Anesthesiologist who Committed Major Fraud Claims Bipolar Defense

In 2009, Anesthesiology News reported that a routine audit at Baystate Medical Center (in 2008) uncovered "one of the largest research frauds in history" committed by anesthesiologist Scott Reuben, MD

Natural News reports (below) that Dr. Reuben, faces a 10 year prison term for fabricating data has agreed to repay $361,932 in research funding to several pharmaceutical companies, and $50,000 in penalties to the U.S. government.

In their effort to lighten his possible 10 year prison sentence, Dr. Reuben’s lawyers are grasping at the defense of last resort–the psychiatric escape hatch.

They claim that Dr. Reuben suffered from "serious, but undiagnosed" bipolar disorder which led him to fabricate data and falsify research.

However, that tactic is unlikely to wash. Glenn J. Treisman, a professor of psychiatry at Johns Hopkins University School of Medicine, expressed skepticism that Reuben, an MD married to a psychiatrist, could suffer from undiagnosed bipolar disorder for so long.

See also, AHRP Infomail
See also, List of Dr. Reuben’s 21 retracted publications

Vera Hassner Sharav

NATURAL NEWS
Research fraud: Dr. Reuben now claims he had "bipolar disorder" which caused him to fake clinical trials

by David Gutierrez

(NaturalNews) Defense attorneys for the perpetrator of one of the largest research frauds in history have claimed that their client, Scott S. Reuben, MD, suffered from "serious, but undiagnosed" bipolar disorder that led him to fabricate data and otherwise falsify his research.

Reuben graduated from medical school in 1985, and soon became a widely published and cited pain researcher. By 2009, he had published at least 72 research studies, and his work had led to a major change in the way pain is treated. But a routine audit in 2008 at Baystate Medical Center, where Reuben had worked since 1991, uncovered discrepancies in Reuben’s research. This led to allegations that Reuben had not actually conducted many (or even any) of the studies that his supposedly groundbreaking findings had been based on.

More than 20 of Reuben’s papers have since been retracted. He has pleaded guilty to fabricating data and patients, and has also been accused of adding the names of uninvolved co-authors without 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.

Seeking a light sentence for Reuben — who faces up to 10 years in prison for his crimes — defense attorneys have argued that his undiagnosed bipolar disorder caused Reuben to commit suicide twice, be hospitalized three times, and fabricate his data.

Yet many of Reuben’s colleagues questioned this story.

"To my knowledge, nobody in the department was aware … that he had any mental illness," said anesthesiologist Steven Dunn, MD, of Baystate.

Glenn J. Treisman, a professor of psychiatry at Johns Hopkins University School of Medicine, expressed skepticism that Reuben, an MD married to a psychiatrist, could suffer from undiagnosed bipolar disorder for so long.

"By the time someone’s tried suicide twice, their psychiatrist wife would have known something was going on," he said.

Sources for this story include: http://www.anesthesiologynews.com/i… http://www.nytimes.com/2009/03/11/h….

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THE WALL STREET JOURNAL
MARCH 11, 2009.
Top Pain Scientist Fabricated Data in Studies, Hospital Says
By KEITH J. WINSTEIN and DAVID ARMSTRONG

A prominent Massachusetts anesthesiologist allegedly fabricated 21 medical studies that claimed to show benefits from painkillers like Vioxx and Celebrex, according to the hospital where he worked.

Baystate Medical Center, Springfield, Mass., said that its former chief of acute pain, Scott S. Reuben, had faked data used in the studies, which were published in several anesthesiology journals between 1996 and 2008.

The anesthesiologist allegedly faked data in 21 studies on the use of various painkillers, including Vioxx.

The 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 Merck & 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.

"Dr. Reuben deeply regrets that this happened," said the doctor’s attorney, Ingrid Martin. "Dr. Reuben cooperated fully with the peer review committee. There were extenuating circumstances that the committee fairly and justly considered." She declined to explain the extenuating circumstances. Dr. Reuben didn’t respond to requests for comment sent through Ms. Martin and left at his former office.

The retractions, first reported in Anesthesiology News, have caused anesthesiologists to reconsider the use of certain practices adopted as a result of Dr. Reuben’s research, doctors said. His work is considered important in encouraging doctors to combine the use of painkillers like Celebrex and Lyrica for patients undergoing common procedures such as knee and hip replacements.

Last month, the journal Anesthesia & Analgesia retracted 10 of Dr. Reuben’s studies and posted a list of the 11 published in other journals on its Web site. The journal Anesthesiology said it has retracted three of Dr. Reuben’s articles.

Dr. Reuben had been a paid speaker on behalf of Pfizer’s medicines, and it paid for some of his research. "It is very disappointing to learn about Dr. Scott Reuben’s alleged actions," Pfizer said in a statement. "When we decided to support Dr. Reuben’s research, he worked for a credible academic medical center and appeared to be a reputable investigator."

Wyeth said it isn’t aware of any financial relationship between the company and Dr. Reuben.

An FDA spokeswoman said late Tuesday she wasn’t aware of the matter. Merck had no immediate comment.

Hal Jenson, the chief academic officer at Baystate Medical, said a routine audit last spring flagged discrepancies in Dr. Reuben’s work. That led to a larger investigation in which Dr. Reuben cooperated, Dr. Jenson said. "The conclusions are not in dispute," he added.

Dr. Reuben is on an indefinite leave from his post at Baystate, the hospital said. He no longer holds an appointment as a professor at Tufts University’s medical school, according to the university.

