Biz as Usual: Novo Nordisk Settles re NovoSeven, Seeks Brand Manager

June 14th, 2011. By AbiK

In case this one slipped under your radar, Danish drug company Novo Nordisk agreed to a settlement to the tune of $25 million to put to bed whistleblower allegations that it wrongly marketed its drug, NovoSeven (aka recombinant human coagulation Factor VIIa, or simply, Factor VII) as a treatment for traumatic bleeding due to injury.

Of course, outside of hemophiliacs—the obvious and intended audience for such a drug—who else could such a drug be marketed to? Well, gee, who might bleed a lot…let’s see…uh…well, there’s been a war going on over in Iraq and Afghanistan…maybe NovoSeven could be used to stop a soldier’s bleeding…whatdya think?

Sure, I’m being facetious here as I’m wont to do—but could such a scenario have really been all that far off—even if Novo Nordisk claims otherwise?

And ordinarily, this might have a shred of altruism to it—who wouldn’t want to help our soldiers? But here’s the catch: it seems that, according to The Baltimore Sun, NovoSeven was “a largely experimental drug” and it lacked FDA approval for combat wounds. According to the article, Novo Nordisk began promoting NovoSeven to military doctors way back in 2000, and by 2006, “Army protocol in Baghdad called for injecting it into virtually every casualty with signs of serious bleeding. Some Special Forces units in Afghanistan supplied combat medics with the drug, to inject in the field.”

Sounds like fairly extensive and routine use to me. 

Add to this that studies have shown that off-label use of NovoSeven—which not only includes using it to treat combat wounds but also using NovoSeven for intracranial hemorrhage, cardiac surgery and aortic aneurysm, liver transplants and prostatectomy—has not translated to a reduction in mortality rates, and the use of NovoSeven for heart surgery and intracranial hemorrhage actually increased the risk of thromboembolism.

And this is how we want to treat our soldiers’ combat wounds?

I use the term “treat” a bit loosely—The Baltimore Sun had profiled three soldiers who’d been “treated” with NovoSeven in a series of articles written back in 2006. Sadly, two of those three soldiers later died as a result of complications related to blood clots. (Post script, the FDA has since added a warning to NovoSeven.)

Regardless, Novo Nordisk claims no wrongdoing (of course) in the NovoSeven settlement and, as business must keep on movin’ on, it appears Novo Nordisk is now seeking a new Senior Brand Manager for NovoSeven (see job posting above).

Tags: Afghanistan, Factor VII, Iraq, Novo Nordisk, NovoSeven, NovoSeven Lawsuit, NovoSeven Settlement, Soldiers, Veterans, Whistleblower

This was posted on Tuesday, June 14th, 2011 at 11:26 am and is filed under Drugs/Medical, Veterans, Whistleblower . Feel free to respond, or trackback. Read our comments policy.