Supporting our troops by making them guinea pigs?

November 21, 2006 2:08 PM

Recombinant Activated Factor VII--the Food and Drug Administration said that giving it to patients with normal blood could cause strokes and heart attacks... 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. ...
posted by amberglow (17 comments total)

and from inside that story: ...But in the hospitals away from the front lines, military doctors tell anecdotes about patients with strange clots in their lungs or brains that defy any obvious clinical explanation. And Factor VII has become a prime suspect.

When researchers at Walter Reed studied cases of blood clots in 2003, before Factor VII was introduced in Iraq, they concluded that war casualties had the same frequency of complications as victims of civilian trauma. A year later, the New England Journal of Medicine published a report on military care for the wounded, including the nine-month period after the Army had begun using Factor VII, and this time noted a "startling" rate of pulmonary embolism and DVT. ...
posted by amberglow at 2:11 PM on November 21, 2006

You say the Army's faith in the $6,000-a-dose drug is based almost entirely on anecdotal evidence? Pshaw. I'm sure it's also based on a highly persuasive PowerPoint presentation.
posted by Milkman Dan at 2:21 PM on November 21, 2006

Why should the FDA's opinion mean any more than the CIA's did?
posted by Kid Charlemagne at 2:22 PM on November 21, 2006

If they die at the front, they're KIA and have to be reported that way. If they die of their wounds in a hospital in Germany, they're not KIA. Keep the KIA count low, keep up support for the war.
posted by orthogonality at 2:23 PM on November 21, 2006

Who would have guessed that being in the Army was so dangerous?

And orthogonality, that's pretty cynical, even by intarweb standards. Front-line doctors want to save soldiers who are bleeding to death. I don't blame them for using the stuff - faced with definitely die now versus maybe die later... seems like a fair choice.

Unless they're injecting everyone with the stuff for no good reason (earache? Have some Factor VII!). Which is just sloppy.

Also, A+ for having an awesome sci-fi B-movie name for the drug. "He's dying doc!" "We'll have to use... Factor Seven!"
posted by GuyZero at 2:30 PM on November 21, 2006

It's really not a question of an absolute safety level, but rather a ratio of benefit to risk that has to be established," said Dr. Michael Shalmi, vice president of biopharmaceuticals for Novo Nordisk

I love this kind of measuring ! No, really ! It suggests that the outcome of taking the drug should be compared with the outcome of certain death. Clearly even the worse drug looks a lot better when compared with death, but that doesn't make the drug "good" it just makes it look better in the light of the worst outcome ever. Bah !

And doctors outside Iraq say they don't always know which patients received Factor VII inside Iraq because complete medical records may not travel with each casualty from hospital to hospital. Patients occasionally arrive in Balad or Germany with notes from frontline surgeons written on their bandages.

Absolufuckingincredible. Guess what ? They'll blame that on MASH like surgeonm busy with booze and girls ! Yet what is more likely is that accounting and accountability are like kryptonite to military , no wonder keeping track of their own soldiers injuries is.....laughable.

Defense officials denied The Sun's request to review autopsy reports of soldiers killed in Iraq and Afghanistan, first on privacy grounds

Dead people don't give a fuck about privacy, news at 11.
posted by elpapacito at 2:32 PM on November 21, 2006

Seconding GuyZero on the name of the drug. "I'm afraid we'll have to use... it." *gasp* "No... you can't mean -- Factor Seven!" *cue dramatic music*

If the choice is between bleeding to death right there in the field or possibly developing a blood clot in a hospital full of doctors, then the choice seems clear. That said, the Army should warn its medics of the danger, so they can hold off on using this unless it is truly necessary.
posted by vorfeed at 2:39 PM on November 21, 2006

You don't find out who's really behind Factor VII until the fourth level, in the corporation's lab.
posted by geoff. at 2:50 PM on November 21, 2006

GuyZero writes "Also, A+ for having an awesome sci-fi B-movie name for the drug. 'He's dying doc!' 'We'll have to use... Factor Seven!'"

The weird name wasn't invented by the army or the pharmaceutical company. It's just one of the "factors" in the coagulation cascade. It's pretty longstanding terminology.
posted by mr_roboto at 3:26 PM on November 21, 2006

If the choice is between bleeding to death right there in the field or possibly developing a blood clot in a hospital full of doctors, then the choice seems clear.

