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Military using Iraqi wounded as guinea pigs

Military use of hemophilia drug raises questions.

>> It stops bleeding, but it may cause strokes, even death...

Recombinant Activated Factor VII is approved in the United States only for treating rare forms of hemophilia, affecting about 2,700 Americans. In a warning last December, the Food and Drug Administration said that giving it to patients with normal blood could cause strokes and heart attacks. Its researchers published a study in January blaming 43 deaths on clots that developed after injections of Factor VII.

The U.S. Army medical command considers Factor VII to be a medical breakthrough in the war, giving frontline physicians a powerful new means of controlling bleeding that can be treated otherwise only with surgery and transfusions. They have posted guidelines at military field hospitals encouraging its liberal use in all casualties with severe bleeding, and doctors in Iraq routinely inject it into patients upon the mere anticipation of deadly bleeding.

"When it works, it's amazing," said Col. John Holcomb, an Army trauma surgeon and the service's top adviser on combat medical care. "It's one of the most useful new tools we have."

Yet the Army's faith in the $6,000-a-dose drug is based almost entirely on anecdotal evidence and persists despite public warnings and published research suggesting that Factor VII is not as effective or as safe as military officials say. <<

It may well be that the added risk is worth the benefit to a soldier rapidly bleeding to death of multiple GSWs. But the issue should be examined a bit more closely, don't you think?

-- Dave K, Speakeasy Moderator
click here to email semods4@yahoo.com

The opinions expressed above are my own,
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How does one examine more closely?

In reply to: Military using Iraqi wounded as guinea pigs

Well, probably by gathering data over time in real life situations. Surely this will be done but, hopefully, those opportunities will be few. Another way might be to line up people, pump them full of lead and try out the drug to see how many they can save and how many suffer ill effects instead. Sounds to me a lot like the seat belt arguments. Some are saved and some are hopelessly trapped. What does real life data say on this issue?

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Our hospital in Baghdad has a very high success rate...

In reply to: Military using Iraqi wounded as guinea pigs

.... saving lives. (Note they treat wounded Iraqis, including insurgents/terrorsts.)

Patients enter with multiple traumas, including gun shots, shrapnel, burns, maimed and missing arms and legs, massive head wounds, torn bellies. In other words, whatever damage can be done to a human body.

Much of the procedures used in civilian hospitals today is a result of what military medical personnel learned through caring for the terrible wounds suffered by their patients.

Medical personnel in the field are not likely to have the time to publish their experience with the new tools made available to them. Thus I object to the use of the word "anecdotal" in the article. When a patient is bleeding to death, usually from multiple sites, the focus is on stopping the bleeding. So I also obect to the use of the word "guniea pigs".

If the medical people in the field ever saw any untoward reactions/results from the product, they would immediately report it. After all, their job is to save lives. And they are very dedicated to that mission.

Some people can't eat peanuts, or take aspirin, or who die from bee stings. There can be rare reactions from much to which people are exposed. Some do not survive common surgical procedures. I doubt if those cited in the article are on the ground.

Yes, it is worth it.

Angeline
Speakeasy Moderator
click here to email
semods4@yahoo.com

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my math may not be too good, but

In reply to: Military using Iraqi wounded as guinea pigs

if #During one 24-hour period three U.S. soldiers arrived in the emergency room with traumatic injuries and all of them were injected with Factor VII. Two died, not from battlefield injuries but from complications related to blood clots, according to medical records and interviews with doctors#

and #Wounded troops requiring transfusions of 10 or more units of blood have a 25 to 50 percent chance of dying from injuries#

then why bother using the drug?

#researchers published a study in January blaming 43 deaths on clots that developed after injections of Factor VII#

i wonder out of how many people injected?


and just a BTW, your header led me to think that Iraqi wounded were being used, not "coalition casualties in Iraq"


,.,

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Consider estimates...

In reply to: Military using Iraqi wounded as guinea pigs

re: deaths in US hospitals caused by simple mistaken applications of fully approved medications...

consider how many folk die in US hospitals of secondary infections contracted after admission...

consider hew many of our soldiers have received experimental vaccinations designed to be prophylaxis against biological and nerve agent weapons...

I asked a psychiatrist overseeing one of my patients one day, how he decided what drugs to proscribe... his answer was simply "whatever worked the best, and had the least amount of side effects".

