Celecoxib: a big research fraud stands exposed


R. PRASAD


21 of the 72 papers published in medical journals contain fabricated data




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His “protocol” of combining two drugs became the mainstay in
post-operative pain management

He has been submitting papers containing fabricated data for the last 13 years


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One of the biggest research frauds in recent times has come to light.
At last count, 21 of the 72 papers published in various peer-reviewed
medical journals by Dr. Scott S. Reuben, of the Baystate Medical
Center in Springfield, Massachusetts, U.S. have been found to contain
fabricated data.

The fabricated data involved the drug celecoxib (celebrex) — a
non-steroidal anti-inflammatory drug (NSAID) — manufactured by Pfizer.

The first paper containing concocted data was published in 1996 and
the latest one in 2008.

While the South Korean stem cell researcher Hwang Woo Suk’s fraud of
image duplication, among other things, was detected very early, it is
unfathomable why Dr. Reuben’s fraud was not detected earlier. He has
been submitting papers containing fabricated data for the last 13
years or so!

Internal investigations initiated by the Baystate Medical Center, and
not the journals, helped expose Dr. Reuben’s fraud.

All the 21 papers are being retracted by the medical journals.
According to an Editorial to be published in the May 2009 issue of the
Anesthesiology journal, “the retracted papers have been considerably
cited since 2002. …The retracted articles have been cited more than
twice as often as those not retracted.”

The biggest irony is that Dr. Reuben’s “research” helped set the
protocol for post-operative pain management!

Multimodal analgesia

He “pioneered” the “multimodel analgesia, where a combination of two
drugs is given to manage pain. He claimed that multimodel analgesia,
where celecoxib was given along with lyrica — a neuropathic agent —
was preferable to giving narcotics (opioids). Lyrica is also
manufactured by Pfizer.

This multimodal analgesia became the “mainstay in pain management,”
notes the British Medical Journal (March 9, 2009). His “research” also
claimed that celecoxib “reduces pain at six and 12 months after
surgery” (British Medical Journal, March 9, 2009).

Now with the very foundation of his claim coming down like a house of
cards, the best protocol to manage pain is not known.

“We are left with a large hole in our understanding of this field.
There are substantial tendrils from this body of work that reach
throughout the discipline of postoperative pain management.

“Those tendrils mean that almost every aspect will need to be
carefully thought through,” Steven L. Shafer, Editor-in-Chief of
Anesthesia and Analgesia journal was quoted as saying in Anesthology
News (a medical newspaper).

Anesthesia and Analgesia is one of the journals where he published his
“findings.”

The editorial in the Anesthesiology journal to be published in May
2009, notes: “Although we may not be lost in the woods, these
retractions [of papers by journals] clearly raise the possibility that
we might be heading in wrong directions or towards blind ends in
attempts to improve pain therapy.”

Never before has a person’s cooked up data formed the basis for
setting a protocol for treating people in a particular field of
medicine. Multimodal therapy is an expensive option. So why did Dr.
Reuben advance it as a better option to manage pain based on cooked up
data?

There are many disturbing questions now being asked. Will the data
fabrication fraud turn out to become a bigger scandal?

According to the Anesthology News, Dr. Reuben had received research
grants from Pfizer and was a member of the drug company’s speakers’
bureau. So far Pfizer has not been accused of any wrongdoing.

“Independent clinical research advances disease treatments and
improves the lives of patients,” Raymond F. Kerins Jr., a Pfizer
spokesman was quoted as saying in the New York Times.

“As part of such research, we count on independent researchers to be
truthful and motivated by a desire to advance care for patients. It is
very disappointing to learn about Dr. Reuben’s alleged actions.”

A Pfizer spokesperson was quoted as saying in the British Medical
Journal that the retraction of papers “does not change the
risk-benefit profile” of the drug.