Blood clotting drugs given to soldiers...problems resutl may include death

[nolies32fouettes]

What's your ideas?

http://www.progressiveu.org/174009-dangerous-drug-being-administered-to-wounded-soldiers

[BleedingHeartPatriot]

1. Until this drug is APPROVED by the FDA for this use, they should desist immediately.

I imagine that the numbers of troops who die after receiving this drug are higher than the article implies.

Until we have much, much more than anecdotal evidence that it's effective, this practice needs to stop. There have been no peer reviewed studies.

The article gives the impression that it's a roll of the dice whether the drug is effective. Certainly, it sounds as if there have been multiple instances of untoward reactions to the medication, which are well known and well documented.

This is a lousy risk/benefit ratio.

My immediate thought is "Who stands to benefit financially from this drug's increased use?" MKJ

edited to add more thoughts on the matter

[nolies32fouettes]

2. Isn't it a catch 22? Maybe it could save lives?

Though i personally just say, "GET the troops out!" That will take away the need for that other question.

[BleedingHeartPatriot]

3. The "maybe" is the problem. And our troops are being used as guinea pigs.

This is unethical at best, illegal at worst. MKj

[nolies32fouettes]

8. unethical and illegal. But I wonder if they ask the soldiers to sign a

waiver.

[nolies32fouettes]

32. 2 more Recs needed...please if you think the comments are

worthy of wider viewing...please Recommend!

[ray of light]

37. Hey FOLKS--Give this thread TWO Rec's. This thread is fantastic!

[spoony]

42. The horrible irony of modern combat medicine

is that while it saves more lives, in many ways it leaves more victims. Physical and mental damage that never goes away.

I'm with you, though. The best way of saving lives is to bring them home.

[nolies32fouettes]

48. Hi! Welcome to DU.

I'm honored to have your comment on my thread.

:hi: :hi: :hi:

[spoony]

50. Thank you!! :) n/t

[crispini]

6. Use of drugs for other than their FDA-approved purpose..

is actually fairly common in the United States. It's called "Off-Label Use"

http://en.wikipedia.org/wiki/Off-label_use

I'm not sure what to think about this particular off-label use, but it sounds from the article like it's a lot more justified than the off-label use of Botox!

[BleedingHeartPatriot]

9. Here's a more detailed article about this, which is clear about the huge danger of using this drug

http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2006/11/19/MNGHUMFTR01.DTL

MKJ

[nolies32fouettes]

10. thank you. Can you post that link to my blog?

[BleedingHeartPatriot]

30. Only if I don't have to register with my name, email and all that. You are welcome to post it,

I am not an attribution demanding sort. :hi: MKJ

[nolies32fouettes]

14. I wondered the same thing.

[benddem]

4. I agree that this needs to be studied

but this is a situation where you are damned if you do and damned if you dont. If you've ever seen a GI bleed to death cause they'd been transfused with so many units of blood you have changed their blood type, you might think this through. You cannot stop the bleeding. In Vietnam sometimes we just put buckets at the end of the bed so it could drip in. You are helpless to do anything their blood just won't clot. In Vietnam most of the deaths before the wounded got to the hospital were because of blood loss. They didn't have enough blood volume to support life functions. So they could bleed to death, or have a stroke or heart attack...seems to me that there are a percentage that survive with no problems. Since it seems that the deaths or injury from clots occurs after they leave Iraq, they could also think using anticoagulants after the surgeries which stop the fresh bleeding. I'm just glad I don't have to make this decision.

[BleedingHeartPatriot]

7. This is not a brand new drug. Certainly, if there had been evidence that it was effective

against massive hemorrhaging and DIC (disseminated intravascular coagulation), it would be approved for that use.

I worked as an ER nurse, and saw horrific traumatic injuries (MVA's, gunshots, etc.) which I would have been on my knees in gratitude if we had available a drug which safely increased the clotting factors and potentiated the benefits of the transfusions. This drug is narrow spectrum because it is targeting those individuals with specific clotting factor deficiencies, not the wide domino effect of clotting factors involved with a massive bleed.

Yes, I can so understand the desire to do something, anything to save our men and women horrifically injured in combat. But, it's beyond egregious to use the medication this way and put these young people at an enormous risk for developing emboli, especially after an extended period of inactivity and transport.

