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Probe Urged on Blood-Clotting Drug Use

Posted on: Thursday, 30 November 2006, 18:00 CST

BALTIMORE - Two U.S. senators are calling for a military probe of the use of a blood-clotting drug on wounded troops in Iraq, after reports of life-threatening clots following its use.

The Defense Department should track all patients who receive the drug, Factor VII, on the battlefield to determine whether they are more prone to blood clots or other complications, Sen. Barbara Mikulski, D-Md., said in a letter to Dr. William Winkenwerder Jr., Assistant Secretary of Defense for Health Affairs.

"We need to know if the long-term risks of this drug pose a greater danger to our service member's lives than can be justified by the short-term benefits," Mikulski said in a letter sent Wednesday.

Melissa Schwartz, a Mikulski spokeswoman, said the senator's office had not received a reply as of Thursday morning.

"I have no indication how fast we are going to hear," Schwartz said.

Senate Minority Whip Richard J. Durbin, D-Ill., said a series of articles by The (Baltimore) Sun on the military's use of the drug prompted him to seek answers from the Pentagon.

"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," Durbin said in a statement.

The military has justified the use of the drug, originally designed to treat rare forms of hemophilia, by saying it gives front-line doctors a way to control often fatal bleeding. Wounded troops requiring transfusions of 10 or more units of blood have a 25 percent to 50 percent chance of dying from their injuries, they note.

Military doctors in Iraq have injected it into more than 1,000 patients, and doctors at military hospitals in Germany and the United States have reported unusual and sometimes fatal blood clots in soldiers from Iraq.

Lt. Gen. Kevin C. Kiley, the Army's surgeon general, sent a letter to The Sun saying the use of the drug has been mischaracterized.

"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."

Meanwhile, a group of seven scientists and physicians who specialize in hematology and blood-clotting have written an editorial for an upcoming issue of the journal Applied and Clinical Thrombosis/Hemostasis saying there are "rightful concerns" about the use of the drug.

"Our soldiers are already in great danger and the availability of a lifesaving drug such as (Factor VII) is welcome," the editorial said. "It is, however, equally important to recognize and investigate the reported adverse reactions with its use to avoid additional risk to these Army personnel."

Rep. Roscoe G. Bartlett, R-Md., said he had confidence in the decision-making abilities of military doctors.

"It would be very nice to have some definitive study of the risks and benefits of using the drug prophylactically, and I hope that kind of research will be done," said Bartlett, a former professor of physiology at Howard University's College of Medicine. "But this war won't wait for that, and we have to let these doctors make their own judgment calls about what is necessary to save these soldiers."

Source: Associated Press/AP Online

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