLY under full consent, NOT THE LACK OF DENIAL. This seems to go against all ethics and standards.

If it’s not certified organic, then dont’ put it in my veins. That goes for genetically engineered too, forget it!!
If God meant for me to die, then let me go, thank you very much……

The only part I really object to in this is lack of clarification as to the conditions regarding it’s use. It should only be used without consent if conventional methods have low odds of saving a life. Of course rigorous lab testing prior to use in the field is 100% required. I do have to agree with some of the above statements that describe this article as one sided.

The point is not the design, concept, or type of artificial blood being designed.. the point was the “seemingly” lack of concern about an individuals rights as to wither or not they wanted the treatment in the first place..
Doctors are less an issue as is the politics involved and the human rights to choose what is best “for them” regardless of others input..
I am not saying that rules should be grossly ignored (such as walking up and shooting someone for no reason but the shooters own) I am saying that if a person wants to live, it should be their choice and their choice alone, or if they are completely incapacitated, then a member of family or close friend should be consulted.. would the family or friend have the best interest of the person in question at heart? .. that’s a question with an infinite “no answer” assigned to it (and you know this on some base level)
No the point is the rights of the individual versus the “assumed’ action the individual would normally want to have happen to them.. Giving examples where it has saved lives is never grounds for a reason to ignore the rights of the “individual” and that is why we have a bill of rights in the first place and a constitution.. both work together (or are supposed to) to insure that a group of people (community or nation) does not have absolute or controlling power over the rights of an individual nor can an individual have absolute controlling rights over the community or nation as they cover “both sides” of the double edge sword of freedom (regardless of circumstances)
To point out that is saves many lives or not is never a reason to justify the means.. I personally would rather have a choice in the matter right up to my last breath taken rather then have it removed from my possession by a group or nation of “good intention minded” people. as it has been said. “The road to hell is paved with good intentions”, [while the path to heaven is difficult and hard to find]
James A.

If there doing this sort of thing without the public having any choice then whats next, micro chips in our bodys so they can watch our every move!

Many of these comments reek of astroturfing. Maybe ABC should check the IPs and investigate whether the drug company is trying to deceive people here on ABC’s own website.

I am looking for the blue wrist band and see nothing on this web site as broadcast recently. Where would I get some?

Thank you for shedding light on this story. Far too often, we are victims of deception and covert acts of businesses so that the masses can profit. Northfield Lab’s practice of having victims unknowingly participate in their experimental study is an example of immoral and unethical business practices. What other experiments will the FDA permit companies and laboratories to abuse a person’s individual rights for the sake of big business. Wake up PEOPLE! Do you really want to unknowingly participate in an experiment? Do you really want to give up your individual rights? Big businesses already have enough power and resources to persuade and influence the FDA and other representatives of governmental agencies. Only until people start dying will the FDA rescind Northfield privileges….Don’t be naive and think this is in your best interest to be deceived. If polyheme was so beneficial for you, why is it necessary to have unscrupulous business practices? Wouldn’t Northfield and the hospitals eagerly disclose this information up front and give you the right of refusal, rather than expect every American who does not want to participate in their experiment to wear a blue bracelet. It is preposterous!

where can i get one of the bracelets please email me with the info

Only thing lacking was the address of where to get the opt-out bracelet.

The only reason to do the trial on trauma patients is because they cannot give consent. Anyone who could, in their right mind, give consent – probably would NOT. They may as well test it on mental patients who cannot give informed consent either. If you are sane AND awake then you know your rights and are a bad test subject.

Anyone who suggests this isn’t happening might want to research a recent story about one of Hank Williams J.R.’s daughters who receieve “Artificial Blood” recently in Nashville. Needless to say they weren’t exactly happy to be guinea pigs for some nefarious corporation.

I WOULD LIKE TO KNOW WHERE TO FIND A BRACELET PLEASE EMAIL WITH THIS INFO!!!!!

Regarding the JS post. I realize products can be valuable in terms of lives saved not to mention the benefits across the board for our population, i.e. less blood needed. However, the point this indivdiual misses is called The Constitution!!!!! Just because a product is good or there is a good faith effort on the part of pharm companies to promote it doesn’t mean that the FDA, arrogant docs or anyone else should have the right to circumvent the Constitution to invade our rights or our privacy. Get the informed consent like all the other pharm companies do!!!!!

where can I get one of these bracelets? please email me the the information. Thanks!!

first i would like to say to all of those who think this is such a great idea, how stupid can you people really be.don’t you’ll know when it’s your time to go,BYE-BYE.STOP CHALLENGING GOD, HE HAS EVERY THING PLAN FOR YOU. HE’S THE BEST KNOWER.

Lets let them up more synthetic stuff into human bodys no-wonder there r so many diseases with no cure. “Synthetic Diseases”

Where can one obtain a bracelet mentioned in the 20/20 article?

WAKE UP AMERICA! I love this country as much as the next person. But for the government to allow this unscrupulous study reminds me of (dare I say it) the days of Adolph Hitler… performing test on Jewish victims that had NO human rights at all. I don’t care if the product does save lives. My rights as a citzen are at stake here. It is ludicrous that I have to wear a bracelet so as NOT to be a part of a study. Come on. America, please write your representives! I will! By the way, THANK YOU MR. ROSS!

The point is that we are not be informed of this. No consent needed? Does that make sense. I agree it could be a great medical breakthrough, but no consent???? That just scares me!!!!

You would have a better chance of winning the super mega lottery lottery than getting a blue bracelet and in a major trauma accident before this phase 3 clinical trial ends. 700 of 720 were enrolled by mid June.

I assume from the sentence in your text that indicates one can order a “Decline” or opt out bracelet from the company that people interested in doing so must click on the picture in your article, then squint closely to discern the name of the company and their address, look in the phone book or on the internet for their phone number, and call them. After indicating in last night’s TV newscast that you’d be providing info on your website today about how to order these bracelets, why didn’t you just provide ordering info more directly, and easily? I certainly hope it’s not because Northfield Laboratories got in touch with and influenced you not to!!

Where can I get one of the bracelets please e-mail me with the information.

The thing that shocked me most about the story wasnt the fact that it was done without people’s consent, but the fact that it seemed like people had little knowledge about the experiment, which terrified me, whether it saves your life or doesnt, people need to know about it.

STUPID PEOPLE OF THE WORLD, UNITE!! Go get a blue bracelet so you can opt out. Your rights- which you feel are so vitally important- will not be violated. But you will die when you had a chance to live. Natural selection will win out and the world will be full of smarter people!!

I know that some of you posting all the positive comments about the polyheme are paid bloggers! Yes big business pays people to say nice things about them! Polyheme may be the holy grail of inventions but lets not confuse the issue. It does not change the fact that people were used. We should have the right to refuse being tested on w/out having to wear some tacky plastic bracelet. Where do you even get those?! These shady practices of experimenting on the American public should be banned. This is an outrage! Just ponder a minute on all the recalls of products approved by the FDA. I live in one of the cities affected! You want to talk about our troops? Lets talk about them! They are fighting for our many freedoms! I would think that among these freedoms is the freedom to choose not to be used like a lab rat. What are they afraid of anyway? If polyheme is as wonderful as you paid bloggers say then people will be lining up willingly to be tested on. People were intentionally left in the dark on this one. These practices shame our nation. It makes me think of Nazi concentration camp experiments. They did not have a choice either!

After viewing the show and comments, the one question that is left out and what bothers me with this “better than blood” product is this…It’s a chemical, and even if it works well in saving lives,we should also ask this question..”How will it react with neccessary medications the patient needs?”

I want to be able to print out the story about the experimental blood substitute Polyheme.

Forgive me Nancy. Apparently JS posted the quotes I responded to. I find it confusing to associate the correct author with the posts.

The way I see the situation is; it’s either yes or no on whether or not a person receives the artificial blood. I’m neither for nor against it, and I would just like to be given the choice. First of all, before humans became guinea pigs for this testing, the public should have been well informed of exactly what this chemical is, and be given the ALL pros and cons on how it can effect our bodies in the short and long term.
Just as we have organ donations on the back of our driver’s license, why not leave a space open to show if we are willing to accept artificial blood. This would be much easier than wearing a tacky blue bracelet 24/7. Northfield Labratories know people won’t do that. So they appear to be taking our rights away in this situation. How many times will something like this happen in the future and no one does anything to stop it?
I don’t care how many names are dropped of people who were helped from this, it’s a matter of freedom. Just because it worked for other people, it does not give anyone the right to force it on me.
If I am given the choice to use the “blood”, and give permission ahead of time,
go for it. If I choose not to take it ahead of time and I die, it was my choice.
Instead of acting like a bunch of children in debate here, why not encourage one another for a solution to the problem? This isn’t Nazi Germany, and we shouldn’t
be experimented on without our permission.
I applaud 20/20 for informing the public about the artificial blood. I listened with an open mind, thought it was fair, and can see both sides. It’s seems those with preconceived ideas are the ones with the most anger here. It seems you watched the segment gearing up for a fight. I feel science can do what it wants. Just don’t use us like white rats in a laboratory. This is America, land of the free.
Remember?
Linda

An addendum—- Can you get two blue Flea braceletsfor me to keep the polyheme pests away from my carcass?

Mr. Ross. Thanks for the show and the info. Based on my own experiences, I strongly suspect that that is only the tip of the iceberg. I would love to personally speak with you to tell you my horror story of having an implant which hadn’t been approved by the FDA when implanted (don’t know if has ever been approved for my purpose)and the other implant which was inserted one month after it was recalled! FDA told me that it expected that none would be used after the recall was issued! I’m still alive, but in horrible pain because the docs keep denying that my problems exist. I hope to live long enough to get this problem taken care of and then they had better look out.My thoughts on the medical profession have had a 180 degree change. I believe that many in that profession are only there to make themselves rich.Citizens or the insurance companies are funding “long term research” while the mfgrs & drs laugh all the way to the bank. We don’t need to fear foreign terrorists – we have them right here in our hospitals and drs offices.Tell your critics that things don’t always work out for the victims of these research projects. I’ll be more than willing to talk about it soon.

Polyheme may very well save lives and that would be great. Nut every drug that has ever been pulled off the shelves, including those that cause birth defects were considered groundbreaking in their time.
My biggest complaint is the method of exclusion. I am a frequent traveler who has been to 15 of the cities list in the last year. Yet, I have never had the opportunity to hear about the test or had an opportunity to exclude myself. Northfield does not have a way to exclude yourself on their site. So I fly into a city and get in an accident, I could be a guinea pig for this? That is a crock and I am pissed. How dare you decide for me whether this experimental and yet unproven treatment is best for me. The trial is for 720 people, half of which will be control. That means that this could come to be with only 360 test subjects? How about historical dat? Long term effects? I will be watching closely for the class-action suit that is sure to follow. How many of those treated so far were not from an informed community, say passing through on vacation? That takes the informed out of the consent doesn’t it.