And, as I said, it appears our troops have now become experimental subjects at the behest of who? At $6000/dose I say FOLLOW THE MONEY. MKJ



edited to add snippet from article in post, above:

During one 24-hour period in May, at the 10th Combat Support Hospital in Baghdad, 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.

Civilian trauma and blood specialists think the military is taking an unwarranted risk with wounded soldiers because the drug has never been subjected to a large-scale clinical trial to verify that it is safe for patients without hemophilia.

"It's a completely irresponsible and inappropriate use of a very, very dangerous drug," said Dr. Jawed Fareed, director of the hemostasis and thrombosis research program at Loyola University in Chicago and a specialist in blood-clotting and blood-thinning medications.

"It's insane, using it that way. Absolutely insane," said Dr. Rodger Bick, a University of Texas hematologist and editor of the Journal of Clinical and Applied Thrombosis/Hemostasis.

[benddem]

15. sorry

I didn't mean to imply that this drug would work against DIC. I meant that if we could get the blood to clot before we had to give them 20 units or more of blood...we could prevent DIC. I'm amazed that when they are seeing kids die at the csh they have continued its use.

[nolies32fouettes]

16. So you'd follw the money to who? & are they being gunnea pigs?

[BleedingHeartPatriot]

23. At $6,000 per dose without clinical evidence to support its use, those are the questions.

MKJ

[nolies32fouettes]

25. Is there something morally wrong about NOT using it?

It really does seem like a no-win situation.

[BleedingHeartPatriot]

27. Well, someone's making a profit. This has never been used for severe trauma before.

It's never been proved, in controlled, peer reviewed studies to reduce deaths by massive bleeding. Never. MKJ

[nolies32fouettes]

12. OMG...your story is incredible! I wish you'd post it on my blog.

My blog does get some 'freepers' too.

[lyonn]

5. How hard would it be to figure out how many who died of

unusual blood clots, heart attacks, etc. had received that drug? Should give them a fairly good basis for either stopping or continue using it. Imagine if someone had both legs blown off how much blood they would lose and no doubt die from the bleeding alone.

[nolies32fouettes]

11. The problem is the coverup! Look at Gulf War 1.

They denied the depleted uranium they were using there. They denied the shots they gave the soldiers caused birth defects.

They can't be trusted!

[ray of light]

40. it would be very difficult. I met a military soldier who told me that

he worked with an official who told him ways to fudge the data.

[Dunvegan]

13. My thoughts on the use of this drug on the battlefield is somewhat "sanguinely" conflicted...

If a critically injured soldier lives long enough to make it out of the MASH Unit...yet dies later because of a proven relationship and direct reaction from the intervention use of a controversial off-label (and relatively new) drug, does this kind of "delayed death" show up in our Iraqi/Afghanistan war death count?

I certainly hope this drug saves far more lives than it eventually ends. In many near-hopless cases, the common battlefield wisdom says this is a miracle drug that reverses massive bleed-out and stabilizes patients in heretofore impossible to stabilize extreme bodily injury situations.

I also have to wonder just how far the DoD is willing to go in order to obscure the truth, regarding the overall welfare of our soldiers and any possible later fallout, just so as to rely on an unproven protocol that can shave immediate numbers off the death figures for our troops.

In other words: Are military doctors making the decision to use, in a creative fashion, the hemophilia Recombinant Activated Factor VII as the best choice in near-hopless situations with the belief that this unusual use of this drug is very much (on percentage) a true life-saving winner for our soldiers in battlefield military medical units?

Or is the DoD approving this experimental usage in an attempt, with knowing intent, to literally and cynically "stop the bleeding" and lower the current numbers of death from war, but ignore the eventual and life-long effect on the welfare of our troops?

The DoD creates cynicism by it's continuing aloofness and remove concerning the fate of our soldiers after the battle is done.

It's well documented (e.g., Agent Orange) that the usual fallout from the use in war of unusual compounds (when evidence eventually uncovers unexpected and terrible long-term consequences) is the manufacture of a DoD fog of confusion, and this makes it very difficult for military families to obtain later VA care or (in case of death) acknowledged compensation.

This drug points to stroke and heart attack as the contraindicating side-effects. Both are easy for the DoD to call non-military casualties, and both are hard to prove as being the fault of an experimental battlefield treatment to families seeking compensation from the military.

