Team Infidel
Forum Spin Doctor
New York Times
November 6, 2007
By Alex Berenson
SAN ANTONIO — Since the war in Iraq began, Col. John Holcomb has been working to change the way the military takes care of its wounded.
Along the way he has suffered a few dings himself.
A tall medical doctor with a Southern lilt and close-cropped gray hair, Colonel Holcomb, 48, has spent his entire 27-year career in the Army, earning a reputation as one of the military’s top trauma surgeons. Since 2001, he has headed the Army’s Institute of Surgical Research, based on the campus of the Brooke Army Medical Center here.
Under his watch, Army surgeons have become aggressive users of a controversial drug called Factor VII, which promotes clotting in cases of severe bleeding. He has also guided a redesign of the transport system for wounded soldiers, encouraging helicopter pilots to take the severely injured to the hospitals best able to treat them, even if they are not the closest.
Colonel Holcomb also strongly advocates conducting clinical trials to improve trauma care. It is an ethically tricky area, because trauma research can involve trying novel treatments on severely injured patients who cannot give informed consent. But he argues that any ethical problems pale in comparison to the toll that traumatic injuries take on civilians and soldiers every day.
He is fond of quoting a surprising statistic: trauma is the third-leading cause of death in the United States, taking 160,000 lives in 2004, more than any other cause except heart disease and cancer. Because it primarily affects the young, trauma leads all diseases in terms of life-years lost.
And besides the 4,000 American deaths in Iraq and Afghanistan, there have been 29,000 injuries from hostile fire, including 9,000 severe enough to require transport to hospitals outside the war zones.
In the face of that toll, Colonel Holcomb said, doctors must run clinical trials to ensure that patients are receiving the best treatments. Without those trials, even basic questions — which patients should be put on breathing tubes, for example — remain unanswered.
In an interview in his office at Brooke, Colonel Holcomb said he was determined to generate data that would help military and civilian surgeons answer those questions.
“We run a research institute,” he said. “Everything we do, we try to drive on data.”
Colonel Holcomb’s backers, who include surgeons both in and out of the military, say he is an exceptionally hard-working physician whose single-minded focus on wounded soldiers has led to improvements in the way the military treats its injured.
“John Holcomb is making a huge contribution to the advancement of trauma care in this country,” said Dr. Brent Eastman, the chairman of trauma for Scripps Health in San Diego and a regent of the American College of Surgeons.
But Colonel Holcomb is not without critics, who say his efforts, however well intended, may be doing more harm than good.
Dr. Andrew F. Schorr, a former military physician who is associate director of critical care medicine at Washington Hospital Center in Washington, said he believed that Colonel Holcomb had pushed military surgeons to use Factor VII despite a lack of data on its benefits — and some evidence that it can increase the risk of blood clots that cause strokes. Factor VII is a naturally occurring protein that helps the blood clot; an artificial version is produced by the Danish company Novo Nordisk under the name NovoSeven.
“I certainly disagree with his approach to Factor VII,” Dr. Schorr said.
Colonel Holcomb has also been criticized for his advocacy of an experimental blood substitute called PolyHeme, which recently failed a clinical trial in trauma patients. The trial, which ran from late 2003 until last year, was conducted on people who were severely injured and could not give consent to the experiment.
The trial followed an earlier failed test of PolyHeme in patients undergoing surgery for aneurysms. In the earlier trial, 54 percent of people who took it went on to suffer serious adverse events, compared with 28 percent who did not.
But the Brooke Army Medical Center and Colonel Holcomb did not disclose the results of the earlier trial to the public when they agreed to participate in the new trial. “Up to now, PolyHeme has not caused any clinically bad problems,” researchers for Brooke wrote in materials prepared for a public meeting, according to a 2006 article in The Wall Street Journal.
“He knew about this data, and he should never have approved the trial for his center and allowed the Army to participate in it,” said Keith Berman, a medical products consultant who specializes in research on blood substitutes. “Many, many centers declined to participate in this trial.”
Colonel Holcomb does not apologize for his advocacy of PolyHeme or Factor VII. Hemoglobin substitutes like PolyHeme, which enable the body to transport oxygen to its cells even after massive blood loss — could save lives, he said. And trials based on consultation with a public entity like a hospital review board, rather than individual informed consent, are necessary to improve the care of trauma patients.
In addition, the Food and Drug Administration approved the PolyHeme trial even though it saw the unreleased data from the earlier test, and many other medical centers participated in it, he said, adding, “We’re not irresponsible people going out and doing evil experiments on small groups of patients.”
As for Factor VII, Colonel Holcomb said he understood the concerns of the Army’s critics and agreed there was no strong evidence that the drug decreases mortality or other complications in trauma patients.
The F.D.A. has approved the drug to stanch bleeding only in hemophiliacs and people with a congenital deficiency of Factor VII, not in those whose blood is otherwise normal. And the label warns that the drug should be used “only under the supervision of a physician experienced in the treatment of bleeding disorders.”
