Dangerous Gamble
Dec. 5, 2006 — -- U.S. military doctors are using a controversial drug in a setting unmatched by any U.S. civilian hospital -- while civilian doctors in hospitals across the country are carefully watching to see whether the military is blazing a new life saving frontier or subjecting badly injured soldiers to a drug that may be doing more harm than good.
Trauma surgeons on American soil use the same drug on civilians, with only anecdotal evidence to suggest that the drug isn't causing harm to patients who are sometimes at death's doors when the drug is administered.
The question is, knowing its potentially deadly risks, is the use of this drug a responsible medical move?
Recombinant Factor VIIa -- or rF7a, sold as NovoSeven -- is a blood-clotting medication approved by the FDA only to control bleeding episodes in some hemophiliacs and in patients whose bodies don't make natural rF7a.
The drug is designed to work with the body's own blood-clotting machinery to slow down and stop uncontrolled bleeding in hemophiliacs. It is not FDA approved to stop uncontrolled bleeding in soldiers who have suffered blast wounds, or in civilians caught in car crashes or gunfire, but that's exactly how doctors in Iraq and the United States have been using it.
To use a drug for any use other than that for which it has been approved is called off-label use. Off-label use is very common in medicine -- but can be very risky.
In the case of rF7a, the very things that make the drug work for hemophiliacs also make it risky -- or potentially deadly -- for anyone else.
"Because rF7a works by activating the body's blood-clotting system, a potential risk is clotting at sites other than the injury [thromboembolism]," said Paul Richards, an FDA spokesman.
The FDA and the drug maker, Novo Nordisk, warned doctors in 2005 that the rF7a could potentially increase the risk of blood clots and complications from blood clots in nonhemophilia patients.
"The moment [rF7a] reaches the bloodstream, it triggers clotting," said Jawed Fareed, a pharmacologist and director of the hemostasis and thrombosis research program at the Loyola University Stritch School of Medicine in Loyola, Ill.
That means rF7a could cause strokes, heart attacks or worse. That danger might be even greater in trauma patients -- especially military trauma patients -- where splintered bone fragments attract blood factors that increase the risk of blood clots. But doctors have no evidence now that the drug is in fact causing harm to patients -- nor do they have conclusive evidence of the drug's benefits.
The very population in which the drug is being used is an at-risk population. Trauma victims are already at a high risk of developing clots and pulmonary emboli just by the nature of their injuries.
The military's use of rF7a -- as it was recently described in a series of articles by Baltimore Sun reporter Robert Little -- embraces those potential risks in favor of the possible benefits to wounded troops.
Roughly 5 percent to 10 percent of soldiers brought into military trauma wards are treated with aggressive treatment guidelines that include giving rF7a.
Civilian hospitals in the United States use rF7a off-label only as a last resort, but military hospitals are very different from civilian hospitals. They see vastly different degrees of trauma. Combat hospitals are in a war zone. Civilian hospitals are not.
Trauma surgeons at combat support hospitals see soldiers who have been hit by roadside bombs, improvised explosive devices (IEDs), or worse. Patients arrive suffering multiple kinds of serious trauma wounds -- what doctors refer to as blunt and penetrating trauma.
Blunt trauma is like what a civilian would suffer in a car accident. Penetrating trauma is like a stab wound. Typically, civilians suffer one or the other.
"The most common injury you see in Iraq is a wounded soldier after a truck explosion," said Dr. Martin Lucenti, director of clinical operations at Northwestern Memorial Hospital in Chicago and a member of the Vermont Army National Guard.
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