Federal agents probing Army's use of trauma drug

Criminal investigation looking at military's use of blood-clotting injections for treating war casualties

May 16, 2010|By Robert Little, The Baltimore Sun

Federal criminal investigators are exploring the Army's use of a controversial and expensive blood-clotting drug injected into wounded troops in Iraq and Afghanistan.

The drug, called Factor VII, was hailed as a lifesaving breakthrough by military leaders and administered to hundreds of soldiers and Marines earlier in the wars. It has since proved largely ineffective in clinical trials and been the subject of safety warnings by U.S. and European regulators, who say it can cause potentially deadly blood clots.

Within the past several weeks, agents from the Army's Criminal Investigation Command have interviewed scientists and officers at the Army's medical laboratory in San Antonio about Factor VII, according to military sources with knowledge of the investigation. Researchers in San Antonio were among the first to explore Factor VII's role in treating trauma patients and have produced some of the few scientific studies suggesting that the drug saves lives in combat.

The manufacturer, the Danish drug company Novo Nordisk, said it had received a subpoena in January from the Defense Department's inspector general's office. Company officials said they are cooperating with the U.S. attorney's office in Baltimore, which is overseeing the investigation.

Federal investigators and prosecutors, according to agency policy, refused to discuss the investigation or to acknowledge its existence, and a spokeswoman for the Army Medical Command declined to comment.

But statements from Novo Nordisk and interviews with military officials make it clear that the probe is centered on the Army's history with Factor VII, sold under the brand name NovoSeven.

"We do not know the specific reason or scope of this investigation," Novo Nordisk's chief financial officer, Jesper Brandgaard, said in a conference call in February. "The thing we are aware of is that U.S. Army doctors have, at their discretion, been using NovoSeven and the U.S. Army had been purchasing NovoSeven for trauma use within soldiers."

A manufactured version of a natural blood-clotting protein, NovoSeven is approved by the U.S. Food and Drug Administration only for the treatment of rare forms of hemophilia. It is made from cells extracted from the kidneys of baby hamsters and, at more than $6,000 per dose, ranks among the more expensive drugs in the world.

A series of articles in The Baltimore Sun in 2006 chronicled three injured soldiers injected with Factor VII during one 24-hour period at the Army's main trauma hospital in Baghdad. All three survived their combat wounds, but two subsequently suffered blood clots and died. The Army has declined to discuss the cases in detail but told family members that the deaths were not related to the drug.

Army officials with knowledge of the government probe, who asked not to be identified because they are not authorized to speak publicly, said investigators have asked about the Army's research methods and about financial arrangements between the service and Novo Nordisk.

The federal agencies involved conduct criminal probes, rather than civil or advisory investigations, the sources said. One investigator who interviewed employees in San Antonio worked for the Criminal Investigation Command's Major Procurement Fraud Unit.

In a February conference call with investors, during which Novo Nordisk disclosed the subpoena, company officials sought to distance themselves from the Army's less-conventional use of the drug.

"The interesting thing is, we've not been marketing the product to the Department of Defense," said company CEO Lars Rebien Sorensen. "That was a program which was adopted based on a presidential waiver of the label [and] research on NovoSeven in the United States."

It is unclear whether such a waiver was ever sought or granted. Federal law allows the president to waive rules for conducting medical research, including provisions against human research without the subjects' permission, if such a decision is necessary to support military operations and is "in the interests of national security."

But since NovoSeven has been legally available to prescribe since 1999 — even for non-FDA-approved uses, which are allowed at a physician's discretion — no waiver should have been necessary for military trauma use.

Novo Nordisk officials declined to elaborate, but released a statement saying that they are cooperating with the federal investigation and adding: "It is our goal that we conduct our business according to a high ethical standard, living our values and operating our company with integrity, honesty and professionalism."

An FDA spokeswoman said she had no further details.

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