Polyheme: Ethicists want fake blood study stopped

[MMiz]

Ethicists want fake blood study stopped

CHICAGO, Illinois (AP) -- Imagine being in a car crash, lying unconscious and bleeding in an ambulance. With no blood on board, paramedics give you an experimental substitute, but even at the hospital, you get fake blood for several hours before doctors try the real thing.

Medical ethicists say a study that is doing just that on hundreds of trauma patients without their consent should be halted.

It's a renewed attack on research that began in 2004 after Northfield Laboratories got federal approval for its study of the blood substitute Polyheme.

Debate was reignited by a Wall Street Journal story last week that suggested the company tried to hide some crucial details about another blood substitute study back in 2000. The Journal reported that 10 heart surgery patients in that Polyheme experiment had heart attacks, while other patients given real blood did not.

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[Jon]

I saw this and meant to post it.

"ER" on TV actually talked about some of the ethical dillemas in Season 4.


Long story short - Prehospitally, the study is a GREAT idea. In hospital, it becomes a slight gray area, BUT the case law backs it up for now.

 

[Raf]

I'm a bit confused. So basically they want to use this Polyheme stuff to comfort the patients and possibly create some positive feeling within them to encourage healing? Or does this stuff actually have some physical therapeutic properties?

 

[ffemt8978]

I'm a bit confused. So basically they want to use this Polyheme stuff to comfort the patients and possibly create some positive feeling within them to encourage healing? Or does this stuff actually have some physical therapeutic properties?

Actually, the purpose of Polyheme is to provide pre-hospital care providers with something that can actually help trauma patients in the field by providing an artificial source of hemoglobin that can carry oxygen to the bodies cells (the theraputic properties since with NS, all you do is thin out the concentration of RBC's during a major bleeding incident such as trauma).. Being an artificial substance, you don't have to worry about disease transmission (as with real blood), it has a longer shelf life, and better storage capabilities than previous versions.

I can understand the ethics question that is being posed, but I think you must first answer the question, "Is the Polyheme a direct cause of death in these patients?" The answer is, we'll never know because we will never know if they would have survived without it. How many of these patients would have never made it to the hospital in the first place without Polyheme? How many of these patients would still be alive if they received real blood?

And the most important question is this: How do we balance the needs of the patient with the needs of legitimate medical research? The needs of the patient are of obvious importance, but in some ways they must be balanced with the needs of research. After all, that research may not only save lives in the future, it may actually save that patient.

 

[Jon]

Polyheme SOUNDS good....

And, prehospitally, seems to be working. You do end up with an intresting ethical question of using fake blood or real blood once the option exists, but otherwise....

 

[JJR512]

Here's a twist on the ethical issue: Some religions, I believe Jehova's Witnesses is one if I'm not mistaken, do not allow blood transfusions. I believe they think that blood from another person put in their own body is a contamination or something to that effect. Anyway, I wonder if they would allow this stuff to be put in? Technically it's not blood, it's not from another person. And unless I'm mistaken, it's not putting something in their own body that's the problem, it's the fact that it comes from another body that's the problem, so this fake stuff should be no problem.

 

[Jon]

I think that they DO permit it.... that was also an issue.

 

[Raf]

If the polyheme is helping patients to some extent right now (at least lengthing their life span) I am sure this substance has more potential and can eventually save hundreds of lives. But unless we experiment with it and find out how to improve it, we will never be able to learn it's full capabilities.

I say we go for it and use it. What makes it any less unethical than using other drugs and life support to save people's lives? Is it just because it seems like we are trying to create something that God has created?

 

[GaEMT]

I have seen this stuff in action and it is a promising product. Check out http://www.northfieldlabs.com/polyheme.html There are some issues regarding storage of the product, but I would imagine the market place will offer solutions for this if approval is granted.

 

[squid]

The ethical issue is one of informed consent, Raf.

 

[Jon]

The ethical issue is one of informed consent, Raf.

BUT.... in the field, it is working better than saline... the issue becomes with the hospital continuing "fake blood" when there is real blood availible.

 

[squid]

Did I misunderstand? I thought that was still an informed consent issue -- they weren't giving the patients a chance to decide to participate in the study or not.

 

[squid]

Well, for heaven's sake, you can't edit messages.

So anyhow, the ethical issue is one of informed consent. It's not about using fake vs. real blood or about how well it works -- it's about not giving patients in the hospital the chance to agree to participate in a study. I was posting in response to Raf, who seemed to be asking what the problem was.

 

[ffemt8978]

Well, for heaven's sake, you can't edit messages.

You can edit your own posts, but you're limited to a 5 minute window to do so. After that, only a mod/admin can edit posts.

