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SouthernDZ
06-15-2011, 06:57
Downloaded this off the Early Bird and thought it would be more relevent to this forum. I hope this doesn't end up tarnishing Dr. Holcomb and the fine research they do at the ISR.


San Antonio Express-News, June 15, 2011

Army Again Probing Fort Sam Payments
Physicians allegedly were wooed by maker of NovoSeven.

By Sig Christenson and Don Finley

The Army said Tuesday it has reopened an investigation into the payment of honoraria to physicians at Fort Sam Houston's Institute of Surgical Research.

The Army Medical Command said it resumed its probe after the Justice Department unveiled a settlement in which the Danish pharmaceutical firm Novo Nordisk agreed to pay $25 million to the federal government, a pair of whistleblowers, Texas and 23 other states.

Responding to a request for information by the San Antonio Express-News, the Army said its probe had been on hold during the Justice Department investigation.

In the settlement, which was unsealed Friday in a Maryland court, the Justice Department said Novo Nordisk targeted the doctors in a “scheme” to market the drug NovoSeven in part by wooing influential Army doctors at the ISR.

The suit charged the firm improperly paid military doctors to use and promote NovoSeven, a costly hemophilia drug, to slow bleeding in wounded GIs — even though it may not save lives and was risky.

“The Army surgeon general and commanding general United States Army Medical Command re-opened the AR 15-6 investigation to include a systematic review of honoraria in the medical research environment,” the command stated. “Until the conclusion of the subsequent AR 15-6 investigation, the office of the surgeon general must refrain from any further comment.”

The lawsuit, joined by Justice Department attorneys, alleged Novo Nordisk reached out to influential military doctors and researchers at the ISR.

Studies and presentations made by Army physicians and researchers led to NovoSeven's use in combat wounded, and influenced civilian doctors to administer the drug as well.

Novo Nordisk has denied wrongdoing and said it settled the case to avoid a long court battle.

The Army still uses NovoSeven in the war zone. Present and former ISR officials have defended its use, stating in scientific papers that it's safe and reduces red blood cell transfusions for trauma patients.

According to one Army document, “It is well documented that increased exposure to blood products increases the risk of infection, multi-organ failure, and mortality.”

But the 147-page Justice Department settlement stated that while the drug “may help minimally reduce the amount of blood transfusion needed in trauma patients, it does not affect survivability.”

The settlement said “Novo Nordisk's scheme to promote NovoSeven for off-label use in trauma patients was illegal and dangerous.”

Two large studies published in the Annals of Internal Medicine two months ago said there was no evidence NovoSeven prolongs life in any “off-label” use — those not specified by a Food and Drug Administration license.

Studies of strokes and heart surgery, but not trauma, concluded it raised the risk of blood clots in the brain and heart. A large national study of the drug's use in trauma, sponsored by Novo Nordisk, was stopped.

NovoSeven was approved for use in 1999 for select hemophiliacs. It's a bioengineered version of a protein the body uses in blood clotting called Factor VIIa, and costs up to $10,000 per dose.

Army guidelines issued to physicians call for giving a maximum of three doses of the drug over six hours if necessary to control bleeding.

As the Army resumes the NovoSeven investigation, it said its Medical Research and Materiel Command last July uncovered information during the Justice Department probe “indicating that Novo Nordisk potentially targeted federal employees for improper marketing and influence.”

The settlement said Novo Nordisk directed its sales representatives and medical science liaisons to promote NovoSeven “for uses that were not contemplated by the FDA-approved label.” It also said the company “funneled hundreds of thousands of dollars in unrestricted grant monies to civilian and military physicians in order to encourage them to speak and publish articles” supporting the drug's use in trauma patients.

One of the whistleblowers, Novo Nordisk physician research liaison Dr. Oscar Montiel, stated in a 2005 evaluation that he had identified Brooke Army Medical Center as a “key center” for promoting the off-label use of NovoSeven, and had cultivated a relationship with the ISR's chief, Dr. (Col.) John Holcomb.