I work for a main hospital in Denver, and I have never heard any of the patients complain of participating in the Polyheme Study. To be honest, to some, this is the very thing saving their lives. Hopefully the FDA qill approve this, and it becomes a more well known thing. The journalist who did this interview needs to get his facts straight.

This information is new to me and i appreciate the information given. I still feel that a person should still be given a choice. If the person is unconscious then a family member should be given the right to make the decision if whether or not polyheme should be given. It is not a matter of being guinea pigs, but most of us complain about not having rights or having freedom of speech, well if we are given this blood without our knowledge then where is our rights. Also it makes you wonder what else is being experimented into our bodies without our knowledge. It is not the reporters fault for providing this information but it is helpful. There should be more information on this blood. Even at hospitals, there should be pamphlets with this type of information so that patients won’t wondering what is going in their bodies once they are on that table.
with all these problems in the world, this is just another worry we have to work out.
Mary padron

The issue is not whether polyheme is an OK product, but rather how the study is being conducted. The “transparent and ethical” approach would have been to ask people who wanted to receive polyheme to carry a card stating their wishes, as is done for organ donors.
I can’t believe that FDA approved this unethical approach.
Jane

By Nelia Schrum
July 20, 2005
FORT SAM HOUSTON, Texas (Army News Service, July 20, 2005) – An Army initiative to test a blood substitute in San Antonio may eventually help Soldiers on the battlefield.
Brooke Army Medical Center and University Hospital will participate in a national clinical trial to evaluate the safety and usefulness of PolyHeme, an oxygen-carrying blood substitute designed to increased the survival of critically injured and bleeding patients.
In the study protocol, treatment would begin before arrival at the hospital, either at the scene of the injury or in the air ambulance, and continue during a 12-hour post-injury period in the hospital.
The study will compare the survival rate of patients receiving PolyHeme to those who receive saline solution, the current standard of care.
“Were excited to be included in this groundbreaking clinical trial,” said Col. Toney Baskin, an Army trauma surgeon and principal study investigator.
Because the patients eligible for this study are unlikely to be able to provide informed consent due to the extent and nature of their injuries, the study will be conducted under federal regulations allowing for clinical research in emergency settings using an exception from the requirement for informed consent.
Use of this provision in a study protocol is granted by the Institutional Review Board responsible for approval of the research study, if IRB finds that patients are in a life-threatening situation requiring emergency medical intervention, currently available treatments are unsatisfactory, potential risks are reasonable, and participation in the study could provide a direct benefit to the patients enrolled.

Forbes
Evan Hessel, 06.06.05
Steven Gould has sucked up millions of investors’ dollars to develop a blood substitute. Why hasn’t it been approved?
Surgeon Steven Gould has spent the last quarter of a century developing a blood substitute that might be as safe and effective as O negative, the universal donor type. Chances are he’ll never find out because he can never seem to get enough human subjects to prove a clinical benefit. Northfield Laboratories, the company he cofounded in 1985, has posted $140 million in cumulative losses without selling a drop of the stuff. Where did he get the money? From investors who believed that approval from the Food & Drug Administration was just around the corner. Gould hasn’t lost the faith. “We believe this product has the potential to revolutionize how we treat trauma,” says Gould, 57.
This tale of woe begins in 1979. That’s when Gould and four medical colleagues at the University of Chicago, with a small grant from the U.S. Army, invented a method for purifying and preserving hemoglobin, the oxygen-carrying protein in red blood cells. They figured out how to extract hemoglobin from donated blood, treat it with glutaraldehyde–commonly used as a tissue fixative–and bond single hemoglobin molecules together into polymer chains. Dubbed PolyHeme, it is compatible with all blood types and has a 12-to-15-month shelf life, compared with only 42 days for donated blood.
In 1984 the Department of Defense ended Gould’s funding and backed Baxter International, which spent 20 years and $500 million trying to produce artificial blood, to no avail. Eyeing a ready market in ambulances, rural hospitals and the military, Gould helped raise $1 million in venture capital. Northfield’s then chief executive, Richard DeWoskin, told the Chicago Sun-Times in 1987 that he expected FDA approval in three years.
A couple of years into Phase I trials two of eight volunteer surgery patients reported shortness of breath and muscle aches after being injected with tiny doses of PolyHeme. Gould burned two years improving Northfield’s purifying process and running new tests on rats and baboons. On the cusp of passing into Phase II trials, in May 1994 Northfield went public, raising $15 million at $6.50 per share. But the company now had to find hundreds of trauma victims, which wasn’t a snap: Because such patients are typically unconscious when they arrive at the ER, their families had to approve PolyHeme in lieu of real blood. Gould’s doctors were able to inject only 171 patients (127 of whom were trauma victims). But that was enough, apparently, to establish relative safety; the mortality rate for patients receiving PolyHeme instead of blood was 10.5%, compared with 16% for a control group of patients refusing all blood products on religious grounds. That, to be sure, is not a very useful comparison; most accident victims have access to blood. But it was enough to keep the dream alive.
A 240-patient Phase III trial, designed to show more persuasively that this product could help patients, started in 1997. Northfield infused 75 or so patients with PolyHeme, injecting only volunteers undergoing high-blood-loss abdominal aortic aneurism repair to ensure they received several liters of PolyHeme. But when Northfield had only 90 patients remaining in the trial, FDA regulators asked the company to add 440 patients.
Short of cash and unsure of finding additional test subjects, Gould decided to end the trial. Mysteriously, he never published its results. More puzzling still was Northfield’s decision to apply for approval in August 2001, three years after the trial ended, touting in a press release that its clinical data “provides the substantial evidence of safety and efficacy required by the FDA.”
Unsurprisingly, the agency rejected Northfield’s application and demanded more clinical trials. Its stock slid from $13.25 to $3.05, almost completely depriving the company of its lifeblood, new infusions of equity capital. Around that time, in June 2002, a minority shareholder launched a proxy fight to shake up Northfield’s board. “We had a real credibility problem,” Gould admits.
In July 2002 Northfield’s board ousted DeWoskin and named Gould chief executive. After eight months of strategizing and negotiating with the FDA, Gould in 2003 convinced regulators to approve a groundbreaking trial. Northfield would inject 360 mostly unconscious trauma victims with PolyHeme in ambulances and ERs. Gould used a little-known federal regulation that waived the informed-consent requirement for research in emergency situations where no acceptable treatments exist. Since paramedics don’t usually carry blood, Gould argued, PolyHeme offered a potential clinical benefit when used in ambulances.
It gets dicey. In the trial, at the scene of the accident eligible trauma victims are randomly placed into one of two treatment groups. Patients assigned to the control group receive the current standard of trauma care: saline injections to maintain blood flow in the ambulance and donated blood in the hospital. For patients getting PolyHeme, doctors withhold real blood, even if it is available, until they have injected 3 liters of the substitute. “I’m mortified by this,” says Dr. Nancy King, who teaches bioethics at University of North Carolina at Chapel Hill. “If real blood is available, this does not fit the waiver of informed consent.”
But before Northfield can launch the trial in each of 18 cities, the FDA requires Northfield’s researchers to run “community consultations,” often including TV spots and speaking to community groups about PolyHeme’s risks and benefits. Residents who hear the spiel and refuse to participate can request a blue plastic wristband excluding them from the trial. Capitalizing on the free publicity, Gould sold 7.1 million shares for $52.8 million between July 2003 and May 2004, and another 5.2 million shares for $78 million in February. He has earmarked part of the cash to fund the construction of a 35,000-square-foot factory.
Gould’s confidence may be misplaced. He admits he may not see the same reduction in the mortality rate for patients receiving PolyHeme in this trial (with short transport time to urban hospitals) as he would for those traveling greater distances. His agreement with the FDA stipulates he has to show only that PolyHeme is not significantly worse, on a statistical basis, than the normal standard of care.
Such proof may be impossible without a sizable trial. If the mortality rates in the PolyHeme and control groups prove equivalent, Northfield would need to inject some 2,200 patients for its trial to be statistically significant, says Dr. Thomas Cook, a biostatistician at the University of Wisconsin who handled the statistical analysis for Baxter’s Phase III trial. Gould disputes the high number. “There’s no way you could make that argument without seeing the proposed statistical analysis we agreed on with the FDA,” he says. Yet he refuses to disclose or publish those metrics.
Gould should expect more tough questions. In April scientists at Walter Reed Army Institute of Research published a study suggesting PolyHeme might not be so safe after all. Comparing resuscitative fluids, it found that hemorrhaging lab rats treated with PolyHeme experienced higher mortality rates than those that received two commonly used solutions. Says Gould:”This treatment is not relevant to our current study.”

Considering the alternatives: certain death, HIV, Hepatitis, or a myriad or other contaminates sometimes found in whole blood, I think this could be a very important study. It comes at a time, however, when most of the public is feeling betrayed by a government who is slowly but surely taking away our rights to privacy just so a certain President can continue his personal vendetta against those who MAY have threatened his father! Serious reporting and serious research are the backbone of this country and are principles that our young men and women are dying for every day. Why not do the reporting at the front end of the story? Alarmists are everywhere, the media, the president, yes even the labs may be really screwing up a potential medical miracle by being “sneaky” about something that EASILY could have been done way above board. THAT’S THE REAL SHAME IN THIS STORY. I couldn’t be more disappointed in ABC.

From what I can see, most of the people responding on this issue is missing the point. I watched the show and 20/20 is not criticizing the product, they are criticizing the way it is going about it. Not giving us, the patient the opportunity to decide for ourselves. I personally would like to be alive test subject but I WANT the option, not it made for me. The bracelet should be for those who would not mind being the test subject, not the ones who may not want to be but are not given any choice or facts. As stated in the show, what if you forgot to wear it and personally, I don’t want to have to wear something that makes me look like an inpatient if I chose not to be a test subject. This is reverse of what it should be.

Polyheme has great potential to save lives. As a soldier, I like the idea that one day there may be a shelf stable blood supply ready for our wounded troops on the battlefield. However, I wouldn’t want my wife or son to be used as a test case in order to validate this new product. I believe that if you are unable to give written or verbal consent it should be illegal for an experimental product to be used on you. Northfield Labs is using a shady tactic requiring those who don’t want to be part of the product testing to wear a bracelet saying that they opt out. Seems to me that the proper way conduct the testing would be that those wishing to take part be the ones to wear the bracelets. I’m appalled at the FDA for approving this plan and at the hospitals and doctors who went along with it.

STOP STOP STOP
Please read every community spent a lot of time on informing the community. Hundreds of newspaper and TV ad’s.
This is not plastic or something made at the Twinkie factory. The product is made from REAL HUMAN BLOOD. Educate yourself before you take the medias word as gospel.
The trial has had independent doctors looking at the data at 4 intervals to see it was harmful. The concluded to continue the trial it is not causing harm. If it was the trial would have been stopped.

There you go again confusing the issues. O.K.! We get it!!!Polyheme will save lives. Understood. It does not change the fact that the people were deliberatley left in the dark and robbed of the right to choose. That is the issue. Why don’t you comment on that?

