The U.S. Department of Justice has charged Scott Reuben, MD, the anesthesiologist and influential researcher who faked the results of nearly 2 dozen surgical pain control studies, with healthcare fraud, a crime that carries a maximum penalty of 10 years in prison.

In charges filed in federal court in Boston on Jan. 14, prosecutors allege that Dr. Reuben, formerly the chief of acute pain at Baystate Medical Center in Springfield, Mass., defrauded drug maker Pfizer out of more than $73,000 and supplies of the non-steroidal anti-inflammatory drug celecoxib. While the money and drugs were intended to support the treatment of 100 patients receiving multimodal anesthesia for anterior cruciate ligament reconstruction surgeries, prosecutors say Dr. Reuben never ran the trial and published fake results in a 2007 issue of the journal Anesthesia & Analgesia.

A plea hearing will be held on Feb. 22, according to a Department of Justice spokesperson. A plea agreement put forth by prosecutors suggests jail time toward the "low end" of the sentencing guidelines and the payment of about $417,000 in fines and restitution to Pfizer and other pharmaceutical companies.

In a statement issued to Outpatient Surgery Magazine, Dr. Reuben's attorney, Paul Cirel of Boston, says that his client "has cooperated fully with Baystate Medical Center and, more recently, with the authorities. Notwithstanding the single-count accusation that has been filed in the district court, we hope to resolve this matter through a cooperative and just resolution."

The Pfizer trial was 1 of 21 studies retracted by peer-reviewed journals after a routine audit by Baystate revealed that Dr. Reuben had faked the results of many influential papers he'd published between 1996 and 2008.

Since the news of Dr. Reuben's fraud surfaced in March 2009, anesthesia providers have been trying to assess the impact of the fake studies on clinical practices. In the December issue of the journal Anesthesiology, European researchers examined the effects of the retractions on other systematic reviews. The researchers repeated 25 reviews and meta-analyses with Dr. Reuben's studies removed from the mix. In most cases, the removals had little effect on the results.

"Even after retraction of Reuben reports, classic NSAIDs and coxibs are still analgesic in surgical patients, they still have an opioid-sparing effect, and they still decrease pain intensity in the immediate postoperative period," write the authors. However, some clinical issues - such as the effects of coxibs on bone healing and preemptive analgesia and the efficacy of adding ketorolac or clonidine to local anesthetics during intravenous regional anesthesia - will need to be re-assessed as a result of the fraud, write the authors.

Kent Steinriede

Bariatric surgical outcomes improved for Medicare beneficiaries after CMS began covering 3 types of bariatric procedures to treat morbid obesity in 2006, according to a study published in the January issue of Archives of Surgery.

Researchers report seeing an uptick in minimally invasive techniques, a reduction in the duration of hospital stays and a decline in overall complication rates after CMS issued its national coverage determination (NCD) for bariatric surgery in February 2006. The NCD expanded Medicare coverage to include laparoscopic and Roux-en-Y gastric bypass, laparoscopic adjustable gastric banding and laparoscopic and open biliopancreatic diversion with duodenal switch at centers doing more than 125 procedures a year and certified by the American College of Surgeons or the American Society for Metabolic and Bariatric Surgery.

To assess the impact of CMS's decision, researchers led by Ninh T. Nguyen, MD, of the University of California, Irvine Medical Center, analyzed the outcomes of 3,196 bariatric procedures performed on Medicare beneficiaries before the NCD and 3,068 performed after. They report that the volume of gastric banding doubled and the proportion of laparoscopic gastric bypass grew from 60% to 77% after the NCD. In addition, patients' average hospital stays shortened from 3.5 to 3.1 days and complication rates fell from 12.2% to 10%. There was not a significant difference in in-hospital mortality rates between the 2 groups.

The authors attribute the improvements in surgical outcomes after the NCD to the increase in gastric bypass procedures being performed laparoscopically and the movement of care to high-volume centers. They also note that while the NCD did not impede access to care for Medicare beneficiaries, the number of facilities providing care to morbidly obese patients fell from 60 to 45 after the NCD.

Irene Tsikitas

Infection rates in Pennsylvania's hospitals are generally lower than the national average, while Minnesota and California hospitals saw adverse surgical events increase, according to data from those states' departments of health.

The Pennsylvania Department of Health says 13,771 healthcare-acquired infections were reported in 213 hospitals (83.5% of the state's total) over the second half of 2008. About 22% of all reported infections were surgical site infections, while about 8% of all infections were attributable to methicillin-resistant Staphylococcus aureus.

A published report notes that 1,538 serious and preventable events were reported in California during fiscal year 2009, including retained objects, wrong-site surgeries and patient falls resulting in serious injuries. That's up from 1,224 reported incidents in 2006, the first year in which hospitals were required to notify the California Department of Public Health of errors, according to the report.

The Minnesota Department of Health released its 2010 report of adverse events, which occurred in 58 of 134 reporting hospitals and 4 of 55 reporting ASCs. The report notes the number of wrong-patient, wrong-procedure and wrong-site surgeries increased from 39 to 44 since 2009, while incidences of retained foreign objects following surgery jumped from 37 to 38 over the past year. Breakdowns in communication and ineffective polices and procedures were the most common causes of adverse events, according to the Minnesota report.

Surgical teams can avoid adverse events related to wrong-site surgery, says the report, by scripting pre-op verification policies, clarifying which staff member is responsible for calling a pre-op time out, using surgical safety checklists, implementing EMRs to highlight critical case information and using a towel or other barrier to cover instrument sets until a time out is performed. Meanwhile, policies that call for multiple staff members to independently count and reconcile items used during surgery are most effective in preventing objects from being left in patients, notes the report.

Daniel Cook

Tell us in this week's InstaPoll whether or when you use so-called consciousness monitors to prevent anesthesia awareness and reduce the administration of volatile anesthetic gases. We'll report the results in this space next week.

Last week, we asked you if manufacturers' sales reps were fixtures in your ORs. The answer came back an overwhelming "yes." Of 117 respondents, 79% answered in the affirmative.

Dan O'Connor