Scott Reuben, Massachusetts based anesthesiologist received six months in prison for faking medical research into Pfizer painkillers. At the same time Baystate’s legislature considered repealing the ban on doctors who accepted gifts from drug companies.
Anesthesiologist Scott Reuben was considered as a pioneer. Over the past 12 years he had revolutionized the way in which physicians dealt with pain relief to patients who underwent orthopedic surgery from torn ligaments to worn-out hips. All his effort went for a toss when an investigation revealed that 21 of Reuben’s papers were pure work of fiction, and that the pain drugs he boasted about actually delayed postoperative healing.
After attending State University of New York at Buffalo School of Medicine & Biomedical Sciences in 1985 for his medical degree, followed by residency at the Mount Sinai Medical Center in New York City. In 1991, he started working for Baystate, and has worked as a staff anesthesiologist and the director of acute pain management. Soon after medicine school he became a widely published and sited researcher. By the year 2009, he had published over 72 research studies, his work was often cited and led to a major change in the treatment of pain. A routine audit in 2008 at Baystate Medical Center, uncovered discrepancies in Reuben’s research. This led to allegations that Reuben had not conducted any of the studies that led to his groundbreaking findings.
Last year during routine audit at Baystate Medical Center in Springfield, Mass., Chief Academic Officer, Hal Jenson, discovered that Reuben had not received approval from the hospital’s review board to conduct two of his studies. This was just a can of worms waiting to be opened and that led to an investigation on Reuben’s finding. Jenson believes that Reuben has violated the not only the trust of Baystate, but also of the community and science.
Reuben was touted as being a pioneer in redesigning pain management protocol in a 2007 editorial in Anesthesia & Analgesia.
Editor in chief of the journal Anesthesia & Analgesia, which published 10 of Reuben’s fraudulent papers, Steven Shafer, adds that Dr. Reuben research findings affected postoperative pain management of millions of patients worldwide.
Another editor at the same journal, Paul White, adds that sale of billions of dollars’ worth of the potentially dangerous drugs known as COX2 inhibitors, Pfizer’s Celebrex (celecoxib) and Merck’s Vioxx (rofecoxib), increased because of Reuben’s studies, whose therapeutic benefits on application are now under the scanner.
It is to be noted that Reuben received five independent research grants from Pfizer and he was a member of Pfizer’s speaker’s bureau. The editors add that they believe patients were not significantly harmed by the short-term use of these pain management drugs with COX2 inhibitors but add that the therapy may increase the length of the recovery periods.
Reuben’s lawyer, Ingrid Martin of Dwyer & Collora, LLP, in Boston, pointed that Reuben had cooperated with the investigation and that he deeply regrets everything that had happened and with the guidance of the investigating committee, he was taking steps to ensure this never happens again.
In early 2000, Reuben, in his now-discredited research, tried to get orthopedic surgeons to shift from the first generation NSAIDs to proprietary COX2 inhibitors like Vioxx, Celebrex, and Pfizer’s Bextra (valdecoxib). His claim that this combination along with the Pfizer anticonvulsant Neurontin (gabapentin), and later Lyrica (pregabalin), if used prior to and during surgery could decrease postoperative pain and thus reduce use of morphine, during recovery.
The animal studies of COX2 inhibitors showed short-term use might hinder bone healing and this made several orthopedic surgeons to be vary of adopting it. Increased risk of heart attacks and strokes led to Vioxx and Bextra being pulled from the market, this left Pfizer with just Celebrex as the only COX2 inhibitor. After a study suggested that Celebrex too, posed a heart attack risk there was a 40% drop in sales. In spite of all this Reuben’s Pfizer funded research and findings harped about Celebrex’s alleged benefits with little importance given to the potential negative side effects.
In 2005, aiming to downplay the negative side effects Reuben persuaded Evan Ekman, an orthopedic surgeon at Southern Orthopedic Sports Medicine in Columbia, S.C., to co-author papers with him and published a study on the use of Celebrex to control pain in back surgery patients. In the Journal of Bone and Joint Surgery, they wrote that the short-term administration of Celecoxib resulted in no significant deleterious effect on bone or ligament healing or cardiovascular outcomes.
