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Serious Medical Fraud

In an earlier Chance News wiki can be found a detailed treatment of the scientific fraud perpetrated by Eric Poehlman of the University of Vermont. In that same issue of Chance News there is a discussion of Poehlman predecessors who, it is claimed, were even more egregious producers of fraudulent data. But now we have another contender for the title, Scott S. Reuben of Tufts University and Baystate Medical Center.

According to Anesthesiology News,

Scott S. Reuben, MD, of Baystate Medical Center in Springfield, Mass., a pioneer in the area of multimodal analgesia, is said to have fabricated his results in at least 21, and perhaps many more, articles dating back to 1996. The confirmed articles were published in Anesthesiology, Anesthesia and Analgesia, the Journal of Clinical Anesthesia and other titles, which have retracted the papers or will soon do so, according to people familiar with the scandal. The journals stressed that Dr. Reuben's co-authors on those papers have not been accused of wrongdoing.

In addition to allegedly falsifying data, Dr. Reuben seems to have committed publishing forgery. Evan Ekman, MD, an orthopedic surgeon in Columbia, S.C., said his name appeared as a co-author on at least two of the retracted papers, despite his having had no hand in the manuscripts. "My names were forgeries on the documents," Dr. Ekman told Anesthesiology News.

The reason Reuben’s fraud is so serious is because

1. Dr. Reuben has been an extremely active and visible figure in multimodal analgesia, particularly as an advocate for its use in minimally invasive orthopedic and spine procedures. His research has provided support for several mainstays of current anesthetic practice, such as the use of nonsteroidal anti-inflammatory drugs [NSAIDs] and neuropathic agents instead of opioids and preemptive analgesia. Dr. Reuben has also published and presented data suggesting that multimodal analgesia can significantly improve long-term outcomes for patients.

2. From here: "We are talking about millions of patients worldwide, where postoperative pain management has been affected by the research findings of Dr. Reuben," says Steven Shafer, editor in chief of the journal Anesthesia & Analgesia, which published 10 of Reuben's fraudulent papers.

Paul White, another editor at the journal, estimates that Reuben's studies led to the sale of billions of dollars worth of the potentially dangerous drugs known as COX2 inhibitors, Pfizer's Celebrex (celecoxib) and Merck's Vioxx (rofecoxib), for applications whose therapeutic benefits are now in question. Reuben was a member of Pfizer's speaker's bureau and received five independent research grants from the company. The editors do not believe patients were significantly harmed by the short-term use of these COX2 inhibitors for pain management but they say it's possible the therapy may have prolonged recovery periods.

From the Wall Street Journal:

The [Baystate Medical Center] hospital has asked the medical journals to retract the 21 studies, some of which reported favorable results from the use of painkillers like Pfizer Inc.'s Bextra and Merc & Co.'s Vioxx -- both since withdrawn -- as well as Pfizer's Celebrex and Lyrica. Dr. Reuben's research work also claimed positive findings for Wyeth's antidepressant Effexor XR as a pain killer. And he wrote to the Food and Drug Administration, urging the agency not to restrict the use of many of the painkillers he studied, citing his own data on their safety and effectiveness.

Discussion

1. The Anesthesiology News article provided this intriguing statistical insight: "Interestingly, when you look at Scott's output over the last 15 years, he never had a negative study," said one colleague, who spoke on the condition of anonymity. "In fact, they were all very robust results--where others had failed to show much difference. I just don't understand why anyone would do this or how anyone could pull this off for so long." How is this similar to the Madoff scandal? 2. The fraud was uncovered in a strange way. During a routine audit at Baystate, two of Reuben’s abstracts had not been approved by the hospital’s institutional review board (IRB), causing a possible breach of ethics because, whenever patients are involved, IRB approval is required. It turned out that IRB approval was not needed “because the data were fabricated” according to Dr. Jenson, chief academic officer of Baystate. “He told Anesthesiology News that simply put, Dr. Reuben had concocted the data—and in many cases the patients themselves—out of vapor.” Use Google to see the similarity and differences between this and that of the famous Cyril Burt fraud involving identical twins putatively separated at birth.

3. From here: In hindsight, Anesthesia & Analgesia editors Shafer and White admit that it should have been a "red flag" that Reuben's studies were consistently favorable to the drugs he studied. White, who has also received drug company educational grants, says that such funding comes with "subtle pressure" to give the companies the results they want. For now, at least, neither the drug companies nor Reuben's co-authors are officially sharing in the blame, but that's expected to change. "There's a lot of responsibility to pass around," White says, "It's all being focused on Scott Reuben, but the reality is there are many other responsible parties." What might be the subtle and not-so-subtle pressures of the sponsoring agencies and the institution itself?

4. Reuben’s journal articles are full of very small p-values and clinically significant effect sizes indicating that NSAIDs are safe and effective for pain medication after surgery. Indeed, his journal articles have the exquisite appearance of how proper comparisons should be presented. Below is a figure taken from an article supposedly co-authored with Ekman. What does this indicate about the peer review process?

