Baghdad, Iraq – American military doctors have injected more than 1,000 of the war’s wounded troops with a potent,largely experimental blood- coagulating drug despite mounting medical evidence linking it to deadly blood clots that lodge in the lungs, heart and brain.
The drug, called Recombinant Activated Factor VII, is approved in the U.S. for treating only rare forms of hemophilia affecting about 2,700 Americans. In a warning in 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, 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 potentially 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.
Doctors and researchers at civilian hospitals, including Johns Hopkins and Massachusetts General Hospital, have rejected it as a standard treatment for trauma patients. Other hospitals say they are cautious about administering it because of clots found in their recipients.
Meanwhile, doctors at military hospitals in Germany and the U.S. have reported unusual and sometimes fatal blood clots in soldiers evacuated from Iraq, including unexplained strokes, heart attacks and pulmonary embolisms, or blood clots in the lungs.
At Walter Reed Army Medical Center in Washington, doctors said they tried to determine last year whether a high incidence of blood clots in their patients was related to Factor VII use in Iraq, but they discovered that the Army was not collecting sufficient information about the drug to draw any conclusions.
Doctors at Landstuhl Regional Medical Center in Germany said they plan to track complications among war casualties who got Factor VII after concluding that a heart attack in a patient in August was probably caused by an injection of the drug in Iraq.
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 of Loyola University in Chicago, a specialist in blood-clotting and blood- thinning medications.
Army trauma specialists say that clots in severely injured patients could be caused by many things and that using Factor VII is worth the risk.
But some civilian doctors who have worked with the drug say its clotting capabilities are so profound that they have to assume it is responsible for deaths among the military casualties who have received it.
Yet they were less troubled by the dangers, which they said might be justified given the injuries in Iraq, than by the lack of scientific evidence that war casualties are getting any benefit for taking the risk.