Three years later, Ekman began to suspect foul play. This was after Ekman agreed to review a manuscript on surgery on the anterior cruciate ligament (ACL) in the knee by Reuben, but when Ekman asked the name of the orthopedic surgeon on the study, Reuben stopped all communication. But Ekman later found that the manuscript was published in Anesthesia & Analgesia with his name listed as a co-author, turns out Reuben had forged his signature on the submission form.
Pfizer funded Reuben’s research between 2002 and 2007, but Baystate is uncertain if the research funds were directly paid to Reuben. Though the Pfizer spokesperson Sally Beatty insists that the grants were properly disbursed to Baystate and were in accordance with Pfizer policy. She adds that Pfizer was not familiar with the records retention policies of Baystate Medical Center and that independent investigator-initiated research grant agreements were executed between Pfizer and Baystate Medical Center.
The question remains why it took 12 long years before a routine audit revealed Reuben’s data fabrication? Jenson clarifies that Baystate publishes about 200 studies every year, and the audit rate might only be 5 percent. Adding that it is Baystate responsibility to ensure that research is properly conducted and reported. He states that the hospital is strengthening its oversight program while also in the process of getting accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) in Washington, D.C., to get an independent evaluation of an organization’s ethical standards and oversight.
Anesthesia & Analgesia editors Shafer and White acknowledge that the red flag should have been that Reuben’s studies always favorable to the drugs he studied. White adds that with such funding comes the “subtle pressure” to give the companies the results in their favor.
Reuben was convicted of orchestrating bogus pain management study involving patients who had knee surgery. The trial was to gauge the effectiveness of Pfizer’s, Cox-2 painkiller, Celebrex in decreasing post-operative pain and Pfizer paid $73,000 towards this research grant. Several of Reuben’s pain studies were retracted by medical journals. In a period of 15 years he managed to write 21 manuscripts . The journal Anesthesia & Analgesia retracted 10 of Reuben’s studies while Anesthesiology retracted three. Several of the studies were funded by Pfizer, Wyeth or Merck.
Pfizer aimed at presenting how Cox-2 painkillers work but also reinforce its “operate for cash” promotion, in which surgeons are persuaded by pharmaceutical sales reps to write “protocols” for using Pfizer’s post-operative painkillers like Bextra and Celebrex instead of opioid drugs, which isn’t approved by the FDA.
Reuben’s defense attorneys claimed that their client suffered from ‘serious, but undiagnosed’ suicidal bipolar disorder that led him distorted research and falsify research. But the fact remains that he was doing trials on Pfizer’s drugs, and producing results that Pfizer could use; Pfizer who is the source of Reuben’s funding.
Reuben pleaded guilty to fabricating data and patients. He is also guilty of adding the names of uninvolved co-authors without seeking their permission. He has agreed to repay $361,932 in research funding to several pharmaceutical companies, and $50,000 in penalties to the U.S. government.
Reuben could face up to 10 years in prison for his crimes and is seeking a lighter sentence with his defense attorneys arguing that his undiagnosed bipolar disorder made him attempt suicide twice, be hospitalized three times, and fabricate his data.
Several of Reuben’s colleagues are vary of the story and question its authenticity.
Co-worker and Anesthesiologist Steven Dunn, MD, of Baystate wonders how nobody in the department was aware of his mental illness.
Professor of psychiatry at Johns Hopkins University School of Medicine, Glenn J. Treisman, wonders how an Reuben who is an MD married to a psychiatrist, could suffer from undiagnosed bipolar disorder for so long, tried suicide twice without his psychiatrist wife knowing that something that wrong. The pile of retractions of Scott Reuben manuscripts keep increasing.
The list reaches 25 retractions but that’s not where the story ends, unfortunately many of Reuben’s retracted papers are still being cited years after they’ve been pulled from the scientific record.