But a 300-patient clinical trial showed that Factor VII reduced the need for transfusions in patients and showed a trend toward reducing mortality in patients who received it, though the difference was not statistically significant. A larger trial to confirm those findings is under way, but the results will not be available for several years.
With soldiers severely injured every day in Iraq, Colonel Holcomb said, the military cannot afford to wait for a definitive answer.
“You have a drug that you know is safe from the prospective randomized controlled clinical trials,” Colonel Holcomb said. “And you have to make a decision. It’s not something you can decide to talk about. It’s really yes or no. You have a lot of people bleeding to death in Iraq.”
Other trauma surgeons support that attitude.
Dr. John R. Hess, a professor of pathology and medicine at the University of Maryland and a physician at its Shock Trauma Center in Baltimore, said the Army was right to use Factor VII aggressively. Severe bleeding, he noted, quickly exhausts the natural resources of Factor VII.
In trauma patients, “hemorrhage is the second-leading cause of death,” behind only brain injuries. “But you can do something about it.”
Civilian hematologists rarely see injuries as severe as those the Army faces, Dr. Hess said, so they may not understand the need for the drug. He added that Colonel Holcomb, whom he has known for two decades, would never encourage the use of Factor VII if he thought it was endangering soldiers.
“He feels deeply concerned about the soldiers, he goes over there, he takes care of them,” Dr. Hess said. “If you were hurt, he’s the guy you’d want taking care of you.”
Colonel Holcomb has spent several months in Iraq since the war began. In addition to working as a surgeon, he has helped redesign the system that transports wounded soldiers to hospitals.
In previous conflicts, the wounded were evacuated to nearby forward operating stations, even if their injuries were so severe that doctors at those stations might not have been able to help them.
Now, helicopter pilots coordinate care more closely with the half-dozen large hospitals throughout Iraq, making sure that a soldier with head trauma, for example, is taken to a hospital that has a neurosurgeon available. The system is modeled on regional trauma systems in the United States, where patients with severe injuries go directly to regional trauma centers.
“Sometimes fast is slow and methodical is fast,” said Col. Stephen Flaherty, the chief of surgery at Landstuhl Regional Medical Center, an Army hospital in Germany that treats wounded soldiers from Iraq and Afghanistan. “And if you do things fast and take them to the wrong location with the wrong resources, you may not wind up giving them the best care.”
But changing the system required the notoriously bureaucratic Army to make significant changes in the way medical helicopters were positioned, as well as increasing coordination between hospitals, forward surgical teams and front-line units.
November 6, 2007
By Alex Berenson
SAN ANTONIO — Since the war in Iraq began, Col. John Holcomb has been working to change the way the military takes care of its wounded.
Along the way he has suffered a few dings himself.
A tall medical doctor with a Southern lilt and close-cropped gray hair, Colonel Holcomb, 48, has spent his entire 27-year career in the Army, earning a reputation as one of the military’s top trauma surgeons. Since 2001, he has headed the Army’s Institute of Surgical Research, based on the campus of the Brooke Army Medical Center here.
Under his watch, Army surgeons have become aggressive users of a controversial drug called Factor VII, which promotes clotting in cases of severe bleeding. He has also guided a redesign of the transport system for wounded soldiers, encouraging helicopter pilots to take the severely injured to the hospitals best able to treat them, even if they are not the closest.
Colonel Holcomb also strongly advocates conducting clinical trials to improve trauma care. It is an ethically tricky area, because trauma research can involve trying novel treatments on severely injured patients who cannot give informed consent. But he argues that any ethical problems pale in comparison to the toll that traumatic injuries take on civilians and soldiers every day.
He is fond of quoting a surprising statistic: trauma is the third-leading cause of death in the United States, taking 160,000 lives in 2004, more than any other cause except heart disease and cancer. Because it primarily affects the young, trauma leads all diseases in terms of life-years lost.
And besides the 4,000 American deaths in Iraq and Afghanistan, there have been 29,000 injuries from hostile fire, including 9,000 severe enough to require transport to hospitals outside the war zones.
In the face of that toll, Colonel Holcomb said, doctors must run clinical trials to ensure that patients are receiving the best treatments. Without those trials, even basic questions — which patients should be put on breathing tubes, for example — remain unanswered.
In an interview in his office at Brooke, Colonel Holcomb said he was determined to generate data that would help military and civilian surgeons answer those questions.
“We run a research institute,” he said. “Everything we do, we try to drive on data.”
Colonel Holcomb’s backers, who include surgeons both in and out of the military, say he is an exceptionally hard-working physician whose single-minded focus on wounded soldiers has led to improvements in the way the military treats its injured.
“John Holcomb is making a huge contribution to the advancement of trauma care in this country,” said Dr. Brent Eastman, the chairman of trauma for Scripps Health in San Diego and a regent of the American College of Surgeons.
But Colonel Holcomb is not without critics, who say his efforts, however well intended, may be doing more harm than good.