Submitted by Paul Alper

Serious Medical Fraud

In an earlier Chance News wiki can be found a detailed treatment of the scientific fraud perpetrated by Eric Poehlman of the University of Vermont. In that same issue of Chance News there is a discussion of Poehlman predecessors who, it is claimed, were even more egregious producers of fraudulent data. But now we have another contender for the title, Scott S. Reuben of Tufts University and Baystate Medical Center.

According to Anesthesiology News,

Scott S. Reuben, MD, of Baystate Medical Center in Springfield, Mass., a pioneer in the area of multimodal analgesia, is said to have fabricated his results in at least 21, and perhaps many more, articles dating back to 1996. The confirmed articles were published in Anesthesiology, Anesthesia and Analgesia, the Journal of Clinical Anesthesia and other titles, which have retracted the papers or will soon do so, according to people familiar with the scandal. The journals stressed that Dr. Reuben's co-authors on those papers have not been accused of wrongdoing.

In addition to allegedly falsifying data, Dr. Reuben seems to have committed publishing forgery. Evan Ekman, MD, an orthopedic surgeon in Columbia, S.C., said his name appeared as a co-author on at least two of the retracted papers, despite his having had no hand in the manuscripts. "My names were forgeries on the documents," Dr. Ekman told Anesthesiology News.

The reason Reuben’s fraud is so serious is because

1. Dr. Reuben has been an extremely active and visible figure in multimodal analgesia, particularly as an advocate for its use in minimally invasive orthopedic and spine procedures. His research has provided support for several mainstays of current anesthetic practice, such as the use of nonsteroidal anti-inflammatory drugs [NSAIDs] and neuropathic agents instead of opioids and preemptive analgesia. Dr. Reuben has also published and presented data suggesting that multimodal analgesia can significantly improve long-term outcomes for patients.

2. From here: "We are talking about millions of patients worldwide, where postoperative pain management has been affected by the research findings of Dr. Reuben," says Steven Shafer, editor in chief of the journal Anesthesia & Analgesia, which published 10 of Reuben's fraudulent papers.

Paul White, another editor at the journal, estimates that Reuben's studies led to the sale of billions of dollars worth of the potentially dangerous drugs known as COX2 inhibitors, Pfizer's Celebrex (celecoxib) and Merck's Vioxx (rofecoxib), for applications whose therapeutic benefits are now in question. Reuben was a member of Pfizer's speaker's bureau and received five independent research grants from the company. The editors do not believe patients were significantly harmed by the short-term use of these COX2 inhibitors for pain management but they say it's possible the therapy may have prolonged recovery periods.

From the Wall Street Journal:

The [Baystate Medical Center] hospital has asked the medical journals to retract the 21 studies, some of which reported favorable results from the use of painkillers like Pfizer Inc.'s Bextra and Merc & Co.'s Vioxx -- both since withdrawn -- as well as Pfizer's Celebrex and Lyrica. Dr. Reuben's research work also claimed positive findings for Wyeth's antidepressant Effexor XR as a pain killer. And he wrote to the Food and Drug Administration, urging the agency not to restrict the use of many of the painkillers he studied, citing his own data on their safety and effectiveness.

Discussion

1. The Anesthesiology News article provided this intriguing statistical insight: "Interestingly, when you look at Scott's output over the last 15 years, he never had a negative study," said one colleague, who spoke on the condition of anonymity. "In fact, they were all very robust results--where others had failed to show much difference. I just don't understand why anyone would do this or how anyone could pull this off for so long." How is this similar to the Madoff scandal? 2. The fraud was uncovered in a strange way. During a routine audit at Baystate, two of Reuben’s abstracts had not been approved by the hospital’s institutional review board (IRB), causing a possible breach of ethics because, whenever patients are involved, IRB approval is required. It turned out that IRB approval was not needed “because the data were fabricated” according to Dr. Jenson, chief academic officer of Baystate. “He told Anesthesiology News that simply put, Dr. Reuben had concocted the data—and in many cases the patients themselves—out of vapor.” Use Google to see the similarity and differences between this and that of the famous Cyril Burt fraud involving identical twins putatively separated at birth.

3. From here: In hindsight, Anesthesia & Analgesia editors Shafer and White admit that it should have been a "red flag" that Reuben's studies were consistently favorable to the drugs he studied. White, who has also received drug company educational grants, says that such funding comes with "subtle pressure" to give the companies the results they want. For now, at least, neither the drug companies nor Reuben's co-authors are officially sharing in the blame, but that's expected to change. "There's a lot of responsibility to pass around," White says, "It's all being focused on Scott Reuben, but the reality is there are many other responsible parties." What might be the subtle and not-so-subtle pressures of the sponsoring agencies and the institution itself?

4. Reuben’s journal articles are full of very small p-values and clinically significant effect sizes indicating that NSAIDs are safe and effective for pain medication after surgery. Indeed, his journal articles have the exquisite appearance of how proper comparisons should be presented. Below is a figure taken from an article supposedly co-authored with Ekman. What does this indicate about the peer review process?

Submitted by Paul Alper