Date: Mon, 16 Mar 2009 22:59:37 -0700 (PDT)
The Wall Street Journal report on this tragic medical event:

http://online.wsj.com/article/SB123672510903888207.html?mod=article-outset-box

MARCH 11, 2009

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withdrawn -- as well as Pfizer's Celebrex and Lyrica.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.

Printed in The Wall Street Journal, page A12