Considering the cases this drug is used in (massive injury casualties) there is a good chance that a large percentage of the soldiers stabilized using this drug would have never made it into the operating room due the impossibility of stabilizing them for surgery. This is true. And saving lives (in and of itself) is an unarguable goal.

However, a great deal regarding this debate falls back on the real politik of the top-down intent concerning the rationale of this particular experimental drug use, and the government's willingness to take responsibility over time to the soldiers, and the families of soldiers, treated with this drug.

[Mayberry Machiavelli]

17. A couple of points:

The soldiers in question are hemorrhaging, so there is definitely potential benefit as well as potential risk if it prevents some from bleeding to death. The biggest problem I see is that if the Army is going to use this drug in this way, data should at least be collected well enough so that a definitive answer, if possible, can be obtained to the question of whether any benefit outweighs any risk. The anecdotal disapproval of the hematologists in the article does not necessarily outweigh the anecdotal enthusiasm of the Army trauma doctors for the treatment. What is needed is data, and if it is clear that risks outweigh benefits, then the treatment should be abandoned. If benefits of increased survival outweigh increased deaths from clots, then the treatment has a role.

Since even without this treatment, victims of major trauma sometimes die from blood clots, it's impossible to know in any one case whether a death from a clot was due to this drug, or a complication that would otherwise have happened anyway. The effectiveness and risk of the treatment can only be determined by looking at larger bodies of data in treated and untreated groups: Benefit being how many fewer (if any) die from hemorrhage, and risk being how many more die from clot type complications in the treated as opposed to the untreated groups.

It's important for DUers to understand that medical personnel practicing in the Iraq theater taking care of active duty military members are not legally held to the same standard of medical care as exists in the United States, according to well established legal precedent. The personnel, equipment, medications and environment available at the Combat Support and Air Transportable Hospitals are not the equal of what is available in a big city trauma center in the United States. As a result of this, and other factors, active duty members cannot sue for malpractice for care rendered in such a setting, where presumably people are simply doing their best with what is available. Actually, active duty personnel can't sue for malpractice even for care rendered electively in stateside military hospitals, but that's a tale for another time...

This however does not absolve the military medical personnel of the moral responsibility to exercise due caution in their care, and not to experiment recklessly on the active duty personnel without clear indications of benefit from the proposed treatments.

[nolies32fouettes]

19. Thanks for your thoughts. You're so right! AND that was one reason

I wanted to discuss this topic.

[nolies32fouettes]

18. Please k & R for the troops. I think we need to know these answers.

[ray of light]

20. K and R!!! this needs to be front paged! AND I'm amazed by

how much I've learned from the replies.

Thanks for the indepth replies everyone!

[Horse with no Name]

21. Without more information it is hard to say

It is worthy of noting that when limbs are blown off traumatically, there is always a risk of embolus.
There is also risk of blood clots when people are confined to long spaces with their legs folded (there was an embedded reporter that died of a blood clot this way early in the war).
It is worth investigating to see if this drug is helping or hurting.
Because if the person would die from their blood not clotting anyway, and then end up dying from being given the drug, there really isn't a lot of difference so it would be prudent to figure out
1. If the initial injuries were traumatic enough to cause clots
2. If the patient would have died without receiving the drug
At that point you can try to assess the benefit ratio because at a cost of $6000 a dose, I am going to assume that it isn't given without careful consideration.

[BleedingHeartPatriot]

26. The experts in the field of hematology think it's insane, direct quote.

Civilian trauma and blood specialists think the military is taking an unwarranted risk with wounded soldiers because the drug has never been subjected to a large-scale clinical trial to verify that it is safe for patients without hemophilia.

"It's a completely irresponsible and inappropriate use of a very, very dangerous drug," said Dr. Jawed Fareed, director of the hemostasis and thrombosis research program at Loyola University in Chicago and a specialist in blood-clotting and blood-thinning medications.

"It's insane, using it that way. Absolutely insane," said Dr. Rodger Bick, a University of Texas hematologist and editor of the Journal of Clinical and Applied Thrombosis/Hemostasis.

http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2006/11/19/MNGHUMFTR01.DTL

MKJ

[Horse with no Name]

29. Were those the only hematologists that they talked to?

Or did they deliberately leave information out of hematologists that said it might be effective?
Go ahead and give me a research grant, let me cherry-pick the information in the direction that I want my story slanted, and I guarantee I can find doctors to back up what I say.
Which is what brings me back to my initial statement:
"Without more information..."

