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NewsToBeRead
March 12th 09, 02:29 AM
http://online.wsj.com/article/SB123672510903888207.html

a.. 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 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Inc.'s Bextra and Merck & Co.'s Vioxx -- both since withdrawn -- as well as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 and David Armstrong at