Untested In Battle

New Military Medical Procedures Were Often Rushed Into Theaters Of War With Little Oversight And Little Evidence Of Their Effectiveness

Sun Special Report

March 29, 2009|By ROBERT LITTLE | ROBERT LITTLE,robert.little@baltsun.com

BAGHDAD -The U.S. Army has quietly altered or abandoned some of its more experimental medical treatments for troops injured in combat, as advances it once hailed as groundbreaking are found largely ineffective or perhaps even dangerous.

Advanced battle dressings, a blood-clotting drug, alternative procedures for emergency blood transfusions - each was introduced early in the Iraq war, often with little evidence to support them beyond anecdotes or tests on animals. A few were adopted widely by civilian hospitals, based almost exclusively on accolades from the military.

But an investigation by The Baltimore Sun reveals that military doctors and medics, and in some cases uniformed leaders, have rejected or curtailed use of many of the new devices and techniques as clinical experience and data from the war zone yield disappointing and sometimes troubling results.

Senior Army doctors rushed medical innovations onto the battlefield without the rigorous review common in civilian hospitals, The Sun found, and sometimes changed or disregarded data from their own scientists. In some instances, wounded service members were among the first humans on whom the treatments were used. And while virtually all of the Army's published research supports the treatments, some Army studies concluding that they are ineffective or potentially dangerous haven't been published.

The aggressive push is a point of pride to some Army doctors and officials. Others deride it as reckless, and still others say they felt pressured to defy their own judgments in favor of the military's favored, but unproven, treatments.

"I worry that some soldiers were hurt by the overzealous use of unproven therapies," said Dr. Ian H. Black, head of anesthesia at the Army's main combat hospital in Baghdad in 2006 and 2007 and a former Army researcher. "I look back and I wonder, did I hurt someone?"

The Army's surgeon general, Lt. Gen. Eric B. Schoomaker, said in an interview that changes in combat medical care show that Army medicine is nimble and responsive to the lessons learned in warfare. "We're not doing experimentation in theater. It's unethical," Schoomaker said.

But he also said, in response to questions by The Sun, that the Army will re-examine its treatment protocols to make sure the service is not "out ahead of the headlights" with novel but unsupported treatments.

"We'll redouble our efforts to make sure that isn't happening," Schoomaker said. "I think we should be concerned about that, and we are."

Among The Sun's findings:

* Roughly 17,000 packages of a blood-clotting substance were shipped to Iraq last year for distribution to Army medics, despite cautions from the service's own scientists against using it on humans. It was quickly recalled when tests on pigs revealed potentially deadly complications.

* An $89 bandage given to every combat soldier and honored by the Army as one of its "greatest inventions" was deployed despite two unpublished studies from the service's research lab showing that it was no more effective than gauze. After mixed reports from the battlefield, it is being recalled and replaced.

* Liberal use of a blood-clotting drug, injected copiously into wounded soldiers in 2005 and 2006, became the Army's "standard operating procedure" more than a year before any clinical studies evaluating the drug's use on trauma patients had been completed. The drug has since proven largely ineffective in three unpublished Army studies and potentially dangerous in at least one, and is now used only in extreme cases.

* Transfusions of fresh whole blood, considered dangerous and unnecessary in civilian medicine, became standard treatments early in the war, based on anecdotes and theoretical arguments. They unwittingly exposed 20 or more patients in Iraq and Afghanistan to hepatitis. Studies of the practice have since found mixed results, and it is now used only in emergency situations.

There is little data or documentation from either the Army or civilian hospitals to prove that the military's aborted new treatments were either helpful or harmful on a broad scale. But a group of current and former military physicians and researchers, many of whom spoke with The Sun, have complained formally to Army investigators that senior medical officials manipulated research and "stressed results at the expense of good science." The complaints have sparked at least two reviews by Army investigators. The Sun's requests under the Freedom of Information Act about the scope or status of the reviews were denied.

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