The reason for this is that we had a problem before with a member going back and editing all of their posts to remove all content. It caused some difficulty with thread continuity. If you think the 5 minute limit is too short, feel free to post a poll in the Suggestions Forum and we'll see what the membership says.

 

[squid]

No, no problem! It's just that I had an edit button but it wouldn't let me do it, which was frustrating.

 

[Jon]

Well, for heaven's sake, you can't edit messages.

So anyhow, the ethical issue is one of informed consent. It's not about using fake vs. real blood or about how well it works -- it's about not giving patients in the hospital the chance to agree to participate in a study. I was posting in response to Raf, who seemed to be asking what the problem was.

The issue is "in hospital" use, where you would "deny" the patient real blood by enrolling them in the study for fake blood. So yes, it is an issue of consent.

 

[podmedic@mac.com]

I have seen this stuff in action and it is a promising product. Check out http://www.northfieldlabs.com/polyheme.html There are some issues regarding storage of the product, but I would imagine the market place will offer solutions for this if approval is granted.

I featured this recently on my podcast. The main issue is one of informed consent and the withholding of real blood from patients for 12 hours once enrolled as an experimental subject. The ethicists argue that the maintaining of the patient on polyheme once they have arrived at the ED is irresponsible and violates implied consent.

I have some links to both sides of the arguement and info on the nature of the studies in my shownotes here:

http://www.mediccast.com/blog/2006/03/07/episode-5-shownotes/

 

[krj00]

--------------------------------------------------------------------------------

Polyheme is part of a story in USA Today. Hank Williams Jr.'s daughter's rights were abused when a lifeflight crew unwittingly made her a guinea pig and infused her with that Polyheme stuff.



http://www.usatoday.com/news/health/2006-06-13-traumas-trials_x.htm?POE=NEWISVA

 

[gradygirl]

Wow, I had to write a research paper on PolyHeme for my college chem. class.

The use of PolyHeme is going to greatly advance the science of emergency medicine. As of yet (knock on wood), there have been no adverse reactions or other sort of physical harm done to any patients who have been given PolyHeme instead of whole blood. In fact, PolyHeme is the only human hemoglobin-based HBOC on the market. More or less, think of it as saline on steroids, a volume expander that carries oxygen. There is, more or less, nothing about the actual product itself that could cause any harm to a patient. It is completely sterile, has been chemically engineered so that the hemoglobin tetramers (the base units of hemoglobin) are are stabilized by polymerizing the tetramers into higher-order polymers, which prevent premature binding with NO (which causes mass vasoconstriction), as well as liver and kidney damage.

PolyHeme is incredible. It has a shelf life of four months. There is no need for cross typing, and so no chance of the body rejecting it. One extraordinary case of the use of PolyHeme was when a pt. experiencing massive hemorrhaging received 20 units of the HBOC in 20 minutes. 20 units of PolyHeme equates to more than 10 L of blood products. Also, as there are no blood products in PolyHeme, it can be used for pt.s that have a religious belief against receiving blood.

The only unethical aspect of the Phase III PolyHeme trials is the fact that the company, Northfield Labs, has not done an adequate job informing the communities in which the trials are being performed of their rights to refuse treatment with PolyHeme by wearing a special wrist band, one that, if seen by emergency personnel, will alert them to the unconscious patient's wishes to receive actual blood products.

 

[Banana]

Here's a twist on the ethical issue: Some religions, I believe Jehova's Witnesses is one if I'm not mistaken, do not allow blood transfusions. I believe they think that blood from another person put in their own body is a contamination or something to that effect. Anyway, I wonder if they would allow this stuff to be put in? Technically it's not blood, it's not from another person. And unless I'm mistaken, it's not putting something in their own body that's the problem, it's the fact that it comes from another body that's the problem, so this fake stuff should be no problem.

"Whole blood transfusions are rejected.[72] This is based on their understanding of the biblical admonition to "keep abstaining from blood" based on Acts 15:28, 29 (NWT). According to the conscience of the particular individual, they may accept derivatives of blood. In current medical practice, whole blood transfusions are very rare, and blood derivatives are used instead. Witnesses may accept a process called normovolemic hemodilution, a treatment that processes the individual's own blood in a closed loop that does not interrupt the circulation of blood, and delivers it immediately back into the person's body. Also left to conscience are procedures where a "quantity of blood is withdrawn in order to tag it or to mix it with medicine, whereupon it is put back into the patient."[73] Many members carry carefully prepared durable power of attorney outlining their medical wishes with respect to blood.
Jehovah’s Witnesses have been known to highlight the potential dangers of blood transfusions. Witness representatives have stated that plasma volume expanders are often times sufficient to take care of various medical emergency situations.[74][75]" - wikipedia

They might not reject it on the grounds of it being blood but they could decide that doing so is "going against Gods will" as if he wants to take their life, people shouldn't interfere.