Senators seek review of blood drug’s use

BALTIMORE —  Two senators called on the Pentagon on Wednesday to investigate the military’s use of a largely experimental blood-coagulating drug that doctors inject into wounded troops to control bleeding, but which has been linked to unexpected and potentially deadly blood clots.

Sen. Barbara A. Mikulski (D-Md.) sent a letter to Dr. William Winkenwerder Jr., assistant secretary of Defense for health affairs, asking him to launch an investigation into use of the drug, called Recombinant Activated Factor VII.

“Our military medical professionals are working miracles on the battlefields of Iraq and Afghanistan, achieving historical rates of survival even in the face of devastating new battlefield injuries,” wrote Mikulski, who serves on the defense subcommittee of the Senate Committee on Appropriations.

“Like you, I will continue to fight to give them the cutting-edge tools they need in their lifesaving work. But the serious questions that have been raised about Factor VII must be answered, so our service members and their families can be confident that we are providing them the safest possible care.”

Mikulski’s letter followed a series of articles in the Baltimore Sun highlighting the Army’s liberal use of Factor VII despite evidence of potential complications, and which profiled two wounded soldiers from Illinois who got the drug and later suffered blood clots that might have contributed to their deaths.

Sen. Richard J. Durbin (D-Ill.), the Senate minority whip, said the series had prompted him to seek similar answers from Pentagon officials.

“The safety of our troops is the top priority, and my office is discussing the serious findings reported in the Baltimore Sun with the Defense Department,” he said in a statement released Wednesday.

Defense spokeswoman Cynthia Smith said she could not discuss correspondence between members of Congress and the Pentagon’s civilian leaders, and said Winkenwerder would respond to Mikulski directly.

Factor VII is approved by the Food and Drug Administration for treating rare forms of hemophilia, and it was introduced in Iraq in early 2004 as a treatment for traumatic bleeding that military doctors could not stop by any other means.

Since then, the $6,000-a-dose drug has been administered to more than 1,000 wounded American troops, and doctors have grown liberal with its use, often injecting wounded patients on the mere anticipation of future bleeding.

The FDA warned last year that its use in nonhemophiliacs had been associated with unwanted blood clots leading to deadly conditions including stroke, heart attack and pulmonary embolism, or blood clots in the lungs.

Lt. Gen. Kevin C. Kiley, the Army’s surgeon general, sent a letter to the Sun on Wednesday saying the newspaper had mischaracterized the service’s use of Factor VII and calling its series “a disservice to our doctors, their commitment to injured soldiers and their families.”

“This product is used on a case-by-case basis, in specific circumstances as ordered by the physician, to control life-threatening bleeding,” Kiley wrote. “It saves the lives of our most severely injured troops.”