Top Pain Scientist Fabricated
Data in Studies
By KEITH J. WINSTEIN and DAVID ARMSTRONG
MARCH 11, 2009
http://online.wsj.com/article/SB123672510903888207.html
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and Merck & Co.’s Vioxx — both since withdrawn — as well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.