This Phase III Clinical Trail will be announced completed any day now so this story is very late. It appears the story bias was to help the “carpetbaggers” win financial gains by pushing the stock price down. I hope ABC News and 20/20 are not so easily manipulated, but I now realize all of their stories can be baised. If one wants accurate information, one must do their own research.

I WOULD LOVE TO KNOW WHERE I CAN GET A BRACELET. SO I CAN DECIDE FOR MYSELF IF I WANT TO BE PART OF THE ARTIFICIAL BLOOD EXPERIMENT.

I am all for new medical tecnology…it saves lives. I don’t necessarily give my consent to every single thing they do to me when there is an emergency and they have to make quick decisions to save my life. I want them to be free to make those decisions. However, I am not so sure I want to be an experiment either. I think I would feel better about all this if “those braclets” were more easily and readily available. Their web site gives no where to opt out of this unless you write to them and who knows if they will answer. The web site should have an area where you can order a braclet to opt out. The fact that they don’t have this makes me feel that they want to make it difficult for you to opt out which in turn makes me question this even further.

I am surprised at the response from this story. I was horrified that such a study is being conducted WITHOUT consent. To me, that is the issue. Drugs aren’t allowed to be tested on people without consent; why should this be any different? The point of the story was to make people aware of what is going on. If there is a situation where there is no other safe alternative, by all means, use it. But keep the public informed.

This is a direct violation of 1st Ammendment rights. Any ethical discussion has to be put aside until people have the right to decide to recieve this blood or not. What if we start doing controversial surguries on persons without their permission? Think of what this could lead to…

To Brian and ABC News:
The various news outlets in our society have a responsibility to help educate the public. The piece you ran on Northfield Labs and the Polyheme trial was very biased and you ran it with the intent of inflaming the viewer. I can understand where you may have issues with this type of trial. However, it is being done under Federal law as passed by Congress. I work in the area serviced by Duke Trauma Center and attended a community information meeeting. I found out about the meetings from the Raleigh News and Observer newspaper. They held other community meetings, spoke at any church that would have them, had a booth at Durhams 4th of July celebration and had people go to the Durham free health clinic and pass out info, among other thing. Perhaps it would have reached more viewers if you had reported you piece BEFORE the trial and not after.
While the previous foreshortened Polyheme trial certainly raises questions, one still must look at the full body of 20 years of history with the developement of Polyheme to get the full picture. “Getting the full picture” and delivering that to your viewers is what your goal should be.

I don’t mind drug companies trying to develop artificial blood, although I believe it is very likely impossible. The problem is testing it on people without there consent.

There are couple of knowledgeable groups reporting here 1) People in the medical field who have studied or used Polyheme in this phase 3 clinical trial or the previous trials. 2) people who are knowledgeable bio-investors who have spent years researching before investing in this small bio-tech.(not paid by any means) 3) People who are paid which fall into two groups… bio-ethicists who make their living researching and debating these very issues ..take a bow those who have all posted here in the last three day’s without disclosing their vested interest.The deep back ground on the Duke situation comes from the fact that Duke went to court and had a State law changed so the trial could continue.The second and sleaziest are the paid competitors of Northfield who are quite desperate to keep Northfield from succeeding .These last two groups are have fought a losing battle and are not only unwilling to tell you who and what they represent but will not tell you this trial is all but done and over over and you have no need for a blue bracelet….Disclosure I am invested in this company which is going to meet a critical unmet medical need in the field of trauma.

Thanks ABC for exposing this. I have not seen any other reference to this secret experiment as our government has seen fit to hide this from the very people it might affect.
UNBELIEVABLE!!! What will the Bush administration give away next.
I am very angry that my right to choose what medical procedure I am subjected to has been taken away! This is a possible life threatning treatment and we don’t even have the right to know about it?
I don’t care how beneficial it may be, I WANT THE RIGHT TO CHOOSE!!
This reminds me of the secret medical experiments that a certain country did during WW II.

Sadly, if this is such a good thing why don’t those who want to do the study just reverse the blue non-consent band and have those who will accept the experimental product wear the band? I think that would alleviate objections, such as I have, about ‘Big Brother’ using us as non-informed guinea pigs.

For all those that think this is great all I have to say is good for you. You use it. But everyone else has the right to be informed and to aconsent to ANY medical treatment they recieve.
Why cant some people get that just because YOU think it is good doesnt make it right for everyone.

Boy did ABC pull the wool over your eyes. The problem is you only saw one side of the story. Ask yourself this, in the hundreds of meetings that were conducted at elks lodges, senior citizen centors, and Malls around the country why were the questionnaires 90% positive to run the trial?
Because they were give both sides of the story. Blood causes strange reactions and people die because of blood major blood loss.
For the gentleman that posted he was in the military. Just wanted to let you know that the Secretary of defense gave his ok to have this trial run at Brooke Army in TX.
BTW this regulation to run non consent trials is a law. The company is following the law.
If you feel slighted that you did not know about the trial go to FDA Dot Gov and do a search on the dockets for Polyheme. You will find every community did there best to inform the public.
You don’t like it get a bracelet and take your chances.

I watched this two or three nights ago and was really mad of what I saw. I may be young and maybe older people may say I don’t have a say because it’s for older people and that I shouldn’t be worried, but I am. I’m in total disagreement. I feel that artificially-made substitutes for blood, is outrageous! People nowadays, are being TOO dependable on medications and sanitation products. IT may help half of the people that use it, but what about the other half? These people, near to their deaths need natural-made products.I mean, it’s really wonderful that they are many medical advances and all, but now this so-called Polyheme? I don’t know what’s going through the minds of these people. But I just want to say this, brief and simple. Even I may be in an accident and maybe close to death, I do not want to be a human guinea pig. I think it is extremely wrong that these people toy with our lives acting as if they’re God or some other type of powerful being. I am positive that one day.. all of this ‘advances’ may lead up into creating something , we all may regret. Maybe this ‘wonderful’ Polyheme, maybe the start of it.
I’m not just saying it’s all bad though…and i’m not saying that I’m right of it being the first step…. it may be good… but look of what we all created during on our time on this Earth. Little by little… we’re destorying something most of us take for granted. Our home…
Wow.. that was off subject… oh well….

At least one of us here has lost a loved one in a traumatic car accident. I also lost a loved one to heart attack at the age of 53. Both deaths may have been prevented if the correct medical product was available at the scene.
To that end I put my money where my mouth is, as an investor in products that can save lives in emergency treatments. So for the sake of disclosure, I have been an investor in Northfield Labs for almost 3 years and proud of it.
So I ask, if you invented a product that could bring people back from the brink of death, how do you test it? Don’t they have to be at the brink of death. Where do you find people in this condition? How do you conduct the discussion for obtaining informed consent?

For all you potential guinea pigs out there here is the list of community consultation from one location in PA, plus a lot more in the link attached.
Strange that almost every location had the ABC affiliate as part of the community outreach and then they run this story 2 years later.
Pathetic Mr. Ross!!
As per the Institutional Review Board (IRB) letter dated November 19,2004 the following
documentation of community consultation and public disclosure activities is being submitted for
review for the application of the above referenced research. Copies of the following are included:
Part 1:
1. PolyHeme Website information – available on the Internet and HMC Infonet
2. Response card – placed in selected inpatient areas of HMC as well as selected locations
of UPC and UPG clinics
3. Crescent article December 29,2004
4. Campus Events and Activities Week of l/2/05
5. Attendance record from HMC staff information meetings held January 4,2005
6. Penn State Newswire Release January 5,2005
7. Media packet given to members of press attending sessions on January 5,2005 -
Materials included Media Advisory, Exception from Informed Consent Requirement,
PolyHeme Backgrounder, Questions and Answers, PolyHeme Trauma Trial presentation
slides. In attendance were David Wenner from The Patriot News, WITF radio, WLBR
radio, WI-I&TV/Radio and ABC 27 (WHTM-TV)
8. Penn State Live article January 5,2005
9. Media Advisory Announcing study
10. ABC News Channel 27 story
11. WGAL Channel 8 announcement (site has video clip as well)
12. The Patriot News article, January 6,2005
13. Central Penn Business Journal article, January 6,2005
14. The Innominate News, January 2005
15. FOX 43 News website Iink after interview
16. Medical + Buzz Health News website
17. Science Daily website
18. PSU The Graduate School article
19. The Sentinel (Cumberland county) newspaper article, January 7,2005
30. LINCSS – online newsletter sent to 700 local churches
2 1. Cumberland County Commissioners meeting media advisory/public notice
22. The Sentinel (Cumberland county) newspaper article, January 11, 2005
2. KYWI 060 News Radio release
24. The Daily Item (Northurnberland/Snyder county) newspaper article, January l&2005
25. The Patriot News article, January 12,2005
26. The Patriot News (Carlisle bureau) article, January 14,200s
27. The Patriot News editorial, January 14,200s
28. Dauphin County Commissioners meeting media advisory/public notice
29. Lebanon County Commissioners meeting media advisory/public notice
30. Lancaster County Commissioners meeting media advisory/public notice
3 1. Crescent article (page 2) January 19,2004
32. Letter to local and state Congress officials with accompanying list of names
33. Response letter from Senator Jeffixy Piccola
34. Lancaster Intelligencer Journal (Lancaster county) January 26, 2005
35. Lebanon Daily News article, January 29,2005
36. NewsTarget article, January 3 1,2005
37. Letter that accompanies bracelet for those wanting to decline participation in study
Pending community education efforts at the time of this letter include:
1. Article in The Call newspaper (SchuyIkiII County) to appear February 16,2005
2. Radio Uspots” to be aired on local stations starting the week of February 14,200s
targeting specific minority listeners
3. Presentation to the GI Clinical Management Conference group on February 16,2005
4. Contacting a representative in the Lancaster County region to facilitate a discussion and
awareness of the study for Amish individuals living in the area
Other presentations to hospital and community forums included a presentation to the COM
Teams Council, Pastoral Care Services, Medical Advisory Committee of the Emergency Health
Services Federation who serves as the regional oversight committee for EMS services in central
Pennsylvania, and a presentation by Dr. Darrell Kirch to the Board of Directors. I also
participated in a presentation for Black History Month by ABC 27 (WHTM-TV) on February 4,
2005.
WHP 580 Radio, in attendance at the media event on January 5,2005, is a member of the Clear
Channel radio group and broadcast reports about the study on their sister channels including-.
1. KISS FM 99.3 – young listeners station target audience women primarily ages 18-34
2. WRW 97.3 – target audience primarily adults ages 25-54
3, BOB 94.9 – country station target audience adults ages 25-54

Thanks for reporting this. My husband and I are “no blood” people because of his religion and a few other carefully considered reasons. We count on the fact that paramedics only have saline to use at accident scenes, as they don’t tend to look for our wallets and cards immediately. This issue is one we have long considered, and we would prefer to die rather than receive blood or blood products. The fact that they can do this sort of thing now with no respect to our wishes is frightening. what next?

PLEASE GIVE BLOOD!