[BleedingHeartPatriot]

31. When it comes to managing clotting factor issues, a drug which only manages a single factor

won't do the trick with the cascade effect related to DIC.

It might work once in a while, however, it will kill those who don't respond to the specific spectrum of Recombinant Activated Factor VII.

Basically, if it doesn't help you, it will kill you. And, odds are, you will be killed rather than helped.

Risk/benefit ratio on this one is horrible. MKJ

on edit, I will be happy to provide you with the clinical evidence that it is ineffective in treating anything but the narrow spectrum hemophiliac patients for which it was developed. And, the mulitiple FDA warnings that have come out regarding this medication. MKJ

[nolies32fouettes]

41. Thanks

clinical evidence is always good. I like to be complete with these thigns...

But htanks for the great points! I'm posting your link on my blog...

[nolies32fouettes]

49. That's a good point. But bleedingheart offered the statical data for you.

[nolies32fouettes]

34. Is this a "liberal" view? Or more widespread?

[nadinbrzezinski]

22. I'm not a doctor but as a medic wtih ten years in the field

I will describe teh problems before this drug was first used by the Israelis

When yuo give blood products to a trauma victim one of the things that happens, especially with full blood, is that the more you give the worst problems you will have with coagulation.

I have no idea what the cut off point is, but it reaches the point that if yuo don't give them this they are going to bleed to death.

So you are truly in between a hard rock and a hard place. Give them this and risk the complications or watch them die.

[nolies32fouettes]

24. Another great point. Thanks!

[BleedingHeartPatriot]

28. Please provide the link to the studies that support its use in DIC. n/t

MKJ

[BleedingHeartPatriot]

33. My final summation. This drug, if it doesn't help you, it kills you.

Which means it's not the kind of drug of which one can say, it won't hurt, it might help. You know, the acceptable risk/benefit ratio to which we in medicine ascribe.

This drug's ratio: You might be helped, however, even if helps you in the short run, the odds are, it will eventually kill you even if you had a chance to survive without it.

Follow the money. MKJ

[nolies32fouettes]

35. But if you're going to bleed to death in the 'field' is it worth the risk?

[BleedingHeartPatriot]

36. So, nolies, what are your thoughts about this? You've been asking a lot

of provocative questions.

You know how I feel. I'd love to hear your perspective. MKJ

[nolies32fouettes]

38. Well, obviously its a tough situation.

But I really dont think they should be using it without more thorough information on how people OTUSIDE of its intended purpose react to it. If htey HAVE information on that it needs to be released, but certianly i've not seen anything about htat. Like the FDA said, its approved for a narrow spectrum, and benefits only that spectrum.

I don't support soldiers bleeding to death en route to the hospital, but nor do I think they should be given "anecdotally supported" medications. I would prefer for use of it to be discontinued until there IS more evidence about its effects on those outside of its intended users. Survey teh hospitals adn find out who was injected, etc. Give someone a grant... But Don't play with our troops lives.

But it also brings to mind another point htat irks me. THese deaths AREN'T included in our death counts, as are most deaths that occur en route to the hospital, or "outside" of Iraq. IT makes me wonder how bad it REALLY is...

Again, I think its use should be discontinued in this manner until we have information PROVING its safe.

Not to mention that at 6000 a dose, I'd want to see if the parmaceutical company has done any of its OWN research to PROMOTE it for such use.

[ray of light]

39. Good comment. The taxpayers would probably be paying

for these studies. (If there are any)

[ray of light]

43. This seems like a heart wrenching decision.

[genie_weenie]

44. Big Deal. After all the signed the contract..

Oh, I suppose I could have typed a scathing heart rendering comment at the evils of this program here but it's no differnet than the non-FDA apporved Anthrax shots which were forced upon servicemembers post Anthrax scare 2001.

Until enough complaints and complications caused a DoD wide stop to be put into place around Christmas 2003.

Which lasted 24 hours as the FDA then decided to approve it and the mandatory shots began again.

[BleedingHeartPatriot]

45. .

Don't get me started the "Anthrax vaccine". You are so, so right, sadly. MKJ

[ray of light]

46. What about the shot they gave Gulf War 1 soldiers.

Wasn't that causing birth defects too? (And many other problems?)

[nolies32fouettes]

47. Please get started. I don't know anything about this and would

appreciate your insight.