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

Linda Lynch

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

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

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

Thanks

Lyle

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

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

Mr. Brian Ross:

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

Sincerely,

Gary A. Bottinelli

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Anecdotal stories that the product is saving lives

Hilary Williams daughter

Erik Silkworth

Jan Dalton

Paramedics praising polyheme

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

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

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

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

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