We put our lives in the hands of medicine everyday without fully realizing how small our knowledge actually is. In this case, I can forgive the needed use of this drug to stop someone from bleeding to death (ultimately it is a judgement call)... but if it comes out that it was used when not needed, then I could have a problem. Still, in the past when you gave yourself to the military, they have sometimes used our soldiers for experimentation (from radiation studies to LSD) so it appears that there is some legal precedent for the military to experiment if and when they feel it is appropriate. Anyone here know about this aspect of military service?

grim

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That's a tough situation ...

In reply to: Military using Iraqi wounded as guinea pigs

Trauma management is a bit out of my field, but my impression is that good quality trials for trauma techniques are few and far between. That is especially true in situations where the medical decisions are made by non-professionals in the field.

My suspicion is that anecdotal reports are about all we can get near term. BTW: I understand Angeline's objection to the word 'anecdotal' but I believe it is the appropriate label. Anecdotal evidence is evidence. It's not as good as a randomized controlled trial (RCT) but conducting an RCT in battlefield situations is unlikely. Military personnel have far more important things to worry about than checking a patient assignment protocol while they work with these guys. Any RCT will probably have to come from the civilian sector. It won't be easy to do but it will be a lot easier in an urban medical center dealing with the Friday/Saturday evening 'knife and gun club' victims than it will be in the battlefield.

In the interim about all the battlefield personnel can do is rely on the best judgment of the medical corps folks who write the protocols. It is possible that Factor VII is not as good as the Army says, but at some point we have to rely on the experts to make good faith decisions in the face of considerable uncertainty.

That should not come as a surprise. Our current standards for CPR/ACLS are still based primarily on expert opinion rather than RCT despite years of work trying to improve the algorithms. Doing high quality research on treatments for truly emergent problems is hard, and it is getting harder as the ethical rules regarding consent become more strict. How does one get informed consent from an unstable dying patient?

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I say "go for it"

In reply to: Military using Iraqi wounded as guinea pigs

they do not have the luxury of debate in the war zone. I would want the best option immediately if I am bleeding to death. "give me the shot" then discuss it during the 'lessons learned' class at walter reed after the field results are in. "stop, when and if you know it ain't working"

I would think that modifications might be made to reduce those side effects. hey, you might still be alive when they find a way to prevent strokes unrelated to this drug. if you die, what is learned may save another, so think of it as 'experimental altruism'.

I also thought that the OP 'headline' referred to iraqis only and was something sinister, hopefully not intentional. I will include the lab rat reference in that opinion.

I agree that unfortunately so many good things are born in war. 'necessity': the mother of....'

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I agree.

In reply to: I say "go for it"

Fix the big problem first...then work on the fallout.

I also was taken in by the misleading OP title. A more accurate subject line would have been nice.

Cindi

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But, without the misleading title,

In reply to: I agree.

it wouldn't be a condemnation of our military...

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Battlefield medicine has always been a less stringent

In reply to: Military using Iraqi wounded as guinea pigs

more experimental area of medicine. The odds are that an expensive drug like Factor VII is used in a "use it or lose the patient" setting in order to slow catastrophic bloodloss. Hopefully in 10 or 20 years it will have been turned into a topically applied agent that will not have the systemic effects that Intravenous use of Factor VII now has.

I remember an Air Force friend of my father's who had a neck problem that left him with numb or tingling fingers after high G maneuvers, partly due to the weight of the helmet. An Air Force surgeon volunteered to fix his neck, but when he woke up, Bob H. was paralysed on one side, permanently. Eventually he ended up working in the VA and one day a few years later had a young guy come into his office who told him the exact same story, and had the exact same disability. They both just had to come to terms with it. One of the drawbacks of military life.

Rob

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The use of term 'guinea pigs' is pejorative

In reply to: Military using Iraqi wounded as guinea pigs

and wording that is deliberately calculated to arouse repulsion and dislike of the use of the drug.

The expression that something being used as a guinea pig has become term derogatory of whatever procedure or event it refers to, connoting the value of the 'guinea pigs' is considered less.

The study raises questions of do they need to evaluate current limited data that is only available because of the use in Iraq in relation to future use.

The title is unnecessarily insinuating a disregard for 'Iraqi wounded' and suggesting the military PTB are cold blooded uncaring, etc. Such attempted subtle prejudicial verbiage trying to discredit the military command structure sadly distracts from the importance of the question of future use based on very limited current results by implying they shouldn't have even tried it as a method to control extreme blood loss.

Roger

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