Fraud Case Rocks Field of Post-operative Pain Management
A US anaesthesiology researcher, Scott Reuben, has been accused of falsifying data in numerous publications over the past twelve years. Unfortunately these discredited publications have had a worldwide influence on therapeutic guidelines for postoperative pain management, reveals Bettina Dupont.
Scott Reuben of Baystate Medical Center in Springfield, Massachusetts, USA, is said to have fabricated data in 21 articles published in anaesthesiology journals between 1996 and 2008. Additionally, two of Reuben's patient studies were not approved by an internal hospital review board. The anaesthesiologist is currently on medical leave. His lawyer told
Scientific American that Reuben has co-operated with the investigation and that he "deeply regrets that all of this happened."
The compromised articles were published in
Anesthesiology,
Anesthesia and Analgesia, in the
Journal of Clinical Anesthesia and other titles. Reuben notably recommended the combination of COX2 inhibitors, such as Merck's Vioxx and Pfizer's Celebrex or Bextra, with the Pfizer drugs, Neurontin or Lyrica, during and after orthopaedic surgery. He claimed that by combining several modes of pain relief, there was a better control of postoperative discomfort and faster recovery from surgery. To be taken with smaller doses of potentially addictive morphine-related drugs.
Reuben himself received several research grants from Pfizer between 2002 and 2007 and he gave talks about Pfizer drugs to colleagues. Nevertheless, the pharmaceutical company denies any involvement in the discredited publications.
Anesthesia and Analgesia retracted ten of Reuben's publications, and
Anesthesiology three. But Reuben' s co-authors have not been accused of wrongdoing.
For example, although Evan Ekman, an orthopaedic surgeon in Columbia, South Carolina, is listed in PubMed as co-author on four of Reuben' s publications (between 2005 and 2007), he told
Anesthesiology News that he had done nothing on two of the discredited manuscripts. But, PubMed is freely accessible so presumably he could have become aware of his "guest authorships" earlier. Then again, his lack of objection to these additions to his publication list has presumably thus far aided his career.
Yet what astonished me was that so many of Reuben' s fraudulent manuscripts survived the peer review process. How? Were the peer reviewers too naive, overburdened, or just too lazy? Maybe there were conflicts of interest, or didn't they dare to alienate their famous colleague? Overall, the peer review process strongly relies on a fair measure of trust in the academic integrity of manuscript authors. Furthermore, the peer reviewer is not directly involved in the experimental work or in the writing of a submitted manuscript. He cannot tell whether the described experiments were really performed. This is especially true if the fraud was committed in skilfully and the fabricated data appears plausible. In Reuben' s case, his scientific misconduct was only discovered accidentally during a routine review - for two of his studies, he had not received formal approval to conduct human research.
Steven Shafer, editor-in-chief of
Anesthesia and Analgesia fears that researchers have to re-examine the literature in the field of postoperative pain management and they may be forced to repeat clinical trials.
However, Reuben' s therapeutic recommendations are not only of questionable value - they may even delay recovery after surgery, because COX2 inhibitors have been reported to interfere with bone healing by other studies (see Vuolteenaho K et al.
Basic Clin Pharmacol Toxicol. 2008 102(1): 10-4)!
In this way, Reuben' s research findings might have affected the postoperative pain management of millions of patients worldwide. Anaesthesiology expert, Winfried Meißner, of Jena' s university hospital told the magazine
Spiegel that everybody in the field of pain therapy knew of Reuben' s studies. By May 2007, the studies had influenced therapeutic guidelines for how to treat patients optimally after surgery.
But it usually takes years until these guidelines are translated into routine treatments. The new therapeutic guidelines for acute pain management have been immediately revised and patients are generally obtaining the correct medical treatment, assured representatives of the German Interdisciplinary Association for Pain Therapy (DIVS) at
Zeit Online.
Paul White, editor of
Anesthesia and Analgesia, estimates that Reuben' s discredited studies led to sales of COX2 inhibitors worth billions of dollars. Echoing calls made elsewhere in clinical research, anaesthesiology expert Meißner told
Spiegel that options were required to permit careful testing of new drugs without any influence from pharmaceutical companies.
On reflection, perhaps it would be much more economical if we could strictly enforce ethical scientific attitudes in medical research.
Bettina Dupont
