Lifesaver or Liability?

Dec. 6, 2006 — -- "I can't bring my kid back but maybe we can get somebody to take responsibility," says Tammy Lufkin. "I am so upset."

Lufkin was still absorbing the death of his son, Pfc. Caleb A. Lufkin, who died last May from injuries sustained in a bombing in Iraq, when he got the news: Army doctors had given Caleb a controversial drug in a futile attempt to save his life. One of Lufkin's customers at his lumberyard in Galesburg, Ill., who'd read news reports in connection with Caleb's death, told Lufkin about it.

The drug, which has been approved by the FDA only to control bleeding in rare forms of hemophilia that affects about 2,700 Americans, has been given to more than 1,000 of the Iraq War's wounded troops. Though it's touted as an important medical advance by U.S. Army medical specialists, rF7a is not considered a proven treatment by many civilian doctors and its longterm effects on trauma patients have never been studied.

Civilian doctors use the same risky drug on U.S. soil, for similar reasons.

"I am so upset that I didn't know that they'd given him Factor VII," says Lufkin, referring to Recombinant Activated Factor VIIa -- or rF7a, sold as NovoSeven -- a blood-clotting medication. "When he was at Walter Reed and his arms were always swelling up and he was itching like crazy, I was asking them a million questions and they didn't tell me anything. It felt like they were blowing me off."

Medical experts contacted by ABC News say that using any drug off-label is a risky endeavor. When there is little scientific data to support the safety and dangers of a drug, off-label use becomes a judgment call that clinicians must make and make carefully every time they use the drug.

"Any drug that is used off-label is dangerous because we don't have any data in objective clinical trials that discusses risks and benefits," says Jawed Fareed, a pharmacologist and director of the hemostasis and thrombosis research program at the Loyola University Stritch School of Medicine in Loyola, Ill.

The U.S. military insists that its data shows no increase in complications attributable to rF7a in their trauma patients. "Our ongoing clinical experience continues to indicate that this drug can be very effective in stopping fatal hemorrhage," says Col. Paul Cordts, an Army vascular surgeon.

Like the military, civilian doctors have no scientific evidence to prove the benefits -- or the risks -- of the drug. Some doctors swear that rF7a works miracles, but none deny its potential dangers.

"I believe we have saved many lives using it and we have had a few complications," said Thomas Scalea, physician-in-chief at the Shock Trauma Center at the University of Maryland in Baltimore.

"One of my fellows said of rF7a that it was like turning off the faucet -- the bleeding stopped and the patient survived," he said.

Designed to enhance the body's ability to slow down or stop uncontrolled bleeding, rF7a is not approved for that use in soldiers who've experienced blast wounds. (Since the FDA regulates only products and not medical practices, doctors are free to use drugs for off-label uses.) And one of the drug's risks is that it has the potential to clot blood not at the site of injury but elsewhere in the body, which could cause strokes, heart attacks or worse.

When he first arrived at a hospital in Baghdad, Lufkin was given rF7a. Two weeks later, he suffered a blood clot in his lung. Lufkin was placed on anti-coagulant drugs and underwent surgery a week later, during which he died. Although doctors suspected he died of a blood clot, Lufkin's official cause of death was "complications of blast injuries."

Sgt. Brandon Huff was given rF7a at a hospital in Mosul last year after a bomb amputated his left leg and damaged his abdomen with shrapnel. He later suffered a clot-related stroke -- highly unusual for a young man who does not have high-blood pressure or arteriosclerosis.

Huff's family, who didn't understand why he experienced three mini strokes during his treatment, was later told about the potential risks of rF7a -- and the military's use of the controversial drug -- by a Baltimore Sun reporter.

No one knows for sure that the strokes were definitely caused by rF7a. Don Huff, Brandon Huff's father, was concerned about the use of the drug, and questioned whether the drug could have caused his son's stroke.

But he also recognizes that desperate times call for desperate measures. "It could just as easily have saved his life," says Huff.

"Yes, there were complications and there were some clotting issues," Huff adds, "but this is not like it was during Vietnam. They do everything in their power to help these kids survive and rehabilitate."

Huff says his son, who is currently undergoing some physical rehabilitation at Walter Reed, is leaving this weekend for 10 days of kayaking in Costa Rica. "The first day he got in that kayak, he was smiling from ear to ear."

Roughly 5 percent to 10 percent of soldiers brought into military trauma wards are treated with aggressive treatment guidelines that include giving rF7a.

A Pentagon spokesman would not comment on families or specific cases, but said, "Our official position is that it is our understanding that this product is used only in the most dire situations, when patients are bleeding uncontrollably."

The Army, which has spent almost $11.2 million on rF7a since 2004, continues to use the drug and is looking into expanding its use to front-line medics and medevac crews.

This week, Caleb Lufkin's father is talking to a lawyer to discuss whether, by administering rF7a, the Pentagon is responsible for his son's death. The Feres doctrine, which bars military personnel from suing the U.S. government for injuries "incident" to their military service, according to a 1950 U.S. Supreme Court decision, limits his options.

But that's not dissuading Lufkin. "I don't care if we get a dime out of it," he says. "I don't know lawyer stuff. I just want someone to take responsibility. You can't keep pushing the buck on somebody else."