Dr. Andrew F. Schorr, a former military physician who is associate director of critical care medicine at Washington Hospital Center in Washington, said he believed that Colonel Holcomb had pushed military surgeons to use Factor VII despite a lack of data on its benefits — and some evidence that it can increase the risk of blood clots that cause strokes. Factor VII is a naturally occurring protein that helps the blood clot; an artificial version is produced by the Danish company Novo Nordisk under the name NovoSeven.
“I certainly disagree with his approach to Factor VII,” Dr. Schorr said.
Colonel Holcomb has also been criticized for his advocacy of an experimental blood substitute called PolyHeme, which recently failed a clinical trial in trauma patients. The trial, which ran from late 2003 until last year, was conducted on people who were severely injured and could not give consent to the experiment.
The trial followed an earlier failed test of PolyHeme in patients undergoing surgery for aneurysms. In the earlier trial, 54 percent of people who took it went on to suffer serious adverse events, compared with 28 percent who did not.
But the Brooke Army Medical Center and Colonel Holcomb did not disclose the results of the earlier trial to the public when they agreed to participate in the new trial. “Up to now, PolyHeme has not caused any clinically bad problems,” researchers for Brooke wrote in materials prepared for a public meeting, according to a 2006 article in The Wall Street Journal.
“He knew about this data, and he should never have approved the trial for his center and allowed the Army to participate in it,” said Keith Berman, a medical products consultant who specializes in research on blood substitutes. “Many, many centers declined to participate in this trial.”
Colonel Holcomb does not apologize for his advocacy of PolyHeme or Factor VII. Hemoglobin substitutes like PolyHeme, which enable the body to transport oxygen to its cells even after massive blood loss — could save lives, he said. And trials based on consultation with a public entity like a hospital review board, rather than individual informed consent, are necessary to improve the care of trauma patients.
In addition, the Food and Drug Administration approved the PolyHeme trial even though it saw the unreleased data from the earlier test, and many other medical centers participated in it, he said, adding, “We’re not irresponsible people going out and doing evil experiments on small groups of patients.”
As for Factor VII, Colonel Holcomb said he understood the concerns of the Army’s critics and agreed there was no strong evidence that the drug decreases mortality or other complications in trauma patients.
The F.D.A. has approved the drug to stanch bleeding only in hemophiliacs and people with a congenital deficiency of Factor VII, not in those whose blood is otherwise normal. And the label warns that the drug should be used “only under the supervision of a physician experienced in the treatment of bleeding disorders.”
But a 300-patient clinical trial showed that Factor VII reduced the need for transfusions in patients and showed a trend toward reducing mortality in patients who received it, though the difference was not statistically significant. A larger trial to confirm those findings is under way, but the results will not be available for several years.
With soldiers severely injured every day in Iraq, Colonel Holcomb said, the military cannot afford to wait for a definitive answer.
“You have a drug that you know is safe from the prospective randomized controlled clinical trials,” Colonel Holcomb said. “And you have to make a decision. It’s not something you can decide to talk about. It’s really yes or no. You have a lot of people bleeding to death in Iraq.”
Other trauma surgeons support that attitude.
Dr. John R. Hess, a professor of pathology and medicine at the University of Maryland and a physician at its Shock Trauma Center in Baltimore, said the Army was right to use Factor VII aggressively. Severe bleeding, he noted, quickly exhausts the natural resources of Factor VII.
In trauma patients, “hemorrhage is the second-leading cause of death,” behind only brain injuries. “But you can do something about it.”
Civilian hematologists rarely see injuries as severe as those the Army faces, Dr. Hess said, so they may not understand the need for the drug. He added that Colonel Holcomb, whom he has known for two decades, would never encourage the use of Factor VII if he thought it was endangering soldiers.
“He feels deeply concerned about the soldiers, he goes over there, he takes care of them,” Dr. Hess said. “If you were hurt, he’s the guy you’d want taking care of you.”
Colonel Holcomb has spent several months in Iraq since the war began. In addition to working as a surgeon, he has helped redesign the system that transports wounded soldiers to hospitals.
In previous conflicts, the wounded were evacuated to nearby forward operating stations, even if their injuries were so severe that doctors at those stations might not have been able to help them.
Now, helicopter pilots coordinate care more closely with the half-dozen large hospitals throughout Iraq, making sure that a soldier with head trauma, for example, is taken to a hospital that has a neurosurgeon available. The system is modeled on regional trauma systems in the United States, where patients with severe injuries go directly to regional trauma centers.
“Sometimes fast is slow and methodical is fast,” said Col. Stephen Flaherty, the chief of surgery at Landstuhl Regional Medical Center, an Army hospital in Germany that treats wounded soldiers from Iraq and Afghanistan. “And if you do things fast and take them to the wrong location with the wrong resources, you may not wind up giving them the best care.”
But changing the system required the notoriously bureaucratic Army to make significant changes in the way medical helicopters were positioned, as well as increasing coordination between hospitals, forward surgical teams and front-line units.