We fought WW2 to stop Hitler from doing this very thing. Over 30 million people died to stop him. How many have to die to stop George Bush and the Republican party from doing the same thing. A Nazi is a Nazi no matter what they call themselves. Wake up America.

Yes Linda, it is.

I tried to search Northfield’s website to opt out and it wasn’t easy. I never found out how to do it so I found a phone number that I’m calling tomorrow.

Sounds like a telephone company, charging customers to delete there name from the telephone directory. (Commie Bas…..!)

Our men are dieing on the battlefields for Bushes oil not our freedom, wake up!
If I die, I die, so be it, I am sure the other side is better than this world at the moment, but I still would like the right to choose, if such a problem occurs, thank you!

this experiment is totaly unconstitutional,forcing a human being to participate in an experiment without thier consent.just goes to show that GODS word is true, the anti christ is about to take his stand but first he has to rid the blood lineage of DAVID.that the true blood is no good, fake is better.

“I am shocked that this is happening in the United States of America. Isn’t this why our men are dying on Battlefields?”
Sadly Colleen, yes, this is why many are dying. They are dying because the current standard of care dictates that saline is injected into their bodies to replace lost blood. Many never make it to the point where they can get whole blood and the saline, while temporarily filling their circulatory systems, does not carry life extending oxygen. Their vital organs begin to shut down until life ceases.
Some who survive to the point where they can receive donor blood suffer fatal affects of their own body attempting to reject that substance as foreign. Recent studies have demonstrated that the beneficial characteristics of donated blood can be seriously compromised as that blood ages towards its six week expiration date.
Polyheme can eliminate many of these concerns, not only for those on battlefields but for victims of violence and accidents in every neighborhood in America.
I understand the concerns of those opposed to non-consent testing but have enough information (certainly more than has been provided in the 20/20 story) to understand the absolute necessity of testing trauma treatments on real trauma patients.
Remember, severely injured trauma victims are treated every day without their consent. They get saline at the scene, they may eventually get blood at the hospital, they get defibrillated, they get CPR. Amazingly, none of those common life-saving practices were tested on consenting patients before being put into use. Would you deny another life saving practice? Or shall we wait until we can find volunteers to be shot, stabbed, or mortally wounded in combat or accidents?

Whew! I just checked the list and thankfully Florida is not on it. We have enough problems down here without that. Great job. I just can’t believe that people who seem to be at least semi intelligent would agree with Northfield. The issue is….our rights..get it? I believe thats what Brian was trying to tell us. As far as the moral issue believe what you want, I on the other hand am going to contact “MARTHA” to see if she would help me make a band of my own. Keep up the good work Mr. Ross, we need guys like you who are not afraid and don’t candy coat the news.

The Govt knows what is best for us and we are basically all too stupid to take care of ourselves. Surrender all rights and achieve total freedom and safety….

Doesn’t anyone have the right to die anymore? So what if it saves lives. Does the gov’t really give a rats behind if you live or die. It’s just another ploy for some fat-cat to get rich and pass the buck.

Being an E.R. and ICU nurse I can see the value of an alternative to blood products. In many cases the availability of life saving blood is not there. Some people have rare antibodys in their blood that make type and crossing impossible.
People whom are brought into an E.R. and are in a state where they cannot make decisions for themselves areatthe mercy judgement of the E.R. doctor. I have seenmany decisions made that without any family members to speak on the behalf of the injured get proceedures they normally would not had done for themselves when conscious.
An artificial blood product gives the benefit of life saving fluid volume without the complications of receiving blood. The thought should be this, the person is in dire need of blood, they are going to die without it, then what the heck, give it a try. You are not going to get AIDS, Hepatitis or some other disease from the solution. Sonya G, R.N.

For such a God loving (or rather god fearing) people and a strong belief in God, why do westerners fear and avoid death at all costs. It may sound evil what I am saying but think about it, you ask the rest of the world to accept the salvation of God and the concept of resurrection and the life after death, but you refuse to believe it yourself. We must stop playing God. I believe there is a great need for research and medicine, but there is also a great need for those to refuse and resist this dogma. It is the concept of yin and yang, you cannot possibly have one without the other, this is necessary just in case we are stuck in a dogma that may not be reality (remember we once thought the world was flat, earth was the centre of the universe, nothing smaller than a cell or atam, we have learned over and over that what we have learned required those who thought outside the box to prove incorrect). If your belief is very strong in invasive research, then you be the first to step up and be the guinea pig, not only for this but for every expiramental drug on the market. Don’t inject me, I choose not to participate.

This is not about saving lives, it is about being uninformed guinea pigs with no rights. Were the receivers of this “miracle agent” given legal/binding documentation stating time and amount given? We are currently in Vioxx litigation. Our parents were given this FDA approved Godsend years ago. Our family was by their bedside through their slow painfull agonizing death. Revenge was very much on my mind, to those who approved it and those who lied about it and got big money because the advantages outweighted the risks. Well, only time will tell

I wish to know which hospitals in the area of newark,nj are apart of this study…

Researchers debate ethics of blood study
By
Sep 2, 2005
After more than a year of delays, Duke University Hospital has joined several other trauma centers nationwide in testing PolyHeme, the first blood substitute to reach the clinical trial stage.
But people could end up as subjects in the PolyHeme study of the without their knowledge.
The substitute has shown promise in lab settings and could potentially be more effective than the saline and electrolyte solution typically used in ambulances.
For PolyHeme to become standard across the nation, the U.S. Food and Drug Administration requires clinical testing to determine its safety and effectiveness—a process that began this summer after researchers obtained state and federal approval. In the testing, trauma victims being transported via Durham Emergency Medical Services can receive PolyHeme while in transit and during the first 12 hours spent at Duke Hospital. Survival rates will be compared to patients who receive a standard treatment.
But several ethicists and medical professionals in the research community are expressing objections to the testing, noting that the study targets critically injured patients who are often unable to give consent.
“Each of us as human beings has certain rights; informed consent is a critical part of respecting a person’s autonomy and allowing them to make their own decisions about what they get involved in,” said Dan Nelson, director of the office of human research oversight and ethics at the University of North Carolina at Chapel Hill.
Despite criticisms, Dr. Philip Rosoff, who will become the new director of clinical ethics at Duke Hospital Sept. 1, said appropriate measures have been taken to protect patients.
“There are many safeguards that have been put in place over the last six or seven years to judiciously and ethically perform this research,” he said.
To address concerns about the study, public informational meetings were held for Durham community members before the trial began. Although poorly attended, the response by community members was generally positive. Those who do not wish to participate in the study can still obtain an “opt out” bracelet from Duke.
“I’m quite comfortable as a resident of Durham county that this is ethical research,” Rosoff said. “I say that as a resident of Durham county who could get into a car accident on my way home tonight. I could potentially need this—I’m not wearing one of those [opt-out] wristbands.”
Federal law mandates that all research participants must give informed consent, with a narrow set of exceptions for studies in emergency medicine—a field that until a few years ago had been unable to advance as much as other areas of medicine because of such rules, Nelson said.
Allowing for a “waiver of consent” in certain situations has since allowed research studies to take place that previously would not have been possible.
“At the root of this, you have the inherent tension between a situation where we all want to respect the rights and welfare of the public, but at the same time you have a potentially beneficial medical intervention that we really won’t know the benefits of until you can test it in a controlled research environment,” Nelson said. “There’s a narrow window of opportunity where an intervention like this could be tried. So that sets up this difficult circumstance.”
Initially, the FDA, Durham County administrators and the Institutional Review Board of Duke University Medical Center approved the study. EMS workers began training, but the North Carolina Attorney General’s office hit the brakes on the study because state law differed from federal law and contained no exceptions to the rule of consent.
The discrepancy between federal and state law was ultimately resolved in March 2005, when a state medical board agreed to permit a waiver of consent for emergency medicine studies under certain conditions. The temporary rule, which is in the process of being approved permanently, requires studies to comply with FDA rules and notify the North Carolina medical care commission about the research, among other stipulations.

If this product were completely safe, then why does it have to be done in secret, without knowledge or consent. How do you know what the long-term effects will be? Will you moniter the patients in the future, or simply shrug your shoulders when they have long-term side effects? Sounds like a real violation.

the first post says “This is BS. No IRB would approve this study as you say. It’s not happening.” had to respond…just because it doesnt seem right doesnt mean they arent doing it. Also, this should be the other way around. People who want to participate wear a bracelet so they know they can experiement on them but we already know….. Its all about the Benjamins. This is all about making money just like all of the diseases that could be cured if there wasnt so much money in not curing them.

Everyone reading should keep in mind that most of the people posting here that keep repeating the same talking points (Hilary Williams, life-saving, what if it was you, etc) are PEOPLE WORKING FOR NORTHFIELD LABS, maker of PolyHeme. When something hits the press, they are paid to log on as if they were ordinary joes and given a list of things to say. Happens all the time in the corporate world- gotta keep stock value up.

The FDA and Northfield were both giving an opportunity to tell their side of the story. As you already know if you watched, FDA stopped the interview and Northfield declined. So think about that. If PolyHeme has saved so many lives, why didn’t they take advantage of selling this to the public? I might have purchased a few shares of Northfield stock.

Mr. Ross is so wrong on this issue.
His research is so lacking. This is high school reporting. Blood is big money, whole blood or part blood, money will always be involed.
Money wants this product to fail, money also wants this product to work better than blood.
All this aside, brighter minds than Mr. Ross’s, will in the end decide. He was so one sided and wrong. The FDA is not a friend of mind, but the way Mr. Ross treated the Doc from the FDA was so sad, uncalled for.
Please Mr. Ross, spend more time on your subject.

This isn’t about medical advancement, this is about a persons right to make a choice. This is about authority figures making decisions for the uninformed public. No one has a problem with blood substitutes, the problem is being force fed the stuff. Having to opt out of anything implies that opting in was ever an option. I was never offered a choice.

CALLED BLOOD BANK AT OUR HOSPITAL
AND WAS TOLD BY A VERY CHATTY
EMPLOYEE THEY WERE NOT USING IT ANYMORE BECAUSE IT WAS BEING “QUIETLY” PULLED FROM THE MARKET DUE TO
CIRCULATORY COMPLICATIONS.
IF IT’S SO GREAT WHY ARE THEY
PULLING IT? DON’T YOU JUST LOVE BEING A GUINNE PIG? SPARE ME STORY
ON HANK WILLIAMS DAUGHTER WILL YAH?

Don’t believe the hippe unless you have researched it for yourself!! I believe that this experiment is wrong unless permission is obtained from the participants. How quickly we forget!!! Yes, remember Tuskegee and other experiments like it. Those who see nothing wrong with this type of treatment of people/or experimentaion should rethink their position. This will not stop with just auto crash victims. What’s next surgery patiences, war casualties, where will it stop?? Would Northfeld executives want polyheme given to their family members or even too them in a crisis situation. I don’t think so. I believe they would want real blood. Why would Northfeld force individuals into being a part of this experiment instead of asking for volunteers? How can this be morally or ethically right? How about doing the experiments on animals first???

