Below is an article published in this morning's Wall Street Journal about the fabrication of
positive results of at least 21 published research articles involving Vioxx, Bextra, Celebrex,
Neurontin, and Lyrica by an anesthesiologist and pain "expert" from the Baystate Medical
Center, Springfield, MA.
Baystate is a 653-bed academic teaching hospital that serves as the
Western Campus of Tufts University School of Medicine and advertizes on its Web that it is
recognized for quality care. The hospital sounds like it would be a perfect site for APPE rotations
for pharmacy students could observe cutting edge pharmacotherapeutics in the clinical setting.
So much for science the Lyrica combination is on preprinted post-op orders at some
The anesthesiologist dubbed the "Medical Madoff" by Scientific American
is recognized for encouraging prescribers to combine the use of painkillers like Celebrex and Lyrica
for patients undergoing common procedures such as knee and hip replacements.
Among the many
disturbing aspects of this episode is that investigators may be heading down dead ends based on the
positive results of these 21 retracted articles.
If anyone would like the list of the 21
retracted papers please just let me know.
MARCH 11, 2009
Scientist Fabricated Data in Studies, Hospital Says
By KEITH J. WINSTEIN and DAVID
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the use of painkillers like Pfizer Inc.'s Bextra and Merck & Co.'s Vioxx -- both since withdrawn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.
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.
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
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.
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
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."
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.
to Keith J. Winstein at email@example.com and David Armstrong at firstname.lastname@example.org
Printed in The Wall Street Journal, page A12
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