June 21st, 2011

US Army Probes Pharma Payments To Military Docs

Pharmalot

In the wake of a recent settlement between Novo Nordisk and the US Department of Justice over charges the drugmaker illegally promoted its hemophilia drug to both civilian and military physicians, the US Army has reopened its own investigation into the episode and will now widen that effort to include “a systematic review of honoraria in the medical research environment.”

An Army spokeswoman declined to provide more specific information, such as which drug and device makers may be examined as part of the probe or which Army locations the review will encompass. However, one source familiar with the probe tells us the investigation extends beyond the Institute of Surgical Research, which is based in Fort Sam Houston, where one military physician was located before filing a whistleblower lawsuit.

The lawsuit, which was jointly filed by a a former Novo Nordisk medical liasion, charged that that Novo Nordisk improperly promoted its NovoSeven medication for such unapproved uses such as blood trauma, intercranial hemorrhage and various surgeries and that payments were made to various military personnel (here is the lawsuit).

The drugmaker allegedly provided unrestricted grant funds, speakers fees and other kickbacks to encourage doctors to publicly support the use of the medication in trauma units to control bleeding among patients who were not hemophiliacs. Novo Nordisk also allegedly funneled money through non-profits to hide indirect payments made as educational grants.

According to attorneys for Ian Black, a former US Armed Forces physician who also filed suit, he became uncomfortable when he saw how frequent NovoSeven was used while serving in a combat hospital in Iraq as an anesthesiologist. The drug was also widely used in Afghanistan and was eventually incorporated into Army protocols, which are called clinical practice guidelines. At that point, Novo Nordisk began to use this as a selling point to civilian physicians for use in trauma units in the US.

To settle the case, Novo Nordisk agreed to pay $25 million and signed a Corporate Integrity Agreement

The Army, meanwhile, had been assisting the DOJ, which had joined the whistleblower lawsuit, and it Medical Research and Materiel Command had uncovered info indicating Novo Nordisk was “potentially” targeting federal employees for improper marketing and influence, according to a statement sent us by the Army spokeswoman. That was in July 2010.

At that point, the Army began what it calls an AR 15-6 investigation to determine “whether fiscal law or procurement integrity violation occurred.” But that was suspended the following month, pending the outcome of the DOJ investigation. Now, though, the Army Surgeon General and Commanding General United States Army Medical Command, has reopened the investigation. The probe was first reported by The San Antonio Express.

Read more: http://www.pharmalot.com/2011/06/us-army-probes-pharma-payments-to-military-docs/

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