Many have commented on ABC’s failure to timely and thoroughly report and educate the public in regards to the Polyheme human subject experiment. The fact is, the alternative newpaper that initially broke the story in San Diego (July 2005), The San Diego Reader was forced to stop educating San Diego residents after Northfield sued the San Diego Reader and was subsequently granted a restraining order prohibiting the paper from disclosing information they had obtained via the California Public Records Act. Northfield argued that trade secrets on its Polyheme product would be compromised. San Diego Reader argued that the public records did not contain trade secrets but since the paper had not received notice in advance of the hearing on the matter, the lawyer for the San Diego Reader did not have the opportunity to present his evidence. As the attorney for the San Diego Reader correctly pointed out, restraints are supposed to be issued only under the most extreme circumstances.
The paper wasn’t interested in disclosing trade secrets, but rather in informing the public on what the study consists of, how and where it was being conducted, who was overseeing it, and possible adverse reactions.
Apparently, the judge, Superior Court Judge Joan M. Lewis who issued the restraining order had little or no understanding of the main requirement for waiver of informed consent requirements for emergency research which is public disclosure to the communities in which the clinical investigation will be conducted and from which the subjects will be drawn, prior to initiation of the clinical investigation, of plans for the investigation and its risks and expected benefits. Thanks to the San Diego Reader, residents of San Diego were informed and the clinical trials in San Diego suspended-STOPPED! Thanks to Northfield’s attorneys the San Diego Reader was stopped before their investigative journalism reached the rest of the country. Too many are blaming Brian Ross and ABC for not providing enough information. ABC provided as much information as their attorneys thought they could without being slapped with a lawsuit by attorneys for Northfield. No doubt lawyers for ABC thought long and hard before they did the right thing by informing the public. ABC presented enough facts and a forum for the public. This forum meets the definition of the type of community outreach and education that is supposed to occur per the FDA regulations BEFORE the initiation of emergency experimental research. Thank you ABC attorneys for having the courage and ethics to go up against Northfield’s legal team!

My husband and I went to an attorney and paid good money to get health care directives so we would not get treatment we did not want. Now the FDA has decided that my husband and I can participate in a trial without safety precautions and without our consent. Christiana Hospital in Delaware is one of the hospitals participating and I have written to them to get the bracelets. Just for your info though, Northfield Labs has closed off the internet site for requesting them. Guess they do not want to many people to get the bracelets. I am also going to send a bill for our attorney fees to the FDA and to Northfield. If they feel they can do what they want, then they can pay for the privilege.

The issue is whether the trials were conducted per normal practice or whether exceptions were granted. If the latter, the question is why. If the former, the question is whether that normal practice is reasonable or should be examined. This may have been an appropriate trial, but there is insufficient information presented to know that.

As sorry as I feel for the “victims” (I put that in quotes because the story didn’t mention anyone being badly affected in this most recent set of experiments, and I’m glad the one man they profiled recovered, but they were still used without their knowledge, much less, informed consent), their plight is nothing compared to laboratory animals who are tortured everyday in the pursuit of these “medical miracles.” Let’s have a story about that on Primetime or any other news magazine show. Why should we have to rely only on (admittedly bias, though I agree with much of what they say, not all, but most) undercover videos from PETA? I’m sure a ‘respected’ news outlet sending in a person to film in these animal hells would get good ratings (since we know it’s really only the bottom line that counts with executives).
I did to a scan to find “animal”s mentioned by anyone among these responses and I found only two. PR’s, “It’s bad enough that animals are used in research” to which I say, “Here, here” and John Warrick asking, “How about doing the experiments on animals first???” oh Mr. Warrick, you can bet they’ve experimented mercilessly and repeatedly on animals before this product (I refuse to give them publicity by mentioning it) came anywhere close to the current human trials. Don’t worry, they’ve figured out it’s not 100% poison. I’m sure they took plenty of innocent, terrified animals, sliced open a vein, drained a high volume of their blood, then filled them back up with this stuff and observed (before you challenge me on that, ‘scientists’ have no compunction about slicing the spinal cords of rats to try to ’cure’ paralysis) the effects. These animals they use are abused and discarded. They never give their consent and neither they, nor their relatives, can sue or are compensated for anything done to them (the way humans can). This goes on everyday and is at least as scandalous as the FDA being ’in bed’ with the pharmaceutical companies. I understand that medicines and procedures must be tested, but surely, in the 21st century, we can come up with better ways than animal torture and unknowing human subjects. Shame on them for doing it and shame on us for not stopping them.

I know I have no doctor degree but it worries me that my famliy members could have recieved this “fake blood”. When is technology to much for the mind to handle? Do we want our future resting in the hands of those who love to experment on humans with there newest FDA approved experment?

This countries Veterans risk their life from the day they enter military service .They risk life and limb the minute they enter a war.Why should they be expected to conduct a phase 3 clinical trial in a combat Zone .In America today fewer than 5% of the population have ever served in the military and half that in a war zone. The Freedom you are all bitching about was paid for by veterans .So when the minuscule chance that comes that when your in a life threatening accident and the even smaller chance that you get a chance at helping prove that this product saves lives it is your turn to serve.

I think the supporters of this “experiment” are forgetting the fact that we live in a free society. We have freedom of choice. Let those willing to receive this “experimental” transfusion wear the purple bracelet. That is freedom of choice as opposed to those unknowing recipients, that is called being hoodwinked.

There are facilities in the country for this and other types of research,USE THEM. There are too many individuals admitted to facilities that cannot speak for themselves and should not be used for GOVERNMENTAL RESEARCH without prior consent., and most often there is a family member needed to speak for them. In an emergency situation this is of the utmost importance. Some think an inserted ID which when scanned to show a patients medical history is one resolution to such situations. One MAJOR PROBLEM in our MEDICAL PROFESSION is their lack to read ones chart. Which therefore lacks a complete medical history and their current complaints. There have been numerous “so called testings” in the past. How many more people need to die needlessly because of a mandatory and possibly unwanted participation in a medical study?
If such research is beneficial WHY NOT MAKE IT FDA APPROVED ECT. WHY KEEP IT SO SECRETIVE??????????????
LET THE WHOLE PUBLIC KNOW ITS BENEFITS AND PITFALLS!!!

Questions about PolyHeme arose after an article in The Wall Street Journal (February 2006).
Sen. Charles Grassley, R-Iowa, then pressed the U.S. Food and Drug Administration for details about the agency’s role in allowing the experiment.
In a letter to U.S. Health and Human Services Secretary Mike Leavitt (March 2006), Grassley said officials from the Office for Human Research Protection told his staff that the ongoing PolyHeme study is unethical and that they would never have approved it.
June 8, 2006 – Grassley questions FDA about risks to children, infants in antibiotic drug trials
June 8, 2006 – Grassley Advances Bill to Help Children Affected by Methamphetamine
May 26, 2006 – National Vigil for Lost Promise Clears Senate
May 26, 2006 – Grassley Remains Concerned about Drug Use in America
May 24, 2006 – Grassley Concerned that ONDCP is Manipulating Data
May 1, 2006 – Grassley slams FDA for citing fraudulent safety study

I have looked into this and as far as I’m concerned, if I’m in an accident and need it…PLEASE give it to me!!!
I would rather be alive and run the riks of perhaps having a few side effects than be carried by six to my grave.
And for all of you who think this is bad, or a form of “Big Brother” having control over you… I’m going to go and buy stock in cemeteries, and I’ll get rich as you fools refuse the Polyheme.

I think that it is communist to experiment on humans without their consent…brace yourself America, it will only get worse.

This is very unprofessional. What are these people doing? It would be fine if the whole world knew about it and if the person would agree and give their consent but to do it without their knowledge is sickening. People should be able to make a choice “Freedom of Choice” People say that we are the land of the free but in reality we are being so watched by this government and experimental stuff. BUSH PROBABLY PUT PEOPLE UP TO THIS EXPERIMENT. No wonder many countries hates us because we are full of crap. America has no morals and values and us people who are living day to day and getting by are the target……..

Also, hospitals who consent to the trial are compensated for the trial. For the PolyHeme trial they are being given around $10,000 per patient. So, they want as many people participating as possible. In the clinical trial done earlier 10% of patients who received PolyHeme had heart attacks, 8% died from the heart attacks. In the control group there were no heart attacks. In earlier research on blood substitutes there were problems with fluid retention, the same problems that they are seeing with PolyHeme.

I do not like this idea! How can they do this, w/o prior written consent? No. I do not see this being beneficial at all! Artificial blood doesn’t seem logical, in saving any life what so ever! Blood platelettes, white blood cell counts, DNA…something no one can replicate to help anyone! And even if this did help, I guarantee the effects would be temporary. What about any side effects? What’s next? Artificial DNA replacement? No. This is absurd!

After reading may of the pro arguments, I need to send another email.
We need to GET this-this is not about saving lives, it is about govenment control without our consent. If we let this go, what next?
Fortunately the doctors and hospitals in MA are too smart to do this.
Northfield is going to make billions on this if it used everywher.
Not enough studies-besides, it is plastic blood, and no one know how it will affect your body.

I am someone who lives within close proximity to 2 of the hospitals that are participating in this clinical trial. I have never heard about this experiment nor have any of my friends or family members who also live in the same area as I. I also have dear friends who live in Ohio who also live near 2 hospitals who are also participating in the trial. They also, have never heard of the experiment. Obviouslly the public is not being notified. It is not about wether this is necessarily a good or bad product. The point is who among us wants things done to our bodies without or knowledge or consent. Adults have the knowledge that if they are unconscious doctors will perform proven life saving measures. Those measures are done on a case by case evaluation by a true physician. In most cases this trial is being started on patients in the field by emergency workers not qualified physicians. Who could make the assumption that someone could introduce something into your body that could potentially kill you if your accident didn’t already do the job. I applaud ABC and 20/20 for giving myself and the public this information. I also want to include these bracelets are not easy to come by. The company, I believe is making it very difficult to OPT OUT of this experiment. I DO NOT wish to be a test subject on anything without my INFORMED consent. If we can be test subjects for fake blood why not medicines that are still in trials? Because it can kill you that is why.

