Mikulski Demands Answers on Report That Battlefield Drug Puts Soldiers at Risk


WASHINGTON - Senator Barbara A. Mikulski (D-Md.), a member of the Senate's Appropriations Defense Subcommittee, today urged Assistant Secretary of Defense for Health Affairs Dr. William Winkenwerder Jr. to launch an investigation into a report by the Baltimore Sun that a drug used by military doctors on the battlefield - Factor VII - may cause fatal blood clots. The series, written by Sun reporter Robert Little, ran over several days last week.

"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," said Senator Mikulski. "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."

The text of Senator Mikulski's letter to Dr. Winkenwerder is reprinted below:

Dear Dr. Winkenwerder:

I am writing to alert you to a serious issue affecting the lives of our service members injured on the battlefield. According to The Baltimore Sun, there is evidence that a drug used by military doctors to stop bleeding from traumatic wounds may cause fatal blood clots. I urge you to immediately review the use and effects of this drug, known as Factor VII.

As a member of the Defense Subcommittee of the Senate Appropriations Committee, I am committed to ensuring that our men and women in uniform have the best available medical care. 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. Like you, I will continue to fight to give them the cutting-edge tools they need in their life-saving 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.

In particular, the Defense Department should track all patients who receive Factor VII on the battlefield, to monitor their progress throughout recovery. It is important to know whether Factor VII patients are more prone to blood clots or other complications, which may not develop in the first hours or days after initial treatment. 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.

If closer scrutiny of Factor VII finds that this drug poses too high a risk, we must have an alternative technology available to stop life-threatening blood loss on the battlefield. Important research in this field is underway through the Restorative Injury Repair Program at Defense Advanced Research Projects Agency (DARPA), as well as through the Combat Casualty Care Research Program at Fort Detrick, Maryland. Civilian hospitals are also developing new technologies for treating traumatic injuries. I will work closely with you to support the development of safe alternatives to Factor VII, should that become necessary.

Thank you for reviewing the alarming issues raised in The Baltimore Sun series on Factor VII. I look forward to working with you to support our outstanding medical professionals as they care for our nation's heroes and their families.



RELATED INFORMATION:

Factor VII Report Series, Baltimore Sun, Nov. 2006

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