Holcomb now directs the Center for Translational Injury Research at the University of Texas Health Science Center at Houston. His office didn't return a phone call.

The ISR conducted more than 25 research projects run by Army physicians at BAMC with funding from Novo Nordisk, an act the Justice Department said was a possible violation of military law. Army Regulation 40-38, it said, prohibits clinic investigations from being “conducted with funds or other resources provided by business groups operating for profit.”

ISR physicians attended conferences at the Ritz Carlton Hotel in Atlanta and Koblenz, Germany, among other places, and put on lavish dinners.

“It's all hindsight, but they were so shrewd. It was brilliant because you had all these young physicians,” said Army Reserve Maj. Ian Black, a physician and former chief of anesthesiology at the ISR who emerged as a whistleblower, sharing around $3.5 million from the suit with Montiel.

“They had no research background. It's not like they had been in a research lab for years and years,” Black, 48, of Burlington, Vt., told the Express-News. “They asked, ‘Did you use this drug? Good. You're an expert. Do you want to talk about your experience?' ‘Sure. You're going to fly me where, to Las Vegas or down to Atlanta and I get to eat in Emeril's restaurant? Wow.'”

swatsurgeon
06-15-2011, 10:50
It is a shame that these issues arise but as the article pointed out (correctly) blood transfusions were reduced but mortality was not , in a statistically significant way. The drug costs 5-12k to administer depending on dose and if you repeat the dose, it's a hospital budget killer but made a few people alot of money (paid doc speakers, etc) promoting it to the civilian world. Too bad, i hope Dr. Holcome was not in that group. I know he has lectured and written about its use but hopefully without 'consultant fee paid' bias.:confused:
ss

wet dog
06-15-2011, 11:45
i
It is a shame that these issues arise but as the article pointed out (correctly) blood transfusions were reduced but mortality was not , in a statistically significant way. The drug costs 5-12k to administer depending on dose and if you repeat the dose, it's a hospital budget killer but made a few people alot of money (paid doc speakers, etc) promoting it to the civilian world. Too bad, i hope Dr. Holcome was not in that group. I know he has lectured and written about its use but hopefully without 'consultant fee paid' bias.:confused:
ss

Hey bro, many know the pharmaceutical companies spend a lot of money to hospitals and doctors (private and public), as part of their reseach. Never have I seen a more incestuous relationship. Any surprise that after 10 years of sustained battle we would see their practices cross over to the Military and our good doctors?

I can read the headlines how...

"Pharm X - Gives Millions to Military Doctors to lecture, administrate, and deliver test related drugs to wounded soldiers".

"Pharm X - Stocks rise 3rd Qtr because of the enless supply of available patients".

"After a long and much anticipated wait, Pharm X is contracted by DOD, and the medical machine of the US Navy, Army to administor....."

"A Zombie Apocalypse has begun at the US Army hospital Womak, Ft. Bragg, NC - wounded soldiers from the 3rd Special Forces Group, previously unable to walk are now moving about. Fellow ODA team members welcome returning soldiers as the new "Zombie 18Z" Team Sergeants. ODAs have several new missions, unit patches will now reflect Skull and Cross Bones with dripping flesh. Team members enjoy having the new Team Sergeants around. One soldier reports, 'Ya, it was tough at first, having to keep an eye on Tm Sgt, he kept wanting to interrupt classroom time by taking a bite out of a fellow soldier, but we just handed him a beer. We learned quickly that alcohol does not affect Zombies, so it was an easy solution. One of our missions is to support Zombie attacks against AQ and Taliban forces. Our jobs are to destroy AQ at the heart, literally. Our intent is to have only SF qualified Zombies. It's kinda of cool, Zombie HALO missions, Zombie Dive Missions. Civil Affairs is a big step, but we are testing other applications for Zombies in SF, looking forward to seeing what develops.'"

Richard
06-15-2011, 13:01
Shades of 'The Fugitive' - any one-armed ex-LEOs under surveillance yet? ;)

Richard :munchin

DoctorDoom
06-15-2011, 18:31
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