As with many interveiws mainly one side of the story is really brought to light. Although it may save lives, in the long run it may cause autoimmune diseases or other adverse side-effects. These should be looked at more throughly, as to not release potetially harmful chemicals into the public. Corporations in this capitalistic country are in it for money and only look at the public’s health to insure a sale, as were Partially-Hydrogenated oils cheap ways of preserving foods. Most things with a long shelf-life are unatural, and as the instance with food, unhealthy. Although people who have recieved Polyheme have had heart attacks, it looks promising but needs more work to reduce side-effects

I think it is unfortunate that most folks posting here do not know what was done BEFORE this trial to ensure this trial was appropriate, and even more unfortunate that ABC News did not choose to inform you.
As published in the Journal of the American College of Surgeons (a prestigious publication) in 2002, and peer reviewed, a study was made on giving PolyHeme (modified human hemoglobin) to 171 Jehovah’s Witnesses, who did not have the alternative of blood. Here are some direct quotes:
Conclusion: “In summary, this study demonstrates that PolyHeme increases survival at life-threatening RBC [Hb] in massive blood loss in the absence of red cell transfusion. We believe that PolyHeme is an effective therapeutic option that should be useful in the early treatment of urgent blood loss, resolving the dilemma of unavailability or red cells.” Note that BLOOD IS NOT CARRIED ON AMBULANCES – if you are bleeding massively you WILL die with salt water.
“There were no clinically significant issues related to the infusion of PolyHeme.” (A temporary rash is an occasional side effect.) Note that this conclusion reflects “34 patients who received 10 to 20 units of PolyHeme”, when the body contains only 10 units and NO ONE in the current trial will receive more than 6 units.
“Perhaps more remarkably, there were 12 patients who received PolyHeme in whom the RBC [Hb] fell to less than or equal to 1g/dL. Nine of these patients survived. The literature does not report any experience at this level because this RBC [HB] is inconsistent with survival.” (You would have died with salt water.) “The improved survival is because of the ability of PolyHeme to maintain an adequate total [Hb] and provide effective oxygen transport at otherwise lethal RBC [Hb} levels.”
The bottom line is that ABC News failed to provide extremely important published information to the public. There was an important trial preceding the current one that used the product exactly as in this trial, was the basis for FDA approval of the current trial, and conducted on consenting Jehovah’s Witnesses patients who could not receive blood. That earlier trial showed the product was safe and effective. Furthermore, subsequent published research provides evidence that massive blood transfusions can cause multiple organ failure, which can kill you – which risk PolyHeme is not believed to have.
I have seen an estimate that PolyHeme could save 10,000 lives per year in the USA alone. It could avoid many soldiers’ deaths in Iraq, since it is more durable than blood in harsh conditions and does not require blood typing. It did save Hilary Williams life, as reported by her attending professionals in the paper.

Regarding information available from the previous trial…
“Speaking to a group of the nation’s most prominent surgeons, Dr. Steven A.
Gould, president of Northfield, told his audience that the company’s objective
for its trauma trial was to assess survival in urgent blood loss situations in
patients with life-threatening red blood cell hemoglobin levels when blood may
not be available. When evaluating the data, the company found overwhelming
evidence that the use of PolyHeme substantially increased survival rates in
these critical circumstances.
Northfield’s study compared patients receiving PolyHeme for treatment for
massive blood loss to historical data on bleeding patients with comparable
blood loss who refused blood due to religious objections. The red blood cell
hemoglobin levels were assessed according to the National Institutes of Health
guidelines for transfusion: a hemoglobin level of 12-15 gm/dl is in the normal
range; transfusion is not recommended at a level greater than 10; at a level
below seven, transfusion usually occurs; and a level of three or less is
considered life-threatening. For purposes of this trial, Northfield is most
interested in outcome data from patients at life-threatening hemoglobin levels
of three or below.
“We unequivocally achieved our goal in this trial, reporting survival
rates of 75 percent in patients with substantial blood loss, which is
considerably higher than the historical survival rate of just 20 percent,”
Gould said. “Additionally, PolyHeme was able to sustain its 75 percent
survival rate in patients with hemoglobin levels of two, one, and remarkably
even in patients with hemoglobin levels below one — basically patients with
no circulating red blood cells. The historical data report no patient
survival at these grave levels. Using PolyHeme, we were able to meet our
objective of increasing and maintaining total hemoglobin levels in the safe
range of seven or greater in the absence of red blood cell transfusions.
“Our trial results document a very compelling clinical benefit. In
addition to substantially reduced mortality in the virtual absence of red
cells, PolyHeme is disease-free and can be given to any individual without the
need for compatibility testing, eliminating the concern about transfusion
reactions. The product has a shelf life in excess of 12 months, versus the
42-day maximum shelf life of stored blood.”
With the efficacy of the product established in the trial outcome data,
Gould addressed PolyHeme’s safety record. He reported no evidence of blood
vessel constriction, or renal, pancreatic, gastrointestinal or cardiac
dysfunction. He said the company has encountered no serious product-related
adverse events. “The results demonstrate that the use of PolyHeme is safe
during rapid and massive infusion. This is an essential requirement, since
that is how a blood substitute is likely to be used in the setting of urgent
blood loss. As an oxygen-carrying alternative, we believe that PolyHeme
represents an ideal resuscitative fluid.”

I have a very rare blood condition called a Factor XI deficiency – it scares to me think I could be given this without my consent, and without any awareness of whether my condition would make receiving this product even more dangerous.

I would gather up some tiger/stripe mosquitos and then have them do some artificial blood sucking off a cadaver. If they don’t fall off their stool, then I would say the artificial blood would pass.

Another thought…..Imagine if we all wore bracelets stating “Yes, please dial 911 if I am found injured.”
We have the choice to cosent to or refuse treatment while we are conscious. We also have the choice to maintain living wills which grant or deny medical treatments when our voices are muted by serious injuries rendering us unconscious. We cannot pass off our responsibility to express our wishes in regards to medical treatment to the madical rearchers, doctors, nurses, EMS personnel, etc. We have to be responsible and do it for ourselves.
To the “I hope there are huge lawsuits” from this responses: Do you even get the point here?

Mercedes ..The individual trauma hospitals stocked the blue bracelets during the trial.The trial will most likely be over within the next 10 days. Your using out dated , out of context statements to slander Dr Moore shows a serious lack of ethics… .Dr. William Hoffman, chief of cardiac-surgery intensive-care was previously medical director for Biopure a Boston based blood substitute company whose bovine based product has been on hold with the FDA for three years . Hardly an unbiased opinion.

The point isn’t whether polythene works, the point is that people in dire circumstances are not given a choice, and they should have a say in their own medical care.

I made a request for “OPT OUT” bracelets this past Monday to both Northfield and the Level I Trauma Center located several blocks from my home. I have yet to receive the coveted “OPT OUT” bracelets.
Several individuals on this forum have stated that the trial will most likely be over within the next 10 days. Where are you getting your information?
More importantly, if Level I Trauma Centers across the country are still recruiting they are legally obligated to adhere to the protocol which clearly mandates that CIVILIANS who do not want to be AUTOMATICALLY ENROLLED in the POLYHEME EXPERIMENT are to be provided with “OPT OUT” bracelets.
The majority of the American public had no clue this mass artificial blood experiment was being conducted throughout the United States until ABC 20/20 aired the investigative report by Brian Ross exactly one week ago. So, it only stands to reason that every Level I Trauma Center should have a stockpile of “OPT OUT” bracelets. As I said, I live several blocks away from one of the Level I Trauma Centers in Ohio participating in this experiment. So if my Level I Trauma Center has the bracelets, the study coordinator has a legal duty to provide me with “OPT OUT” bracelets for myself and my family members. Why do you think the study coordinator has chosen not to do so?
Furthermore, I have to question the logic of automatically enrolling trauma victims in the communities surrounding these Level I Trauma Centers in an artificial blood experiment when the STANDARD OF CARE – blood, is only minutes away via ground EMT services.
Trauma victims a distance from the city limits are transported by AIRCARE when they experience a traumatic injury. So, why did the protocol mandate automatically enrolling trauma victims pre-admission enroute to the Emergency Trauma Room? Why risk the victim’s chances for survival by having EMT personnel in FAST moving vehicles perform a procedure that should only be performed in a controlled, emergency trauma room setting?
How much training did the EMT personnel receive before being charged with the responsibility of beginning the administration of a mass transfusion of artificial blood in a FAST moving vehicle enroute to the Emergency Trauma Center?
Since final approval for this experiment came from the local level, I reviewed the minutes posted online for the City Council meeting convened to decide whether the experiment would be approved and noted that the Principal Investigator conducting the Polyheme experiment in my “neck of the woods” had advised the City Council members that the City Fire Department and their employees administering the Investigational Drug Polyheme would be immune from any liability. However, there had been absolutely no discussion in regards to the potential liability for members of City Council.
Typing and cross matching of blood are more difficult because of Polyheme’s red color. For instance, if the victim’s plasma/serum has an hemolysin in it, then the already red color conceivably could interfere with its detection. It would seem one of the problems in a rapidly bleeding patient might be the determination of CBC from the specimen taken in the ambulance which might give a HB and Hcrit reading that is higher than what it would be on arrival to the ER. So, the EMTs would need to draw some blood vacutainers before beginning to administer the transfusion of artificial blood. By the time EMTs performed this necessary procedure those of us who live only minutes away from a Level I Trauma Center would be pulling up in front of the Emergency Room or landing on the helipad on top of the Level I Trauma Center. Once the trauma victim arrives in the Emergency Trauma Room, will the Level I Trauma Center have the special instrumentation required to test altered blood chemistry, i.e. water and electrolyte homeostasis, acid–base status, renal function, and cardiac damage lab values that are affected by the artificial blood Polyheme? It is my understanding that the special instrumentation to measure lab values altered by Polyheme is still in the experimental phase of testing.
Informed consent is an ongoing process, it begins with informing the potential human research subject in regards to the risks versus the benefits of participating in a particular research experiment.
The validity of the research data coming out of this experiment should be challenged if the protocol was not fully adhered to by all of the Level I Trauma Centers throughout the United States participating in the experiment.
We already know, that the information provided to those CIVILIANS who were “targeted” to be in the loop was seriously lacking in regards to the risks versus the benefits of the Investigational Drug Polyheme.
The fact that deaths occurred in previous experiments with Polyheme is not “old” news, it is information that should have been disclosed to the public and to members of City Council and/or members of the Board of Commissioners in each community approached by Research Scientists seeking approval to experiment on citizens and seeking approval to have local government employees participate in the experiment, per the protocol. It is also information that should have been thoroughly evaluated and very carefully considered by the FDA.
Will subsets of data be closely reviewed by the FDA, i.e. urban versus rural experiments? I think the urban Level I Trauma Centers are going to have a very difficult time justifying the use of the Investigational Drug Polyheme pre-emergency hospitalization when the STANDARD OF CARE – blood, is readily and timely available.
Now we get to exclusion criteria of the informed consent process which included excluding, CIVILIANS who chose to “OPT OUT” of the Polyheme artificial blood experiment by wearing an EXCLUSION BRACELET, pregnant females, patients with DNR orders, Jehovah’s Witnesses, patients with severe head injury, patients undergoing CPR, or patients with injuries that are incompatible with life.
The experiment is still recruiting yet, as I said, my request(s) via telephone and email to receive the “OPT OUT” bracelets have yet to result in my being provided with the bracelets.
As far as the remaining exclusion criteria of the protocol: How can EMT personnel determine a victim has a DNR order if the victim is in shock and unable to speak and EMTs have no access to the victim’s medical records? How can EMT personnel determine if a victim is a Jehovah Witness if they are in shock and unable to speak and the EMTs have no access to their medical records?
How can a hospital abdicate their responsibility by permitting public servants who are not licensed doctors to make the determination that a victim’s injuries are incompatible with life?
Many postings on this forum have also repeatedly attempted to reassure those of us with legitimate concerns about the safety and ethics surrounding this experiment that an “Independent” Human Research Review Committee (IRB) has already performed four (4) safety checks and have determined there were “no significant” safety issues. Define significant. Is this a numbers game? One death is significant for a victim and the loved ones of the victim. Who appointed these individuals to the “Independent” Human Research Review Committee(IRB)? Why aren’t their identities known? How can a victim (should they survive) and/or the victim’s family members report adverse events including death if they don’t know the name and telephone number of the individual who has been appointed to Chair the “Independent” Human Research SReview Committee (IRB).
How did each Level I Trauma institution get around the fact that it is the federally mandated responsibility of each Human Research Review Committee (IRB) based at the institution performing the experiment to ensure adherence to the protocol, ensure the victim and/or the victim’s Legally Authorized Representative (LAR) are provided the opportunity to withdraw from the experiment or re-consent, perform safety reviews, report adverse events including death to the FDA and determine if the experiment should be stopped if the adverse events including deaths substantiate the fact that the risks outweigh the benefits.
These are just some of the issues the United States Food and Drug Administration were mandated to begin investigating by Senator Charles Grassley four (4) months ago. Therefore, why did the Medical Director for the FDA, Center for Drug Evaluation and Research (CDER), Division for Scientific Investigations (DSI), Dr. Robert Temple almost choke on his bottled water when Brian Ross attempted to ask him a legitimate question?
Hospitals are compensated $10,000.00 dollars for each trauma victim enrolled in the experiment who lives at least thirty (30) days. Is the cost of the Investigational Drug Polyheme reported to be $1,200.00 absorbed by the Level I Trauma Center or is the cost of the Investigational Drug Polyheme billed to the private insurers and/or Medicare/Medicaid? Who pays for the emergency transport services ground and/or AIRCARE? Who pays for the Emergency and Intensive Care costs during the thirty day period of enrollment in the experiment?
The U.S. Department of Health and Human Services seems to be standing by the information provided to Senator Grassley by Mike Lewitt’s staff. If the U.S. Department of Health and Human Services didn’t approve the experimental human research subject experiment, than certainly none of these Level I Trauma Centers should be billing Medicare/Medicaid for the exorbitant cost of the Polyheme experiment. In addition, private insurers also should not be billed for any costs associated with the care of trauma victims enrolled in the experiment. Health care costs are sky high, $10,000.00 per trauma victim can’t begin to cover the costs associated with the experiment on a per victim basis. I feel quite certain that this is precisely why Senator Chuck Grassley initiated an investigation into the matter.
The FDA should begin their investigation by determining how many people had and/or still have a CONFLICT OF INTEREST in the Polyheme human research subject experiment as well as perform an investigation into why the approval of the Polyheme experiment received preferential treatment from reviewers at the FDA.
The FDA may have been “asleep at the wheel,” but believe me everyone at the FDA will be WIDE AWAKE when performing their “Independent” review of the deaths and adverse events that no doubt have occurred at each of the study sites across the country, considering the fact that the public is now WIDE AWAKE in regards to what has been happening in our own backyards without our knowledge or consent for several years!
My guess is this type of scrutiny will result in the public receiving a more factual reporting of deaths and adverse events experienced during the lengthy experiment than the public could have reasonably expected from the mysterious “Independent” Safety Monitoring Committee that we are being advised have performed four (4) safety reviews in the past two years yet have not released the results to the public per the protocol for the experiment.
“Sunshine is the best disinfectant.”
This is not to say that the public shouldn’t proceed with the following in mind as we monitor the progress of FDA’s investigation into how this experiment managed to remain “under the radar” of the public for years.
“Fool me once; shame on you. Fool me twice, shame on me.”
I think we all just might live to see the day when the Commissioner of the United States Food and Drug Administration is not a political appointment and PHARMA stock investors are not the individuals in charge of America’s health care system!
We also may live to see the day when the majority of the American public will begin demanding that Investigational Drugs that KILL PEOPLE should never be tested on any human in an experiment, especially without their legally effective informed consent or the legally effective informed consent of their Legally Authorized Representative (LAR).
That is, of course, if we aren’t the unfortunate victims of a traumatic injury before this fiasco is stopped and some over zealous EMT employee begins us on a journey to the unknown!

