Hemophilia drug used on GIs labeled risk
Sat Nov 18, 3:24 PM ET
http://news.yahoo.com/s/ap/20061118/ap_on_he_me/hemophilia_drug_troops
BALTIMORE - A blood-coagulating drug designed to treat rare forms of hemophilia
is being used on critically wounded U.S. troops in Iraq despite evidence it can
cause clots that lead to strokes, heart attacks and death in other patients, The
(Baltimore) Sun reported for Sunday's editions.
Recombinant Activated Factor VII, which is made by Danish pharmaceutical company
Novo Nordisk, is approved in the United States for treating forms of hemophilia
that affect fewer than 3,000 Americans. It costs $6,000 a dose.
The Food and Drug Administration said in a warning last December that giving
Factor VII to patients who don't have the blood disorder 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.
However, the Army medical command considers it a medical breakthrough that gives
front-line physicians a way to control deadly bleeding. Physicians in Iraq have
injected it into more than 1,000 patients, reported The Sun, which makes its
first Sunday edition available Saturday afternoon.
"When it works, it's amazing," said Col. John B. Holcomb, an Army trauma surgeon
and commander of the Army's Institute of Surgical Research. "It's one of the
most useful new tools we have."
Critics strongly disagree.
"It's a completely irresponsible and inappropriate use of a very, very dangerous
drug," said Dr. Jawed Fareed, director of the hemostasis and thrombosis research
program at Loyola University in Chicago and a specialist in blood-clotting and
blood-thinning medications.
Military doctors said patients requiring transfusions of 10 or more units of
blood have a 25 percent to 50 percent chance of dying from their injuries, and
there is enough evidence of the drug's effectiveness to continue promoting its
use.
"I've seen it with my own eyes," said Air Force Lt. Col. Jeffrey Bailey, a
trauma surgeon deployed this summer as senior physician at the American military
hospital in Balad, Iraq. "Patients who are hemorrhaging to death, they get the
drug and it stops. Factor VII saves their lives."
However, doctors at military hospitals in Germany and the United States 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. And some have begun to suspect Factor VII, The Sun
reported.
Contacted Saturday by The Associated Press, an Army spokeswoman, Mary Ann
Hodges, declined to comment immediately on the report because she had not seen
it.
Doctors say determining the precise cause of blood clots is rarely possible,
making it difficult to establish definitively whether Factor VII is responsible
for complications. And military doctors caution against drawing any conclusions
from individual cases.
Officials at Novo Nordisk said complications don't mean the drug is too
dangerous to use.
"It's really not a question of an absolute safety level, but rather a ratio of
benefit to risk that has to be established," said Dr. Michael Shalmi, vice
president of biopharmaceuticals for Novo Nordisk.
"We're making decisions, in the middle of a war, with the best information we
have available to us," said Holcomb at the Army's Institute of Surgical
Research.