21 Fabricated Drug Studies At The
Detriment of Our Health In The Name of Profits
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Vioxx -- both since withdrawn -- as well as Pfizer's Celebrex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.
Reference Source 151
March 13, 2009