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Drug Company Illegally Experimented on Wounded Soldiers in Iraq, Suit Says

By Jim Edwards

Updated on: July 5, 2011 / 9:28 AM EDT / MoneyWatch

When Denmark-based Novo Nordisk (NVO) settled a whistleblower case that alleged unlawful promotion of its anti-clotting drug NovoSeven in June, CEO Lars Rebien Soerensen said he was paying the $25 million to avoid the distraction of a lengthy legal battle.

That battle would have been distracting indeed: The plaintiffs -- a former Novo medical science liaison executive and the U.S. army doctor to whom he allegedly offered kickbacks -- claim Novo illegally funded medical experiments on injured soldiers in Iraq in a bid to widen the use of NovoSeven. The research eventually indicated that NovoSeven was not more useful than older alternatives for controlling bleeding in injured patients, and it carried the risk of excessive clotting in wounded patients. Yet Novo's unapproved, "off-label" promotion eventually made NovoSeven the standard treatment for wounded soldiers in Iraq and Afghanistan, according to the suit.

NovoSeven is only approved for use in hemophiliacs, who lack Factor VIIa, a blood-clot promoter that stops healthy people from bleeding to death when injured. There are only 18,000 hemophiliacs in the U.S., putting a cap on potential revenues from NovoSeven even though it costs up to $10,000 per vial, according to the suit.

So Novo promoted NovoSeven to Army doctors through speaker fees, conference fees and research fees that functioned as kickbacks, the suit alleges.

Research on injured soldiers
Some of the research was done on injured soldiers in Iraq, according to the suit:

Experimenting on soldiers injured in battle is illegal. Only the president can sign a waiver allowing research drugs to be used on the military during wartime, the suit claims:

"Stop the bleeding!"

Nonetheless, Novo promoted NovoSeven for soldiers from 2005 through 2007 with conferences and seminars that bore titles such as "Stop the Bleeding! Bleeding Management in Military Trauma Care," "Damage Control Resuscitation in Iraq" and "Blood Product Effect on Survival for Patients With Combat Related Injuries."

It is illegal for a non-government company to pay inducements to federal employees. So Novo funded the "TRUE Research Foundation for the Advancement of Military Medicine," which functioned as a money-laundering device through which Novo funnelled cash to military doctors willing to promote the use of NovoSeven to their colleagues. By amazing coincidence, TRUE suddenly shut down its operations in April, one month before the suit was settled, citing "significant, yet unforseen, circumstances."

Doctors who cooperated with the scheme, and Novo's own sales reps, were rewarded handsomely, the suit claims. Ian Black, the doctor-turned-whistleblower in the case, was offered an all-expenses-paid trip to the Ritz Carlton in Atlanta, plus a $1,000 honorarium, to attend an "advisory board" meeting. Novo's pharmaceutical sales reps received a trip on the Queen Elizabeth II to visit Novo's collection of castles in Denmark:

The shenanigans worked, according to the suit. NovoSeven is now widely used in war theaters, despite the lack of research evidence (or FDA approval) for use of the drug in non-hemophiliacs:

So widespread was the use of NovoSeven in the military that it was taken up by civilian hospitals in the U.S. A survey found that 75 percent of trauma centers in the U.S. now use it for surgical patients, according to the complaint. Yet Dr. Jeremy Perkins, an Army researcher who allegedly received money from Novo, wrote in a September 2007 PowerPoint slideshow that the "bottom line" was that NovoSeven is "an unproven tool currently used on blind faith."

Bonus points: If you noticed that the NovoSeven settlement does not clear up this Department of Justice subpoena served on the company in February regarding "potential criminal offences" at the company.

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Images: Top and middle images depict battlefield simulations, via Flickr user the U.S. Forces in Iraq. Bottom image from Flickr user Dvidshub, CC.