Mercedes -
You seem to know a lot about Polyheme and this trial. Why then do you post so many things that are not factually correct? Your rambling discourse about the cost of Polyheme, as an example, is totally irrelevant as there is no charge made by the company to the patient, hospital, or EMT service for its use in the trial.
You complain mightily that you haven’t received your opt out bracelet requested by phone and email. While they may be quick methods of communication, they can’t do everything – have you checked your mailbox?

As I follow news of the current crisis in the Mideast, I have to wonder…..
Why is it that Israel is the only country in the world that carries blood on ambulances? Maybe the chief trauma surgeon at Hadassah Hospital could shed some light on the medical advances that have resulted in Israel’s ability to carry blood on ambulances.
Why doesn’t the United States Food and Drug Administration (FDA) lobby for taxpayer money to be directed towards ensuring Americans have a safer natural blood supply rather than encouraging the development of a synthetic alternative to natural blood?
Why can’t the FDA (CDER) Ombudsman, Warren Rumble simply pick up the telephone and order attorneys for Northfield and/or attorneys for the University of Cincinnati (University Hospital) to adhere to the protocol for the experiment and mail out Polyheme experiment exclusion wristbands IMMEDIATELY upon request?
“The death of a democratic society is not likely to be an assassination from ambush. It will be a slow extinction from apathy, indifference, and undernourishment.” (Robert Maynard Hutchins)

What is worrisome to me is that this product is synthetic. Sometimes we don’t know the risks until later when we experiment with synthetic materials in the human body. I, for one,don’t think that I should have to wear a ristband for the remainder of this trial to protect myself from a synthetic blood that is being tested without notification. I feel this product is too risky and that I would not want to participate in this trial. They should try this fake blood on people who are willing to try it in the hospital. That way the company has the opportunity to try it out and the people who reside in the cities that are participating in the trial aren’t being subjected to something that they aren’t comfortable with.

Thanks to Mr. Warren Rumble, Ombudsman FDA-CDER, I received the PolyHeme pre-hospital human subject research experiment exclusion wristbands via U.S. Mail yesterday afternoon. “Opt Out” wristbands I initially requested via telephone and electronic mail from both the University of Cincinnati (University Hospital) and Northfield on July 10th.
I have to say, as a resident of Cincinnati, Ohio, I feel angry with the fact that I must wear the “Opt Out” PolyHeme pre-hospital human subject research experiment exclusion wristband, considering the fact that the Cincinnati City Council vetoed the idea of experimenting on Cincinnati residents/visitors after giving due consideration to the information the University of Cincinnati (University Hospital) submitted to the HEALTH, TOURISM, SMALL BUSINESS & EMPLOYMENT COMMITTEE on May 25, 2004.
I submitted a written complaint to Chris Middendorf, Chief, Consumer Affairs Branch, Division of Communication and Consumer Affairs Center for Biologics Evaluation and Research, U.S. Food and Drug Administration earlier this week as I think CBER needs to investigate the decision made by the University of Cincinnati (University Hospital)to circumvent the decision made by the residents of Cincinnati subsequently supported by the Cincinnati City Council not to participate in the PolyHeme human research experiment.
I’m wondering if UC’s arrogance has anything to do with the fact that Jane E. Henney, previous Commissioner of the United States Food and Drug Administration (1/17/1999 – 1/19/2001) was hired in 2003 by the University of Cincinnati to oversee all matters related to human subject research experiments in her capacity as Vice President and Provost for Health Affairs, University of Cincinnati Medical Center?
Since the PolyHeme nationwide human subject research experiment began three individuals have been appointed to serve in the capacity of Commissioner for the FDA.
Mark B. McClellan, M.D., Ph.D
11/14/2002 – 3/26/2004
Lester M. Crawford, D.V.M., Ph.D.
7/18/2005 – 9/23/2005
Currently, Andrew C. von Eschenbach, M.D., is the acting commissioner of FDA.
Acting Commissioner????? What does that mean?
I was glad to see President Bush VETO expanding the federal government’s role in Stem Cell research.
Hopefully, the members of Congress will initiate a full scale investigation into the PolyHeme experiment to determine how this could happening in the United States of America!