The choice is clear--This drug is not necessary, nor is it approved at all for this kind of use--there's clear evidence it's not safe to use this way. They know how to stop bleeding without resorting to this drug.
posted by amberglow at 3:57 PM on November 21, 2006

Yeah, not really a cool name. It's just a factor in the coag cascade. It's trade name is NovoSeven™.

Hemophiliacs take recombinant factor VIII.
posted by i_am_a_Jedi at 4:52 PM on November 21, 2006

Alarmist much?

I think it's safe to say that thrombotic complications aren't exactly a surprise or covered-up risk when you give someone a clotting factor. The point is that most doctors tend not to just inject an extremely expensive medication for kicks. It's typically used for uncontrollable bleeding in critically ill patients who would die otherwise.
posted by drpynchon at 6:06 PM on November 21, 2006

there is more than one clotting factor, no? why 7, especially when it's known to be dangerous? why 7, especially when the FDA and no other country on earth has approved it for use on regular people?
posted by amberglow at 6:57 PM on November 21, 2006

Regardless of the clotting factor used, there's always going to be a concern for clotting since you're typically using it to stop a bleed. In essence you WANT clots, and the clotting cascade is activated most prominently at sites where the endothelial cells that make up the insides of blood vessels have broken down, namely at sites of bleeding. But there's always the risk of clotting elsewhere. The reason why it's 7 in particular is somewhat complicated. If you take a look at this clotting cascade schematic, you might notice that it plays an integral role in initiating clotting particularly at the sites of cellular injury which is part of what makes it in theory a favorable option for targeted therapy.

I can tell you that this medication is used by many physicians in patients without clotting deficiencies as an off-label use, but my experience is that it's been used as a last ditch effort. Frankly without a primary source on how the military is using it I can't really speculate about whether it's appropriate or not. If they're injecting soldiers with papercuts on the field as the article seems to suggest, then yes, that's insane. Furthermore, if the military truly isn't keeping a record of and studying any of the soldiers in whom it's used, I'd say that's irresponsible. That said, in Europe, where it's been used more extensively, the consensus guidelines include recommendations for use in some cases of blunt trauma and uncontrollable surgical bleeding among other settings. This is based on the available medical literature and endorsed by the European Haematology Association, the European Association of Trauma and Emergency Surgery, and others. In the US it's only FDA-approved use to date is in hemophiliacs, but it is in fact used by some physicians on non-hemophiliacs as I noted. And as you probably know, this is far from the only "off-label" use of a medication in the US.
posted by drpynchon at 8:05 PM on November 21, 2006 [1 favorite has favorites]

New here, but wanted to add to this particular discussion. I'm in the National Guard, and recently returned from a year in Iraq. Most of our unit (myself included) received advanced first-aid training, and were issued several intravenous bags of a clotting agent.

I couldn't help but wonder if the Factor VII is the same stuff we were issued. I can say that we had explicit instructions to use our stuff only when absolutely necessary - i.e., if someone has a paper cut, no, it's not necessary; if someone just had their leg blown off and is going to die of blood loss in minutes, then hell yes, stick an IV in them and do whatever you can to stop the bleeding and get them stabilized so they can be medevac'd. I'd be surprised if they were still pumping it into people after they'd been treated, though.
posted by zbaco at 10:41 PM on November 21, 2006

thanks, zbaco--i'm glad you're back ok. I wonder if any of those kids you gave it to had problems later tho? And why is the military still hiding autopsy reports and stats?
posted by amberglow at 9:16 AM on November 22, 2006

and now another one: Blood substitute too risky to test, panel says --A Navy plan to test a blood substitute on civilian trauma victims should remain on hold, federal health advisers recommended Thursday, saying the experiment’s risks outweigh its benefits.

The nonbinding vote appears to be the latest blow to the Navy, which has repeatedly sought Food and Drug Administration approval to test the product, derived from cow blood, on roughly 1,100 trauma victims in emergency situations. It proposes doing so without obtaining the customary informed consent of patients. ...
posted by amberglow at 6:14 AM on December 18, 2006