Medical device manufacturer Medtronic claims that consulting fees it paid to former U.S. Army surgeon Timothy Kuklo, MD, JD, were unrelated to research about the Infuse bone graft that he's accused of falsifying.

Dr. Kuklo's study, which exaggerated the effectiveness of the graft product, appeared in the Journal of Bone and Joint Surgery before being retracted amid allegations that Dr. Kuklo based his research on more patients than the Army's Walter Reed Medical Center could reasonably host and that he forged the signatures of the study's co-authors.

In a Sept. 30, 2008, letter to Medtronic president and CEO Bill Hawkins, U.S. Sen. Charles E. Grassley (R-Iowa) requested that the company disclose the physicians with whom it had arranged consulting agreements for Infuse, including the dates and amounts of payments made as well as the specific focus of the relationships.

Medtronic had initially provided Sen. Grassley with a list of physicians that did not include Dr. Kuklo, but recently disclosed that it had paid him close to $800,000 over the past 3 years to train surgeons on the use of its devices, for speaking engagements and for product development, according to a published report.

Despite its financial ties to and consulting relationship with Dr. Kuklo, Medtronic denies being aware of his forged research. "Neither the JBJS article, nor the data presented in that article, was used by Medtronic to secure any current indication for any product, including the Infuse bone graft," says company spokeswoman Marybeth Thorsgaard.

Daniel Cook

Do gastroenterologists find more polyps in colonoscopy patients under deep sedation than in those under conscious sedation? A recent study suggests that may be the case.

An analysis of about 105,000 endoscopy cases at 61 facilities nationwide showed that physicians were 25% more likely to discover polyps larger than 9mm and possible colorectal tumors in patients who'd been administered deep sedation, such as propofol, than those who'd been more mildly sedated and remained conscious during the procedure, even when prep quality was the same.

"We don't know for sure whether these polyps would have been found if the patients were examined under moderate sedation," says study author Katherine M. Hoda, MD, a senior fellow in the gastroenterology department of Oregon Health & Science University in Portland, who presented her research at Digestive Disease Week 2009 earlier this month.

While she speculates that deep sedation patients are more relaxed, allowing physicians a greater focus on polyp detection, she also warns that more research beyond her limited retrospective database review will be necessary before designating deep sedation the better method.

David Bernard

Patients who have undergone Roux-en-Y gastric bypass surgery are more likely to suffer kidney stones than obese patients who haven't had the weight-loss procedure.

In the largest analysis to date of kidney stone risks after bariatric surgery, researchers at Johns Hopkins University School of Medicine found the complication in nearly 8% of 4,639 post-surgical Roux-en-Y patients, as compared to 5% in the same number of obese patients who hadn't undergone the procedure, according to the study, published in the June issue of the Journal of Urology.

The study was based on three years of continuous claims data from health insurance databases and coincides with recently published research on the long-term effects of Roux-en-Y surgery. Studies have found gastric bypass patients with as much as twice the normal amount of oxalate in their urine, write the authors. An excess of oxalate, which cannot be metabolized, causes kidney stones. While it usually binds with calcium and is flushed from the body, perhaps Roux-en-Y patients are less able to absorb calcium, speculates lead author Brian R. Matlaga, MD, MPH, an assistant professor of urology at Johns Hopkins, according to a press release.

Physicians should balance this risk against the benefits that weight-loss surgery may bring to a patient's life, says Dr. Matlaga. "Our study is not an indictment of bariatric surgery," he says. "The benefits of this surgery are well known."

Kent Steinriede

The operating room is no place for nursing students to be, said a little more than half (54%) of the 24 facility managers who answered last week's InstaPoll question: Do you let nursing students do rotations or training at your facility?

Go to our home page to answer our latest poll question: How many years before career burnout sets in for facility managers?

Dan O'Connor