Interesting…..the medical criteria for requesting emergency air medical response (AIRCARE) is the same criteria for inclusion in the PolyHeme Investigational Drug Experiment.
Interesting…..emergency air medical response (AIRCARE) has the standard of care (blood) available on board (pre-hospital).
So, how does the PolyHeme randomized experiment really work? Blood versus PolyHeme?
Interesting…..why would any of the trauma patients be transported by ground Emergency Medical Services when the On-Scene Air Medical protocols mandate that patients be transported by AIRCARE?
I’m beginning to understand why so many states decided not to participate in the PolyHeme Experiment.
____________________
Requesting On-Scene Air Medical Response
Upon receipt or firsthand knowledge that a patient or patients may require air medical care and transportation, any public safety officer may contact the emergency communications center to activate the response of air medical services.
An attempt should be made to contact medical command regarding the decision for on-scene response. If communication with an approved medical command physician is not possible, there should be no delay in the dispatching of air medical response.
On-scene air medical response may be appropriate for any unstable or potentially unstable multiple system trauma patient who will be delayed on-scene due to extrication or the remoteness of the incident location. To avoid dangerous confusion or duplicating responses, communications should be directed to the communications center serving the area where the incident is located. Services responding from surrounding counties or dispatch areas should not contact their home communications center to request air medical response; they must contact the communications center serving the county or area where the patient is located.
Medical Criteria for Requesting Air Medical Response
When determining the need for air medical response, consider the patient’s medical assessment, the patient’s need for advanced medical care during transport, the need for immediate intervention, and the need for expeditious transportation of the patient to a trauma center.
General medical criteria that may indicate the need for air medical treatment and transport include, but are not limited to:
• Adult patients with vital sign abnormalities resulting in altered level of consciousness, respiratory compromise, or circulatory compromise. These abnormalities may include:
1) systolic blood pressure less than 90 mmHg
2) respiratory rate less than 10 or greater than 35 per minute
3) heart rate less than 60 or greater than 120
• Penetrating trauma or crushing injuries to the head, neck, chest, abdomen, or pelvis;
• Spinal cord injury, or any injury producing paralysis of an extremity;
• Partial or total amputation of an extremity (excluding digits);
• Multiple trauma effecting two or more body systems;
• Two or more long bone fractures or a major pelvic fracture;
• Major burns of the body surface, or burns of the face, hands, feet, or perineum;
• Burns with significant respiratory involvement; or major electrical or chemical burns;
• Patients involved in a serious traumatic event who are less than 12 years of age or more than 55 years of age;
• Patients with near-drowning injuries, with or without hypothermia;
• Significant mechanism of injury, including:
1) Vehicle rollover with unbelted passengers
2) Vehicle striking pedestrian at greater than 10 mph
3) Falls from greater than 15 feet
4) Motorcycle victim ejected at > 20 miles per hour
5) Multiple victims
• Glascow Coma Scale score less than 10;
• Trauma Score less than 12;
• Difficult access situations:
1) Wilderness rescue
2) Ambulance egress or access impeded at the scene by road conditions, weather, or traffic
3) Entrapment in wreckage or machinery
On-Scene Patient Packaging
Information that you will need to provide when you are calling includes the following.
• Referring agency name, callers name and call back number
• Call location. If an exact Landing Zone location is not available at the time LIFESTAR is requested, the nearest city, community or known location will assist in navigation until an exact location can be coordinated.
• Number of patients needing transport and approximate ages
• Nature of incident (MVA, fall, assault, drowning, etc.)
• Contact unit and operating frequency
Preparing the Patient
A primary benefit of air medical transport is rapid access to tertiary care. Optimal patient preparation can allow the flight team to spend only minutes at your location. Our goal is rapid, safe transport. Any assistance you can provide in patient preparation before the team arrives will help reach the goal of short patient bedside times.
If possible and if time permits, we ask that the following patient preparations be made.
• Airway management and oxygen therapy. Patients with a compromised or potentially compromised airway need to have their airways secured before transfer. When in doubt, intubate.
Due to altitude physiology considerations, aggressive airway management is encouraged.
Feel free to contact the LIFESTAR Communications Center at 865.544.9112 and speak with a flight crew member or with one of the medical control physicians, either prior to lift-off or while the helicopter is enroute to your hospital.
Upon arrival, the flight crew also can assist you with any necessary airway needs. The flight crew will frequently utilize Rapid Sequence Induction to facilitate immediate intubation in the patient requiring an emergent airway.
• Oxygen therapy. Cardiac and medical patients need a minimum of 2 to 4 liters oxygen administered by nasal cannula.
Trauma patients or any unstable patient will need 10 to 15 liters of oxygen by nonrebreather mask.
• Intravenous lines. Due to the potential of accidental dislocation of an intravenous line in the transport environment, it is recommended that at least two intravenous lines be established.
Trauma patients should have at least two large bore intravenous lines—14 gauge or 16 gauge—to facilitate rapid infusion of crystalloid and/or blood products, if needed.
Medical patients should have at least two intravenous lines. One intravenous line can be attached to an IV set with an appropriate solution, and any additional lines may be turned into INTs for transport.
If patients are on medications that require IV pumps, please inform the flight coordinator. This will allow the flight crew to bring syringe pumps into your facility.
All intravenous lines should utilize extension sets. This facilitates switching to blood sets, trauma tubing or the receiving hospital’s intravenous sets without contaminating the IV site or risking accidental dislocation of the catheter.
Tape, tape and more tape.
Intravenous lines should be secured with additional amounts of tape to help prevent dislocation. Tegaderms, Veni-Gard’ and other commercial intravenous site protectors are fine, but reinforce them with tape.
• Tubes. Altitude physiology causes gases to expand at altitude, increasing the potential for vomiting or enlargement of a pneumothorax. A nasogastric tube should be placed to prevent gastric dilatation and subsequent respiratory compromise.
Remember to place an orogastric tube if there is a possibility of facial fractures.
Critical trauma and medical patients need a Foley catheter to monitor urinary output.
If the patient has a significant pneumothorax a chest tube should be placed.
• Spinal immobilization. Keep all immobilization equipment in place, even if the X-rays are completed. Spinal immobilization is vitally important in the trauma patient and allows for immobilization of other injuries, regardless of whether there is an associated spinal injury. If possible, pad all pressure points on the spine board for patient comfort.
• Splinting. Do not use air splints. Altitude will cause splints to tighten during transport. If special splinting is required, let the flight coordinator know so that the crew can bring special splinting materials.
Space limitations on the aircraft preclude the use of certain splints. It is preferred that if long bone fractures can be adequately splinted in gutter, vacuum or other types of splints that you use them. If a traction splint is in place, it only should be minimally extended. If the patient’s height plus the addition of the traction splint presents a problem, the flight crew will assist you with alternate splinting options.
• Restraint / sedation / antiemetics. Due to safety considerations, the flight crew will make judicial use of chemical as well as physical restraint on all patients that present combative. Of particular concern, are patients with head injuries and drug/alcohol ingestion. These patients will be physically and/or chemically restrained.
Anxious patients (particularly cardiac) may be sedated prior to arrival of the flight crew, if not contraindicated.
If patients are prone to air sickness or have complained of nausea at any time during their care, antiemetics should be given.
Records. Provide copies of patients’ treatment records, pertinent history, labs and X-rays. If these materials are not immediately available, they can be faxed to the LIFESTAR Communications Center at 865.544.8868. If you are unable to complete these tasks before the flight team arrives, they will assist you in any way necessary to prepare the patient for transport.
Helpful to the flight crew, but not essential, is to enclose two copies of the face sheet on all transfers.
Please call the receiving facility’s inpatient unit with a report so it can prepare medications drips, ventilators, etc., prior to arrival of the flight crew.
• Family. The flight crew will make every attempt to speak with the family members to explain what it is doing and answer questions if the patient’s condition allows.
Family cannot fly on the helicopter. A family member’s reaction to the flight environment and medical procedures cannot be predicted and could detract from or interfere with patient care.
The patient’s valuables and clothes should remain with the family, if present.

On March 18, 2003 the University of Cincinnati announced that the Hoxworth Blood Center (University of Cincinnati Medical Center) had entered into an agreement with the United States Department of Defense to supplement the military’s blood supply during wartime, if and when additional blood is needed.
We have such a high rate of blood donation here in Cincinnati our blood center (Hoxworth-UC Medical Center) is in a position to provide Civilian blood for our troops.
I wonder how many victims of traumatic injuries here in Cincinnati and the surrounding communities have been donating blood to help our troops for the past three years and when they needed blood received the Investigational Drug PolyHeme instead?????
Shouldn’t patriotic citizens (CIVILIANS) who are willing to do their part to help the troops by consistently donating blood expect that they will receive blood rather than the Investigational Drug PolyHeme should they be the unfortunate victims of a traumatic injury?
I’ve been wearing my “Opt Out” wristband for the past five days and I’m beginning to feel like it is time to move to another state. Not sure which one yet but certainly not any state participating in the PolyHeme human subject research experiment.
__________________________
Updated: March 18, 2003
Hoxworth’s Involvement with the Military’s Blood Supply
CINCINNATI – Hoxworth Blood Center, University of Cincinnati Medical Center, as a member of America’s Blood Centers, a network of community blood centers that collects nearly half of the nation’s blood supply, announced on January 30th an agreement with the United States Department of Defense to supplement the military’s blood supply during wartime, if and when additional blood is needed.
With the prospect of a war with Iraq, the military has developed this agreement to assure all blood needs would be met. While the military collects its own blood and relies foremost on that blood for its troops, when requested, America’s Blood Centers’ members such as Hoxworth will be asked to fulfill part of the military blood needs not met by those sources.
“Having this support from America’s Blood Centers and its members will ensure that blood will be available for our servicemen and women. While the military collects much of the blood that supports our troops, we still depend on backup from civilian sources, especially in times of major conflicts. We hope civilians will rise to the call of duty, to help both their military troops and other civilians who need blood,” said Colonel Michael Fitzpatrick, Director of the Armed Services Blood Program Office.
Hoxworth will not ship blood directly to the military, but rather to a pre-assigned regional distribution center. From there the blood will be sent to a designated military location.
Hoxworth will use its best efforts to ensure that the military’s needs are fulfilled by recruiting people to donate not only for the patients their local communities, but also for the men and women who are serving our country.
What can people do to help?
Since the immediate need of the military is unknown, we encourage donors to schedule appointments over the days and weeks to come. Donors are urged to call Hoxworth’s appointment center at (513) 451-0910 or (800) 830-1091 to schedule an appointment to donate at any of Hoxworth’s eight tristate neighborhood donor centers. It is very important to balance the donations over a longer period of time, in order to meet the current needs of our community and the future needs of the military.
How will donors know if their blood is being sent to the military?
Because of the way this is set up, Greater Cincinnati’s blood may not go directly to the military, but rather will be part of the national support system that will assure hub centers will have enough blood when it is requested.
No matter who receives that blood, it is a patient somewhere in need, whether home or abroad, and the blood collected is all part of our national preparedness. Blood donors save lives, period.
Should donors wait until the military needs blood before giving blood?
No. People need to donate blood everyday so that we are prepared. When Hoxworth Blood Center is required to ship blood to the hub center, it will be the blood already on the shelves that we send.

this is a great advancement in the field of science.

Many of these comments point to a common thread: Mr. Ross’ “Investigative Reporting” is alarmist, negative, and often lacking in genuine balance.
In other words, he arrives at the conclusion he set out to prove.

I’d like to note that it seems this drug has gone through the normal steps of new drug development. There is the preclinical testing that is done in animals, once the drug is tested for toxicities, pharmacokinetics, and possible effects it could have, it enters clinical testing that is done in humans.
I’d suggest before any more tears are shed over this topic that this is common. There is a phase IV of drug testing in humans which is the ‘postmarketing surveillance’. If you think about it, all early phases are small scale, but it isn’t until it is unleashed on the public that real effects are known. Vioxx is a prime example of this.
Further reading of this topic is suggested before the river is cried. A blood substitute that can carry O2 seems much more productive that NaCL to me.
See a couple limbs loss in ER from hemorrhagic shock (tissues that do not get enough oxygen die) and you start to weigh the pros and cons.
And really, if you where bleeding to death at an accident, would you want to spend the last few minutes of your life hearing an informed consent lecture?
Think about it, every time you take an Rx drug your a test subject.

Ah, informed consent is interesting.
I hope people understand that the rule in the medical field is to save lives. For example: 54 year old women comes into the ER after a car accident. She has no ID and can not be awoke. She is given blood. The patient recovers. She’s a Jehovah’s Witness (as you know, they can not accept blood products).
So, in this case, what dose the hospital staff do?
1. Let all comatose patients die in ER due to the possibly they might be a Jehovah’s Witness and can not accept blood products.
2. Give the patient blood products are the risk that they are Jehovah’s Witness?
3. Give the patient an accpetable substance that will carry blood and keep her tissues intact while she recovers from blood loss?
It’s hard to to give informed consent to a comatose patient.

It doesn’t matter if anyone thinks this product is GREAT or a DANGER to any living being. The human population should have ALL of the good and bad about any new product and should not be given any new and experimental substance without that persons consent or their next of kin. The manufacturer will be sued sooner or later.

The people that would benefit most from polyheme are the ones most likely to die without it. Some of you who want to have informed consent are missing the point here. Northfield got the waiver of informed consent because the people affected would probably die without polyheme anyway. They are people who are in shock from blood loss and cannot give consent. Waiting for consent means continued loss of blood and eventual death. You can wait for the 30+ minute trip to the hospital, and wait an hour to get blood typed, best of luck surviving massive blood loss while your rights? are protected!

I THINK THIS WHOLE THING IS WEIRD!

gooooooooood