Author retracts weight loss surgery paper after admitting most, if not all, of the subjects were made up

If you had read “Aerobic endurance training improves weight loss, body composition, and co-morbidities in patients after laparoscopic Roux-en-Y gastric bypass,” a 2010 paper in Surgery for Obesity and Related Diseases, you might have been convinced by the title and findings that exercise was a good idea for people who’d had stomach stapling.

After all, the authors had operated on “60 consecutive morbidly obese patients” and then randomized them into “a low-exercise group (aerobic physical exercise 1 time for 1 hr/wk) or a multiple-exercise group (APE 2 times for 1 hr/wk)” so they could collect data on “age, gender, length of hospital stay, operative details, co-morbidities, postoperative complications, initial body weight and height, postoperative weight, and body composition.” When they did that, they found that “The multiple exercise group had a significantly more rapid reduction of body mass index, excess weight loss, and fat mass compared with the low-exercise group.”

Except that at best they had only operated on about a third the number of patients they said they had.

Here’s the retraction notice for the paper:

This article has been retracted at the request of the Editor-in-Chief.

This article has been retracted as the senior author, Dr. Edward Shang, claimed that 60 patients had undergone gastric bypass whereas only 21 patients had undergone surgery during this time period. Dr. Shang was unable to provide the raw data for the study, the name of a single patient, or a witness to patient entrance into the trial. Dr. Shang has agreed to withdraw this manuscript from publication.

Cliff Notes’ version: We don’t have many reasons to trust any of the data.

Surgery for Obesity and Related Diseases editor in chief Harvey Sugerman tells Retraction Watch:

My only knowledge is that his chairman uncovered the fraud when trying to analyze some of his findings.

His chairman requested the retraction.

I made the editor of Obesity Surgery, a journal in which Dr. Shang also published, aware of the fraud and he has proceeded to investigate the issue and has contacted Dr. Shang’s chairman.

Obesity Surgery is edited by Scott Shikora of Brigham and Women’s Hospital. In an editorial last month, Shikora wrote that he is worried about “maintaining a high level of ethical behavior in our bariatric practices.”

The concern is warranted because some of these innovations are not being investigated ethically and following the proper conduct for human experimentation. In some settings, no IRB approval was obtained. In others, little preclinical experimentation was performed. No less shockingly, training courses are being offered to train surgeons to perform procedures not yet considered acceptable. The driving forces for this phenomenon are several: industry support, academic pressures, enticement of fame and fortune for the first “expert” with a new procedure, patient pressures to deliver safer therapies, and the potential financial reward of being marketed as the region expert.

Later in the piece, he writes:

The rush to publish has led a few investigators to knowingly or unknowingly report inaccurate, exaggerated, or even false data.

Shikora does not cite specific examples, so we’ve contacted him and asked him to elaborate on the editorial, and to find out whether he plans to retract any of Shang’s work in his journal. [Please see this update.]

Shang was at University Hospital Mannheim in Germany when he published the paper, but moved soon after to University Hospital Leipzig. That move was heralded by Arya Sharma, a prominent weight loss specialist at the University of Alberta. Sharma and Shang were both course directors for ISORAM, the International School for Obesity Research and Management, held in March of this year. We reached Sharma yesterday as he was about to get on a plane for Europe, so he said we’d have to wait for comment. [See update at end of post.]

It appears unlikely the Surgery for Obesity and Related Diseases study would have affected clinical practice all that much, since exercise after weight loss surgery seems like a no-brainer and is typically recommended. The fact that it has only been  cited twice since being published in 2010, according to Thomson Scientific’s Web of Knowledge, supports that notion.

Still, Surgery for Obesity and Related Diseases is no slouch. It ranks 21 out of 188 among surgery journals by impact factor. And Shang was a co-author of 2011 German guidelines for obesity surgery.

We’ve tried reaching Shang, his coauthor, and officials at Leipzig and Mannheim, and will update with anything we hear back. We suspect there’s far more to this story and will continue to follow it.

Update, 5 p.m. Eastern, 5/2/12: Sharma sent us these comments:

Certainly these are most grave charges and come as a shock. As you note, based on his work in Mannheim (where this paper originated), Dr. Shang certainly appeared a most promising future leader of bariatric surgery in Germany. I am sure his current employers will look at these charges carefully and, if substantiated, are sure to take appropriate measures.