One of the biggest cases of academic fraud in medical history

One of the largest known cases of academic fraud and misconduct made the news this week when Anesthesiology News reported that a leading medical researcher was found to have fabricated much, if not all, of the data in his research.

Scott S. Reuben, M.D., of Baystate Medical Center in Springfield, Massachusetts, is said to have made up and falsified data in at least 21, and perhaps many more, studies published at least since 1996, according to the results of a year-long investigation by Baystate Medical Center. Jane Albert, a spokeswoman for Baystate, said that the fraud was spotted after questions were raised about two studies for which Dr. Reuben had not even received approval to conduct human research.

Dr. Hal Jenson, M.D., Baystate’s chief academic officer, told media that in many cases “there was no clinical trial because there were no patients.” Dr. Jenson added that Dr. Reuben fully cooperated with its investigation and “the conclusions are not in dispute.” Baystate’s investigation also concluded that “Dr. Reuben was solely responsible for the fabrication of data,” Dr. Jenson said.

If the allegations are proven, this case would constitute one of the largest and longest-running cases of medical research fraud in history. The implications are enormous, as are the take-home lessons. Among the hard-earned lessens this story teaches is that the source doesn’t matter, no matter or famous, prestigious or popular — only the integrity and quality of the science counts. It also reminds us of the imperativeness of independent verification of research findings and of weighing the body of sound evidence — not basing any health decision on one source.

Dr. Reuben not only worked for a respected academic medical center and was a leading pioneer in his field, his research has provided the support for several clinical practice standards, Anesthesiology News reported. He is well-known among anesthesiology researchers for his studies of multimodal analgesia, the practice of combining several forms of pain relief to better control postoperative discomfort and promote faster recovery from surgery.

Dr. Reuben was one of the most prolific researchers in postoperative pain management and published extensively. A recent PubMed search turned up 72 citations authored by him, according to Anesthesiology News, the most recent was an article in the December issue of the Journal of Cardiothoracic and Vascular Anesthesia on preventing the development of chronic pain after thoracic surgery.

The fact that Dr. Reuben was able to continue this deception for so long without raising any concerns among his peers or journal peer reviewers is of the greatest concern. While it demonstrates the limitations of the peer review process, one that is based on trust that the data itself is true, it is hard to imagine that not one of his medical colleagues ever noticed anything amiss in nearly two decades. Or, more troublingly, did they notice or suspect and decide to look the other way, not one professional willing to speak out?

Interestingly, in more than 15 years, reported Anesthesiology News, Dr. Reuben never had a negative study. Many of his trials were of Celebrex and Lyrica, drugs of the pharmaceutical company, Pfizer, which sponsored his research from 2002 to 2007, and all reported the drugs to be effective for postoperative pain. Yet, all of his studies showed more robust benefits of the drugs than other researchers, whose studies had failed to show much difference at all, the article reported. This should have been a red flag, yet still, no one noticed?

Dr. Reuben was also a member of Pfizer’s speakers’ bureau. However, a source told Anesthesiology News that Pfizer recently alerted its speakers to remove any reference to Dr. Reuben’s data from their presentations. And “the company has not been accused of wrongdoing in the matter,” the article added.

Dr. Reuben’s 2006 study published in Anesthesia and Analgesia is one of the pillars in support of the expensive drug combination for spinal surgery patients. If that paper is withdrawn, said Dr. Jacques Chelly, M.D., Ph.D., director of the Division of Regional Anesthesia and Acute Interventional Perioperative Pain at the University of Pittsburgh Medical Center (UPMC), then “you really don’t have any evidence that the combination is working.” In light of the situation, UPMC has stopped giving the drug combination to surgery patients until there is strong clinical evidence to support the regimen.

On February 20, 2009, Dr. Steven L. Shafer, M.D., Editor-in-Chief of Anesthesia & Analgesia, published a letter to its readers alerting the medical community that it had received a summary of the investigation of Dr. Reuben on misconduct in research and scholarly activities conducted by Baystate Medical Center. As Dr. Shafer shared, the notice it received stated: “BMC’s investigation determined that Dr. Reuben fabricated data reported in the referenced articles, and that all fabricated data were created under the sole control of Dr. Reuben.”

The journal also compiled a complete list of 21 articles published over 13 years that Baystate Medical Center found to be based on fabricated data. [Click on image to enlarge]. According to Dr. Shafer, most, if not all, of these articles are being retracted by the journals where they were published. Its own journal will publish a form retraction notice, along with two editorials addressing the medical and treatment implications, in its May issue of Anesthesia & Analgesia. Shafer said his fraud “sets back our knowledge in the field tremendously” and researchers and physicians are going to reexamine the literature and may have to repeat clinical trials.

“This would be the largest research fraud in anesthesia,” Dr. Shafer told media. “Doctors have been using [his] findings very widely. His findings had a huge impact on the field. The act of fabricating data is so difficult for me to comprehend. It’s beyond my ability to imagine.”

Patients may have been needlessly put at risk and healthcare resources may have been wasted on unsound or potentially dangerous treatments. But the public has sadly lost even more. Whether or not it's warranted, this misconduct is another chip in their trust of the entire medical profession and in medical professionals to practice ethical and science-based medicine.