Senators urge probe of drug

They want Pentagon to determine if Factor VII's risks outweigh benefits

Sun Follow-up

November 30, 2006|By Robert Little | Robert Little,Sun reporter

Two U.S. senators called on the Pentagon yesterday to investigate the military's use of a largely experimental blood-coagulating drug that doctors inject into wounded troops to control bleeding but that has been linked to unexpected and potentially deadly blood clots.

Sen. Barbara A. Mikulski sent a letter yesterday to Dr. William Winkenwerder Jr., the assistant secretary of defense for health affairs, asking him to launch an investigation into use of the drug, called Recombinant Activated Factor VII. She urged him to "immediately review the use and effects" of Factor VII to determine whether its potential risks outweigh its benefits.

"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 the Maryland Democrat, who serves on the Appropriations subcommittee on defense. "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 Sun this month highlighting the Army's liberal use of Factor VII despite evidence of potential complications. The series profiled two wounded soldiers from Illinois who were injected with the drug and later suffered blood clots that might have contributed to their deaths.

Senate Minority Whip Richard J. Durbin said the series has 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," the Illinois Democrat said in a statement released yesterday.

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

Factor VII is approved by the U.S. 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 more liberal with its use, often injecting it into wounded patients on the mere anticipation of future bleeding.

The FDA warned last year that its use in non-hemophiliacs has been associated with unwanted blood clots leading to deadly conditions such as stroke, heart attack and pulmonary embolism. The Sun's report identified several wounded soldiers treated with the drug who later developed blood clots.

Lt. Gen. Kevin C. Kiley, the Army's surgeon general, sent a letter to The Sun yesterday saying the newspaper had mischaracterized the service's use of Factor VII and calling the 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."

He said a continuing analysis of cases at Landstuhl Regional Medical Center in Germany has found no increase in complications related to Factor VII, and he cited a clinical trial, based in South Africa and published last year, as evidence that the drug is safe.

But that clinical trial, which the FDA would not allow to be conducted in the United States because of safety concerns, also showed that the drug had little effect on trauma patients, and physicians inside and outside the Army have said a much larger trial of 1,500 or more patients is necessary to establish the drug's potential risks. Several doctors at Landstuhl, including the hospital's head of trauma and its director of intensive care, said they have never tracked Factor VII use because the Army's recordkeeping is insufficient.

The Army's enthusiasm for Factor VII is based largely on anecdotal accounts from doctors in Iraq who ascribe to it a dramatic, often-lifesaving ability to stop severe bleeding in patients with multiple injuries. Army and Pentagon representatives have continued to defend the drug's use despite reports of potential complications, saying combat casualties in Iraq often have horrific wounds and few treatment options.

"It is only used in severe trauma cases where severe bleeding cannot be stopped," Smith said.

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