Baystate concluded that "Dr. Reuben was solely responsible for the fabrication of data," Dr. Jenson said.

Jeffrey Kroin, who co-wrote four papers with Dr. Reuben, said he was dumbfounded to receive a letter earlier this year from Baystate, retracting the studies.

"We analyzed it and made figures and graphs, and sent it back, and wrote papers, and everything seemed fine," said Dr. Kroin of Rush University Medical Center in Chicago. "If someone has a good reputation, has 10 years of papers and has a very high position within their medical school, generally you assume they have a lot of integrity."

Jacques E. Chelly, the head of acute interventional postoperative pain service at the University of Pittsburgh Medical Center, said he was "shocked" by the news of the retractions. Dr. Reuben "was very well respected," Dr. Chelly said.

He added that the situation has prompted his hospital to review the protocols it uses to treat patients for pain, because Dr. Reuben’s work was so influential in establishing them. He said the hospital was now conducting its own study to verify the efficacy of drugs that Dr. Reuben claimed were effective painkillers.

In an editorial in the journal Anesthesiology, editor James C. Eisenach warned that "these retractions clearly raise the possibility that we might be heading in wrong directions or toward blind ends in attempts to improve pain therapy."

The retracted studies aren’t expected to affect the drugs’ regulatory status because Dr. Reuben’s studies weren’t part of the packages that manufacturers submitted to the FDA or European authorities.

Write to Keith J. Winstein at keith.winstein@wsj.com and David Armstrong at david.armstrong@wsj.com

Printed in The Wall Street Journal, page A12
Copyright 2009 Dow Jones & Company, Inc. All Rights Reserved

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THE NEW YORK TIMES
March 10, 2009
Doctor’s Pain Studies Were Fabricated, Hospital Says
By GARDINER HARRIS

Correction Appended

In what may be among the longest-running and widest-ranging cases of academic fraud, one of the most prolific researchers in anesthesiology fabricated much of the data underlying his research, said a spokeswoman for the hospital where he works.

The researcher, Dr. Scott S. Reuben, an anesthesiologist in Springfield, Mass., who practiced at Baystate Medical Center, fabricated data in some or all of the 21 journal articles dating from at least 1996, said Jane Albert, a spokeswoman for Baystate Health.

The reliability of dozens more articles he wrote is uncertain, and the common practice — supported by his studies — of giving patients aspirinlike drugs and neuropathic pain medicines after surgery instead of narcotics is now being questioned.

Paul Cirel, a lawyer for Dr. Reuben, said that he could not discuss the case because Baystate had investigated it as part of a confidential peer-review process. Baystate officials “were aware of extenuating circumstances,” Mr. Cirel said.

The drug giant Pfizer underwrote much of Dr. Reuben’s research from 2002 to 2007. Many of his trials found that Celebrex and Lyrica, Pfizer drugs, were effective against postoperative pain.

“Independent clinical research advances disease treatments and improves the lives of patients,” said Raymond F. Kerins Jr., a Pfizer spokesman. “As part of such research, we count on independent researchers to be truthful and motivated by a desire to advance care for patients. It is very disappointing to learn about Dr. Scott Reuben’s alleged actions.”

Drug companies routinely hire community physicians to conduct studies of already-approved medicines. In some cases, prosecutors have charged companies with underwriting studies of little scientific merit in hopes of persuading doctors to prescribe the medicines more often.

“When researchers are beholden to companies for much of their income, there is an incredible tendency to get results that are favorable to the company,” said Dr. Jerome Kassirer, a former editor of The New England Journal of Medicine and the author of a book about conflicts of interest.

Dr. Reuben’s activities were spotted by Baystate after questions were raised about two study abstracts that he filed last spring, Ms. Albert said. The health system determined that he had not received approval to conduct human research, Ms. Albert said.

Baystate investigators determined that Dr. Reuben had concocted data for 21 studies, and the health system asked the journals in which those studies were published to withdraw them.

Dr. Steve Shafer, the editor in chief of Anesthesia & Analgesia, which published many of the papers, said he was considering withdrawing any study in which Dr. Reuben served a pivotal role.

“He was one of the most prolific investigators in the area of postoperative pain management,” Dr. Shafer said. His fraud “sets back our knowledge in the field tremendously.”

CORRECTION: March 19, 2009

An article on March 11 about an academic fraud case against Dr. Scott S. Reuben, an anesthesiologist in Springfield, Mass., paraphrased incorrectly from a comment by a spokeswoman for Baystate Medical Center, where he formerly practiced. The spokeswoman, Jane Albert, said in an interview that an investigating committee concluded that Dr. Reuben fabricated data underlying much of his research, and she added that he had cooperated with the investigation. She did not comment on whether he himself admitted fabricating data.

This article has been revised to reflect the following correction:

Correction: March 24, 2009

An article on March 11 about an academic fraud case against Dr. Scott S. Reuben, an anesthesiologist in Springfield, Mass., paraphrased incorrectly from a comment by a spokeswoman for Baystate Medical Center, where he formerly practiced. And a correction in this space on Thursday failed to correct the headline and another comment by the spokeswoman that was paraphrased incorrectly.

The spokeswoman, Jane Albert, said in an interview that an investigating committee concluded that Dr. Reuben fabricated data underlying much of his research, and she added that he had cooperated with the investigation. She did not say that he himself admitted fabricating data. (This error in the article was repeated in the headline.)

In addition, Ms. Albert said in the interview that the hospital found that Dr. Reuben fabricated data in some or all of 21 journal articles; she did not say that he did not conduct the clinical trials described in those articles.