Key Researcher Advocating Lyrica and Neurontin for Pain Allegedly Faked Studies, Invented Patients

March 11, 2009 · Filed Under Main Content · 1 Comment 

quack1A widely known Massachusetts anesthesiologist whose research has widely influenced how doctors treat surgery patients for pain has been accused of fabricating results in at least 21 published studies and, in some cases, even inventing patients.

Physicians and journal editors said the allegations, if proven, could constitute one of the largest and longest-running cases ever of medical research fraud.

Dr. Scott S. Reuben, who works at Baystate Medical Center in Springfield, has published dozens of articles on “multimodal analgesia,” an important and emerging area of anesthesiology involving use of more than one type of drug to relieve post-surgical pain and foster faster recovery.

Last May, during a routine review of research summaries that were to be presented at the hospital’s research week, physicians discovered that the research Reuben intended to present had not been approved by an internal hospital review board that oversees research on patients, Dr. Hal Jenson, Baystate’s chief academic officer, said yesterday.

That discovery led to a full-scale investigation by the hospital, which was completed in January. The investigation uncovered 21 published papers over 13 years in which Reuben made up some or all of the data, Jenson said.

Jenson said that in many cases “there was no clinical trial because there were no patients.”

The hospital notified several medical journals about the results of its investigation, and the journals are in the process of retracting Reuben’s papers, said Jenson.

“This would be the largest research fraud in anesthesia,” said Dr. Steven Shafer, editor of the journal Anesthesia and Analgesia. “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.”

Dr. Greg Koski, an anesthesiologist at Massachusetts General Hospital and former director of the federal Office for Human Research Protections, said the case is unusual, not because of the number of journal articles involved, but because of the number of years the deception is alleged to have gone on.

“That’s what makes this so remarkable,” he said. “. . It seems to have gone on for so long without being detected by the peer review process. It’s hard to fake something for that long. Pain research is not an obscure area; people look at it all the time.”

Celebex, Lyrica and Neurontin Research Part of the Fraud

In some instances, the studies in question involved data about drugs made by pharmaceutical giant Pfizer Inc., including Celebrex, Lyrica, and Neurontin. The company gave Reuben five research grants between 2002 and 2007, and he was a member of Pfizer’s speakers bureau, in which physicians give talks about Pfizer drugs to colleagues.

In response to the news of this fraud, Pfizer spokeswoman Sally Beatty said the clinical trials that led the US Food and Drug Administration to approve Celebrex and Lyrica for pain did not include Reuben’s research. Celebrex was approved to treat acute pain, including that following surgery, in 2001. Lyrica is not approved for the treatment of acute pain, but doctors can use the drug for that purpose “off-label.” The company’s statement did not address Neurontin.

*It should be noted in the above quote from Pfizer spokeswoman Beatty that it is illegal for a drug company to suggest off-label use of the drug for pain as Beatty does above.

“It is very disappointing to learn about Dr. Scott Reuben’s alleged actions,” Pfizer said in a statement, adding that the company was “not involved in the conduct of any of these independent studies or in the interpretation or publication of the study results.”

The fraud allegations were first reported this week by Anesthesiology News.

Although Reuben often co-wrote papers with other researchers, Jenson said Baystate found that the other researchers did not know about or participate in the alleged fabrications.

In a Feb. 20 letter to readers posted online, Shafer said his journal will publish formal retractions of Reuben’s studies published in Anesthesia and Analgesia in May.

Anesthesiologists agreed there will be an impact on the field, but disagreed over how significant it would be.

Dr. James Rathmell, chief of the Massachusetts General Hospital pain clinic, said the effect is unknown.

“Reuben’s idea of adding Lyrica and Neurontin to the mix.”

“He had some important findings that were very encouraging to all of us,” he said. But, he said, many other researchers have published positive results for Celebrex and other Cox-2 inhibitors for treatment of surgical pain. More in question, he said, is Reuben’s idea of adding Lyrica and Neurontin to the mix. “He’s done the few studies in that area,” Rathmell said.

Shafer, however, said researchers and physicians are going to reexamine the literature and may have to repeat clinical trials. “We have to be open to the possibility there was patient injury,” he said, despite the relative safety of the drugs in question. “Nothing is without risk.”