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

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

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

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

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

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

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

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

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

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

Anecdotal stories that the product is saving lives

Hilary Williams daughter

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

Erik Silkworth

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

Jan Dalton

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

Paramedics praising polyheme

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Dear Mr. Ross:

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

KR